|
The Washington Times
www.washingtontimes.com

By Denise Barnes
THE WASHINGTON TIMES
Published September 17, 2004
District officials have opened clinics in 48 public schools to provide
free vaccinations to the 1,190 students who have yet to receive their shots
or provide up-to-date immunization records. The number of students either
without the shots or the updated records is about 2 percent of the school
system's 60,799 students.
The biggest problems are in the middle, junior and high schools, which
have 884 of the 1,190 students, Ralph Neal, assistant superintendent of D.C.
schools, said Tuesday. Among those students, 614 are in the senior high
schools and 270 are either in the junior highs or middle schools. D.C. officials estimated about two weeks before the Sept. 1 start of
school that roughly 5,000 students were out of compliance. They have since
reduced that number, in part, by working with the city's Department of Health
to open the clinics.
Mr. Neal said the clinics will remain open until Wednesday and that
principals were told to notify parents or guardians by phone and letters to
get shots for their children. The principals also were told to send school counselors to homes in which
students have not received the shots. Vera Jackson, a spokeswoman for the D.C. Department of Health, said the
clinics are not getting as many students as expected, and she urged families
to take action. "We continue to encourage parents to take their children to the doctor
for their shots or return the [signed] consent form to the school nurse," so
that students can be immunized, Ms. Jackson said.
Mr. Neal said the school system continues to follow the policy of "No
Shots. No School," and that students without shots are not supposed to attend
classes. The District has had a similar problem in previous years and has tried
several ways to resolve it, including the threat of a $500 fine and 10 days
in jail for parents of children without shots. In December 2001, about 6,000 students were without the shots and were
sent home for 10 days. Only three students returned without proof of being
vaccinated. The parents were charged with violating the law, but additional
details were unavailable because the court records were closed. "We're better off than we were three years ago," Mr. Neal said. "I am
pleased -- but not as pleased as I would like to be. Some of my parents
haven't taken advantage of immunization [clinics] prior to the beginning of
school. ... Parents should assume responsibility to make sure their children
visit their health care provider before school begins so that we don't have
1,190 students out of compliance."
The required shots are DPT (for diphtheria, pertussis and tetanus), OPV
(oral polio vaccine), MMR (measles, mumps and rubella), HIB (haemophilus
influenza type B), HepB (hepatitis B), and varicella immunizations, if
students have not had chicken pox. Public school officials in Prince George's County, with a student
population of more than 139,000, and Montgomery County, with a student
population of about 141,000, said they have no major problems with student
immunizations.
"We have [immunization] clinics scheduled before school begins," said
Judith Covich, a senior administrator for Montgomery County's Department of
Health and Human Services. "And we get the word out in a variety of ways --
through the media, an immunization-information line and we have an
International Student Office [that includes] a school health services
center." She said the center immunizes students from other countries or those
returning from outside the United States. Ms. Covich said nurses who work for the county's Department of Health and
Human Services review records and work with parents to ensure children not in
compliance are sent to a clinic. "We've been very successful," she said. Barbara Hunter, executive director of Information and Outreach for the
Alexandria public school system, said student immunization is not a problem
for the 11,000-student population. "We have never had the level [of noncompliance] that D.C. experiences,"
she said.

Now I have seen everything!!!

Free movie and immunizations: Horton hears an "ow!'
By Katie Smoker/For the Sun-News
Article Launched: 03/19/2008 12:00:00 AM MDT
This spring break you and your children do not have to travel far or spend a lot
of money to have a great time. The New Mexico Department of Health and several
community partners are holding a spring break Movie Mania day Wednesday, March
26, at Telshor Cinemas, 2811 N. Telshor Blvd.
Children 18 years and younger and their parents will get into the new Dr. Seuss
movie, "Horton Hears A Who!" with their child's shot record. The first 500
children will also get free popcorn and their choice of water, fruit punch or
lemonade. The doors will open at 9 a.m. and movie showings start at 9:30 and
10:30 a.m.
"Movies touch everyone's lives and family movies like this one bring in a lot of
people from the community. That's why we thought that this event would be a
great partnership," said Russell Allen, vice president of operations for Allen
Theatres, a co-sponsor of the event.
Not up-to-date on your children's immunizations? The Department of Health will
have an immunization clinic on-site.
"Children can get free shots at the movie theater," said Liz Castro, outreach
office coordinator for the Department's Office of Border Health. "They need to
have a parent with them and they also need their immunization card."
The free movie event and immunization clinic are in celebration of National
Infant Immunization Week, which is being held April 19-26 this year. The event
is being sponsored by Allen Theatres, Las Compañeras, First Step and Memorial
Medical Center.
"We are celebrating a month early," Castro said. "We thought that it would be a
special treat for the kids if it coincided with their spring break."
National Infant Immunization Week is an annual observance aimed at educating
parents about the importance of protecting their infants from
vaccine-preventable diseases. The Department of Health would like to see all of
New Mexico's infants and children fully immunized.
"Because of the effectiveness of vaccines in the United States, parents are
often unaware of the serious and life-threatening diseases that their children
are at risk of contracting," said John Hartoon, disease prevention program
manager for the Department of Health in Las Cruces. "Keeping your child
up-to-date on all of their immunizations is the best way to protect them."
"Horton Hears A Who!" is based on the Dr. Seuss book of the same title about
Horton, an elephant, who hears a voice on a speck of dust floating in the air.
Horton, voiced by Jim Carrey, realizes that an entire world lives on this speck
and vows to save the Mayor of Who-Ville, voiced by Steve Carell, and his
community. The film teaches children that "a person's a person, no matter how
small!"
"At Allen Theatres, when we donate to the community, it's all about helping
kids," Allen said. "We think this is an excellent program for our community."
For more information about the upcoming Movie Mania event, log onto the
Department of Health's Web site at www.healthynm.org.
Katie Smoker writes for the New Mexico Department of Health. She can be reached
at katie.smoker@ state.nm.us.

YEAH JIM CARREY!!!!!!!!!!!!!!!!!!!!
JIM CARREY HALTS "HORTON HEARS A WHO" VACCINE CAMPAIGN
Jim_and_jennyBy Lisa Ackerman
Horton Hears An "Ow?"
Late last week a story hit the wire about "Free movie and immunizations: Horton
hears an "ow!" (HERE <http://www.lcsun-news.com/healthyliving/ci_8617396>.)
What's this? A new vaccination strategy you say?
The article referenced free vaccinations at a theater in New Mexico featuring
the movie "Horton Hears A Who." In case you have been in a cave under a
rock for the last month, Horton's voice is none other than the amazing Jim
Carrey. And if that rock still has you covered, Jim happens to be Jenny
McCarthy's boyfriend. Jenny is outspoken on vaccines & vaccination safety. A
theme that runs throughout her book "Louder Than Words
<http://www.amazon.com/exec/obidos/ASIN/0525950117/bookstorenow18-20>"
featuring the story of her recovered son, Evan.
Once word from the autism community (Who-ville in this case) got to the Carrey &
McCarthy super team about this story of a New Mexico vaccination plot
things got a brewing. After his morning coffee, Jim made a few calls this
morning on behalf of the autism community. Following a long discussion with his
representatives at Fox
Entertainment -- Who-ville -- once again through Horton - was heard. The New
Mexico test market of drive thru vaccines while at the movies with your children
was stopped. Halted by /*Horton himself*/ because he heard "we are here, we are
here, we are here!" once again.
Thank you Jim & Jenny. You continue to be amazing heroes for the autism
community. (And thanks to Kevin Barry of Generation Rescue <http://www.generationrescue.org/>
for the heads up.)
/Lisa Ackerman is a proud parent of Jeff, a child with autism. She founded the
parent support group Talk About Curing Autism <http://www.talkaboutcuringautism.org/>
in November 2000 with a dozen families in the living room of her Southern
California home. The group has now grown to over 8,000 families. TACA is
dedicated to community building support and disseminating information about
treatments most beneficial including; dietary interventions, biological
treatments, and behavioral based therapies./

http://www.capecodonline.com/apps/pbcs.dll/article?AID=/20070825/NEWS/708250316/-1/NEWS
Cape officials agree: Whooping cough tests faulty
Text Size: A | A | A
By K.C. MYERS
staff writer
August 25, 2007
HYANNIS — Cape Cod Health Care's extensive search for people possibly exposed to
hospital staff with whooping cough in June may have been unnecessary, according
to federal and local officials.
Researchers at the Atlanta-based Centers for Disease Control and Prevention
announced Thursday that the most common laboratory test for whooping cough is
unreliable. The discovery calls into question public health officials' claims
that whooping cough cases are dramatically on the rise, the CDC said.
In early June, about 1,000 patients and staff were notified that they may have
been exposed to infected staff members of the oncology department at Cape Cod
Hospital. Three were suspected of having the disease, which is often fatal in
infants. Two staff members were later positively identified with having whooping
cough, or pertussis. More than 400 people took antibiotics as a precautionary
measure. Yesterday, Alan Sugar, head of the infectious disease department at
Cape Cod Health Care, confirmed the tests used to detect whooping cough are
often unreliable. Growing a bacteria culture taken from an infected person is
the "gold standard" test for whooping cough, Sugar said.
The so-called PCR DNA test, a common test for whooping cough, gives false
positives and false negatives, Sugar said.
There's only a short time period when the bacteria can be tested by growing
bacteria cultures, he said.
If the disease progresses, the body's antibodies kick in and the culture will
not grow. Given the difficulty
of growing bacteria cultures, laboratories often use the less reliable method.
Sugar said one of the two staff members may have received the "gold standard"
test, but he couldn't remember. In the other Cape Cod Hospital case, test
results contradicted each other, he said. Still, he defended the decision to
treat people with antibiotics to stop the potential spread of the infectious
disease, despite the possibility that prescribing antibiotics could lead to the
development of drug-resistant strains of bacteria.
"If there's a good reason, you should take them," Sugar said of antibiotics.
Government officials have said whooping cough cases have tripled since 2001, but
nearly half of those tests were done with unreliable methods, the CDC found.
K.C. Myers can be reached at kcmyers@capecodonline.com.

Vaccine Refusal May Cause NY to Take Children/ Price of
Children First
http://www.healthmall.com/mailarticle.cfm?type=article&id=649
Today, 77 middle-schoolers will be yanked from home and taken into custody by
New York state unless their parents agree to vaccinate them for a disease
usually caught by drug abusers or the sexually promiscuous. On October 10,
students in Utica were sent home for failing to get hepatitis B vaccines by the
state deadline. Parents were warned the children would be turned over to Child
Protective Services for neglect if they were still without vaccination in 2
weeks.
"This is Hillary-Care coming home to roost in NY," said Jane M. Orient, MD,
Executive Director of the Association of American Physicians and Surgeons (AAPS).
President and Mrs. Clinton's 1992 campaign pledge to create the Vaccines for
Children Program (VFC) was to become the first domestic policy initiative of the
administration. It was designed as their first shot to pass the Health Security
Act. "Their campaign to pass VFC was based on creating a false crisis by
claiming that millions of children would
be exposed to risk of disease without a government program."
"This vaccine is a potential death sentence for some children," said Dr. Orient.
"Government studies show that children under the age of 14 are three times more
likely to die or suffer adverse reactions after receiving hepatitis B vaccines
than to catch the disease itself." Hepatitis B is primarily an adult disease,
usually spread by multiple sex partners, drug abuse or an occupation with
exposure to blood. Children are at a very low risk of exposure, unless the
pregnant mother is infected.
The school district will lose a substantial amount of state funding if students
do not comply with the vaccine mandate. "We refuse to let that happen," said
school district physician, Mark Zongrone. "Apparently, Dr. Zongrone is more
interested in protecting his employer's budget than protecting the children
under his care, and Mrs. Clinton cares more about her vision of socialized
medicine," said Dr. Orient.
"It's obscene to seize a child and force him to the custody of strangers just
because his parents refuse medical treatment they think is unnecessary or even
dangerous," said Dr. Orient. "Parents, not Mrs. Clinton's village government
bureaucrats, should make decisions about their children's medical care. We urge
an immediate repeal of all vaccine mandates."

Vaccines
This is a clinical research study to evaluate an investigational combination
vaccine for babies 6 - 12 weeks old and ready to begin the routine
vaccination series. Research site located in Fountain Valley,California.
Please see http://www.centerwatch.com/patient/studies/cat372.html.

I really can't believe they are bringing this back out.... as it's been
totally eradicated in the US for more than 30 years, and now they're
bringing it back to life again! This vaccine they're discussing
here is a LIVE Vaccine.... Was it the Salk or Sabin vaccine that was Live
back in the 40's that killed so many people?
Read the PDF file (mentioned in the article) carefully. They are
saying what we could do, but are pretty much hiding it.
Feds Seek Public Input on Vaccine
http://apnews.excite.com/article/20021101/D7N182PO0.html
Nov 1, 8:28 AM (ET)
By LAURAN NEERGAARD
WASHINGTON (AP) - The government is seeking public input before it decides
whether to let a few dozen toddlers and preschoolers be vaccinated against
smallpox, a study to test the best children's vaccine dose but one raising
thorny questions about safety and ethics.
The vaccine is made of a live virus called vaccinia that can cause its own
infections until the injection site scabs over, so researchers plan to keep
inoculated children out of day care or school for a month. But still there
is a chance that youngsters could tear off their bandages and put relatives,
playmates or others at risk.
There also is the question of whether it is ethical to test in healthy
children a vaccine that could cause a life-threatening reaction when the
children probably won't benefit from it - unless a bioterrorist attacks with
smallpox.
After research oversight boards reached mixed conclusions on these issues,
the Food and Drug Administration announced Thursday that for the next month
it will accept public comment on whether the University of California, Los
Angeles, and Cincinnati Children's Hospital should inoculate 40 2- to
5-year-olds with smallpox vaccine. They would be the first children to get
the shots since routine vaccination ended in 1972.
It's highly unusual for the FDA to seek public opinion on
research.
"It is a very challenging issue because there is no smallpox circulating
right now," said Dr. Karen Midthun, the FDA's head of vaccine research.
"There is great concern that there be a lot of safeguards for studies being
conducted in children." "This is an unusual time, it's an unusual need and I
think the risks are not totally insignificant," said Dr. Joel Ward of UCLA,
the lead researcher. "So I think this extra care is appropriate."
Although wild smallpox was eradicated in the 1970s, officials fear that
laboratory samples might have fallen into terrorists' hands. Faced with that
uncertainty, the Bush administration is preparing to make vaccine available
again, first to certain health care workers and later to the general public.
It's a difficult decision because of the vaccine's risks. Based on studies
from the 1960s, 15 of every 1 million people vaccinated will suffer
life-threatening reactions, and one or two of them will die.
A vaccinated person can spread the vaccine's virus by touching the injection
site, then touching the eyes, mouth or someone else. If the virus spread to
the eye, for instance, it could cause blindness. Someone with a weak immune
system, such as an AIDS patient, could be killed.
Children once routinely got the smallpox shot, so why is new testing an
issue? The vaccine has been kept frozen for 30 years. To ensure there
are enough still-potent shots to go around until new ones are made,
scientists are studying whether diluted doses work. Recent studies in adults
suggest they do. The planned pediatric study, sponsored by the National
Institutes of Health, would test those weaker doses in young children, whose
immune systems work differently than adults.
"I would certainly want these trials to be conducted before I would want my
child to be vaccinated," said Dr. Julia McMillan of Johns Hopkins
University, a spokeswoman for the American Academy of Pediatrics. The
academy has urged the government since last spring to do child studies
before allowing broad access to the vaccine.
It's not just for the child's benefit, she said. The last time children were
inoculated, their relatives and playmates were too, so no one knows how kids
might spread vaccinia through today's unvaccinated population. Federal
regulations require special oversight for research that poses more than a
minimal risk to a child who won't get a significant benefit. Oversight
panels and independent experts consulted by the government have said that is
the case here, because children's risk of getting smallpox is so small.
Still, most of those experts said the research should be allowed because it
could benefit society. They did suggest changes, such as limiting
inoculations to the children of people enrolled in adult smallpox vaccine
studies, because those parents may better understand the risks. Fully
explaining the risks to parents is crucial, many said.
"Many parents incorrectly believe that the risk of potential exposure (to
smallpox) is very high," Johns Hopkins professor Dr. Neal Halsey wrote the
FDA.
Under current study plans, no child would be inoculated if the child or a
family member has immune problems or skin diseases such as eczema that raise
the risk of vaccine complications. Children who live with a pregnant woman
or infant would also be ineligible, because babies under age 1 are at
significantly higher risk of a vaccine-caused brain infection.
Inoculation sites would be covered with a special bandage that in adult
studies proved very effective at preventing spread of the vaccine's virus.
While children are known to rip off bandages, Midthun said this one is extra
sticky, "very, very hard to get off."

This is a vaccine trial for a monkey, now human virus
found in the polio vaccine CMV. So, they are making a vaccine to help stop
the effects of a vaccine...yes that makes a lot of sense.
First Appeared Thursday, 31 October '02
Healthy Men Sought for UCSF
Vaccine Study
UCSF researchers at San Francisco
General Hospital Medical Center (SFGHMC) are looking for healthy men
between the ages of 18 and 45 to participate in a clinical trial to test a
new vaccine strategy for preventing cytomegalovirus (CMV) infection. CMV is a common viral infection —
one of the human herpes viruses — with more than half of all adults
infected. In general, CMV does not cause disease except in profoundly
immuno-compromised patients such as transplant recipients or persons with
advanced AIDS.
However, CMV infection, when
acquired by women during pregnancy, can lead to serious neurological
impairment to the child and is the most common infectious cause of
neurological damage in newborns. “Our strategy is to combine an
anti-CMV vaccine that has been shown to reduce the severity of CMV disease
in kidney transplant patients, but failed to protect against infection,
with interleukin-12 (IL-12), an immune enhancing protein,” said Mark A.
Jacobson, MD, professor of medicine in residence at UCSF’s Positive Health
Program at SFGHMC.
“Both products have been tested
separately and appear to be safe, so we do not anticipate serious toxicity
issues, though this will be the first time they have been used together,”
said Jacobson. Everyone in the study, which opens in November at the
General Clinical Research Center at SFGHMC, will get vaccine but some
participants will receive IL-12 and some a placebo.
Subjects will receive only one
injection. An initial blood sample will be taken to screen for CMV and 11
additional blood samples will be drawn over a year. Participants will receive $50 per
study visit and an additional $200 for completing the study for a total of
$750.
To participate, contact Doug Black,
study coordinator, at 476-4082, ext. 136.

More experiments on children
November 2002
ATLANTA -- The recommendation to vaccinate all healthy children 6 months to
23 months old against influenza may still be years away, according to the
Advisory Committee on Immunization Practices (ACIP).
The influenza vaccine is now strongly recommended by the ACIP for all
children 6 to 23 months old, but the ACIP appears ready to stall
consideration of a universal recommendation due to missing data.
Several members of the panel requested additional safety and efficacy
data before considering a stronger recommendation.
But the optimal data would come from studies conducted over multiple
winters, according to researchers. Because vaccination efforts have already
begun for the 2002 to 2003 season, studies probably could not be
started until next year, which means that consideration of
recommendations would be pushed to at least 2004 for the 2004 to 2005
influenza season, explained Keiji Fukada, MD, a medical epidemiologist
with the CDC.
Although the vaccine has been recommended for use in high-risk children
since the late 1970s, efficacy data have come from a few clinical trials
with relatively small patient populations. There have also been
limited safety studies on the trivalent inactivated influenza vaccine in
young children.
A study by the Kaiser Permanente Vaccine Study group, using information
from the Vaccine Safety
Datalink, a linked databases of five separate managed care organizations
covering 3.5 million children younger than 18, found no signals of any
serious adverse events except for a possible rise in visits for
impetigo after vaccination. Furthermore, said Jason Glanz, MS, of Kaiser
Permanente of Colorado, who presented the data to the panel, the study
confirmed that no signal had been missed by the Vaccine Adverse Events
Reporting System.
The study reported on the odds of a medical event one to 14 days after
vaccination, considered the most likely time for an adverse event, compared
with medical events 15 to 28 days after vaccination, in 8,476 children
6 to 23 months of age.
The study found 33 diagnosis codes for visits in the 14 days post
vaccination, with rises in visits for
uncomplicated diabetes, atopic dermatitis, renal and ureteral disorders and
impetigo during days one to three. However, only impetigo was considered
possibly associated. Other reasons for a second visit included upper
respiratory tract infection or cold, asthma, rhinitis, dyspnea and
pharyngitis.
However, the ACIP was critical of the study, saying it was unclear whether
the visits were after the first or second dose of vaccination and that
further analysis was needed for the possible link to renal and
ureteral disorders.
Jon Abramson, MD, head of the AAP's panel on infectious diseases and an ex
officio member to the
ACIP, said that while more safety and efficacy data would be nice to have,
feasibility issues are more
problematic. He pointed out that the ACIP previously recommended influenza
vaccine for pregnant
women based on no efficacy data.
As well, the Vaccine Injury Compensation Program (VICP) will not immediately
cover the influenza
vaccine, so physicians and providers who vaccinate children will not be
protected against litigation.
Congressional support is needed before the vaccine is added to the injury
compensation table, a move that is likely in the next couple of years,
according to Geoffrey Evans, MD, director of the VICP.
"Given the direction of the governing bodies, it is likely that influenza
will be covered some time down the line," he said, adding that once
influenza is added, it will have eight years of retroactive coverage by VICP.
In other ACIP news, discussion of combination vaccines and their potential
impact on the structure of the childhood immunization schedule has been
pushed to a future meeting, possibly in June. The original agenda included
discussion of combination vaccines, but the ACIP was asked in late September
to strengthen its recommendations on smallpox vaccine use, precluding all
other topics.
As a result, it is unlikely that new combination vaccines will be added to
the 2003 childhood immunization schedule due out in January, even if they
are approved by the FDA in the interim.

More experiments on children:
http://www.ama-assn.org/sci-pubs/amnews/pick_02/hlsc1202.htm
[amednews.com]
HEALTH & SCIENCE
Prudent to test smallpox vaccine in kids? Naysayers worry about the safety
of even the diluted version on today's children; proponents say testing is
warranted before widespread vaccination
is deemed necessary.
By Susan J. Landers, AMNews staff. Dec. 2, 2002. Additional information
Washington -- The Food and Drug Administration sought public opinion on
whether to proceed with a trial to vaccinate young children with the
smallpox vaccine and the public responded.
Within a few days of the FDA's Oct. 31 notice in the Federal Register,
hundreds of people -- physicians, mothers, fathers and preschool operators
among them -- voiced opinions.
Many implore the FDA not to test the vaccine, which is known to have serious
side effects, on children. "Children's bodies and minds are still fragile
and growing," writes one woman. "Please do not place young children in
jeopardy by testing this vaccine on them."
But others offer a different opinion: "Government should proceed with these
tests. Smallpox vaccines should be made available to everyone." The FDA is
proposing to test the vaccine on 40 children ages 2 to 5, a population that
had routinely received the smallpox vaccine until it was discontinued in the
early 1970s.
The trial would test the safety and immune response to the smallpox vaccine,
Dryvax, used at full strength and also diluted at a one-to-five ratio.
The CDC says for every 1 million smallpox vaccinations given, 1 person would
likely die.
Although he didn't weigh in with an opinion to the FDA, Samuel Katz, MD,
professor of pediatrics at Duke University, Durham, N.D., favors proceeding
with the trial. "I think it's very appropriate that any new vaccines that
will be licensed for widespread use be tested on children."
Children may respond differently than adults as they might to any other
pharmaceutical product, he said.
Even though the vaccine is the same one used 30 years ago, the diluent used
to prepare the dry vaccine is different, Dr. Katz pointed out. The trial
would also include a more diluted form of the vaccine, making it an agent
that should be tested in children to determine whether it causes any unusual
reactions and to find out if it produces the appropriate response. The
diluted version has already been tested in adults and found to be safe and
to have produced the desired result -- a raised blister that scabs over.
"I think it would be unethical not to test children," said Dr. Katz.
Several physician groups, including the AMA and the Infectious Diseases
Society of America, where Dr. Katz serves as a liaison to the Centers for
Disease Control and Prevention, have advised against initiating a broad
vaccination campaign before there is any evidence that the disease has made
an appearance.
A dangerous vaccine
Potential adverse reactions from the smallpox vaccine range from fever to
tissue necrosis and extensive lesions to encephalitis. A likely death rate
of one per 1 million vaccinations was established by the CDC. Many predict
that the vaccine carries even more dangers to today's population, which
includes many whose immune systems are suppressed because they have received
organ transplants, are taking cancer drugs or have HIV.
Children vaccinated for smallpox would have to stay out of school or day
care for the next 30 days.
Eczema, which seems more prevalent among children today than in the 1960s,
also places children at greater risk from eczema vaccinata, a rampant
infection that can be contracted either from the vaccine itself or from
someone recently vaccinated.
Because of the risk of person-to-person transmission, children who receive
the vaccine would be excluded from day care or school for at least 30 days
following vaccination, according to the protocol.
The vaccination would be administered to children via five skin scratches
with a bifurcated needle, in contrast with the 10 to 15 scratches received
by adults. The vaccination site would then be covered with a semi-occlusive
dressing.
If any children should develop severe adverse events, treatment would be
provided with vaccinia immune globulin and cidofovir. The latter drug, noted
the protocol, has been approved by the FDA but not to combat adverse
smallpox vaccine events.
The final determination on whether to proceed with the trial will be made by
Dept. of Health and Human Services Secretary Tommy Thompson and FDA
Commissioner Mark McClellan, MD, PhD.

WSJ is subscription only
Thanks to Michael Belkin
Pretty amazing quote from Offit - it must be REALLY bad! ""There is no
vaccine with comparable risks," says Paul Offit, chief of the
infectious-diseases section of the Children's Hospital of Philadelphia. He
is also a member of an advisory committee to the Centers for Disease
Control and Prevention, which has posted decades-old photos on its Web site
of babies and children with inflamed skin lesions (http://phil.cdc.gov/Phil/search.asp).
"I would never give that vaccine to my children because right now there is
no disease out there," he says.

thanks to Michael Belkin
NIH Awards $22.5 Million
To Develop Anthrax Vaccine
By MARILYN CHASE
Staff Reporter of THE WALL STREET JOURNAL
The National Institutes of Health awarded $22.5 million in contracts to
speed development of a new streamlined anthrax vaccine, expected to start
human-safety studies by May.
The contracts went to VaxGen Inc. of Brisbane, Calif., which is a maker of
genetically engineered vaccines, and to a closely held British maker of
chemicals and protein pharmaceuticals, Avecia, of Manchester, England.
The new vaccines aim to produce immunity in three doses, rather than in six
doses over 18 months, as required by the current anthrax vaccine made by
Bioport Inc., of Lansing, Mich.
The vaccines will use genetically engineered copies of a key anthrax protein
-- known as recombinant protective antigen, or rPA102 -- to stimulate the
body to create immunity against the lethal bacteria. In last fall's anthrax
letter attacks, 22 people became ill. Of those people, 11 developed skin
infections and another 11 the more lethal inhalational anthrax, of whom five
died.
Genetically engineered anthrax vaccines have protected monkeys from aerosol
exposure to the deadly bacteria. VaxGen said its anthrax vaccine will
license techniques pioneered by the U.S. Army Medical Research Institute of
Infectious Diseases in Fort Detrick, Md. Avecia will also use the rPA102
protein, made by a different technology.
For more health coverage, visit the Online Journal's Health Industry Edition
at wsj.com/health, and take a tour of the edition.
The grants from the National Institute of Allergy and Infectious Diseases, a
unit of NIH, aim to speed development. The contracts require the delivery of
pilot doses, and a manufacturing plan for producing more than 20 million
doses, by 2003.
In 2004, the U.S. Department of Health and Human Services will award larger
competitive contracts to companies for the manufacture and maintenance of a
25 million-dose stockpile of anthrax vaccine.
In a speech in San Diego last week, Anthony S. Fauci, director of NIAID,
said that the new paradigm of federal biodefense grants stresses the urgency
of product delivery over science-for-its-own-sake. "Come back with drugs and
vaccines," Dr. Fauci said.
As of 4 p.m. in Nasdaq Stock Market trading Thursday, shares of VaxGen rose
13%, or $1.17, to $10.17.

(A good case for home school)
"Ow," says Denae Woods, 15, a sophomore at Westwood High School in
Mesa as Firefighter Steve Ward gives her a tetanus shot during a mock
bioterror drill held Thursday as a practice session for emergency crews.
By Jonathan Sidener
The Arizona Republic
Nov. 22, 2002
Officers with assault rifles and paramedics armed with hypodermic needles
invaded Mesa's Westwood High School on Thursday. The men and women in
uniform were part of a daylong drill at the school to see how ready health,
emergency and military systems are to deal with a bioterror attack.
But the mock attack also helped provide a day of distraction for Westwood
students. Some got breaks from class to participate in the drills. Others
stared at the onslaught of TV satellite trucks and emergency vehicles
surrounding the gym. Several football players on the way to practice were
particularly enthralled with the officers' combat weapons. The
bioterrorism training began at 9 a.m. as paramedics and public health nurses
began dishing out tetanus shots to students. Slightly more than 3,000
students from Mesa's six high schools, including 500 at Westwood, received
the free shots.
Students knew they were getting shots they needed by January, but unless
they read about it in the newspaper, they didn't know they were contributing
to national emergency planning.
"They just told us we needed tetanus shots," student Tracy Theriot said.
While emergency officials routinely conduct mock drills, the opportunity to
immunize thousands of students added realism this time around, said Mary
Cameli, deputy chief of the Mesa Fire Department.
"We've done many of these on the tabletop, but the chance to do it hands-on
is the best," Cameli said. "We had some kids faint and some signs of
anxiety, things we wouldn't have seen if we weren't giving real shots." In
the drill immunizing students, emergency workers discovered bottlenecks when
the paperwork went faster than the needlework, Cameli said. On the one hand,
giving shots to 3,000 students in two hours is an accomplishment, she said.
But it's still a small sample of the number of people who might need
inoculation in a real emergency.
Wednesday, the Centers for Disease Control and Prevention in Atlanta sent a
shipment of mock antibiotics to Tucson from one of 12 secret locations that
make up the National Pharmaceutical Stockpile. Thursday morning, emergency
workers in Tucson unpacked and sorted the labeled, but empty, pill bottles.
Some bottles remained in Tucson for a drill there today.
A team of Department of Public Safety officers escorted the supplies to
Mesa. Wearing flak jackets, combat boots and helmets, they guarded the cargo
until it was carried into the gym.
Inside, 200 adult volunteers waited for antibiotics to treat their fake
anthrax.
Volunteer "victims" went through a medical screening process and waited to
meet with one of the pharmacists, who dispensed the fake antibiotics from
Tucson.
Mostly, they waited.
Christine Mahon, of the Maricopa County Public Health Department, said the
afternoon drills had also turned up some bottlenecks. Officials will look
for ways to smooth out those areas in case of a large-scale crisis.
We're testing our process," Mahon said. "If we can do well with hundreds of
people, then we could do well with thousands."

http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=1808546
US Government Asks Court to Seal Vaccine Records
Tue November 26, 2002 10:47 AM ET
By Todd Zwillich
WASHINGTON (Reuters Health) - Attorneys for the Bush Administration asked a
federal court on Monday to order that documents on hundreds of cases of
autism allegedly caused by childhood vaccines be kept from the public.
Department of Justice lawyers asked a special master in the US Court of
Federal Claims to seal the documents, arguing that allowing their automatic
disclosure would take away the right of federal agencies to decide when and
how the material should be released.
Attorneys for the families of hundreds of autistic children charged that the
government was trying to keep the information out of civil courts, where
juries might be convinced to award large judgments against vaccine
manufacturers.
The court is currently hearing approximately 1,000 claims brought by the
families of autistic children. The suits charge that the
measles-mumps-rubella (MMR) vaccine, which until recently included a
mercury-containing preservative known as thimerosal, can cause neurological
damage leading to autism.
Federal law requires suits against vaccine makers to go before a special
federal "vaccine court" before any civil lawsuit is allowed. The court was
set up by Congress to speed compensation claims and to help protect vaccine
makers from having to pay large punitive awards decided by juries in state
civil courts. Plaintiffs are free to take their cases to state courts if
they lose in the federal vaccine court or if they don't accept the court's
judgment.
The current 1,000 or so autism cases are unusual for the court. Because it
received so many claims, much of the fact-finding and evidence-gathering is
going on for all of the cases as a block. Monday's request by the Bush
Administration would prevent plaintiffs who later go to civil court from
using some relevant evidence generated during the required vaccine court
proceedings. Plaintiffs' attorneys said that the order amounted to
punishment of the families of injured children because it would require them
to incur the time and expense of regenerating evidence for a civil suit.
"Wouldn't it be a shame if at the end of the day our policy would be to
compensate lawyers," said Jeff Kim, an attorney with Gallagher Boland
Meiburger & Brosnan. The firm represents about 400 families of autistic
children who received the MMR vaccine. Kim accused the government of trying
to lower "a shroud of secrecy over these documents" in order to protect
vaccine manufacturers, who he said were "the only entities" that would
benefit if the documents are sealed.
While federal law clearly seals most documents generated in individual
vaccine cases, it has never been applied to a block proceeding like the one
generating evidence in the autism cases. Administration lawyers told Special
Master George Hastings that they requested the seal in order to preserve the
legal right of the Secretary of Health and Human Services to decide when
vaccine evidence can be released to the public.
Justice Department attorney Vincent Matanoski argued that to let plaintiffs
use the vaccine court evidence in a later civil suit would confer an
advantage on plaintiffs who chose to forgo federal compensation. "There is
no secret here. What the petitioners are arguing for are enhanced rights in
a subsequent civil action," Matanoski said of the plaintiffs. "They're still
going to have unfettered use within the proceedings." Hastings would not say
when he would issue a ruling on whether to seal the court documents, but did
say that his decision would be "very prompt

Regular readers of the E-news bulletins
will have followed the saga of the MMR vaccine and the potential link to
autism. Despite the concerns of parents, which has seen take-up levels fall
to a new low, doctors are pressing ahead with plans for a new multi-vaccine
to be given to babies. The new ‘supershot’ will fight up to six separate
illnesses, and the current MMR jab may also be extended to cover chickenpox.
Aside from the concerns about autism,
this new vaccine also raises a number of other worries. Primal health
researcher and WDDTY panelist Dr Michel Odent has been studying the impact
of multiple vaccines on an immature immune system, both in the
immediate term and right through to adulthood.
He is concerned that an immune system, compromised at
such an early stage, could herald a range of systemic and chronic
conditions of adolescence and adult life, such as asthma and arthritis,
which have reached pandemic levels.
But if UK health officials are that unfazed by the autism
concerns, they’re unlikely to be losing too much sleep about Dr Odent’s
research.

Hepatitis A - Creating a Market for
Another Superfluous Vaccine
By Dr. Tim O'Shea
Part 1 of 2
They finally did it. After years of lobbying and angling, GlaxoSmithKline
finally got their new vaccine for Hepatitis A tacked onto the mandated
schedule as of Jan 2002, with no public fanfare. (www.aap.org)
The vaccine is called Havrix, and is delineated on p.1544 of the
2002Physicians Desk Reference, which incidentally was printed much earlier
lastyear. Merck also has a hepatitis A vaccine - Vaqta. The CDC's mandated
schedule is the brass ring that all vaccine manufacturers are going for -
approval of a vaccine can mean annual revenues of $1 billion or more, which
is about what Merck pulls in for their current Hepatitis B vaccine.
Hepatitis A vaccine appears in a brand new category on the mandated schedule
called the 'high risk' category. The significance of this new category will
soon become apparent. But before we get into that, let's take a look at
Hepatitis A the disease and assess the necessity for a mandated vaccine.
What Is Hepatitis A?
As every doctor knows, Hepatitis A is an acute viral disease of the liver.
Hepatitis A virus (HAV) has supposedly been isolated:
"a 27-nm RNA picornavirus (enterovirus) with only one serotype..."- American
Academy of Pediatrics, Dec 1996 The infectious agent is passed from human to
human either through the oral - fecal route, waterborne, often from raw
shellfish or dirty water blood and body secretionsHepatitis A is a mild,
self limiting disease, resolving on its own with no treatment in 4-8 weeks.
Most infections are subclinical, meaning that most people who get the
disease never even know it because they never manifest symptoms. (Merck
Manual, p 377) The journal Pediatrics agrees:
"Most HAV infections in young children are asymptomatic... Clinical
hepatitis occurs in fewer than 10% of infected children." This disease is so
mild that 90%of kids who get hepatitis A never even know it. Even the
National Institutes of Health states that:"Most people who have Hepatitis A
get well on their own after a few weeks." - NIH Manual: What I Need To Know
About Hepatitis A :Most cases of hepatitis A are found in Third World areas, outside the US.The
question pops up: then why are we the only country in the world who
recommends the vaccine on a mass scale?
That billion dollars hanging in the balance wouldn't be in the equation, now
would it?
Diagnosis of hepatitis A is supposedly by IgM antibody. But more often,
diagnosis is by symptoms alone. Symptoms Of Hepatitis A According to Merck
Manual, the chief symptoms of hepatitis A are
loss of appetite
dark urine Hardly life-threatening situations. Jaundice may also occur, but
it usually indicates the beginning of recovery. By the time these symptoms
appear, the disease is no longer infectious. Unlike hepatitis B, Type A
hepatitis disappears completely after acute infection, and does not
contribute to chronic liver disease or to cirrhosis. It is important
to note that after the patient recovers, he has lifetime immunity. True
immunity.
Hepatitis A is a disease of poor personal hygiene, bad sanitation, poverty,
overcrowding - Third World scenario. Even well-groomed, well-fed junkies are
not high risk for Hepatitis A. They're more apt to get Type B. Medline
indicates the lack of sewers in Third World locales as the biggest
contributor to Hepatitis A. Again from the journal Pediatrics we find that:
"The major method for prevention of HAV infections is improved sanitation
and personal hygiene"
Bottom line here: Hepatitis A is not common in most of the United States.
Other Causes
It's shocking to discover that hepatitis can be caused by both hepatitis B
and hepatitis C vaccines!
This fact is found in a disclaimer that GlaxoSmithKlein makes about
Havrix,that it can't cure the hepatitis caused by these other 2 vaccines. So
can we infer from this that Havrix itself also causes hepatitis? We don't
need to infer it.
The manufacturer states it on p 1545 of the 2002 PDR: a possible side effect
of Havrix is hepatitis!
Another source of hepatitis A for children is nososcomial infection. That
means infants in hospital intensive care units pick it up there. We never
hear about it because the new literature is leaving it out. (AAP Policy
Statement, 1996)
So Then What's The Vaccine For?
The question arises - did we really need another vaccine beyond the 40
already mandated for school kids, and specifically did we need a vaccine for
a rare disease that resolves by itself in a few weeks? To answer the first,
we must ask were there any studies done which prove that the new vaccine is
safe when Havrix is added to the other 40 mandated vaccines?
No, there are none.
This concept of the cumulative viral load is discussed at length in the 2002
edition of The Sanctity of Human Blood. Secondly, to substantiate the
necessity for any vaccine, we must look at two
criteria: incidence of disease severity
How Many Cases Really Are There?
This is tricky - research roulette. In the 2002 Physicians Desk Reference,
the manufacturer of Havrix cites 13-year old studies which supposedly show
the incidence of hepatitis A and state that the case death rate is
six-tenths of one per cent. (p 1545)
This is claiming that about six out of a thousand who get hepatitis A die
from hepatitis A. It seems like a rather high death rate until one realizes
that these are not US figures, but global figures, meaning that they were
taken primarily from Third World countries because that's where the majority
of hepatitis A is found!
So that means that these patients are trying to recover from a disease of
poverty, filth, and malnutrition in an environment of poverty, filth, and
malnutrition. Hardly applies in the rare instance of a patient in most of
America. But these are the studies and figures that the vaccine manufacturer
has used to convince the FDA that Hepatitis A is such a serious disease in
the US that a vaccine is necessary.
Numbers, numbers, numbers. Different sources, different stats. From the
American Academy of Pediatricians website we see only half the death rate
reported by the PDR:
"Mortality is rare, especially in children. The case-fatality rate has been
estimated as 3 per 1000 clinical cases in the United States.." - http://www.aap.org/policy/01207.html
Looking at the true incidence of the Hepatitis A in the US is an academic
artifice, a daunting challenge indeed. A standard government reference for
epidemiology is Statistical Abstracts. On p 137 of the most recent edition
(2000), we find that the overall incidence of Hepatitis A has been declining
for the past 2 decades:
1980 --- 29.1 cases per 100,000
1998 --- 23.2 cases per 100,000
This decline is good news, and of course has nothing to do with the vaccine.
The vaccine just came out. But the figures still seem a little high, don't
they? On closer inspection, getting out the magnifying glass and reading the
microprint footnote on that same page, we read:
"Includes cases imported from outside the United States"
Huh? 'Cases imported from outside the United States'? We're not talking
Pinot Noir here. No one doubts that the vast majority of hepatitis A cases
are foreign. It's a disease of poverty, filth, and malnutrition.
Unfortunately in a disease which only manifests symptoms less than 10% of
the time, and with the immense amount of immigration and international
travel going on, there is simply no way to separate foreign from domestic
origin.
To further illustrate the low credibility of government figures for
hepatitis A cases, we need only look at a CDC report which claimed more than
10 times higher incidence: 30,000 cases, which is about 300 cases per
100,000. (Hepatitis Surveillance Report No. 55)
That's a little different from 23 cases per 100,000. So which study is
right?
Who knows? Results depend on who funded it, who wrote it, and who was
responsible for verification.
The truth is no one can really say with authority how many cases of
hepatitis A occur in the US annually.
The Real Number Of Deaths
In an earlier part of that same reference - Statistical Abstracts, p 90 - we
find that the total number of annual US deaths from all 3 types of viral
hepatitis put together (Types A, B, and C) in 1998 was only 4700. Remember
this 4700 also includes complications of autoimmune diseases, terminal
infectious diseases, and other serious illnesses, most in communities of
poverty and malnutrition, alcoholics, drug addicts - individuals of this
nature. This lowest common denominator of life
supposedly represents the necessity of a vaccine for all.
Looking at the PDR's global figures above - a mortality of 6 out of 100,000
- we see the usual attempt by the vaccine manufacturers to grab the credit
for saving us from an already declining disease.
As we learned from the Michael Alderson figures cited in The Sanctity of
Human Blood (p 45), virtually every infectious disease of the past century
had almost disappeared by the time vaccines came on the market.
This is the perfect time to make the same claim for Hepatitis A, before it
disappears completely on its own. Masterful PR in action, a la The Doors of
Perception - www.thedoctorwithin.com
We may be sure that future studies on US hepatitis A incidence will show
vast decreases, for which the vaccine will doubtless be given credit. Just
remember the virtual impossibility of determining incidence at this time,
when the vaccine is being introduced.
Stats game aside, almost all sources agree that children are not the group
dying from hepatitis A:
"hepatitis with mortality occurs mostly in people with underlying
conditions, such as chronic liver disease, and in older age groups" -
http://www.aap.org/policy/01207.html
The Vaccine Itself
This is fun. Hepatitis A vaccine is made from infected human connective
tissue cells.
Not kidding.
Not from just one guy, but rather each batch of vaccine is made from an
infected mass of cells which had 1000 donors. (Pediatrics) Imagine that
party. They are infected with hepatitis A virus, the causative vector
presumed to be present in every case of hepatitis A disease.
The agents are filtered, and attenuated with aluminum, formaldehyde, and
phenoxyethanol - a synonym for ethylene glycol - a component in antifreeze.
Someday we're gonna pay for this.......
Aluminum And Formaldehyde
Just for the sake of argument, let's make the colossally irresponsible
concession that the attenuated viral agent in this vaccine is necessary to
stave off the "epidemic" of Hepatitis A about to sweep through our
children's bloodstreams.
All right, we'll concede that unlikely situation. So do the science wizards
then want to explain the additional presence of one of the most potent of
all human neurotoxins and also of a well known carcinogen in this supposed
life-saving elixir?
Of course I am now referring to the aluminum and formaldehyde which
GlaxoSmithKline thought so vital to the composition of Havrix. (PDR, p 1544)
As Drs. Russell Blaylock and Theo Colburn have well explained, it is not
just the connection with Alzheimer's that makes aluminum such a danger to
human physiology. It's that aluminum can interfere with the formation,
development and survival of virtually any human nerve tissue in an
unpredictable fashion, beyond any timetables yet devised. (Excitotoxins, Our
Stolen Future) We simply don't know.
As for formaldehyde, let's just ask how much danger of cancer is an
acceptable risk in the pure, perfect blood of a newborn? Cancer occurs first
in just one cell. So where are the studies that prove that this "trace" of
formalin or antifreeze will not be sufficient to cause that first cell
mutation that develops into cancer? Where are they? As long as we're talking
about scientific probability here, let's take the discussion one step
further. This single causative viral agent that has been identified for
hepatitis A is a presumption. Remember - diagnosis is often by symptoms and
by the presence of IgM in the blood. Viral infections are not cultured for
diagnosis - it's largely theoretical. So then doesn't the isolation,
concentration, and dissemination of an infectious viral agent seem at least
a little presumptuous if not enormously reckless, especially when we're
talking about the unformed immune systems of the newborn infant population?
That seems like a reasonable question, doesn't it?
Mass Dissemination Of An Unproven Agent
Here's the key point -- is it really necessary to introduce an attenuated
infectious vector into our entire population of children in order to
theoretically prevent a disease which is extremely rare in the vast majority
of US communities, and getting rarer? And is self-limiting, does not
contribute to chronic liver disease, and confers lifetime immunity to the
ones who get it? What are we doing?
Even the manufacturer does not claim that the vaccine confers immunity, but
only delay of the disease.
Thus the need for boosters.
Get the idea - if the vaccine worked, we wouldn't need boosters after 6
months or a year. Following this shaky logic, if the immunity only lasts a
year, the child should get boosters every year for the rest of his life.
Now, the booster shot and the first vaccination shot are identical. So why
does the first shot supposedly last for a year but the last one is going to
be effective for the rest of the patient's life?? Anybody ever think of
that??
The other big issue is that the Hepatitis A virus is supposedly a specific
agent that has been photographed, sequenced, and catalogued, and occurs the
same in every case of the disease. Classical diagnosis is by symptoms and
the presence of the antibody, remember? IgM.
But acute viral liver infections can be of a variety of completely different
agents and disease scenarios. To pretend that they can all be cured by the
dissemination of one single type of attenuated viral agent is disingenuous
at best and scientifically ludicrous, even criminal, at worst. Mass inoculat
ion must be absolutely proven to be necessary, beneficial and free from side
effects, or else it shouldn't even be considered. Havrix meets none of these
criteria.
The New High Risk Category
The most disconcerting - make that horrifying - aspect of the new Mandated
Vaccine Schedule that has just sneaked up on us will prove to be the
creation of this new High Risk category, in my opinion.
As we would expect, this ingenious addition was tacked onto the program with
no fanfare, no general public attention. Suddenly the most vaccinated
children in the history of the world are still not getting sufficient
injections, even at 40 vaccines now mandated.
So for further protection, the CDC has now created the new High Risk
category that they'll christen with just 2 vaccines: Hepatitis A and
influenza. Now folks, these extra shots aren't really part of the mandated
schedule, but are intended for the child who needs that extra protection
because he is what we doctors call 'high risk.'
Which according to the American Pediatrics Association means any child who
seems to have a tendency to get colds, asthma, allergies, the flu, or is
generally sick.
What percentage of kids does that include? Like, all of them?
Step right up. It's such a slick set-up. The script will go something like,
well, little Johnny and little Suzie just got their regular shots, so they
should be fine. By the way, Mrs. Jones, do these children have a tendency to
get allergies, colds, or the flu?
Oh, they do?
Well, then the newest recommendations, just to be on the safe side, are that
for extra protection for Johnny and Suzie we should add just two more shots
today, while they're here. And that's the new Hepatitis A shot and the flu
shot. Yes, and then they should be good for a year. Yes, all the other kids
are getting the 2 extra shots. You can't be too careful these days, you
know.
Who's going to argue with a rap like that? Only the most informed.

Source:Center For The Advancement Of Health
Date:11/25/2002
http://www.sciencedaily.com/releases/2002/11/021125071403.htm
Stressful Feelings May Influence Vaccine Effectiveness A person's state of
mind may influence the body's response to a vaccine against meningitis C,
suggests new research. The findings support previous research showing a link
between psychological factors and antibody response to vaccines. Researchers
at the School of Sport and Exercise Sciences and the School of Medicine at
the University of Birmingham in England asked 60 first-year undergraduate
students to answer a battery of questions about their life events, perceived
stress, psychological well-being, coping styles, social support and health
behaviors. The researchers also took blood samples to measure the
concentration of protective meningitis C antibodies in the students. All of
the students had previously received a meningitis C vaccine as part of a
recently introduced national health program.
The results revealed that a high level of perceived life stress, but not
actual stress, was associated with low antibody levels. A low level of
psychological well being -- feeling anxious or under strain, for example --
was also linked to low antibody levels. The antibody concentrations did not
appear to be associated with the amount of time between the meningitis C
vaccination and the antibody tests, the students' demographics or the
students' health behaviors, however. "These findings suggest that the
feeling that one's life is stressful and the experience of high levels of
distress were more detrimental than actual exposure to stressful life
events," write Victoria E. Burns, Ph.D., and colleagues in the
November/December issue of the journal Psychosomatic Medicine.
"The association between stress and vaccination response has potentially
important clinical implications," the authors conclude. "In light of our
findings, it may be important to monitor subsequent antibody status,
particularly in those reporting high perceived stress and low levels of
psychological well being." The authors note that their research supports
other studies that have found associations between psychological influences
and antibody response to hepatitis B, influenza, and rubella vaccines.
However, theirs is the first
study to show that psychological factors are associated with antibody
response to a conjugate vaccine, a vaccine type used to protect against
meningitis C. Meningitis is an inflammation of the membranes covering the
brain and spinal cord. Bacterial meningitis, including meningitis C, is less
common than viral meningitis, but can be life-threatening. Bacterial
meningitis often appears as single cases, but small outbreaks at
institutions such as colleges or schools sometimes arise. In the United
Kingdom, the meningitis C vaccine is routinely given to students before they
enter a university, the study authors write.

Mexico more effective than U.S. at immunizing children Mexico's
paternalistic approach has led to a 96% vaccination rate for children ages 1
to 4, compared with 79% of American 2-year-olds.
By EDWARD HEGSTROM
Houston Chronicle
MONTERREY, MEXICO - If parents here are late getting their child inoculated,
a public-health nurse will come to their home, pull down the youngster's
pants and give the vaccination right there in the living room. If the
parents are away at work, the nurse does not wait for them to come
home and give permission. Shots are given anyway, and the paperwork is left
with the baby sitter. In Monterrey, like Houston, an industrial city
of more than a million with large pockets of underclass, the government
divides its poor neighborhoods
into sections of about four square blocks each, then puts a nurse in charge
of supervising parents in each area to ensure all of the children are
vaccinated on time.
It is a paternalistic approach almost impossible to imagine in the United
States - where privacy rights and other freedoms are highly valued and
immunizations are increasingly feared - but it has proved remarkably
effective: Mexico has a 96 percent vaccination rate for children ages 1 to
4, compared with an immunization rate of 79 percent for 2-year-olds in the
United States.
The disparity is even greater between Monterrey and Houston, which has one
of the most stubbornly low vaccination rates in the United States. In
Monterrey, 98 percent of the children ages 1 to 4 are fully immunized, a
higher percentage than reached by any U.S. city. In Houston, barely 71
percent of 2-year-olds are caught up on their shots. Mexico's immunization
success is something Americans - particularly Texans
- can cheer. Epidemics of preventable disease used to go back and forth
between the two countries. That no longer happens, thanks mostly to the
remarkable but unheralded improvements in Mexico and other countries in the
region.
"One of the main reasons there is no longer measles in the United States is
because we no longer have measles in Latin America and the Caribbean," said
Dr. Ciro de Quadros, the recently retired director of immunizations for the
Pan American Health Organization. Mexico, he said, has done a "remarkable"
job of vaccinating its children in the past decade. Conventional wisdom says
it is harder to develop a public-health system in a poor country. But
Quadros notes that a wealthy country like the United States has problems of
its own.
"In the United States, there are so many obstacles to vaccinations," said
Quadros, a native of Brazil. "People have so many forms to fill out, and
there are so many more lobbies - anti-vaccine, anti-technology,
anti-everything." The differences in culture and outlook between Mexico and
the United States make it difficult to compare the two systems of
administering vaccinations. But there are similarities, particularly between
two cities that share so much trade and human traffic.
Both Houston and Monterrey suffered from a terrible resurgence of measles
more than a decade ago, and leaders in both places promised to respond by
bolstering vaccine programs to ensure such an epidemic never happened again.
The goal - on both sides of the border - was a 100 percent vaccination rate.
But while Monterrey and Mexico as a whole have come close to keeping that
promise, the improvement in Houston's vaccination program has not been so
great. Vaccinations are clearly up from the winter of 1988-89, when 10
children died from measles in Houston and organizers of the Houston
Livestock Show and Rodeo distributed letters warning that participants may
have been exposed to the disease and risked taking it to other parts of the
country.
Public and private groups responded by forming a number of programs, such as
mobile health clinics, which are designed to better reach the most needy
areas of Houston. But Houston still has no coordinated vaccine registry,
which officials say is necessary to reach the people effectively. And
the effectiveness of the patchwork services now offered by so many different
organizations is hampered by a lack of any central vision for running an
immunization program, critics say.
"There's no real local leadership on the immunization issue," said Barbara
Best, with the Children's Defense Fund. While no one predicts another
measles resurgence, officials in Houston and the rest of Texas have already
started to worry about a return of pertussis, also known as whooping cough.
Mexico, by contrast, has a sharply focused vision. After the measles
pandemic reached Mexico in 1990 and killed 5,899 babies, the Mexican
government established a central authority to oversee the national
vaccination campaign, known as the National Immunization Program.
Immunization campaigns are run three times a year, done with great fanfare.
In addition, uniformed brigades of nurses keep careful watch over
vaccination rates, neighborhood by neighborhood. U.S. health
officials, who have seen the unsparing force of a Mexican immunization
campaign, tend to remember it with both awe and dread. The public-health
nurses of Monterrey begin tracking babies before they are born.
The nurse in charge of immunizations in a particular neighborhood keeps a
census of the area, including maps detailing where women of child-bearing
age live. Babies are given their first immunizations - against polio and
tuberculosis - in the hospital right after birth. They also receive a
government-issued National Vaccination Record, on which the vaccines they
receive throughout their lives will be tallied. The vaccine record must be
presented in order to enter school, to get passports or other identification
papers and even
to get some jobs and loans. Losing the record is not usually a problem,
because the same information is recorded with the federal government and can
be replaced.

HEALTH & SCIENCE
http://www.ama-assn.org/sci-pubs/amnews/pick_02/hlsb1209.htm
Pediatricians praise pentavalent vaccine, question cost Lowering the number
of injections may increase the number of children vaccinated, but experts
worry that inadequate reimbursement levels could stall widespread use. By
Victoria Stagg Elliott, AMNews staff. Dec. 9, 2002. Additional information
Kids can expect fewer vaccine shots in the future. With the promised,
year-end introduction of a vaccine to include antigens for diphtheria,
tetanus, pertussis, polio and hepatitis B, doctors will be able to reduce
the number of injections their youngest patients must endure in a single
visit.
The pentavalent vaccine, which insiders expect to be approved by the Food
and Drug Administration this month, will be manufactured by GlaxoSmithKline
and is expected to be the first of an increasing number of vaccines that
protect against five and even six diseases. "It's less painful for the
child. It is less stressful for the medical staff that is administering the
vaccine, and it's less stressful for the parent who's watching it," said
Edgar Marcuse, MD, MPH, professor of pediatrics at the University of
Washington, Seattle.
Experts say multivalent vaccines may increase vaccination rates and make
parents more willing to let children get all the shots they need in one
visit, rather than scheduling multiple appointments, which can lead to late
vaccinations. "I'm excited about it," said Robert Yetman, MD, professor of
pediatrics at the University of Texas Medical School at Houston. "If the
number of vaccines we are currently giving patients is a reason for some
parents to avoid getting their children immunized, then this will help
eliminate this roadblock to improving our immunization rates." Reimbursement
barrier
Vaccines with antigens for five or six diseases are already in widespread
use around the world. But in the United States no currently available
vaccine includes more than three. Still, as much as physicians say
multivalent vaccines are a significant step in the right direction, there
are many concerns that reimbursement issues may impact the number of doctors
who administer the new vaccine. The cost of the vaccine may not be
adequately covered by insurance.
In addition, physicians may receive less reimbursement for administering
fewer injections in one visit despite the fact that the same number of
antigens are being delivered to the patient. With the number of combination
vaccines expected to increase significantly over the next few years, the
issue is one of great concern and is expected to come up at this month's
American Medical Association Interim Meeting in New Orleans. "Without
reimbursement, this will not be adopted," said Gary L. Freed, MD, MPH,
director of general pediatrics at the University of Michigan School of
Public Health in Ann Arbor. There are also concerns that problems with
record keeping combined with a mobile population may lead to
overimmunization.
Children may shift from one doctor to another, both of whom may stock
different combinations. Records may be incomplete or get lost. "As we get
additional combinations licensed, and the combinations share common
components but also have different components, it's going to increase the
chance of confusion and miscommunication and make far more important the
maintenance of very accurate records," Dr. Marcuse said. Children also may
shift back and forth between public-sector vaccine sources and private
physicians. Most believe that the public sector may be the slowest in
adopting the multivalent vaccines, primarily because of cost issues. "The
public sector may choose not to buy this vaccine if it costs a lot more than
the individual vaccines themselves," Dr. Freed said. Also, not all vaccines
included in the pentavalent vaccine are always delivered at the same time.
Currently, hepatitis B is also frequently administered at birth, by itself,
as well as additional doses during the visits at two and six months when it
is given along with IPV, DTaP and several other vaccines not planned to be
included in the five-valent mix.
"If a physician or hospital gives a child the newborn dose of hepatitis B
yet wants to use this vaccine for at least a portion of the primary
immunization series, they will have to be careful they don't give a child
too many vaccines," Dr. Freed said. "There's no known harm to giving an
extra vaccine, but we need to realize that that is a possibility." And
despite recent anxieties expressed by certain vaccine awareness and parent
advocacy groups over the combined measles, mumps and rubella vaccine,
physicians say that most of their patients would prefer the reduction in
needlesticks. "More than likely, parents will welcome the chance for the
child to get fewer injections," Dr. Freed said.
The initial hope is that the multivalent vaccines will reduce the number of
needlesticks kids must endure. In addition, though, many suspect it will
simply make room in the schedule for new vaccines that are just around the
corner. "We need to make room because there are more vaccines that will be
coming, and you just can't keep giving more shots to children," said Mark
Blatter, MD, medical director of Primary Physicians Research in Pittsburgh,
the company that ran many of the trials on the new vaccine. "After years of
increasing the number of shots, for the first time, we will be able to
decrease the number of shots by as many as six."
ADDITIONAL INFORMATION:
Increased protection
The first pentavalent vaccine in the United States is expected to protect
against:
* Diphtheria
* Tetanus
* Pertussis
* Polio
* Hepatitis B
Vaccine topics from the FDA's Center for Biologics Evaluation and Research
(http://www.fda.gov/cber/vaccines.htm)
CDC National Immunization Program (http://www.cdc.gov/nip/)
Comment from the web:
I'm not a medical person, but I am a person that can think. It
astounds me that the doctors can believe that injecting numerous antigens
(pathogens, viruses) along with an assortment of adjuvants (poisons) that
the tiny immune systems can actually begin manufacturing antibodies to all
of these without a misstep. It seems to me that doctors would realize
how dangerous it is to do this to little babies. I think it is interesting
also that so many newborns at birth have jaundice. I read that Vitamin
K can overwhelm the liver and cause this. But the doctors don't know
that? It is a miracle that most babies live through all these assaults
on their bodies, though we know many don't (SIDS).

Federally funded study measures porn arousal
Rep. Dave Weldon, Florida Republican, cited the
Northwestern study as an example of misplaced research priorities, saying
he asked NICHD three years ago to study whether the measles, mumps and
rubella (MMR) vaccine was associated with autism. "The NIH couldn't find the money to look into this relationship
between kids with regressive autism and the mandatory MMR vaccine, but
they can pay people $150,000 to watch pornography," Mr. Weldon said. "This
is disgusting, and is a clear example of distorted priorities at the NIH.
The NIH message to parents of autistic children: Don't look to us for
help."

Alarm as GM pig vaccine taints US crops
Strict new guidelines planned after contamination
Suzanne Goldenberg in Washington
Tuesday December 24, 2002
The Guardian
US authorities, shaken by a case in which food crops were contaminated
with an experimental pig vaccine, are preparing to impose stringent
guidelines on a new generation of experimental GM crops.
The department of agriculture and the environmental protection agency are
encountering growing disquiet from a coalition of farmers and food
manufacturers about the potential dangers of the next phase of GM products
- "biopharming", or the implanting of genes in food crops to grow drugs
and industrial chemicals.
The idea of tightening regulations on GM products represents something of
a revolution in thinking in the US, where about 70% of the processed food
on supermarket shelves contains genetically engineered ingredients.
But concerns have arisen after a small biotech firm in Texas was fined $3m
(£2m) for tainting half a million bushels of soya bean with a trial
vaccine used to prevent stomach upsets in piglets.
Under a settlement reached this month, the first of its kind against any
biotech company in the US, a firm called Prodigene agreed to pay a fine of
$250,000 and to repay the government for the cost of incinerating the soya
bean that had been contaminated with genetically altered corn.
US authorities said the corn did not reach food crops or animal feed. But
the episode has drawn unwelcome attention to an as yet experimental area
of GM farming.
The premise behind biopharming, or "pharming" for short, is that genetic
tinkering can turn an ordinary-looking corn or barley field into a
potential drug factory, producing insulin, chemotherapy drugs, and other
products for much less than it would cost to set up an industrial plant.
At present, two dozen trials of the experimental GM drugs are under way
across the US.
The biotech firms argue that the new technique can revolutionise health
care, especially in the developing world where hospitals short on syringes
can dispense edible drugs. But in the wake of the Texas case, questions
are being asked.
The latest incident was the worst violation so far of regulations intended
to keep biopharming out of the food supply. It was also seen as the most
serious setback to date to the next generation of GM farming.
Until now, genetic engineering has been used mainly to make crops such as
corn and soya bean resistant to insects and disease, and the US food
industry has been solidly on side.
The Texas alarm has begun to change that. "The incident overall just
reaffirms our concerns that something could go wrong," Stephanie Childs of
the Grocery Manufacturers of America, which represents food companies such
as Kellogg and General Mills, told the Los Angeles Times.
Analysts in Washington said yesterday that they expected the department of
agriculture to impose more stringent guidelines next year. Published
reports said yesterday that guidelines under consideration by the
authorities include moving experimental farms away from America's grain
belt in the mid-west, or requiring growers to dye the leaves of the
altered crops.
The agriculture department's disciplinary measures against the small Texas
firm have crystallised concerns among farmers, environmentalists and
industry about the risks of experimental vaccine crops getting into the
food supply.
"The department of agriculture wanted to send a signal that the companies
need to take the obligation to protect the food supply very seriously,"
Michael Rodemeyer, the director of Washington's Pew Initiative on Food and
Biotechnology, said yesterday.
"The whole issue of growing pharmaceuticals in food crops has certainly
raised concern within the food industry, as well as among
environmentalists and others, about genes from these crops getting into
the food supply."

Journal of Gastroenterology and Hepatology
02/03/2003
By David Loshak
Standard vaccinations of specific hepatitis B antigen have failed to
combat chronic hepatitis B infection in immunotolerant children with
normal aminotransferase levels and high viral load.
Researchers in Diyarbakir, Turkey, report that vaccinated and unvaccinated
immunotolerant children with the infection did not differ in their
clearance of hepatitis B virus DNA. Nor did they differ in their
seroconversion of hepatitis B early antigen to its antibody.
Fifty one children participated in this study. Twenty three were
randomised to standard injections of the GenHevac B vaccine in the deltoid
or quadricep muscles at baseline and at 30 and 60 days. Twenty eight
children, also infected, were not given any medication or vaccination and
served as controls.
Response to therapy was defined as loss of hepatitis B virus-DNA in serum
and hepatitis B early antigen seroconversion (loss of hepatitis B early
antigen and development of antibody to hepatitis B early antigen).
At the first vaccination, the mean alanine aminotransferase value in the
vaccinated children was 33.6 ± 8.1 IU/L. It was 31.7 ± 9.0 IU/L at 6
months and 29.2 ± 7.1 IU/L at 12 months. Mean hepatitis B virus-DNA load
was 3709 ± 1126 pg/mL initially. At 6 months, it was 3569 ± 726 pg/mL and
at 12 months 3295 ± 832 pg/mL.
In the controls, mean alanine aminotransferase values were 32 ± 8 IU/L
initially, 31.8 ± 8 IU/L at 6 months and 29.7 ± 7 IU/L at 12 months. Mean
hepatitis B virus-DNA load values were 3827 ± 1375 pg/mL initially, 3498 ±
886 pg/mL at 6 months and 3059 ± 731 pg/mL at 12 months.
The load of hepatitis B virus DNA of all patients in both groups exceeded
2000 pg/mL.
At both 6 and 12 months, there were no statistically significant
differences between the vaccinated children and the unvaccinated controls
in mean alanine aminotransferase values or mean viral loads of hepatitis B
virus DNA.
The researchers found no hepatitis B surface antigen and hepatitis B early
antigen clearance, nor any antibody to hepatitis B surface antigen and
antibody to hepatitis B early antigen seroconversion during follow-up,
other than in one patient in each group.
The researchers said that other immunisation protocols should be
considered for future investigations into immunotolerant children with
chronic hepatitis B infection. Journal of Gastroenterology and Hepatology
2003;18:2:218-222. "Failure of therapeutic vaccination using hepatitis B
surface antigen vaccine in the
immunotolerant phase of children with chronic hepatitis B infection."

Again - there is NO safe vaccine.
But certainly DPT is a very bad one and
to keep DTaP a secret from UK people
is immoral and criminal
Sheri
http://www.thescotsman.co.uk/health.cfm?id=151072003
Parents must ask to receive safer vaccine
FRASER NELSON
DOCTORS have been told to come clean about Infanrix, the safer whooping
cough jab available on the NHS - but only if directly challenged about it by
parents. The compromise means that parents who ask no questions will
have their children injected with the cheaper DTwP jab laced with ethyl
mercury - a substance ordered out of US medicine on health grounds.
The deal was met with political outrage yesterday as Scotlandâ's opposition
parties accused the Scottish Executive of skirting around its duty to give
parents the full facts about vaccination options before going
ahead. Dr Andrew Fraser, Scotlandâ's deputy chief medical officer, has
written an "urgent message" to Scottish medical specialists alerting them to
fears around thimerosal, a controversial vaccine preservative 50 per cent
composed of mercury.
The substance is contained in DTwP, the £10-a-shot jab from France which
protects against diphtheria, tetanus and pertussis, or whooping cough,
routinely given to all babies aged two, three and four months.
Its rival is Infanrix, a UK vaccine available on the NHS to the few parents
who know to ask for it by name. It is almost twice the price because it
comes without the so-called "junk cells" suspected of giving children fever
after injection.
It is also made without thimerosal - and is the type of vaccine routinely
used in the United States, Canada, Japan, Australia and South Korea.
"Parents are entitled to know if thimerosal is contained in the vaccine
available to them," Dr Fraserâ's letter said. "They should be aware of the
reason for this - ethyl mercury is an essential component of the most
effective vaccine available to protect children."
The Executive explained that this "entitlement" only extends to parents who
ask if they have an alternative. Those who do not will be given the mercury
vaccine.
"The DTwP is recommended, because it is more effective. So that is the one
which is given. If parents were to ask a question, for whatever reason, they
would be told everything - about the choice, the side-effects,
whatever they wanted to know."
The Scotsman revealed yesterday that babies injected with the cheaper DTwP
vaccine are ten times as likely to suffer side effects ranging from fever to
periods of unusual crying lasting more than an hour.
In a Holyrood debate yesterday, Frank McAveety, Scotlandâ's deputy health
minister, admitted that Infanrix does have "lower levels of side effects" -
but said it was less effective. "Our recommendation is that, on the balance
of risk, DTwP offers the best protection against whooping cough. Each
individual or family will have to make those choices in consultation with
their medical practitioners."
Nicola Sturgeon, the SNP’s health spokeswoman, said this is meaningless if
parents are not being told that Infanrix exists. "Choice can only be
exercised if parents have the information to make that choice," she said.
"There will be no consultation if doctors do not pro-actively lay out the
options."
Mary Scanlon, the Tories’ health spokeswoman, asked Mr McAveety to publish
the performance data for both vaccines - saying that only this could let
parents decide which is best for their children. The thimerosal debate has
swept the US, where parents are now suing drug companies. They are fast
building evidence that the ethyl mercury induced autism in their children.
Lord Hodgson of Astley Abbotts, a Tory peer, raised the issue in the House
of Lords on Wednesday night, calling for ministers "to follow a long list of
developed countries and remove thimerosal from vaccines forthwith".
Thimerosal has not survived any public debate in any country. The Scottish
Executive has said it will soon publish the figures it uses to argue that
the mercury vaccine is better.

|
Sunday Herald - 17 October 2004
Plan to make baby buggies from nuclear waste
Industry in bid to recycle contaminated material
By Rob Edwards, Environment Editor, and Peter John Meiklem
http://www.sundayherald.com/print45454
Thousands of tonnes of radioactive scrap metal from nuclear plants could be
melted down and recycled into cutlery, saucepans and baby buggies under a
scheme being promoted by the nuclear industry and its regulators.
A report compiled for the government’s Nuclear Installations Inspectorate and
leaked to the Sunday Herald concludes that “metal melting” is a good way to
deal with nuclear waste because it would save money and be environmentally
friendly.
The aim is to reduce the levels of radioactivity in metal from decommissioned
nuclear facilities by mixing it with less contaminated scrap. Some of the
metal could then be sold on to the open market and used to make household
items.
As the leaked report points out, there is only one snag – the public might
not like it. “There are significant stakeholder issues that must be
considered in order to implement an integrated metallic waste management
strategy,” it says.
“These include public unease regarding the re-use of previously radioactive
contaminated metals, and public concern over the transport of radioactive
waste.”
The report was written by researchers from NNC, a company in Knutsford,
Cheshire, that provides services to the nuclear industry. Commissioned by the
nuclear inspectorate, it was presented at an invitation-only seminar in
Warrington earlier this month.
It points out that there are 70,000 tonnes of medium-level and 383,000 tonnes
of low-level radioactive scrap in the UK. In Scotland, this comes from
nuclear plants that are being decommissioned at Dounreay in Caithness, at
Hunterston in North Ayrshire and at Chapelcross in Dumfries and Galloway.
The establishment of melting plants for radioactive metal would be consistent
with the government’s aim of minimising waste, maximising recycling and being
environmentally sustainable, the report says. It would also “reduce disposal
costs”.
“The idea is to prompt people to take a more wide-ranging approach to the
issue,” said NNC’s Matt Buckley, the lead author of the report. “It is hoped
that this can be considered as part of a strategy by the nuclear industry.”
He stressed that recycling contaminated metal into household goods was only
one option. Metal melting could also help reduce the volume and radioactivity
of waste, making it easier to handle and dispose of.
Glyn Davies, a principal inspector with the Nuclear Installations
Inspectorate, argued at the seminar that “potentially beneficial options for
management of metallic wastes are not being given adequate consideration”.
“If our European friends see metal melting as a benefit and can make it work,
then why not the UK?” he said. “Melting may contribute significantly to the
management of metallic radioactive waste in the UK.”
However Jane Hunt, an independent expert on public attitudes to nuclear
waste, warned that the plan would cause a scare. “This is likely to cause a
lot of public concern because people are very sensitive about radioactive
contamination,” she told the Sunday Herald.
“The idea that radioactivity could be in cooking imple-ments or children’s
buggies will frighten people.”
Coincidentally, the nuclear-free group of local authorities also held a
conference on the issue in Hull on Friday. The group’s chairman, Dundee
councillor George Regan, pointed out that some scientists thought that even
the tiniest amounts of radioactivity could increase the risk of cancer.
“Do you think an ordinary housewife would buy radioactive pans, even if they
told her they were safe? I doubt it. I wouldn’t take the chance. The fact is
that people do not want products recycled from radioactive material.”
The nuclear industry has launched a consultation on a code of practice for
recycling waste that contains so little radioactivity it is “exempt” from
regulation. It would expose people to only a tiny amount of radiation above
background levels, the industry says. David Owen, chairman of the Nuclear
Industry Clearance and Exemption Working Group, said that legislation would
allow companies to recycle nuclear waste. “It is not my place to tell them
what they can and cannot do. It is very important to do the right thing. We
will take good ideas from anywhere .”
The government’s green watchdog, the Scottish Environment Protection Agency (Sepa),
said the aim was to keep radiation doses to members of the public “as low as
is reasonably achievable ”. Radioactivity should be disposed of by the “best
practicable means”.
“As long as safety is assured there is a role for the re-use and recycling of
radioactive contaminated wastes, and this supports sustainable development,”
said a Sepa spokesman. But he accepted that there may be uses, like cooking
utensils, drinks cans and children’s playgrounds, for which recycled
radioactive materials could be inappropriate. “One argument might suggest
that we should develop controls on products that permit some limited rather
than general re-use.”
Environmental groups were less sanguine. “In a desperate attempt to cut
costs, the nuclear industry has now devised one of the most potentially
harmful examples of a ‘dilute and disperse’ policy”, said Duncan McLaren,
chief executive of Friends of the Earth Scotland.
“The idea of contaminated materials entering people’s homes is alarming. The
notion that the nuclear industry has suddenly caught on to the idea of waste
reduction is a nonsense. If it had, then it would stop calling for the
building of more nuclear power plants.”
www.nirex.co.uk
www.dti.gov.uk
www.sepa.org.uk/
www.nuclearpolicy.info

http://www.mercurynews.com/mld/mercurynews/news/local/9787608.htm?1c
Vaccine given to children in 2001 may be ineffective
ANONYMOUS ALLEGATION SPARKS ALERT, LEADS TO AN OFFER OF REVACCINATIONS,
WHICH POSE NO DANGER
By Matthai Chakko Kuruvila
Mercury News
The Palo Alto Medical Foundation and the MayView Community Health Center in
Mountain View announced Tuesday that vaccines given to 1,275 toddlers in 2001
may not be effective, and that they are offering to revaccinate the children.
The unusual public health effort is driven by an unprovable, anonymous
allegation that a former clinic employee mishandled the 2001 vaccines. The
employee, who no longer works for the medical foundation, told the Mercury
News that she is the victim of a smear campaign.
As public health officials and the two medical centers investigated the
allegation, they couldn't account for all the vaccines given to children in
2001. So they felt they had to alert parents. ``We weren't able to prove the
allegations in the letter or disprove them,'' said Jill Antonides, a
spokeswoman for the Palo Alto Medical Foundation. ``But we decided that the
right thing to do would be to take a cautious approach.'' The medical centers
are now offering revaccinations, which they say pose no danger even if
children received effective immunizations.
The various vaccines given in 2001 were at worst ineffective, meaning that
the children would not be immunized against a laundry list of illnesses:
Hepatitis B, haemophilus bacteria, polio, measles, rubella, tetanus,
diphtheria, whooping cough, pneumococcus bacteria and chicken pox. Most of
the children were 1 to 2 years old in 2001, and none of them developed the
diseases they were supposed to be protected against, said Dr. Marty
Fenstersheib, health officer for Santa Clara County.
The investigation into the vaccines began in April, when an anonymous letter
was sent to the Palo Alto Medical Foundation and the Palo Alto Police
Department. The letter stated that the San Carlos woman had transported
vaccines in an unrefrigerated car from the medical foundation and the MayView
Health Clinic. The vaccines need to be refrigerated to be effective.
Officials had no proof that she had done so, but there was enough detail to
warrant an investigation, Fenstersheib said. The county and the medical
centers spent months poring through thousands of records to see whether any
vaccines could have been mishandled.
After finding discrepancies in some vaccine records, authorities issued the
call for revaccination. The registered nurse who is at the center of the
investigation said she had no idea who was sending the letters about her. But
she speculated that it might be related to her pending divorce. The woman,
who said she was dismissed from the medical foundation in 2003 for an
unrelated matter, said she never transported vaccines unsafely. The
foundation has sent letters to the parents of 1,250 children and set up an
information line for questions at (650) 853-2300. The MayView center will
individually contact the parents of 25 children who may have received
vaccines in question. Parents also may call (650) 965-3323, extension 311, to
schedule an appointment.
Both clinics have set up drop-by hours for the revaccinations, which are free
of charge.
Contact Matthai Chakko Kuruvila at mkuruvila@mercurynews. com or
(650)688-7581.

http://www.ama-assn.org/apps/pf_new/pf_online?f_n=resultLink&
doc=policyfiles/HnE/H-440.970.HTM&s_t=H-440.970&catg=AMA/HnE&catg=AMA/BnGnC&catg=AMA/DIR&&
nth=1&&st_p=0&nth=1&
H-440.970 Religious Exemptions from Immunizations.
Since religious/philosophic exemptions from immunizations endanger not only
the health of the unvaccinated individual, but also the health of those in
his or her group and the community at large, the AMA (1) encourages state
medical associations to seek removal of such exemptions in statutes requiring
mandatory immunizations; (2) encourages physicians and state and local
medical associations to work with public health officials to inform religious
groups and others who object to immunizations of the benefits of vaccinations
and the risk to their own health and that of the general public if they
refuse to accept them; and (3) encourages state and local medical
associations to work with public health officials to develop contingency
plans for controlling outbreaks in exempt populations and to intensify
efforts to achieve high immunization rates in communities where groups having
religious exemptions from immunizations reside. (CSA Rep. B, A-87;
Reaffirmed: Sunset Report, I-97)

PNEUMOVAX® 23-Pneumococcal Vaccine Polyvalent-Manufactured and Distributed
by Merck & Co. Inc. Whitehouse Station, NJ. 08889 USA
Vax the mother - with all associated risks - on the presumption that it
will prevent her babe from getting pneumococcal disease.
J Infect Dis. 2004 Nov 15;190(10):1758-61. Epub 2004 Oct 07. Related
Articles, Links
Colostrum Obtained from Women Vaccinated with Pneumococcal Vaccine during
Pregnancy Inhibits Epithelial Adhesion of Streptococcus pneumoniae.
Deubzer HE, Obaro SK, Newman VO, Adegbola RA, Greenwood BM, Henderson DC.
Imperial College, Faculty of Medicine, Department of Immunology, Chelsea and
Westminster Hospital, London, United Kingdom.
Prevention of nasopharyngeal colonization may reduce the burden of
pneumococcal infection during infancy. Colostrum obtained from Gambian
mothers who had been vaccinated with either Pneumovax II or Mengivax A&C (n=8
per group) during pregnancy was examined for inhibition of adherence of
Streptococcus pneumoniae serotypes 6B and 14 to pharyngeal epithelial cells
in vitro. Pneumococcal adherence was significantly reduced in the presence of
breast milk (P</=.0001 for S. pneumoniae serotype 14; P=.036 for serotype
6B), independent of the concentration of secretory IgA antibodies. Maternal
vaccination with polyvalent pneumococcal polysaccharide vaccine boosts the
capacity of colostrum to inhibit adherence of pneumococci to pharyngeal
epithelial cells. In breast-feeding populations, maternal vaccination might
prevent pneumococcal disease in young infants.
PMID: 15499530 [PubMed - in process]

http://www.reutershealth.com/archive/2004/10/22/eline/links/20041022elin025.html
Quarantine used in Iowa to contain measles
Last Updated: 2004-10-22 15:15:28 -0400 (Reuters Health)
NEW YORK (Reuters Health) - A measles outbreak earlier this year was
contained by instituting quarantine measures after exposed persons refused
post-exposure preventative treatment, according to a report from the Iowa
Department of Pubic Health and other state offices.
As described in the CDC's Morbidity and Mortality Weekly Report, local and
state health departments contacted people exposed to a student returning to
Iowa from India who had come down with measles.
Two of these contacts caught measles, and people exposed to them were also
identified.
Altogether, approximately 200 persons were given post-exposure prophylaxis
(PEP), consisting of measles-mumps-rubella (MMR) vaccination within three
days of exposure or immune globulin within six days.
Two of the three infected people belonged to "an insular community with low
vaccination rates," the authors explain. All susceptible members of the
community were offered PEP, but seven individuals refused.
The seven were served with state-issued involuntary home quarantine orders
for two weeks. Compliance was monitored with unannounced home visits or
telephone calls.
"A lot of things went into our decision to use quarantine," Dr. Patricia
Quinlisk, with the Iowa Department of Public Health in Des Moines, told
Reuters Health.
"For example, the highly infectious nature of measles; the fact that in some
of the communities a large percentage of the people were totally susceptible
to measles; the fact that measles can be a serious disease, especially in
adults; and that the community had large daily gatherings which would have
allowed measles to be transmitted."
This episode "was sort of a dry run should something happen that is more
catastrophic," Quinlisk commented. "I think it has made us more aware of how
the system did work quite well in lot of ways."
An editorial note with the report points out that all states have the
authority to detain persons under quarantine laws.
The authors recommend that states that have not recently reviewed their
quarantine laws do so, specifically reviewing issues of quarantine authority,
such as what diseases would be covered and how quarantine is to be enforced,
as well as jurisdictional considerations and due process concerns.
This is a complete abuse of police powers by the health department in Iowa.
They forcibly quarantined people who refused vaccination who were allegedly
exposed to measles. Yes, you read that correctly – they did not have the
measles – they were exposed to measles. Quarantining healthy people for an
exposure to the measles when 99.9% of the people who catch the measles fully
recover (according to sworn testimony at the Texas Legislature by past
Associate Commissioner of Disease Control Dr. Diane Simpson who now works at
the CDC) if they refuse vaccination is nothing more than harassment and an
absolute abuse of powers. Laws granting health departments unchecked
authority to forcibly vaccinate or quarantine someone who is not sick need to
be changed. They even admit in this article that this was practice for them
in case something more catastrophic happened later. If it happened in Iowa,
it can happen anywhere anytime.
If you would like to work on grassroots efforts to stop this in your state,
familiarize yourself with your current state statute and contact your
legislators immediately asking for medical, religious and conscientious
exemptions be inserted into these statutes with reasonable humane quarantines
for those who are actually sick if the disease is unreasonably deadly or
dangerous. In Texas, these abusive laws are contained in the Health and
Safety Code, Chapter 81 called the Communicable Disease Prevention and
Control Act. You can link to them by going to http://capitol.state.tx.us,
clicking on Texas Statutes, Clicking on Health and Safety Code, then clicking
on CHAPTER 81. COMMUNICABLE DISEASES, sections 82 and 83.
”If the department or a health authority has reasonable
cause to believe that an individual is ill with, has been exposed
to, or is the carrier of a communicable disease, the department or
health authority may order the individual, or the individual's
parent, legal guardian, or managing conservator if the individual
is a minor, to implement control measures that are reasonable and
necessary to prevent the introduction, transmission, and spread of
the disease in this state."
" In this section, "control measures" includes:
(1) immunization;
(2) detention;
(3) restriction;
(4) disinfection;
(5) decontamination;
(6) isolation;
(7) quarantine;
(8) disinfestation;
(9) chemoprophylaxis;
(10) preventive therapy;
(11) prevention; and
(12) education."
In Texas and most states, as the article below points out, the health
department has the authority to force the above "control measures" under
suspicion of exposure. These laws are separate and apart from exemptions for
school they apply to all people - adults and children - and grant the health
department way too much power. There are no exemptions for medical reasons,
religion or conscience from immunization for adults or children if the health
department orders vaccination under this law, and this needs to be changed
ASAP. It is reasonable to have someone who is ill with a contagious illness
with a high rate of death and disability to remain quarantined until they are
well, but to disrupt the lives and punish HEALTHY SYMPTOM FREE people
refusing immunization for an exposure to the measles is intolerable and
people need to fight this.
I do know that Connecticut, thanks to the great work of Lisa Reiss and CTVIA,
has exemptions in their state emergency powers laws, but as far as I know,
that is the ONLY state. Please get familiar with your state law and start
contacting legislators to stop this unchecked potential for abuse. We need
these changes in every state. - DR]

Copters to drop rabies vaccine
If you find a fishy smelling chunk, it might be a bait that is designed to
inoculate raccoons, but works on other animals.
By THERESA BLACKWELL, Times Staff Writer
Published February 23, 2005
If the sunshine holds, fishy-smelling bait filled with rabies vaccine will
rain over Pinellas County again starting this week. Pinellas County
Animal Services plans to launch its annual aerial assault on rabies. The
campaign began 10 years ago in response to 30 rabies cases that year. County
helicopters will drop at least 20,000 rabies baits over Pinellas during a
month's time. The U.S. Department of Agriculture is paying for the baits.
The main treatment area lies north of Gulf-to-Bay Boulevard and includes the
Brooker Creek Preserve, the county's borders with Hillsborough and Pasco
counties and Honeymoon and Caladesi islands. Officials will try to put the
baits wherever there are isolated woods, said Welch Agnew, the assistant
director of veterinary services for Pinellas County Animal Services.
Other areas include Weedon Island, Gandy Flats, the St. Petersburg-Clearwater
International Airport, Pinellas County Utilities Solid Waste, Fort DeSoto
Park and other parks south of Gulf-to-Bay. County officials say the
oral vaccine program works, but it's only part of the solution to protecting
residents and their pets from rabies.
"Vaccinate your pets," Agnew said. "That's the key to the whole rabies
control program." Agnew said the vaccine protects your pets. It also provides
a buffer zone between humans and wildlife with rabies. With the aerial
vaccination program, new cases of animals with the raccoon strain of rabies
went down to one animal each year in 1998, 1999 and 2000. Numbers crept up
slightly in subsequent years, so the county put out an increased number of
baits in 2004.
Last year, raccoons confirmed as rabid mingled with humans three times in
Pinellas County, twice in Palm Harbor and once in northern Clearwater. And a
rabid bat crawled up the leg of a woman at an outdoor restaurant in St.
Petersburg. On Feb. 10, a rabid raccoon was found near Clearwater Christian
College, north of Gulf-to-Bay Boulevard.
The oral rabies vaccine is sealed in a covering that ruptures when the
raccoon bites into the fish meal bait. It's not harmful to humans or pets,
Agnew said, except that it may cause pets some stomach upset. And people with
compromised immune systems should avoid the vaccine. If you find one of the
baits in a high-traffic area, use a plastic bag to throw it into woods, if
possible.
The bait targets raccoons, the primary source of rabies in Florida, though
not the only source. The bait works on some other animals, like foxes and
coyotes. Bats also may carry their own strain of rabies, but they eat insects
like mosquitoes, not baits. "It's hard to put (vaccine) in a mosquito," Agnew
said.
For information, call Pinellas County Animal Services at (727) 582-2600 or
the Pinellas County Health Department, Environmental Health Division, at
(727) 507-4336.
TO HELP
The Pinellas County Animobile offers $1 rabies vaccinations with an $8 county
license. The Animobile will be at 1111 18th Ave. S, St. Petersburg, giving
rabies shots from 1:30 to 3 p.m. Thursday and Friday. It will be at the
Clearwater Health Department, 310 N Myrtle Ave., at the same times Tuesday
and March 3, 4, 8, 10, 11 and 15. Pet owners also can get $5 rabies shots and
an $8 county license at Pinellas County Animal Services, 12450 Ulmerton Road,
Largo. Call (727) 582-2600.

Contraceptive vaccines.
Naz RK.
Division of Research, Department of Obstetrics and Gynecology, Medical
College of Ohio, Toledo, Ohio 43614-5806, USA. Rnaz@mco.edu
The world's population is growing at a tremendous rate, affecting growth and
development. Apart from this population growth, unintended pregnancies
resulting in elective abortions continue to be a major public health issue.
In over half of these unintended pregnancies, the women have used some type
of contraception. Thus, there is an urgent need for a better method of
contraception that is acceptable, effective and available. The contraceptive
choices available to women at this time include steroid contraceptives,
intrauterine devices, barrier methods, spermicides, natural family planning,
male and female sterilisation, and recently available emergency
contraceptives. Contraceptive vaccines (CVs) may provide viable and valuable
alternatives that can fulfill most, if not all, properties of an ideal
contraceptive. Since both the developed and most of the developing nations
have an infrastructure for mass immunisation, the development of vaccines for
contraception is an exciting proposition. The molecules that are being
explored for CV development either target gamete production (gonadotropin
releasing hormone, follicle-stimulating hormone and luteinising hormone),
gamete function (zona pellucida [ZP] proteins and sperm antigens) or gamete
outcome (human chorionic gonadotropin [hCG]). Disadvantages of CVs targeting
gamete production are that they affect sex steroids and/or show only a
partial effect in reducing fertility. CVs targeting gamete function are
better choices. Vaccines based on ZP proteins are quite efficacious in
producing contraceptive effects. However, they invariably induce oophoritis
affecting sex steroids. Sperm antigens constitute the most promising and
exciting targets for CVs. Several sperm-specific antigens have been
delineated in several laboratories and are being actively explored for CV
development. Antisperm antibody-mediated immunoinfertility provides a
naturally occurring model to indicate how an antisperm vaccine will work in
humans. Vaccines targeting gamete outcome primarily focus on the hCG
molecule. The hCG vaccine is the first vaccine to undergo phase I and II
clinical trials in humans. Both the efficacy and the lack of immunotoxicity
have been reasonably well demonstrated for this vaccine. The present studies
focus on increasing the immunogenicity and efficacy of this birth control
vaccine.
PMID: 15748095 [PubMed - in process]

Not immunising children against TB should be criminalised
-Ramsammy says at World TB Day observance
By Daniel Da Costa
Monday, March 28th 2005
Minister of Health Dr Leslie Ramsammy on Friday said he hoped to make the
non-immunisation of children against tuberculosis (TB) a criminal act for
which parents could be penalised.
Speaking at the observance of World Tuberculosis Day at the recently opened
multi-million dollar New Amster-dam Hospital, Ramsammy noted that TB was a
curable disease and he urged parents to ensure that their children are
immunised against TB through available vaccinations. "It is inhumane and a
horrible mistake not to immunise children… It is not something to be
ashamed of and all Guyanese must stop stigmatising people with TB."
Addressing a wide cross-section of health workers, regional officials and
patients, Minister Ramsammy noted that the occasion provided an opportunity
to highlight the seriousness of tuberculosis and the great challenge it posed
to the public health sector. "We thought we had beaten TB a few years ago but
today it has re-emerged as a major public health threat across the globe
paralleling the HIV/AIDS crisis and claiming some 5,000 lives worldwide each
day." However, TB can be cured through the Directly Observed Treatment
Short-Course (DOTS) which ensures that the client takes the drugs. Full DOTS
programmes have been established at the Georgetown Hospital and Prisons,
Enmore Polyclinic, New Amsterdam Chest Clinic, Linden Chest Clinic, West
Demerara Regional Hospital, Maba-ruma, Mahdia, Kato and Lethem while a
programme is now being developed at the New Amsterdam Prisons. According to
Ramsammy, the Ministry will this year accelerate the development of the DOTS
programmes with assistance from the Canadian International Development Agency
(CIDA) and the Global AIDS Programme (GAP).
The Department of Health, Region Six (East Berbice/ Corentyne) hosted the
observance under the theme 'Health Workers can make a difference. Stop TB now
through DOTS.' Among those speaking at the mid-morning ceremony on the
institution's lawns were Dr Yakub Vaid, TB/HIV Co-ordinator of the US Centers
for Disease Control/Global AIDS Pro-gramme (CDC/GAP) Guyana and Dr. Enias
Baganizi of PAHO/WHO, Guyana Office.
Dr Vaid pointed out that one third of the world's population or some 1.86
billon people are currently infected with TB. "TB is the biggest curable
infectious killer of young people and adults in the world today. Every second
someone in the world is newly infected with tuberculosis while every year
eight million people become sick with TB, 95 per cent of them from developing
countries."
According to Dr Vaid, "if TB is left unchecked in the next 20 years, almost
one billion people will become newly infected; 200 million will develop the
disease while 35 million will die of it." More than 75 per cent of TB-related
disease and death occurs among people between the ages of 15 to 54, the most
economically important segment of the population. According to the co-ordinator
up to 50 per cent of people with HIV or AIDS develop TB, while worldwide 14
million are co-infected with TB and HIV.
Tuberculosis he said remains a threat to the health and well-being of people
around the world.
"Until TB is controlled World TB Day won't be a celebration. But it is a
valuable opportunity to educate the public about the devastation TB can
spread and how it can be stopped. TB is a global emergency but it can be
cured and the spread of disease stopped."
Dr Baganizi noted that the impact of co-infection with TB and HIV is
enormous. "Each disease speeds up the progress of the other and TB
considerably shortens the survival of people with HIV/AIDS. TB kills up to
half of all AIDS patients worldwide while most people infected with HIV in
developing countries develop TB as the first manifestation of AIDS. The two
diseases represent a deadly combination since they are more destructive
together than either one alone."
Dr. Baganizi said he was confident that with the dedication and commitment
from the Ministry of Health together with the contribution from the
international donors, Guy-ana will be able to achieve the Millennium
Development Goal for TB control. This includes detecting 70 per cent of new
smear positive cases and successfully treating 85 per cent of these cases by
the end of this year and by 2015; to halt and begin to reverse the incidence
of TB and to halve TB prevalence and death rates. "We in PAHO commit
ourselves to continuing our technical co-operation both with countries at a
national level and between countries in the Region of the Americas to reach
these goals in decreasing the burden of TB on people living in the Americas,"
he concluded.
Tuberculosis is a disease caused by bacteria called Mycobacterium
Tuberculosis. It is spread through the air when people who have the disease
cough, sneeze, talk, sing or spit. The TB germs go into the air and can
infect people who breathe in the germs. The German physician Robert Koch
discovered tubercle bacilli, belonging to a group of bacteria called
Mycobacterium, which causes tuberculosis, on March 24, 1882.
http://www.stabroeknews.com/index.pl/article_local_news?id=14936813

Muslim parents in Mali jailed for refusing kids polio
vaccines
http://news.yahoo.com/s/afp/20050511/hl_afp/malihealthislam/nc:1437
BAMAKO (AFP) - Eleven Muslim people presented before a Mali court as members
of a fundamentalist sect have been given jail terms of between six months and
three years for denying their children polio vaccinations, a judge said.
Sidiki Sanogo, the justice of the peace who convicted and passed sentence on
the 11 on Tuesday in the southern town of Yorosso, told AFP: "I was only
applying the law, this sect was gaining ground in the region and its members
lived in a secluded hamlet, their women cloistered separately apart."
The people sentenced included nine Malians and two citizens of the
neighbouring sub-Saharan nation of Burkina Faso. One another person, a
Malian, was acquitted because the court found he was "not opposed to the
vaccination". Without specifying when all 12 were detained and charged,
Sanogo said they were convicted of "resisting authority, disobedience and
rebellion" after they refused to allow their children to be vaccinated,
arguing that "God makes people sick and he saves them."
"These people are Muslims who practise an unclear rite and who want to live
outside any aspect of modern times," a legal source who asked not to be named
told AFP. Witnesses said that the trial proceedings were sometimes
"rowdy" since the defendants stuck "tooth and nail" to their convictions.
Those jailed included the Burkinabe leader of the group, Amadou
Konate,described by witnesses as a visionary guru with a negative influence
on others.

www.courant.com/news/health/hc-anthraxkids0623.artjun23,0,491226.stor
y?coll=hc-headlines-health
Hartford Courant
June 23 2005
Critics Blast Anthrax Vaccine Test
National Institutes Of Health Officials Plan Trial On 100 Children By THOMAS D.
WILLIAMS Courant Staff Writer
The National Institutes of Health is under fire from critics over a plan to test
two anthrax vaccines on children.
The trial will test and compare the reactions in humans to the vaccine
manufactured by BioPort Corp. of Lansing, Mich., and another being developed by
NIH. Bob Bock, an NIH spokesman, said the trial planned for 100 children in
first and second grade will not occur until the vaccines are fully tested
on 350 adults and shown to be safe for them. "The results in this study," says
an NIH announcement, "will help in the development of improved vaccines for
anthrax." The NIH and U.S. Health and Human Services Department are calling for
development of the vaccine to protect civilians from terrorist or other attacks.
Critics, however, are appalled.
"This vaccine is totally inappropriate for children, because the [exposure]
threat is so remote," said Barbara Loe Fisher, president of the National Vaccine
Information Center. "They will likely never be exposed to anthrax either through
contamination by animal products or inhalation of weaponized
anthrax."
"Children are involved in trials of vaccines that benefit children," she said,
"but this vaccine will not do so." Fisher said based on the NIH announcement of
"rare severe reactions" to BioPort's vaccine, she fears the parents of children
used in the experiments will not be given proper warnings of the vaccine's
potential for adverse reactions. However, Bock said adults and parents or
guardians of the children will be given complete information on the two vaccines
and their benefits and risks.
"I don't understand how they can do efficacy tests with children at the same
time that we are discovering more and more U.S. soldiers who have been harmed by
the vaccine," said Steve Robinson, executive director of the National Gulf War
Resource Center for service members and veterans. "[NIH officials] want parents
to want their children to be vaccinated against the anthrax terrorist attacks
that have not happened."
But Bock said that if terrorist attacks occur, both children and adults would be
at risk.
BioPort's vaccine, used almost exclusively on soldiers, has already demonstrated
an adverse reaction rate 100 times the figure initially stated on the label.
Adverse reactions include immune disorders, muscle and joint pain, headaches,
rashes, fatigue, nausea, diarrhea, chills and fever. At least half a dozen
deaths and a number of birth defects have been attributed to its use.
BioPort officials did not respond to repeated messages seeking comment
Wednesday.
Retired Air Force Col. John Richardson, who has independently researched the
vaccine extensively, said that in 2003, there were 16,869 federal adverse
reaction reports for all vaccines and of those, 1,068 were for the anthrax
vaccine. The anthrax vaccine drew more than 6 percent of all vaccine
complaints, said Richardson, even though anthrax vaccinations represented less
than 1 percent of an estimated 100 million immunizations of all types
administered that year.
For last year, he said, there were 15,488 federal adverse reaction reports for
all vaccines, and 806 for anthrax, or 5.2 percent of the total. Complaints to
the reporting system - which even federal officials
acknowledge typically represent as few as 10 percent of all adverse reactions to
vaccines - can be filed by vaccine users, doctors and medical personnel.
The vaccine, aimed at protecting soldiers against anthrax spores fired into the
air in combat, has been under attack by service members and their advocates ever
since the Pentagon mandated its use in 1998. Aside from the anthrax spore
attacks aimed at government officials 3½ years ago, no such attacks are known to
have been used during modern warfare or by any terrorists.

TheBostonChannel.com
Technique May Speed Vaccine For Childbirth Infection
POSTED: 4:19 pm EDT June 30, 2005
WASHINGTON -- Scientists hunting a vaccine to protect newborns from a severe
infection not only found a promising candidate, they developed a new way to
speed the search for vaccines against other hard-to-fight diseases, too.
It's a gene-searching technique that goes by the humble name "multiple genome
screen." But the research, led by Chiron Corp., elicited a "wow" from the
government's infectious disease chief. "It opens up a new arena" in developing
vaccines against multiple strains of diseases, said Dr. Anthony Fauci, head of
the National Institute of Allergy and Infectious Diseases. "This is a very, very
elegant, potentially usable avenue to go after that whole concept of universal
vaccines."
The first candidate: a possible vaccine against Group B strep, a germ that lurks
harmlessly in many women's bodies but that can befatal or brain-damaging if
passed to their infants during birth.So far, the experimental vaccine has been
tested only in mice. But studies reported Thursday in the journal Science
suggest it's the first candidate in two decades that might protect against all
major
strains of Group B strep. Chiron's lead researcher says the company is
discussing with U.S. regulators how to begin human testing.
"We are very excited because we do have, now, something we believe will work."
- Guido Grandi,
Chiron vice president for research
"We are very excited because we do have, now, something we believe will work,"
said Guido Grandi, vice president for research at Chiron's vaccine division in
Siena, Italy. Group B streptococcus, a cousin of the germ that causes strep
throat, is found in up to 40 percent of women. It usually causes
them no symptoms. But it's the most common cause of blood infection and
meningitis in newborns.
In the United States, pregnant women are supposed to be tested for Group B strep
during the third trimester, and carriers are given intravenous antibiotics
during labor. That policy has cut infant
infections by 70 percent since 1996 -- but still, Group B strep sickens about
2,500 U.S. newborns each year and kills 80 to 100. There are numerous strains of
the germ, and previous attempts at
vaccines couldn't offer universal protection.
Enter the new genetic technique.
Instead of laboriously growing the bacteria in laboratory dishes -- a usual step
in vaccine creation -- the scientists used computers to rapidly identify all the
genes in eight major strains of Group B
strep. First they teased out genes shared by all the strains, said Herve
Tettelin, a molecular biologist with The Institute for Genomic Research, a
Rockville, Md., nonprofit group that collaborated with
Chiron. Then they identified additional genes that produce proteins on the
germs' surface -- easy for the immune system to spot and thus important for a
vaccine, he explained.
Mouse testing revealed four proteins that seemed to spark the most immune
response. So the scientists brewed those four proteins into a single vaccine,
inoculated adult female mice, mated them and exposed the resulting babies to
Group B strep.
The vaccine proved 87 percent protective. ( it doesn't work then)
Chiron is most interested in testing the experimental vaccine in
teenagers, to see if protection would last years later when they
became pregnant, Grandi said.
More exciting, the genetic-screening technique may help develop vaccines against
a variety of microbes where multiple-strain protection is a roadblock, said
Fauci, whose National Institutes of
Health division helped fund the research. "We'll certainly be pursuing it," he
said. Already, Tettelin said his research group is using the technique to
identify the genes in multiple strains of food-poisoning E. coli, bacterial
pneumonia and a potential bioterror agent called
burkholderia.

http://www.pharmcast.com/Patents100/Yr2005/
Sept2005/092005/6946448_Utero092005.htm
The present invention is based on the discovery that a single immunization with
a nucleic acid vaccine, delivered orally to a fetus through the amniotic fluid,
induces high serum antibody titers and
cell-mediated immune responses in immunized fetuses, as well as in the newborn
subjects. Moreover, this route of delivery provides direct access to a number of
potential mucosal sites in the upper and lower respiratory tract, induces local
immunity in the oral cavity and does not induce immune tolerance. In utero
nucleic acid immunization, therefore, provides an efficient means of limiting
vertical transmission of infectious diseases before, during and after birth.

Global Drug Industry Launches All-Out Attack on Rights
of Thimerosal-Injured Children
Thimerosal is a mercury-based additive to vaccines that has potentially poisoned
hundreds of thousands of American children. Faced with the prospect of thousands
of lawsuits seeking compensation for the devastating injuries caused by
thimerosal poisoning, the international pharmaceutical companies and their army
of lobbyists are pushing a bill in Congress to wipe out the rights of children
and their families to get legal relief. Rather than seek an answer in a fair
court, these corporations have instructed Senator Frist to champion legislation
that would refuse these children their day in court. Sponsored by Senator Bill
Frist (Republican, TN), the legislation known as SB 2053 or "the Frist Bill"
would:
require that every thimerosal-injury lawsuit currently pending anywhere in
America be immediately dismissed
force thimerosal injury claims into a bureaucratic administrative program in
Washington, DC that is not designed to handle these claims
prohibit any judge from ordering the drug companies to provide the money for
desperately needed research and medical monitoring of children exposed to
thimerosal forever deprive any child over the age of 8 of any legal remedy
whatsoever, either in the courts or in the federal administrative program
prohibit class action lawsuits related to thimerosal injuries and thimerosal
exposure. This website will give you the background information and tools you
need to defeat this anti-child, anti-justice, pro-industry bill. Time is of the
essence, and making sure your voice as well of the voices of your friends and
families need to be heard in Congress to stop this terrible bill.
Please send the following text to your Senator or the Health Committee Members
listed on this page:
Senator, I believe that every citizen of this country has the right to a fair
pursuit of justice when wronged. The drug companies are attempting to move Frist
Bill SB2053 forward quickly. It is set for a hearing in front of Sen Kennedy's
Health Committee. I am asking you to refuse SB2053 (the "Frist Bill"). It is
anti-child, pro-corporation and anti-justice. The Frist Bill addresses
thimerosal and is specifically putting corporate welfare before that of our
children. Thimerosal is a mercury-based preservative that may have damaged
thousands of children. These children and their families have the right to
pursue this issue in court. The Frist Bill blocks that right unilaterally and in
perpetuity in all venues.
I ask you, Senator, as a protector of our nation to choose our children over the
corporations in this matter and stop the Frist Bill from going forward.
washingtonpost.com
Study: Experimental AIDS Vaccine Safe for Babies
By Maggie Fox
Reuters
Wednesday, February 12, 2003; 11:52 AM
An experimental AIDS vaccine seems to be safe for babies born to women infected
with HIV, and early signs suggest it may help protect them from infection, U.S.
researchers said Wednesday. The vaccine, made by Aventis Pasteur, is one of
dozens being tested although few experts believe any of them could actually
prevent HIV infection in a global population.
Instead, doctors are hoping to use different vaccines on different groups in the
hope of preventing some infections. One of these areas is in mother-to-child
transmission of the AIDS virus. About a quarter of children born to HIV-infected
mothers catch the virus, either during birth or through breast milk.
Giving the mother and baby drugs can reduce this risk, but a vaccine might be
safer, more effective and perhaps cheaper. A network of doctors across the
United States, led by Dr. Elizabeth MacFarland of the University of Colorado
Health Sciences Center, tested Aventis Pasteur's experimental ALVAC-HIV vCP205 –
which is a vaccine using canarypox, a distant relative of the virus used in the
smallpox vaccine – combined with several proteins from the AIDS virus.
The idea is to prime cells to recognize and destroy cells infected with HIV.
They tested 23 babies with four doses of the vaccine. All were born to
HIV-infected mothers in the United States. It was a phase I-II study designed to
show that the vaccine was safe, not to prove it works, said Aventis Pasteur's
Jim Tartaglia.
"It wasn't designed as an efficacy trial. You would have to do a whole new trial
to show that," Tartaglia, head of research for the company, said in a telephone
interview. The study showed the vaccine was safe, with no serious side-effects
in the babies, the researchers told the 10th annual Conference on Retroviruses
and Opportunistic Infections in Boston, the major annual scientific meeting on
AIDS.
Tartaglia said it often takes a long time, sometimes years, to determine whether
a baby has contracted the AIDS virus. The babies were not tested to see if they
contracted HIV but the vaccine did cause an immune response in the babies, which
would suggest it may help to prevent HIV infection.
DISCUSSIONS IN AFRICA?
Tartaglia said Aventis Pasteur is now deciding what to do next. He said the
company would discuss this with authorities in Africa – the region hardest-hit
by HIV – and the National Institutes of Health in the United
States.
A separate team of researchers tested a slightly different version of the
vaccine in HIV-infected adults who had been keeping the virus controlled using
drugs. A strong cocktail of medicines known as highly active antiretroviral
therapy or HAART can keep AIDS at bay and keep patients healthy, but they are
expensive and have unpleasant side-effects. And the virus can eventually mutate
to resist the drugs, forcing doctors to re-formulate the cocktail.
Many researchers are testing the idea of a "drug holiday" to give patients a
break and the give the body a chance to fight the virus on its own. A team of
French researchers told the conference they tested 48 patients on HAART with
four doses of the vaccine. Four months after starting, they were taken off HAART.
Again, the study was meant to show the approach was safe and the researchers
noted no severe reactions to the vaccine. After 44 weeks, 21 percent of the
patients still have the virus well under control and have not needed to re-start
the drugs, they said. Tartaglia stressed it is too soon to tell whether the
vaccine can be used to relieve patients on HAART.
"Is it a six-month drug holiday? Is it a 12-month drug holiday? I think we are
in the early stages of the field," he said. Based in Lyon, France, Aventis
Pasteur is owned by French drugmaker Aventis SA.
if it doesn't work, give more is their insane science........
Government told to start Hib boosters for all infants Pulse; Tonbridge; Jan 27,
2003;
Government vaccine advisers have recommended every child between six months and
four years receive a booster vaccination against Haemophilus influenza type b.
The Joint Committee on Vaccination and Immunisation is concerned the effect of
the Hib vaccine, given to children at two, three and four months, wears off over
time.
Full Text:
Copyright CMP Information Ltd. Jan 27, 2003
Hib vaccine
By Rob Gough
Government vaccine advisers have recommended every child between six months and
four years receive a booster vaccination against Haemophilus influenza type b.
The Joint Committee on Vaccination and Immunisation is concerned the effect of
the Hib vaccine, given to children at two, three and four months, wears off over
time.
Latest figures from the Public Health Laboratory Service show rates of Hib
infection in the under-fives have increased four-fold from 0.68 per 100,000 in
1998 to 2.81 in 2001. The joint commitee has advised the Department of Health to
begin a one-off catch-up vaccination programme, immunising all children
currently between six months and four years old with an extra dose of the
vaccine.
Committee members said at their last meeting that although the UK programme had
been highly successful, 'further enhancement of immunity appears necessary'. Dr
Mary Ramsay, consultant in public health at the Public Health Laboratory
Service's immunisation division, said many cases of Hib were occurring in
children whose immunity had declined after getting the vaccine. 'We really need
to do this now,' she warned.'Everybody under four years old is at increased
risk.'
Dr Ramsay said it was not yet known whether a routine booster would have to be
added to the vaccination schedule. 'The campaign, if it goes ahead, would be a
temporary holding measure. Once that's happened we'll be able to see whether we
need a booster in the long- term,' she added.
GPC joint-deputy chair Dr Hamish Meldrum said GPs would be paid for giving the
extra Hib dose as an additional service under the new contract. 'We're still
discussing ways additional services will be funded,' he said. 'It will almost
certainly not be funded by an item- of-service fee.' A department spokesman said
it was still 'considering options' for the vaccination campaign.
http://www.upi.com/view.cfm?StoryID=20030411-033622-1578r
Vaccine attacks four childhood diseases
By Ed Susman
UPI Science News
From the Science & Technology Desk
Published 4/11/2003 11:52 AM
GIARDINI NAXOS, SICILY, Italy, April 11 (UPI) -- The first vaccine designed to
protect children simultaneously against measles, mumps, rubella and chicken pox
appears promising in preliminary studies, researchers reported Friday. The
vaccine, being developed by Merck Research Laboratories of West Point, Pa., is
exciting doctors because they see the potential of increasing vaccine coverage
for infections of varicella, the organism that causes chicken pox.
"This is first in the world vaccine aimed at these four major childhood
diseases," said Dr. Jay Lieberman, a researcher at the UCLA Center for Vaccine
Research in Torrance, Calif. "We think that if we can reduce the number of shots
young children have to take to be protected against these diseases we have the
potential to get our numbers up to around 90 percent vaccinated against chicken
pox," he told United Press International. Lieberman presented his findings at
the annual meeting of the European Society for Pediatric Infectious Diseases.
Vaccination for varicella -- recommended for U.S. children under age 2 --has a
wide range of coverage state-to-state. About 70 percent of the U.S. childhood
population is covered. "The drive in this field is to combine vaccines," said
Dr. Jodie McVernon of the Public Health Laboratory Service Communicable Disease
Surveillance Center in London. "The more visits you make to the doctors, the
worse your vaccine coverage is likely to be." In his presentation, Lieberman,
who also is associate professor of medicine at the University of California,
Irvine, said his study compared the ability of vaccinated children to produce
antibodies to the diseases in three different lots of the medication -- a step
required by the U.S. Food and Drug Administration to show the vaccine can be
manufactured consistently.
The vaccine was administered to about three-quarters of 3,928 healthy children
ages 12-to-23 months. The other children were given one injection of the MMR-II
(measles, mumps, rubella) vaccine, which has been given to children for decades.
These children also received a second injection of Varivax -- a chicken pox
vaccine. The shots generally were given in each arm. Researchers looked at
seroconversion -- how well antibodies to the diseases developed -- after the
inoculations were performed. They found the results were similar for each
vaccine lot and, in turn, were similar to seroconversion seen in children
receiving the two approved vaccines. Lieberman also reported:
--In measles, 97.6 percent of children receiving experimental ProQuad vaccine
showed seroconversion, compared to 98.5 percent of those getting the two
vaccines.
--In mumps, 96 percent receiving ProQuad showed seroconversion, vs. 97.9 percent
of those receiving the two vaccines.
--In rubella, 98.8 percent getting ProQuad showed seroconversion, vs. 99.2
percent of those getting two vaccines.
--In varicella, 93.5 percent getting ProQuad and 95 percent getting Varivax
showed seroconversion.
Lieberman said children receiving ProQuad appeared to suffer more fevers in the
six weeks following the inoculations -- 39.1 percent vs. 33.1 percent -- but he
said he did not think the figures were clinically relevant. However, he noted
there was no difference between the group receiving ProQuad and those getting
the two vaccines, in terms of developing worrisome, fever-related seizures.
Lieberman said he expects Merck likely will file with the FDA for approval of
the vaccine "soon" but he said he was not aware of an exact timetable to do so.
"Doctors are excited about the idea that they can deliver this vaccine in one
shot," Lieberman said. "That has the potential to enhance compliance especially
against chicken pox at an early age."
http://abcnews.go.com/wire/US/reuters20030416_779.html
April 16
— By Ransdell Pierson
NEW YORK (Reuters) - U.S. scientists have asked more than a dozen American and
European healthcare companies to help develop a vaccine to protect against SARS,
the flu-like disease that has killed 159 people around the globe. But officials
from companies who attended the meeting in Washington last week said it could
take years to come up with a safe and effective vaccine.
Top scientists from the U.S. Centers for Disease Control and the National
Institutes of Health last week issued the call for help, at a meeting attended
by Secretary Tommy Thompson, head of the U.S. Department of Health and Human
Services. "Now that the virus has been identified, the government made it clear
it wants to talk to anyone who can make a vaccine," said Una Ryan, chief
executive of Avant Immunotherpeutics, a small company that is developing an oral
vaccine to protect against both anthrax and plague infections.
Company officials said the government scientists gave updates about SARS, but
have not yet offered specific financial assistance to get their research
rolling. Ryan said government scientists at the meeting favored the quickest
possible vaccine approach -- of growing the virus, killing it and then
delivering it by injection to spur protective antibodies against future
infection with the virus. "Developing a vaccine from a killed virus is the
quickest and easiest thing to do," Dr. Anthony Fauci, head of the U.S. National
Institute of Allergy and Infectious Diseases, said in an interview.
"You grow the virus, kill it, and there you go. You have a vaccine. But it would
still take years to actually have the vaccine in the bottle and ready to
distribute," Fauci said, because of the need to prove its safety and
effectiveness. U.S. and Canadian scientists earlier this week said they had
independently mapped the genome of the coronavirus blamed for SARS. It has been
carried to a score of countries in the past six weeks, killing about 4 percent
of those infected. Attendees at the meeting included U.S. vaccine makers Merck &
Co. Inc., Wyeth, Chiron Corp., Vical Inc. and Avant, as well as Europe's
GlaxoSmithKline Plc, Aventis, PowderJect Pharmaceuticals Plc and Berna Biotech .
Also on hand for the meeting were U.S. healthcare companies Johnson & Johnson
and Baxter International Inc. . Fauci said companies could also help by testing
whether their drugs work against SARS, including ones "sitting on their shelves"
that have never been approved. "Another more-sophisticated route would be for
companies to design drugs that interfere with structural and regulatory genes of
the virus," Fauci said. Such an approach was used to develop pills that control
HIV, the virus that causes AIDS.
Scientists have not yet developed an effective vaccine against HIV. Researchers
have shied away from developing a vaccine using a killed virus because HIV,
unlike SARS, is life-threatening to almost everyone it infects, Fauci said.
"With HIV, we have been concerned that if you inject someone with the 'killed'
virus and you have not actually killed it, you might inadvertently infect the
person." Scientists agreed it could take years to analyze the SARS virus and
develop a vaccine. "This is a tough target. You have to grow the virus in a cell
line, kill it, test it, and you need a highly secure facility in which to do all
this," said Vijay Samant, the chief executive of Vical. Vical is working with
the government to develop vaccines against anthrax, ebola and malaria.
"The meeting in Washington last week was only an information-sharing session, so
we're still trying to determine what role to play," said Merck spokeswoman Janet
Skidmore. Skidmore noted Merck has been working for a decade to develop an HIV
vaccine, and said it could take awhile for an effective SARS vaccine to emerge.
Ryan said Avant favors developing an oral vaccine, loading key proteins called
antigens from the surface of the SARS virus into live but genetically disabled
cholera bacteria. He said this could be more effective and safer than the
approach the government favors. "We will be dependent on the government to
identify which antigens from the virus they think should be used," Ryan said.
Aventis, the world's biggest vaccine maker, has already given government
researchers a culture made of monkey kidney cells in which to grow and test the
virus that causes SARS. "We don't know what next step we can take to help, but
we're ready to partner with the government in whatever manner that makes sense,"
said Aventis spokesman Len Lavenda.
Lavenda said Aventis has several highly secure laboratories for performing
studies with dangerous bacteria and viruses, all of which are now being used.
"But perhaps one or more of them could be converted for SARS research."
(Additional reporting by Toni Clarke)
http://www.ama-assn.org/sci-pubs/amnews/pick_03/hlsc0526.htm
HEALTH & SCIENCE
Scientists eye new developments on the vaccine front The vast range of pathogens
and their ability to mutate beyond the reach of many antibiotics continue to
challenge researchers.
By Susan J. Landers, AMNews staff. May 26, 2003.
Washington -- Vaccines that target influenza, measles, polio and pneumonia are
wiping out those infections that have long taken a toll on human life. But there
are plenty of other pathogens to keep microbe hunters on the job developing new
vaccines to eradicate infections that are fatal to many patients, especially the
youngest, oldest and most frail. Microbiologists, epidemiologists and public
health physicians gathered early this month for updates on the ongoing search
for new vaccines at the 6th Annual Conference on Vaccine Research in Arlington,
Va. The conference was sponsored by the National Foundation for Infectious
Diseases.
Presentations ranged from the search for a safer, next-generation smallpox
vaccine to those that prevent infection by such nasty bugs as Staphylococcus
aureus and Clostridium difficile. The threat of bioterrorist attack has kept the
smallpox virus center stage, prompting researchers to step up work on a new
vaccine that can be used safely to inoculate individuals not currently deemed
eligible for the existing one.
For instance, individuals who have a compromised immune system or a history of
eczema are cautioned against receiving the smallpox vaccine unless there is an
actual smallpox outbreak.A new smallpox vaccine is being evaluated, said Richard
N. Greenberg, MD, professor of medicine at the University of Kentucky College of
Medicine in Lexington, although, because of the small numbers of volunteers in
the trial, there is no definitive outcome.
Resistant Staphylococcus aureus appeared in 2002.
"The new vaccine, known as CCSV, contains a strain of the vaccinia virus that is
grown in cell culture," Dr. Greenberg said. DryVax, the vaccine now in use to
immunize those deemed first responders to bioterrorist attacks, contains a
similar virus but was produced by infecting cows. Vaccines that target the
following infectious agents also were described as being in varying stages of
development, although none has gained Food and Drug Administration approval for
general use.
Staphylococcus aureus. A phase III clinical trial has shown that the vaccine
StaphVAX is providing some immunity against S. aureus infections among a group
of trial participants who were undergoing hemodialysis. The new vaccine targets
a sugar molecule on S. aureus that allows the pathogen to evade the body's
immune system. Findings from the trial were published last year in the New
England Journal of Medicine.
Another vaccine, Veronate, has completed a phase I trial.
Providing urgency to the development of an effective vaccine is the increase in
antibiotic-resistant strains of S. aureus and their emergence as a source of
community-acquired infection. This constantly growing resistance to existing
antimicrobials is troubling. The bacteria have been resistant to penicillin
since the 1940s, and strains resistant to methicillin have been noted since the
1960s. Resistance to vancomycin, the so-called last resort antibiotic, surfaced
in 2002.
By 15, almost all children with cystic fibrosis harbor Pseudomonas aeruginosa.
Pseudomonas. A vaccine to target Pseudomonas aeruginosa has been sought for
years. It would be particularly important for children with cystic fibrosis. By
15, nearly 100% of children with the chronic disease harbor large numbers of the
bacteria that cause pulmonary infections. Phase I trials have now concluded for
the vaccine candidate Cytovaxine. Respiratory syncytial virus. In the United
States, it is estimated that 70,000 to 126,000 infants are hospitalized annually
with RSV pneumonia or bronchiolitis. RSV can also cause life-threatening
pulmonary disease in bone marrow transplant recipients, and it is a major source
of infection for elderly people. Two types of candidate vaccines are in clinical
trials.
Clostridium difficile. Vaccines are also in development for C. difficile, a
major cause of diarrhea among hospitalized elderly and immunocompromised
patients. The pathogen is also responsible for most cases of antibiotic-related
diarrhea.
http://news.bmn.com/news/story?day=030430&story=1
BCG gets new lease of life against HIV
29 April 2003 12:00 GMTby Julie Clayton
BCG, the vaccine that has lost favor in many countries for its poor level of
long-term protection against tuberculosis (TB), could have a new lease of life
as a vehicle for an HIV vaccine, say researchers. The strategy could ultimately
prove more affordable and practical for developing countries, they say, compared
with DNA-based vaccines currently in clinical trials. "DNA vaccines are so
expensive to make they're really not suitable in the real term," said Enid
Shephard, immunologist at the University of Cape Town's Department of Medicine,
and principle investigator at the South Africa AIDS Vaccine Initiative (SAAVI).
In her view, cost effectiveness is going to be a major criterion when deciding
whether or not a particular vaccine is likely to become widely available.
In South Africa, BCG vaccination is routinely given to all children as part of a
national childhood vaccination program. Despite its poor level of protection
specifically against TB, the vaccine is widely acknowledged to help protect more
broadly against a number of different infections, including helminth parasites
(worms), by triggering Th1-type immune responses, which favor antibody
production and the release of inflammatory cytokine mediators, says Shephard.
"Children actually fight off other infections if they are BCG-positive," she
said, adding that they also appear to be less prone to certain allergies. The
BCG program also means that the necessary infrastructure is already in place for
delivering a BCG-based HIV vaccine.
So far, in tests on mice, a recombinant BCG construct containing a selection of
HIV genes appears to be equally as effective for boosting responses as is a
DNA-based vaccine. In both cases, mice were first exposed to an initial
DNA-based vaccination. The next steps will be to see if the recombinant BCG
vaccine can work alone in triggering HIV-specific responses, and to test its
efficacy in baboons, according to Shephard.
"Recombinant BCG as a vector has some advantages," agreed Pontiano Kaleebu,
virologist and principle investigator for the International AIDS Vaccine
Initiative (IAVI) vaccine trial at the Uganda Virus Research Institute in
Entebbe. "It is not expensive, the vector has been extensively administered in
humans worldwide, and it's safe."
Kaleebu cautions, however, that no one yet knows the effect that prior BCG
vaccination may have in individuals receiving a recombinant BCG-based HIV
vaccine. "These have to be evaluated."
In the meantime, SAAVI's DNA-based vaccine is already further down the pipeline,
and may enter Phase I safety trials in around 18 months time, depending on
animal toxicity studies, according to Shephard's colleague Anna-Liese Williamson
of the Department of Clinical Laboratory Sciences and Institute of Infectious
Disease and Molecular Medicine at the University of Cape Town.
"To have vaccines made in such a short time is more than we thought we would
achieve," said Williamson, "I'm a believer that we should have as many trials as
possible so that we can get information to figure out what works."
SAAVI is a consortium of labs and hospitals forming Africa's first home-produced
pipeline for taking experimental HIV vaccines from the bench to the clinic. In
particular, their vaccines focus on the sub-type C clade of HIV, which prevails
in South Africa. The DNA-based vaccine will be tested in a prime-boost strategy
similar to that already in clinical trials elsewhere, including the University
of Oxford's candidate now in Phase II trials in Oxford, London and Nairobi, and
the IAVI Phase II trial in Uganda.
The SAAVI DNA vaccine contains a combination of HIV antigens (gag, reverse
transcriptase, Tat and nef) and is being produced to good manufacturing practice
standards by UK firm Cobra Therapeutics. This will be used for an initial
vaccination, or primer, to be followed by a second booster step with another
vaccine based on the smallpox-like vector, modified vaccinia Ankara (MVA). The
latter is in production at the US-based company Therion.
The DNA vaccine has so far been tested in both mice and baboons. "Our DNA
results are very promising," said Shephard, who presented unpublished data at
this week's Federation of African Immunological Societies meeting in Victorial
Falls, Zimbabwe.
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
http://www.ahrp.org
Contact: Vera Hassner Sharav
Tel: 212-595-8974
e-mail: veracare@ahrp.org
FYI
Malaria kills millions of African children yearly. For many decades malaria
vaccines have been sought but have been dismal failures. NATURE and BBC report
that a vaccine experiment will be conducted
in 2,000 children in Mozambique--even though the vaccine's safety has only been
tested in adults in small phase I trials.
The sponsors are GlaxoSmithKline and the Malaria Vaccine Initiative (MVI, funded
by the Gates Foundation). In addition to the malaria parasite protein, the
vaccine contains "a fragment of hepatitis B" and an adjuvant. Nature reports
that the vaccine trial sponsors (GSK and MVI) claim that in the adult tests the
vaccine (RTS,S) "protected up to 71% of adults from being infected with
malaria."
However in the next paragraph the article notes that Melinda Moree,director of
the MVI admits that "Chances of success are slim. We're going to hear more about
failures than successes....Even negative results move us quite a way forward,'
she says." BBC reports that in the adult trial the vaccine’s protective action
wore off after two months. The experiment raises serious ethical concerns that
need to be addressed before 2,000 children are exposed to an experimental
vaccine that the sponsor admits is likely to fail:
1. What are the subjects' parents told about the vaccine?
2. Since the vaccine has not been tested in children before, its safety in
children has not been assured. Therefore this is essentially a phase I safety
trial. Why then, are 2,000 children being exposed before its safety in children
has been established?
3. If the efficacy rate in the small phase I adult trials was 71% what led the
sponsor to state that the vaccine's "chances of success are slim"?
4. What were the negative findings of the adult trials?
5. What is the adjuvant used with the vaccine?
6. What is the adjuvant's toxicity in humans--since it is not licensed in the
US?
7. What is the toxicity of the portion of the Hepatitis B virus that is
included, given that France halted its countrywide Hepatitis B vaccination
program several years ago due to serious neurologic side effects in a minority
of recipients?
8. Since the vaccines protective effect of the vaccine in the adult safety
trials wore off after just two months, does the sponsor and those conducting the
trial anticipate inoculating the children every two
months?
9. If so, what evidence is there that multiple shots are safe? Shouldn't
children’s exposure to an experimental vaccine be guided by precautionary
measures? Phase I (vaccine safety trials) do not
test multiple inoculations.
10. What is the ethical justification for a “trigger happy cowboy approach?”
Should scientists be allowed to take risky leaps without adequate safety data
and expose 2,000 children to an experimental vaccine that the sponsor admits has
“slim” chances for success?
Vera Hassner Sharav, President, AHRP
Meryl Nass, MD, Board member, AHRP
http://www.nature.com/nsu/nsu_pf/030707/030707-4.html
Two thousand kids to get experimental malaria jab Largest ever test of malaria
vaccine to begin in Africa. 9 July 2003
Tom Clarke
Malaria kills one million people a year in Africa.
© WHO
The most advanced test of a vaccine against malaria ever conducted in children
begins in Mozambique next week. The hope is that immunization will become a
primary weapon in the fight against malaria, which kills 1 million Africans each
year, most of them toddlers and babies. Currently, drugs - to which resistance
is rapidly developing - and protections like bed nets are the only ways to
control the disease.
Two thousand children under five will take part in the trial, funded by the
Malaria Vaccine Initiative (MVI), an independent organization based in
Rockville, Maryland, which coordinates international efforts to develop malaria
vaccines, and drug giant GlaxoSmithKline. "This is the largest malaria vaccine
trial carried out in Africa to date," says Pedro Alonso, scientific director of
the study's base, the Manhiça Health Research Centre in Mozambique.
Tests with small numbers of volunteers have satisfied researchers that the
candidate vaccine - called RTS,S - is safe. The next stage, a phase 2 trial,
will now ask whether the vaccine actually prevents malaria in children. Results
should be available in 18 months.
RTS,S consists of a protein found on the surface of the malaria parasite at the
stage when a mosquito's bite injects it into the human body. It also contains a
fragment of the hepatitis B virus, too little to cause the disease, but large
enough to goad the body's immune system into recognizing the malaria fragment.
A chemical mix called an adjuvant is the final ingredient. This tricks the
immune system into mounting a strong immune response to the vaccine, helping it
to remember the crucial parasite protein. In tests in the Gambia, RTS,S
protected up to 71% of adults from being infected with malaria. If the vaccine
has similar success in children it must then pass further tests in babies. Those
under a year old are excluded from this trial for safety reasons but are at the
highest risk of dying from malaria.
Chances of success are slim, admits Melinda Moree, director of the MVI. Only one
of 80 current malaria vaccine concepts is estimated to succeed, she explains:
"We're going to hear more about failures than successes." But a clinical trial
is the only way to find out what approaches do and don't work. "Even negative
results move us quite a way forward," she says.
That RTS,S is in the most advanced stages of testing doesn't mean it is the best
candidate vaccine. It has been in development since the 1980s and has the
backing of a large company, says Adrian Hill at the University of Oxford, UK.
Hill's team is working on a different approach using modified viruses to carry
malaria genes into the body; initial results are promising1. Around nine other
candidate vaccines are also in safety trials this year.
References
McConkey, S. J. et al. Enhanced T-cell immunogenicity of plasmid DNA
vaccines boosted by recombinant modified vaccina virus Ankara in humans.
Nature Medicine, published online, doi:10.1038/nm881 (2003).
© Nature News Service / Macmillan Magazines Ltd 2003
Twins stop breathing after jabs
Calls are being made for more information about the safety of vaccinations for
premature babies after twin brothers nearly died. Niles and Harvey Johnson, who
were born nine weeks prematurely, stopped breathing within hours of having their
first vaccinations.
Their father, Tom, resuscitated them while his wife, Melanie, telephoned for an
ambulance. Although Niles and Harvey survived, their parents say they were not
warned of the risks vaccines posed for premature babies. Daventry and South
Northamptonshire Primary Care Trust said the benefits of vaccines outweighed the
risks, but it would be investigating the case.
The twins had their first injections at a GP surgery near their home in Long
Buckby on 21 August just over a week after arriving home. The first vaccinations
are to immunise babies against whooping cough, diphtheria, tetanus, meningitis
and polio. We just went into a state of panic - you just don't expect to see
your babies stop breathing
Melanie Johnson
Mr and Mrs Johnson said hours later their eight-week-old babies were rushed to
hospital with breathing difficulties. "We just went into a state of panic. You
just don't expect to see your babies stop breathing," said Mrs Johnson. "Thank
goodness Tom was able to stimulate them while I was on the phone to the
ambulance. "We thought all the problems were all behind us - we thought when we
came home we would be a happy family." She added: "It could have been a very
different Saturday morning we were waking up to."
Mr and Mrs Johnson want more information given to parents of premature babies
warning of the possible dangers of injections. Daventry and South Northants
Primary Care Trust said such side-effects were very rare. The trust has arranged
for the twins to have their next injections in hospital, where they will spend
48 hours under observation.
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/1/hi/england/northamptonshire/3198721.stm
Published: 2003/09/01 17:57:05 GMT
"Niger: Focus on the Vaccination of Nomadic Children"
Africa News Service (www.allafrica.com) (10/08/03)
UNICEF says that few of Niger's children have been vaccinated against
preventable diseases; Niger has nomadic tribes, who are hard to track. According
to UNICEF, almost 30 percent of Niger's children die before they are five--in
large part due to preventable diseases--so the organization has decided to focus
on preventative actions, protection issues, and development. During August, the
national vaccination rate of children up to 11 months old climbed to 50 percent,
but UNICEF says that some southern districts are resisting the polio vaccination
due to religious or cultural beliefs. UNICEF makes use of an annual ceremony
held by the nomadic tribes, vaccinating children at the celebrations.
"Scientists Create 'Pharmacy in a Chip'"
TechNewsWorld (www.technewsworld.com) (10/21/03); Mitchell, Steve
Potentially revolutionizing the pharmaceutical industry, researchers are
developing an implantable microchip capable of delivering precise doses of
several different drugs over a period of months. The chip is likely to benefit
patients taking numerous drugs per day as well as doctors who want to ensure the
complete dosage is taken by the patient. The chip could also release multiple
doses of a vaccine, which could ensure patients are fully immunized even if they
live in rural areas and are unable to reach clinics for multiple doses of a
vaccine. Current time-release technology in capsules or patches release the
drugs continuously, but the chip is able to release specific dosages at specific
intervals. Cost is an issue keeping the technology from reaching the general
public. Once the chip has completed its tasks, it degrades within the body and
is gone within a matter of months. The technology is currently undergoing
clinical trials in order to receive Food and Drug Administration approval.
U.S. IMMUNIZATION NEWS
"Vaccine to Fight Staph Infections After Surgery"
Wall Street Journal (www.wsj.com) (10/29/03) P. B4D; Hovey, Hollister H.
Nabi Biopharmaceuticals has developed a vaccine against the Staphylococcus
aureus bacterium. The vaccine, called StaphVAX, is important because antibiotics
currently used to treat staph infections could eventually become ineffective as
the bacteria develop resistance to the drugs. StaphVAX is currently undergoing
clinical trials with dialysis patients; however, it could eventually become
useful for any hospitalized patient at risk of infection. The vaccine could
prove useful to as many as 12 million Americans per year, according to
market-research firm Mattson Jack Group. Nabi hopes to enter the European market
with StaphVAX in two years and the U.S. market by the end of 2006.
Can't you just hear the CHA CHING?
http://www.healthypages.net/newspage.asp?newsid=3842
Chickenpox vaccine okay for nursing mothers
2003-11-18 16:32:13
NEW YORK (Reuters Health) - The virus that is used in the chickenpox vaccine
doesn't seem to enter a mother's breast milk or pass to feeding infants, new
research shows. This means that nursing mothers who are susceptible to
chickenpox do not need to wait to get the vaccine. Although chickenpox is often
thought of as a childhood illness, adults can get it too and usually it is much
more serious than in kids.
Because chickenpox can be especially harmful during pregnancy, the vaccine is
recommended for susceptible, non-pregnant women of childbearing age. Ideally,
vaccination would occur before pregnancy, but, in reality, many susceptible
women are not identified until after they've given birth.
Based on reports of certain viruses being excreted in breast milk, there has
been concern about giving the chickenpox vaccine to breastfeeding mothers.
However, it was not known whether the vaccine virus did find its way into breast
milk or even if exposing babies to the virus was harmful. To investigate, Dr.
Kari Bohlke, from Group Health Cooperative in Seattle, and colleagues tested for
the virus in blood and milk samples obtained from 12 women who received two
doses of the vaccine while breastfeeding. In addition, blood samples were
obtained from the mothers' infants and tested for the virus.
As reported in the medical journal Obstetrics and Gynecology, none of the 217
milk samples obtained after vaccination showed any evidence of the virus.
Moreover, there were no signs of the virus in blood samples taken from the
babies. "Although we cannot completely exclude the possibility that excretion
(into breast milk) occurs, these findings suggest that vaccination should not be
delayed in breast-feeding women who are known to be (chickenpox) susceptible,"
the researchers note.
"Offering the first vaccine dose before a susceptible woman is discharged after
delivery and the second dose at the postpartum follow-up visit would provide
early protection for the woman and would facilitate compliance with the two-dose
vaccine schedule," they add.
SOURCE: Obstetrics and Gynecology, November 2003.
http://www.newscientist.com/news/news.jsp?id=ns99994318
US develops lethal new viruses
19:00 29 October 03
A scientist funded by the US government has deliberately created an extremely
deadly form of mousepox, a relative of the smallpox virus, through genetic
engineering. The new virus kills all mice even if they have been given antiviral
drugs as well as a vaccine that would normally protect them. The work has not
stopped there. The cowpox virus, which infects a range of animals including
humans, has been genetically altered in a similar way.
The new virus, which is about to be tested on animals, should be lethal only to
mice, Mark Buller of the University of St Louis told New Scientist. He says his
work is necessary to explore what bioterrorists might do. But the research
brings closer the prospect of pox viruses that cause only mild infections in
humans being turned into diseases lethal even to people who have been
vaccinated.
And vaccines are currently our main defence against smallpox and its relatives,
such as the monkeypox that reached the US this year. Some researchers think the
latest research is risky and unnecessary. "I have great concern about doing this
in a pox virus that can cross species," said Ian Ramshaw of the Australian
National University in Canberra on being told of Buller's work. Ramshaw was a
member of the team that accidentally discovered how to make mousepox more deadly
(New Scientist, 13 January 2001). But the modified mousepox his team created was
not as deadly as Buller's.
No rebound
Since then, Ramshaw told New Scientist, his team has also created more deadly
forms of mousepox, and has used the same method to engineer a more deadly
rabbitpox virus. But this research revealed that the modified pox viruses are
not contagious, he says. That is good news in the sense that these viruses could
not cause ecological havoc by wiping out mouse or rabbit populations around the
world if they escaped from a lab.
However, this discovery also means some bioterrorists might be more tempted to
use the same trick to modify a pox virus that infects humans. Such a disease,
like anthrax, would infect only those directly exposed to it. It would not
spread around the world and rebound on the attackers. But there is no guarantee
that other pox viruses modified in a similar way would also be non-contagious.
Ramshaw's team made its initial discovery while developing contraceptive
vaccines for sterilising mice and rabbits without killing them. The researchers
modified the mousepox virus by adding a gene for a natural immunosuppressant
called IL-4, expecting this would boost antibody production.
Instead, the modified mousepox virus was far more lethal, killing 60 per cent of
vaccinated mice. The addition of IL-4 seems to switch off a key part of the
immune system called the cell-mediated response.
Maximised production
Now Buller has engineered a mousepox strain that kills 100 per cent of
vaccinated mice, even when they were also treated with the antiviral drug
cidofovir. A monoclonal antibody that mops up IL-4 did save some, however. His
team "optimised" the virus by placing the IL-4 gene in a different part of the
viral genome and adding a promoter sequence to maximise production of the IL-4
protein, he told a biosecurity conference in Geneva last week. Buller has also
constructed a cowpox virus containing the mouse IL-4 gene, which is about to be
tested on mice at the US Army Medical Research Institute of Infectious Diseases
at Fort Detrick, Maryland.
Cowpox infects people, but Buller says the IL-4 protein is species-specific and
would not affect the human immune system. The experiments are being done at the
second-highest level of biological containment.
Nine-eleven
Ramshaw says there is no reason to do the cowpox experiments, as his group's
work on rabbits has already shown the method works for other pox viruses. While
viruses containing mouse IL-4 should not be lethal to humans, recombinant
viruses can have unexpected effects, he says. "You'd hope the combination
remains mouse-specific."
Why his group's engineered viruses are not contagious is a mystery, he says. It
is not, for instance, because the host dies faster than usual, taking the virus
with it. But his findings could explain why pox viruses containing IL-4 have
never evolved naturally, even though the viruses frequently pick up genes that
affect their host's immunity. Despite the concerns, work on lethal new pox
viruses seems likely to continue in the US. When members of the audience in
Geneva questioned the need for such experiments, an American voice in the back
boomed out: "Nine-eleven". There were murmurs of agreement.
Debora MacKenzie, Geneva
CPS finally swoops in, just not in right case
Oct. 15, 2003 12:00 AM
When the call came in this summer about a 7-year-old boy living in a closet,
Child Protective Services was too busy to check it out. A few days later, police
found the boy, stripped and starving. When the call came in about 3-year-old
twins in cages, CPS declared it a low priority and tossed it to a social worker
who couldn´t get past the front door. This summer, police found the boys, now 5,
still living in filthy cages.
When the call came in about a mother who decided her kids did not need rabies
shots, well, you can imagine what happened. That´s right. CPS was on her in an
instant. Within hours of getting a complaint, no less than a unit supervisor
showed up on Anita Masse´s doorstep in Strawberry, threatening to immediately
seize her three children. This, because Masse wouldn´t agree to get the painful
shots to guard against a disease she felt they had no chance of contracting.
Neighbors were shocked to hear that CPS was knocking on the Masses´ door. "This
is an exemplary family here," said Dee Cox, who lives across from the Masses, on
Peach Lane. "Every kid should be so lucky to live in a home like this. It´s the
last home in Arizona where you would expect CPS to come."
Apparently, no longer. Comes now the inevitable other end of the spectrum of
child protection, the ultimate result that you knew would come when CPS began
taking heat for all the times it didn´t do enough to protect children. Comes now
the next swing of the CPS pendulum: overreaction in all the wrong cases. The
Masses live in a trim home tucked into the woods of Strawberry, just a ride
through the pines up from Payson. Dominic works in construction while Anita
takes care of the kids: Rebecca, 11, Cody, 10, and Emily, 8.
Their problems began in July when bats got into the house. At first, it was one
or two at a time, sightings that would send the parents running for a broom and
a dustpan and the kids running for cover. Dominic tore out the ridge of the roof
to find out how the bats were getting in and fix it. Unfortunately, he didn´t
build in an escape route for the bats already in the rafters. The family was
watching TV the evening of July 27, when six bats suddenly swept into the living
room.
The Masses stayed at the Coxes that night and the next, after five more bats
were found. Meanwhile, Anita called Gila County Rabies Control for help. She got
it - and more.
County workers told her that state health guidelines say you should get rabies
shots if you´ve been bitten, scratched or slept in a room with a bat that has
not been tested. But Anita says none of those things happened with her children.
After doing some research - talking to her pediatrician, state biologists and
the local hospital - Anita decided the shots weren´t necessary. Meanwhile, two
of the bats were tested and came up clean. Still, the county continued to
insist, so Masse called a reporter and appeared on TV, suggesting that if the
state wanted her to get shots, the state should pay for them. Within 24 hours,
Mary Meyers, a CPS supervisor, was at her door with an ultimatum: agree to the
shots or lose your kids tonight.
In the eyes of CPS - eyes that see no immediate danger in parents who closet or
cage their kids - Masse was providing an unsafe home. So unsafe, according to
CPS records, as to require that the children be immediately taken and parceled
out into foster care. Of course, Masse couldn´t let that happen so she agreed to
force her children to endure the painful shots. Shots which, by the way, are
recommended by the state, not mandated.
CPS wouldn´t discuss the case, employing the usual confidentiality dodge. Craig
Levy, the bat expert at DHS, acknowledged that the recommendations are advisory
only. "You´d hope that parents would make the appropriate decision to protect
their kids," he added. But the thing is, Anita Masse thought she had made the
appropriate decision. She knows the disease is fatal. She also contends her kids
were never near the bats. "I go out of my way to protect my children," she said.
"If I had ever thought they were in danger they would have gotten the shots.
It´s not up to the state. I think that it is my decision as a parent."
Apparently not. Not anymore.
http://nachrichten.boerse.de/anzeige.php3?id=775c11cf
Developing and Launching Novel Medicines and Vaccines
In addition to the 2003 submissions, Merck has novel vaccine candidates and a
diabetes drug in its late-stage pipeline. The company expects to submit a
Product License Application (PLA) to the FDA for its PROQUAD vaccine, a
pediatric combination vaccine for measles, mumps, rubella and chicken pox, in
the second quarter of 2004. Merck expects to file PLAs with the FDA for three
novel vaccine candidates in the second half of 2005: a human papillomavirus (HPV)
vaccine; a shingles (zoster) vaccine; and ROTATEQ, a vaccine for
rotavirus-induced infant diarrhea.
Merck's investigational HPV vaccine has the potential to be the first vaccine to
prevent HPV infection and is expected to have the broadest HPV coverage in
vaccines currently known to be in development. HPV infection can lead to the
development of cervical cancer, which is the second-most common cancer in women.
Cervical cancer impacts approximately 470,000 women each year and leads to more
than 200,000 deaths. An estimated 30 million adolescents and adult females in
the United States are at risk for developing HPV infection. Enrollment in
Merck's large Phase III quadrivalent HPV vaccine program is complete, with
approximately 17,000 subjects enrolled. The HPV vaccine is expected to reduce
the risk of HPV infection and the associated development of cervical cancer and
genital warts. HPV 16 is one of the more serious forms of HPV and is associated
with cervical cancer deaths. Merck's Phase II proof-of-concept study with an HPV
16 vaccine showed 100-percent efficacy. The company is confident that competing
intellectual property claims will not delay the HPV program. Enrollment in
Merck's large Phase III program for a zoster vaccine is complete. The vaccine is
being developed for the prevention of shingles, a painful condition, which
affects up to 1 million adults each year in the United States and is caused by
the reactivation of the chicken pox virus.
Each year, rotavirus-induced infant diarrhea leads to more than 500,000
physician visits and 50,000 hospitalizations in the United States and causes
more than 400,000 infant deaths in the developing world. Currently, no rotavirus
vaccines or anti-viral treatments exist for the prevention of rotavirus. Merck's
Phase III trial for ROTATEQ is under way with more than 60,000 infants enrolled.
The company is also studying a DP-IV inhibitor, a glucose-lowering mechanism
used alone and in combination for the treatment of Type II diabetes. The number
of people suffering from Type II or Non-Insulin Dependent Diabetes Mellitus
today in major pharmaceutical markets is 40 million and that total is expected
to more than double to 90 million by 2015. Merck plans to enter Phase III with
this investigational compound in the second quarter of 2004 and expects to
submit an NDA to the FDA in 2006.
In addition to reviewing the late stage pipeline, Peter S. Kim, Ph.D., president
of Merck Research Laboratories, outlined the company's preclinical and Phase I
and II programs during the meeting. Merck's research programs, which span 28
therapeutic categories, focus on the development of novel medicines that can
address large, unmet medical needs.
"When you look at the Merck pipeline, from preclinical to Phase III," Dr. Kim
said, "you can see the breadth and depth of our work in the areas of diabetes,
obesity, Alzheimer's disease, respiratory disease, coronary heart disease,
rheumatoid arthritis and vaccines. We are pleased with the developments in our
early stage pipeline and with the new technologies that give us the potential to
move compound candidates into later stages for development faster than before.
For example, we expect to move our DP-IV candidate from preclinical to Phase III
in just over two years, compared with the industry average of just over four
years."
Eyeless children championed by Observer win $7m test case
http://observer.guardian.co.uk/uk_news/story/0,6903,1111159,00.html
Ten years ago, we revealed the possible link between a fungicide and a tragic
birth defect. Now a US court has found a chemical giant guilty
Antony Barnett, public affairs editor
Sunday December 21, 2003
The Observer
A group of 30 British families who blame a controversial pesticide for causing
their babies to be born without eyes have won a historic breakthrough in their
quest to get justice and multi-million pound compensation. Ten years after The
Observer first revealed the possible link between the agricultural chemical
Benlate and this tragic medical condition, the Supreme Court in Florida has
ruled that the fungicide was responsible for causing the birth defects.
After fierce legal wrangles and appeals through the US courts, judges have
awarded an American family almost $7 million (£3.9m) in damages after their son
was born with empty eye sockets in 1990. The US chemical giant DuPont, which
made Benlate and has spent millions of dollars fighting the case, is understood
to have already handed over the money to the family.
It is the first time in legal history that a chemical company has been found
guilty of causing birth defects. The case has echoes of Thalidomide, the drug
found to cause babies to be born with deformed limbs. The American judges
concluded that John Castillo's condition was caused as a result of the boy's
mother, Donna, being sprayed with Benlate when she was seven weeks pregnant in
November 1989 as she walked past a fruit farm in Florida. Benlate was used for
years on farms and in gardens in Britain to control fungal infections until
DuPont took it off the market two years ago.
Jim Ferraro, the American lawyer who acted for the Castillos and is representing
the British families, said: 'This is a major victory and we now hope to win
justice for the British families who have suffered for years from this tragedy.'
Next year the affected British families are to sue DuPont in Delaware, the home
state of the chemical giant. Marty Griffin from Norfolk, whose son Darren was
born with only one eye in 1995 and who is suing DuPont, welcomed the
development.
'This is fantastic news,' he said. 'It shows that a large corporation cannot
railroad over the terrible problems its chemicals have caused. My wife was
exposed to Benlate very early on in her pregnancy and we are absolutely
convinced that it caused Darren's problems. 'When he was born, the hospital in
King's Lynn had never seen anything like it before and there is no family
history of any eye defects. We are looking forward to our day in court, when we
hope to finally get justice for Darren.'
The safety of benomyl, the chemical ingredient of Benlate, has been questioned
for several years. In 1991 scientists at the University of California discovered
that more than 40 per cent of pregnant rats fed high levels of benomyl produced
foetuses with severe eye defects. When the dosage of benomyl was administered to
rats given a protein-deficient diet, almost two out of three pregnant animals
gave birth to babies without eyes. The study was designed to show the impact of
the chemical on those with a poor diet.
As long ago as 1972, the US official watchdog, the Environmental Protection
Agency, advised that DuPont should put a label on Benlate warning that it could
'cause birth defects ... and exposure during pregnancy should be avoided'. But
lobbying from DuPont persuaded the EPA that the warning was misleading and
unnecessary, so it never appeared.
One of the most dramatic pieces of evidence to emerge during the legal disputes
has been an internal DuPont report on research the company funded in 1997 by an
independent laboratory in Yorkshire. Scientists tested benomyl on rats and
discovered that a 'high' proportion of the chemical was drawn to the eyes. The
report revealed that after two hours a third of the benomyl was concentrated in
the eyes, rising to two-thirds after 24 hours. After 10 days, 80 per cent of the
benomyl was pooled around the eyes.
Some scientists believe this reveals how the eyes act as a kind of powerful
magnet to attract the benomyl and explains how the chemical destroys the eyes of
a foetus. DuPont has always argued that humans could be exposed to large doses
of this fungicide without any risks to health. But scientists say the risks are
at a very different level for a foetus at the very early stages of pregnancy,
when the essential structures of a baby's eye and brain are being formed. DuPont
has recently withdrawn Benlate from the global market because of mounting
litigation costs.
The company has always denied that Benlate was the cause for the birth defects
and argued that the families' claim was based on 'junk science'. It claims to
have spent more than $1.3 billion over the past decade fighting Benlate lawsuits
and paying damages. Most cases have emanated from hundreds of growers of
flowers, ornamental plants and food crops who alleged that the fungicide wrecked
their produce.
antony.barnett@observer.co.uk
Better than a McDonalds voucher I suppose.
Susan
No link available.
Cairns Post, The (Australia)
November 6, 2003
ANY Cairns child aged between four and seven who is immunised in the next three
months will go in the draw to win a bike. The promotion, by the Cairns Division
of General Practice, aims to address an alarming shortfall in the number of
children who receive their scheduled four-year-old immunisations. GP's
spokeswoman Wendy Wall said children at that age should be vaccinated against
several diseases including diphtheria, tetanus, whooping cough, mumps, measles,
rubella, meningococcal C and polio. "Immunisation is so important and parents
should ensure their children are fully immunised," Dr Wall said.
The bike has been donated by Cairns Bicycle Works.
http://www.medilexicon.com/medicalnews.php?newsid=5149
TB bacteria may have key to preventing diabetes
04 Jan 2004
Scientists in Australia are investigating whether the bacteria responsible for
tuberculosis (TB) could prevent childhood diabetes. Childhood diabetes, also
known as insulin-dependent and type one diabetes, occurs when the body's immune
system attacks its own insulin-producing cells in the pancreas.
James Cook University Comparative Genomics Centre head Alan Baxter has disclosed
his research suggests a link between diabetes and the lack of exposure to
bacterial infections. 'If the immune system is busy fighting other infections it
tends not to cause the tissue damage associated with diseases like diabetes,' he
said. 'It's like a teenager at the movies - if it's a good movie they stay
occupied but if it's not, they get bored and start cutting up the seats.'
Experiments exposing diabetes-prone mice to Mycobacterium bovis, the cattle TB
found in unpasteurised milk, found they did not develop the disease. Dr Baxter
said his Townsville-based Australian research unit had isolated a molecule of
the bacteria which could be administered without causing other diseases.
A phase one trial on humans by the Centenary Institute in Sydney is scheduled
for mid-2004, although a second trial will be needed before scientists can
describe it as a breakthrough.
'We've taken the bacteria used for the TB vaccine, grown enormous amounts,
crushed them and then isolated one molecule,' Dr Baxter said. 'It's that
molecule we will be administering. 'Instead of using live bacteria, we're
injecting a small amount of killed bacteria ... by not using live bacteria, even
if someone has got HIV they won't get infected.' Dr Baxter said his theory
linking diabetes and lack of exposure to bacteria is supported by a rise in type
1 diabetes after World War II.
Since then pasteurized milk and sanitized lifestyles, involving a proliferation
of bacteria-fighting cleaning agents, have become the norm. 'The incidence of
type one diabetes has doubled every 15 years since the Second World War,' Dr
Baxter said. 'Back when people had TB in World War II there was a very low
incidence of type one diabetes. 'It's our hypothesis that type one diabetes is
related to lack of exposure to bacterial infections, but it's not proven yet ...
in the mice, we've certainly proven it.'
January 21, 2004
White House Seeks to Control What Public Learns About Health, Environmental
Emergencies
****This is the first of two articles on this subject. The second will appear
tomorrow.****
How and what Americans are told about public health emergencies would be
controlled by the White House, not by the agencies with the medical or
scientific expertise to handle these crises, under a new plan proposed by the
Office of Management and Budget (OMB).
The proposal would strip authority from federal health, safety and environmental
agencies and give the White House final say over how the public is told about
such emergencies as nuclear power plant accidents, outbreaks of mad cow disease
or drugs that are found to be harmful.
Critics fear such a move would delay the release of critical public information
and politicize the way it is presented. In comments submitted to the OMB, Dr.
Jordan Cohen, president of the Association of American Medical Colleges, and
Robert Wells, president of the Federation of American Societies for Experimental
Biology, described several recent public health emergencies where delays in
releasing information could have endangered the public. Among those examples
were the emergency termination of a clinical drug trial that showed the drug was
dangerous, and the announcement that hormone-replacement therapy was more
harmful than beneficial to many post-menopausal women. [1]
OMB's "Proposed Bulletin on Peer Review and Information Quality," which could
take effect as early as several months from now, is also being opposed by a
group of former top federal agency officials from both Democratic and Republican
Administrations. [2]
###
SOURCES:
[1] "White House Seeks Control on Health, Safety," St. Louis Post-Dispatch, Jan.
11, 2004.
[2] Letter to Joshua B. Bolton, Director of the OMB from 20 former agency
officials, Jan 9, 2004.
January 22, 2004
White House Seeking Control Over Scientific Peer Review of Environmental, Health
Research Which Shapes Federal Policies
****This is the second of two articles on this subject. The first appeared
yesterday.****
Environmental and health studies conducted for or used by the federal government
would require White House approval before their release, under a proposal now
under review at the Office of Management and Budget (OMB). The plan would also
give the White House authority to select which scientists take part in the
system known as peer review -- the process by which fellow researchers evaluate
the validity and reliability of studies before they are published.
Critics fear such a plan would undermine the impartiality of research that
guides government policies and regulations. For example, it would open the door
for the Administration to hand-select industry-friendly scientists to review
studies that investigate the safety of chemicals in our food and consumer
products, or studies that examine the environmental impact of energy plant
emissions. The White House has frequently expressed its commitment to easing
regulations for American industries. [1]
In a January 9 letter to the OMB, 20 former top federal agency officials, from
both Democratic and Republican administrations, urged the White House to drop
its proposal. The letter -- signed by former EPA Administrators Carol Browner
and Russell Train; former Secretary of Labor Robert Reich; former Assistant
Secretaries for Occupational Safety and Health Eula Bingham and Gerard Scannell;
and others -- warned that the proposal, "in its current form, could damage the
federal system for protecting public health and the environment." [2]
Currently, each federal agency controls peer review of its own projects. The
government's rules to ensure research quality are already less stringent than
those used by leading biomedical journals. For example, these journals require
authors to disclose who paid for the research; and the journals will only
publish studies done under contracts in which the investigators have the right
to publish regardless of the results. Federal agencies do not have these
requirements, nor do they consistently attempt to find out who paid for the
studies. [3]
Far from ensuring the validity of the peer review process, the plan's critics
assert that allowing the White House to control it would only add a layer of
politics to what should be a purely scientific process. [4]
###
SOURCES:
[1] "White House Seeks Control on Health, Safety," St. Louis Post-Dispatch, Jan.
11, 2004.
[2] Letter to Joshua B. Bolton, Director of the OMB from 20 former agency
officials, Jan 9, 2004.
[3] Michaels D, Wagner W. Disclosure in Regulatory Science. Science. 2003;
302:2073.
[4] "Peer Review Plan Draws Criticism," Washington Post, Jan. 15, 2004.
http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=4253390
Food Poisoning Bug May Lead to Better Vaccines
Fri January 30, 2004 05:10 PM ET
NEW YORK (Reuters Health) - US researchers have used a protein found in Listeria
monocytogenes, a microbe that can cause food poisoning, to create more effective
vaccines. The protein, known as listeriolysin O (LLO), helps the bug break
through the walls that surround the body's cells. Given this effect, the
researchers believed that the protein might also help vaccines gain entry into
cells, resulting in a stronger immune response. "We harnessed the clever
invasive machinery of Listeria and developed it into a potentially safer and
more effective vaccine delivery formulation," senior author Dr. Kyung-Dall Lee,
from the University of Michigan in Ann Arbor, said in a statement.
"We've shown that vaccines produced using the listeriolysin O protein can
dramatically boost the immune response" in mice, he added. In the current study,
Lee's team injected mice with an LLO vaccine against a test virus, a regular
vaccine against the same virus, or an LLO vaccine against no virus. After being
vaccinated, the animals were then injected with the virus to see if the vaccine
protected them from infection. The new findings are reported in the journal
Molecular Pharmaceutics.
Mice given the LLO vaccine against the test virus showed a stronger immune
response than did animals that received the other vaccines. Moreover, treatment
with this vaccine completely protected the animals from death after virus
injection, whereas the other vaccines did not. "We're very excited about this
promising vaccine delivery system, which could pave the way for the next
generation of safer, more effective vaccines," noted Lee, who holds a patent
related to the LLO delivery method.
SOURCE: Molecular Pharmaceutics, January 2004.
From: http://new.globalfreepress.com/article.pl?sid=03/12/30/1827249
Illegal Aerial-Aerosol ‘Vaccines’ Coming…
Michael Kane continues with his series about the latest BioDrills and possible
connections with Bio-Weather Modification Weapons
Read between the lines, and keep your eyes on the sky
Scarlet Cloud drills point to illegal aerosol “solution” Aerosol based
“vaccines” already contracted to Maxygen Maxygen working on AIDS ‘vaccine’ via
Rockefeller Foundation Test run of “vaccine” delivery during 411-east coast
blackout?
Many vaccines proven to promote disease
by Michael Kane
December 30th, 2003
Judith Miller broke the story of a secret cabinet level experiment named
“Scarlet Cloud”, in the NY Times on Dec. 28th. Miller writes that officials
stated the exercise “…showed that antibiotics in some cities could not be
distributed and administered quickly enough and that a widespread attack could
kill thousands” – she referred to anthrax.
So what is the solution? Judith doesn’t go into this in her piece, but if you
read her epic book “Germs” and pay close attention, you clearly see what the
“solution” is in the minds of DARPA.
Aerial-Aerosol Vaccination
“Perhaps someday the military would have a detergent that could be sprayed over
people and neutralize an anthrax attack” (J. Miller: “Germs”, pg. 307). DARPA –
the Defense Advanced Research Project Agency, gave Maxygen a $3.8 million
contract in 1998, and a $7.7 million contract in 1999. (Maxygen
reports the contract as $6.7 million)
Maxygen says this is a three year grant to use it’s proprietary
MolecularBreeding ™ directed evolution technology to protect against a broad
spectrum of Pathogens. Maxygen is involved in what they themselves call
“gene-shuffling”.
The military asked Maxygen to develop aerosol-based vaccines that could be
inhaled to safeguard people against a broad range of pathogens. Shaun Jones, the
first director of DARPA’s Unconventional Countermeasures program has said the
value of many of their programs will not be known till they are tested on people
(J. Miller: “Germs”, pg 308)
On May 11th, 2000, Clifford Carnicom posted the findings of strange red blood
cells in a ground sample believed to be part of an aerosol operation. Could this
have been part of the testing Jones contends is necessary for one of DARPA’s
projects? That is unknown, and what makes it a harder nut to crack is that the
EPA has refused to test the sample in question (which was sent to Carol M.
Browner, former head of the EPA).
411 blackout – testing ground for aerosol “vaccinations”?
I myself witnessed an aerial-aerosol spray operation at 8pm on August 14th, 2003
during the east coast blackout. I believe, just like 911, the 411 blackout was a
war game. Part of that war game scenario involved aerosol spray operations, but
what for?
I am convinced the spin for this, when the government is forced to fess-up to
portions of what really happened during the 411 blackout, will be that they were
running “drills” for mass aerosol vaccination of the public. Of course, the
claim will be that they did not spray “live” vaccine, but rather they were
testing the effectiveness of the delivery method via placebo. Who knows what the
rank of the lie will be; but they will be forced to recognize what they were
doing, and why, at some point, and this is the spin they will
use.
Is it true?
Possibly, but to get a more accurate picture of truth we must delve deeper into
this. Many top doctors and medical experts feel most vaccines have never been
proven to prevent disease, quite to the contrary. Many vaccines directly weaken
the immune system, and often times, can cause the disease
they are meant to “vaccinate” you from.
Might there be a hidden agenda behind “vaccines”? The leading research on the
dangers surrounding vaccines has been compiled by Gary Null. Well worth reading
- vaccines are not what they seem. Here is one of the best summaries I’ve ever
heard about vaccines, in laymen terms, from Verney-Elliot…
“The vaccine scam works like this. Identify and magnify an ‘epidemic’ disease,
whip up world panic, and devise a vaccine against the supposed causative agent.
Administer the vaccine, preferably just before the epidemic starts to wane
naturally, and then, when the cases of the disease start to diminish, claim the
vaccine has worked and the pharmaceutical company who manufacturers it will get
the credit for saving mankind. There will be bouquets and Nobel prizes all round
and every one makes a lot of money. One has only to look at the cases of the
anti-polio and anti-smallpox vaccine campaigns to see the classic modus operandi
in taking credit for ending the epidemics, which in the manner of all
self-limiting phenomena, were already dying out before the vaccine was
introduced…
Are vaccines scams? The answer is usually: Yes, at least a scam, often worse.
Forcing Illegal Vaccines on Soldiers
The military was ordered by the courts to stop using it’s soldiers as guinea
pigs for experimental, likely dangerous, anthrax vaccines. But back in October,
the government gave an $80.3 million contract to Vax Gen Inc. to develop yet
another experimental anthrax vaccine. That is a serious contract. Obviously
there must be those in the military-industrial complex who are not pleased with
that court decision.
www.anthraxadeadlyshotinthedark.com.
Even President Clinton (not one of my favorite people) banned experimental
vaccines on military personnel with a Presidential Executive Order, in September
of 1999. It seems every few years they bring back mandatory military anthrax
experimentation.
Oops! Did I say “experimentation”? - I meant to say “vaccination”
Maxygen & AIDS
In September of 2000, Maxygen announced a collaboration with the Scripps
Research Institute to identify potential vaccine candidates for an HIV vaccine.
In February of 2001 Maxygen announced collaboration with the IAVI –
International Aids Vaccine Initiative, and DBLV, LLC, an entity established and
funded by the Rockefeller foundation, to work on an AIDS vaccine. http://www.maxygen.com/newsview.php?listid=112
“Vaccines” in the Air?
Can we really trust the military to vaccinate our air? These are the same people
who put Gulf War I veterans through hell from depleted uranium - and guess what
else? You guessed it, anthrax vaccines.
Of course we can’t trust them to “vaccinate” our air! One only need reference
“Clouds of Secrecy”, written by Leonard A. Cole, which documents clandestine
American military aerosol operations unleashed in the subways of New York and
sprayed in San Francisco. Cole details the case of Edward J. Nevin, who died of
a mysterious infection in a Standford hospital. His grandson filed suit in 1981
against the government, claiming the aerosol operation in San Francisco was
responsible for his Grandfather’s death. The judge in the case barred a
scientist from testifying on the plaintiff’s
behalf (J. Miller: “Germs”, 347 note 42). The entire escapade reeked of
cover-up.
Then there is Project Shad, which Judith Miller leaves out of her book “Germs”.
The book is 400+ pages and I have not read all of it, but Project Shad is not
listed in the book’s extensive index. Let us not forget, this is the same Judith
Miller who used Ahmed Chalabi as an unidentified source for her spectacular (and
now completely discredited) weapons of mass destruction claims before Gulf War
II in Iraq.
Project Shad was the despicable U.S.G. experimentation - spraying aerosol clouds
over tugboats filled with Americans. VX Nerve agent and Sarin gas were used, but
the military never said exactly when this was done. To admit the exact date of
such an illegal experiment leaves those who were responsible wide open for
prosecution.
Guardian
More, more, more
DARPA, the government agency supporting many of Maxygen’s experimental
vaccination programs (from our tax dollars), has seen budget increases from $59
million in 1998 to $162 million in 2001, and estimated to rise to $205 million
by 2005 (Miller, Germs; pg 308). DARPA has also brought us Total Information
Awareness (TIA) – the big brother system created by convicted criminal John
Poindexter designed to rape any-&-all concept of privacy rights.
Keep your eyes on the sky and your ear to the ground peace eternal
Michael Kane was organizer of the 9/11 Investigative Film Exhibition and Panel
in New York at Riverside Church, September 2003. He is staff member of SGTV and
GFP since 2003.
In early 2004, his group Kane + Salem will release a 9/11 album which will also
cover other dark secrets of the U.S. Government.
http://www.vidyya.com/vol6/v6i25_4.htm
New vaccine for herpes in final trial phase
Approximately one in four women in the United States has genital herpes.
Symptoms are often subtle, and most people don't know they have herpes, but
genital herpes is among the most common infectious diseases. This is why Mount
Sinai School of Medicine has joined with the National Institute of Allergy and
Infectious Diseases and GlaxoSmithKline Biologicals in the Herpevac Trial for
Women. Healthy women aged 18-30 may be eligible to participate in the trial.
The herpes virus causes cold sores and genital herpes. Although thousands or
millions of Americans have the disease, 90% are unaware of this infection. Even
people who do not have visible symptoms can spread the disease. The disease
burden is estimated at between $300 million to $1 billion per year in the US
alone. There is no treatment that can eliminate the virus.
The Herpevac Trial for Women is investigating a promising vaccine to protect
women against genital herpes. This vaccine does not contain live virus and
cannot cause herpes infection. It has passed preliminary testing for safety and
effectiveness and is now in its final phase of clinical trials.
For this study, Mount Sinai and the more than 20 other sites involved in the
trail are seeking to enroll approximately 7,550 women. The Herpevac Trial for
Women is open to healthy females between the ages of 18 and 30 who are negative
for both HSV-1 and HSV-2.
Women who are interested in volunteering for the clinical trial will receive a
very accurate blood test that looks for antibodies (the immune system's
response) to both HSV-1 and HSV-2. Participants can obtain results of the test
by calling the Herpevac Trial for Women Test Result Hotline two weeks after
having the blood drawn. In addition to providing results, this Hotline has
trained counselors to answer questions about the test and test results so that
women who test positive for herpes can understand what this means to them.
Volunteers will be randomly assigned to receive either the candidate herpes
vaccine or and an investigational hepatitis A vaccine. Participants will receive
three doses of either vaccine within the first six months of the trial and will
be followed for a total of 20 months through periodic clinic visits and
contacts.
doi:10.1016/j.vaccine.2004.01.002 Cite or link using doi
Copyright © 2004 Published by Elsevier Science Ltd.
Breaking new ground are changes in immunization services needed for the
introduction of future HIV/AIDS vaccines and other new vaccines targeted at
adolescents?
C. J. Clementsa, Q. Abdool-Karimb, M. -L. Chang, , c, B. Nkowanec and J.
Esparzac
a Centre for International Health, Burnet Institute, Melbourne, Australia b
Nelson Mandela School of Medicine, University of Natal, Durban, South Africa c
Department of Immunization, Vaccines and Biologicals, Initiative for Vaccine
Research, World Health Organization, 1211, Geneva 27, Switzerland
Received 9 July 2003; revised 15 December 2003; accepted 7 January 2004. ;
Available online 28 January 2004.
Abstract
The first generation of HIV vaccines will soon be here, but many questions
remain unanswered regarding their administration. For instance, which vaccines
should be given to whom at what age and how many doses? We argue that pre- and
early-adolescents will be one of the main target groups for future HIV vaccines,
that is, before the age of exposure to the virus. Historically, immunization has
mainly focused on infants. Indeed, vaccines have only occasionally been
systematically targeted at adolescents, even in industrialized countries.
Delivering vaccines to pre-adolescents and adolescents in developing countries
would, to a great extent, be a new challenge.But it is not just HIV/AIDS
vaccines that are coming down the pipeline. Herpes simplex type2 (HSV-2) and
human papillomavirus (HPV) vaccines are also among the exciting candidate
vaccines that may be the agents of change needed to encourage even the poorest
countries to develop strategies for reaching adolescents with vaccines and other
health services in the coming decade. Together, they may also provide the
impetus for changing the paradigm for how vaccines are administered.Not only
will more antigens be included in national immunization schedules, but the age
of target groups will range much more widely than at present, encompassing older
children, adolescents and young adults. While presenting major difficulties for
delivery, these new ingredients also offer stimulating opportunities to
completely rethink how vaccines are presented, administered and delivered. We
predict that even the poorest countries will be looking to developing
integrated, sustainable strategies for reaching pre-adolescents and adolescents
with vaccines in the coming decade. Author Keywords: Immunization; HIV/AIDS;
Vaccines
Subject: Pertussis vaccination strategies for neonates––an exploratory
cost-effectiveness
doi:10.1016/j.vaccine.2003.11.057
Copyright © 2004 Published by Elsevier Science Ltd.
Pertussis vaccination strategies for neonates––an exploratory cost-effectiveness
analysis
P. A. Scuffham, , a and P. B. McIntyreb
a York Health Economics Consortium Ltd., Level 2, Market Square, University
of York, York YO10 5NH, UK
b National Centre for Immunisation Research and Surveillance, University of
Sydney, Sydney, Australia
Received 2 July 2003; accepted 24 November 2003. ; Available online 29 January
2004.
Abstract
Hospitalisation and death from pertussis in highly immunised populations largely
occurs before the first vaccination at 2 months. A Markov model was constructed
to estimate the costs and health consequences of three strategies to reduce
pertussis over the first 6 months of an infant's life. Earlier vaccination (at
either birth or 1 month in addition to current practice) or vaccination of the
parents soon after birth was compared with the current practice of vaccination
at 2, 4 and 6 months. The model was populated using data on the incidence and
costs from Australia. Disability-adjusted life-years (DALYs) were used as the
primary outcome measure. The cost to the Australian public health
system was chosen as the economic perspective, and Monte-Carlo simulations were
used to accommodate uncertainties in the variables.Vaccination at birth was
estimated to cost (S.D.) an additional A$33.21 (A$1.60) per infant and to reduce
cases, deaths and DALYs by 45%. Vaccination at 1 month was estimated to cost an
additional A$43.24 (A$8.98) per infant and to reduce morbidity by approximately
25%. Parental vaccination at birth was the most expensive alternative, costing
an additional A$73.38 (A$4.98) per infant and reducing pertussis morbidity by
38%. The costs per DALY averted were A$330,175 (A$15,461) A$735,994 (A$147,679)
and A$787,504 (A$48,075) for the birth, 1 month and parental vaccination
strategies, respectively.Changing the estimated factor by which hospitalisations
and deaths are under-reported, and the efficacy of early vaccination, had large
effects on results. Parental vaccination at birth was most cost-effective where
protection persisted for subsequent children. The birth vaccination strategy
appears to offer the greatest potential benefit for one-child families, but the
efficacy at birth (and 1 month) needs to be established. Author Keywords:
Economic evaluation; Costs; Whooping cough; DALY; Health outcomes
Corresponding author. Tel.: +44-1904-433-620; fax: +44-1904-433-628.
Tonsillitis vaccine could prevent heart disease - Science -
www.theage.com.au
May 7, 2004
A new vaccine that targets the cause of tonsillitis could protect against one of
the biggest causes of heart disease in Aboriginal people, Queensland scientists
said today. The vaccine, being developed by the Queensland Institute of Medical
Research (QIMR), is designed to target Group A streptococcus (GAS), a bacteria
which causes tonsillitis and can lead to rheumatic fever and rheumatic heart
disease. "(This) is a unique vaccine because it uses small protein fragments
rather than a weakened form of the bacteria itself, which conventional vaccines
against infectious diseases currently use," said Dr Colleen Olive.
"This new technology uses (those fragments) combined with lipid (fat)
components, ... which help target the vaccine to the immune system to stimulate
a strong protective response." The vaccine is also designed to target parts of
many different types of GAS, Dr Olive said, so it should remain effective even
if the bacteria evolves. "A small part of the protein has been identified that
is virtually identical amongst all GAS strains," she said.
"This ... was used to immunise mice and shown to generate protective antibodies
against multiple GAS strains." GAS usually makes itself known as tonsillitis,
but repeated infections lead to the more serious rheumatic complications.
Australia's Aboriginal population has the world's highest rate of rheumatic
heart disease, which causes irreversible damage to heart tissues and valves,
leads to heart failure and shortens life expectancy to an average of just 33
years.
Current treatment for GAS infection is with antibiotics - when the infection
turns into rheumatic fever the patient must take high-dose antibiotics for the
rest of their life.
- AAP
The Seguin Gazette
http://seguingazette.com
Copyright © 2004 The Seguin Gazette
SISD teams up with state
By Janet Grafe
Seguin Gazette
Published May 18, 2004
Today’s children get a series of shots to prevent diphtheria, tetanus, measles,
mumps, hepatitis B and a host of other maladies. Making sure children get these
required shots just got easier for parents in the Seguin Independent School
District. The district formed a partnership with the Texas Department of Health
allowing school nurses to become trained and licensed to give immunizations at
school.
Texas Department of Health spokesperson Maria Jimenez said the state is
providing the vaccines, syringes, alcohol, bandages, paperwork and information
sheets, as well as emergency kits to have on hand in case of allergic reactions
to the shots. Parents are notified of immunization opportunities and must return
signed permission sheets and fees to their child’s school. The first SISD
immunization clinic in Seguin was held last month at Joe F. Saegert Middle
School, where about 100 Saegert students received immunizations. A clinic at A.J.
Briesemeister Middle School Monday provided immunizations to about 50 students.
“This is a win-win situation,” said Yolanda Guerrero, registered nurse, with
SISD Health Services.
"It helps the parents, because they don’t have to take time off from work to
take their children in to be immunized. It helps the school because the students
don’t have to spend so much time out of class to get their shots,” Guerrero
said. Middle School students and freshmen typically need Hepatitis B and tetanus
immunizations, said Carolyn Whitener, licensed vocational nurse, who works at
the freshman center.
Students at the Seguin High School Freshman Center can get immunized Tuesday.
Whitener completed the training and said the nurses hope to coordinate with the
elementary schools next year to give immunizations to the 4-year-olds during
registration. Guerrero and Whitener said they became interested in providing the
service at Seguin schools when they heard at a conference that other schools
were providing immunizations for students and staff. It took more than six
months to get the training and complete all the requirements to provide
immunizations at school. “We’ve crammed as many [school immunization] clinics as
possible into May,” Guerrero said. “Next year, we’re ready to go.” Guerrero said
parents still need to take children in for well-child checkups with their
regular doctor, even if they get their immunizations at school.
http://www.wtok.com/home/headlines/790942.html
WTOK-TV
May 25, 2004
Healthwatch: Birth Control Vaccine?
Sciencentral
Karen Lurie
Researchers are working on an annual shot that would use a woman's immune system
to prevent unwanted pregnancy. Stephanie McEvoy does yoga to calm herself after
a day spent parenting her teenage son. "I feel like raising children is like
being pecked to death by a chicken," joked McEvoy.
This frustration, along with other reasons, made her decide not to have more
children, so McEvoy uses a birth control patch, but she has to remember to
change it on the same day every week. "You're not supposed to forget to change
the patch," McEvoy said. Now, Peter Sutovsky, a reproductive biologist, is
creating a more convenient form of birth control that works like a flu shot. As
reported in Discover Magazine, the shot blocks fertilization using the immune
system, not hormones. So far, he's used it in a lab with eggs and sperm from
pigs. "It does not affect hormonal levels, for instance, which I believe is very
important especially with regard to possible side effects of altering hormonal
levels in the body," said Sutovsky of the University of Missouri.
Normally, a sperm fertilizes an egg after bursting a cap on its head, releasing
molecules that eat a hole through the egg's protective coating. Then, one sperm
pushes inside through the hole. Sutovsky envisions an injection that would
trigger the body's immune system to disable those sperm molecules so they can't
break into the egg.
"Maybe a good analogy would be if you drop a little drop of acid on a wooden
table. If the acid is neutralized it wouldn't do any damage," said Sutovsky.
Nevertheless, McEvoy said she has her doubts. "Sometimes when you get a flu shot
you get flu symptoms. If there were even a remote chance that I would be nauseas
for a year I wouldn't take that medicine," said McEvoy. The shot doesn't disturb
hormonal levels, so Sutovsky says he believes there won't be side effects, but
years of research are ahead. Meanwhile, McEvoy continues to put up with the
patch.
For more details, visit www.sciencentral.com
$3.5 million grant to develop AIDS vaccinations
Tuesday, 25-May-2004, by News-Medical
Researchers at the Vaccine and Gene Therapy Institute (VGTI) and the Oregon
National Primate Research Center at Oregon Health & Science University have
received a $3.5 million grant from the National Institutes of Health to develop
new methods for vaccinating humans against human immunodeficiency virus (HIV),
the virus that causes AIDS. Louis Picker, M.D., associate director of the VGTI
and director of the institute's vaccine program, will serve as principal
investigator of the five-year study. The National Institute of Allergy and
Infectious Diseases, a component of the National Institutes of Health, is
funding this research. The research team is hoping to develop a new class of
viral vaccine vectors to serve as the basis of HIV vaccine. Vectors are modified
viruses used to safely deliver proteins from a disease-causing virus to the
body. Vectors infect individuals, but do not cause any disease themselves.
Rather, they serve to present the proteins from a disease-causing virus to the
vaccinated person's immune system. This presentation allows the system to
generate an immune response capable of protecting the vaccinated person from
subsequent encounters with the disease-causing virus.
Most of the HIV vaccine development to date has focused on weakened viral
vectors designed to infect the vaccinated person only briefly, insuring that the
vector itself does not persist and potentially cause problems. For example,
current approaches for HIV vaccines include weakened versions of the smallpox
vaccine virus (vaccinia) or adenovirus engineered to produce HIV proteins. Both
of these vectors can only survive for a limited time in the human body before
they are eliminated by the immune system. While these vectors can generate high
anti-HIV immune responses immediately following vaccination, these responses
decline with time and may not produce an immune response of the correct
characteristics to contain a chronic aggressive virus like HIV.
"Unlike other infectious diseases successfully countered by vaccines, HIV is
very robust and able to evade most immune responses," explained Picker. "One
theory about why the AIDS vaccines developed so far have not been entirely
effective is because they provide only a brief period of time for the anti-HIV
immune response to develop, perhaps compromising the protective capacity of the
response as well as its ability to persist over subsequent years. We believe a
persistent viral vector could produce a superior and more durable anti-HIV
immune response that would, in effect, hold the line against HIV."
The OHSU researchers are hoping to develop a viral vector based on
cytomegalovirus (CMV). It's believed that approximately 70 percent to 90 percent
of the population currently is infected with CMV, a virus that causes little to
no effects in immunologically normal hosts, but generates large immune responses
that persist for life. CMV vectors have the capacity to re-infect such already
infected individuals and generate immune responses to new proteins engineered
into the vector. To develop and test this vaccine method, scientists will study
animals at OHSU's Oregon National Primate Research Center.
"What makes CMV such an attractive viral vector is a combination of its strong
ability to stimulate immune responses and its limited effect on the host,"
explained Jay Nelson, Ph.D., director of the VGTI and a co-investigator of the
study. "More importantly, CMV infections last a lifetime. Therefore, we believe
that HIV proteins delivered through a modified CMV vector may boost and maintain
anti-HIV immunity enough to protect a person against AIDS throughout his or her
lifetime."
In addition to constructing and testing candidate vector based on CMV, the
scientists will measure its effectiveness. Investigators will also test vaccine
delivery methods and further explore the reasons behind previous AIDS vaccine
failures. http://www.ohsu.edu/
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&
dopt=Abstract&list_uids=15168315
Am J Perinatol. 2004 May;21(4):173-82. Links
Tetanus in pregnancy.
Sheffield JS, Ramin SM.
Department of Obstetrics and Gynecology, University of Texas Southwestern
Medical Center, Dallas, Texas.
Tetanus remains a leading cause of maternal and neonatal morbidity and mortality
in developing countries. It is caused by the release of two toxins produced by
Clostridium tetani, a noninvasive gram-positive anaerobic bacillus.
Tetanospasmin is taken up by the neuronal end plates and prevents
neurotransmitter release at the synaptic junction. This leads to spasms and is
irreversible. Recovery requires the formation of new neurons and may take
months. Generalized muscle spasm, respiratory compromise, and autonomic
dysfunction are all common clinical manifestations. Diagnosis is based mainly on
history and clinical examination. The management of the pregnant woman is
similar to the nonpregnant individual. The main objectives are prompt prevention
of further toxin absorption, wound debridement, antibiotic therapy, and
aggressive supportive care. Primary and secondary prevention protocols are
important worldwide because tetanus is a preventable disease. The tetanus toxoid
vaccine can be given in pregnancy. (Pregnancy? Can you imagine?)
PMID: 15168315 [PubMed - in process]
Botswana: Religious Sects Refuse Polio Vaccination"
Africa News Service (allafrica.com/stories/200406110696.html) (06/11/04)
Some members of the Apostle Church of God in Botswana are facing jail sentences
and fines for refusing to allow their children to be vaccinated against polio in
the country's latest round of immunizations, which will take place this week.
The campaign will target about 200,000 children
under five years in response to a new case of polio that was discovered in the
northern Ngami District last month. The Apostle Church of God believes that
diseases can only be healed by prayer, and its members reject any type of modern
medicine. However, Botswana law enforcement and health officials have been
authorized by the High Court to compel parents to have their children immunized
or face fines and up to three months in jail. The government says the actions
are necessary to ensure all children are immunized in the interest of public
health. Police have already arrested several parents and guardians belonging to
the Apostle Church of God for refusing vaccinations.
VOLUNTEER OPPORTUNITY
Your help is needed!
Panhandle Health District is recruiting over 500 volunteers to participate as
"mock patients" during a Public Health Emergency Drill at the Sandpoint High
School on June 19, 2004.
The Health District and its community partners are hosting the event in an
effort to enhance the regions ability to prepare and respond to public health
emergencies. The drill will test the Health District's ability to mobilize and
operate a mass smallpox vaccination clinic in the event of a bioterrorism attack
in our area.
This effort cannot succeed without the support of our community volunteers. We
would like to invite your organization to participate in this public health
preparedness event. Everyone is welcome, so feel free to invite your friends and
relatives to participate in the exercise. The volunteer time commitment is
approximately 1 1/2 hours. To thank you for participating, all volunteers are
invited to stay and enjoy a free picnic lunch.
Again, the success of the drill depends on the support of our community
volunteers. If you are interested in volunteering, please fill out the sign-up
sheet (see attached) and return to: Sara Fladeland, Public Health Preparedness,
Panhandle Health District, 2195 Ironwood Court, Coeur d'Alene, Idaho 83814 Tel:
208-676-1751 Fax: 208-664-8582
Sfladland@phd1.state.id.us
***************
The link below gives the number of smallpox vaccine doses that were shipped on
4/30/04 to all the states. While Idaho only has 1,000 doses and Arizona has 500
doses, the two Bush states seem to have plenty. Florida was shipped 24,000 doses
and Texas... 30,000 doses!
http://www.cdc.gov/od/oc/media/smallpox.htm
The following link will take you to the numbers of civilians and healthcare
workers by state who have been successfully vaccinated with the smallpox
vaccine.
http://www.cdc.gov/od/oc/media/spvaccin.htm
And this link will take you to the number of adverse reactions that were
actually reported to the CDC. These numbers appear to be incredibly low. But
then again, it does not include the military where they were given smallpox with
anthrax and several other vaccines all at the same time --within an hour.
http://www.cdc.gov/od/oc/media/spadverse.htm
***************
Activistic response -
* Organize a group to attend these meetings in your area. Make sure your group
is educated on smallpox and can pepper the public health folks with appropriate
questions. We suggest you spend sometime on our Smallpox Index and re-read the
Smallpox Alert!
http://www.vaclib.org/basic/smallpoxindex.htm
http://www.vaclib.org/news/smallpoxalert.htm Have a person on the outside put
our 1/2 page smallpox flyer on car windshields (at above link). Write letters to
the editor, and get on talk radio, always raising issues and questions regarding
the appropriateness of preparing for mass vaccination,
and the planned violation of our basic right to control what we will or will not
inject into our bodies.
* We have received many requests to reprint Smallpox Alert! If there are enough
people who are committed to purchasing 100 - 500 copies of Smallpox Alert!, we
will consider reprinting an expanded version in 24 pages - similar to the new
Artificially Sweetened Times - an expose of the current epidemic poisoning
America. If you are interested in reviving this publication to share among those
who "simply don't know" and use this as an educational tool in your community,
please contact us at the contact points in my signature.
Thanks in advance for your willingness to share accurate and vital smallpox
vaccine and smallpox disease information widely. "When the majority of mankind
start walking, on their own, to the slaughter house out of ignorance or apathy,
it is cause for extreme alarm!"
~Onnie Kahlenberg in an email to VacLib
In the Spirit of Truth,
Ingri Cassel, director
Vaccination Liberation
P.O. Box 457
Spirit Lake, Idaho 83869
(208) 255-2307/ (888) 249-1421
vaclib@coldreams.com
Hmm...maybe they are finding out how vaccines really work? They attack cells
instead of prevent disease?
http://www.ledger-enquirer.com/mld/ledgerenquirer/news/nation/9064918.htm
Ledger-Enquirer
Posted on Fri, Jul. 02, 2004
Texan first in U.S. to try pancreatic cancer vaccine
BY JAN JARVIS
Knight Ridder Newspapers
ARLINGTON, Texas - (KRT) - Every two weeks, Benjamin Butts' upper arm is
injected with a clear liquid that he hopes will gobble up the pancreatic cancer
inside him like a Pacman with a voracious appetite. Butts, who had his first
injection June 17 at the Arlington Cancer Center, knows the odds are against
him. But the vaccine, which uses a smallpox relative to attack advanced tumors,
is his best chance of getting more time. "I know what I got, and I know the
trouble I'm in," said Butts, 58. "There are few survivors of pancreatic cancer,
but I'm looking for more time."
Butts is the first patient in the United States to participate in the Phase III
clinical trial of PANVAC-VF for the treatment of metastatic pancreatic cancer in
patients who have not responded to treatment with the drug gemcitabine,
according to Therion Biologics Corp., the maker of the vaccine. About 50
treatment centers and 250 patients nationwide will participate in the study. It
will compare the overall survival rates of those who receive the vaccine with
the rates of those who receive palliative chemotherapy and the best supportive
care.
Pancreatic cancer is one of the deadliest forms of cancer. The American Cancer
Society estimates that 31,860 cases will be diagnosed this year in the United
States and that 31,270 people will die from the disease. Only about 24 percent
of people with the disease live more than a year after diagnosis. The vaccine
stimulates the immune system to target and destroy two proteins found in more
than 90 percent of pancreatic tumor cells, according to Therion. A virus related
to smallpox helps deliver the vaccine that finds and attacks cancer cells, said
Dr. Alfred DiStefano, an oncologist at the Arlington Cancer Center. "Once the
virus gets into the cells, it replicates and makes a lot of viruses," he said.
Because the cancer cells can quickly become immune to the vaccine, three
boosters made with a fowlpox virus relative are also given. PANVAC-VF is not a
vaccine in the traditional sense of a measles or mumps shot, DiStefano said. It
does not prevent cancer but was designed to recognize and destroy a foreign
substance in the body, he said. For Butts and others with metastatic pancreatic
cancer, the vaccine is the newest weapon for treating a disease that generally
responds poorly to other therapies. Surgery to remove the cancer is difficult.
Among patients who have the surgery, the five-year survival rate is about 20
percent. Radiation alone has little effect. Recent studies have found that the
drug gemcitabine is more effective than other drugs in treating metastatic
cancer.
The disease is especially difficult to treat because the symptoms - including
jaundice, heartburn and fatigue - are not specific to the disease, DiStefano
said. Butts had no obvious symptoms in July when, during a medical exam, he
learned that he had the disease. "I found out I had gallstones, kidney stones
and cancer all on the same day," he said. Although he had lost 50 pounds, Butts
attributed it to a diet and exercise regime he had just started. He was in the
best shape of his life except for the cancer, Butts said. Doctors tried to
remove the tumor, but, as is often the case, the cancer had already spread. But
chemotherapy and radiation reduced the tumor by 60 percent, Butts said. "They
caught it soon enough for me to get treatment," he said. "Another two or three
months, and I don't think they could have done anything." The treatment allowed
Butts, who owns a manufacturing business in Arlington, to go on with his life.
He continued working and playing golf in his free time.
In February, he learned that the cancer had spread to his lungs. He tried
chemotherapy again, but the tumor was unresponsive. Butts and his wife, Sarah,
decided to try the vaccine. "It's been much easier than chemotherapy," Butts
said. "Fatigue has been my biggest problem." Only a week has passed since Butts
had the first injection, but he said he hopes to get treatment for the next
year.
Butts said he may not have made it this far without the support of family,
friends and the medical staff. Sarah Butts said she is confident that everything
will work out. "We know it's not a cure," she said. "But if we could get five
years, maybe there will be a cure around then."
For more about the pancreatic cancer vaccine, go to www.acctx.com.
http://theedge.bostonherald.com/healthNews/view.bg?articleid=33261
‘Super’ vaccine on tap
By Kay Lazar
Friday, June 25, 2004
Hoping to ease kids' trauma - and the number of time-consuming trips to the
doctor - the state will make a new five-in-one childhood vaccine available free
of charge at doctors' offices starting July 1.
``If you ever had a child and had to hold him down while he's getting shots,
it's a painful thing, probably more for the parent than the child,'' said
Christine Ferguson, commissioner of the state Department of Public Health.
With children needing up to 23 shots by the age of 2, the new five-in-one
Pediarix will eliminate up to six shots from the complicated immunization
schedule. Pediarix contains vaccines to guard against diphtheria, tetanus,
pertussis, hepatitis B and polio.
For years, the state has funded vaccines, while private insurers pay doctors to
administer them. Facing tight financial times, the state considered sharply
cutting the program earlier this year. But state lawmakers last week approved a
$24.8 billion budget that boosts funding for vaccinations and Gov. Mitt Romney
[related, bio] is expected to approve that increase. ``We were planning to bring
Pediarix online in January but we couldn't because we weren't sure of the fiscal
situation,'' Ferguson said. ``We're now in the position to be able to offer
parents the choice.''
http://www.illinoisleader.com/news/newsview.asp?c=17748
IL launches compulsory mental health screening for children and pregnant women
Monday, July 19, 2004
By The Leader-Chicago Bureau
CHICAGO -- This week, a series of public forums on a program requiring all
pregnant women and children through age 18 years to be tested for mental health
needs is being held this week in five different locations statewide.One group of
parents learned about the state's plans to proceed with this program and on
Monday issued an alarm asking for parents and citizens concerned about the new
program to voice their opinions at the forums."We're moving toward social
training over academic
training with this program," Larry Trainor, a Mt. Prospect parent of four
children and a contact for Citizens Commission on Human Rights, based in Los
Angeles, said today. "Since psychiatric involvement in education, SAT scores
have gone down for the past few decades. Evaluating mental conditions is not
based on scientific evidence, it's subjective," he said.
The $10 million plan for the setup of the Children's Mental Health Act of 2003
is being considered at this week's public forums starting Monday, July 18 in
Champaign. Signed into law, the bill passed the Illinois General Assembly last
spring, sponsored in the House by State Representatives Julie Hamos (D-Evanston)
and Patricia Bellock (R-Westmont). State Senator Maggie Crotty (D-Oak Forest)
and Susan Garrett (D-Highwood) shepherded the legislation through the Senate.
The legislation passed the House with a 107 to 5 vote, and the Senate
unanimously. "What if they find a student has a math disorder, a reading
disorder. Would that be a mental health disorder, one that would cause the
parents to put their children with a drug for a condition they may or may not
have?" Trainor asked.The mental health program will develop a mental health
system for "all children ages 0-18 years," provide for screening to "ensure
appropriate and culturally relevant assessment of young children's social and
emotional development with the use of standardized tools."Also, all pregnant
women will be screened for depression and thereafter following her baby's birth,
up to one year. Follow-up treatment services will also be provided.Trainor said
that he is trying to get parents and citizens out to voice their opinion about
the new program.
Apparently, children's mental health will be assessed along with their academic
standards in the new proposed testing. The Illinois State Board of Education has
been given the responsibility to develop the appropriate tests, according to
last year's legislation.The Task Force hosting the public forums this week are
to send a recommendation to Governor Blagojevich by the end of the summer,
according to the Act (HB 2900).
http://www.upi.com/view.cfm?StoryID=20040629-063134-5244r
Accounting shift threatens vaccine program By Dee Ann Divis
United Press International
Published 6/30/2004 7:12 AM
WASHINGTON, June 29 (UPI) -- Drug companies that have participated for decades
in a federal program to stockpile children's vaccines are considering
withdrawing because new accounting guidelines require them to delay booking
production payments as revenue until the drugs are removed from the stockpiles
for use, United Press International has learned.
The shift could mean a delay of up to a year in recognizing revenue from the
contracts, potentially hurting officially reported profits and earnings per
share and, by extension, stock prices. All four major vaccine manufacturers --
Aventis of Strasbourg, France; GlaxoSmithKline of London; Merck & Co. Inc. of
Whitehouse Station, N.J., and Wyeth of Madison, N.J. -- are publicly traded. The
problem is serious enough that Aventis, one of the world's largest vaccine
manufacturers, already has told the Centers for Disease Control and Prevention
in Atlanta it will not extend a stockpile contract.
"We are unable, because of the financial issues ... to proceed until this is
resolved," Christine Grant, Aventis vice president for public policy and
government relations, told UPI. CDC officials are worried other firms might back
out as well. "It is definitely a concern," said Dr. Stephen Cochi, acting
director of the CDC's National Immunization Program. The agency has maintained
stockpiles of selected childhood vaccines since the 1980s. These caches enable
public health officials to respond to sudden outbreaks of illness, bridge
disruptions in supplies and reduce the cost of vaccinations through negotiated
purchases. The CDC recently tapped into the reserves to help the Marshall
Islands deal with an outbreak of measles.
Not all vaccines are stockpiled, however, and over the past four years the
United States has suffered chronic shortages of vaccines needed to prevent
diphtheria, tetanus, measles, mumps and meningitis. Some children went without.
After an investigation, Congress ordered the CDC to expand the existing program
to include all routinely recommended pediatric vaccines. The original program
was aimed mainly at disadvantaged children, but the new stockpiles would be
large enough to fulfill the entire county's needs for six months. The agency
spent some $168 million on the effort in fiscal year 2003 and will spend
approximately $680 million more by the end of FY 2006.
The accounting issue, however, threatens the expansion effort.
"This problem needs to be solved," Cochi said. "It's the main obstacle to our
proceeding successfully, to have a six-month stockpile of all the pediatric
vaccines by 2006/2007. It's the only major obstacle to that." The controversy
centers on how the stockpiles are managed. To reduce chances of spoilage during
shipment, the CDC established arrangements years ago to pay manufacturers to
store the vaccines near where they are made. The stockpiles are maintained and
constantly replenished by the companies.
Replenishment takes place gradually as the vaccines are sold and/or distributed.
Manufacturers are allowed to remove and sell older doses of vaccine well before
their expiration dates, putting one new dose in for every older dose taken out.
Some vaccines are supplied free of charge under the Vaccines for Children
program. The stockpile is continually refreshed as doctors and public health
programs are supplied, explained Kimberly Lane, associate director of management
and operations for the CDC's National Immunization Program. Few if any doses are
thrown away.
The approach has been regarded as routine and beneficial by both the
manufacturers and the CDC. There also has been no dispute over when the firms
are paid. "We pay them upon on delivery into the stockpile. We pay them for
everything in full, up front," Lane said. "We (also) pay them a separate fee
just to rotate that product and keep it fresh." In December, however, the
Securities and Exchange Commission, which has the last word on accounting
questions, codified official guidance on how to handle such "bill and hold
arrangements," as the transactions are called. The update affected SEC Staff
Accounting Bulletin 101, which officially was issued in 1999.
Auditors now are telling drug companies they cannot count payments for the
vaccines as revenue until the vaccines actually are taken out of the stockpile
for use -- a delay that could be as long as a year. Though they still have the
cash in hand, delays in counting the cash as revenue can put firms in a bind.
"If you store a product for the U.S. government, and for whatever reason the
U.S. government does not take title to that, under the accounting rules you
can't recognize the revenue for that," Kim Bush, president of the Vaccines
Business Unit of Baxter Healthcare Corp., in Deerfield, Ill., told experts on
vaccine finance at a meeting in Washington this week.
"Whether a company gets to recognize revenue immediately or not ... is going to
have a direct impact on the bottom line profits," said Dan Noll, director of
accounting standards for the American Institute of Certified Public Accountants.
"That means, for example, that a very common measure that investors look at,
earnings per share, will be directly impacted as a result of whether the company
can record the revenue up front or not." "Our concern now," Grant said, "is
(that), after several decades, this new SEC guidance document says that when you
enter into a contract for a new stockpile, or get an amendment for or renew an
old stockpile you, our auditors say, can no longer report what the government
actually pays you."
The reason for the shift is unclear, but it might be rooted in increased
scrutiny of revenue transactions after recent corporate scandals. "In general, a
large number of restatements that were forced by the SEC were because of revenue
matters," said Noll. An SEC spokesman declined to comment on the matter and said
opinions are expressed solely through the precisely worded materials issued
officially by the SEC.
"We don't speak beyond the document," he told UPI. The firms have met with SEC
officials to express their concern and Congress is now getting involved.
"Senator Harkin is looking at (the issue) and seeing if there is any way to
resolve this, said Maureen Knightly, communications director for Iowa Democrat
Tom Harkin. None of the government or company officials who spoke to UPI,
however, were clear on how the problem could be solved. The SEC rules are not
aimed specifically at vaccine manufacturers, but are general guidance for all
companies. Any changes could have far wider impact than intended.
One suggestion is to have the CDC take possession of pediatric stockpiles. The
agency plans to take possession of smallpox and anthrax vaccine stocks being
created to deal with potential bioterrorism attacks, said Bush, of Baxter
Healthcare, which will prevent firms working on those stockpiles from having to
deal with the delayed revenue issue. Should the CDC take possession, however,
the agency could end up facing commerce-like problems of inventory control,
sales and shipping -- matters now handled by the manufacturers.
"This is something that is actively being worked on and needs to be fixed," said
Lance Rodewald, director of CDC's Immunization Services Division. "(It) has to
be fixed because right now it really does get in the way of our being able to
build up the stockpile. I am confident it is going to be resolved but it has not
been resolved yet."
Dee Ann Divis is UPI's Senior Science & Technology Editor. E-mail ddivis@upi.com
08/02/04
Medical Record Difficulties
If you go to a doctor, you want them to know your medical history. That includes
your records from other doctors. But some parents in the Coastal Empire have had
trouble getting their children treated or in school because they can't get those
records. Parents say with little notice, their doctor closed up shop, and
without records they must start from scratch.
On the first day of school, four-year-old Hannah Berry is less than excited.
When her mother brought her to Glennville Elementary this morning, she says her
arms were still swollen from vaccinations she's now had twice. "For her father
and me, it's upsetting watching her go through all this unnecessarily because if
we had the records she wouldn't have to go through it," said Tara Berry.
They and other parents say they can't get their children's medical records from
Dr. William Morrissey. They claim they've been trying since he closed his
Hinesville practice in March.
For years, Carol Jarrett swore by the pediatrician. Now she'd like the chance to
swear at him. "I'm not trying to hurt him as a person," she told us. "He was a
good doctor and this just isn't his character."
The attempt to get records is especially trying for parents of special needs
children or some who've undergone surgery this summer. "My new doctor is
treating Dakota blindly," said mother Crystal Stanfield. "He only has what I've
told him is wrong with him. He really needs to see that stuff for himself."
For little Hannah, it's not over yet. "Every four weeks, we'll have to go in for
more shots until she catches up, which I'm not sure how many that is," her
mother told us.
Parents say they just want what they feel is theirs already. The parents we
spoke with say they've tried directly and through their new doctors to get
records, all with no luck. We've tried since Friday afternoon to get Dr.
Morrissey through his new employer and had no luck as well.
Reported by: Dal Cannady, dcannady@wtoc.com
http://www.wtoctv.com/Global/story.asp?S=2121717
GSU Lab Harbors Deadly Virus"
Atlanta Journal-Constitution (www.accessatlanta.com/ajc) (08/08/04) P. 3A;
Wahlberg, David
Georgia State University's Biosafety Level (BSL)-4 lab is one of five biomedical
research facilities in the United States devoted to the study of the world's
deadliest pathogens. The lab, located in downtown Atlanta, concentrates its
efforts on the study of herpes B, a virus common to some monkeys though rare in
humans. But human contagion is not unheard of, usually among workers at primate
labs who get bit or scratched by monkeys, and is lethal if not treated early.
The other labs are part of a federal system developing ways to combat emerging
infectious diseases and preparing for a potential bioattack, each with numerous
researchers trying to create diagnostic tests, treatments, and vaccines. The
government is pushing ahead with plans to build more BSL-4 labs at the Fort
Detrick Army complex in Maryland and in Galveston, Texas; Hamilton, Mont.; and
Boston, where the
plans have met with stiff opposition from community activists and a group of 150
scientists, including two Nobel Prize winners, who question the wisdom of
building such a site in an urban landscape
Babies as guinea pigs.
Whooping Cough Vaccine
Ivanhoe Broadcast News
NASHVILLE, Tenn. (Ivanhoe Broadcast News) -- Pertussis or whooping cough has
been called the hundred-day cough because it can last that long. After a vaccine
was developed in the 1940s, the number of cases dropped, but now it's rising
with as many as 8,000 cases a year. In infants, it can be fatal. Here's what's
being done to protect more babies from the disease.
Four-month-old Hamp Morris visits the doctor today, but his appointment is
special. Hamp is part of a clinical trial that's changing his vaccine schedule.
Normally, a baby starts their series of three whooping cough vaccines at two
months. Hamp got his first dose when he was born. "We are glad to be in this
study," says Hamp's mother, Anne Marie. "We are glad to be helping and glad that
we can be part of something that might help children, especially later down the
line." Pediatrician Natasha Halasa, M.D., says whooping cough is highly
contagious. If infants catch it from an adult, it can turn deadly. That's why
the earlier they start to be protected, the better.
"Kids could actually mount an immune response and get their second vaccine by
two months of age, protecting them earlier, instead of waiting until four
months, where they get the second shot," Dr. Halasa, of Vanderbilt Children's
Hospital in Nashville, Tenn., tells Ivanhoe. It happened to 9-month-old Blayne
Sands. When he was 5 weeks old, he got whooping cough and stopped breathing for
21 seconds. Blayne's mom, Starla, says, "You just cannot explain the fear, the
emotion you go through, the helplessness." She says, while it's hard to talk
about what happened to her son, she feels it's important to tell parents to take
this disease seriously. "If it is an adult-sounding cough, and they are gasping
for air, they need to be checked out," she says.
Like many babies, Hamp is not happy about his vaccines. What he doesn't realize
is that the study he's involved in could save babies in the future from a
dangerous disease. There are two other options being considered to decrease the
number of whooping cough cases. Researchers are looking at vaccinating women
while they are pregnant or to add another vaccination during the adolescent
years. This article was reported by Ivanhoe.com, who offers Medical Alerts by
e-mail every day of the week. To subscribe, go to: http://www.ivanhoe.com/newsalert/.
If you would like more information, please contact:
Carole Bartoo
Public Relations Manager
Vanderbilt Children's Hospital
2200 Children's Way, Suite 2515
Nashville, TN 37232
(615) 322-4747
http://www.vanderbilt.edu
Last Updated: August 16, 2004
Copyright© 1994-2000 HealthCentral.com. All rights reserved.
More experiments on babies...
http://www.mc.vanderbilt.edu/reporter/?ID=3023
Deadly pertussis focus of VCH study
“I think several strategies would be good to try,” said Halasa. “Pregnant
mothers given the vaccine may pass some protection on to babies, adolescent
boosters would reduce the chances of adolescents or adults giving it to babies,
but we’re about to study how effective it would be to give a baby’s first
pertussis vaccination earlier in life… at birth.” Right now Halasa is looking to
enroll 50 women who are preparing to deliver full term babies or healthy infants
between the ages 2-14 days who have not yet received their Hepatitis B
vaccination. In this pilot study, 25 newborns will get the normal Hepatitis B
vaccine at birth, while the other 25 will get a diphtheria, tetanus and
acellular pertussis (DTaP) vaccination along with their Hepatitis B vaccine,
that’s two months before the normal schedule to begin vaccination for pertussis.
The main purpose of this study is to determine if it is safe to administer an
additional dose of the pertussis vaccine in the first days of life and also to
see if babies can mount an adequate immune response. If it is successful, Halasa
hopes an eventual change in the immunization schedule might save babies’ lives.
For more information on the study email NPVstudy@vanderbilt.edu or Call Alice
O’Shea at 343-8518.
http://www.aidsmap.com/en/news/7C32EE0F-7FAD-4B44-BE69-5DEDE586E8AC.asp
Julian Meldrum
Thursday, September 02, 2004
In two separate presentations at the AIDS Vaccine 04 meeting in Lausanne, Dr
Frederic Tangy from the ANRS in Paris advocated the use of a licensed live
attenuated measles vaccine – the very same one used in the MMR system given to
millions of children – as a vehicle to deliver an HIV vaccine for future
generations. The proposal marked a welcome shift in the direction of serious
consideration of how to make future HIV vaccines available to infants and
adolescents – especially girls - who are, in many countries, the populations
most desperately in need of protection against the epidemic. A Swiss company,
Berna Biotech, has already made prototypes based on a live measles vaccine with
HIV genes inserted, and a progress report on this work was also presented.
The vision would be that a child would be vaccinated from before the age of one
and boosted at around the age of 10 to achieve a level of immunity that could
and should last until adulthood. Adults with pre-existing immunity to measles –
or at least those who have been previously vaccinated – could either receive
repeated doses of measles-based vaccine or a prime-boost using measles with
another vector, both containing HIV-related sequences.
The arguments put forward in support of this strategy include the excellent
safety record of this live vaccine, its remarkable ability to offer long-term
and boostable protection against disease, and that large-scale manufacturing
facilities in several countries produce tens of millions of doses at extremely
low cost. By inserting HIV-related sequences in one or more of three distinct
locations in the vaccine strain, immunity to HIV could be induced in addition to
protection against measles at no extra cost.
There are, however, one or two problems identified in the course of the meeting.
The first difficulty is that no-one knows precisely what components of HIV, and
in what form, should be included in such a vaccine. The very long-acting effect
of the measles vaccine could itself generate serious problems, if the wrong
elements were added to it. At worst, children vaccinated in infancy might have
inappropriate immune responses and would be unable to benefit as adolescents
from a better vaccine that might by then be available to them.
The second problem is that the idea of using an established vaccine in this way
would need to be discussed and agreed with stakeholders who are not currently
involved in the AIDS vaccine effort and were not represented at the meeting in
Lausanne. Given that millions of children in developing countries are still
dying each year from measles, nothing should be done that could in any way
undermine public confidence in the vaccine programme.
Measles is far from being eradicated, and mass vaccination with the live vaccine
is therefore likely to continue for decades to come. However, the same is
hopefully not the case for polio.
Some researchers would like to include HIV antigens in a version of the
currently licensed live Sabin polio vaccine.They point to animal studies in
which polio-vectored SIV components have been one of the very few systems shown
to protect monkeys against some particularly virulent forms of SIV. The only
comparable protection has been achieved with live attenuated forms of SIV
itself, which is unacceptable as a prototype for HIV in the light of evidence
that such viruses do, eventually, cause SIV-related disease.
This proposal flies in the face of moves in countries such as the UK to abandon
live polio vaccine in favour of less potent but non-replicating vaccines given
by injection. If the politics and other circumstances of the last refuges of the
virus in Africa and Asia allow polio to be eradicated, will anyone really want
to continue to use live polio vaccines? Those vaccines can – at a rate of less
than one in a million – revert to forms that cause damage to the nervous system.
It is claimed that with “high fidelity” variants of a key enzyme, this risk can
be reduced. But since the only way to prove this would be through giving the
vaccine to millions of people, will anyone ever be prepared to make the
experiment, at the risk of re-introducing polio in a world where immunity to the
disease would be waning fast?
References
Andino R. Polio vector – another strategy with a pediatric vaccine. AIDS Vaccine
04, Lausanne, Abstract 76b.
Lorin C et al. Measles vaccine as a potential vector for AIDS vaccination. AIDS
Vaccine 04, Lausanne, Abstract 13.
Tangy F. Viral vectors overview. AIDS Vaccine 04, Lausanne, Abstract 74.
Zuniga A et al. Live attenuated measles virus: a candidate vector for HIV
vaccine. AIDS Vaccine 04, Lausanne, Abstract 12.
http://www.southmanchesterreporter.co.uk/news/index/articles/article_id=1512
0.html
MMR nurse ready to lead with the jab
HEALTH chiefs have taken on a specialist nurse to ensure that more parents take
their children for the MMR jab. Fewer people are presenting their children at
surgeries in Chorlton, Fallowfield and Whalley Range for the vaccine as compared
with the rest of south Manchester. And medical staff say apathy and lingering
fears that the jab has links with autism mean 20pc of parents are not taking up
the service. The government says that figure should be no more than five pc in
all areas of the country.
Anne Shepherd, 41, has been employed as the new Immunisation Awareness officer
at Central Manchester Primary Care Trust and has a remit to increase rates for
the take-up of both the MMR jab and the latest winter flu vaccine. She said:
"Some people may have read a fragment in a newspaper about MMR and instead of
getting more information they have decided against having it. "It’s a question
of rebuilding confidence. Some people are complacent because they don‘t see
anyone suffering from the diseases. What they don‘t realise is that measles and
mumps can lead to meningitis or acquired deafness. In certain circumstances they
can be fatal."
Anne is now helping health clinics and surgeries chase down those families who
have failed to respond to NHS reminders about MMR. She is even preparing to
‘mug’ mums at nurseries with syringe in hand and has even held MMR ‘parties’
with free food and drinks to entice families along. She added: "Some people have
made a choice, others find there are more pressing issues in their lives. One
woman told me she’d been on holiday and thought she’d missed her chance."
Families who have failed to respond may receive a telephone call from Anne
Shepherd or GPs’ surgeries.
Call to Action: Seniors for Childhood Immunizations
W. Seventh Ave.
Amarillo, TX 79101
Seniors for Childhood Immunizations needs volunteers 55 or older to visit new
mothers in the hospital to inform them of the importance of vaccinating their
babies. Volunteers will hand out packets and register mothers to receive
reminder cards of shot dates. Contact Larue Johnson at 373-8389.
Call to Action is an effort to match volunteers with agencies in need of
assistance. Agencies can submit requests for assistance to be published in the
Amarillo Globe-News by calling the United Way Volunteer Action Center at (806)
373-2662, faxing them to (806) 345-7981 or e-mailing them to vac@unitedwayama.org.
http://seattletimes.nwsource.com/html/localnews/2002057338_danny08.html
Friday, October 08, 2004, 12:00 a.m. Pacific
Danny Westneat / Times staff columnist
Flu shot helps job security?
Last year, the flu shot didn't work so well. It's estimated that half the adults
who came down with flu had first gotten the shot.
This year, some flu vaccine is contaminated. When discovered in August, U.S.
officials promised it was no big deal. They were undercut this week by the
British, who, citing bacterial contamination, shut down a plant that makes half
our vaccine supply.
Now imagine, amid this mess, that your employer comes to you and says: "Get a
flu shot or you're fired." That's the predicament faced by 5,000 workers at
Seattle's Virginia Mason Medical Center. They have until Jan. 1 to get the shot,
or get canned. It's believed to be the first hospital in the nation to require
flu vaccines. In doing so, it pits two ethical principles central to the
practice of medicine against each other. The Hippocratic Oath says "do no harm."
The hospital argues that vaccinating everyone reduces the chance a sick doctor
or nurse will give the flu to vulnerable patients.
That seems reasonable. But it's also up to patients whether to accept any
medical care, from surgery to drugs. Typically patients — in this case, the
staff — are free to assess the risks and benefits, and decide what is injected
into their bodies, without being threatened. The union representing the
hospital's 600 nurses filed suit last week against the mandatory shots. Like
most ethical conundrums, this one has no easy answer. In this case, though, I
side with the nurses.
The reason? Our nation's flu program is in shambles.
We're being treated to a press frenzy this week about how citizens allegedly are
panicking to get their flu shots before supplies run out. But I'd argue the
opposite: Unless you're in one of the high-risk groups, who would want one?
Consider the nation's medical professionals. They talk unceasingly about how
everyone should get shots. But they don't follow this advice themselves. Only 36
percent of America's health-care workers get vaccinated — about the same rate as
the rest of us, according to the U.S. Centers for Disease Control and
Prevention. In their court filing, the nurses go so far as to allege that
requiring flu shots violates the hospital's duty "to maintain a safe and healthy
workplace." They contend the shots pose risks, and that the hospital's backup
plan — antiviral medicine — is even worse because those medicines have
"significant side effects."
Add to that the constant problems with the vaccine supply and its spotty record
at warding off flu. It hardly inspires confidence, does it?
I'm not saying the flu shot is categorically bad. It's one of the safer
vaccines, and vulnerable people, such as the elderly, should consider getting
it. Even if Virginia Mason ends up backing away, its policy is part of a
movement toward "universal vaccination." The idea is that the only way to beat
the flu for anyone is to give shots to everyone. Until healthy, intelligent
doctors and nurses are willing to take the shot without being forced, count me
out.
Danny Westneat's column appears Wednesday and Friday. Reach him at 206-464-2086
or dwestneat@seattletimes.com.
http://www.freep.com/news/health/polio19e_20041019.htm
"Repeated visits by vaccinators every six to eight weeks gnaw at some parents'
patience. Some children have swallowed the vaccine 20 times; at most, six or
seven doses are needed to immunize a child. International health officials
insist that overuse of the vaccine isn't harmful."
Did you wonder why so much attention has been devoted to reporting whooping
cough outbreaks? To scare you into the new vaccine!
(WebMD) An experimental whooping cough booster shot called Boostrix may help
stamp out the infection, a new study shows.
If approved by the U.S. Food and Drug Administration, Boostrix could be added to
a booster shot, which boosts the immune system’s protection against diphtheria
and tetanus.
In a clinical trial of more than 4,000 healthy youth aged 10-18, Boostrix was as
safe and effective as the current diphtheria vaccine. It also triggered a
greater immune response against whooping cough than that seen in infants who had
received the primary immunization for diphtheria-tetanus-pertussis and were
protected against pertussis. The vaccine’s maker, GlaxoSmithKline, conducted the
study. The company is also a WebMD sponsor.
Diphtheria, tetanus, and pertussis (whooping cough) are bacterial infections
that cause serious illness. Vaccination, given as a series of injections during
childhood, helps protect against these illnesses. But older children,
adolescents, and adults still require boosters of protection against these
illnesses. These boosters are given at ages 11-12 and every 10 years for
diphtheria and tetanus.
However, many people may be surprised to learn that whooping cough can be a
problem for adolescents.
The current vaccine recommendations call for the pertussis vaccine to be given
to children in a series of five doses, ending by age 6. However, results usually
last about five to10 years after the last dose is given, which can leave teens
vulnerable. Leonard Friedland, MD, of GlaxoSmithKline, and colleagues reported
their findings in Washington, at the 44th Interscience Conference on
Antimicrobial Agents and Chemotherapy. In the last 20 years, whooping cough
diagnoses have nearly tripled, despite the fact that more babies and young
children are getting the pertussis vaccine. Better diagnostic methods may
partially account for the increase, but a rise in cases among adolescents and
young adults has also occurred.
Whooping cough is usually not a life-threatening illness in teens and young
adults. However, its symptoms can last for months, interrupting daily life, and
threatening to infect other people. The highly contagious infection can cause
severe coughing spasms that sometimes make it difficult to eat, speak, or
breathe. In 2003, there were 11,000 cases of whooping cough reported to the
Centers for Disease Control and Prevention. That’s the highest number in nearly
40 years, according to a GlaxoSmithKline news release. Of those 11,000 cases, 40
percent occurred in people aged 10-19, according to the CDC.
SOURCES: 44th Interscience Conference on Antimicrobial Agents and Chemotherapy,
Washington, D.C., Oct. 30-Nov. 2, 2004. News release, GlaxoSmithKline.
By Miranda Hitti
Reviewed by Brunilda Nazario, MD
© 2004, WebMD Inc. All rights reserved.
I guess it depends on how bad you need money... and a free camcorder.
From www.truthout.org:
EPA Plan to Study Pesticides' Effect on Kids Spurs Backlash Within Agency
By Juliet Eilperin
The Washington Post
Sunday 31 October 2004
Poor families may join just to get the perks, staff fears.
Washington - An Environmental Protection Agency proposal to study young
children's exposure to pesticides has sparked a flurry of internal agency
protests, with several career officials questioning whether the survey will harm
vulnerable infants and toddlers.
The EPA announced this month that it was beginning a two-year investigation,
partially funded by the American Chemical Council, of how 60 children in Duval
County, Fla., absorb pesticides and other household chemicals. The chemical
industry funding initially prompted some environmentalists to question whether
the study would be biased, and some rank- and-file agency scientists are now
questioning whether the plan will exploit financially strapped families.
In exchange for participating for two years in the Children's Environmental
Exposure Research Study, which involves infants and children up to age 3, the
EPA will give each family using pesticides in their home $970, some children's
clothing and a camcorder that parents can keep.
EPA officials in states such as Georgia and Colorado sent e-mail messages to
each other last week suggesting the study lacked safeguards to ensure that
low-income families would not be swayed into exposing their children to
hazardous chemicals in exchange for money and high-tech gadgetry. Pesticide
exposure has been linked to neurological problems, lung damage and birth
defects.
Suzanne Wuerthele, the EPA's regional toxicologist in Denver, wrote to her
colleagues on Wednesday that after reviewing the project's design, she feared
poor families would not understand the dangers associated with pesticide
exposure.
"It is important that EPA behaves ethically, consistently, and in a way that
engenders public health. Unless these issues are resolved, it is likely that all
three goals will be compromised, and the agency's reputation will suffer," she
wrote in an e-mail obtained by the Washington Post. "EPA researchers will not
tell participants that using pesticides always entails some risk, and not using
pesticides will reduce that risk to zero."
Troy Pierce, a life scientist in the EPA's Atlanta-based pesticides section,
wrote in a separate e-mail: "This does sound like it goes against everything we
recommend at EPA concerning use of (pesticides) related to children. Paying
families in Florida to have their homes routinely treated with pesticides is
very sad when we at EPA know that (pesticide management) should always be used
to protect children."
Linda Sheldon, acting administrator for the human exposure and atmospheric
sciences division of the EPA's Office of Research and Development, said the
agency would educate families participating in the study and inform them if
their children's urine showed risky levels of pesticides. She said it was
crucial for the agency to study small children, because so little is known about
how their bodies absorb harmful chemicals.
"We are developing the scientific building blocks that will allow us to protect
children," Sheldon said, adding that the study design was reviewed by five
independent panels of academics, officials of the Centers for Disease Control
and Prevention, and representatives of the Duval County Health Department.
Families can remain in the study, even if they stop using pesticides, Sheldon
said, as long as they were using them before the experiment started. It was
unlikely that any family would volunteer for the study out of financial need,
she added, because researchers will require parents to invest time in monitoring
their children's activities and diet.
"Nobody can go into this study just for that amount of money," Sheldon said.
R. Alta Charo, a professor of bioethics at the University of Wisconsin at
Madison's law and medical schools who co-wrote a National Academy of Sciences
report last year on the use of pesticides for research, said EPA officials were
struggling with how to balance the need to protect the individual child's
interests against the goal of pursuing a broader scientific agenda. While she
said the agency's approach was reasonable, Charo said it does raise ethical
questions.
"Where is the line between enticement and a godfather offer" that impoverished
families would find hard to refuse? Charo said. "That is really troubling. We
make these decisions over and over in public policy. This is one of those
moments."
Several EPA officials, all of whom asked not to be identified for fear of
retaliation, also questioned why the agency removed the study design and its
recruitment flyer from the EPA's Web site once some scientists started to
complain about the project. Sheldon said the agency is rewriting how it portrays
the research.
"We removed it so we could modify it, so it would make more sense," she said.
Good News!!
We are gratified to inform you that the EPA has suspended a pesticide experiment
in which would have exposed 60 babies to the hazards of pesticides-rather than
educating the public about the hazards pesticides pose for children. The purpose
of the cynically named experiment, CHEERS, was to study how children absorb
poisonous chemicals.
The EPA alloted $7 million of taxpayer money and accepted an additional
$2million from the American Chemical Council.
A similarly unethical experiment which was co-sponsored by the EPA exposed young
children to lead poison-without any effort to prevent harm. In a landmak
decision, the Maryland Court of Appeals ruled that exposing children to any risk
above minimal risk in non-therapeutic experiments was unethical and violated
fundamental moral principles. The Court ademonished the research community for
approving such research to be conducted on helpless children. Check the AHRP
website for a link to the court decision and to AHRP's amicus curiae brief in
support of the Court.
See also, See AHRP Infomail, Nov. 3 at: www.ahrp.org <http://www.ahrp.org/>
(we are in the process of upgrading /updating our website, so if you don't find
it, try again)
We applaud Juliet Eilperin of The Washington Post for her coverage bringing
public attention to the experiment.
http://www.washingtonpost.com/wp-dyn/articles/A10728-2004Oct29.html
http://www.washingtonpost.com/ac2/wp-dyn/A62569-2004Oct25?language=printer
<http://www.washingtonpost.com/>
Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org
http://www.washingtonpost.com/wp-dyn/articles/A37931-2004Nov9.
<http://www.washingtonpost.com/wp-dyn/articles/A37931-2004Nov9.html> html
<http://www.washingtonpost.com/wp-dyn/articles/A37931-2004Nov9.html>
EPA Suspends Study on Kids And Pesticides
By Juliet Eilperin
Washington Post Staff Writer
Wednesday, November 10, 2004; Page A06
The Environmental Protection Agency has suspended a controversial study aimed at
exploring how infants and toddlers absorb pesticides and other household
chemicals, officials said yesterday.
Several rank-and-file EPA scientists had questioned the ethics of the two-year
experiment, which would have given the families of 60 children in Duval County,
Fla., $970 each as well as a camcorder and children's clothing in exchange for
having the children participate. The critics said low-income Floridians might
continue to use pesticides -- which have been linked to neurological damage in
children -- in their homes to qualify for the project. Environmentalists had
also criticized the study because the industry-funded American Chemistry Council
had agreed to pay $2 million of the project's approximately $9 million cost.
EPA spokeswoman Cynthia Bergman said officials had asked a group of independent
experts to reexamine the study design, which has already been reviewed by
several independent panels of academics, officials of the Centers for Disease
Control and Prevention, and representatives of the Duval County Health
Department. The new panel is set to give the EPA its assessment next spring.
"Since the study was announced last month, many have raised concerns, including
scientists within EPA. We want to be responsive to those concerns," Bergman
said. Jeff Ruch, executive director of Public Employees for Environmental
Responsibility, said, "Regardless of the number of reviews, paying poor parents
to dose their babies with commercial poisons to measure their exposure is just
plain wrong."
Administration and industry officials said it was important to pursue the study
to give regulators better information on how harmful chemicals get into
children's bodies. At the American Chemistry Council, spokeswoman Marcia Lawson
said the group "continues to strongly support the study because of the great
importance of increasing understanding of the exposures of young children to
pesticides and other chemicals they naturally encounter in their daily lives."
C 2004 The Washington Post Company
http://www.stopfristbill.org/

Here it comes..the REAL reason..
The driver's license part, among many others, is just UNBELIEVABLE!
http://www.latimes.com/features/health/la-he-mumps24apr24,0,6618280,full.story?coll=la-home-health
College, a petri dish for mumps Health officials focus on vaccinating young
adults after an outbreak among students.
By Melissa Healy, Times Staff Writer
April 24, 2006
When Iowa college students early this year began turning up in doctors' offices
with puffy necks, headaches, fevers and, among some young men, swollen
testicles, many physicians missed a diagnosis most doctors could have made in
their sleep 25 years ago. These patients had the mumps — as do at least 1,100 in
eight Midwestern states as of Friday. The outbreak is still unfolding, spreading
east and west, and beyond the 18- to 25-year-old set.
Their affliction was missed by many physicians unaccustomed to seeing —
especially in college students — a childhood disease largely quashed by
widespread vaccination in the 1980s. Now public health officials are trying to
understand how this disease, which in rare cases can cause deafness,
encephalitis and male sterility, could have regained a foothold in the U.S.
after so many years.
The Midwest mumps outbreak has been all the more surprising because it has
largely affected the first generation of young adults to have commonly had not
one, but two doses of the vaccine that protects against measles, mumps and
rubella. Double vaccinations, widespread since a 1989 outbreak of measles, were
thought to confer complete mumps immunity to about 90% of recipients.
Experts suspect two factors: spotty vaccination coverage among college-aged kids
and the unique bacterial and viral mixing bowl that is dorm life. The virus that
causes mumps appears to have found its perfect home in the college scene — with
multiple kids lolling on beds in great heaving groups, swigging drinks in
common, kissing and cruising the bars even when they're sick, and — oh, yes —
attending classes en masse.
"They eat after each other, drink after each other, share other personal items —
we know that living under those settings, people run higher risks of infection,"
says Dr. Georges Benjamin, executive director of the American Public Health
Assn.
Health experts say the outbreak should help focus new attention on the need to
vaccinate adolescents against a growing variety of diseases before they leave
the nest and dive into this unique germ pool.
The U.S. military ensures comprehensive vaccinations for new recruits. Given its
unique powers of enforcement, coverage is virtually universal there. But on
campuses, lax rules and even more casual living arrangements provide ideal
conditions for the spread of germs. On many college campuses, vaccinations
are recommended but not mandated. Waivers are granted — ostensibly on health or
religious grounds — liberally.
A call to change this state of affairs has been building steadily, fueled by the
development and approval of a raft of new vaccines designed for youths between
10 and 18 years of age.
In February 2005, the Centers for Disease Control's Advisory Committee on
Immunization Practices recommended that all teens — especially those about to
enter college dorms — receive a new vaccine against meningococcal disease, which
can cause meningitis and lead to brain damage; loss of hearing, eyesight or
limbs; and death.
The CDC's advisory committee has also recommended that all adolescents get a
booster of a new tetanus, diphtheria and pertussis (or Tdap) vaccine that
protects against the bacterial infection pertussis, also called whooping cough.
Whooping cough cases have been on the rise across the nation, especially among
young adults.
In the next few years, additional vaccines aimed at teens are expected to win
Food and Drug Administration approval, making it likely that young adolescents
will have a list of recommended immunizations almost as long as the preschool
set. Among the vaccines moving through the pipeline are ones to protect against
sexually transmitted diseases such as human papilloma virus — a principal cause
of cervical cancer — as well as chlamydia and gonorrhea.
In the coming years, vaccines that would protect against the herpes simplex
virus (which causes fever blisters and genital sores) and the respiratory
syncytial virus (which causes flu-like respiratory illness) are also expected to
be recommended for children 12 to 18 years old.
Roughly half of the states, including Iowa, do not have precollege vaccination
requirements in place, according to Dr. Jane Seward, acting deputy director of
the CDC's viral diseases division.
Such rules are typically left to colleges to enforce, and where state rules are
absent, colleges and universities are left to adopt regulations on their own.
"It's more rigorous at some schools than others," says Victor Leino, research
director of the American College Health Assn.
The result: When students at a college in Dubuque, Iowa, returned to homes
across the Midwest for winter break, they brought with them the highly
contagious mumps virus, as well as their own vulnerability. In fewer than
five months, the outbreak spread to Kansas, Nebraska, Minnesota, Missouri,
Wisconsin and Indiana. It's expected to move next toward Arizona and the Eastern
Seaboard.
Seward said that many heads of state and territorial public health agencies were
confronting for the first time a gap in their state vaccination requirements at
the crucial college entry point.
"They're certainly going to be thinking about that" now, she added.
But if teen vaccinations are the immunization community's next big push, health
officials have their work cut out, says Dr. Robert S. Lawrence, a dean at Johns
Hopkins Bloomberg School of Public Health.
Unlike preschoolers, whose parents drive them to yearly check-ups, adolescents
are less likely to see a physician for routine physicals, more likely to reject
a shot when they feel fine and often not covered for preventive healthcare.
Adding to the problem, parents of teens often think childhood vaccinations
should have been enough and have less power to persuade their older children to
get immunized.
"Teens are pretty unresponsive in general — they tend to believe that they'll
live forever and don't need these things," says Lawrence, who led a study by the
Institute of Medicine of future U.S. vaccine priorities.
To get around this problem, some experts have suggested making immunization a
requirement for getting a driver's license — a powerful lever of enforcement
that would cover college-bound kids as well as those who move into the job
market.
"It's very hard to capture this group of kids," says Benjamin. He recently
learned this firsthand as one of his own kids got ready to go off to college.
Excited to get her school experience underway, his daughter was a little too
eager to sign a college release form waiving the need for immunization with the
new meningococcal vaccine.
"I had to suddenly become a more firm parent," says Benjamin. "The last thing I
want is for my child is to die from a vaccine-preventable disease

 HoustonChronicle.com --
http://www.HoustonChronicle.com | Section:
Aldine/North Houston News
Oct. 30, 2006, 1:14PM
Vaccination clinics at polling sites
Free shots given to those 50 and older in East End, North side
Voters 50 and older will have another choice to make when they head to the
polls.
They can decide to protect themselves for the winter by getting a free flu
shot at one of the vaccination clinics set up by the Houston Department of
Health and Human Services and Amerigroup Foundation at four polling sites.
The "Vote & Vaccinate" clinics will be set up from 9 a.m.- 4 p.m. today
through Friday, Nov. 3, at:
•Sunnyside Multi-Service Center, 4605 Wilmington
•Acres Homes Multi-Service Center, 6719 W. Montgomery
•Moody Park, 3725 Fulton
•Ripley House, 4410 Navigation.
Voters will need to present any official document proving that they are at least
50 years old to receive a flu shot.
HDHHS and Amerigroup secured 3,000 doses for the initiative, sponsored for
the first time in Houston through funding from the Robert Wood Johnson
Foundation. Houston is one of 25 cities nationwide sponsoring the Vote and
Vaccinate clinics.
The four polling sites with vaccination clinics are located within Hispanic
and black communities. National studies by the Centers for Disease Control and
Prevention indicate that blacks and Hispanics have the lowest influenza
vaccination rates when compared to other ethnic groups.
The CDC recommends that all Americans age 50 and older receive annual flu
shots to help limit the spread of the influenza virus. Elderly people are
particularly vulnerable to the disease, which kills more than 32,000 people over
age 65 every year.
Caused by different viruses, the flu is a contagious disease that results in
symptoms such as fever, headache, tiredness, cough, nasal congestion, sore
throat and body aches. Most people recover in one to two weeks, but some develop
complications such as pneumonia, bronchitis and sinus and ear infections.
Details: 713-794-9267.

Park Officials Try Birth Control Method To Curb Squirrel Population
March 7, 2007 9:04 p.m. EST
Nidhi Sharma - All Headline News Staff Writer
Santa Monica, CA (AHN) - In a bid to control the ever-growing population of
squirrels, officials at Santa Monica's Palisades Park are injecting them with
birth control medicine. The squirrels will be injected with an immuno-contraceptive
vaccine meant to stunt sexual development as a form of birth control.
The officials decided to opt for this method of birth control after other
methods like euthanasia; poison or gassing failed to control their population.
There are around 1,000 squirrels in the Park that can be aggressive and
dangerous to the health of people they come in contact with.
SF Gate quotes Joe McGrath, the city's parks chief as saying, "We don't want to
kill them if we don't have to. I personally like squirrels, but we also have to
be receptive to the county's concerns."
Squirrels are possible carriers of rabies, or fleas, which could carry diseases
like bubonic plague. The new vaccine that stops lactation and ovulation in
females and testicular growth in males has no side effects. Berkeley is the only
other city to try this method, which was developed by the U.S. Dept. of
Agriculture. It comes at a cost of $2-$10.

http://www.cnn.com/2009/HEALTH/08/20/h1n1.flu.kids.trial/index.html#cnnSTCText
Kids roll up sleeves for H1N1 clinical trial
By Val Willingham
CNN Medical producer
(Risking your child's life for $40)
FREDERICK, Maryland (CNN) -- Andrew Stein, 10, and his brother, Nathan, 7, are
having a typical end-of-summer vacation: hanging out at the pool, visiting their
grandparents and waiting for the beginning of school.
But this week they're doing something most of their classmates will never do.
The Stein brothers will be testing the new vaccine to prevent swine flu. Because
the younger population, from 6 months to 24 years, is at high risk of developing
complications from the H1N1 virus, the National Institutes of Health is
conducting a clinical trial specifically to make sure the vaccine is safe for
children. Vaccine developers hope to get the doses out by mid-October, before
the flu season really shifts into high gear.Although both boys dislike needles,
they are willing to make the sacrifice. "One boy that I knew at our school died
from a type of the flu," said Andrew, frowning. "So I wanted to prevent that as
much as I could."
The boys, who live in the suburbs between Baltimore, Maryland, and Washington,
got their first inoculations at the vaccine satellite office in Frederick,
Maryland. The trial is being conducted by the University of Maryland School of
Medicine, one of 11 institutions across the country holding pediatric trials.
Researchers will test the boys' blood, have them keep journals and make sure
they have no severe reactions after each vaccine. The pediatric studies are
divided into two groups within the United States. Half the sites will be
comparing reactions between the H1N1 shot and the seasonal influenza vaccines on
kids; the others will be looking at the effectiveness of a two-dose vaccine. The
Steins are enrolled in the dosage trial.
The data are crucial for developing a safe vaccine, said Dr. Karen Kotloff, who
heads both the pediatric and adult trials at Maryland. "The purpose of the
studies we are doing is to try to collect information that will help to inform
policymakers about the best way to give the pandemic H1N1 flu vaccine," she
said. "Whether we need one or two doses and what strength we need."Before they
received their shots, both boys, along with their parents, Christy and Eric
Stein, got an explanation of the procedure and were warned about possible
complications. Nancy Wymer, who coordinates the study, says the boys will
receive two inoculations over six weeks and will continue to check in
periodically over the following six months. Neither brother gave more than a
grimace as he rolled up his sleeve and took a shot for science. Andrew Stein
said it was no big deal. "It was in and out, in a couple of seconds."
Why would parents have their children be part of such a trial? Most say to help
other children. Christy Stein was involved in a pediatric trial for the swine
flu vaccine in 1976 and understands what her sons are going through. But she
also believes it's good for the country's public health. "I trust the people who
are running the study," she said. "And I'm not concerned about it at all."The
studies are based on other influenza trials in the past. Many parents have
already volunteered their children but openings still exist. Children 6 months
to 35 months are needed, Kotloff said. "Like with any shot, children may have a
sore arm. Your arm can be red...There might be some fever or achiness, but the
symptoms go away in a couple of days.
"There can be allergic reactions, mostly rashes, but in some rare circumstances
there can be severe allergic reactions," she added. "Each volunteer is informed
about these possibilities, so it's up to the parents to make that choice."The 11
main sites across the U.S, in nine states, are currently recruiting children for
the vaccine trials. The two-dose vaccine tests are being conducted at the
University of Maryland Baltimore; Duke University in Durham, North Carolina;
Children's Mercy Hospital in Kansas City, Missouri; Children's Hospital and
Regional Medical Center in Seattle, Washington; and Vanderbilt University in
Nashville, Tennessee. And the trial comparing H1N1 and seasonal flu vaccines is
at Hope Clinic, Emory University in Atlanta, Georgia; St. Louis University in
Missouri; the University of Iowa in Iowa City; Cincinnati Children's Hospital
Medical Center in Cincinnati, Ohio; Baylor College of Medicine in Houston,
Texas; and the University of Texas Medical Branch in Galveston.
Each location has a Web site to sign up if more children are needed.
Andrew and Nathan are doing fine. They will keep a diary on how they feel and
what, if any, reactions they have. Each was rewarded with a $40
gift card for his trouble. And even after being stuck with a couple of
needles, Nathan Stein says it was worth it.
"Not just for the gift card," he said, "but for being able to help other kids."
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