abcnews.go.com/sections/wnt/DailyNews/NEJM_policychange020612.html

The New England Journal of Medicine will announce Thursday that it has given up finding truly independent doctors to write and review articles and editorials for it, as a result of the financial ties physicians have with so many drug companies in the United States The Journal says the drug companies' reach is just too deep. In 2000, the drug industry sponsored more than 314,000 events for physicians — everything from luncheons to getaway weekends — at a cost of almost $2 billion. On top of that, many doctors accept speaking and consulting fees that link them to drug companies. No publication in this country influences the way your doctor treats an illness more than the New England Journal of Medicine. Since 1812, the Journal has scrutinized and published thousands of clinical studies. These "review" articles on drug therapy that can be pivotal. They tell doctors the strengths and weaknesses of new medications for everything form high blood pressure to obesity to cancer.

Now, the Journal will allow these critical evaluations to be written by people with financial ties to drug companies. "This change will allow us to recruit the best authors, the people who have experience with new treatments to write these editorials and review articles," said Dr. Jeffrey Drazen, the medical journal's editor-in-chief. Under the new policy, doctors writing reviews in the Journal can accept up to $10,000 a year from each drug company in speaking fees and consulting fees.

Concerns About Possible Bias
Not everyone thinks this is such a good idea.
"So if a doctor is doing that kind of business with four or five companies, he or she can get as much [as] $40- to 50,000 a year and not violate the new New England Journal policy," said Dr. Sidney Wolfe, the director of the Public Citizen Health Research Group, one of the country's largest medical consumer groups.

"The bias introduced by drug companies paying writers of review articles a large amount of money can have the consequence of slanting articles and influencing physicians in a way that isn't really in the best interests of their patients," said Wolfe. The Journal, in a letter to its readers, says the policy change is necessary because it simply could not find enough qualified authors who did not already have ties to drug companies.

"There are areas where we simply have not published anything because we didn't think we could get a person who was good to write in an area that had absolutely no interaction with a commercial entity," said Drazen. But Jerome Kassirer, who was the Journal's editor between 1991 and 1999, says he had no problem finding independent authors.

"There's a lot of depth in academic medicine, sufficient depth, so that it's almost always possible to find a first-class person to write an editorial or review article in which they do not have a conflict of interest," said Kassirer, now a professor at the Tufts University School of Medicine. Some doctors are concerned that by relaxing conflict-of-interest standards, the Journal is reducing the prestige and influence that it has taken 190 years to build.
 

By Brian Ross and David W. Scott

http://www.drugawareness.org/Drug_Firms_Still_Lavish_Pr.html
 

Drug Firms Still Lavish Pricey Gifts On Doctors

By Bill Brubaker
Washington Post Staff Writer
Saturday, January 19, 2002; Page E01   

A week ago last night, about two dozen doctors gathered for cocktails and dinner at the Plaza Hotel in New York, guests of a pharmaceutical company that planned to solicit their "advice" and "feedback" on the treatment and management of depression. The doctors didn't have to rush home after dinner. Forest Laboratories Inc. treated them to an overnight stay at the Plaza, where even the least desirable rooms -- those without Central Park views -- go for about $250 a night.

Saturday morning, after a free breakfast, the doctors participated in a four-hour discussion about depression, which can be treated with Forest's best-selling product, Celexa. Then, after a free lunch, each doctor was offered a token of Forest's appreciation: a check for $500. The Plaza event, and a more modest one that Pfizer Inc. sponsored Jan. 11 at the Improv comedy club in downtown Washington, illustrate how the harmaceutical industry spends an estimated $2 billion a year on events for doctors in the United States.

Despite a barrage of direct-to-consumer ads for drugs, only doctors can write the prescriptions needed for a sale.

Drugmakers have been wining and dining physicians for years, and the practice has been controversial enough to prompt periodic reviews by Congress and the American Medical Association. The issue was raised again Wednesday when board members from the AMA and the Pharmaceutical Research and Manufacturers of America, an industry trade group, met in Washington.

Timothy T. Flaherty, a Wisconsin radiologist and chairman of the AMA's board of trustees, said he's satisfied with the association's 12-year-old ethical guidelines on gifts. But, he said yesterday, "this is an issue that may be reopened." The guidelines say physicians should accept gifts worth only "in the general range of $100" and that serve a "genuine educational function" and "entail a benefit to patients." Last summer, the AMA launched a campaign -- funded largely by the pharmaceutical industry -- to reeducate the nation's 700,000 doctors on ethics.

The guidelines offer some wiggle room. Doctors who have been deemed "advisers" to drug companies, if only for a few hours, can accept honorariums and travel perks, for example. Forest Laboratories calls its advisers advertising/marketing consultants" in the confidentiality agreements they are asked to sign. Rep. Fortney "Pete" Stark (D-Calif.), who introduced a bill that would eliminate corporate tax deductions for perks given to doctors, called the AMA guidelines "window dressing."

"It's 'how to play golf often without having to call attention to the fact that the pharmaceutical companies are paying your greens fees,' " Stark said. A study published in 2000 in the AMA's journal concluded that doctors who have regular interactions with drug companies are influenced in their prescribing behavior by the gifts and perks they accept.

"From a business point of view, the drug companies do this because it works," said Julia Frank, a Washington psychiatrist. Critics say the practice helps drive up the use of expensive prescription drugs, a major factor in the escalating cost of health insurance. Pharmaceutical company executives say frequent interaction with doctors is necessary to gain insights into how their drugs can be more effective. "We don't have -- on staff -- doctors with all of the expertise in the areas that we work," Forest President Kenneth E. Goodman said before the meeting at the Plaza. "When we have a product where we are designing clinical studies . . . we go to outside experts to seek their advice.

"We might share with them clinical data and talk about . . . how could this be positioned in the market? You know, is this good data from a marketing standpoint? Is there something that would cause you to prescribe this product for your patients?" Ultimately, drug company executives say, the perks and gifts they give to doctors can boost corporate profits.

"Although Celexa is a product with a highly favorable profile for the treatment of depression, product virtues do not produce sales unless prescribers are informed and reminded of them," Forest Chairman, Howard Solomon, wrote in a letter to shareholders, published in the company's 2001 annual report. "And in markets with powerful competitors with immense budgets, it requires competitive budgets and super-competitive skills and highly motivated representatives to convey product information."

Forest reported profits of $215 million for its last fiscal year -- an increase of 91 percent over the previous year, with Celexa its biggest money-maker. The antidepressant competes against Eli Lilly's Prozac (now available in a generic form) and Pfizer's Zoloft, among others. Nothing in the AMA guidelines discourages doctors from accepting as many free breakfasts, lunches or dinners as they want.

Typical is the "evening of education and fun" Pfizer offered Washington-area doctors Jan. 11 at the Improv. Pfizer's invitation said the evening would begin with a reception, dinner and lecture on "antimicrobials and the treatment of respiratory tract infections." Then the lights would go down for Kathleen Matigan -- "voted female comic of the year."

The AMA guidelines say free meals must be "modest" and have an educational component.

How does the AMA define "modest"?

"It's a meal that you would typically go out to on a Tuesday night with your family," said Andrew M. Thomas, a physician and Ohio State University educator who is a member of the AMA's working group on ethical guidelines. "Probably not something that's at a five-star restaurant." The guidelines do not rule out five-star treatment -- or honorariums -- for doctors who provide "genuine" -- not "token" -- services as company advisers.

"The drug companies have invented this terminology -- advisory committee -- to get around the AMA guidelines," said Richard J. Brown, a retired New York psychiatrist. "Putting the doctors on an advisory committee avoids the ethical issue. You know, it's like you're on board with them." Brown is a critic of freebies, yet he makes the free-dinner rounds. "I no longer treat patients or write prescriptions so I am not influenced in that sense," he said. He recalled a "summit" in southern California last year, sponsored by Wyeth, at the Ritz-Carlton, Laguna Niguel in Dana Point, Calif. "They paid for a weekend at this resort plus air transportation -- ah, the whole schmeer," he said. "They spared nothing. It was just outrageous. They also gave me -- are you seated? -- $2,000 to attend."

The summit was called to announce new clinical data on Effexor XR, an antidepressant. All 120 guests were Wyeth "advisers," though some didn't serve in that capacity at the event, company spokesman Douglas Petkus said. Petkus said that while Wyeth supports the AMA's ethics campaign, "the guidelines are not specific enough to be a practical guide for everyday practice in our industry." Some doctors say drug companies are more interested in promoting products than gaining clinical insights.

"I don't think it's appropriate for doctors to even accept trivial gifts from these companies," said Dan C. English, a retired surgeon who taught bioethics at the Georgetown and the University of Maryland medical schools. "These gifts are an attempt to influence physicians to prescribe and overprescribe based on what the companies have done for them." Others say the perks don't influence them at all. "Doctors will do what's best for their patients," the AMA's Thomas said.

Stanley S. Moles, a Largo, Fla., cardiologist, doubts that many doctors would prescribe a drug based on information they got over a prime-rib dinner. "The guy that's giving the talk has been paid by the company to give that report," he said. "These guys are biased." Moles said he routinely declines invitations to such events. "I'm invited almost every day to a fine gathering to hear a 30-minute talk," he said. Thursday night, he had invitations to two dinners in Tampa -- at Ruth's Chris Steak House (Merck & Co. Inc.) and Fleming's Prime Steakhouse and Wine Bar (GlaxoSmithKline).

Moles chuckled. "Well, I did go to one about three years ago. They bugged me and bugged me and in a weak moment with a pretty sales rep I told her: 'I'll only go if you send a limo with a bottle of champagne.' And Merck sent a limo with a bottle of champagne and I took another cardiologist to an Italian restaurant in Tampa."

Gregory Reaves, a Merck spokesman, said such limo rides are not permitted under the company's gift-giving policy. What is permitted? "I can't discuss this," Reaves said, "because of the competitive and strategic activities that we deal with."   
 

Physicians' behavior and their interactions with drug companies. A controlled study of physicians who requested additions to a hospital drug formulary.

Chren MM, Landefeld CS.

Department of Dermatology, Cleveland (Ohio) Veterans Affairs Medical Center, University Hospitals of Cleveland 44106.

OBJECTIVE--It is controversial whether physicians' interactions with drug companies affect their behavior. To test the null hypothesis, that such interactions are not associated with physician behavior, we studied one behavior: requesting that a drug be added to a hospital formulary. DESIGN--Nested case-control study. SETTING--University hospital. PARTICIPANTS--Full-time attending physicians. Case physicians were all 40 physicians who requested a formulary addition from January 1989 through October 1990. Control physicians were 80 randomly selected physicians who had not made requests. MAIN EXPOSURE MEASURE--Physician interactions with drug companies, as determined by survey of physicians (response rate, 88% [105/120]). RESULTS--Physicians who had requested that drugs be added to the formulary interacted with drug companies more often than other physicians; for example, they were more likely to have accepted money from companies to attend or speak at educational symposia or to perform research (odds ratio [OR], 5.1; 95% confidence interval [CI], 2.0 to 13.2). Furthermore, physicians were more likely than other physicians to have requested that drugs manufactured by specific companies be added to the formulary if they had met with pharmaceutical representatives from those companies (OR, 13.2; 95% CI, 4.8 to 36.3) or had accepted money from those companies (OR, 19.2; 95% CI, 2.3 to 156.9). These associations were consistent in multivariable analyses controlling for potentially confounding factors. Moreover, physicians were more likely to have requested formulary additions made by the companies whose pharmaceutical representatives they had met (OR, 4.9; 95% CI, 3.2 to 7.4) or from whom they had accepted money (OR, 1.7; 95% CI, 1.0 to 2.7) than they were to have requested drugs made by other companies. CONCLUSION--Requests by physicians that drugs be added to a hospital formulary were strongly and specifically associated with the physicians' interactions with the companies manufacturing the drugs.

PMID: 8309031 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?
cmd=retrieve&db=pubmed&list_ui
ds=8309031&dopt=Abstract"Entrez-PubMed

 

http://bmj.com/cgi/content/full/324/7334/383/a

Authors of guidelines have strong links with drugs industry
Alison Tonks, Bristol

Most guidelines on clinical practice are written by experts with undisclosed links to the pharmaceutical industry, researchers from Toronto, Canada, say in an article in the journal of the American Medical Association (JAMA 2002;287:612-7[Medline]).

In a survey of nearly 200 authors of 44 clinical guidelines, 87% of respondents admitted to financial links with one or more pharmaceutical companies. Over half of the authors had been paid to conduct research, over a third had been an employee or consultant, and two thirds had received fees for speaking. On average each respondent had links with 10 companies, including companies whose products they recommended in guidelines. Only one of the 44 guidelines carried a declaration of the authors' competing interests.

"I'm not at all surprised by these findings," says Dr Bob Goodman, internist at Columbia University in New York and founder of No Free Lunch, the campaign for independent prescribing. "Other studies have already shown extensive links between physicians, researchers, and even policy makers and the pharmaceutical industry. It's particularly worrying, though, in the case of practice guidelines. These documents are widely distributed and intended to change physicians' practice.

"Any influence of a drug company on an individual author is multiplied thousands of times. Worse, there's a subjective element to the recommendations in clinical guidelines that makes them particularly vulnerable to bias."

Most (93%) of the study's respondents said their relationships with pharmaceutical companies did not affect their recommendations on treatment. But evidence cited by the researchers makes it clear that accepting money from drug companies alters prescribing, drives requests for additions to hospital formularies, and contributes to publication bias. The researchers were unable to check whether authors' financial interests influenced the treatments recommended in guidelines, because there were too few independent guidelines in the sample to make a meaningful comparison.

The study looked at guidelines on the management of 10 common diseases, including asthma, coronary artery disease, heart failure, depression, and peptic ulcer. All the guidelines were endorsed by professional societies in North America or Europe and were published between 1990 and 1999.

The researchers contacted 192 authors, but only 52% responded, despite a second mailing. They blame the low response rate on authors' reluctance to admit to links with drug companies and speculate that those who did not reply had even more to declare than those who did. If so, the links between authors of guidelines and the drugs industry are even more widespread than the study indicates, they conclude.

The researchers want a formal process built in to guideline development that forces authors to declare their financial interests. They also want written declarations of competing interests on every guideline.

Thought this might be interesting as well. Please do note all the references.


Just as the recent literature on professionalism ignores history, it slights  the structural barriers, apart from managed care, to the accomplishment of  the principles of professionalism. Most of the authors, for example, pay  little attention to the interactions between pharmaceutical companies and  physicians or the influence of such companies on undergraduate medical education and residency training. Despite the evidence that this influence is  far-reaching, the few analysts who do remark on the issue fail to convey its importance. Pellegrino and Relman,1 for example, assert that contributions from pharmaceutical companies should not dominate the budgets of professional  associations. But they do not cite the data showing how extensive these contributions are or discuss what the associations might have to do to survive without them. To select one example from an organization that specifies in its budget reports the contributions of pharmaceutical companies, all 21 major donors to the American Academy of Family Physicians in 1995 were drug companies.9 If more professional societies divulged information about such contributions, this example might be multiplied many times over. There is also substantial evidence that gifts from pharmaceutical companies (such as subsidies for meetings and travel) influence the prescribing practices and formulary choices of physicians.10 A discussion of threats to professionalism that does not address the influence of pharmaceutical companies omits a critical consideration, one that, unlike managed care, is largely subject to the control of physicians.

http://content.nejm.org/cgi/content/full/342/17/1284?ijkey=1cdZD.PCVPsgI
 

http://www.suntimes.com/cgi-bin/print.cgi
Ties to drug company raise vaccine questions

January 27, 2002

BY JIM RITTER HEALTH REPORTER

Next fall, thousands of Illinois schoolchildren are likely to have to get a chickenpox vaccine, under orders from the state health department. The department followed the recommendation of a panel of experts, its Immunization Advisory Committee, while rejecting the advice of others who thought the decision should be left to parents and pediatricians.  But in what critics consider a conflict of interest, 5 of the committee's 18 members have financial ties to Merck, which makes the chickenpox vaccine.

Two members of the committee have given talks for Merck, receiving up to $750 per speech. A third member directs a nonprofit group that has received $20,000 in grant money from the company. And two other members own stock in Merck, including one who has owned as much as $16,000 worth.

Though only one of these five members of the committee participated in the vote to recommend making the vaccine mandatory, the others participated inthe discussion, committee member Fran Eaton said.

Last year, the Illinois House and Senate unanimously passed a bill that would have banned anyone with financial ties to pharmaceutical companies from serving on the committee. But Gov. Ryan, who has received $9,000 in campaign contributions from Merck, vetoed the bill, and the Senate failed to override the veto. The bill was sponsored by Sen. Patrick O'Malley (R-Palos Park), who is running for governor.

Since 1994, Merck has contributed $75,050 to political candidates in Illinois, including Ryan.

Merck spokesman Christopher Loder said Merck seeks to "have a voice in the debate about the most effective means to achieve the goal of improving the state of health care." Mandating the chickenpox vaccine, he said, "is good public policy." When Ryan vetoed the bill last year, he said the restrictions on financial ties to drug companies would have severely limited the number of pediatricians, infectious disease specialists and other experts who could serve on the committee. Ryan noted that members are required to disclose financial interests in drug companies that exceed $5,000 and abstain from votes if they have a conflict of interest.

"The people who do this work are principled people," said committee member Robyn Gabel, executive director of the Illinois Maternal and Child Health Coalition. "The amount of money they get from the companies is not enough to do something that is harmful." But critics say the financial ties damage the committee's credibility. "It's outrageous that Gov. Ryan vetoed this," said Dr. Linda Shelton, an Oak Lawn pediatrician. "If you have even the appearance of impropriety, people won't trust you."

On the federal level, members of committees that advise the Food and Drug Administration and the Centers for Disease Control and Prevention on vaccine policy also often have conflicts of interest, according to a report of the House Government Reform Committee. The FDA approves vaccines, and the CDC issues guidelines for their use. The federal report examined the financial interests of expert advisers who endorsed a rotavirus vaccine to prevent childhood diarrhea. Shortly after the vaccine was approved, it was pulled from the market after being linked to severe bowel obstructions in babies that caused vomiting and bloody stools and sometimes required surgery.

The House committee report documented that members of the FDA and CDC advisory committees held stock in vaccine companies, owned vaccine patents, received grants and research funds from vaccine manufacturers and were paid speaking and consulting fees. Some of these members abstained from the vote to approve the rotavirus vaccine, but still participated in committee discussions, the report said.

"We've taken a good hard look at whether the pharmaceutical industry has too much influence over these committees," said committee chairman Dan Burton (R-Ind.) "From the evidence we found, I think they do."

The issue is part of a larger debate over whether the pharmaceutical industry wields too much clout over the nation's medical practices and health policy. Drug companies routinely give doctors free meals, medical textbooks, drug samples and generous speaking and consulting fees. Companies that develop new drugs pay for the studies that determine whether the drugs will be approved for use. Drug companies also are a major source of advertising dollars for medical journals, and they help pay for medical conferences.

Eaton, a non-medical member of the state immunization advisory committee and the only member to vote against the chickenpox vaccine, said she was "amazed at the number of lobbyists from pharmaceutical companies that attend these meetings." Industry representatives, she added, are on a first-name basis with committee members and sometimes participate in discussions.

In April 2000, the committee voted 6-1 to recommend requiring the chickenpox vaccine. Seven members were absent, three abstained and one recused himself, citing a conflict of interest. Eight months later, the health department received conflicting advice. The state Board of Health voted 4-3 against making the vaccine mandatory. Health board member Ernst Ott said people who attended three public hearings expressed overwhelming opposition to requiring the vaccine. And board member Colin McRae said there is no "far-reaching public health issue" to justify a mandatory vaccine.

Last October, Dr. John Lumpkin, the state's public health director, decided to make the vaccine mandatory. He said he weighed the advice from both committees, along with recommendations in favor of the vaccine from the CDC, the American Academy of Pediatrics, the American Academy of Family Physicians and his staff.

"It would not be fair to say that one committee had more weight than the other," said Lumpkin, whose order still must be reviewed by a legislative committee. "It was the sum total of all the information and recommendations."
 

http://news.bbc.co.uk/hi/english/health/newsid_1842000/1842236.stm

Tuesday, 26 February, 2002, 14:23 GMT
'Scrap GP vaccine payments'

GPs are paid for meeting vacciation targets

Pressure is mounting for the abolition of the scheme under which GPs receive extra payments if they immunise a high proportion of their patients. Currently, family doctors receive extra money if they give sufficient numbers of children particular vaccines. These include the combined vaccine for diphtheria, tentanus and polio and the controversial combined jab for measles, mumps and rubella.

" Immunisation target payments pollute the doctor-patient relationship " Dr Evan Harris

However, opponents say that it is wrong that doctors stand to profit from convincing parents to allow their children to have the jab.  Currently, GPs are paid a standard amount once 70% take-up of the MMR vaccine is achieved and higher payments once take-up tops 90%. Speaking in a House of Commons Adjournment Debate on Tuesday, Dr Evan Harris, the Liberal Democrat health spokesman, added his voice to calls for the abolition of the current scheme.

He said: "Immunisation target payments are a conspiracy theorist's paradise and they pollute the doctor-patient relationship. "How can we expect parents to believe they are getting the best independent advice from their GP, when the spectre of financial incentives hangs over the consultation?" Dr Harris also criticised GPs who suspend patients from their lists in order to achieve immunisation targets.

"It is totally unacceptable and wholly unethical for practices to strike families off their list for refusing to accept immunisation, or to suspend children temporarily from their lists in order to claim the immunisation target payment. "The GMC and primary care trusts must re-issue urgent guidance and clamp down on any such practices."

Doctors' move

The British Medical Association's GP Committee has written to the Department of Health calling for a "moratorium" on immunisation target payments.

If agreed, family doctors would continue to encourage the take up of MMR and other vaccines but would not be financially penalised if parents - possibly influenced by adverse publicity - decided against immunisation. Leeds GP Dr Robert Addlestone, said that doctors were being pressured into recommending MMR by the prospect of financial penalties. Although he thought MMR was safe, he said parents should be able to choose whether their child had the jab.

He said: "I think it's just morally and ethically wrong that the target payments should be tied up with having to persuade parents to have the MMR vaccine. "Patients should not be affected by our financing. GPs shouldn't be thinking about finance when talking to parents about this."
 

http://www.telegraph.co.uk/news/main.jhtml?xml=
/news/2002/07/03/nbma03.xml&s
Sheet=/news/2002/07/03/ixhome.html

Doctors abandon bonus scheme for MMR jabs
By Celia Hall, Medical Editor
(Filed: 03/07/2002)

Doctors voted yesterday to abandon a system of payments for vaccination targets, which they say destroy their credibility with patients, and could contribute to a feared epidemic of measles. In a deal introduced 12 years ago, GPs can earn £2,865 extra if 90 per cent of the children on their list are vaccinated or £955 if 70 per cent are vaccinated. But since the controversy over the MMR triple jab, with many parents fearing that it can lead to bowel disease and autism, the doctors want a new payment system.

MMR vaccination levels have fallen to 84 per cent and as low as 73 per cent in some areas. GPs told the British Medical Association conference in Harrogate, North Yorks, that they should not be put in the position of bullying patients into having their children vaccinated. Dr Richard Vautry, a Leeds GP, said that two weeks ago he had sat in his surgery with his son waiting for his booster injection of MMR.

"I was there to ensure that my son had the best possible protection against measles mumps and rubella and I believe that MMR is the best way to protect our children from these dreadful diseases.
"However, yesterday I met with one of my one patients who is yet to be convinced. She is a sensible mum who wants nothing but the best for her child, but she still needs a little more time to think about whether she should bring her daughter for the MMR.

"She should be allowed that time. She shouldn't be pressured or bullied as a result of some diktat from a Whitehall civil servant." Dr Vautry said that the target system failed in that situation. "Surely patients have a right to say no. Surely patients of young children have the right to make an informed decision and surely GPs should not be penalised as a result of the decisions their patients make."

He said he refused to pressurise his patients however much money he might lose. "For if I did my patients would start to wonder whether my advice could be trusted as they could see that I have a vested interest in reaching a target." The doctors also heard that there was an alternative to target payments which is being negotiated as part of the new GP contract.

Dr Hamish Meldrum, joint deputy chairman of the association's GPs' committee, said they had proposed a system of "informed dissent" in which an informed patient who decided against vaccination would not be included in a revised target list. He said later that just as patients understood the idea of informed consent there should also be a system in which they could refuse treatment.

"Patients don't want to deprive their doctors of income because they don't want their child immunised. The majority of parents just want to exercise parental choice. "I fully support MMR and I am convinced of its safety but I don't think I want the Government to make it mandatory. He said that GPs were so convinced of the value of MMR that they would strive to have as few informed dissenters as possible. Dr Joan Black, a GP from West Berkshire, told the conference that it was easy to understand a patient's fears. "Target payments are an inappropriate way to run a service in a free society. Patients must be aware of a conflict of interest when their doctor stands to lose or gain a substantial sum of money depending on what the patient decides to do."
 

Simon Bowers
Tuesday March 12, 2002
The Guardian

SmithKline Beecham, which merged with Glaxo to become Glaxo SmithKline, has become embroiled in a criminal investigation into the alleged bribing of more than 1,000 German doctors in order to secure orders for the drugs it manufactured in the late 1990s.  The company is suspected of having paid bribes of up to DM60,000 (£20,000) to individual doctors in almost every city across Germany in return for them taking SmithKline Beecham products.

The public prosecutor's office in Munich has started an investigation following raids on a string of businesses two years ago, according to reports in the German press. Yesterday, a spokesman for GSK said they had not known the investigation was under way until the reports appeared. Most of the doctors under suspicion are believed to have received between DM1,000 and DM3,000 between 1997 and 1999, but some individuals may have received DM60,000.  Investigators are thought to have heard varying explanations for the payments from those interviewed.

Raids on SmithKline Beecham offices in Munich took place in May 2000, months before the completion of the merger with Glaxo Wellcome. The combined business today has an annual turnover in Germany of about £500m.  Details of the investigation overshadowed the departure of chairman Sir Richard Sykes, who yesterday announced his retirement. During the past seven years, Sir Richard drove through two huge mergers - with Wellcome in 1995, and SmithKline Beecham in 2000 - transforming the business into Europe's largest pharmaceuticals firm.  He stepped back from the role of chief executive in 1997 to become non-executive chairman, but remained the leading figure behind GSK's acquisitive zeal. 

But yesterday several City analysts insisted there were no signs that GSK had overstretched itself under Sir Richard's stewardship. The GSK chairman, who plans to concentrate on his work as rector of Imperial College, will retire in May taking with him an annual pension expected to be worth more than the £657,000, secured two years ago. The exact figure will be released in the company's annual report, published next month. Sir Richard said: "Having overseen the successful merger of GSK and as I approach my 60th birthday in August, I feel now is the right time to depart."  His successor is to be Sir Christopher Hogg, who is already a non-executive director at GSK, and holds a similar post at Reuters. 

BMJ 2002;324:693 ( 23 March )

News
German doctors face investigation in drugs scandal
Annette Tuffs, Heidelberg

Some 3500 doctors in several German towns are currently being investigated for alleged undue financial advantages and corruption after aggressive marketing by a drugs company. The district attorney's office in Munich, which is carrying out the investigation, said that suspicions were raised over excessive marketing activities by SmithKline Beecham, the company which merged in 2000 with GlaxoWellcome to form GlaxoSmithKline. From 1997 to 1999 SmithKline Beecham invited hospital doctors and their spouses to conferences in Germany and abroad.

An additional 5800 payments of up to 25000 each (£15477; $22051) were made, in some cases for travel costs, conferences, studies, lectures, or expert consulting. In other cases, books, personal computers, and donations were given. When SmithKline  Beecham held a conference on its new ACE inhibitor drug, doctors were invited to visit the final of the football world championship or a formula one race nearby. However, 2220 of the initially suspected cases have been closed by the district attorney's office because less than 500 was paid.

After nationwide reporting of the scandal in the media, federal health minister Ulla Schmidt, like other politicians, was enraged and asked for a thorough investigation. The German director of GlaxoSmithKline, Thomas Werner, did not deny that the former SmithKline Beecham was responsible for these excessive marketing activities. He protested, however, against premature judgments on doctors and employees of the company.

When GlaxoSmithKline was formed, new guidelines had been issued, said Dr Werner. He also pointed out that clinical studies were essential for the introduction of innovative therapies and that doctors have to be informed about new drugs. Doctors' integrity must not be put at risk without real reason, he said.

Lawyer Alexander Ehlers, who specialises in questions of health law, pointed out that only doctors employed in hospitals were involved. If they received money or any other reward without adequate work, the anti- corruption law had to be applied. Whereas a dinner invitation at a conference was acceptable, the doctor's spouse should not be invited, and luxurious entertainment was also unacceptable, he said. Funding of clinical research by firms was possible if the money was paid and administered in special accounts.

Jïrg Hoppe, the president of the Bundes rztekammer, the German Medical Association, pointed out that again and again doctors were unfairly publicly prosecuted andas in the so called "heart valve scandal"in only a few cases did legal prosecution follow. In the "heart valve scandal" thousands of doctors were said to have received money for using very expensive types of heart valves. In the end, 34 doctors were sentenced, for various other reasons.
 

Companies Use Enticement to 'Educate' Physicians
By Brian Ross and David W. Scott

It was doctors' night out last June at the world-renowned Museum of Modern Art in New York City, and the Saturday night party, put on by Pfizer Inc., was lavish. The event was strictly private, closed to reporters, as the pharmaceutical company entertained a very select list of doctors and their guests.

But Primetime's undercover cameras saw the kind of big-money splurge that some say drives up the cost of prescription drugs and corrupts the practice of medicine. Further investigation into the $6 billion spent by drug companies for what they say is a way to educate doctors showed that tactics like lavish gifts and trips are surprisingly common.

"It's embarrassing, it's extravagant and it's unethical," said Dr. Arnold Relman, a Harvard Medical School professor and the former editor of the New England Journal of Medicine. "It makes the doctor feel beholden . it suborns the judgment of the doctor." But doctors seemed thrilled to have been invited for a weekend in New York City with some seminars along the way, with all expenses paid by Pfizer on behalf of one of its drugs, Viagra.

One Small-Town Doctor: $10,000 in Goodies

Few doctors were willing to talk publicly about their relationships with pharmaceutical companies, but one upstate New York doctor was willing to come forward. "It's very tempting and they just keep anteing it up. And it's getting harder to say no," said Dr. Rudy Mueller. "I feel in some ways it's kind of like bribery."

Disgusted by how the free gifts and trips add to the high price of medicine, and moved by the plight of patients forced to skip needed medication, Mueller agreed to provide Primetime with a rare glimpse of the astounding number of drug company freebies he was offered by various drug companies in a four-month period. He was presented with an estimated $10,000 worth, including an all-expenses-paid trip to a resort in Florida, dinner cruises, hockey game tickets, a ski trip for the family, Omaha steaks, a day at a spa and free computer equipment. "It changes your prescribing behavior. You just sort of get caught up in it," said Mueller, who said he was offered a cash payment of $2,000 for putting four patients on the latest drug for high cholesterol. The company called this a clinical study; Mueller called it a bounty.

"I've never been offered money before," he said. "I don't remember that 10, 15 years ago."Though Mueller normally declines the offers, he agreed to attend a dinner, which Primetime secretly taped. Not only were the doctors wined and dined, but each was also offered a payment of $150 for just showing up to listen to a pitch for a new asthma treatment for children. The company called it "an honorarium," but Mueller saw it differently. "Again, it's bribery," he said. "This is very effective marketing." There's a wide range in value of the free gifts offered to doctors - from lavish trips to free Mother's Day flower bouquets for doctors willing to hear a pitch about a new osteoporosis medicine.

In the latter example, when asked whether a floral shop was the most effective place for a discussion on pharmaceuticals, one of the representatives said, "I'm sorry, we're not allowed to comment on anything."

Detail Men

The goodies are dispensed by an army of drug company representatives known as detail men and women, of whom there are 82,000 nationwide. It's the job of the detail people to quietly befriend doctors, keeping close track of which doctors take the free gifts and then determining which drugs the doctors later prescribe. "I think it's sleaze," said Relman. "Anybody who's been in that position knows that yes, those gifts, $60, $100, $40, again and again, do influence your attitude about that company and will influence the prescriptions that you write."

And the multibillion-dollar drug company blitz extends throughout the profession, even at the yearly gathering of one of the most prestigious medical groups, the American College of Physicians. It was like a carnival: Doctors could be seen taking free massages, free food, free portraits, free Walkman players, free basketballs, and from one company pushing a new antacid drug, free fire extinguishers.

Many doctors say it's no different than any other business or convention, and that it doesn't affect their medical judgment. But that's not the view of the new president of the American College of Physicians, Dr. William Hall, who says anything beyond a pen or a mug could have an impact.

"Whether we like it or not, it can cloud our clinical judgment," he said. "Unequivocally, I would say that."

So why are some of the very practices Hall publicly criticizes permitted at his group's supposedly scholarly convention? "I think there it's a situation where every physician is going to have to balance what's right or wrong," said Hall. "We are concerned about it," he added, saying that at some point the system may be changed. But right now, Hall's group receives $2 million a year from the drug companies to have their exhibition booths at the convention, yet another example of how the big drug companies spend billions to influence doctors in this country.

"The basic mistake we're making with our health-care system now is that we regard it as just another business. And it's clearly not just another business. Patients, sick patients and worried patients, are not like ordinary consumers," said Relman. "Doctors ought to be incorruptible . That's the doctor's sacred obligation. They're being corrupted and undermined by this kind of salesmanship."

ABC News.com

I know you will appreciate this. I work with a person whose wife is a school nurse. Last night she was wined and dined by the Massachusetts Nurses Association and a pharmaceutical company. This even took place at a swanky place. The MNA and this company where postulating the nurses to write their legislators to MANDATE a meningitis vaccine for all College freshmen. This vaccine costs $90.00 a shot. You can do the math. Also think about the possible health ramifications

 A new American company called Time-Concepts LLC is offering doctors $50 (£34; 55) each time they listen to a short sales pitch from a drugs company representative in their office.

The new company receives $105 from the drug manufacturer each time it secures a consultation, $50 of which goes to the doctor, $5 of which goes to a charity that the doctor selects, and $50 of which it keeps. Doctors are accepting the payments, despite the fact that guidelines from the American Medical Association specify that they should not accept cash payments from drug companies.

Dr Neal Moser, a pulmonary and critical care physician with a 13-doctor group in Edgewood, Kentucky, for example, told AMANEWS.com, the American Medical Association's newspaper for physicians, that he signed up because the plan lets him control when and how he talks to sales representatives. He said that it gave him a more efficient way to get the drug information he needed. He saw no ethical problem with the arrangement and said that the fee barely covered the cost of his time.

But Dr Frank Riddick, chairman of the American Medical Association's council on ethical and judicial affairs, said that accepting cash payment contravenes the association's guidelines for physicians. The guidelines say that physicians are entitled to accept gifts of low value ($100 or less) if they serve an educational, practice related, or patient care function. "If the purpose of the contact is to educate the physician, then there is no need to pay the physician," he said.

The new scheme is similar to a scheme launched last year by a group of doctors in Cincinnati, called the Queen City Physicians. The group set up a subsidiary company called Physician Access Management, which charges sales representatives $65 a time to talk to Queen City physicians for 10 minutes. Ms Pamela Coyle-Toerner, president and chief executive officer of Cincinnati's Queen City Physicians and one of the owners of its subsidiary, said that the proceeds helped to pay for an electronic medical records system.

Time-Concepts LLC claims its methods are efficient and ethical.

Footnotes:

More information is available on the American Medical Association's website at
www.ama-assn.org/sci-pubs/amnews/pick_02/bil20506.htm

Bill to Boost Industry Fees That Fund FDA
Critics Fear Conflicts
By Marc Kaufman
Washington Post Staff Writer
Thursday, May 23, 2002; Page A01 With little public discussion and limited debate on Capitol Hill, Congress is moving to substantially expand the program through which companies pay large fees to the Food and Drug Administration to review their new drug applications -- making the agency increasingly dependent on the businesses that it regulates.

The expansion, a top priority for makers of drugs and medical devices, was put on a congressional fast track and added to the bioterrorism bill, a popular bipartisan effort that negotiators signed off on early this week and the House overwhelmingly approved yesterday.

The expanded FDA "user fee" bill is speeding toward final approval after receiving unusually little public debate or scrutiny. The program was crafted in private meetings between the industry and the FDA, was never debated or voted on in either chamber before going to the negotiators, and is moving forward before a General Accounting Office review of the current program can be finished and made public.

If passed as proposed, the user fees from pharmaceutical and biotechnology companies would add almost 500 employees to the FDA centers that review proposed new drugs and other substances used to treat patients by 2007 -- bringing the FDA workforce funded by industry to at least 1,530. That would constitute more than 55 percent of the FDA staff involved in reviewing drug applications.

Having drugmakers fund the FDA is viewed as such a success by lawmakers and industry representatives that other health product suppliers are eager to follow, and the makers of medical devices and drugs for animals completed negotiations recently with the FDA to start similar industry-funding programs. Intense efforts to tack those programs onto the bioterrorism bill failed Tuesday, but industry spokesmen said they will continue pressing for quick congressional approval.

The FDA user-fee program is a decade old, and agency leaders say that funds from drugmakers have allowed the agency to review applications more promptly and efficiently, and with the same intense scrutiny as before. The result, they say, is that new drugs get to patients more quickly and more than half of the world's new drugs are launched first in the United States.

But some legislators and public health advocates are concerned that industry funding of the FDA will undermine its independence and credibility with the public. Some also worry that the user fees -- plus the accompanying requirements for the FDA to act on drug applications within set periods of time -- are encouraging the agency to move too quickly when it reviews new drug applications and without enough attention to safety. Nine drugs approved in the past 10 years were later withdrawn because of deadly side effects.

Because of such concerns, Sen. Edward M. Kennedy (D-Mass.) last summer requested a GAO evaluation into "potential unintended consequences" of the current FDA user fees and asked that it be completed before Congress took up the bill to reauthorize and expand the program. That report has not been finished or made public.

Kennedy still strongly supports the user-fee legislation, but some of his colleagues are skeptical. "Our concern is that with so much industry money coming in, the fox may be guarding the henhouse at FDA," said Rep. Bart Stupak (D-Mich.) before the final bill was approved. "There's no doubt in my mind that bigger and bigger [user fees] harm the credibility of the agency."

But those arguments have carried little weight on Capitol Hill, especially since congressional authority for the FDA to pay the drug reviewers currently funded through industry fees expires in September. The agency has said it would have to start sending out layoff notices by mid-summer unless the authority was renewed -- a deadline that encouraged congressional leaders to
act quickly and attach it to the popular bioterrorism bill.

Health and Human Services Secretary Tommy G. Thompson said yesterday that the expanded drug user-fee program, as well as the proposed medical device and animal drug user fees, are "vitally important" to his department. "If you look at the scarce resources that all of us have, you have to balance the good with the problems," he said. "And the good is that . . . the public will get drugs faster than if we didn't have the fee situation."

The drug and biotechnology industries pay about $160 million yearly in user fees to the FDA, but that sum would jump to $260 million yearly in 2007under the proposed expansion. The new money would not only allow the agency to hire more staff but also to upgrade its technology and improve management at FDA headquarters. In return, the FDA would commit to maintaining its speedier pace for new drug reviews and to more quickly move applications for new uses of older drugs. In addition, it would begin pilot programs to further speed review of certain fast-track drugs.

The proposed fees for veterinary medicine and medical devices would be much smaller, but would embed the program throughout the FDA. According to industry sources, private funding of the Center for Veterinary Medicine would reach $10 million within three years under the negotiated agreement, and more than $25 million for the Center for Devices and Radiological Health.

Drugmakers pay three user fees to the FDA -- one when they submit an application for a new drug, one for inspections of their manufacturing plants and another for each approved drug on the market. The funds, which will total $1.2 billion over the next five years, go to staff and supply the two FDA centers that review new drug applications. FDA officials say the industry money does not affect agency decision-making -- that it speeds the review process but makes it no more likely that any single drug application will be approved.

The details of all the user-fee programs have been negotiated in private between the FDA and organizations that represent the industries involved -- the Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization for drugs, the Animal Health Industry for veterinary drugs and the Advanced Medical Technology Association for medical devices.

When the first drug user-fee bill was passed in 1992 and when it was reauthorized in 1997, intense debates followed in Congress before the program became law. But with the current expansion, Congress had only one limited hearing (in March in the House) and the animal drug and medical devices user-fee programs were never publicly debated. The final negotiations on medical devices were completed over the past weekend.

"It's an amazing thing that all this is going on behind closed doors, that this bill isn't being discussed in the sunshine at all," said Diana Zuckerman, president of the National Center for Policy Research for Women & Families, a public interest group in Washington. "Patient and consumer groups are really not getting a chance to weigh in properly."

But the expanded drug user-fee bill contains some provisions that patient and consumer groups applaud. It would allow the FDA to use industry funds to pay for expanded safety reviews after drugs come on the market and sets aside up to $20 million in dedicated funds. The bill that passed the conference committee also requires greater public participation in the future in the user-fee negotiations between the FDA and the drug industry. The decision to add the drug user-fee bill to the bioterrorism legislation was initially announced by conference committee chairman Rep. W.J. "Billy" Tauzin (R-La.). He and other legislators agreed to keep all "controversial" elements out of the user-fee proposal, but that effort hit some roadblocks.

The medical device user-fee legislation was opposed by some smaller manufacturers in the industry, and makers of generic veterinary drugs also fought the fee program for their center. Large trade associations representing both industries believe that the FDA centers that regulate their products are underfunded and that the drug user-fee program has increased that underfunding.
 

Symposiums Sponsored by Pharmaceutical Companies Trouble Some Psychiatrists

By Shankar Vedantam
Washington Post Staff Writer
Sunday, May 26, 2002; Page A10


PHILADELPHIA -- In the days leading up to the American Psychiatric Association's annual meeting here this past week, pharmaceutical companies mailed attendees hundreds of free phone cards, as well as invitations to museums, jazz concerts and fancy dinners.

As thousands of psychiatrists streamed into town, they were greeted by a highway billboard advertising AstraZeneca Pharmaceutical’s anti-psychotic medicine Seroquel. Each of the 19,000 attendees was given a gray bag with the insignia of the meeting and the orange logo of GlaxoSmithKline PLC, the maker of the antidepressant Paxil. Outside the giant convention center, curb signs for buses ferrying doctors to their hotels advertised Eli Lilly and Co., the maker of Prozac.

In one part of the convention hall, companies erected 20 foot-high monuments to their medicines and handed out promotional material, candies and gifts. Company executives hailed passing physicians, imploring them to stop and pick up information. And in several dozen symposiums during the weeklong meeting, companies paid the APA about $50,000 per session to control which scientists and papers were presented and to help shape the presentations.

The perks, freebies, handouts, promotions and corporate sponsorships are not unique to the APA's meeting or to psychiatry. But many psychiatrists increasingly feel that the industry's aggressive promotional activities are particularly troublesome in their field, potentially swaying psychiatrists into writing prescriptions for the products of companies that woo them, raising health care costs and tilting the profession away from insight-oriented psychotherapies to a near-total focus on medications.

"A line has been crossed in terms of pharmaceutical company marketing," said Henry Levine, a psychiatrist from Bellingham, Wash.

Officials at the APA defended the sponsorships and symposiums, and said the money helped pay for a vast range of educational activity and advocacy on behalf of the mentally ill. They said the bottom line is that no physician would ever mistreat a patient whatever the inducement.

"Of course, it's going to bias us -- the question is whether the bias is benign," said David McDowell, a Columbia University psychiatrist who helped monitor industry sponsorships for the APA. Without industry money at the gigantic Philadelphia Convention Center, he said, "we'd be sitting in the basement of the YMCA."

Jeff Trewhitt of the Pharmaceutical Research and Manufacturers of America said ties between companies and doctors have led to more informed medical practices and better knowledge about how drugs work. He said new guidelines taking effect on July 1 will ask companies not to give doctors tickets to sports and entertainment events, and to offer them only modest meals.

The industry-sponsored symposiums at this conference are unusual – most major medical associations do not allow them -- said James Thompson, the APA's deputy medical director. If companies want to take advantage of the conferences of those other groups, they have to set up their own "satellite symposiums."

Thompson and other APA officials said allowing the symposiums to be part of the convention permits doctors to first screen the studies for scientific accuracy. Drug companies then select the papers they want to sponsor, and APA officials monitor the proceedings for signs of bias or marketing.

The diagnosis and treatment of mental illness have risen sharply in recent years. While studies show that many patients are still untreated, pharmaceutical marketing has raised fears that others are getting prescriptions they do not need.

Concern over psychiatry's ties with industry was widespread enough to be the focus of several panels at this year's convention. Some psychiatrists said the association should simply sever all ties with industry. Harvard Medical School psychiatrist David Osser suggested that companies pool symposium money into a common fund, which could then be used to conduct sessions chosen exclusively by mental health professionals. Andrew Ho, a University of California at Los Angeles psychiatrist, said the extent of industry involvement -- and the dependence of the association on the money – raised questions about who was controlling the association and the profession.

"Let's face it -- they make the money back" through greater sales and prescriptions, said Robert Eilers, a psychiatrist in the state Office of Mental Health in New Jersey, in a session where several doctors assailed top APA officials. "It's totally out of control." Levine told APA officials that even patient organizations such the National Alliance for the Mentally Ill had been shunted to the "far, far corner of the auditorium" as funding companies got center stage in the exhibitors' hall.

Officials at the APA warned, however, that there were no simple answers to questions about industry influence in psychiatry. "There are strings attached," agreed Stephen Goldfinger, the APA's top monitor of industry sponsorship at the conference, at a session discussing potential conflicts of interest. "When you dance with the devil, you can't control all the steps." 

 The idea of setting up a common pool of money for symposiums was "naive." Industry would never sponsor symposiums they have no control over, said Muskin, and warned that the critics were forgetting the many important educational and advocacy services that would be slashed if the money was refused.

"Are you willing to pay $3,000 a year for membership dues if we didn't take drug company money?" asked Anand Pandya, a psychiatrist who helps the APA evaluate new research presented at the conference. "That's how much you would pay." The APA's 31,000 psychiatrists -- who account for three in four American psychiatrists -- currently pay about $540 in dues to the national association, and between $200 to $500 in state dues, said the APA's Thompson.

Part of the APA's dependence on industry sponsorship is because the association has been ailing financially, and revenue from the annual convention represents about 22 percent of all funding. That money is becoming increasingly important, as revenue from dues has dropped in recent years from $11 million in 1998 to $9.9 million last year, and is expected to drop further. The association has run at a loss for three out of the past four years.

Thompson said that it is ultimately the responsibility of physicians to evaluate what they hear for scientific accuracy and signs of bias. Goldfinger said that observers and evaluation sheets at the symposiums rated each session and that warning letters were sent to researchers whose presentations fell short or who had shown biases for particular medicines. If a pattern of bias is observed, said Goldfinger, scientists would be barred from presenting research at the APA for five years. In the three years the policy has been in place, he said, nobody has been so sanctioned.

In the end, the appearance of a conflict of interest may be more harmful than any actual conflict itself. Several doctors noted that it may even keep good treatments from receiving the attention they need.

Jeffrey Levine, chairman of psychiatry at Bronx-Lebanon Hospital Center, an affiliate of the Albert  Einstein College of Medicine in New York, said he had once been approached by a marketing representative who complained that a particular drug was not being made available in Levine's hospital. Levine said he thought the medicine was effective, and would likely have recommended that it be added to the formulary, but hesitated because he was worried that others might think he was in the pocket of the drug industry. "There isn't a simple headline or a bottom line," he said. At his panel discussing the ethics of industry influence in education, Levine dubbed the meeting "the American Psychiatric Association GlaxoSmithKline Convention."  Still, he noted that the psychiatric residents who had presented data about the dangers of conflicts of interest would not have been able to attend without industry funding. Saying that a company-marketing representative he knew had helped arrange a grant, he added: "It has paid for our residents to come here today. Now you all don't know that, but it's got to be said.

Drug company push on doctors disclosed

By Liz Kowalczyk, Globe Staff, 5/19/2002

Newly unsealed court files provide an inside view into how one of the largest pharmaceutical companies sought to influence doctors - many of them prominent Massachusetts physicians - into prescribing a key drug, a strategy that included ghost-writing journal articles for doctors and rewarding the largest potential prescribers with seaside trips.

The files, hundreds of pages of internal company memos, voicemail messages, and records on individual physicians are part of a civil lawsuit brought by a former company sales representative turned whistleblower against Pfizer Inc. and Parke-Davis, which merged two years ago. The civil lawsuit and a parallel criminal investigation by the US attorney in Boston seek to prove that Parke-Davis and its parent company, Warner-Lambert, illegally influenced and paid kickbacks to doctors to prescribe the antiseizure drug Neurontin for a range of medical problems for which the drug was never approved.

One company memo in March 1996 directs sales representatives to ''target neurologists with the greatest potential'' for an all-expenses paid weekend at the Jupiter Beach Resort in Florida that included a $250 honorarium for each physician. To do so, the company generated a list of the top prescribers of antiepileptic drugs for sales representatives and said ''it is essential that the invitees are from this list.''

In a memo after the April conference, the Neurontin marketing team wrote that doctors who attended ''were delivered a hard-hitting message'' about the drug. The company included charts for each physician and told salesrepresentatives to tally their prescriptions before and after the trip.

Many drug companies have used such strategies for years to increase sales of their drugs. But federal and state prosecutors, angry over the soaring costs of prescription drugs to state Medicaid programs, are increasingly investigating and bringing charges against companies that market drugs illegally.

A key issue is whether pharmaceutical companies are promoting their drugs for conditions not approved by the US Food and Drug Administration - an illegal practice. It is not illegal for doctors to prescribe drugs for ''off-label'' uses. Neurontin is approved only as combination therapy for seizures. But in one undated transcript of a voice mail message, the whistle-blower, Dr. David Franklin, said he recorded a manager telling company medical liaisons: ''When we get out there, we want to kick some ass. We want to sell Neurontin on pain. All right?'' In Massachusetts alone, Medicaid spending on Neurontin grew from $1.1 million in 1996 to $14.1 million in 2000, the height of the Parke-Davis marketing campaign. Two years ago, about three-quarters of Neurontin prescriptions were written for off-label uses, pushing sales to $1.75 billion last year.

The American Medical Association responded to the government investigations by launching an ethics-education campaign with the pharmaceutical industry for doctors and sales representatives last year. The organization's ethical guidelines - which generally prohibit physicians from accepting trips unless they are conference speakers - have been in place since 1992. But  the AMA contends that many doctors remain unfamiliar with them. Doctors who violate AMA guidelines can get expelled from the organization, but the guidelines don't carry the force of law. Both the AMA and medical journals, including the Journal of the American Medical Association, have guidelines on authorship of articles that require doctors to have made significant intellectual contributions to articles on which their names appear and the disclosure of others who have provided substantial assistance in research or writing. JAMA editors would not comment on whether they had reviewed the authorship of Neurontin articles.

Doctors say they're savvy to sales pitch In talking to doctors Parke-Davis courted, it's clear that some
marketing practices are well established in the medical community and that many physicians don't believe that drug company gifts and trips influence what medications they offer patients. Many doctors assert that they see through exaggerated drug company claims. Sales people from competing companies bombard them with so much information, physicians say, that messages essentially cancel each other out. ''Each time we go for a talk, the expert is spinning it for the company sponsoring the talk - we all know that,'' said Dr. Alan Kurland, a neurologist at Norwood Hospital who attended the Florida meeting, called Advances in Anticonvulsants. ''I've got people walking into my office every day giving me a hard sell. But this is not all of the information I'm receiving. I'm also looking at articles and talking to other doctors I respect about using the drug. The bottom line here is that I did not feel unduly influenced or coerced to try anything that's inappropriate.''

Company hires firms to draft articles Pfizer, which is now the world's largest drug company, defends itself against Franklin's allegations in the court filings. Company spokeswoman Mariann Caprino said she could not comment on pending litigation specifically. But she said that the allegations against Parke-Davis were made up to six years ago, before the merger with Pfizer. ''It's firm and established policy at Pfizer that our representatives do not promote off-label use of our medicines under any circumstances,'' she said.

The court documents, unsealed by US District Judge Patti Saris in Boston on April 23, also describe how Parke-Davis hired Medical Education Systems of Philadelphia to draft 12 articles and opinion letters on antiepileptic drug therapy. According to company memos, MES compiled a list of topics, such as the use of antiepileptics for pain and psychiatric illnesses, and proposed physicians to act as authors. The company paid the doctors $1,000 each to review and revise drafts written by MES and lend their names to the articles, some published in prestigious journals, including the Annals of Internal Medicine and JAMA.

In an Oct. 29, 1997, memo, MES told Parke-Davis that it still was trying to track down Dr. John Pellock of the Medical College of Virginia for an article about pediatric seizure disorders: ''Author interested; still playing phone tag. MES HAS DRAFT COMPLETED, WE JUST NEED AN AUTHOR.'' Pellock did not return a telephone call to his office.

Parke-Davis also hired another company, AMM/Adelphi, to draft articles. In a November 1996 memo, the company wrote ''these physicians are clinicians rather than academicians or researchers, making them less than accessible scientific authors.'' The company said it ''input data'' on 100 patients who'd taken Neurontin or a placebo for restless leg syndrome for Dr. Bruce Ehrenberg. The company returned the data to Ehrenberg, a neurologist at New England Medical Center, for review.

In an interview, Ehrenberg said he was not concerned that the company would distort the data because he randomly checked them and analyzed the results himself. Entering the data into a computer spreadsheet was busy work, he said, and his department had no secretarial support at the time. But, he said, a later experience with another company that confused some study data convinced him to stop using outside firms for this purpose.

The court documents also describe a shadowing program involving 75 to 100 doctors in the Northeast; they were paid $350 or more each day they allowed sales representatives to watch as they examined patients.

Ethical guidelines difficult to enforce

Prosecutors have targeted drug companies more than doctors in their investigations. Franklin's lawsuit, brought by Boston lawyer Thomas Greene, does not name any physicians as defendants. And medical boards have not been aggressive about disciplining doctors for their dealings with drug companies - few even have policies covering these relationships.

Drug companies have millions of dollars to pay large fines, and law enforcement officials often count on doctors as witnesses to win large settlements. And while doctors cannot accept plane tickets and hotel rooms from drug companies under AMA guidelines, it is far more difficult to prove this behavior is actually a crime. In other words, did the doctor specifically take the gifts as a kickback in return for prescribing the company's drugs?

Several doctors interviewed about drug company trips said that there are never any such agreements and that speakers often present information about drugs made by several companies - even those not sponsoring the conference. In October, the US attorney in Boston forced TAP Pharmaceuticals of Illinois to pay a record $875 million to settle civil and criminal charges over its best-selling prostate cancer drug, Lupron. Four doctors pleaded guilty in the case, for billing insurance companies for free Lupron samples, and a fifth was indicted. None of these doctors has lost his license.

In the TAP case, doctors chose between Lupron and a competing drug, Zolodex, which were equally effective for cancer patients, said Dr. Frank Riddick, chairman of the AMA Council on Ethical and Judicial Affairs. ''This was a choice of product A or product B; they do essentially the same thing,'' he said. ''That's not as bad from the patient's standpoint as if a physician was convinced to use a worse product.''

''The enforcement of ethical guidelines is more or less hit and miss,'' he said. ''There is probably no physician in the US that hasn't violated in spirit or in fact some aspect of these guidelines. But given the new focus on this, some of these abuses will probably disappear over the next few years.''


This story ran on page A1 of the Boston Globe on 5/19/2002.
© Copyright 2002 Globe Newspaper Company.
END QUOTE

By Denise Gellene
Los Angeles Times

A government crackdown on Medicare fraud produced its biggest catch Wednesday when a drug company agreed to pay $875 million and plead guilty to criminal charges that it engaged in a kickback scheme with doctors in marketing its prostate cancer drug.

AND
"The indictment, unsealed Wednesday in federal court in Boston, details a conspiracy in which TAP sales people used an array of freebies, ranging from free ski trips to such mundane items as VCRs, to entice urologists to prescribe Lupron, a prostate cancer drug with sales of about $800 million last year. As part of the conspiracy, TAP employees gave doctors free samples of Lupron knowing the doctors would prescribe the samples for patients and fraudulently bill Medicare for them"
 

LONDON -- The editor of a top medical journal on Friday accused the U.S. Food and Drug Administration, the world's most powerful drug watchdog, of endangering people's lives.

Richard Horton of The Lancet said the FDA, which safeguards the health of 274 million people and regulates over $1 trillion worth of products, was compromised by funding from the drugs industry and pressure from Congress.

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€     Everybody's got issues in PoliticsIn an editorial, he slammed the FDA
for its handling of GlaxoSmithKline Plc's controversial bowel drug Lotronex.

The FDA approved Lotronex in February 2000, but the company voluntarily withdrew it from the market nine months later after the deaths of five patients who had been taking it.  Senior FDA officials are now trying to reintroduce it, Horton said.

"This story reveals not only dangerous failings in a single drug's approval and review process but also the extent to which the FDA, its Center for Drug Evaluation and Research (CDER) in particular, has become a servant of the industry," he wrote in an editorial in the journal. According to Horton, serious side effects were evident during the pre-approval process and shortly afterwards but the FDA kept the product on the market. "The decision was to prove fatal," said Horton.

The Lancet said scientists within the FDA who raised concerns about the drug's safety were sidelined and excluded from future discussions. An independent review of research found serious flaws but calls for more studies were ignored. "That is where there has been a terrible failure in evaluating the safety of this drug," Horton told Reuters.

"The FDA is not only compromised because it receives so much funding from industry, but because it comes under incredible congressional pressure to be favorable to industry. That has led to deaths," he added. A spokesman at the FDA said he could not comment on the editorial but added that the agency was formulating a response to the allegations. The agency monitors the safety, labeling, import, transport, storage and sale of food ingredients, drugs, cosmetics and surgical supplies. GlaxoSmithKline confirmed the company was in discussions with the FDA but refused to discuss the timing of any decision.

"We are in discussions with the FDA over Lotronex," spokesman Martin Sutton said. "Both the FDA and ourselves are trying to find a resolution that will benefit and protect patients." Lotronex was developed to treat irritable bowel syndrome which can cause disabling bouts of constipation, diarrhea, abdominal pain and bloating. But soon after its launch reports of side effects such as severe constipation and ischaemic colitis, a restriction of blood flow to the colon, began to surface. "It is an impossible conflict for safety issues to be overseen by a center that receives funding from industry to review and approve new drugs," Horton added.

Copyright © 2002 Reuters Limited.

 

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States Accuse Bristol-Myers of Fraud

June 5, 2002
By MELODY PETERSEN and MARY WILLIAMS WALSH

Attorneys general from 29 states accused Bristol-Myers Squibb yesterday of illegally profiting through several fraudulent schemes to keep lower-priced generic versions of Taxol, a life-extending cancer drug, off the market.In a lawsuit filed in Federal District Court in the District of Columbia, lawyers for the states said one scheme involved collusion between Bristol-Myers and a small California drug company, American BioScience, to extend Bristol-Myers's exclusive right to sell Taxol in the United States. American BioScience, which was named as a co-conspirator but not a defendant in the lawsuit, has received financing from Premier Inc., a hospital-owned group that is supposed to help hospitals save money by buying medical supplies more cheaply.  "It would be ironic if it wasn't so egregious," said Betty D. Montgomery, the attorney general of Ohio. A Senate panel overseeing antitrust issues is already investigating  Premier, in part to review its investments in medical companies.  The states' lawsuit says Bristol-Myers and American BioScience filed a "sham court action" that helped delay the availability of a cheaper version of Taxol, a drug that can cost up to $10,000 for a course of treatment lasting several months.  The New York attorney general, Eliot L. Spitzer, said the companies' actions had cost state governments, patients and their insurers "many, many millions of dollars." The lawsuit seeks to recoup the extra money that the plaintiffs contend that state governments and cancer patients were forced to pay for Taxol from December 1997 to April 2001, when several companies began selling generic versions of the drug and the price fell.

"We cannot tolerate anticompetitive and deceptive practices that allow drug companies to fatten their bottom lines illegally at the expense of people who depend on this drug," Mr. Spitzer said. He said he knew of some patients who had decided against treatment because of the cost.  "They looked at it and decided it was too expensive," he said.

Bristol-Myers said yesterday that it planned to defend itself against the lawsuit, which it said was similar to other recent suits involving Taxol that were filed by generic drug companies and consumer groups. "The only news in this lawsuit is that the states have chosen to enter late in the litigation," the company said in a statement. "The actual events at issue are several years old and have been the subject of litigation for some time." Lew Phelps, a spokesman for American BioScience, said the allegations in the lawsuit were "false and without merit." "The concept of collaboration between American BioScience and Bristol-Myers is preposterous," Mr. Phelps said.
 
Premier declined to comment other than to confirm that its venture capital unit still owned a minority stake in American BioScience. That unit, which has since stopped making investments, invested several million dollars in American BioScience in 1996. A Premier executive also took a seat on the board at American BioScience; he has since left Premier and is no longer on the board of American BioScience. Premier acts as a purchasing agent for nearly 1, 500 nonprofit hospitals and is owned by many of those hospitals.

Until the arrival of generic competitors, Taxol was one of Bristol-Myers's top-selling products, with sales of more than $1 billion a year. The states' lawsuit is the latest setback for Bristol-Myers. Its stock has declined by more than 40 percent in the last year after the company lost battles to keep competitors from selling generic versions of Taxol and two other drugs that had lost patent protection.

Taxol, which is known generically as paclitaxel, was discovered by government scientists at the National Cancer Institute. The government spent more than $32 million to develop it, according to the states' lawsuit. Later, the government granted Bristol-Myers the exclusive right to sell Taxol in the United States for five years, starting when the Food and Drug Administration approved the drug in December 1992.  The states' lawsuit contends that Bristol-Myers illegally extended the five-year period by fraudulently obtaining two patents from the United States Patent and Trademark Office. Taxol itself cannot be patented, but delivery methods can. The lawsuit contends that Bristol-Myers misused the patents to keep generic companies from selling a lower-priced version of the drug.

When that tactic eventually failed, according to the lawsuit, Bristol-Myers then colluded with American BioScience in a scheme that involved yet another patent, this one obtained by the smaller company.

In September 2000, with Bristol-Myers's extended period of exclusivity about to expire, American BioScience sued Bristol-Myers, demanding that it file information about its patent with federal regulators. That step would effectively bar any generic drug companies from selling their own versions of Taxol for as many as 30 additional months.  But that litigation, according to the states' lawsuit, was a "sham" aimed only at delaying the sale of lower-priced versions of the drug. The Federal Trade Commission has said that it is investigating the relationship between Bristol-Myers and American BioScience, trying to learn whether they "were working together," according to a court document.

Consumer groups, which have long complained about Bristol-Myers's control of the Taxol market, praised the states' suit, which has been planned for more than a year.  "If they win, it will put up a big, strong, bright warning light to other companies that think it's in their best interest - and in the best interests of their shareholders - to use any means necessary to extend their patents," said Cynthia A. Pearson, executive director of the National Women's Health Network. "This trend has been escalating to the point where consumers are being gouged," Ms. Pearson added.

State attorneys general have filed other suits contending that brand-name drug makers have illegally delayed the generic versions of their products. One such case involves BuSpar, an anti-anxiety drug, which is also sold by Bristol-Myers. Ms. Montgomery, the Ohio attorney general, expects the states to file more such suits. "Our biggest concern is to change the behavior of the drug companies," she said. "That is what we are looking for."

http://www.nytimes.com/2002/06/05/business/05DRUG.html
?ex=1024833428&ei=1&en
=f36dc3e010313262
 

With an army of lobbyists 623 strong, the pharmaceutical industry "easily outnumbered" members of Congress and managed to gain ground in 2001 despite mounting pressure to make prescription drugs more affordable, Public Citizen. While overall pharmaceutical industry spending on lobbying dropped to $78.1 million in 2001 from $92.3 million the year before, its lobbying efforts paid off, enabling the industry to preserve patent protections and profits.

Still, the 10 most active drug companies and industry groups spent $49.8 million on lobbying in 2001, a 16% increase from the previous year. The number of lobbyists they employ jumped 30% to 540. The industry's main trade association, Pharmaceutical Research and Manufacturers of America (PhRMA), spent more on lobbying than any single drug company did, boosting its investment in hired lobbyists by 51% to $11.3 million last year.

The report also lists the most popular firms and lobbyists and documents their connections to Congress and other branches of the federal government. The industry's army of "hired guns" included 23 former members of Congress, it says. In all, 340, or 54%, previously worked for Uncle Sam.

Public Citizen June 13, 2002

http://www.sundayherald.com/25686
Drug companies and charities accused of conflict of interest


Investigation: pharmaceutical giants pump millions into charities ... who in turn campaign to get the firm's drugs prescribed
By Sarah-Kate Templeton, Health Editor

The latest campaign by Arthritis Care appears to be a straight- forward battle by a charity to ensure the most effective drugs for the patients it represents. It features a survey carried out by Arthritis Care which found that only one in three GPs is prescribing a new type of arthritis drug called COX-2 inhibitors which, according to the charity, are not associated with the stomach complications caused by the older form of the drug. In getting the message across that arthritis patients are losing out on the most effective treatments, the charity also warns that 2000 patients die a year as a result of gastrointestinal complications brought on by the older medicines.

But the message becomes less clear cut when it emerges that the Arthritis Care campaign is partly funded by Pharmacia and Pfizer, the companies which manufacture the new COX-2 inhibitor drug celecoxib which costs up to 10 times more than the drugs it would be replacing. There are also claims that the initial results of a trial, funded by Pharmacia and showing that its new drug is safer than the cheaper ones, were misrepresented.

The Arthritis Care study, published in September 2000 in the Journal Of The American Medical Association , stated that COX-2 inhibitors were associated with a lower incidence of complications than traditional anti-inflammatory drugs. But by August 2001 letters published in the same journal drew attention to the fact that complete information about the trial, available to the United States Food and Drug Administration , contradicted these conclusions. The authors had claimed that celecoxib was safer than older drugs, with less gastrointestinal bleeding.

However, only six months of data was recorded in the paper. When results for the entire 12-month period of the trial were analysed, critics claimed the side effects were shown to be similar to those of older drugs. But by this time the findings published in the original article were widely distributed and believed. An editorial in the British Medical Journal records that a total of 169 articles reported the initial results and this coincided with the sales of the drug increasing from $2623 million (£1752m) in 2000 to $3114m (£2080m) in 2001.

In July 2001, following the positive paper published in the Journal Of The American Medical Association, the government's drug rationing body the  National Institute of Clinical Excellence (NICE) issued guidelines recommending the drug for specific 'at risk' categories of patients. Armed with these guidelines, Arthritis Care launched a campaign for wider prescription of COX-2 inhibitors.

The campaign was funded by Pharmacia and Pfizer, who make the new COX-2 inhibitor drug. Both companies are listed on the Arthritis Care website as donors, but exactly how much they donate is kept secret.

Dr Simon Maxwell, senior lecturer in clinical pharmacology and therapeutics at the University of Edinburgh and a doctor at the city's Western General Hospital, is deeply concerned about the conflict of interest.

'The data that was presented was skewed in favour of COX-2 inhibitors. I, as someone who spends a lot of time looking at drugs, would say that these are an advance -- they have benefits for some patients -- but the extent of that advance has been over-hyped. The interest is in the fact that these
drugs cost about 10 times more than what they are replacing. What they are replacing are among the most commonly prescribed drugs, and so it is easy to work out the maths of what this would do to drugs bills. To insist that all GPs prescribe these new drugs in preference to the older drugs is a nonsense.'

Maxwell believes that when medical charities and patient groups campaign in favour of a new drug, they should declare their interests. 'The pharmaceutical industry do this because they realise that the people who can really have the strong political message are the patient groups themselves. 'It is great to get patient groups' opinions but the pharmaceutical industry knows that this is the lobby that has the power with the government and with health professionals.

'This causes great concern. As a doctor involved in new drugs, I have to declare all of my interests when I state an opinion about a drug. If I travelled anywhere funded by the pharmaceutical industry then, quite rightly, I would need to declare that. So, if these patient bodies state their opinions, and they are perfectly entitled to do that, they should make the same declaration that they have an interest in this.'

An investigation by the Sunday Herald has discovered that many of the country's leading charities fail to make public details of the funding they receive from pharmaceutical companies.

In the last financial year Diabetes UK received around £1m in funding from the pharmaceutical industry. Around 7.5% of the charity's income consists of such donations -- this is roughly the same amount as is raised by community fund-raising. Although a page of the charity's annual report is dedicated to community fund-raising activities, including the £300,000 raised by the charity's presence at the London Marathon, funding from the pharmaceutical industry is not mentioned at all in the public document.

Last year, Diabetes UK received funding from 11 pharmaceutical companies manufacturing diabetes drugs. A spokeswoman for the charity said: 'We don't publish exact figures as often donors prefer us not to." Eight major pharmaceutical firms selling asthma medication are listed on the National Asthma Campaign website as donating at least £10,000 a year for three years. For this the companies are granted 'elite corporate gold membership'.

Describing the rewards of 'gold membership' the website states: 'This is the solid foundation upon which a long-term partnership, beneficial to both parties, is then built. The scheme is targeted predominantly at companies with a commercial interest in asthma. It enables them to raise their profile in the asthma/health care market, and increase their understanding of the needs of people with asthma through close contact with key staff within the National Asthma Campaign.'

The National Asthma Campaign received £185,000 in the last financial year from the pharmaceutical industry. Inhaler manufacturers Allen & Hanburys donated £60,000. Another pharmaceutical company donated £40,000 towards setting up a helpline.

Every year, the Patients Association, a national health watchdog standing up for patients' rights, receives over £100,000 from the pharmaceutical industry and health care companies. Pharmaceutical giants such as Pfizer, GlaxoSmithKline and Pharmacia pay £5000 each to become platinum members of the group's donation scheme. Donations from the pharmaceutical industry
contribute up to 20% of the group's income.

But Mike Stone, director of the Patients Association, insists the group is open about its links. 'We as an organisation get funding from pharmaceutical companies. There are a number of companies and we are quite open about it -- in no way would we let them influence policy.

'We are a national organisation and for an organisation our size this is just a percentage of our income -- about 15% to 20%.' Some medical charities are now becoming increasingly aware of the potential conflict of interest. In their most recent accounts the MS Society made a point of listing exactly how much it receives from the pharmaceutical industry. The charity lists all donations over £500, including one for £22,000 from Biomedical Research Ltd and another for £13,000 from Schering Health Care which makes the expensive multiple sclerosis drug beta interferon for which the charity campaigned to make more widely available.

The accounts state: 'The society is aware of public interest in the financial relationship between medical charities and the pharmaceutical industry.' Similarly, Alzheimer Scotland has a strict policy to protect the charity's activities from being influenced by the pharmaceutical industry. Chief executive Jim Jackson said: 'We are aware that this is a sensitive issue but we feel that we have got clear policies to protect the integrity of the charity. We are aware of the narrow line that we have got to draw.

'On the one hand we are desperate to generate as much income as possible so that we can do as much as possible for people with dementia and their carers, but we are careful not to endorse particular products.' Arthritis Care last night defended taking cash from Pharmacia and Pfizer to fund its COX-2 drug campaign. Kieran Kettleton, director of communication for the charity, said: 'NICE actively contacted Arthritis Care and said we need you to promote our new guidelines to people with arthritis because it is important to get the message to people with arthritis, particularly those with gastrointestinal complications.

'We are a charity and money to do this does not come from anywhere. We received a grant from Pharmacia and Pfizer for this campaign but we said that the campaign would not mention any product and Pharmacia and Pfizer make just one of the five COX-2 drugs available.'

Kettleton would not reveal exactly how much Pharmacia and Pfizer paid for the campaign.

'They have agreed to contribute towards the costs and the campaign has not finished yet. It is an expensive campaign,' he said.Arthritis Care dismissed the study which found that the new, more expensive COX-2 drugs were no better than older medicines. He said many other studies found them to be an advance on the other drugs on offer.

Diabetes UK pointed out that it has a policy on the 'ethics of working relationships' and a spokeswoman for the National Asthma Campaign said that donations from the pharmaceutical industry form only 1.7% of the charity's income. Richard Ley, spokesman for the Association of the British Pharmaceutical Industry, pointed out that the Long Term Medical Alliance, an umbrella body for voluntary organisations for people with long-term illness, has guidelines advising that charities should make public where funding comes from.

'These organisations perform a valuable function and clearly they need funding. In many cases the pharmaceutical industry is happy to do what it can to help. This funding is without strings attached and it is always up to the patient groups how they spend the money. It must be an equal
partnership with both sides benefiting.'

http://www.sundayherald.com/25738
Drug firms' magic money circle

By Sarah-Kate Templeton, Health Editor

Medical charities which campaign for expensive new drugs receive millions of pounds of funding from the pharmaceutical industry, a Sunday Herald investigation can reveal. One charity, Arthritis Care, has admitted that the pharmaceutical giants Pharmacia and Pfizer fund their latest campaign, which calls for the wider prescription of a new class of drug which they make called COX-2 inhibitors. But the charity refuses to say how much cash it received.

Health experts say the benefits of the expensive new drug have been exaggerated. Results of a trial, funded by Pharmacia, showing the new drug is safer than those they would replace, have been disputed in medical journals.

Another charity, Diabetes UK, has admitted that last year it received about £1 million from the industry while the national health watchdog, the Patients Association, receives up to 20% of its funding from pharmaceutical companies. But funding from the industry to charities is often kept secret. Now the extent of the funding has prompted leading medical experts to call for all sums to be made public. Dr Simon Maxwell, senior lecturer in clinical pharmacology and therapeutics at Edinburgh University and a doctor at the city's Western General Hospital, said: 'The pharmaceutical industry do this because they realise that the people who can really have the strong political message are the patient groups.

 The pharmaceutical industry knows that this is the lobby that has the power with the government and health professionals. 'This causes great concern. As a doctor involved in new drugs I have to declare all of my interests when I state an opinion about a drug. If I traveled anywhere funded by the pharmaceutical industry then, quite rightly, I would need to declare that. So, if these patient bodies state their opinions, and they are perfectly entitled to do that, they should make the same declaration that they have an interest in this.'

Professor Warlow, professor of medical neurology in the department of clinical neurosciences at Edinburgh University, added: 'Medical charities are an increasingly important source of advice and information for patients and, if a company can influence that advice, then of course it may try to do so. 'I have no idea how much all this actually does influence charity and medical advice, but presumably the more money that is provided, the more the advice could be changed.

'That is why I, and others, are keen to see exactly how much money is involved in research grants, consultancy fees, and 'educational' meetings.'

 

BBC Newsonline.
http://news.bbc.co.uk/hi/english/health/newsid_2093000/2093852.stm
Friday, 5 July, 2002, 00:37 GMT 01:37 UK 

Trials often involve recently licensed drugs Doctors have been criticised for not admitting they receive payments for recruiting patients to clinical trials. In a paper in the British Medical Journal, ethics researchers say doctors can be paid thousands of pounds per patient by pharmaceutical companies.

They say well-organised general practices can earn up to £15,000 a year for work that takes just three hours a week. The researchers, from the West Midlands Multicentre Research Ethics Committee, say they have heard anecdotal evidence that some hospitals depend on the regular income they receive from clinical trials.  

There can't be any harm in putting the facts before the patients

 Dr Michael Wilks, BMA

The researchers say being paid could influence a doctor's decision to join a trial, and the payments involved in commercial studies could mean that research which does not offer payments could fail to attract medics.

Time payment

Royal College of Physicians guidelines say per capita payments, which reward doctors for the number of patients they recruit, are unethical. The rules add payment for time spent working on trials is acceptable, but should be declared to a research ethics committee. The researchers say commercial companies effectively do pay per capita, saying they are paying for the work involved in conducting the trial rather than for recruiting patients, then overestimating the amount of time required for each patient.

Many patients also believe such payments are wrong. An American study found 80% of patients felt they had a right to know if their doctor would be paid for enrolling them in a study. Just over half said payments to clinicians were unacceptable. The most common scenario where doctors are offered payments is for so-called postmarketing (Phase IV) research, which takes place once a drug has been licensed. The aim is to familiarise doctors with the new drugs.

Pharmaceutical companies say this work has to be carried out as research and not as part of the system of monitoring new drugs, because that may not pick up every adverse reaction or problem with a drug. The researchers add there would be no opposition to changes to regulations to make disclosure mandatory.

Frank disclosure

In the BMJ, the researchers write: "A system that allows commercially driven and clinically dubious research to crowd out good and much needed clinical trials, and denies patients the opportunity to put their altruism to the best possible test, is unethical and unacceptable." They add: "If we are ever to reach the ideal of involving patients in the design and conduct of clinical trials then we could do worse than to treat patients as equal partners by making full and frank disclosure if payments that trial sponsors make to doctors for recruiting their patients."

Dr Jammi Rao, chairman of the West Midlands Multicentre Research Ethics Committee who led the study, told BBC News Online: "At the moment the guidelines and requirements of the Central Office for Research and Ethics Committees do not make it explicit that the amount of money a doctor is
paid has to be put in the patient information form."

He added that, in contrast, patients sometimes found it hard to be reimbursed for taking part in studies. "I find it absolutely appalling that patients get paid only 'reasonable' expenses, and have to give receipts for those things." Dr Michael Wilks, chairman of the British Medical Association's medical ethics committee said: "I think this is a grey area but it would be helpful to reform it in the direction of openness to patients.

"There can't be any harm in putting the facts before the patients.

"I wouldn't think it's going to affect very many patients' decision about being recruited into trials."

 

Quote (not my own): "The New York Times has the following excellent article on how marketing and media exposure define medical treatment before it has been scientifically determined to be safe and effective.  It cannot be emphasized enough that a good percentage of the medicine practiced today is supported only by the cleverly crafted marketing campaigns of the pharmaceutical industry.  Read this article carefully and fully.  Your health and life depend on it."


July 16, 2002
Preventive Medicine, Properly Practiced
By SUSAN M. LOVE
http://www.nytimes.com/2002/07/16/opinion/16LOVE.html?tntemail1=&pagewanted=
print&position=top

LOS ANGELES - There are at least 6 million women in this country who are asking themselves, "What happened?" Over the last several years they have read books and magazine articles, listened to TV pundits and talked to doctors and friends - all of whom assured them that taking hormone replacement therapy for the rest of their lives would keep them healthy.

 

July 18, 2002 Posted: 9:21 AM EDT (1321 GMT)


WASHINGTON (Reuters) -- The top U.S. drug companies spend twice as much on advertising, marketing and administration as they do on research and development, according to a report issued on Wednesday. Families USA, a nonprofit healthcare advocacy group, said their analysis rebutted drug company arguments that lowering drug prices and promoting the use of cheaper, generic drugs would cut into their ability to develop new medicines.

"Drug companies are spending much more on advertising and marketing than they are spending on research and development," Ron Pollack, executive director of Families USA, told a news conference.
"The drug industry should stop scaring American seniors by saying that moderating prices will limit the development of new drugs. These claims are both irresponsible and wrong."

Senators said the report showed the need for a prescription drug benefit plan for seniors.

"These numbers ... are absolutely astonishing. It is worse than obscene," said Georgia Democratic Sen. Zell Miller, who is co-sponsoring a bill that would encourage the use of cheaper generic drugs by Medicare, the state-federalhealth insurance plan for the elderly. The bill is up for debate this week.

The group's report, which uses numbers from the annual reports of nine leading  drug companies, shows, for instance, that Merck and Co. Inc., which reported $47.7 billion in revenue in 2001, spent $6.22 billion or 13 percent of that on marketing, advertising and administration. Merck reported a net income, or profit, of $7.28 billion -- 15 percent of revenue, or triple the $2.46 billion it spent on research and development, Families USA pointed out.

Pfizer, which makes the blockbuster Viagra impotence pill, spent 35 percent of its $32.2 billion in revenue on marketing, advertising and administration and 15 percent on research and development.
Richard Smith, vice president of policy and research for the Pharmaceutical Research and Manufacturers of America, which represents drug companies, defended the industry record.

"Last year, PhRMA member companies spent $30.3 billion on new drug research and development," he said. "In contrast, according to IMS Health (which provides healthcare information to drug companies), the industry spent about $9 billion on promotion to consumers and doctors and about $10 billion on free drug samples," Smith said. "When Families USA attacks our promotional spending, they are really attacking the $10 billion in free drug samples that we give away each year to doctors who often use these free medicines to help needy patients."

But Pollack said the numbers, available in each company's annual report, speak for themselves. "At the same time drug prices are skyrocketing, drug companies are spending more and more promoting their drugs," he said. Michigan Democratic Sen. Deborah Stabenow noted that drug companies get a tax break for research and development costs, and also get to use, for free, the results of basic research done at taxpayer expense by the National Institutes of Health.

"They get the write-off. Then we give them a 20-year patent," Stabenow said. "We protect them from competition for 20 years. And what do we get in the end, the American taxpayers? The highest (drug) prices in the world."
 

http://www.villagevoice.com/issues/0229/lerner.php

The Menopause Industry's Marginalized Critics Are Finally Proven Right
Hormonal Outrage
by Sharon Lerner
July 17 - 23, 2002

You'd think she'd be happy. After more than 15 years of challenging the dogma that all women need hormone replacement to prevent heart disease and bone breaks after menopause, Maryann Napoli has been vindicated.

Last week, after its findings revealed that the combination of hormones taken by some 6 million women was doing more harm than good, causing an increase in heart attacks, breast cancer, blood clots, and strokes, a national study was halted mid-stream. Wyeth, which has raked in more than $2 billion a year from its top-selling hormone therapies-and received its share of precisely worded, critical letters from Napoli over the years-is now watching its stock price dive. Doctors who once eagerly prescribed the treatment are admitting their error. Yet Napoli, associate director of the Center for Medical Consumers in Manhattan and one of a handful of women's health advocates who have tirelessly played David to the hormonal establishment's Goliath, seems a little sad.

"I just wish there had been more caution about giving women this drug combination in the first place," she says, looking up at the shoes passing by the window of her tiny, donated office space in a West Village basement.  Instead, "they turned a stage of life into a disease for which you're supposed to take drugs every day for the rest of your life," she says. "It was a pharmaceutical industry's dream come true." For many women, though, the treatment of menopause has been a nightmare. Greed and misogyny dovetailed in a massive marketing campaign for products that turned out to be both dangerous and unnecessary. Introduced more than 50 years ago as a remedy for hot flashes and other irritations of menopause, estrogen therapy (to which another hormone, progesterone, was later added) was subsequently promoted as a way for women to remain youthful and sexy. In Forever Feminine, a 1965 book funded by Wyeth-Ayerst (the precursor of Wyeth), the pills were touted as a way of keeping women' s breasts and genitals from shriveling.

In recent years, the ageism and sexism driving the push for hormones grew more insidious, as the desire to "correct" women's bodies was couched inscientific terms. Though hormone therapy's effect on the heart was unclear (and is now known to be harmful), aggressive, multi-layered marketing campaigns convinced many doctors to recommend hormones to prevent heart disease even in healthy patients. As a result, for the better part the last decade, Wyeth's estrogen pill Premarin has been the best selling drug in the country.

"A lot of [doctors] actually believed that estrogen prevents heart disease, " says Cindy Pearson, executive director of the National Women's Health Network, a Washington, D.C.-based nonprofit that published The Truth About Hormone Replacement Therapy. "They read review articles and didn't realize that the author had accepted a fee. They went to conferences and didn't realize that the drug companies had inserted slides into presenters' talks.   Some doctors got continuing education materials funded by drug companies that make unproven claims."

For activists, the struggle over hormone replacement came to epitomize the power of pharmaceutical interests to steamroll patients' concerns. As one might expect in a battle with billions at stake, those who challenged that consensus were marginalized. In her basement office, Maryann Napoli quietly pored over the journal articles, circling the unsubstantiated claims in hormone ads and firing off letters to the drug companies, many of which went unanswered. She fielded phone calls from women across the country who were made to feel like outlaws for questioning the treatment. Barbara Seaman, author of the 1977 book Women and the Crisis in Sex  Hormones, found her work increasingly unwelcome in mainstream publications as she became more outspoken about the issue. And the National Women's Health Network's Pearson attended countless medical and pharmaceutical meetings-though she was rarely invited.

"We almost never were asked to speak," says Pearson. "At women's conferences, yes, but not at the big Washington meetings. I can't tell you how many times I've sat on the aisle as close to the open mic as possible so I can jump up just before the last speaker stops. I've even approached female doctors in the women's room."

If the activists' urgency sprouted from the feminist conviction that women deserve to be heard, their message was scientific: The proof that hormone replacement prevented heart disease was too weak to support the routine promotion of the drugs, they argued, and the long-term effects were still unknown. Their prodding was partly responsible for the study that showed them to be right. In an article in the July 10 issue of the Journal of the American Medical Association, the national study's researchers reported that heart attacks and other "coronary events" went up 29 percent in women on the drug combination compared to those taking placebos; they also had twice the rate of blood clots in the lung and 26 percent more breast cancer.

Which is why the victory is bittersweet. For Maryann Napoli, the should-I-take-estrogen inquiries have been almost instantly replaced by worried calls "from women who have breast cancer and want to know if they got it from the hormones," she reports. She can't answer that question-no one can-but Napoli does have one hopeful message for patients everywhere: "We should all be skeptical of the next thing they try to sell us in a big way."

Even that seemingly obvious lesson may be difficult to retain amid the power flow of messages from profit-driven companies. "Though their product is dangerous, the drug companies still have all the resources . . . to cloud the issue," says Pearson. "On the day the news broke, they had two of their people stationed at the doors of the National Press Club offering industry experts. At the Network, we're still just five people with three phone lines and one photocopier."
 

Ties to drug manufacturers cause undue influence

By Ivan Oransky and Jeanne Lenzer

 When you see a doctor, you want unbiased advice and prescriptions that are best for your health. But what if the treatment your doctor gives is skewed by drug company influence? What if the pill prescribed for you is several times more expensive than other equally effective drugs? Or, what if it isn't the right drug at all?

Unfortunately, you may never know what really sways your doctor's decisions, thanks in part to The New England Journal of Medicine. It recently loosened its guidelines regarding the financial ties of experts who write for it. Now such authors who write reviews and editorials can receive up to $10,000 per year from interested companies.

Such articles are an important way for your doctor to keep up with new treatments. Long regarded as one of the last bastions of scientific integrity, the journal stood apart from other medical journals by not allowing commentary from those with a financial stake in the therapy or drug they reviewed. The Journal of the American Medical Association, for example, already allowed its experts to receive money from drug companies.

The New England Journal's editor, Dr. Jeffrey Drazen, said the fact that he couldn't find experts to write for him prompted the change. Every one he found had financial ties to the firms that made the drugs they would be writing about. In 2000, before Drazen became editor, the journal acknowledged — following a story by Los Angeles Times reporter Terence Monmaney — that it had violated its own conflict-of-interest guidelines in 19 out of 40 articles since 1997.

The dilemma Drazen cites is real. Clinical research is increasingly funded by private interests — particularly biotechnology companies and drug companies — with a stake in the results. In turn, researchers and universities have become increasingly dependent on the good will and cash of the drug industry, putting them in a precarious ethical position.

Whether journal editors can reliably weed out bad or questionable medical information from authors with financial ties is debatable. Researchers can slant reviews in many ways: by not offering their results for publication if the data undermine a desired outcome; by writing conclusions that are contradicted by their own data, or by emphasizing certain studies while ignoring others.

Take non-steroidal anti-inflammatory drugs such as ibuprofen. Virtually all of the clinical trials of such drugs between 1987 and 1990 were sponsored by the manufacturer of the specific drug being studied. A miraculous 100% of the studies concluded that the sponsor's drug was equal or superior to the comparison drug; 86% also dubbed the sponsor's drug safer. Clearly, if the manufacturer pays, the manufacturer wins.

It also will become difficult for doctors to track discredited studies. The manufacturer of Celebrex, a new form of anti-inflammatory medicine known as a COX-2 inhibitor, claims it causes fewer ulcer symptoms than older drugs such as ibuprofen. The authors of a Journal of the American Medical Association editorial agreed — until they learned that the study's authors didn't provide all the data. Dr. Michael Wolfe, one of the editorialists, was "flabbergasted" at the deception. When all the data were reviewed, he noted, Celebrex's safety advantage all but vanished.

However, most doctors attending a conference remained unaware of the study's flaws, believing the results of the original study.

The New England Journal of Medicine's decision was a mistake, even though it says it will disclose financial ties below $10,000. That helps somewhat, but the real answer is to cut commentators' financial ties to their subjects. Even Drazen would seem to agree: "For a journal to be of value, it must publish authoritative, up-to-date information that is free of commercial influence," he and Gregory Curfman wrote in an editorial announcing the change.

Indeed. Doctors should know what's influencing the articles they read — and you should know what's influencing your doctor's decisions. Increasing publicly funded research would help ensure that science is not deformed by the rush for profits.

Ivan Oransky, M.D., and Jeanne Lenzer are writers in New York.

Soured milk of Monsanto's 'kindness'
By Gregory Palast
Guardian Unlimited

Sunday February 21, 1999


Thirty seven per cent of Americans over the age of 15 find sexual intercourse painful, difficult to perform or just plain unenjoyable. Who says so? Doctors Edward Laumann and Raymond Rosen, that's who. And because they said it in the prestigious Journal of the American Medical Association, it popped up last week in every US newspaper.

Oh, did I forget to mention that the study's authors recently worked for Pfizer, maker of Viagra? In the article JAMA did not mention it either. The not-tonight-honey study reflects a dangerous new problem: the threat to the impartiality of medical scientists evaluating the products of drugs companies for which they have worked. Another example: calcium channel-blocking drugs reduce the risk of heart disease. Unfortunately, they can also give you a heart attack. Yet 70 learned articles in medical journals vouch for the drugs' safety and efficacy.

According to an investigation by the New England Journal of Medicine, 96 per cent of the scientists who wrote articles supporting the drugs received financial benefits from the pharmaceuticals companies that make them. Only two out of 70 articles disclosed their authors' financial interest.

Such financial interests raise concerns as to the objectivity of scientists responsible for granting government approval for drugs. One US manufacturer, Monsanto, is a case in point. The Observer has received copies of letters, memoranda and meeting notes indicating that Monsanto was sent restricted documents from an international regulatory committee investigating the company's controversial bovine growth hormone. BST boosts a cow's milk output, but some European experts say BST has such yummy side-effects as increasing the amount of pus in milk, promoting infection in cow udders and potentially increasing risks of breast and prostate cancer in humans who drink the milk.

According to an internal Canadian health ministry memo of November 1997, Monsanto received advance copies of three volumes of position papers intended for review in closed meetings of the UN World Health Organisation's joint experts committee on food additives. This is one valuable set of documents. The European Union's ban on the genetically altered hormone expires this year. The experts committee advises the international commission, which will soon vote on whether to add BST to the Codex Alimentarius, the list of approved food additives. Codex listing would make it difficult for many nations to block imports of BST-boosted foods.

Monsanto's cache included submissions by EC Directors-General for food and agriculture as well as analyses by British pharmacologist John Verrall. I spoke with Verrall just after he learned that his commentary had been passed to Monsanto. He was stunned, not just by the release of reports he believed confidential - participants sign non-disclosure statements - but by the source of the leak. The memo identifies Monsanto's conduit from the UN committee as Dr Nick Weber of the US Food
and Drug Administration.

Weber, it turns out, works at the FDA under the supervision of Dr Margaret Miller. Miller, before joining government, headed a Monsanto laboratory studying and promoting BST.

After seeing the committee's documents, Monsanto faxed a warning to its allies in government that one participant on the expert committee, Dr Michael Hansen, was 'not completely on board'. Indeed he is not. Hansen is furious. A BST expert with the Consumers' Policy Institute in Washington, Hansen regards the memos as putting in doubt the impartiality of the scientists in some US and Canadian authorities.

Other memos discuss plans by some US and Canadian officials to 'share their communication strategy' with industry, speak to members of the experts committee and obtain Monsanto's comments ahead of the vote of the experts in February 1998 - in which Monsanto prevailed.

Because proceedings were confidential, we cannot know how a majority overcame objections of known dissenters. But we can presume Monsanto was not harmed by the late addition of BST defender Dr Len Ritter to the deliberations. An intra-office memo obtained from Canada's Bureau of
Veterinary Drugs states that Ritter's name was suggested to the bureau's director in an August 1997 telephone call from Dr David Kowalczyk, Monsanto's regulatory affairs honcho.

Of course, obtaining government approvals to sell BST-laden milk is not much use to Monsanto if no one will buy the stuff. Luckily for Monsanto, the US FDA not only refuses to require labeling of hormone-laced products, but in 1994 published a rule that effectively barred dairies from printing 'BST-free' on milk products.

This strange milk-carton exception to America's Bill of Rights was signed by Michael Taylor, deputy to the FDA commissioner. Prior to joining the US agency, Taylor practiced law with the firm of King &
Spalding, where he represented Monsanto. Taylor, no longer in government, did not return our calls to his office at his current employer, Monsanto Washington.

According to Canadian health ministry researcher Dr Margaret Haydon, Monsanto offered her bureau between US$1 million and $2m in a 1994 meeting. Monsanto counters that the funds were proffered solely to support the cash-strapped agency's research.

Haydon and five other government scientists have filed an extraordinary plea with Canada's industrial tribunal seeking protection for their jobs. They fear retaliation for exposing damaging facts about BST. America's rush to approve the hormone in 1993 rested on a study published in the journal Science by FDA researchers that concluded there were no 'significant changes' in BST-fed rats.

The rats appear to tell a different tale. Their autopsies revealed thyroid cysts, prostate problems and signs of BST invading their blood. The US researchers failed to publish these facts and the FDA suppressed the full study.

The Canadian scientists, finally winning access to the full study, blew the whistle. The facts became public only weeks ago via their labour board action, a decade after the original.

Bon appetite.
 

PRESCRIPTION DRUG BENEFITS

Lobbies Force A Bitter Pill

The drug industry has a lock on Congress, and most of us don't realize how bad Medicare is

By Vikki Kratz
Vikki Kratz is an investigative reporter at The Center for Responsive Politics, a non-partisan research group based in Washington, D.C., that tracks money in politics.

August 4, 2002

This week, as senators head back to their home states for August recess, they'll blame each other for the failure to pass a prescription drug benefit for the elderly this year. Don't be fooled. While it's true that an ideological divide - Republicans want a private benefit, Democrats want a government one - kept them from reaching a compromise, another, more powerful force was also working against the bill: the pharmaceutical industry.

One of the most powerful lobbying groups on Capitol Hill, drug manufacturers have always been a top industry when it comes to giving campaign contributions. During the 2000 presidential elections, when a drug benefit for Medicare recipients was the issue du jour, the industry gave more than $19 million in contributions, 77 percent to Republicans. George W. Bush was the top recipient, taking in nearly $300,000.

This time around, with mid-term elections only a few months away, the industry has stepped up its giving, contributing $12 million so far in the 2002 election cycle, 77 percent to the GOP. That's already significantly more than the $8.8 million the industry gave during the last mid-term elections in 1998, when talk of a Medicare benefit was also being bandied about.

The amounts are impressive, but even more important to the industry's success at derailing legislation is its timing. Last June, when the House was debating its prescription drug plan, half a dozen drug companies helped sponsor a record-breaking GOP fundraiser the same week. The gala evening netted $30 million for the Republican party. President Bush headlined the event and during his speech, he singled out the chief operating officer of GlaxoSmithKline to thank him for the company's $250,000 soft money contribution. The industry's trade association, the Pharmaceutical Research and Manufacturers of America, also gave $250,000 that night. Pfizer gave $100,000. Eli Lilly and Bayer each gave $50,000.

A week later, when the House passed a prescription drug bill, it had everything the industry wanted. The bill bunted the Medicare benefit to the private sector, keeping it out of government hands. More importantly, the bill barred the government from setting price controls or interfering with the price negotiations between drug companies and private insurers, virtually assuring that the cost of prescription drugs will continue to go up, not down. How did that happen? Because lobbyists for the pharmaceutical industry helped the congressmen write the bill. Then they all sat down to dinner at the GOP fundraiser.

Not only does the industry know when to give, it knows whom to favor. The industry's predilection for favoring Republican congressional candidates has long held it in good stead, no matter who occupies the White House. Back in 1999, when President Bill Clinton wanted to expand Medicare coverage, it was the Republican-controlled Congress that held him back.

Last week, when the Democrats introduced their plan to add a benefit, they couldn't garner the 10 extra Republican votes they needed to break the deadlock in the evenly divided Senate. Forced to negotiate with Republicans or go home to face their voters empty-handed, the Democrats dramatically scaled back the size of the benefit to cover only the poorest Americans. But even that wasn't enough to entice the 10 extra senators. Even if the Democrats had managed to pass their bill, there was little guarantee it would have survived the conference committee intact. The industry-backed House plan was more to the liking of nearly all the Republicans and President Bush, who has always favored a private sector benefit.

Even so, the pharmaceutical industry does not just stop at individual corporate contributions. Two years ago, during the presidential election, the industry turned to a time-honored tradition: the "grass-roots coalition, creating Citizens for Better Medicare, a group that generated $65 million in television and newspaper ads opposing the prescription drug benefit. Members of the coalition, which read like a "Who's Who" of the drug industry (including Merck, Bayer and Bristol-Myers Squibb), contributed $20 million to federal candidates and parties in 1999-2000. This year, the drug industry teamed with the United Seniors Association, which represents 1.5 million older Americans. The association used a special "education grant" it got from the drug industry to run a $3-million ad campaign in favor of the industry-friendly bill the House eventually passed.

On the other end of the spectrum, the American Association of Retired Persons, which with 35 million members arguably represents the elderly population better than the United Seniors Association does, released a poll in March that showed 80 percent of Americans over age 45 support a Medicare benefit like the one in the Democratic plan. But AARP ran no ads. And while
the drug-industry trade association increased spending on lobbying from $7 million in 2000 to more than $11 million in 2001, AARP spent just $4 million in both years. The AARP has no political action committee and gives no campaign money to any candidates.

About 20 different lobbying shops now do work for the pharmaceutical trade association, all of them with extensive ties to Congress. Among the recent hires are former aides to Sens. Chuck Hagel (R-Neb.), Robert Kerrey (D-Neb.) and Bill Frist (R-Tenn.). The organization even boldly hired Sonya Sotak, Sen. John McCain's legislative assistant for health care issues, a month before the Senate was due to take up McCain's bill limiting the legal maneuvers companies can take against the marketing of generic drugs. Sotak, who would have worked on drafting the generics bill, now has the job of convincing members of Congress not to pass it.

Of course, campaign contributions and lobbying expenditures alone don't determine the fate of legislation. If they did, then there would be no new penalties for corporate executives who commit accounting fraud. The accounting industry has given $5.7 million so far in 2002, but that barely slowed the Senate down. Faced with an endless barrage of corporate scandals and newspaper headlines, the Senate unanimously passed new corporate reforms.

So why did the accounting industry fail to stop legislation where the pharmaceutical industry did? The answer is, it didn't. For a long time, the industry warded off any whisper of corporate reform. In 2000, when Arthur Levitt, then chief of the Securities and Exchange Commission, wanted to ban accounting firms from acting as consultants (the practice that got Arthur Andersen and Enron in trouble), the accounting industry responded with a lobbying crusade that Levitt later called "venal." The industry got 46 congressmen to deluge Levitt's office with phone calls and letters until, subdued, the SEC chief finally backed down. Only this year, when the scandals grew too big to ignore, did Congress finally act.

None of the tactics that the pharmaceutical industry used to stall, change or defeat the prescription drug bill are unusual on Capitol Hill. It's not the only special interest jealously guarding its profit margin. But even in the face of overwhelming public support for the prescription drug benefit, the industry knows how to win in the end.

Copyright © 2002, Newsday, Inc. <http://www.newsday.com/ 
 

I wanted to pass this on to everyone....My hubby subscribes to Playboy Magazine and in their newest issue (October 2002) they did a small piece in their Raw Data column (page 24) on Eli Lilly the makers of the thimerasol that did so much damage to our kids. The same company that falisifed their findings on the effectiveness and safety of said Thimerasol. So here is the piece concerning the practice of the company.

Buying Happiness:
Amount pharmaceutical firm Eli Lilly expected tp profit from its antidepressant Prozac when it was developed: $70 million per year. Amount Lilly actually made during peak Prozac years: $3 billion per year. Annual amount now spent by drug manufacturers to market antidepressants to consumers: $200 million. Annual amount spent marketing them to doctors (and here the KEY): $1.5 billion!!!!

Oh, on an appalling note... I was at my endocrinologist on Monday, and he said he was appalled at the invitation he recently got from a drug company... (He didn't want to go, but his wife made him!) The drug company was introducing a new drug, and for 6 hours of their time, here's what they got in return: airfare for two, 3 day weekend at the new Ritz Carlton in Half Moon Bay, CA (really swank new spa hotel), all meals, golf, massages, etc, and a $1000 stipend. This boondoggle probably cost
$4000-5000 per doctor. My doc says there were about 250 doctors there. You do the math! All for 6 hours worth of time for a few hundred doctors. Amazing.

 

  Here's more on Eli Lilly and their supposed Sarafem!

Cindy

http://depression.about.com/library/weekly/aa082100.htm

A Drug By Any Other Name 

How Safe Is Sarafem?
By Nancy Schimelpfening

On July 6, 2000 Eli Lilly announced the FDA approval of Sarafem (fluoxetine hydrochloride) for the treatment of premenstrual dysphoric disorder (PMDD).  PMDD is a severe form of premenstrual
syndrome (PMS) characterized by mood changes, breast tenderness and bloating around the time of menstruation. 

What makes Sarafem unique is that it is the first and only  prescription medication indicated for the treatment of this condition.  But, that's where it's uniqueness ends.  Sarafem is actually not a new drug.  Fluoxetine hydrochloride has been available by the brand name Prozac since 1988.  So why the new name? According to Gary Tollefson, president, neuroscience products for Lilly,  "Lilly's primary goal is to help provide relief for the millions of American women who suffer from this disorder."  Tollefson adds, "Our research with women and physicians confirms that a treatment option with its own identity could help women and their physicians differentiate PMDD from depression, ultimately helping PMDD sufferers receive appropriate diagnosis, treatment and follow-
up."

It may be, however, that Lilly's motives are not so pure.  One motivation behind the name change could have been the well-founded fear that their grip on the fluoxetine hydrochloride market would
slip if they could not retain patent protection on their best selling brand Prozac.  On August 10, 2000 these fears were realized when a US appeals court reversed a decision giving them patent protection until 2003.  Commenting on this decision, analyst Neil Sweig said, `This is by far their No. 1 drug.  This is a significant negative event for Lilly.'' It appears that if Lilly could establish Sarafem as a drug separate from Prozac then perhaps they would not lose as many customers when other brands began to hit the market.  The association between Sarafem and PMS would already be made in women's minds. Even with patent protection, Prozac was facing the prospect of declining sales.  As newer drugs with better side effect profiles emerged, Prozac's grip on the market was becoming more tenuous.  In January of this year it was edged out for the first time ever by a competing drug, Zoloft (sertraline). 

Perhaps even more damaging to Eli Lilly is the fact that Prozac has had some very serious allegations leveled against it.  Opponents of the drug claim that it is a trigger for violent and/or suicidal behavior in certain susceptible individuals.  The most damning evidence against Eli Lilly consists of  internal documents ("They Said It Was Safe" The Guardian, Oct. 30, 1999) going back as far as 1978 proving that they did indeed recognize these problems but chose to hide them.  Some excerpts from these documents:

Minutes of an August 2, 1978 meeting:  "There have been a fairly large number of reports of adverse reactions... Another depressed patient developed psychosis... Akathisia and restlessness were reported in some patients."   Opponents of Prozac such as Dr. Peter Breggin have blamed this agitation as a contributing factor to violent behavior while on the drug.

A similar meeting 10 days earlier:  "...some patients have converted from severe depression to agitation within a few days; in one case the agitation was marked and the patient had to be taken off [the] drug."  The minutes further state that "in future studies the use of benzodiazepines to control the agitation will be permitted".   This key information is still not provided to physicians and patients in the product label for Prozac.

A May 25, 1984 letter from the German licensing authority, the Bundes Gesundheit Amt (BGA) expressing concern about the drugs's safety: "During the treatment with the preparation [Prozac], 16 suicide attempts were made, two of these with success. As patients with a risk of suicide were excluded from the studies, it is probable that this high proportion can be attributed to an action of the preparation [Prozac]."  The fact that these patients were not suicidal prior to taking the drug directly contradicts the assertions of Eli Lilly that suicidality while taking the drug is due solely to the patient's illness.

In January 1985, the German agency told Lilly that they would not license the drug, giving "suicidal risk" as one of the reasons for their decision. Lilly's scientists continued trying to persuade the BGA to grant a license, but focused most of their efforts on the US. Eventually a warning, stating that there was a "risk of suicide", went on the German package insert in 1992.  The warning stated, "For
his/her own safety, the patient must be sufficiently observed, until the antidepressive effect of Fluctin [Prozac] sets in. Taking an additional sedative may be necessary."  This warning about the possible necessity of a sedative to counteract agitation did not find its way onto US packaging.  The current product label is carefully worded to imply that any suicidal tendencies while taking the drug are due to the illness itself, not the drug.

As recently as July 22, 2000 Lilly continued to maintain their official stance that "there is no credible evidence that establishes a causal link between Prozac and violent or suicidal behavior."  February 21, 2001 - The article that this was quoted from has been removed from Prozac.com, the official Eli Lilly Web site for Prozac information.  A new page about product safety does not mention this issue.

Despite what Eli Lilly tells the public, a picture comes together of a corporation so desperate to hold on to their market position that they will lie to the public and endanger the lives of the very people
they claim to be helping.  The actual degree of risk that this drug poses remains to be seen, but women need to be aware of its true history.  Whether we call it Prozac or Sarafem, the jury is still out
as to how safe it really is.  If you choose to use this drug, educate yourself and make an informed decision.  Don't rely on what the product label tells you. 
 

Vermont to Require Drug Makers to Disclose Payments to Doctors
June 13, 2002
By MELODY PETERSEN

Amid rising concern about the cost of prescription drugs, Vermont is expected today to become the first state in the nation to require pharmaceutical companies to disclose their gifts and cash payments to doctors, hospitals and other health care providers.

"Drug companies are giving doctors free dinners and flying them to Florida for a vacation," said Vermont's governor, Howard Dean, a Democrat.  He plans to sign the disclosure bill, which has been passed by both houses of the Legislature, in Montpelier, the state capital, today. Governor Dean, a doctor who has talked of seeking the presidency on a health care platform, said he thought such gifts could influence physicians to prescribe certain drugs - often the most expensive ones.  Vermont officials hope the disclosure requirement will force doctors and drug companies to change their behavior.

The legislation in Vermont is part of a growing effort by state and federal lawmakers to rein in drug companies' marketing practices.  On May 31, Gov.  Benjamin J.  Cayetano of Hawaii signed a law that requires drug companies to report how much they are spending on marketing, including the cost of television advertisements broadcast in the state.  Legislators in other states, including New York, have proposed bills to prevent drug companies from deducting the cost of advertising on their state tax returns.  In all, measures regulating pharmaceutical company marketing have been introduced in at least 15 states, according to the National Conference of State Legislatures.

In Congress, a recently introduced bill would block drug companies from deducting consumer advertising costs that exceed the amount they spend on research.  Other federal legislation would allow the Food and Drug Administration to impose penalties as high as $10 million for advertising the agency found to be misleading.

"The patient needs to know whether the doctor is prescribing drugs based on good sound medical practice or whether he has been influenced by gratuities from the manufacturer," said Richard T.  Moore, a Massachusetts state senator who has introduced legislation there to force doctors to disclose gifts from drug companies. The drug industry spent $19 billion last year on advertising and promotion - more than double the $9.1 billion it spent five years ago, according to IMS Health, a consulting firm.  About half that consists of the value of free drug samples given to doctors.  The rest includes the cost of sales representatives, gifts to doctors and advertising.

The pharmaceutical companies say the sales visits and discussions with doctors are essential for transmitting the most recent scientific information on how medicines should be prescribed.  Their consumer ads, they say, help prompt people who are suffering from undiagnosed medical problems to seek care and remind them to take their medicine.

Earlier this year, the Pharmaceutical Research and Manufacturers of America, the industry trade group, revised its ethics guidelines to make it clearer that certain gifts - particularly those related to entertainment rather than education - are inappropriate.

The industry has long had rules aimed at limiting such practices, but many companies appeared to ignore them, perhaps because the rules were too vague.  The new guidelines go into effect on July 1.

"We now consider theater tickets and sporting events to be inappropriate," said Jeff Trewhitt, a spokesman for the trade group. The issue has caught the attention of state legislators as they seek
ways to slow the increasing cost of drugs paid for by Medicaid programs, which provide health care to the poor.  At the same time, elected officials are hearing complaints from elderly constituents who lack drug coverage and say they cannot afford the medicines that their doctors have prescribed and that they see advertised on television.

Marjorie Powell, assistant general counsel at the pharmaceutical manufacturers' group, said the industry had not taken a position on the Vermont legislation.  "We'll be interested to see how the state implements it," she said.

The Vermont law would require drug companies to disclose any gift or payment of $25 or more to doctors, hospitals, nursing homes, pharmacists or health insurers for the purpose of marketing their products.  The companies would not have to disclose the value of free drug samples or medical student scholarships. State officials said they planned to make the information available to the public, possibly via the Internet, so that patients can see what gifts their doctors have accepted.

The measure had broad support from both Republicans and Democrats and from the Vermont Medical Society.  Yesterday, the American Medical Association said it supported the bill's intent.  "The ideal circumstance is that no inappropriate gifts are offered or received," said Dr. Richard F.  Corlin, the association's president.

The only state with a similar law is Minnesota, which in the mid-90's prohibited companies from giving gifts valued above $50 to doctors or other health care providers. A Vermont Senate leader, Peter E.  Shumlin, a Democrat who sponsored the bill, said drug companies appeared to have "a two-pronged marketing strategy." "They get consumers to want the drugs and then make it pleasurable for the doctor to prescribe them," Mr.  Shumlin said.  "It is just getting more and more out of control."

The industry's guidelines would continue to allow drug companies to pay doctors for services like consulting or to give speeches about drugs before other physicians. In a recent example, Shire Laboratories invited a group of psychiatrists to dinner at the Omni Berkshire Place Hotel in Manhattan on April 25. The doctors were paid $300 for their participation in an "advisory board meeting," according to the invitation, where they were asked to discuss how the company's drug Carbatrol could be used to treat bipolar disorder. Vermont's legislation would require disclosure of such cash payments. Carbatrol, an epilepsy medication, has not been approved by the F.D.A. to treat patients with bipolar disorder, but physicians are free to prescribe drugs as they see best.
 
A spokeswoman for Shire, Michele Roy, said the company had paid the doctors for their expert advice about the drug. "This was not a gift," she said.  "The honorarium was compensation for the time they gave us."

http://www.nytimes.com/2002/06/13/business/13DRUG.html?ex=
1025010742&ei=1&en

=960066d9f095fa6a
 

Source: http://www.beyondpesticides.org

Pharmaceutical Giant Accused of Human Pesticide Experiments
(from September 11, 2002) 

In 1998, the pharmaceutical giant, Bayer, conducted pesticide experiments on humans in what was called the Inveresk trials. Three years later the company behind the tests stands accused of breaking the Nuremberg Code -- established as a response to Nazi experimentation on Jews -- and of using the results to boost profits. One of the 50 Scots who were a part of the human testing, Bruce Turnbull, blew the whistle on Bayer.

The Sunday Herald reports, the subjects were given a single dose of a substance called azinphos-methyl (AM) and then observed for seven days. Test subjects were even presented with documents predicting the outcome of the experiment stating: "The results of this study will confirm that use of
azinphos-methyl does not pose an unreasonable threat to either workers or consumers."

What they did not know was that the chemical, which they were given in minute doses, was a pesticide deemed 'highly hazardous' by the World Health Organization. Nor did they know that the test had been commissioned by Bayer as part of a forceful effort to get the US Environmental Protection Agency to reverse pesticide controls introduced to protect children. The 50 subjects have not been offered follow-up examinations to test for the long-term effects of exposure to AM. Instead, the key finding of the study -- that the pesticide test had 'no effect' on humans -- is now Bayer's key
weapon in its battle to raise the safety limit on the use of the pesticide by US farmers.  

The EPA is unequivocal in its stance on pesticides. A spokesman told the Sunday Herald: "There is nothing for individuals to gain -- no disease will be cured because of this." And this position extends to its attitude to human pesticide testing. "We do not accept human data concerning pesticides. There is, however, a lot of pressure from pesticide companies who would argue that we get a fuller picture of pesticide use if we look at these tests [the Inveresk trials], but there are significant moral and ethical issues." Erik Olson, a senior attorney at the American Natural Resources Defense  Council (NRDC), is fighting Bayer's attempts to reverse the pesticide controls and believes Turnbull's experience was "shocking and unethical."
 
Olson adds, "he wasn't told about conflicts of interest, long-term side effects, the purpose of the test or the fact that the company's profits would be boosted. If you don't look for any ill-effects then it's not surprising that you won't find any." This hasn't stopped Bayer presenting the test evidence as part of its campaign to persuade the EPA that azinphos-methyl is safe. The company also denies the test breached the Nuremberg Code, insisting that the use of the pesticide benefits society. Bayer spokesman Peter Kraus said he was satisfied that the test had been carried out to the highest standards.

Azinphos- methyl is one of its most widely used pesticides, sprayed on apples  in the Pacific northwest, blueberries in Maine and sugar cane in the deep South. But it is highly controversial, even in America.

In Louisiana in 1991, a flash thunder storm caused azinphos-methyl to run off sugar cane and into rivers, killing up to a million fish, along with turtles, alligators, snakes and birds. Six weeks ago Canadian officials reported that azinphos-methyl was found in high concentrations in the Wilmot River, where up to 15,000 fish had died. Three years ago the EPA reported that exposure to the pesticide caused enzyme changes in the red blood cells of 127 Californian farm workers, creating fears about potential nervous system damage. The EPA has now commissioned the National Academy of Sciences to advise it on whether or not human data in pesticide testing is acceptable. Bayer and other pesticide companies have lost patience and are suing the agency in an effort  to get a decision on the increased use of azinphos-methyl.
 
Read the full text of the article from the Sunday Herald.
http://www.sundayherald.com/print27510

* * * * * * *

Daily News Archive
From June 13, 2002
Bayer Pushes for Human Testing

The chemical company giant Bayer is working to allow use of pesticide testing on humans to determine toxicity. EPA currently has ban on use of such information. On June 9, The Independent reported claims that Bayer is playing a major role in EPA's decision on whether or not to reverse this ban. Bayer holds a major stake in the decision, as they have results of a human test for dangers of azinphos methyl that took place in 1998. Bayer is a major producer of this chemical. A spokesman for the Natural Resource Defense Council stated, "There is strong evidence that Bayer did not obtain fully informed consent because the subjects lacked knowledge and comprehension of  the goals and risks." Fear is spreading that if the U.S. begins accepting such data, Europe will follow suit. Bayer's interest is furthered since their takeover of Aventis Croplife. Human testing could be used for both pesticides and genetically modified products. It is reported that EPA Administrator Whitman will consult with the National Academy of Sciences to reach a conclusion. A decision is expected within the next few months.

$ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $
 

And now some good news!

http://www.ama-assn.org/sci-pubs/amnews/amn_02/edlt1007.htm

Physicians should give ultimatum on direct-to-consumer drug ads I have yet to meet a physician who has anything but contempt for the present-day direct-to-consumer advertising by the drug companies. The ads are slick promos designed not to inform and educate but to sell product. The cost is immense, and it is borne by our patients in ever-increasing drug costs.

So here is my proposal. We, all the U.S. physicians, give notice that as Nov. 1, either the companies pull all DTC ads or face having detail reps shut out of all of our offices. The dollars saved will go to lower the cost of the advertised drugs.

Be your patients' advocate. Will you do it ?

--Dennis E. Sumski, DO Farmington, Mo.
 

Drug firms and doctors: the offers pour in

By Liz Kowalczyk, Globe Staff, 12/15/2002

http://www.boston.com/dailyglobe2/349/nation/
Drug_firms_and_doctors_the_offers_pour_in+.shtml

during the past six months, Dr. Eugene Fierman and his two colleagues were showered with offers worth thousands of dollars. At least once a week, the nation's pharmaceutical firms invited them for ''educational evenings'' at some of the city's priciest restaurants, including cocktails and dinner at Radius paid for by Pfizer, an insomnia discussion at Locke-Ober, and a depression talk at Maison Robert - both on Wyeth's tab.

Drug firms through intermediary companies paid for at least 50 hours of free continuing medical education courses, which the psychiatrists could complete by phone, mail, on the Internet, or at hotels - required courses for doctors that traditionally were the province of medical schools but now are increasingly funded by the industry. Some pharmaceutical companies wanted to hire them as temporary advisers, including Forest Pharmaceuticals, which promised the doctors $500 each for listening to a Saturday morning talk about the firm's new antidepressant, Lexapro, at a Cambridge hotel and then providing ''advice and feedback.'' And occasionally, drug company employees dropped off at the doctors' rented office at Faulkner Hospital small gifts: a box of cookies from the Wyeth salesman, four classical CDs from the Pfizer representative.

With investigations into the industry's sales tactics growing, and a new voluntary code of conduct in place that stresses educating rather than entertaining doctors, Fierman, Dr. Ann Potter, and Dr. Gregory Harris - like many of their colleagues throughout the medical profession - said sales representatives now rarely offer the most lavish gifts that were routine in past years: theater tickets, golf trips, and resort weekends.

Instead, drug makers are paying for or offering more consulting opportunities, even for one evening, continuing medical education courses, and dinners billed as educational events with specialist speakers. At the Globe's request, the three doctors kept track of pharmaceutical-related invitations and offers they received over a five-month period. The material was enough to overflow a 1-foot-square, 2-foot-high box.

''It's hard to resist all this money and free stuff floating around,'' said Harris. ''But it's a slippery slope, and I don't want to be in the position of doing something that crosses the line.'' The shift in the tactics drug companies are using to establish close relationships with doctors was occurring even before the industry adopted the new guidelines in July. The amount of money pharmaceutical firms spent on meetings and events, including continuing medical education, teleconferences, dinners, symposia, and get-togethers with physician advisers, more than doubled over four years to $2.1 billion in 2001, according to Verispan, a company that tracks promotional spending.

Drug industry funding of continuing medical education courses alone last year totaled $540 million, and the national organization that accredits continuing medical education providers has become so concerned about potential bias that it plans to issue stricter rules as early as January. Drug makers say these classes and gatherings provide physicians with crucial information about medicines that could help their patients - and allow doctors to speak to each other about their experiences. But Dr. Marcia Angell, former editor of the New England Journal of Medicine, said the danger is that companies simply disguise marketing as education, while slanting presentations toward their own products and helping to increase health-care costs.

''These companies are in the business of selling drugs, period,'' Angell said. ''It's ludicrous to think you'd look to a company for education about a product they're trying to sell.'' Physician leaders also are concerned about what they see as a rise in consulting and question whether doctors are providing meaningful advice to the companies - something required by the new guidelines - or are merely being paid large sums to listen to a sales pitch. And federal law prohibits companies from offering doctors cash inducements to prescribe their drugs. Dr. Sidney Wolfe, director of Public Citizen Health Research Group in Washington, D.C., said some consulting fees have gotten so high that he believes they border on illegal inducements. He has referred several cases to the US inspector general.

With the focus on drug industry marketing intensifying, doctors are increasingly concerned about their interactions with sales reps, and some are taking steps to limit their visits - or keep them out of their offices entirely. But that - Fierman, Harris, and Potter discovered - is not so easy. The doctors decline consulting offers, and they no longer attend dinners. The cookies go to Bill Johnston, the practice's part-time receptionist, who brings them to his fellow band members. Their one concession: They accept drug samples for uninsured patients, a marketing tool on which the drug industry spent $10.5 billion last year.

In early summer, Potter felt the practice was overrun with Eli Lilly salespeople. One day, she found a 22-year-old sales representative in the waiting room talking to a patient. Potter called his manager and requested only one Eli Lilly sales visit a month. The manager said no. The reason: The doctors get too many samples, he said. They gave in to two visits a month - as long as they got to choose the sales rep - even though they know samples probably increase their prescribing of those particular drugs.

''You can't totally drop out of this crazy system,'' Fierman said.

`Dinners are exploding'

At least once a week between August and November, sales representatives invited Fierman, Harris, and Potter for cocktails and dinner. The most modest restaurants: Figs and the Newton Marriott. The most posh were Radius, the Ritz-Carlton, and the Four Seasons - all dinners they didn't attend.

Dr. Ronald Katz, an internist in a large, busy practice on Beacon Street in Brookline, said ''dinners have exploded in the past couple of months,'' which he believes are ''in lieu of trips and the most expensive things they used to do.''

The industry's new code of sales conduct requires dinners be ''modest as judged by local standards'' - a guideline some companies are complying with and others are not. ''This should not include the city's most expensive restaurants,'' said Jeff Trewitt, a spokesman for the industry trade group, the Pharmaceutical Research and Manufacturers of America. ''We want there to be no distractions. We want the focus to be on a meaningful conversation about a new medicine and its potential value and characteristics.''

Dr. Susan Black, a family practice doctor in Tewksbury, drove into the city one night this fall for a dinner and discussion at the Four Seasons on urinary incontinence in women, sponsored by Pharmacia, which makes a drug for overactive bladder called Detrol LA. She earned one hour of continuing medical education credit; Massachusetts doctors must earn 40 hours of medical education credits with an approved provider every two years to remain licensed.

''They were discussing their own research, the company's research. And they were trying to show the drug was better than their competitor's,'' Black said. ''I thought I should go because this is a big issue for my older patients. There are some really good new physical therapy approaches and surgical approaches, but they didn't discuss those.''

Executives at Pfizer, which has paid for dinners at pricey restaurants in Boston since July, said the choice of restaurant is a ''judgment call'' made by local sales reps. ''The price of the meal is so inconsequential, given what we're grappling with around the guidelines and what's educational or not,'' said Dr. Mark Horn, Pfizer director of medical alliances. ''I would focus on the speaker, the content, and the quality of the presentation. As long as it's balanced and fair, I'm less concerned with the selection of the eateries.''

Many education courses

Last Thursday at 1 p.m., Fierman called a toll-free number to earn one hour of continuing medical education credit listening to a teleconference called ''Stabilizing the Dopamine-Seratonin System: A New Era in the Treatment of Psychosis'' - one of dozens of free, pharmaceutical-company-funded continuing medical education courses offered to the practice during the past six months.

This course, which Fierman enrolled in at the Globe's request, was organized by a private California company called Continuing Medical Education Inc. and paid for with an unrestricted grant from Bristol-Myers Squibb and Otsuka America Pharmaceutical. The companies in November received approval from the Food and Drug Administration for a new antipsychotic medication called Abilify.

As Fierman listened from his small office overlooking Arnold Arboretum of Harvard University, Dr. Peter Weiden, director of the Schizophrenia Research Program at SUNY Downstate Health Science Center in Brooklyn, began with a history of antipsychotics and a description of why newer drugs like Zyprexa and Risperdal are superior to older medications like Haldol. (Fewer side effects like tremors.) But he devoted more than half the hour to the benefits of Abilify, often referring to it as ''the new kid on the block.'' Although companies are not allowed to promote unapproved drugs, Continuing Medical Education Inc. began offering the course before Abilify was approved, something allowed under continuing medical education rules.

Fierman said the science in the class was sound, and that Abilify might very well be the next blockbuster for the mentally ill. But he said advertising the course as an objective class on brain receptors was misleading. ''If this were a lecture saying we're introducing our new drug, that would be fine,'' he said.

Drug companies usually aren't accredited continuing medical education providers themselves. They pay for the classes offered by medical schools and accredited third-party companies like Continuing Medical Education Inc. In this case, Continuing Medical Education Inc. suggested the class topic to the drug firms and they had no input into the content, said Steve Mandell, the company's vice president of sales and business development.

But Dr. Murray Kopelow, chief executive of the Accreditation Council for Continuing Medical Education, which oversees the continuing medical education system for doctors, said third-party companies and medical schools may have grown so dependent on drug companies for their livelihood that they're no longer independent providers and have lost control of the agenda - and sometimes the content.

''These relationships have complicated the situation,'' said Kopelow, whose organization will consider sending physician volunteers to monitor the courses for commercial slant. ''There's probably more bias than we know.''

Consulting offers grow

Pharmaceutical companies, physicians said, also are pushing to increase their consulting relationships with them. Drug firms for years have hired respected physicians, often referred to as ''thought leaders,'' to speak about their drugs at conferences and serve on advisory boards. Some doctors earn thousands of dollars from these extracurricular activities.

But some doctors said drug firms are offering more small, one-time consulting opportunities. And Fierman, Potter, and Harris received dozens of requests from drug marketing research firms - whose clients are pharmaceutical companies - to provide their opinions for a fee on the effectiveness of proposed direct-to-consumer ads and even report on how often competitors' sales reps visited their offices.

Other physicians reported similar offers: Novartis promised Dr. Richard Parker $300 to give ''feedback about hypertension'' and Dr. Martin Solomon $500 to provide advice on hormone replacement therapy.
Eli Lilly promised Dr. Jonathan Moray $750 to attend a dinner meeting on therapy for attention deficit hyperactivity disorder and ''provide his perspective on ... potential new treatment options.''Novartis spokeswoman Christine Landy said the company ''needs this feedback to guide future marketing and research'' and draw up written contracts - as required by the sales code - to clearly outline the doctor's role. But most of these dinners include a presentation about a drug the company makes or is developing.

''The companies used to call it coming to dinner,'' Solomon said. ''Now it's called consulting.''

Potter attended a consultants dinner meeting in the spring for which she was paid $400. The company, which she did not want to name, asked physicians how to catch their attention so they would prescribe the firm's antidepressant. ''I thought, `What am I doing here?' It was advice,'' she said, ''but it was advice on marketing.''

Alice Dembner of the Globe Staff contributed to this story.

 

Curbed contact makes new docs wary of drug sales pressure
By Adam Marcus
HealthScoutNews Report
November 1, 2001 4:52 AM

Keeping drug marketers away from doctors in training makes them more skeptical of pharmaceutical industry marketing later, a new study said. The findings are based on a survey of doctors in Canada, some of whom trained at a McMaster University Medical Centre in Ontario that in the 1990s imposed strict no-contact rules between drug company representatives and certain residents studying there.

The researchers said the policy gives young doctors the sense that regular and close contact with drug companies is unhealthy."By banning drug reps, it sends a message to your residents that these aren't people you should be spending your time with," said study co-author Dr. Allan Detsky, chief of physicians at Toronto's Mount Sinai Hospital. The findings appeared in the Oct. 24/31 issue of The Journal of the American Medical Association.

On the other hand, the study didn't address whether it's better for patients if doctors are skeptical about drug company pitches, said Detsky, who also is an economist. "How much of their marketing is not helpful, how much is really helpful, it has never been studied," Detsky said. "It may be that what they do in McMaster is prevent doctors from getting information that really helps their patients. I don't know that."

Whatever the case, one thing is certain: Pharmaceutical firms are waging an all-out information war for the eyes and ears (and ultimately the prescription pads) of physicians. The industry spent more than $13 billion last year marketing their wares to doctors in America, according to IMS Health, a research firm in Plymouth Meeting, Pa. That includes nearly $8 billion in free samples, free lunches, company-sponsored junkets and promotional materials, including pens, caps and tote bags.

At least one group of Ohio doctors has exploited the eagerness of drug company reps to get a hearing by charging them for the privilege: $65 for a 10 minute interview. Earlier this year, the American Medical Association, whose flagship journal published the latest study, announced stepped-up efforts to educate its members about the ethical perils of accepting gifts from the pharmaceutical industry.

Dr. Herbert Rakatansky, a gastroenterologist at Brown Medical School in Providence, R.I., and past chair of the AMA's council on ethical and judicial affairs, said gift-taking is "getting out of hand" after
falling off in the early 1990s. Rakatansky said drug reps "have a motive, and there's nothing wrong with their motive. But our motive is different." Wary of the growing influence of drug reps on campus, the department of medicine at McMaster implemented a policy in 1992 to reduce contact between the reps and internal medicine trainees in residency there. The new rules banned drug reps from educational events, ended firm-sponsored free feeds and rejected pharmaceutical industry funding linked to specific diseases.

To learn if the 1992 policy altered the opinions of McMaster-trained doctors about drug company information, Detsky and his colleagues surveyed 57 former McMaster residents who attended the program both before and after the policy went into effect, as well as 242 trainees from the University of Toronto, which doesn't have such restrictions. Nearly 90 percent of doctors in each group who responded said drug reps had visited their office in the last year, so the McMaster policy didn't seem to influence the amount of contact between the industry and physicians.

However, internists trained under the restrictive policy tended to have somewhat fewer contacts than the other doctors. And those trained after the policy began were much less likely than the others to say the information they received from the drug reps was helpful in guiding their treatment choices. "There was a difference, and the difference was not small," said Detsky.

The McMaster policy did not prohibit contact between drug reps and all doctors in training, Detsky said. And the study found that doctors who had the most contact with drug reps were much more likely than those with the least contact to say the information they got from drug company reps was useful. Detsky said he's amazed that doctors continue to insist that they're above the influence of marketing. "It's unbelievable to me the extent that they can deny that they can be biased in some way," he said.

Dr. Ron Wright, a University of Arizona psychiatrist who has studied the effects of marketing on physicians, said two well-known psychological forces help explain the influence drug company reps have in the doctor's office. Although the so-called "buy-off" problem is the most hotly debated in medicine, Wright said another factor, which he called "cognitive accessibility," is at play. Given a choice of which medication to prescribe, said Wright, "You think of the one that's the most in your face." So, he said all those sticky notes and calendars that shout a brand serve as a constant, soft voice whispering a name that's bound to be the first to appear on a doctor's prescription pad.

The second force is somewhat more subtle and involves a concept called cognitive dissonance, Wright said. In essence, cognitive dissonance theory argues that people will be more willing to believe a lie when they're paid less, not more, to listen to it. If a drug company offers doctors an all-expenses paid trip to Hawaii, "I'm on my guard about that," Wright said. But if the "bribe" is instead small favors, "I'm not on my guard, but I am positively inclined toward" the company's representatives and their products. "They tend to give you things that are extremely useful that you really are going to want to keep around. And every time you see that you see that drug name."

As a result, Wright said, "Small gifts may in fact be more dangerous than large gifts, and all of the regulations go in the other direction." Wright said he doesn't accept drug company marketing paraphernalia to avoid biased prescription choices for his patients. He said advertising drugs to doctors is different from selling televisions to the masses. "In normal advertising you make decisions and suffer the consequences. But with [drug marketing] I decide what you're going to get, your insurance company or you are the one that pays for it, and you take it."

The Pharmaceutical Research and Manufacturers of America, a drug industry group, did not respond to a request to comment on the study. What to do

Try the American College of Physicians-American Society of Internal Medicine for a look at how direct-to-consumer advertising affects doctors, as well as the ethics of taking gifts from drug companies.

 

Lilly settles Prozac lawsuit
 Terms of the deal not disclosed; new litigation in Georgia is targeting metabolization issue.

 By Jeff Swiatek

 jeff.swiatek@indystar.com

 November 30, 2002

 A two-year-old Prozac negligence lawsuit, set for trial Tuesday, has been settled out of court by defendant Eli Lilly and Co. and the Pennsylvania plaintiffs.  The case was brought by Diane and Melvin Cassidy, of Monroeville, who in July 2000 picketed outside Lilly's corporate headquarters in Indianapolis, handing out fliers proclaiming, "Lilly, how many people are maimed or dead on your drug today?"

 The Cassidys' lawsuit, filed in federal court in Pittsburgh, charged that Diane Cassidy's doctor prescribed the antidepressant Prozac to her for weight loss and that the drug caused suicidal thoughts that led her to slash her wrists and overdose on a painkiller. She suffered intracranial bleeding from the painkiller, which left her paralyzed on one side and mentally impaired, according to the lawsuit, which sought $4.84 million in tangible damages.

 The Cassidys were represented by Houston trial lawyer Andy Vickery, who has negotiated settlements of several Prozac cases against Lilly.  Terms of the settlement, reached this week, were not disclosed.

 The Indianapolis drugmaker said in a statement that it "made a business decision to settle . . . for factors completely unrelated to the safety and efficacy of Prozac. Such factors included the extensive time demands that litigation would have placed upon our scientists, keeping them away from their primary objective of discovering lifesaving medicines. In no way was our decision to settle in any way motivated by concerns over the safety and efficacy of Prozac."

 The settlement comes the same week that a fresh Prozac lawsuit was filed against Lilly, in U.S. District Court in Georgia. It raises a new charge in the more than decadelong litigation over Prozac: that Lilly has failed to publicize research showing some people are "poor metabolizers of Prozac" and a test can reveal if a patient might be affected.

 The Georgia product-liability and wrongful-death suit, in which Vickery is assisting the plaintiff, was brought by William H. Shell, the widower of LaVerne M. Shell. She shot herself to death at age 63 in November 2000, 11 days after starting on a prescription of Prozac to treat migraine headaches.

 The lawsuit charges that a human enzyme dubbed CYP2D6 normally metabolizes or breaks down Prozac and similar drugs in the body, but fails to do so in a minority of people. In their bodies, the active ingredient in Prozac builds up to high levels, putting them at risk of violence and suicide, the lawsuit says.  "Lilly is negligent in failing to make this information public, to convey it to doctors, or otherwise to take reasonable measures to implement appropriate patient screening techniques," the lawsuit says.

 Lilly spokesman Blair Austin said that company officials hadn't seen the lawsuit and couldn't comment on the new charge.  The metabolization issue is gaining currency among some activists who publicize side effects from the Prozac class of antidepressants and other drugs.  Self-employed businessman Jim Harper of Glendale, Calif., who runs a Web site called Prozactruth.com, said he hopes to soon offer a DNA test through his site that can tell if a person is a poor metabolizer of Prozac and related drugs.

 "I should not have to be the one" to publicize the test, Harper said Friday. "I'd rather be doing other things on my nights and weekends." But drug companies and doctors aren't doing enough to warn users of serious side effects from antidepressants, said Harper, who noted he receives hundreds of e-mails a week from people who read his Web site.

 Harper said he hopes to arrange to sell the test for about $245 through Genelex Corp. of Redmond, Wash., a direct-to-consumer DNA testing firm.

 

This article from NYTimes.com
has been sent to you by dfoster@ucsd.edu.

Drug Makers Battle Plan to Curb Rewards for Doctors

December 26, 2002
By ROBERT PEAR

WASHINGTON, Dec. 25 - Drug companies and doctors are fighting a Bush administration plan to restrict gifts and other rewards that pharmaceutical manufacturers give doctors and insurers to encourage the prescribing of particular drugs. In October, the Department of Health and Human Services said many gifts and gratuities were suspect because they looked like illegal kickbacks. Since then, a few consumer groups, including AARP, have voiced support for the restrictions. But they are outnumbered by the drug makers, doctors and health maintenance organizations that have flooded the government with letters criticizing the proposal.

In contending that the proposed federal code of conduct would require radical changes, those opposing the change discuss their tactics with unusual candor and describe marketing practices that have long been shrouded in secrecy. Drug makers acknowledged, for example, that they routinely made payments to insurance plans to increase the use of their products, to expand their market share, to be added to lists of recommended drugs or to reward doctors and pharmacists for switching patients from one brand of drug to another.

Insurers, doctors and drug makers said such payments were so embedded in the structure of the health care industry that the Bush administration plan would be profoundly disruptive. Moreover, doctors said that drug companies were a major source of money for their professional education programs, and that the administration proposal could drastically reduce such subsidies. "Without financial support from industry, medical societies would most likely be forced to curtail or stop offering these important educational activities," said Dr. Michael D. Maves, executive vice president of the American Medical Association.

Doctors of all types echoed that concern.

The arguments were made in a public comment period. The administration said it was considering those comments and expected to issue final guidelines in a few months. In its guidance to the industry, the government warned drug makers not to offer financial incentives to doctors, pharmacists or other health care professionals to prescribe or recommend particular drugs. The government said the industry's aggressive marketing practices could improperly drive up costs for Medicare and Medicaid, the federal health programs for 75 million people who are elderly, disabled or poor.

But a coalition of 19 pharmaceutical companies, including Pfizer, Eli Lilly and Schering-Plough, said the Bush administration proposal was "not grounded in an understanding of industry practices." The payments and incentives to which the government objects are standard in the drug industry, they said.

Merck & Company said it routinely gave discounts and payments to health plans to reward "shifts in market share" favoring its products. Merck complained that the administration proposal would "criminalize a wide range of commercial conduct" that the industry regards as normal and entirely proper.

The Pharmaceutical Research and Manufacturers of America, the chief lobby for brand-name drug companies, acknowledged that these payments created a strong incentive to prescribe certain drugs, or to shift patients from one drug to another. But, it said, that did not make the payments "illegal kickbacks."

Solvay Pharmaceuticals of Marietta, Ga., told the government: "We understand that bribes and other hidden remuneration should be prohibited. However, a policy statement that declares well-established commercial practices potentially criminal creates a chilling effect on commerce and ultimately harms all consumers." The American Association of Health Plans, which represents most of the nation's H.M.O.'s, said the proposed standards "cast doubt on the propriety of many well-established practices undertaken by health plans to develop and administer their drug benefits."

Drug manufacturers said they often encouraged the use of their products by making payments or giving discounts to H.M.O.'s and to the specialized companies that manage drug benefits for millions of Americans. Such companies, known as pharmacy benefit managers, can exert immense influence
over what drugs are prescribed and dispensed.

H.M.O.'s and pharmacy benefit managers said they typically received money from the manufacturer of a drug if sales of that drug reached a certain level - say 40 percent of all the prescriptions for cholesterol-lowering agents. The manufacturer may agree to a higher payment if the drug achieves a larger share of the market. While describing such arrangements, the drug companies, doctors and insurers did not divulge who received how much for promoting a specific drug, nor did they provide details of individual marketing campaigns.

The Bush administration proposal received support from one H.M.O., the Great Lakes Health Plan, which serves more than 90,000 Medicaid recipients in Michigan. Eric J. Wexler, general counsel of the Great Lakes plan, said pharmacy benefit managers sometimes sent letters to doctors recommending that they shift Medicaid patients from generic drugs to brand-name medicines. In many cases, Mr. Wexler said, the brand-name drugs cost more, but are less effective.

For each letter sent to a doctor, Mr. Wexler said, "the pharmacy benefit manager receives an administrative fee, and it may get additional remuneration for converting patients from one drug to another." AdvancePCS, a pharmacy benefit manager based in Irving, Tex., confirmed that it received payments from drug companies for letters sent to doctors and patients urging them to use particular drugs.

But it said the payments - typically a flat fee for each letter - were for educational services that could help control drug spending. Kaiser Permanente, a nonprofit H.M.O. based in Oakland, Calif., said the administration plan would impair its ability to negotiate lower drug prices for its 8.5 million members because it suggested that discounts and rebate payments create "a prosecutorial risk" under the kickback law.

The Blue Cross and Blue Shield Association said the proposal would impede what it described as legitimate cost-control measures. "Pharmaceutical companies may be less willing to offer large discounts if those discounts cannot be tied to movements in market share," said Alissa Fox, policy director for the association, whose members insure more than 84 million people.

LaVarne A. Burton, president of the Pharmaceutical Care Management Association, which represents pharmacy benefit managers like Express Scripts and AdvancePCS, said that "manufacturers may cease offering discounts," rather than run the risk of liability under the proposed guidelines. But the Food Marketing Institute, whose members operate 12,000 supermarket pharmacies, applauded the proposal. "Pharmacy benefit managers routinely refuse to disclose their financial arrangements with drug companies," said Tim Hammonds, president of the institute, "and they do not wish to be subjected to any kind of accountability, such as an annual audit."

As a result, Mr. Hammonds said, "it is not possible to know with any certainty whether P.B.M.'s are helping to control drug costs for the federal government or if these middlemen are contributing to skyrocketing drug costs." The administration proposal says that when drug executives discover evidence of illegal conduct, they should report it to federal authorities within 60 days. Also, it said, drug makers should consider offering rewards to whistle-blowers and should prominently display the phone number for reporting Medicare fraud to the government (1-800-447-8477).

The coalition of drug makers objected to these recommendations, saying they would undercut the companies' efforts to police themselves. The American Medical Association said drug companies should not be forbidden to give doctors pens, notepads and other items of nominal value that have "no correlation to any service provided by the physician to the pharmaceutical company." Such "giveaway items" are harmless, it said.

But the Massachusetts Medical Society suggested that "these items would not be so readily produced if they were not an effective form of advertising." The society asked: "Is the physician who writes a prescription with a company's logo on the pen more likely to write a prescription for that advertiser? Are patients more likely to request a certain drug because they see the notepad on the doctor's desk?"

http://www.nytimes.com/2002/12/26/politics/26DRUG.html?ex=
1041929155&ei=1&en=c09ed9fd20c3d089
 

http://www.newsoftheworld.co.uk/news/news5.html
New of the World 1/12/02 (December 1, 2002)

DOCS BRIBED TO BULLY PARENTS INTO MMR JABS Kids struck off to meet targets

DOCTORS are being offered cash by the government to give children the controversial MMR jab.   And some GPs are so desperate to get the money, they are ‘striking off' youngsters who don't have the injection. The combined MMR vaccine for Measles, Mumps and Rubella has been linked to autism and bowel conditions and the News of the World is campaigning for the government to offer parents single jabs for each disease. However the Department of Health has set doctors a target which means they can claim £2,730 if they immunise 90 per cent of their patients aged two and under with the MMR jab.

The medics get the money if the youngsters also have injections to protect them against other diseases.  But while parents have no objections to vaccinating their kids against  illnesses such as whooping cough, polio and diphtheria, thousands are worried that the MMR jab could cause harm and are refusing to let the GPs give it to their kids.  So, in order to get the bonus, some doctors are ‘cooking the books'. They de-register those youngsters on their lists who don't have the injection and re-classify them as ‘temporary residents' instead.

A temporary resident can get the same care from their GP as a permanent resident, but may have to pay for their treatment. Magda Taylor, from The Informed Parents Charity, is adamant that doctors are fixing the figures to get the cash. She said: "Doctors seem to be cooking the books. They may tell the government they've reached the 90 per cent target, but in reality that figure is much less.  "If they exclude patients who are reluctant to have the vaccination from their registers, the figures aren't true."

Mum Karen Kennedy-Milne, of Kingston, Surrey, was furious when she got a letter from her doctor saying her toddler Abigail would be treated as a ‘temporary resident' because she hadn't had the MMR jab.  She said: "My choice for my children has been compromised by doctors trying to cash in on my child's health."

Power

Abigail's doctor refused to comment when we contacted her at the Canbury Medical Centre, but the tot was reinstated as a full member of the surgery after we called.  John Stark, communications director of the Kingston Primary Care Trust, told the News of the World: "The trust tried to resolve the issue between the Canbury Medical Centre and the Kennedy-Milnes by contacting the family to offer assistance. The issue has now been resolved." But he admitted the trust did not have the power to stop GPs de-registering patients for monetary gain.  He said: "The trust's policy is that children should not be removed from GP lists to influence target payments. But GPs are self-employed and they don't have to follow our guidelines."
 

http://www.nytimes.com/2002/12/04/health/04DRUG.html

Investigators Find Repeated Deception in Ads for Drugs
By ROBERT PEAR

ASHINGTON, Dec. 3 — Some companies have repeatedly disseminated misleading advertisements for prescription drugs, even after being cited for violations, and millions of people see the deceptive commercials before the government tries to halt them, Congressional investigators said today. The investigators, from the General Accounting Office, said Pfizer, for example, had continued to make misleading claims in advertisements for its cholesterol-lowering drug Lipitor, despite several letters from the Food and Drug Administration in the last four years.

In a new report, the accounting office said that drug company advertising appeared to produce a significant increase in the use of prescription drugs, as well as higher drug spending. The report criticized delays in the enforcement of federal standards for the accuracy of drug advertising and attributed much of the delay to a recent change in procedure by the Bush administration that lengthens the review process

The study estimates that at least 8.5 million Americans each year request and receive prescriptions for specific drugs after seeing or hearing advertisements for those products. The drugs cited in the report include Flonase, an allergy drug; Prilosec, for ulcers and heartburn; and Actonel, for osteoporosis.

Senator Susan Collins, a Maine Republican who was one of five members of Congress who requested the study, said: "The evidence suggests that consumers are paying a lot of attention to these ads, so it's imperative that they be accurate. If the increase in utilization is based on false claims, that's very troubling."

The report rejected a contention by critics of the pharmaceutical industry, including many Democrats in Congress, who say drug companies spend more on advertising than on research and development. Using data obtained mainly from the drug industry, the report said that drug makers spent much more on research. Last year, it said, companies spent $30.3 billion on research and  development and $19.1 billion on all promotional activities, including $2.7 billion for advertising aimed at consumers. But the report said that ad spending rose at a far greater rate than spending on research. Consumer advertising has shot up almost 150 percent since 1997, when the Food and Drug Administration revised its guidelines to permit more ads, and drug makers have shifted much of their spending from print media to television, the report said.

The accounting office said that the recent change by the Bush administration had "adversely affected" the government's ability to curb deceptive ads, by significantly increasing the amount of time required to issue a notice of violation. The new procedure has delayed enforcement actions anywhere from 2 weeks to 11 weeks, the accounting office said. Government lawyers have used that time to review the notices.

But Senator Collins said, "It takes so long to get letters issued by the F.D.A. that the advertising campaign for a drug may have run its course before the company receives a letter demanding corrective action." Typically, when the F.D.A. finds that a drug advertisement is so inaccurate, misleading or incomplete that it violates federal law and regulations, the agency writes a letter instructing the manufacturer to halt the ads. In November 2001, the Department of Health and Human Services told the agency that it could not issue such letters until they had been reviewed for "legal sufficiency and consistency with agency policy."

But, the report said, many advertisements "are on the air for only a short time — about one-fifth of them for one month, and about one-third for two months or less." Under the new policy, it observed, misleading television ads for prescription drugs can complete their "broadcast life cycle" before the agency admonishes the manufacturer. Since 1997, the report said, the F.D.A. "has issued repeated regulatory letters to several pharmaceutical companies, including 14 to GlaxoSmithKline, 6 to Schering Corporation and 5 to Merck & Company." Some companies, it said, "have received multiple regulatory letters over time for new advertisements promoting the same drug."

In its most recent letter to Pfizer, on Aug. 12, the agency said that an advertisement in Time, Reader's Digest, Good Housekeeping and other magazines was misleading because it falsely suggested that Lipitor was safer than other statin drugs used to lower cholesterol. Vanessa McGowan, a spokeswoman for Pfizer, said: "We complied with F.D.A.'s request. We pulled the ads and corrected them." Commenting on the report, the Department of Health and Human Services acknowledged that it needed to issue enforcement letters more quickly. But it said the letters had to go through a rigorous legal review because "the F.D.A. cannot afford to be considered a paper tiger."

Federal rules say drug ads must present a fair, accurate account of both benefits and risks. From August 1997 to last August, the food and drug agency issued 88 letters accusing drug companies of advertising violations — 44 for broadcast advertisements, 35 for print ads and 9 that cited both types of ads. In many cases, the agency said, companies overstated the effectiveness or minimized the risks of medicines. Last year, for example, the agency told Procter & Gamble to halt certain commercials for its osteoporosis drug Actonel after finding that information about the drug's risks was obscured by "fast-paced, rapidly changing, distracting images" on the screen.
 

LONDON (Reuters) - Vaccines, until recently a sleepy backwater in the global healthcare industry, are now outpacing drugs in terms of sales growth, the world's two largest vaccine makers said on Thursday.

GlaxoSmithKline Plc and Aventis Pasteur, who both claim a 24-percent share of the $6.5 billion-a-year global vaccine market, said demand was being driven by new products, including combination jabs and new adult treatments. The infant sector currently accounts for two-thirds of vaccine sales but market dynamics are changing, helped by growing demand for flu shots among the elderly and increased use of vaccines by tourists visiting tropical countries.  At the same time, the threat of bioterrorism in the wake of September 11, 2001, has spawned a new business in supplying vaccines against smallpox following fears that the deadly virus might be used as a weapon.  The result has been the birth of a new generation of niche vaccine companies, typified by Britain's PowderJect Pharmaceuticals Plc and Acambis Plc, both of which will make their first profit this year.

Jean Stephenne, vaccines head at GlaxoSmithKline Plc, told an ABN AMRO conference that global vaccine sales would rise by more than a fifth to about $8 billion by 2005, underlying a long-term trend which has seen a tenfold increase in sales since 1980, while drug sales have risen only five times. Both GSK and Aventis expect to clock up vaccine sales of around $1.6 billion this year. Adrian Howd, biotechnology analyst at ABN AMRO, said vaccines were now one of the fastest-growing areas of healthcare, with demand for new products outweighing supply, and the total market set to top $10 billion by 2010.  Consolidation within the sector is likely, Howd says. The industry at present is highly fragmented, with more than 60 companies, but firms will seek critical mass to compete effectively.

NEW PHASE

"You're seeing the launch of a new phase in the industry today," said Paul Kirkconnell, corporate vice president of business development of Aventis Pasteur.

He predicted the global vaccine market would double over the next decade after 14 percent compound annual growth in the 1990s. That compares with global drug sales of just eight percent in the year to September, according to healthcare information firm IMS Health. The revival of the vaccine industry, which was once dismissed as a low-margin and commoditized business by many big drugmakers, reflects a series of innovations ranging from new pediatric combinations to novel disease targets.

Among new disease targets, Stephenne said he was particularly excited by experimental vaccines to prevent infection by the human papilloma virus (HPV) that causes cervical cancer. Both Merck and GSK have HPV vaccines in development that will compete in a market that Stephenne estimated would eventually be worth some $3 billion pounds a year.

Professor George Dougan, director of the Center for Molecular Microbiology and Infection at Imperial College, London, said recent scientific progress had opened many new opportunities. These include the development of innovative drug delivery mechanisms and the use of new adjuvants, substances that are added to vaccines to enhance their effectiveness. Ultimately, vaccine developers could move to using DNA to trigger an immune response. Such DNA vaccines, if successful, would be simple to use and store, and might have therapeutic applications in treating patients already suffering from diseases, including cancer. ($1=.6364 Pound)

http://www.medscape.com/viewarticle/447937

Group Proposes Tighter Rules to Curb Drugmaker Influence on Doctor Education


By Karen Pallarito

NEW YORK (Reuters Health) Jan 14 - The outfit that accredits providers of continuing medical education programs for physicians on Tuesday released proposed standards to prevent pharmaceutical companies from controlling the content of those programs.

The Accreditation Council for Continuing Medical Education (ACCME), which sets and administers standards for CME providers, said the proposed standards would stiffen rules implemented in 1992.

Since pharmaceutical companies fund a majority of the CME offered to physicians each year, the industry may be inappropriately influencing the content of those programs, some critics say. The rules represent "an additional step" toward the goal of ensuring that CME is free from commercial bias, said Dr. Murray Kopelow, chief executive of the ACCME.

Currently, individuals or organizations must disclose any potential conflict with a commercial interest before the educational event. ACCME is proposing that individuals who have a conflict with a commercial interest, such as a drug company, be barred from planning or conducting an educational session, unless the conflict can be resolved. The proposed rules also prohibit any drug or device company accredited by the ACCME from engaging in CME activities in which they have a commercial interest.

The ACCME directly accredits some 700 CME providers and another 1,800 through a program that recognizes state or territory medical societies to accredit CME providers. A handful of ACCME-accredited organizations are makers of products regulated by the US Food and Drug Administration.

An ACCME task force developed the proposed standards as part of a broader overhaul of the accrediting body's standards and policies. The draft document is being circulated among CME providers, medical societies and other interested parties and is available on the ACCME's Web site. Comments are due by March 15 and will be considered before a final version is adopted. The council's full board could approve the document as soon as July or, more likely, in November.

 

http://www.nursing-standard.co.uk/thisweek/news3.htm

Drop in London’s vaccination rate prompts call for
review of GPs’ target payments

MMR incentives ‘should be paid to health visitors’

By Sarah Harrison


HEALTH VISITORS should be paid financial incentives to improve take-up of the measles, mumps and rubella (MMR) vaccine, the London Assembly’s health committee has recommended. The assembly has urged the Department of Health to give health visitors the immunisation benefits of up to £3,000 per year that are currently handed out to GPs. It called for a review of the payments after its research disclosed that vaccination rates in the capital were well below the national average. The assembly report showed 73 per cent of the capital’s 94,000 two year olds have had the MMR vaccine, compared with the national figure of 85 per cent.

Some parents have steered away from the triple vaccine because of fears of a link with autism and bowel disease. Others have failed to have their toddlers protected against other childhood diseases such as polio, diphtheria and whooping cough. Target payments were introduced in 1990 as incentives to GPs to encourage as many parents as possible to have their children immunised.

Family doctors receive £2,730 per year if they immunise 90 per cent of children aged two or under on
their list. This drops to £910 for a coverage of  70 per cent.

The report says: ‘It is often the health visitor who gives the jabs and good health workers do a lot of proactive work visiting parents and encouraging them to have their children vaccinated. We are concerned that the financial incentives may not be properly set to help break the declining trend of vaccination cover.’ But RCN primary healthcare adviser Lynn Young urged caution. She said: ‘While I am pleased it has been recognised that health visitors immunise and not doctors I think financial incentives could lead to problems. It is a form of performance-related pay and this could cloud the judgement of some workers. The pressure to achieve the targets could also be detrimental.’ Community Practitioners’ and Health Visitors’ Association director Mark Jones strongly opposes the idea. He said that GPs should not be paid as an incentive to immunise children and neither should nurses. ‘It is implicit in the health visitor’s role, and that of all health professionals working with children, to stress the importance of vaccination, whether or not there is a cash incentive,’ he said.

Faith Kelleher, a health visitor based at Lambeth Primary Care Trust in south London, told Nursing
Standard: ‘Although it would be nice to receive a big financial benefit for doing our job well, the money
should really be distributed to the surgery and not to an individual.’
 

Subject: New York Will Sue 2 Big Drug Makers on Doctor Discount

http://www.nytimes.com/2003/02/13/business/13DRUG.html?pagewanted=2&th

New York Will Sue 2 Big Drug Makers on Doctor Discount

By REED ABELSON and JONATHAN D. GLATER

New York plans to sue two major pharmaceutical companies today, accusing them essentially of paying doctors and pharmacists to choose the companies' drugs over competing medicines. The state is joining six other states, including California and Texas, in a growing legal attack on a longstanding practice that the states say has cost state and federal governments and consumers hundreds of millions of dollars in recent years.

The lawsuits contend that GlaxoSmithKline and Pharmacia, the two large drug  companies, gave discounts to doctors and pharmacies that bought their drugs. Doctors often buy and dispense injectable drugs like chemotherapy medicines. Pharmacies buy drugs in bulk to fill prescriptions, and sometimes recommend particular drugs to doctors.

The discounts work this way. The drug companies establish a price for the drug that the government and insurance companies use to determine how much to reimburse the doctors and pharmacies for the drugs they buy. The companies then allow the doctors and pharmacies to buy their drugs at much lower prices than the ones reported to the government. The doctors and pharmacies then pocket the difference. The lawsuits argue that the drug companies, doctors and pharmacists all profit from this arrangement, at the expense of the taxpayer and the patient, who has a higher co-payment.

The lawsuits are expected to be filed this morning in state court in Albany by Attorney General Eliot Spitzer, who is holding a news conference to announce New York's action. A third drug maker, Aventis, has been notified that it may also be sued. Some cancer doctors have come under fire from members of Congress and private insurers for profiting from providing chemotherapy drugs to their patients, but the states are now taking direct aim at the overall pricing practices of some of the nation's largest pharmaceutical companies.

Regulators say it is easier to pursue the big drug makers for setting the high prices, known as average wholesale prices, than it is to investigate numerous individual doctors. "What we're trying to do is focus on the entire practice, rather than a particular drug from a particular company," Mr. Spitzer said in an interview on Tuesday. "What underlies this is a larger failure of the marketplace to properly price drugs," he added.

As an example of the problem, Mr. Spitzer cited Adriamycin, a chemotherapy drug made by Pharmacia. According to his staff, a doctor may pay as little as $7.40 for 10 milligrams of the drug after the discounts from the drug maker. But Medicare would reimburse the doctor $34.42, based on Pharmacia's average wholesale price, and a Medicare patient in New York would make a co-payment of $8.60. The doctor would pocket $35.62, the difference between the amount paid for the drug and the payments received from the patient and from Medicare.

Many of the companies and lawyers who defend pharmaceutical companies argue that their pricing practices are legal, and say that attorneys general are overreaching in their lawsuits. Any changes to the Medicare and Medicaid reimbursement system, they say, should be made by Congress, which has so far chosen not to act.   "The question from the standpoint of the policy makers is whether this is the kind of promotion that they want to, as a policy matter, stop," said James M. Spears, a lawyer with Ropes & Gray in Washington. "That's a question for Congress to answer."

But the state suits pose a worsening problem for pharmaceutical companies as regulators examine health care costs amid a nationwide squeeze on state budgets. Several states, including California, Texas, Minnesota and Nevada, have filed suits against numerous drug makers in the last three years over their prices, and they say they are prepared to expand their activities as they gather more evidence.

In California, for example, the attorney general expects to file new suits in addition to one filed there last month against Abbott Laboratories and Wyeth.

More states are contemplating lawsuits of their own, and state attorneys general have formed a working group to share information and discuss legal strategies. Private lawyers, many of them veterans of the tobacco class-action litigation, have also joined the fray. Attorneys general are trying to use litigation to force companies to change their practices, not just to win damages, said Jennifer Arlen, a law professor at New York University.

"They're filing cases where they know full well that it's not clear that they can win if they go to trial," she said. "But because they're not seeking damages in many of these situations — they're seeking structured settlements — they're often getting a big bang for the buck by filing their case."Although the states are sharing information, they have filed separate lawsuits rather than a single, unified suit, and they are using different laws and pursuing different legal strategies. Several drug companies are battling to have the lawsuits consolidated in federal court in Boston.
   
While the states are suing on behalf of their individual Medicaid programs, which pay for drugs for the poor, some are also suing on behalf of state residents covered under the federal Medicare program. Medicare does not pay for most drugs, but does cover part of the cost of certain kinds of medicines, like chemotherapy drugs administered in a doctor's office. Patients are responsible for paying 20 percent of the bill." They're harmed much more than the states," said Mike Hatch, the attorney general for Minnesota, which sued Pharmacia last year. Regulators are also concerned that cancer doctors may have a financial incentive to recommend inappropriate or unnecessary chemotherapy because they are able to profit from prescribing particular drugs. While New York is focusing on Pharmacia and GlaxoSmithKline as makers of anti-nausea drugs, the lawsuits include all of the drugs they  make. (Aventis also makes anti-nausea drugs.) Medicaid is significantly overpaying for many drugs, Mr. Spitzer said, although it is unclear exactly how large those overpayments may be. "I sense there is waste everywhere," he said.The New York suits charge Pharmacia and GlaxoSmithKline with consumer fraud and making false statements to government health plans when they establish the drug prices, as well as with commercial bribery for trying to wield inappropriate influence on doctors' decisions. The suits take advantage of a New York statute that makes it a crime to try to interfere with the fiduciary relationship between a doctor and a patient. Each drug company benefits if it can enlarge its share of the market by inducing doctors to choose their drugs based on the difference, or spread, between what doctors pay for the drug and the amount they are reimbursed, Mr. Spitzer said. "They gain by marketing the spread." Pharmacia and GlaxoSmithKline both argue that Congress has chosen to allow the current system of setting prices for drugs to continue. Spokesmen for those companies and for Aventis said they had not seen the suit to be filed today and could not comment on it. A spokeswoman for Aventis said yesterday that the company voluntarily stopped reporting an average wholesale price in August 2001, but declined to say how the government now sets reimbursement rates for its drugs."We really have to wait until we see and then review any additional allegations," she said.But Mr. Spitzer defended his decision to pursue the litigation, despite inaction by Congress and the government programs. "Regulatory lapses elsewhere don't create a justification for the perpetuation of a system that is broken," he said.The escalating price of drugs is motivating many states to try to tackle these practices. In California, prescription costs for the Medi-Cal program, which provides health insurance to low-income residents, doubled from 1997 to 2001, even as the number of patients declined by 15 percent."The public should be incensed that the pharmaceutical giants are fleecing the Medicaid program," said Collin Wong, the director of the state attorney general's bureau of Medi-Cal fraud and elder abuse. The Texas lawsuit, which was one of the first to be filed, has turned up some evidence unfavorable to the pharmaceutical companies, said Jeff Boyd, deputy attorney general for general litigation.Some former drug company employees who were deposed have provided evidence that manufacturers deliberately used the spread between the government's reimbursement and the price paid by doctors to persuade doctors to use their drugs. Mr. Boyd said he thought some drug companies might try to avoid taking cases to a jury."We're hopeful that as some of these dominoes begin to fall, some of these companies will see the writing on the wall and come forward and start trying to negotiate a resolution," he said. 

Seniors groups boycott Glaxo over Canada move
 
Seniors groups from 12 states, including Minnesota, launched a  boycott Thursday of nonprescription products of GlaxoSmithKline because the drug company has cut off drug sales to Canadian firms that resell the drugs to Americans.

"People in America, including Minnesotans, pay the world's highest prices for drugs," said Kate Stahl, 83, metro president of the Minnesota Senior Federation. "Now, if they're going to boycott us, we're going to boycott them." The federation began a drug-import program for members last month on the same day Glaxo announced it would not provide its drugs to companies supplying programs such as the federation's. British-based Glaxo is one of the world's largest drug makers, with  sales last year of $31.8 billion, 85 percent of that from sales of pharmaceuticals such as Paxil, Advair and Zyban. Its pretax profit margin last year was 30.5 percent.

"We're not asking people to stop using Glaxo prescriptions if that's what you need," Stahl said. "But we are asking you to stop buying their other products, like Aqua Velva Aftershave, Nytol, Polident, Sominex and Tums. The boycott is called "Tums Down to Glaxo," and includes seniors' groups in New York, California, Wisconsin, Indiana, Pennsylvania, Maine, Vermont, Massachusetts, New Hampshire, Washington and Texas. Glaxo officials Wednesday told some of the boycott organizers they  would like to meet, said Peter Wyckoff, executive director of the federation. No meeting has been set yet.

Some seniors picketed outside Glaxo's U.S. headquarters in Philadelphia Thursday, and rallies were held in New York and San Francisco. The Minnesota Senior Federation has provided staff support for organizing the nationwide boycott. The coalition of seniors groups is chaired by Miriam Reibold, 86, of West St. Paul, who also heads the National Coalition of Consumer Organizations on Aging.

In addition, the senior groups have asked state attorneys general in Minnesota and New York to investigate whether Glaxo's action violates state laws.

Glaxo cites safety

A Glaxo spokeswoman said the sales through Canadian firms to Americans represent less than 1 percent of total U.S. sales, and said the company's concern is not lost profits but whether the shipped drugs are safe for patients. The U.S. Food and Drug Administration has warned consumers that there  may be safety risks in using imported drugs, and that it violates U.S. law. But it has not taken action against the estimated 1.2 million Americans who are spending between $500 million and $1  billion a year in the rapidly growing reimportation market.

Sen. Mark Dayton, D-Minn., who has used his Senate income to finance the federation's bus trips to Canada to buy cheaper drugs, endorsed the boycott during a news conference Thursday at the federation office in St. Paul.The drug company's action "reminds me of the robber barons back in the days of the industrial monopolies, when somebody tried to set up economic competition and they sent in their goons to bust it up," he said. "Now we have companies trying to dictate trade policy."

On Wednesday, Dayton joined as a sponsor of legislation proposed by Sen. Russell Feingold, D-Wis., that would withhold tax breaks to pharmaceutical companies that restrict shipments of drugs to Canada.

Cut-rate prices

On Jan. 21, the federation unveiled a program, test marketed by 400 members for the previous half-year, in which members could order prescriptions at prices averaging about 45 percent lower than in the Twin Cities. About 1,800 drugs are available.

Within 10 days, the number of people ordering through the program grew from 400 to 700, and federation officials said they expect about 1,500 users by the end of February. Since Jan. 22, more than 1,000 people have joined the 25,000-member group. But the same day the federation announced the program, Glaxo announced it would stop selling drugs to about 70 Canadian companies selling them to Americans at prices near those the government has set for Canadians.

The Canadian government regulates both wholesale and retail drug prices. The Minnesota Senior Federation and other groups have lobbied Congress for years to either control prices or negotiate lower prices in the United States. CanadaRX, a Toronto-based company that supplies prescriptions to the Minnesota Senior Federation program, has been cut off from Glaxo drugs but still has several weeks of supplies, its president, John Lubelski, said Thursday.

"Glaxo drugs represent about 10 percent of our sales, so we can continue supplying prescriptions, but we may run out of Glaxo drugs if there is no change," he said.
 

Sunday Herald - 02 March 2003
Dying medicine boss: 'Drug trials are pointless ... and unethical'
Exclusive: Volunteers stand little chance of recovery
Treatments kept from public
Companies scupper rivals
By Sarah-Kate Templeton, Health Editor

For the past 40 years Professor David Horrobin has been developing new medicines. In 1977 he founded Scotia Holdings, which was once one of Scotland's most promising biotechnology firms. But today, as the drug company boss is dying of cancer, he has decided to expose the unethical experiments that his industry carries out on patients. Horrobin reveals that patients recruited to clinical trials are prescribed highly toxic drugs with serious side effects, while they stand little chance of benefiting personally. He says that only around one in 30 patients on trials will respond positively to treatment, but that participants are not informed of this slim hope.

Horrobin, who is currently chairman of Stirling-based firm Laxdale Ltd, which develops new psychiatric drugs, claims that pharmaceutical companies even deliberately recruit more patients than they need for trials so that there are too few sufferers left for competitors to test rival drugs. He also reveals that promising cancer treatments are not available to patients because, unless they are a completely new compound and qualify for a patent which will secure profit from their sale, no company will pay for them to go through the lengthy trial process.

Two years ago Horrobin was diagnosed with lymphoma, cancer of the lymph tissue. As the cancer was at an advanced stage, he was told that he could not realistically expect to live more than six months.  In a paper in the Lancet medical journal, which was fast-tracked for urgent pub lication, he writes: 'I entered a universe parallel to the one in which I had lived for 40 years. I became a patient and suddenly saw everything from the other side. I discovered a whole new attitude to clinical trials and experimental treatments.

'I believe that patients who are asked to volunteer for large trials in cancer or other lethal diseases are being misled. Most such trials cannot be justified on ethical grounds.' He points out that large trials are needed to show up a small improvement on present treatments.

'If a trial has to be large, say more than 100 patients, it is large only because the expected effect size is very small. That means that most patients entering the trial have little or no chance of receiving benefit. With the toxic nature of many oncology [tumour] treatment regimens, there may well be a substantial chance of harm. Although the risk of harm is usually well described in patient information leaflets, almost nothing adequate is ever said about the assumed effect size and the real chance of benefit. Almost all patients volunteering for most trials in oncology are doomed: at best they can expect little benefit. They are not usually being properly told about this low expectation.'

As a cancer patient, Horrobin came to the conclusion that it was not necessarily in the best interests of the sufferer to take part in trials. 'In view of the frequently severe adverse events, usually much more predictable and reliable in their occurrence than ... a therapeutic response, a decision on the patient's part not to be treated is not irrat ional. I learned that few patients are made aware of this fact: that is unethical. 'Patients with lethal diseases want to get better, not to have their lives extended by a few weeks or months at great cost in toxicity and time in treatment.'

The most damning alleg ation in Horrobin's paper is that pharmaceutical companies actually try to sign up as many patients as possible to their trials so that competitors have difficulty finding sufferers to test rival drugs. Speaking from the Western General Hospital in Edinburgh where he is currently undergoing treatment, Horrobin insisted he had been present at industry meetings where this unscrupulous practice had been discussed.

'For the past 20 years I have been working in the pharmaceutical industry. Although everyone in the industry will deny it, and I doubt whether there is documentary evidence of this statement anywhere, I know that several of the larger firms use overpowered trials as a way of keeping competitors out of that particular subject. Especially with less common cancers, if a company, by manipulating the power cal culations, can recruit for a trial several times more patients than is necessary, then they will gain a clear competitive advantage by making it more difficult for rivals to recruit.'

Horrobin addded that hospitals conducting clinical trials for pharmaceutical firms profit financially from the experiments -- without necessarily telling the patients.

'Most patients entering most oncology trials will be dead before the results are known. But the institutions in which they are being treated probably benefit greatly financially. Most patient information leaf-lets do not tell them either fact. This omission is unethical. 'I cannot find any patient information which states that the hospital will benefit from that patient taking part in the trial and by how much. This could be between £3000 and £20,000 per trial.'

Putting new medicines through trial is expensive, and the costs are covered only when the drug can be sold at a high profit. If a medicine is not considered novel enough to be granted a patent, guaranteeing a high price when it comes on the market, it will not be financially worthwhile pursuing. Unprofitable but helpful ther apies are therefore denied to patients, says Horrobin.  The former professor of medicine at Montreal University says his knowledge has allowed him to access medicines that would not be available to most patients.

'The high cost of large trials means that they can be done only on patent-protected new chemical entities. Since such companies have to seek a return for investment, trials will be conducted for only a tiny part of the wide range of potential cancer therapies. Cancer patients are, of course, not told that such a small part of potential therapies is open to them. 'The Western General has collaborated with me completely. I have had no difficulty using the treatment I wanted -- but I have a special position in that I am running a pharmaceutical company.'

Charles Warlow, professor of medical neurology at Edinburgh University and a consultant at the city's Western General hospital, is a staunch advocate of clinical trials. But even he admits he refused to take part in a clinical trial himself when he was diagnosed with colon cancer. 'I declined to be randomised in a trial of chemotherapy after my carcinoma of the colon was removed seven years ago. I was too frightened by the side effects of the new treatment and didn't think the risk could be worth the likely benefit so I stuck with the old treatment. So far so good.

'The problem is that if a benefit is very small, does it offer anything to patients and is it worth the side effects of treatment? It depends. If there is a very small benefit it may be worthwhile if the drug is cheap, easy to take, and there are no or very few side effects -- like aspirin to prevent another stroke in a stroke survivor. Yet with some cancer drugs there may only be a small advantage, allowing patients to live for just a few weeks or months longer, but they may have to put up with some pretty toxic side effects. In that case it may not be worth it and I don't know if patients are always informed of that -- although I myself certainly was.'

Warlow added that patients in clin ical trials generally get better care than those in routine practice because they are closely followed up by doctors. Jim Eadie, director of the Association of the British Pharmaceutical Industry in Scotland, said: 'Clinical trials are essential to develop new and better treatments for patients, and play a crucial part in ensuring that the UK and Scotland are at the forefront of the development of modern treatments and research.

'It is important that trials involve as many patients as possible in order to obtain the most accurate, scientifically valid data. Companies carry out multi-centre clinical trials all over the world and are not restricted to seeking patients only in the UK. It is therefore impossible for any single company to sign up all patients with a particular condition for its clinical trial work.

'It is true that sometimes medicines may be withdrawn at a late stage in development, but this will invariably be because of problems assoc iated with safety and efficacy, not because of imminent expiry of patent life.'

Copyright © 2003 smg sunday newspapers ltd. no.176088
 

Few meds tested for children

http://www.freelancestar.com/News/FLS/2003/032003/03092003/897539

Few drugs are tested for use by children.

RECENTLY, I had a patient's mother call me frantically. She had read on the Internet that the medication I had prescribed for her 5-year-old was approved by the Food and Drug Administration only for children 6 and over. I reassured her that this medication is frequently prescribed for 5-year-olds, and since her daughter was as big as most 6-year-olds, there was nothing to worry about. Throughout our discussion, all I could think was, "Little does she know, the majority of what I prescribe every day is not even approved for children at all."

Amazingly enough, 75 percent of medications prescribed for children are not approved by the FDA for use in children, because sufficient testing has not been done. Pediatricians are forced to use many medications "off-label," meaning that the FDA hasn't labeled it for children, or not for that particular use. For example, using drops made for eyes in the ear instead.

In researching this article, I found that off-label use is more common than I thought, and I suspect other pediatricians would be surprised by the 75 percent number as well. During our training in teaching institutions, where medicine is on the cutting edge, off-label is the norm.

I justify it to myself now because I know that the practice is legal, and sometimes there is no choice but to use something that is not FDA approved when a sick child is not improving with standard therapy. I also read as much as I can by experts in the field, and I have used many of these on enough patients to feel comfortable about their safety. The American Academy of Pediatrics has been trying for years to rectify this situation. Unfortunately, there isn't much incentive for drug companies to do the expensive research needed to get approval for use in children.

The big money is in adult medications, and it's much easier to get subjects for these tests. In these studies, subjects may get the real drug or a placebo--a sugar pill--and they don't know which they are getting. Different doses are tried to find out how high a dose is needed to get a therapeutic effect and what dose is toxic.

Would you want your child to be a subject in that kind of study?

Oftentimes, low-income parents are enticed into entering their children in a study because they can't afford treatment for an illness, or because they are paid for their participation.

In 1997 Congress passed the Best Pharmaceuticals for Children Act, which was renewed for another five years in December 2001. This has been helpful in getting drug companies to do more pediatric research by offering incentives, like an extension of their patent. The companies can get exclusive rights on a medication for a longer period of time, before it can be produced in a generic form.

However, participation in BPCA is voluntary, so the companies can choose whether they want to test any new drug in kids. The FDA was concerned that the BPCA was not strong enough, and that it would expire at some point, so in 1998 the FDA published the Pediatric Rule.

Under this policy, the FDA requires that all new drugs be studied in children at the same time as, or soon after, the drug is approved for use in adults. The Pediatric Rule had not yet been fully invoked when it came under fire from the pharmaceutical industry, which balked at the additional time and expense this would add to a cumbersome process.

A suit against the FDA was soon filed by Consumer Alert, the Competitive Enterprise Institute and the Association of American Physicians and Surgeons. They won last October, when a U.S. district court struck down the Pediatric Rule, saying that it went beyond the FDA's authority.

Unfortunately, the FDA decided not to appeal, hoping that Congress would pass a law to replace the Pediatric Rule. Given the economy and the administration's priorities, it is unlikely that this will happen in the near future. Therefore, the AAP and the Elizabeth Glaser Pediatric AIDS Foundation received permission to appeal without the FDA's participation. As a pediatrician, it scares me a little that the majority of drugs I prescribe every day have not been well tested in children. The doses we use are often based on trial-and-error methods from teaching institutions, but not on the kind of rigorous study that the FDA requires in adults. As a parent, it scares me even more. But then again, I don't want my girls to be in one of those studies.

Some interesting medications have been well tested in children and approved by the FDA. These include Prevacid for gastro-esophageal reflux disease in ages 1 to 11; Pediarix immunization for diptheria, tetanus, pertussis, polio and Hepatitis B in one shot; Zithromax to treat ear infection in a single dose; Omnicef to treat ear infection or strep throat in 5 days; Lipitor for high cholesterol in ages 10 to17; and Strattera, the first nonstimulant medication approved for ADHD for ages 6 to adult.

Despite all these advances, there are many drugs out there that we need for kids that won't be tested enough for FDA approval until Congress mandates it.

I learned so much researching this article that I have to stop writing now so I can go write letters to my representatives in Washington. I strongly believe that children have the same right to safe, effective medications as adults do, and that the FDA should be given the authority to make this happen.

Dr. Allegretti is a pediatrician with Preferred Pediatrics in North Stafford.

 

Ann M. Veneman
AGRICULTURE SECRETARY

Corporate Connections:
Calgene/Monsanto; Pharmacia

Between her tenure at the U.S. Department of Agriculture (under George Bush Sr.) and being named head of California’s Department of Food and Agriculture in 1995, Ann Veneman served on the board of directors for Calgene Inc. In 1994, Calgene became the first company to bring genetically-engineered food, the Flavr Savr tomato, to supermarket shelves. Calgene was bought out by Monsanto, the nation’s leading biotech company, in 1997. Monsanto, in turn, became part of pharmaceutical company Pharmacia in 2000. Monsanto, which donated more than $12,000 to George Bush’s presidential bid, wants two things this year: no mandatory labeling of biotech foods and better access to international markets. Veneman also served on the International Policy Council on Agriculture, Food and Trade, a group funded by Cargill, Nestle, Kraft, and Archer Daniels Midland.

 

Research funding:
The ties that bind

from Nature Reviews Drug Discovery

Adam Smith

http://www.nature.com/cgi-taf/Gateway.taf?g=5&
file=/drugdisc/res_high/articles/nrd1071.html&filetype=&_UserReference=


An ever-increasing proportion of biomedical research is funded by industry. In 2000, the National Institutes of Health estimated industry's share of the total investment to be 62%, representing a doubling of the estimate for 1980. As the relationships between academia and industry become closer, the  question of whether or not these ties are influencing the outcomes of  published biomedical research becomes more pressing. Contributing to this debate, a recently published meta-analysis in the Journal of the American Medical Association reports a significant correlation between industry sponsorship and the publication of pro-industry conclusions.

In their substantial analysis of studies published on the topic of conflict of interest between 1980 and 2002, Bekelman et al. looked at three main areas: the frequency of financial arrangements between industry and academic investigators or institutions, the impact of such relationships, and how they were managed. Data were drawn from 37 published studies, of which 10 dealt with the extent of financial relationships, 23 were concerned with the effect of such relationships on published findings and 8 looked at financial management.

The authors found that around a third of investigators at academic  institutions had personal financial ties with industry sponsors. They also point out the relatively new phenomenon of academic institutions themselves holding extensive equity in companies, and the consequent shift that might result in institutional priorities. When assessing the impact of funding on research outcomes, the authors defined a pro-industry conclusion as a study outcome that was favourable to the industry sponsors, such as showing that a therapy produced by the company was superior to existing therapies or placebo. Combining the data from articles that examined 1,140 studies led to the conclusion that industry-sponsored studies were significantly more likely to reach favourable conclusions than comparable nonindustry studies.

Among the possible reasons for this difference, the authors cite the findings of four papers that show that industry preferentially supports study designs that tend to give positive results, such as the use of placebo rather than comparison therapies in controlled trials. The greater disinclination to publish negative data by industry-sponsored researchers is also likely to contribute to the observed bias.

Despite the widespread nature of financial relationships, the policies  adopted by federal agencies and academic institutions towards managing these entanglements were found to vary greatly. The same seems to be true of biomedical journals, as most do not require disclosure of financial conflicts of interest and most of those that do find that few articles contain such disclosures.

The JAMA study, which focused heavily on clinical research, is of particular relevance at a time when clinical trials are rapidly transferring from an academic to an industrial setting, with contract research organizations now consuming more than 60% of industrial clinical research funding. Although conflicts of interest can take many forms, and financial conflicts of interest are just part of the equation, the results of this study underline the need for further research into the extent and impact of financial relationships, with a view to the setting of balanced, standardized procedures for disclosure, to which the majority of institutions and individuals will adhere.

References

ORIGINAL RESEARCH PAPER
Bekelman, J. E., Li, Y. & Gross, C. P. Scope and impact of financial conflicts of interest in biomedical research. J. Am. Med. Assoc. 289, 454–465 (2003)
FURTHER READING
van Kolfschooten, F. Conflicts of interest: can you believe what you read?
Nature 416, 360–363 (2002)
 

Medical Ghostwriting

      [Air Date: Mar 25, 2003 Reporter: Erica Johnson Producer:

Michael Gruzuk Associate Producer: Colman Jones.  Thanks to Mike Glavic.]

http://www.cbc.ca/consumers/market/files/health/ghostwriting/index.html

      Medical ghostwriting. You may not have heard of it, but you'll probably want to know about it. It's a world that could make your doctor prescribe the wrong drug. For trusted guidance — articles rigorously reviewed in medical journals are the gold standard when it comes to scrutinized, scientific reports. They're what our doctors rely on to make decisions affecting our health. But more and more — we can’t be sure who’s serving up that medical advice.  Medical ghostwriting can be as scary as it is spooky. People with
scientific backgrounds — often, with PhDs — are paid to stay in the shadows and crank out Medical Ghostwriter can make $100,000 a year writing favourable drug reports

      favourable reports for drug companies. Then, drug companies get doctors to put their names on the studies — for money, prestige, or perks.  Marketplace tracked down ghostwriters in Vancouver, Montreal and Ottawa — one agreed to talk with us, but only if we protected their identity. Their job could vanish if their identity is revealed. We'll call our busy ghostwriter, Blair Snitch. Blair Snitch: I’m given an outline about what to talk about, what studies to site. They want us to be talking about the stuff that makes the drug look good.
      Erica Johnson : They don’t give you the negative studies?
      Blair Snitch: There’s no discussion of certain adverse events. That’s just not brought up.
      Blair Snitch is paid to write up positive reports. So bad side effects that could affect patient safety, are sometimes completely ignored.  Snitch makes over $100,000 a year as a medical ghostwriter. An article that makes its way into a prestigious medical journal — like the Lancet, British Medical Journal, New England Journal of Medicine — will earn up to $20,000.

      Snitch’s work is brisk and busy, but not problem free.  Erica Johnson: How much pressure is there from the drug company to write something favourable?     Blair Snitch: You’re being told what to do. And if you don’t do it, you’ve lost the job.
      'A matter of efficiency'
      Snitch works for what’s called a “medical writing” company. There’s a whole industry churning out drug company bumph. It’s partly a matter of efficiency, says Snitch.  “Doctors don’t have time to write those articles. The people who have their names on those articles are very busy professionals.”  Busy — and usually high-profile. The higher the profile, the greater the credibility for the article. “What appear to be scientific articles are really 'What appear to be scientific articles are really infomercials..." Dr David Healy, Univ of Wales  infomercials of some sort,” says Dr. David Healy of the University of Wales.

      Healy’s no stranger to controversy: his job at the University of Toronto was suspended after he criticized the pharmaceutical industry. But he still gets invited to lecture and remembers one in particular. “I said 'yes' to the meeting. To my big surprise I had an e-mail shortly afterwards. 'In order to reduce your workload, we have had our ghostwriters produce a first draft based on your published work. I attach it here.'

      Healy wasn’t comfortable with the glowing review of the drug, so he crafted his own article. The drug company wrote back and said he’d missed something key. In the end, the drug company put someone else's name on the article. Healy is spooked by the deception. He says it goes beyond being misleading — it can be dangerous. He’s seen a lot of articles on drugs — like anti-depressants — that don’t mention serious problems. “People and children, for instance, that have been put on these drugs, actually committing suicide. Or becoming suicidal. But the finished articles actually don’t reflect this at all.”

      Reason for concern Blair Snitch says the public should be concerned. "Are they being prescribed a drug because it’s the best drug or because it’s the drug most favourably positioned?"   Erica Johnson: Do you have any concerns about what you’re doing? Blair Snitch: I don’t feel ownership of the product.      Erica Johnson: But you are taking the research and delivering to the drug company something that’s favourable.       Blair Snitch: I expect that all the drug companies are doing it with all the drugs. So I figure in the end, it’ll be balancing itself out. Healy’s not so sure. He’s seen internal drug company documents. They had lists of scientific papers written up, ready to go.  All that was missing, was the name of a high profile doctor to be listed as author.

     Healy estimates as much as 50 per cent of the literature on drugs is ghostwritten. Ghostwriters we talked to said they do a good job of taking complicated science and turning it into something understandable.   We wanted to ask a doctor why they’d agree to sticking their name on a paper.  But it’s tricky getting people to fess up.  Some doctors didn’t call back. One we reached said he “couldn’t remember who wrote the paper” his name was on.  Then said the drug company “might have” written the first draft.  But by the end of our conversation, he’d remembered — he’d written every word. The world’s leading medical journals – say they're trying to ferret out who lurks behind the pen. When a study is submitted to top journals like the Canadian Medical  Association Journal, The Lancet, New England Journal of Medicine, everyone whose had anything to do with the article is listed — like a film credit. John Hoey, the editor of the CMAJ, admits it's a tough rule to enforce.  "We have no way of checking.

      We barely have the resources to do what we’re doing, let alone whether so-and-so is telling us honestly what they did." Hoey says drug companies don't just want positive articles, but positive research results.       But some critics say all this industry influence is a problem because ghostwriters rely on research material that's given to them by drug companies — so it may be biased to begin with.  That means even ghostwriters might not know about negative side effects and safety problems.  'Clearly unethical' “I think it is clearly unethical," said Dr. Mohit Bhindari, an orthopaedic surgeon at McMaster University. He’s just penned a report on drug company studies — one that he wrote himself.   “If you have funding from an industry sponsor, you are four times more likely to include a positive, pro-industry result which favours that particular industry’s product.” Bhindari says researchers have told himthere's pressure to come up with "good results." Dr. David Healy says that’s dangerous and has to change.  “The only way to know whether the articles really are honest is for people, if need be, to be able to get access to the raw data.” Blair Snitch is in a rush to go.

      There’s another big drug company contract to work on, with no regrets.  Blair Snitch: As long as I do my job well, it’s not up to me to decide how the drug is positioned. I’m just following the information I’m being given.  Erica Johnson: Even though you know that information is often biased? Blair Snitch: The way I look at it, if doctors that have their name on it, that’s their responsibility, not mine.       So for now, keep in mind that medical information you read may be other-worldly.  Since people paid big bucks to spin research show no sign of giving up the ghost.

 

http://www.cbsnews.com/stories/2003/02/19/60II/main541202.shtml

CBSNews.com Home
Pitching Prozac
February 19, 2003

Last spring, hundreds of people in Florida opened their mailboxes and found, in and among the junk mail and bills, padded envelopes full of powerful prescription drugs. Each package contained a one-month starter supply of Prozac Weekly, a new anti-depressant made by pharmaceutical giant Eli Lilly.

None of the people had asked for the drugs or knew they were coming. How could that happen? It was a marketing scheme for pitching Prozac - spearheaded by Eli Lilly sales reps - but also involving doctors, pharmacies and the medical records of unsuspecting patients. Correspondent Vicki Mabrey reports. Michael Grinsted was 16 when he found the package of Prozac Weekly  addressed to him one day after school. The prescription was sent with a letter from the head doctor in the family practice Michael and his mother Susan go to in West Palm Beach, Florida. In order to switch to Prozac Weekly stop your current daily antidepressant today and start Prozac Weekly tomorrow.

But Grinsted was not taking an antidepressant and never had. He says he has "no clue" where the sender would get the idea that he wanted or needed Prozac. 30 miles away in Ft. Lauderdale, 59-year-old Ann Parsons received a similar package from her doctor. "At first I was startled and confused," she says. "Why would they suggest I take Prozac Weekly?" What Parsons didn't know was that she was targeted because she takes Zoloft - a drug manufactured by one of Lilly's competitors. Parsons says she was taking it for panic attacks she suffered after September 11th - a closely guarded secret she thought only her doctor knew.

She says she threw the pills in the garbage disposal and shredded the package. "I didn't want to be involved with it," she says. "I don't think there are many things about our lives that we hold so personal as the medication that we're taking in the privacy of our own home," says attorney Gary Farmer, who represents Ann Parsons and Michael Grinsted in a lawsuit against their doctors, the Walgreens Pharmacy chain, and Eli Lilly. He says his clients' medical privacy was violated after Prozac's patent ran out and patients turned to the cheaper generic version.

"Their sales, it's well documented, have dropped 80 percent since they went off patent. This is one of the most profitable drugs in the history of the United States drug manufacturing industry. And they're desperate to regain some of that market share," he says. To do that Lilly instructed its sales reps to push its new product, Prozac Weekly, the first and only anti-depressant that can be taken just once a week. The new drug meant a new patent and new profits - if Lilly could just get people to take it instead of the generic.

60 Minutes wanted to ask Eli Lilly how patients were targeted for the Prozac Weekly mailing, but the company wouldn't talk to us. But Frank LaCorte did. A 23-year veteran of Eli Lilly, he was one of the sales reps at the heart of the mailing. He agreed to explain how it worked. What kind of patients were supposed to be targeted for Prozac Weekly? "Prozac daily patients. And patients on other anti-depressants," he says. In other words, patients who were taking the competitors' medication were also targeted. As a sales rep, LaCorte didn't have access to patient records, so he went someplace that did: the Holy Cross Medical Group in Ft. Lauderdale, where he'd been pitching Lilly drugs for almost a decade. He asked the doctors to come up with a list of patients suffering from depression. For that they searched their computer files.

He says there was a code in the database that said this is a person treated for depression. LaCorte took that computer generated patient list to a Walgreen's, along with a "Dear Patient" letter signed by all the doctors in the group. Lilly covered the cost of the prescriptions and Walgreens sent the drugs out. Says LaCorte: "It was called a win, win, win situation. The patient got a free course of therapy. The doctor looked like a hero to his patient because he was updating them on the most new and improved medication. And Eli Lilly got a win because they've got a sale, at least one sale on Prozac."

"Win win win strategy sounds very much like corporate speak," Mabrey says. "It is corporate speak. There's no doubt about it. It was a way to convince everybody involved that this was a good thing," LaCorte says. Says Farmer: "The drug company has no business making itself a doctor. That's what they're trying to do. They're trying to force their will on physicians: 'Just give us the names doctor, we'll take care of the rest.'" Ann Parsons' doctors in the Holy Cross Medical Group and Michael Grinsted's doctor wouldn't talk about their participation in the Prozac Weekly mailing.

But Dana Richard, a physician in West Palm Beach, Florida and his wife Linda, his office manager, did agree to talk. They also were approached by an Eli Lilly sales rep pitching Prozac Weekly. He says an Eli Lilly sales rep asked him for patient names. "I didn't think it was a good idea. So I told him, 'No,' without any hesitation." But the Lilly rep didn't take no for an answer. He asked someone else in the office for help. As one email from a manager in southern Florida shows, reps were taught to "involve the staff member with greatest computer skills…" and find out their ability to "generate a list of patients."

The Richards say that in their office, a medical assistant, who has since been fired, gave the Lilly rep access not only to an unauthorized list of patients, but also some office letterhead, on which the rep printed this letter to patients under the heading "change of prescription." Richard says he did not write the letter. "It has your name at the bottom," says Mabrey. "Correct. I never let anything go out without my signature," says Dana Richard.

In fact the letter has no signature. It advises patients to stop their "current daily anti-depressant today and start taking Prozac Weekly tomorrow." We compared this letter to the one used by Frank LaCorte in his mailing and found that the language is almost identical. LaCorte says that's because the template for the letters was written by Lilly reps, not by the doctors. It was important that it go out to the patient on their doctor's stationery, he says: "It was the only credibility that would work." But in the Richards' case, the mailings never went out: A pharmacy claims manager became suspicious and called Eli Lilly when it appeared that more than 20 of Dr. Richards' patients had prescriptions for Prozac Weekly filled on the same day. Dr. Richard says it's a good thing the drugs never went out because antidepressants can cause serious problems when switched abruptly. In fact, one patient on the list was a man dr. Richard says had suffered a violent psychotic reaction to Prozac in the past.

"I think it would have been a catastrophe," he says. "God forbid if someone has gotten these and taken it and died or ended up in the hospital. I mean it was horrible," says Linda Richard. Farmer lays the blame with the people at Eli Lilly: "They're just as bad as the guy selling illegal drugs down on the corner. They're pushing their product. They don't care what happens to the patient who takes that when they walk away with that drug." "Isn't it reasonable for a pharmaceutical company to want to inform people about something new on the market, something that may be better for them?" Mabrey asks.

Says Farmer: "The drug companies have commercials running every half-hour. You cannot turn the television on at night without seeing drugs for any number of very personal and private conditions being marketed over the television. That's acceptable. Sending drugs in the mail is not acceptable." In a public statement, Eli Lilly seems to agree, calling the mailings "limited incidents… inconsistent with corporate policy." It says the company does not "support programs in which medicine is mailed to patients without the patients' request." In fact, we've seen no conclusive evidence that knowledge of the program reached corporate headquarters. But what is clear according to LaCorte is that the people heading his regional sales team knew all about it.

"We're always told how to market. Salespeople in the field are not developing programs. Salespeople in the field are implementers of programs. We've given a program and we're told, 'Ggo, do it.'" he says. LaCorte says that's what he did - informing his supervisors every step of the way. In this email to two different managers, he describes the "sample packet of what the patient receives…" including a "filled prescription." After Prozac Weekly went out to 145 patients, LaCorte received kudos in this email from a manager: "You guys rule!.. I can't wait to see "spike in the [prescription] data." That manager also sent instructions for duplicating the program to managers in five other states. LaCorte says he received "accolades." "I was on top of the world," he says.

But not for long. After some of the people who received the Prozac Weekly filed a lawsuit against Lilly, the company issued its statement saying it takes the matter "extremely seriously" and that "three sales managers and five sales representatives have been disciplined." LaCorte was fired. He is suing Eli Lilly for character defamation. In the end, about 300 people in southern Florida received the Prozac Weekly in the mail. But short of mailing drugs, pharmaceutical companies target patients all the time. The main difference is, instead of asking doctors to compile lists of patients, more often the drug companies go straight to big pharmacy chains. They pay them up to two dollars a head for each patient they send letters to, touting the company's drugs. These multi-million dollar agreements are legal under new federal privacy guidelines.

Legal or not, Ann Parsons says it's wrong. In her case, being targeted for Prozac Weekly carried unforeseen consequences. She found that out when her pharmacist refused to refill her Zoloft prescription. "He said, 'Oh, Miss Parsons, you can't have your Zoloft.' And I said, 'Why?' 'Well, I see here on our records you're taking Prozac." I said, 'I'm not taking Prozac. My prescription has not been changed.' I said, 'Why you people sent it to me is beyond my comprehension.'" She says. She finally got her Zoloft - but she's also got Prozac Weekly on her permanent records - and so does Michael Grinsted - even though he's never been diagnosed with depression and says he has never taken anything stronger than an antibiotic.

The pharmaceutical companies and drugstore chains insist they protect patient confidentiality - but Susan Grinsted isn't convinced. Before her son was sent Prozac Weekly, she thought only the doctors' office had access to her and her son's records. Now, who does she think has access? "Anybody who's willing to pay for it."
 

http://www.reuters.co.uk/newsArticle.jhtml?type=scienceNews&storyID=2848508

Doctors' Links with Drug Companies Under Fire

By Ben Hirschler
LONDON (Reuters) - Doctors have an over-cozy relationship with pharmaceutical companies that can adversely influence prescribing and affect research, a leading medical publication said on Friday. The prestigious British Medical Journal believes regular contacts between drug reps and doctors can lead to unnecessary use of medicines while industry sponsorship of research may result in biased results. "Our central argument is that doctors, drug companies and most importantly patients would all benefit from greater distance between doctors and drug companies," said editor Richard Smith, who devoted this week's edition to the issue.

There is a growing debate about conflicts of interest in relations between physicians and the $400 billion-a-year global pharmaceutical industry. Earlier this month, the World Medical Association, grouping 80 national medical associations, discussed a draft paper setting out new rules governing doctors' dealings with companies. "There is a feeling that it's all gone a bit far and it's time to try and throw it into reverse," Smith told Reuters. The drug industry rejects suggestions it is trying to unduly influence doctors, arguing that open discussion between doctors and manufacturers is vital if patients are to get the best treatment.

"It is important...that regular dialogue is maintained to ensure that patients, everywhere, benefit from the most appropriate treatment," said Trevor Jones, director general of the Association of the British Pharmaceutical Industry.  The latest issue of the BMJ, however, cited several areas of concern. One study of 1,000 doctors across England, for example, showed that those who saw drug industry representatives at least once a week were more likely to prescribe new drugs when an old one would do just as well.

Other research showed that clinical trials financed by drug firms were more likely to have outcomes favoring the sponsor than studies with other backers. Smith said doctors were being flooded with clinical data from company-sponsored drug trials but there was a dearth of research comparing rival products. Such head-to-head studies could be hard for firms to swallow but were invaluable for doctors -- like the discovery from a major U.S. investigation of blood pressure medicines last year that older and cheaper diuretic pills worked as well as and often better than newer and more costly drugs.
 

http://story.news.yahoo.com/news?tmpl=story&cid=514&e=
20&u=/ap/20030603/ap_o
n_re_us/contaminated_blood_11

Suit Says Drugs Made From Tainted Blood
Tue Jun 3, 2:56 PM ET Add Top Stories - AP to My Yahoo!
By KIM CURTIS, Associated Press Writer

SAN FRANCISCO - Several hemophiliacs filed a lawsuit against Bayer Corp. and other companies, claiming they exposed patients to HIV (news - web sites) and hepatitis C by selling medicine made with blood from sick, high-risk donors. The lawsuit alleges the companies continued distributing the blood-clotting product in Asia and Latin America in 1984 and 1985, even after they stopped selling it in the United States because of the known risk of HIV and hepatitis transmission. The lawsuit filed Monday in federal court seeks class-action status on behalf of thousands of foreign hemophiliacs who received the product, said attorney Robert Nelson. It accuses the companies of negligence and fraudulent concealment. "This is a worldwide tragedy," Nelson said. "Thousands of hemophiliacs have unnecessarily died from AIDS (news - web sites) and many thousands more are infected with HIV or hepatitis C." Bayer rejected the claims, saying in a statement from its headquarters in Leverkusen, Germany Tuesday that it would examine the lawsuit and prepare its defense.

"Bayer at all times complied with all regulations in force in the relevant countries based on the amount of scientific evidence available at the time," the company said, adding that decisions made 20 years ago should not be judged by today's scientific knowledge. Nelson said the lawsuit was filed in California because defendant Cutter Biological, now a division of Bayer, was formerly based in Berkeley. Several plasma donation sites also were located in the San Francisco Bay area, he said. The lawsuit was filed less than two weeks after an investigation by The New York Times accused the company of selling old stock of the medicine abroad, while marketing a newer, safer product in the United States. Bayer told Times it sold the old medicine because some customers doubted the effectiveness of a new version of the product, and because some countries were slow to approve its sale. While the company said it acted responsibly and in line with the best medical knowledge at the time, Bayer and three other companies that made the concentrate settled 15 years of U.S. lawsuits from people who took the drug, paying about $600 million. The medicine, called Factor VIII concentrate, can stop or prevent potentially fatal bleeding in people with hemophilia.

Early in the AIDS epidemic, the medicine was commonly made using mingled plasma from 10,000 or more donors. Because there was not yet a screening test for HIV, the virus that causes AIDS, thousands of hemophiliacs were infected. But the lawsuit alleges Bayer and the others refused to take precautions that could have made the product safer. As of 1992, the contaminated blood products had infected at least 5,000 hemophiliacs in Europe with HIV. More than 2,000 had already developed AIDS and 1,250 had died from the disease, the lawsuit said. By the mid-1990s in Japan, hemophiliacs accounted for the majority of the country's 4,000 reported cases of HIV infection and virtually all infections of Japan's hemophiliacs have been linked to contaminated blood products imported from the United States, the lawsuit said. In Latin America, at least 700 HIV cases are linked to use of contaminated blood products by hemophiliacs, the lawsuit said.

 

http://www.sunspot.net/templates/misc/printstory.jsp?slug=bal-te.vaccine09ju
n09&section=/printstory

In post-9/11 world, vaccine research gains new respect
Bioterror, other scares fuel funding, technology, outside interest in
science


By Erika Niedowski
Sun Staff

June 9, 2003

Dr. Robert Edelman has long had to field questions - from his own parents - about why he's not a "real" doctor, seeing patients, prescribing medicines and curing their ills. His response: "I'm a real doc, except you don't see what I do every day." Edelman's lifework is vaccine research - long one of medicine's most undervalued pursuits, even though vaccines have helped conquer some of the world's worst diseases. But now, with bioterror a household word and infectious diseases such as SARS scaring millions around the globe, the discipline is getting more respect - from the scientific community, the federal government and even Edelman's parents, who keep seeing their son quoted on television.

"All you need is one vaccine," said Edelman, 66, associate director of clinical research at the University of Maryland's Center for Vaccine Development. "You've made an impact on potentially tens of millions of people. Take that to bed with you at night." With increased funding and new technology, vaccine research is thriving, scientists say. "I think it's a very exciting time for vaccinology," said Dr. Regina Rabinovich, director of the infectious diseases program at the Bill & Melinda Gates Foundation. The Seattle-based foundation has committed more than $1 billion since 1999 to developing new vaccines and expanding access to existing ones worldwide.

"It's definitely more robust," said Dr. Myron M. Levine, a prominent vaccine researcher who heads UM's Center for Vaccine Development. Since Edward Jenner developed the first vaccine, for smallpox, in 1796, vaccines have been some of the most successful public health interventions ever, wiping out smallpox and protecting people from scourges including polio, mumps and measles. Children in this country now receive about two dozen shots by age 6. But vaccine research practically became a victim of its own success. Over the years, it came to be viewed as something of a scientific backwater as the epidemics that afflicted earlier generations faded into memory. Some ambitious scientists began to look elsewhere.

Yichen Lu, principal research scientist for the Harvard AIDS Institute and the Harvard School of Public Health's immunology and infectious diseases department, has heard the field degraded by prominent scientists. "They think that doing vaccine research doesn't require a lot of brain power," he said. "My point of view is that, 20 years after AIDS, we haven't been able to come up with a vaccine."

Tedious and expensive

Because vaccine-making is based in large part on trial and error, and there is no universal blueprint for how to do it, the process can be tedious and expensive. Scientists have had difficulty getting funding - most drug makers considered vaccines for Third World diseases such as malaria or cholera unprofitable. The work also requires a multidisciplinary team of researchers who might spend half a career or more on a single vaccine, with no guarantee of success and a high risk of failure. The emergence of AIDS in the early 1980s was a sobering reminder that infectious disease was not a distant threat. Since then, outbreaks of Ebola, West Nile virus, severe acute respiratory syndrome and other illnesses have driven the point home.

"It's become clear over the last decade or so, or even longer, that infectious diseases are not going away," said Emilio A. Emini, head of vaccine development at Merck Research Laboratories, which recently began work on a SARS vaccine. In the post-Sept. 11 world, the federal government has emphasized the need to develop, produce and stockpile the safest and most effective vaccines against deadly bioterror agents such as smallpox and anthrax. Officials have earmarked more than $1 billion to that end at the National Institutes of Health alone. The Bush administration has proposed, in Project BioShield, to create a guaranteed market for those who make the vaccines.

"There's a great influx of resources, and that means there are a lot of people who are going to be working on problems related to these agents that wouldn't otherwise have been involved," said Dr. Francis A. Ennis, director of the Center for Infectious Disease and Vaccine Research at the University of Massachusetts Medical School.

Maryland institutions have benefited from the largess. In February, theJohns Hopkins Bloomberg School of Public Health received a $30 million grant from the Global Alliance for Vaccines and Immunizations to speed development of several new childhood vaccines. Last summer, UM's Center for Vaccine Development got a $22 million federal grant for new vaccines against anthrax, malaria and other diseases. That's welcome news for researchers such as Dr. Wilbur Chen, who even before going to medical school became intrigued by the field while he was a lab technician at the Food and Drug Administration, working on vaccines against meningitis and influenza.

"For me, it's a great thing, because you're preventing disease from even happening in the first place," said Chen, 33, who is an infectious disease fellow at the University of Maryland Medical Center. He is
applying to the vaccinology training program at UM's Center for Vaccine Development. Chen likes the potential of being able to have an impact in the Third World, where infectious diseases are still a major killer. And he thinks the growing understanding of the importance of vaccine work - beyond the research bench - will only help his cause. "Now I can talk about my desire to do vaccine research and people can identify with it," he said. "Before they were like, 'Gee, vaccines are just what you get from your pediatrician.'"

'Inelegant' science

Leaps in technology have helped dissolve the long-held impression that vaccine research is based on "inelegant" or unsophisticated science. For example, Dr. Jonas Salk was hailed as a hero in the 1950s for developing the first polio vaccine, using "killed" poliomyelitis virus. But even then, scientific rival Dr. Albert Sabin derided Salk's work as "pure kitchen chemistry."

Dr. Gary J. Nabel, director of the Vaccine Research Center in the National Institute of Allergy and Infectious Diseases, said some scientists still rely on traditional methods of vaccine development.
"But, by and large, particularly within the last five years, the sophistication of our science has really reframed the whole field," he said. Researchers have devised novel ways of delivering vaccines, including an edible vaccine. With advances in microbiology and genetics, scientists are working on DNA-based vaccines as well as therapeutic vaccines against cancer and other diseases.

"I think it's advancement in science that validates the field more today than ever before," said Garo H. Armen, chief executive officer at Antigenics, a Massachusetts biotechnology company working on a
personalized cancer vaccine using individual patients' cancerous cells. But challenges remain. Harvard's Lu said more resources and outside interest in the field have helped - but only to a point.

"Morally speaking, it makes us feel like we're doing the right thing," he said. "It makes us realize our experience is badly needed. It's not redundant. It's not nobody's interested." He said his last three grant applications have been turned down because the work he has proposed on an AIDS vaccine doesn't have an innovative scientific hypothesis. And private industry, he said, is still primarily interested in making a profit. But Ennis, of the University of Massachusetts Medical School, urges his colleagues to remember why they got into vaccine research in the first place. "One of the things that the scientists have to bear in mind is to try todo the best work they can and not lose their perspective," he said, "because the resources will come and the resources will go."

Copyright © 2003, The Baltimore Sun
 

THE NEW YORK TIMES
August 3, 2003

Undisclosed Financial Ties Prompt Reproval of Doctor
By MELODY PETERSEN

http://www.nytimes.com/2003/08/03/national/03CONF.html?pagewanted=print&posi
tion=

Two scientists are raising concerns about an article in a medical journal that described experimental treatments for depression because an author did not disclose his significant financial ties to three therapies that he mentioned favorably.

WHAT DOCTORS DON’T TELL YOU - E-NEWS BROADCAST No.46 - 31 July 03

MENOPAUSE: Well, can I interest you in a powerful antidepressant? (Or: The Resourcefulness of the Drugs Industry, part I)

Readers of last week's Enews will know that the pharmaceutical industry has lost one of its best money-spinners after HRT therapy was so thoroughly trashed by the influential Women's Health Initiative trial.

But the pharmaceuticals didn't get where they are today by being anything other than resilient (and creative).  They are already suggesting that a powerful antidepressant could be a suitable replacement for HRT. Specifically they have been testing paroxetine (Paxil), a selective serotonin reuptake inhibitor.  They tested it on 165 menopausal women who had been complaining of hot flashes-and, compared with a placebo, it seems to be effective over a six-week period.  In fact, the researchers conclude, Paxil could well be a good alternative therapy to HRT.

This breakthrough discovery may lose its edge a little if we now reveal three facts: Fact 1:  Paxil is manufactured by GlaxoSmithKline.  Fact 2: three of the four researchers are full-time employees of GlaxoSmithKline, and the fourth is a consultant to the company. Fact 3: GlaxoSmithKline paid for the research. The employees (sorry, researchers) may also have been diffident to talk about adverse reactions to the drug.  That's a pity because Paxil is not well tolerated, with around 16 per cent of users having to discontinue treatment.  The more common reactions include sweating, tremor, dizziness and insomnia (Aren't they supposed to be menopausal symptoms? -Ed), headache, sleepiness, constipation, and female genital disorders.  Serious reactions have included hypertension, tachycardia, pain, ulcers, arthritis, osteoporosis, delirium, hallucinations, grand mal, asthma, conjunctivitis, eye hemorrhage, breast atrophy, and kidney malfunctioning.

Still, compared with hot flashes, it's got to be a winner.

(Source: Journal of the American Medical Association, 2003; 289: 2827-2834).


VIAGRA: Now would you like to take it for your prostate, sir? (Or: The Resourcefulness of the Drugs Industry, Part II)

Drugs are not always prescribed to treat the condition for which they were originally intended, or for which they earned their original licence. The latest to get the 'off-label' treatment is that great urban myth Viagra (sildenafil).  It was licensed to treat impotence, or erectile dysfunction (ED)-but now experts are looking for other conditions it can treat.  It's been mooted as a therapy for rapid ejaculation, lower urinary tract symptoms, and for those undergoing radical prostatectomies.

"With the efficacy and safety issues of sildenafil for erectile dysfunction basically settled, you need to explore new frontiers", said Harin Padma-Nathan, clinical professor at the University of Southern California, in a paper presented to the Annual Scientific Meeting of the American Urological Association.

This Star Trek-like adventure, to boldly go where the drug hasn't been licensed to go, doubtlessly grabbed the imagination of all who read these heroic words.

But once we've cleared the tears from our eyes, some of Prof Padma-Nathan's comments might make a Vulcan blush.  It's interesting he considers the safety issues to have been settled.  It is a view with which the Israeli drug regulators may take issue as they banned the drug because of its dubious safety record.  It might also cause consternation in the homes of the men who died after taking the drug.

But these are the mere twitterings of a sourpuss.  Warp factor nine, Scottie, the drug can take it (even if the public can't).

* And here's a funny thing.  'All-natural' herbal products that also claim to treat penile dysfunction are allowed on the American market by the drug regulator, the Food and Drug Administration (FDA).  But the FDA will swoop if they discover the products contain Viagra.  Perhaps the FDA knows something that Prof Padma-Nathan doesn't.

(Source: Journal of the American Medical Association, 2003; 289: 2784-6).


ALZHEIMER'S: Now let's try an arthritis drug for it (Or; The Resourcefulness of the Drugs Industry, Part III)

Most of us know that there's very little similarity between arthritis and Alzheimer's disease, other than the fact that they both start with the letter 'a'.

The drugs developed to treat them are likewise dissimilar.  Common drugs for treating arthritis, for example, are the NSAIDs (nonsteroidal anti-inflammatory drugs), which, as their name suggests, try to reduce swelling and inflammation, so easing pressure on arthritic joints.  An increasingly popular anti-inflammatory is the COX-2 inhibitor, designed to be kinder to the stomach.

It's hard to see, therefore, why some therapists are beginning to treat mild, early-stage Alzheimer's with an NSAID or a COX-2.  The only likely reason is the belief that Alzheimer's is, in some way, an inflammatory disease.

But researchers have tested the theory, and found it wanting.  They tried tested the NSAID naproxen and the COX-2 inhibitor rofecoxib against a placebo on 351 patients. They found that neither drug was any better than the placebo in slowing the progress of the disease over a year.  Worse, many of those on one of the drugs suffered at least one adverse reaction, such as hypertension, fatigue or dizziness.

So, in short, they were worse off while taking one of the arthritis drugs.

(Source: Journal of the American medical Association, 2003; 289: 2819-26).
 

http://www.nytimes.com/2004/06/06/opinion/06SUN2.html
New York Times

When Drug Companies Hide Data

Published: June 6, 2004

Mr. Spitzer has now taken on pharmaceutical companies that suppress data showing their drugs to be useless or possibly even dangerous.

http://www.nytimes.com/2004/06/27/business/27DRUG.final.html

June 27, 2004
As Doctors Write Prescriptions, Drug Company Writes a Check
By GARDINER HARRIS

he check for $10,000 arrived in the mail unsolicited. The doctor who received it from the drug maker Schering-Plough said it was made out to him personally in exchange for an attached "consulting" agreement that required nothing other than his commitment to prescribe the company's medicines.

http://www.billingsgazette.com/index.php?id=1&display=rednews/2004/08/10/bui
ld/state/60-doc-law.inc
Billings Gazette, MT
August 10, 2004

Doctor reporting law proposed

By CHARLES S. JOHNSON
Gazette State Bureau

HELENA - Democratic gubernatorial candidate Brian Schweitzer said Monday he will push for a new state law requiring pharmaceutical companies to disclose all payments, gifts and subsidies of more than $100 they make to Montana doctors and health-care providers.
 

Iowa Doctors Say No to Drug Companies

By Associated Press

January 24, 2005, 8:11 PM EST


CEDAR RAPIDS, Iowa -- A group of doctors say they'll no longer accept free coffee mugs, pens or other trinkets and free lunches from pharmaceutical representatives in an effort to keep their brand names in view, along with hopes the doctors will prescribe the drugs. "It's just plain ethically wrong and it's designed to color our judgment," Dr. Dean Abramson of Gastroenterologists P.C. said of the practice. "I don't think patients realize how much drug companies spend on this."

According to a report by the California Public Interest Research Group, U.S. spending on "detailing" efforts by drug representatives to reach doctors directly totals nearly $5 billion annually, costs that are passed on to consumers. A notice posted at the Cedar Rapids office notes the "exorbitant" price patients pay for drugs, adding: "Although we are fully aware that discontinuing our lunches will not lower this cost, we feel it is necessary for our company to do so."

The American Medical Association guidelines, which govern what doctors can accept, include items valued under $100 and the lunches drug representatives bring to office staffs. The six Gastroenterologists P.C. doctors voted last month to no longer accept the trinkets and lunches or meet with drug representatives who come to the office. Pharmaceutical companies bring speakers to the dinners to provide physicians with the latest health information. But Abramson sees it differently. "It's a bribe," he said.

If doctors across the country chose to no longer accept the lunches and gifts, it might make a difference, Abramson said, adding "I'd like to see doctors everywhere say, 'We don't need a free lunch.'"

Drug industry officials disagree.

Ed Sagebiel, spokesman for Eli Lilly & Co., the maker of Prozac, said the pharmaceutical company spends more on research and development in one week than it does in a whole year on advertising. According to the Pharmaceutical Research and Manufacturers of America, the pharmaceutical industry invested an estimated $33.2 billion in 2003 to develop new treatments for diseases, or nearly 18 percent of domestic sales on research and development, a higher ratio than any other U.S. industry. Sagebiel said what Gastroenterologists P.C. has done is rare; most doctors value the role sales representatives play in providing useful product information.

http://www.newsday.com/news/nationworld/wire/sns-ap-no-more-freebies,0,465351
5.story?coll=sns-ap-nationworld-headlines

 

Posted on Wed, Dec. 21, 2005
A sneaky handout to makers of vaccines
SENATOR'S PROPOSED LIMIT ON LIABILITY HAS NO PLACE IN A DEFENSE-SPENDING BILL
Mercury News Editorial
Merry Fristmas, drug manufacturers.
In the dead of the night Sunday, Sen. Bill Frist, R-Tenn., used his power as Senate majority leader to attach liability protections for pharmaceutical companies making flu vaccines to the Defense Appropriations Bill, which funds military operations in Iraq and Afghanistan. If you are struggling to see the connection between liability protections for vaccine makers and military funding, join the growing line.
But Frist knows lawmakers won't dare vote down funding for military spending in Iraq -- not in a time of war. By linking immunity for the drug industry to military spending, he provides the surest guarantee that the legislation will make it to President Bush's desk to be signed into law. By the time Republican lawmakers finished adding to the defense bill, everything but the proverbial kitchen sink was tacked onto it, including the controversial oil drilling in the Arctic National Wildlife Refuge (ANWR) and emergency relief funds for Hurricane Katrina relief victims.

Sen. Dianne Feinstein, one of the Senate's most reasonable voices, vowed to lead the fight against the inappropriate provisions -- as well she should. Her first goal should be to oppose a vote to limit debate on the defense-appropriations bill. Then she should insist that the Senate follow its rules on when and how measures can be attached to appropriations legislation. The issues should be debated on their merits.

The problem for Frist is he knows the legislation won't stand up to that degree of scrutiny. The senator's intent is well-meaning. The United States needs to ramp up production of new vaccines to protect Americans against the next pandemic, and the vaccine business isn't very profitable. But severely limiting Americans' ability to seek redress for negligence is the wrong way to go about it. Especially when Frist compounded the problem by failing to provide a funding source for the weak compensation program established by the legislation. The United States should offer suitable financial incentives for drug manufacturers to ensure enough long-term profitability that they will begin ramping up vaccine production to meet the nation's future needs. And the Senate should work next year on an immunization against viruses attached to future defense-appropriation bills.

http://www.mercurynews.com/mld/mercurynews/news/opinion/13455612.htm
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http://www.healthcentral.com/newsdetail/408/532110.html


Many Researchers Break the Rules: Study Pressures in and outside lab may be to blame, experts say.

By Amanda Gardner
HealthDay Reporter

THURSDAY, April 13 (HealthDay News) -- If you think the average scientist ain't misbehavin', think again. A new study has found that scientific misbehavior appears to be endemic and is occurring far more often than just the more egregious, media-hyped examples, such as faking research.

"Not all scientific misconduct is these gross violations like falsifications, plagiarism and fabrication," said study lead author Raymond De Vries, an associate professor of medical education and a member of the Bioethics Program at the University of Michigan in Ann Arbor. "A lot of us aren't making up data and stealing data," he said. However, he believes that intense competition within the sciences is having a negative effect on researchers.

"Many scientists are worrying more about little things that go along with working in the lab," De Vries said, "like how do you interpret your data, how do you stick with the increasing number of rules in science, how do you deal with the increasingly intense competition for rewards that are staying
more or less the same as we're producing more and more scientists?"

De Vries is lead author of the research that appears in the premier issue of the Journal of Empirical Research on Human Research Ethics. A second paper in the same journal, for which De Vries is senior author, looked at "organizational justice." It found that scientists who believe they are
being treated unfairly are more likely to behave in ways that push the envelope of integrity.

But it's been flagrant instances of falsification and plagiarism that have made headlines recently.

The downward tailspin in science gathered speed early this year, when it was revealed that two studies detailing South Korean researcher Hwang Woo-suk's supposed "breakthroughs" with stem cell cloning were faked. That was preceded by the revelation in December that Merck employees had
withheld critical data about heart attacks in a landmark trial involving the now-banned cox-2 inhibitor, Vioxx.

And, most recently, a paper that first appeared last October showing that non-steroidal anti-inflammatory drugs (NSAIDs) reduced the risk of oral cancer, turned out to be completely false. The database of 908 study participants itself was fabricated, with 250 of the people sharing the same
birth date. The author of that study, Dr. Jon Sudbo, of the Norwegian Radium Hospital in Oslo, Norway, has now also confessed to faking data for mouth-cancer studies published in 2004 and 2005.

But what of indiscretions occurring outside of the media spotlight?

For this study, De Vries and his colleagues conducted six focus groups with a total of 51 researchers culled from top U.S. research universities. Participants said they were more concerned with mundane, everyday problems that seemed to fall into four categories: the meaning of data, the rules of
science, life with colleagues and the pressure to produce. "After the focus groups, we felt like we had been at a confessional," De Vries remarked. "We didn't intend this, but the focus groups became a place where people could unburden themselves."

One young scientist up for her master's degree was advised by an external examiner to "chop off the last two data points." Another participant told of a famous scientist who wrote unflattering letters of recommendation for students he liked (so they would never leave his lab) and accolades for students he hated (so someone else would hire them). Other problems mentioned included manipulation of the peer review system, exploitation of junior colleagues, unreported conflicts of interest, stealing of ideas and withholding of data.

In the second study, a national sample of 4,367 National Institutes of Health-funded scientists were asked to review a list of 33 behaviors identified in the focus groups and indicate if they had engaged in any of the behaviors, or if they had seen another scientist engage in them during the past three years. Results of the national survey corresponded well with the focus group results, the authors stated.

According to De Vries, it's the organizational culture, not individual foibles, that are ultimately responsible for these transgressions.

Others agreed.

"One of the issues we're going to have to address is institutional culture, which makes it easier for such behavior," said Adil Shamoo, professor of biochemistry and bioethics at the University of Maryland, Baltimore and editor-in-chief of the journal Accountability in Research. "Institutions
haven't really dealt with these issues in a forthright manner. They're closing their eyes to it, or only opening them slightly." "Our top research institutions brag about the amount of money they bring in, not the amount of new knowledge," Shamoo said. "It's really disturbing."

"What can we do institutionally to help reduce both the misdemeanors and the temptation to cross lines and how do we inculcate virtue in practitioners?" added David Magnus, associate professor of pediatrics and director of the Stanford Center for Biomedical Ethics. "How do we make sure ethics is
integrated into the practice of science?"

http://www.nytimes.com/2007/05/09/business/09anemia.html?