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."

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