Admirable resistance to drug company influence claimed by AIDS researchers
Critics of the overwhelming commercialisation of scientific and medical research fear that human nature will fail to resist the influence on judgement involved. Can scientists and researchers remain impartial in assessing drugs when they have pocketed payments from the companies that make them?
A story on Oct 25 in the New York Times was interesting for the fact that the reporter, Nicholas Bakalar, upon reading in Nature a report that caught many researchers with their hand in the till, as it were, actually called up one of them and asked him what he thought he was doing.
Since the gentleman concerned was a prominent AIDS researcher, we were interested in his answer:
The survey cited clear instances of potential conflicts. Dr. Paul Volberding, a well-known AIDS researcher, led a panel that produced guidelines for the treatment of anemia in H.I.V.-positive patients. Ortho Biotech, the maker of the drug, organized the conference and paid the expenses for the panel.
According to the report in Nature, all six members of the group, including Dr. Volberding of the University of California, San Francisco, had previously accepted consulting or lecture fees from the company.
The guideline, published on May 14, 2004, in Clinical Infectious Diseases, recommends the use of epoetin alfa for H.I.V.-positive patients with anemia. It is distributed by Ortho Biotech under the brand name Procrit.
”It’s appropriate to be cautious with any pharmaceutical company involvement in research or, certainly, in the publication of guidelines,” he said.
Where a single company and a single product are involved, he added, ”caution should increase.”
Dr. Volberding said in a telephone interview that the potential for bias always existed.
The answer he and others have to the suspicion that they might be biased by their cosy relationship with the hand that feeds them, and be unlikely to bite it, is that if the relationship is not denied or concealed, all is well.
Dr. David A. Kahn, a professor of psychiatry at Columbia who has worked on several industry-financed guidelines, said he shared Dr. Volderbing’s confidence that industry sponsorship did not necessarily lead to bias.
”It can be addressed to some degree with full disclosure of the relationship to the company,” he continued. ”There would be serious concern if this were in any way hidden.”….
This is an interesting position, in our view roughly equivalent to saying that if a group of journalists is transported in a ‘junket’ to Portugal, say, via the Portuguese national airline, and put up in the splendid ‘pousadas’ there (monasteries with eight foot thick walls which have been turned into luxury hotels with excellent food), and taken around to a pick of the landscapes, castles, restaurants, and nightspots of that country, all without any cost in money or preparation, they are just as likely to come back to the US and write an impartial guide to Portugal as a tourist destination as any independent reporter whose visit is expensed by the Times Travel section.
Maybe Dr Kahn would believe it, but thousands would not. In fact, the Times would not. At a panel held two weeks ago (Oct 18 Tues) by the Center for Communication in New York City, Stuart Emmrich, the editor of the Travel section of the Times, startled the audience by telling them that any travel writer who had ever been on a junket would not be given an assignment by the Times. Ever.
This absurd statement was objected to vociferously by several members of the audience and even a fellow panelist. However realistic it might have been in that context (not too many freelancers have the means to write about travel without ever going on a junket) it was certainly inconsistent with the easy moral self indulgence of the main sources in talking to Bakalar.
What a pity that Nicholas did not go on to explore the ramifications a bit further. But we already know enough, perhaps. That is, by their own testimony these stalwart actors in the upper echelon of research who advise on which drugs to use are not easily influenced by the open purses of the drug makers.
No, sir.
Click (show) for the whole short story to display:
Potential Conflicts Cited In Process for New Drugs
By NICHOLAS BAKALAR (NYT) 649 words
Published: October 25, 2005
The authors of the guidelines widely used to establish standards for prescribing medicines are often paid by the drug companies whose products they discuss, a new survey has found.
The study, by the journal Nature and published in its Oct. 20 issue, found that more than one-third of the guideline authors acknowledged some financial interest in the drugs they recommended, including owning stock and being paid by the company to speak at seminars.
Almost half the published guidelines, the survey found, included no information about potential conflicts.
In half of the more than 200 guidelines examined, at least one author had received research financing from a relevant company, and 43 percent had at least one author who had been a paid speaker for the company.
Thirty-four percent of guidelines explicitly stated that their authors had no conflicts of interest at all.
The survey examined guidelines deposited last year with the National Guideline Clearinghouse, a database maintained by an agency in the Health and Human Services Department that summarizes and evaluates the documents. The database relies on the guideline authors for information about potential conflicts.
The survey cited clear instances of potential conflicts. Dr. Paul Volberding, a well-known AIDS researcher, led a panel that produced guidelines for the treatment of anemia in H.I.V.-positive patients. Ortho Biotech, the maker of the drug, organized the conference and paid the expenses for the panel.
According to the report in Nature, all six members of the group, including Dr. Volberding of the University of California, San Francisco, had previously accepted consulting or lecture fees from the company.
The guideline, published on May 14, 2004, in Clinical Infectious Diseases, recommends the use of epoetin alfa for H.I.V.-positive patients with anemia. It is distributed by Ortho Biotech under the brand name Procrit.
Dr. Volberding said in a telephone interview that the potential for bias always existed.
”It’s appropriate to be cautious with any pharmaceutical company involvement in research or, certainly, in the publication of guidelines,” he said.
Where a single company and a single product are involved, he added, ”caution should increase.”
”It can be addressed to some degree with full disclosure of the relationship to the company,” he continued. ”There would be serious concern if this were in any way hidden.”
The anemia guideline specifies that the group’s consensus conference was ‘’supported by an educational grant from Ortho Biotech,” but it does not mention company payments to individual members.
Practice guidelines, written by ad hoc groups, specialty societies, companies and governmental agencies, have become important in recent years because of the demand for ”evidence based” practices based on expert opinion and the results of clinical studies.
The American College of Obstetricians and Gynecologists publishes a guideline on inducing labor, and the American Psychiatric Association publishes one for treating schizophrenia. Kaiser Permanente, the health management organization, publishes a lengthy guideline on treating diabetes.
Dr. David A. Kahn, a professor of psychiatry at Columbia who has worked on several industry-financed guidelines, said he shared Dr. Volderbing’s confidence that industry sponsorship did not necessarily lead to bias.
”Some of the funding was simply good will by companies with no strong link to any product likely to be highly recommended,” Dr. Kahn said. ”In other cases, the outcomes could be guessed at in advance based on known clinical evidence and anticipated sentiment, and the funding was designed to promote expected good news rather to influence its creation.”
In any case, Dr. Kahn said, researchers are generally ”making the best of a funding system controlled mostly by commercial enterprise.”
”That’s the market-driven system the American people have chosen to live within, and it has its pros and cons,” he continued.
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Qualified outsiders and maverick insiders are very often right about the need to replace received wisdom in science and society. This site exists to back the best of them in their uphill assault on the massively entrenched edifice of resistance to and prejudice against reviewing, let alone revising, ruling ideas. 