On Thursday, Dr. José Baselga resigned from his position as chief medical officer at Memorial Sloan Kettering Cancer Center. Earlier this month, ProPublica and The New York Times revealed that he’d received millions of dollars from drug and device companies whose fortunes he stood to affect. He also sat on the board of at least six companies, where his fiduciary responsibility to them might conflict with his obligations to the cancer center. Most of his outside income was not disclosed to the journals in which he published, in violation of their requirements.
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Baselga "se oculta" del fisco (USA)
I was an editor of The New England Journal of Medicine for over two decades, and was there in 1984 when we became the first major medical journal to institute a policy that required authors of research articles to disclose all financial ties to companies that could be affected by their research. We had become aware that academic researchers were receiving large payments from drug companies and that it was distorting their work. For example, I once phoned the senior author of a paper submitted to us to ask why he had neglected to mention the side effects of a potent new drug he was testing. Without any apparent embarrassment, he said that the sponsor wouldn’t let him. We didn’t publish the paper, but another journal did.
In order to get prescription drugs approved by the Food and Drug Administration, companies must conduct clinical trials to show that the drugs are safe and effective. But drug companies don’t have direct access to human subjects, so they’ve always contracted with academic researchers to conduct the trials on patients in teaching hospitals and clinics. Traditionally, they gave grants to the institutions for interested researchers to test their drugs, then waited for the results and hoped that their products looked good. The grants were at arm’s length; the companies didn’t design or analyze the studies, they didn’t own the data, and they certainly didn’t write the papers or control publication.
That began to change in the 1980s, partly as a result of a new law that permitted researchers and their institutions, even if funded by the National Institutes of Health — that is, the taxpayers — to patent their discoveries and license them exclusively to drug companies in return for royalties. That made them business partners, and the sponsors became intimately involved in all aspects of the clinical trials.
It also gave the drug companies direct access to highly influential physicians, like Dr. Baselga, known to the industry as key opinion leaders. These are the people who write textbooks and medical journal articles, issue practice guidelines, sit on the F.D.A. and other governmental advisory panels, head professional societies and speak at the innumerable meetings and dinners where clinicians are taught about prescription drugs. Having key opinion leaders on the payroll is worth every penny a drug company spends.
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KOL´s en PHARMACOSERIAS
Ratón de Biblioteca: K.O.L. (Líder de Opinión) / Rafael Sepúlveda Blanes
What do they get for their money?
- First, there are the intangibles. It’s human nature to feel warm toward people with whom one collaborates closely, particularly when they’re so generous, and key opinion leaders become a sort of informal sales force.
- Second, there’s good evidence that drug company involvement biases research in ways that are not always obvious, often by suppressing negative results. A review of 74 clinical trials of antidepressants, for example, found that 37 of 38 positive studies — that is, studies that showed that a drug was effective — were published. But 33 of 36 negative studies were either not published or published in a form that conveyed a positive outcome.
Bias can also be introduced through the design of a clinical trial. For example, the sponsor’s drug may be compared with another drug administered at a dose so low that the sponsor’s drug looks more powerful. Or it can be compared with a placebo, when the relevant question is how it compares with an existing drug. In short, it’s often possible to make clinical trials come out the way you and your sponsors want.
Disclosure is better than no disclosure, but it does not eliminate the conflict of interest. It’s simply a way of saying caveat emptor, and leaving it to readers to decide whether the research was biased. But most people — even doctors and science reporters — aren’t really equipped to make those judgments, particularly when data are suppressed.
I would suggest two reforms.
- First, researchers at academic medical centers should not accept any payments other than research support from drug companies, and that support should have no strings attached — no control over the design, interpretation and publication of trial results. We should go back to arm’s length grants.
- Second, doctors should not accept gifts from drug companies, even small ones, and they should pay for their own meetings and continuing education, as is standard in other professions. They can afford it.
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Pagos d la Industria: Los conflictos de intereses y su efecto en Rx...
In the meantime, those of us who read these studies should remain skeptical about them until several different trials reach the same result.
The indignation about Dr. Baselga is justified. But the fact that other physicians disclose their myriad conflicts of interest does not solve the underlying problem. Collaboration with industry can lead to important scientific contributions, but we should not let drug companies buy the hearts and minds of researchers. The cost of this is high, and not just in drug prices. It means both doctors and patients believe prescription drugs are better and safer than they really are. (Ver)
Marcia Angell, a member of the faculty of global health and social medicine at Harvard Medical School and former editor in chief of The New England Journal of Medicine, is the author of “The Truth About the Drug Companies.”
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