Transparency needed in drug researchers' finances
IN AN UNUSUAL move last month, the journal Clinical Infectious Diseases published a critique by 109 clinical researchers of an investigative report by David Willman of the Los Angeles Times. Willman had probed whether Thomas Walsh, a senior researcher at the National Institutes of Health, had manipulated a trial to give a new drug a better chance of succeeding. Willman's story also questioned whether a federal employee should be presenting data to the FDA on behalf of a drug company -- in this case
The researchers wrote that ``there is good reason to fear that public will conclude, on the basis of Willman's article, that the entire process of drug development in the United States and abroad is corrupt and that they should refrain from participating in clinical trials." Future patients, they say, ``might suffer as a result of Willman's irresponsible report."
What's missing, however, is the fact that last year, an NIH ethics report found Walsh guilty of ``serious misconduct" for accepting about $100,000 from 25 drug companies -- including Merck -- and not disclosing it, a violation of NIH rules at the time. Selected quotation, anyone? Those rules are now even stronger than they were before December 2003, when David Willman exposed rampant violations such as those by Walsh in December 2003. But Willman doesn't need me to defend him; he's a Pulitzer Prize winner, and his work speaks for itself.
The episode reminded me of another recent example of scientists coming to the aid of a colleague who they feared was unjustly maligned. When Thomas Butler, a plague researcher, was indicted by the federal government on a number of charges, including fraud and improperly shipping samples of the bacterium that causes plague to Tanzania, scientists rallied to his cause, saying the government's prosecution was heavy-handed. Three charges were that he did not describe the contents of the Federal Express plague package in detail, that he did not attach a hazardous materials warning, and that he did not obtain a Department of Commerce permit for it.
Butler served 19 months of a two-year sentence before being released in late 2005. Again, judge the merits of the case for yourself. But I wonder whether Butler's supporters had ever considered the
If scientists want to have a robust debate over NIH guidelines on conflicts and rules over shipping biohazards -- debates they're almost certain to lose, given the current scrutiny of research and the attention to bioterrorism threats -- let's have it. So far, the debate in congressional subcommittees over NIH guidelines has strengthened the conflicts of interest policy, not relaxed them. But I don't think scientists want to have that debate. Instead, they want to praise Walsh's and Butler's research as saving the lives of innocent children -- hard to argue with that, actually -- and suggest they're above the law. And I just don't see how that attitude strengthens clinical trials.
Unfortunately, the Clinical Infectious Diseases screed's omission of Walsh's financial relationship with Merck and other companies is consistent with how clinical researchers seem to feel about disclosure. A survey published in the Journal of Law, Medicine, and Ethics of clinical researchers' attitudes on conflicts of interest included this mind-boggling response: ``Let's say . . . we do a dozen studies for [Company X] . . . and it is a $2 billion company. . . Let's say that I owned a lot of stock in [Company X]. I mean, the application of a new drug to the company, let alone our ability to participate in that drug, would not affect that one iota. So, as far as I am concerned, conflict of interest is overblown." Message received: Researchers know best. Please stop bothering us with these silly rules and your sensationalist investigations.
Sorry, neither Willman's irresponsible report nor the government's alleged heavy-handedness in trying to protect the public are going to hurt patients. What is going to hurt clinical research and patients is the continued lack of transparency by a number of researchers. Like most Americans, I'm a strong believer in the importance of research, clinical trials, and the role of drug companies in improving the public health. But I'm also a strong believer in disclosure. When someone hides something, I want to know why. If there's nothing wrong with financial relationships between researchers and drug companies, why not disclose them?
Dr. Ivan Oransky is deputy editor of The Scientist. 
