Those Who Hold the Gold Make the Rules¹
In 2002-2003 The Los Angeles Times reported in a series of articles that senior NIH scientists were also industry consultants, paid in fees, stock, and options for their moonlighting. According to the series, the compensation was often permissible under lax agency regulations, however more often the scientists didn't disclose the income as required by the NIH. Congress followed the paper's reports with their own investigations. Then, an internal NIH review released in 2005 found that in 44 of 81 cases, NIH researchers who worked in industry did not follow the agencies' internal ethics rules.
The investigations triggered a debate over what industry activities should be allowed by public agency scientists, a debate that continues to roil today. Some of the NIH turmoil over ethics evolved naturally as a result of a changing research environment and changes in the nature of relationships between public and private research. The NIH tried to accommodate these change and ease concerns about the agency's ability to hire the most desirable candidates in 1995 under NIH head Harold Varmus. The organization loosened the rules, allowing employees to accept industry stock, options and consulting fees, but limiting the income to $25,000 and outside work to less than 500 hours per year. A mere seven years later the investigations revealed that certain scientists had pried open this chink of opportunity and defined their own, much more lucrative ethics boundaries, thus compromising an agency dedicated to deciding science objectives in the public interest.
In 2005, in the wake of the unfavorable media coverage and congressional investigations, the NIH proposed new rules to limit NIH scientists from any consulting engagements or stock ownership². However when the NIH announced the rules, some NIH scientists mounted a strong defense, hiring lawyers and lobbyists to fight the proposal and forming an inter-agency committee called the Assembly of Scientists to promote their own vision of ethical research. In what looked like a compromise to the lobbying efforts both inside and outside the agency, the NIH backed away from the most "draconian" limitations, but still barred certain consulting engagements and stock ownership.
The rules did not quell the concern over conflicts of interest. Today, some people say that the NIH rules are flagrantly ignored and that the agency fails to impose penalties on those who flout the limits. Congress held a panel discussion on the issue in September 2006, their 6th such meeting since the scientists activities were uncovered. Representative Joe Barton, Chairman of the House Energy and Commerce Committee noted that to date, none of "over 100 individuals identified by the NIH" for violating NIH policies had been terminated.
By the end of last year however, a couple of researchers had at least been reprimanded. One of those researchers was Pearson "Trey" Sunderland III, chief of the geriatric psychiatry branch of the National Institute of Mental Health and an Alzheimer's disease researcher, who was identified in the initial investigation. Sunderland had transferred spinal tissues stored at the NIH to Pfizer under a private contract he made with the company. Investigators never determined whether his consulting fees included payments for the "thousands" of NIH samples he gave to the company. But last month, he pled guilty to misdemeanor charges in federal court for failing to disclose payments of $285,000 that he had received for his consulting with Pfizer, although originally investigators alleged that he had accepted over $600,000 in payments. Sunderland was sentenced on December 22nd 2006 to two years of probation, 400 hours of community service and a restitution payment of $300,000. He could have been sentenced to a year in jail. He was never charged for transferring tissue samples. Some think that Mr. Sunderland was let off easily. Sunderland worked at the NIH throughout the investigation. He continued to benefit from agency perks and last year was offered a $16,000 retention bonus. However in his courtroom statement at the sentencing he said that he was "humbled".
Another publicized case was that of a pediatric oncology doctor, Dr. Thomas J. Walsh. The NIH found that Dr. Walsh had violated agency rules in at least 38 instances and had accepted over $100,000 in consulting fees from pharmaceutical companies. The doctor also promoted certain antifungal drugs for patients despite debatable evidence of efficacy, and industry affiliations that some scientists felt biased his recommendations . The LA Times delineated Dr. Walshes alleged offenses in July of last year in a damning article. The excorciation prompted a hearty rebuttal from many of Dr. Walsh's peers.
Both doctors are highly respected, have published widely, and have been with the NIH since the 1980s. They are also part of U.S. Public Health Service Commissioned Corps. The NIH has said that they have no authority over how discipline is meted out, however some members of Congress are incensed over the NIH's inaction. The September panel attempting to untangle the ethics mess was disheartened by the NIH's progress cleaning up its organization. Said Barton , "This is really an ethical Potemkin village, where a hollow system appears to provide the illusion of integrity, but transgressors never leave."
Four Out of Five Doctors Recommend Taking....
While the resolution of past conflicts of interest is murky, perhaps a change in political leadership in Washington will nudge the NIH in a more disciplined and transparent direction. A few days ago, the NIH canceled a meeting for February 23, scheduled for scientists to discuss policy for pregnant women for herpes.
The cancellation, that commentators uniformly characterized as "abrupt", followed a front page Wall Street Journal article on a nationwide education campaign that GlaxoSmithKline organized on pregnancy and herpes. GlaxoSmithKline markets Valacyclovir hydochloride, a patented oral anti-viral drug that is converted to internally converted to acyclovir. Acyclovir is an older antiviral which is also effective against the virus that came off patent in 1997. The company paid doctors to speak at conferences in hospitals across the US and advocate that all pregnant women be for herpes. Dr. Zane Brown, one member of the five person team chosen for the NIH herpes panel, is a University of Washington doctor who the company paid $1,000 to $2,500 per lecture, two or three times per week.
If testing were required it would naturally lead to more women being treated and more drug sales. But the studies have shown that the practice would be costly, with insufficient patient benefits. Furthermore the side effects and potential hazards for babies is unknown. The FDA hasn't approved the drug for use in neonatal herpes, however that doesn't prevent doctors from prescribing it, or giving lectures about the possible benefits.
According to Citizens for Science in the Public Interest, Four of the five panel members, including Dr. Zane, had financial ties to companies or organizations with interest in herpes drugs. A letter from 44 physicians and 16 health groups, including Lancet editor Richard Horton and two former New England Journal of Medicine editors, Marcia Angell and Jerome P. Kassirer, "called on director Elias A. Zerhouni to adopt an agency-wide rule prohibiting scientists with financial conflicts of interest from sitting on guideline-writing panels".So the NIH canceled the meeting following media coverage and public protest over what looked like an egregious effort by biased scientists to promote industry friendly policy.
It's not clear what lies ahead for herpes testing, but the increasingly pro-business environment in Washington perhaps coincides with an increase in pharma opportunities for NIH employees. As more and more doctors and researchers take advantage of lucrative opportunities to supplement their income working for pharmaceutical companies, government agencies have greater difficulty finding recognized experts who come without pharmaceutical associations -- or who even look like their unbiased enough to serve in policy decision making roles.
Medical research and treatment is certainly not the only area where colliding interests chafe along a hazy line between public interests and business interests, however in public health issues, the stakes are particularly high for both sides. But despite the consequences of appearing to let pharma have undue influence on public policy, it's unclear that the current paradigm will be changed.
----------------------------------
¹This article was edited and re-published January 30, 2006
²Acronym Required commented on the proposed rules here.
