NIH in the spotlight over conflicts of interest

Abstract

On September 23, National Institutes of Health (NIH) Director, Elias Zerhouni, announced a 1 year moratorium on any NIH employee participating in paid consultancy work for the biotech or pharmaceutical industry. This is the latest move by Zerhouni to counter escalating concern that NIH researchers are supplementing their income with consultancy payments from drug companies. Investigations were sparked by a news story reported in the Los Angeles Times in December last year, which alleged that researchers at several NIH institutes had received consultancy payments from outside sources that could inappropriately influence their research. The Los Angeles Times story opens by recounting an incident 5 years ago when a participant in a clinical trial of a treatment for kidney inflammation died from an adverse reaction. According to the news story, the director of the NIH institute at which the study was being done was a paid consultant for the company that manufactured the drug. The news story goes on to reveal alleged financial conflicts for several senior researchers at various NIH institutes. Many people have questioned how—in the light of such huge potential conflicts of interest—the American public can maintain their faith in the integrity of clinical research at NIH. Zerhouni's immediate response to the article was to set up a Blue Ribbon committee to review NIH's policies on conflicts of interest and to provide recommendations for their revision. The panel's report, published in May, lists 18 recommendations (http://www.nih.gov/about/ethics_COI_panelreport.pdf). Among these, the panel recommended that all senior management and extramural employees should not engage in any paid consultancy activities and intramural scientists involved in research on human beings should not have any financial involvement with companies whose interests could be affected by their research. In June, the House Energy and Commerce Committee's oversight and investigations subcommittee presented the findings from their own investigation: after asking 20 drug companies to provide records of payments to NIH researchers, about 100 agreements were brought to light that did not appear on NIH's records. One example is a researcher at the National Institute of Mental Health who is thought to have received over half a million dollars in consultancy fees, honoraria, and expenses from Pfizer since 1998. In light of these findings, Zerhouni—who had previously defended the consultancy activities of NIH staff—announced a ban on senior researchers participating in paid consultancy activities, a ban that has now been extended to all staff. The deficiencies in NIH's current conflicts of interest policy stem from the reign of Harold Varmus, Zerhouni's predecessor. In 1995, Varmus changed NIH's policies such that there was no limit on the amount of money employees could earn from outside activities and removed the ban on senior staff doing paid consultancy work. Some scientists welcome Zerhouni's moratorium and a return to the pre-1995 policies, hoping that NIH will now develop a clearer policy that leaves employees in no doubt of the rules. Others fear that if the moratorium becomes more than a temporary measure, such extensive restrictions on the interaction between academic and commercial research will choke important scientific advances. In addition, NIH may find it harder to attract top scientists if they cannot supplement their income with consultancy fees. One feature of financial conflicts that is often overlooked is the potentially limitless source of revenue from patent royalties. Indeed, Zerhouni's Blue Ribbon panel recommends that “there should be no restriction on royalties … or income received from patents”. It is The Lancet Neurology's policy, and that of other journals, not to commission reviews or commentaries from authors who hold or are applying for patents related to the subject of their article. The reasoning behind this policy is that, like other finanical conflicts, an author's objectivity may be blurred by the ownership of intellectual property. Is this policy fair to the academic researcher who is merely safeguarding their discoveries? Let's look at it from the standpoint of a patient in a clinical trial. Would you be any more comfortable knowing that the study investigator had a patent on use of the trial drug for treatment of your disease than if that investigator had been a paid consultant for the trial sponsor? A new study—the Conflicts of Interest Notification Study—has recently begun at Johns Hopkins University to help establish policy and practice on how to disclose potential conflicts of interest to participants in clinical trials. Although conflicts of interest are a major worry for Zerhouni and NIH, and a regular headache for journal editors, the most important consideration is to ensure the safety of patients in clinical trials.