The National Institutes of Health (NIH) has been stung in recent years by numerous reports of financial conflicts of interest (COI) involving staff scientists and drug, biotech, and medical device companies. Now its attention is turning to similar misconduct among its extramural grant recipients, typically scientists at universities and non-profit research institutes.
NIH Director Francis S. Collins, MD, PhD, said the agency would issue a Notice of Proposed Rulemaking by February in an effort to tighten relationships between industry and academic scientists who receive federal research funding.
Ongoing congressional investigations and several recent reports have highlighted weaknesses in the government’s oversight of grant recipients. One of the more prominent examples involved Charles B. Nemeroff, MD, PhD, chairman in 2008 of Emory University’s Department of Psychiatry, who did not report payments of hundreds of thousands of dollars from GlaxoSmithKline plc while receiving millions in NIH funding to study the effects of the company’s drugs. Dr. Nemeroff maintained the payments did not affect his research objectivity. He resigned his chair in 2008 and left the university last year.
“The integrity of biomedical research is something we must not compromise,” Collins told C-SPAN in December. “We have to tighten up on that. There is a process ongoing at NIH to put out some new ideas about how our grantee institutions and investigators need to be more forthcoming about disclosure.”
NIH awards more than $24 billion annually through almost 50,000 research grants to more than 325,000 investigators at more than 3,000 universities, medical schools, and other institutions in the U.S. and worldwide. At present, NIH generally leaves it to each grant-receiving university and institute to identify and manage financial conflicts among its researchers. These institutions in turn rely on the individual scientist to determine if a financial conflict exists related to his or her research.
The current threshold for reporting is $10,000 for income and 5% for company stock ownership. Even after a disclosure has been made, however, institutions rarely take action to reduce or eliminate it, according to a November 2009 audit by Daniel R. Levinson, inspector general (IG) of the Department of Health and Human Services (HHS), which oversees NIH.
“It will certainly be quite a change from the way that NIH has, in the past, largely left [managing conflicts] to institutions,” Collins said. “Now NIH is going to want to have a lot more information about what its investigators are up to as far as any potential conflicts.”
Among other things, NIH is considering expanding the scope of COI regulations to cover researchers who receive Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants; reduce the minimum financial thresholds for reporting; and require all those involved in human subjects research to disclose all outside financial interests, regardless of amount, according to a request for comments published last May.
In January, NIH imposed tougher disclosure conditions on Baylor College of Medicine after determining that university officials failed to report a potential conflict involving a staff cardiologist. Christie Ballantyne, MD, chief of atherosclerosis and vascular medicine at Baylor, received $34,000 in consulting fees from Merck & Co. while conducting NIH-funded research. While Dr. Ballantyne followed proper procedures, Baylor failed to report the disclosure to NIH. The agency now requires Baylor to provide more specific assurances on its grantees.
Taking it on the chin
The pharmaceutical industry has been taking it on the chin for such previously common practices as support for continuing medical education (CME), speaker fees to physicians and the ghostwriting of scholarly articles, a practice that Sen. Charles Grassley (R-Iowa)—a sharp critic of industry-physician ties—has compared to plagiarism.
An April 2009 report by the Institute of Medicine, part of the National Academy of Sciences, recommended doctors stop accepting free drug samples, food, medical refresher courses, and speaking payments from drug companies. It also called for legislation requiring drug and device manufacturers to publicly disclose all physician payments. Sens. Grassley and Herb Kohl (D-Wis.) have cosponsored legislation to require that, even as some companies, including Merck & Co., Eli Lilly and Co., GlaxoSmithKline, Pfizer Inc., and Medtronic have already voluntarily begun or plan to start publishing such information.
Two Harvard Medical School teaching hospitals in January restricted outside pay to senior physicians who serve on corporate boards. The doctors may still be paid up to $5,000 per day for their services, but can no longer accept stock or stock options as payment. Other institutions, including Johns Hopkins, Stanford, Northwestern, and the Cleveland Clinic have said they would disclose the names of their physicians with financial ties to drug and device manufacturers.
The translation of research discoveries into clinical practice is strongly affected by a “complex web of relationships” among industry, academia, medical educators, and clinicians, with “growing evidence that each strand of this web is compromised by ethical lapses and financial conflicts of interest,” wrote 100 researchers and medical ethicists in a Nov. 17 letter to Collins, asking NIH to fund studies on conflicts of interest in medicine and research.
It’s not only NIH that is experiencing conflict of interest problems. In December, the HHS IG reported that the Centers for Disease Control and Prevention (CDC) did a poor job in reviewing and approving conflict of interest disclosures submitted by government employees who sit on CDC advisory panels, such as for vaccine safety. In 2007, the audit found, CDC failed to identify or resolve conflicts of interest for 64% of employees who submitted disclosure forms. Thirteen percent failed to even have appropriate forms on file, and 3% voted on matters that ethics officers had previously barred them from considering. CDC in response promised to improve training.
Ironically, all this attention comes at a time when industry-academia partnerships appear to be on the decline. A survey published in the November 2009 Health Affairs journal found that only 20% of 3,080 faculty members at the top 50 NIH-funded universities reported having some kind of industry relationship in 2007, compared to 28% of faculty who reported having similar relationships in 1995.
About the Author
Contributing editor Ted Agres, MBA, is a veteran science writer in Washington, DC. He writes frequently about the policy, politics, and business aspects of life sciences.
This article was published in Drug Discovery & Development magazine: Vol. 13, No. 1, January/February, 2010, pp. 10-11.
Filed Under: Drug Discovery