Well – I spent the afternoon in research integrity heaven listening to exceptional plenary lectures on conflict of interest in biomedical research by Sheldon Krimsky (Tufts) and Catherine DeAngelis (JAMA editor). Both presentations were thoughtful and thought-provoking and delivered with delightful enthusiasm. Both noted with concern the rise of COI issues starting in the mid-80s and escalating to near daily headlines in current times.
Dr. Krimsky (Corporate Sponsorship of Public Science: Are They Reconcilable? … with a running banner of Corrupted Science) discussed ghostwriting, manufactured science, suppressed science, and manipulated science. He discussed how big pharma is a vertically integrated industry (perhaps the best), with penetration to consumers as young as 6 years old (drug ads in kindergarten Scholastic magazines) up through the FDA. In a study he coauthored in 2006, he noted that 56% of contributors to the latest DSM (DSM-IV) had undisclosed financial conflicts of interests and that 100% of the members of expert panels preparing the chapters on Mood Disorders and Schizophrenia etc. had financial ties to the drug companies whose products were promoted in the DSM. Whoa.
Catherine DeAngelis (COI in Medical Research – Facts & Friction) reviewed the issues facing major medical journals and the scientific community overall with many up close & personal anecdotes. A few facts: 515 articles on COI in Medline in 2006 … published results of industry-funded research were 4x as likely to support the industry’s interests (JAMA 2003;289:454) … 59% of contributors to Practice Guidelines had financial ties to the products recommended in the guidelines (JAMA 2002;287:612) … roughly 20% of researchers delay publication 6 mo due to patent/IP protection issues, corporate pressure, etc. Some of the friction: delaying tactics with lawsuit threats involved (HIV Immunogen – JAMA 2000;284:2193) … deliberate lying (Celebrex – JAMA 2000;284:1247 & JAMA 2001;286:2398) … hide bad news (Vioxx – NEJM 2006;354:1193) … and much more. She now trusts no one and gets everything in writing – plus she turns down about $1.5M in advertisement and rejects many top articles that later appear in other journals because she is not satisfied with the disclosure provided.
With entrepeneurship now the “4th” mission of academic health centers (along with teaching, research, and clinical care), COI is a fact of life that cannot be avoided but must be managed … and not by the person with whom the COI lies. COI disclosure must be complete, detailed, prospective, and forward-looking (ie, if plan to invest two weeks after journal article accepted), and those responsible for monitoring COI & taking appropriate action must be completely separate from those seeking to benefit (through grants, tech transfer, licensing, etc.) from the research. Drs. Krimsky and DeAngelis agreed that a “National Institute of Drug Testing” of sorts should be created to design and implement all drug & medical device clinical trials (funded by industry through fees for independent trial service rather than by paying salaries, as currently happens at the FDA). And a comprehensive public database like clinicaltrials.gov should serve as a repository for all clinical trial results – the good, the bad, and the ugly.
I can sit up a little straighter knowing a University-wide policy of refusing tobacco money is in place (per both the Provost & the SVC for Health Sciences) at my current place of employment and that the academic health center has or is in the process of implementing a total ban for faculty, staff, and students on industry-sponsored gifts, personal samples, free lunches, hospitality, speaker bureaus, ghost-writers, etc. And they have had no qualms removing an exceedingly productive department chair due to a COI problem and not renewing faculty contracts when COI goes undisclosed but is discovered.