What Would You Do? Disgrace and Conflicts in Medical Clinical Studies
The fall and resignation of the renowned Chief Medical Officer and physician-in-chief of Memorial Sloan Kettering Cancer Center, researcher Dr. Jose Baselga, once again sound the alarm of questionable ethics, conflicts of interest, and integrity in clinical studies. Dr. Baselga is known as one of the world’s top cancer doctors, credited with new, life-saving therapies.
Drug companies sponsor interested researchers (like Dr. Baselga) and related institutions (Sloan Kettering) to conduct clinical trials and gain access to human subjects. Research institutions say that without industry collaboration they cannot gain approval of new lifesaving treatments. Invoking the principle that sunlight is the best disinfectant, medical journals and professional societies require researchers to disclose financial ties to drug and health care companies.
But joint investigative reporting by ProPublica and the New York Times revealed that Dr. Baselga, in a majority of his publications and speaking engagements, failed to disclose extensive financial ties amounting to millions of dollars he pocketed from health care companies such as Roche, Bristol-Myers Squibb, and biotech start-ups. The financial largesse went beyond pure research-support to board memberships, company directorships, “advisory” or consulting roles, and actual stakes in companies. His positions sometimes placed him in a fiduciary role, with a duty to further the best interests of a company at the same time he conducted “independent” clinical studies.
Prior secret influence by industry on drug research is well documented. Researchers and their institutions are permitted to patent and license discoveries to drug companies. The promise of lucrative royalty revenues creates business partnerships and risks undue influence on prominent doctors’ conclusions and messaging about specific research. Biased reporting of research has resulted, as recently laid out by the editorial board of the NY Times.
Failure to disclose financial ties deprives the public, scientists, and doctors from the opportunity to evaluate medical research more fully. Taxpayer support of clinical studies (through the National Institutes of Health) that might turn out to be secretly biased is sorely tested when researchers disregard simple disclosure rules. And wrongdoing related to clinical studies that affects government funding or harms investors can give rise to whistleblower claims under the False Claims Act or SEC whistleblower programs.
In resigning his positions at Sloan Kettering, Dr. Baselga said: “It is my hope that this situation will inspire a doubling down on transparency in our field.”
But is sunlight enough? Does the underlying conflict skew the medical research itself? Some ethicists urge that even full transparency in financial relationships is not be enough to counteract the structural bias inherent in the cozy business partnerships between industry and researchers. Twenty-year editor of the NEJM, Marcia Angell, agrees in her recent opinion piece in the NY times.
Loading ...Tagged in: FDA Fraud, Pharma Fraud, What Would You Do?,