Ilyas J. Rona and Palko S. Goldman Lead Presentations on Off-Label Promotion and the False Claims Act
On May 16 and 17, Greene LLP professionals Ilyas J. Rona and Palko S. Goldman led a series of talks in Vancouver related to off-label promotion of drugs by pharmaceutical companies and efforts to curb those pharmaceutical marketing practices. Mr. Rona and Dr. Goldman were invited to the 32nd Annual Meeting of the Society for Clinical Trials to make a presentation entitled “The Legal System: Evidence-Based Medicine’s Last Stand?” That talk, which took place on May 17 at the Hyatt Hotel in Vancouver, focused on the ways that non-publication, delayed publication, or selective publication of clinical trial results of drug investigations prevent physicians from practicing evidence-based medicine.
In threatening medicine’s evidence base, off-label promotion undermines the cornerstone of modern medicine. As Mr. Rona and Dr. Goldman observed, most forms of publication bias and selective outcomes reporting are not correctible or even detectable without intervention from the legal system. They reviewed the ways that the legal system can uncover the true evidence about drug treatments, and the resulting opportunities that are available to researchers, clinicians, and the academic community. The talk concluded with questions from attendees, many of which related to whether evidence-based medicine can survive in the face of strong profit motives to distort clinical trial results in order to pad off-label sales. Mr. Rona and Dr. Goldman also answered questions about recent efforts to force pharmaceutical firms to register clinical trials as part of the 2007 Food and Drug Administration Amendments Act (FDAAA), and whether those efforts will have a favorable impact on reducing the instances of publication bias and selective outcomes reporting.
Prior to their presentation at the Society for Clinical Trials, Mr. Rona and Dr. Goldman gave a similar presentation at the University of British Columbia. The seminar was hosted by Dr. Thomas Perry, Jr., who chairs the Education Working Group at the Therapeutics Initiative, and Dr. James M. Wright, Managing Director of the Therapeutics Initiative. Dr. Wright is also Professor of the university’s Departments of Anesthesiology, Pharmacology & Therapeutics and Medicine, which hosted the program as part of its Department Seminar Series. Mr. Rona and Dr. Goldman presented background on the use of the American legal system as a tool to combat pharmaceutical fraud. The recent trend of large settlements against drug manufacturers was presented, along with background on the False Claims Act, which triggers the bulk of U.S. government recoveries in cases involving false or fraudulent statements by the pharmaceutical industry. Mr. Rona and Dr. Goldman then reviewed the case of Neurontin, whose manufacturers embarked on a plan to turn a niche epilepsy drug into a sales blockbuster by tapping into the lucrative pain, psychiatric, and migraine markets. To accomplish this goal, negative evidence of inefficacy were hidden from the medical community long enough to allow the drug to remain an off-label juggernaut by the end of its period of marketing exclusivity.
Mr. Rona and Dr. Goldman also held a seminar directed toward lawyers, at the downtown Vancouver offices of Bull Housser Tupper. The legal seminar focused on whether the American legal system is succeeding or failing to hold drug companies accountable for fraud. Mr. Rona and Dr. Goldman reviewed the various legal tools that are used to hold drug companies accountable, from qui tam actions under the False Claims Act, to direct actions by large health plans, to class actions. They discussed the large fines levied against drug companies, evaluating whether they have had an effect or whether they have been treated as a cost of doing business. A key aspect of the presentation also included the question of whether industry executives have been emboldened by the fact that few, if any, may ever go to jail for their conduct, including a update of the role of the Park doctrine as a tool to hold executives accountable.