Society for Clinical Trials
Hyatt Hotel, Vancouver, May 17, 2011
Ilyas J. Rona, J.D., Palko S. Goldman, M.D., Greene LLP, Boston, Massachusetts
Randomized controlled clinical trials (RCTs) are the gold standard for determining efficacy and effectiveness in modern drug therapy. Regulatory bodies, physicians, and researchers rely on RCTs to make drug therapy decisions. But what if the apparent results from RCTs do not reflect the real evidence? What if important negative results are inaccurately reported or never even published? And what if a pharmaceutical manufacturer’s profit motive guides these publication decisions? Can physicians, medical researchers, and policy makers ever look beyond the biomedical literature to get to the truth about the drugs we use every day?
This presentation discusses how the legal system—specifically private litigation—can uncover the real results of RCTs. We will describe the decade-long legal saga of gabapentin (Neurontin), which culminated in 2010 with a federal jury in Boston finding that the manufacturer of gabapentin had engaged in fraud and racketeering by withholding or deceptively publishing results of RCTs while marketing the drug. The jury ordered the manufacturer to pay $142 million to a private insurer. The gabapentin case study is an important example of how litigation can expose unpublished or selectively published data. When physicians, researchers, and peer reviewers cannot access underlying data, the courts can unearth the real evidence.
We will also review briefly how other lawsuits and government investigations in the United States have elucidated the relationships between pharmaceutical manufacturers, academic medicine, medical journals, and medical education. Can the historical enmity between doctors and lawyers be transformed into an alliance for truly evidence-based medicine?
About the Author
Ilyas J. Rona, J.D.
Ilyas J. Rona received his undergraduate education from Brown University, where he graduated magna cum laude in 1995. He received a law degree from Northwestern University School of Law in 1998. Mr. Rona joined Greene LLP, of Boston, Massachusetts, where he has litigated complex, multiparty cases for more than a decade. Many of his cases focus on illegal or deceptive marketing campaigns conducted by pharmaceutical companies.
Mr. Rona and his firm represented David Franklin, a whistleblower who sued Pfizer for the illegal, off-label marketing of the drug Neurontin. In 2004, that lawsuit was resolved as part of a $430 million criminal and civil settlement between Pfizer and U.S. federal government. Subsequently, Mr. Rona represented various consumers and health plans that had paid for Neurontin prescriptions, alleging that Pfizer’s off-label marketing for various uses was also fraudulent and deceptive. In March 2010, after a five-week trial, a federal jury in Boston found that Pfizer had violated U.S. anti-racketeering and organized crime laws by fraudulently marketing Neurontin as being effective for four specific off-label uses. The jury found that Pfizer either concealed or delayed publication of negative clinical trial results, or deceptively disseminated the results of negative clinical trials to sound positive. The jury returned a verdict in favor of the plaintiff, Kaiser Foundation Health Plan, for $47 million dollars, an amount that was statutorily trebled to $142 million.
Palko S. Goldman, M.D.
Palko S. Goldman received his B.S. in biology from the University of Massachusetts at Amherst, graduating cum laude as a member of Phi Beta Kappa and the Golden Key National Honor Society. He received his M.D. from Temple University School of Medicine, where he received the Achievement in Internal Medicine award. He has also studied Computer Science at the University of Massachusetts and will be attending Suffolk University Law School in the fall of 2011.
Dr. Goldman joined Greene LLP in 2006 as a medical consultant, working with Mr. Rona in cases involving the marketing practices of pharmaceutical companies. In the Neurontin consumer and health plan litigation, Dr. Goldman was responsible for collecting, reviewing, and performing initial analyses of the results of all DBRCTs studying Neurontin’s efficacy for the four off-label uses in question. He also coordinated the development of medical and scientific expert reports demonstrating Neurontin’s inefficacy for the off-label uses in question. The expert reports found that Pfizer intentionally utilized various types of selective publication bias to create the illusion of effectiveness in the biomedical literature, continuing medical education, and evidence-based reviews.  In November 2010, U.S. federal judge Patti Saris, who presided over the Kaiser trial, separately found that Pfizer’s intentional misreporting of clinical trial results and selective publication bias, which previously might only have been deemed scientific misconduct, also constituted fraud in a legal sense. Judge Saris ordered Pfizer to pay in excess of $100 million to Kaiser.
- Landefeld CS, Steinman MA. The Neurontin legacy–marketing through misinformation and manipulation. N Engl J Med. 2009 Jan 8;360(2):103-6.
- Pfizer to pay $142M for drug fraud. CBC News. March 26, 2010 (http://www.cbc.ca/news/health/story/2010/03/25/gabapentin-ubc.html)
- Saul S. Experts Conclude Pfizer Manipulated Studies. New York Times. October 8, 2008 (http://www.nytimes.com/2008/10/08/health/research/08drug.html?partner=rssnyt&emc=r).
- Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med. 2009 Nov 12;361(20):1963-71.
- Saris J. Findings of Fact and Conclusions of Law. United States District Court for the District of Massachusetts. November 3, 2010 (http://pacer.mad.uscourts.gov/dc/cgi-bin/recentops.pl?filename=saris/pdf/ucl%20opinion.pdf).