Secret tapes of a meeting between GlaxoSmithKline (GSK) executives and a prominent medical researcher reveal deceptive tactics by the company, according to a Feb. 22 New York Times article detailing the recordings, which were never previously disclosed.
In 2007, GSK executives flew to Ohio to meet with Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic who had conducted a landmark study suggesting that the best-selling diabetes drug Avandia raised the risk of heart attacks. The study was published in The New England Journal of Medicine shortly after the meeting.
The executives, and the rest of the GSK group, did not know that Dr. Nissen was recording the meeting, as allowed by Ohio law, which allows recording of private conversations by one party without telling the other parties in the conversation. Dr. Nissen recorded the meeting because he “[feared] he would face pressure and criticism from executives,” according the report in The Times.
The report of the secret tapes follows Saturday’s release of a Senate report harshly criticizing GSK actions to hide Avandia dangers and citing government health officials who want Avandia withdrawn from the market because of the drug’s dangers.
Among the GSK deceptions revealed by the secret tapes:
- GSK executives told Dr. Nissen they had data that would contradict his recently completed study. In fact, they did not.
- GSK executives told Dr. Nissen they intended to soon share the allegedly contradictory data with him and cooperate with him on a joint study. They never did share any such information or cooperate with Dr. Nissen after these statements.
- The Times reports that “during the meeting, Dr. Ronald L. Krall, GlaxoSmithKline’s chief medical officer, predicted almost exactly the results of another crucial study of Avandia that was two months from publication and whose results, according to scientific protocols and the company itself, should have been kept secret from the company.” (Dr. Krall told The Times he did not see the study results until “many days after the meeting.”)
- GSK executives spoke as if they had not yet seen the yet-to-be-published Nissen study. In reality, a journal reviewer who also worked as a consultant to GSK had secretly and inappropriately faxed a copy of the study to GSK, violating the rules of the journal and professional ethics. GSK admitted to The Times that GSK had received the fax and that some of the executives who met with Dr. Nissen had read it.
- GSK has publicly fought the Nissen study results, even though experts within GSK knew the results were sound. A GSK statistician stated that “there is no statistical reason for disregarding the findings” of Dr. Nissen’s study. GSK’s head of research, Dr. Moncef Slaoui, wrote that federal regulators, Dr. Nissen and the company’s own researchers all agreed that Avandia substantially increased the risks of death and heart attacks (ischemic events), finding an increased risk “ranging from 30 percent to 43 percent!” (exclamation in Dr. Slaoui’s text)
- GSK executives asked Dr. Nissen to hold off on publishing his study until he or GSK had also done an even more detailed “patient-level” analysis, even though GSK had already done such analysis — with frightening results — and had no intention of publishing the results in a medical journal. “It is the right approach,” Dr. Nissen said. “Now I’m going to be equally blunt: you should have done this a long time ago.”
An exchange between Dr. Nissen and GSK’s Dr. Krall during the meeting reveals just how profit-driven GSK officials were, in spite of the dangers they already knew:
Dr. Nissen lost patience regarding the increased risk of heart attacks, or myocardial ischemia, in Avandia patients. “I hope you guys understand how much trouble G.S.K. is in here,” he said. “You’ve got a bunch of people who are incredibly vulnerable to myocardial ischemia, and you’ve had evidence that you’re provoking ischemia in those people, and that is of grave public health consequences.”
Dr. Krall asked Dr. Nissen if his opinion of Avandia would change if the Record trial — a large study then under way to assess Avandia’s risks to the heart — showed little risk. Dr. Krall said he did not know the results of Record.
“Let’s suppose Record was done tomorrow and the hazard ratio was 1.12. What does…?” Dr. Krall said.
“I’d pull the drug,” Dr. Nissen answered quickly.
The results of the “Record” study were published two months later, showing an 11 percent increased risk of heart problems for Avandia users — a hazard ratio of 1.11. In spite of Dr. Krall’s prediction, GSK claims Dr. Krall and GSK did not have access to the study data until four days later. The study results were supposed to be kept confidential until that point, to ensure scientific validity.
Numerous Avandia users have filed lawsuits against GSK over the past several years, as more patients suffer heart attacks, heart failure, and other problems after using Avandia. The law firm of Aylstock, Witkin, Kreis & Overholtz (AWKO Law) has been actively engaged in the litigation for years, including a leadership role in the national Avandia multi-district litigation (MDL), which consolidates thousands of lawsuits to streamline the information discovery process. For more information about patients’ legal rights, Avandia users and their families can contact the lawyers of AWKO Law at www.AWKOLAW.com (888-255-2956).