A recent story published in the NY Times tells the story of Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic. He conducted a large study of the diabetes drug, Avandia. His conclusions in the study were not favorable for the drug or the pharmaceutical company, GlaxoSmithKline, that produces it. There is quite the controversy over the drug because of the dangers it poses to patients who take it and because of the cover-up that has ensued from GlaxoSmithKline. Now more evidence of crooked behavior on behalf of executives from GlaxoSmithKline.
Dr. Nissen conducted a landmark study that suggested that the best-selling diabetes drug Avandia raised the risk of heart attacks. The study led to a Congressional inquiry, stringent safety warnings, a sharp drop in the drug’s sales and a plunge in the share price of GlaxoSmithKline. The battle between GSK and Dr. Nissen was kept professional and legitamate until May 10, 2007, 11 days before his study was to be published in the New England Journal of Medicine.
Dr. Nissen was set to meet executives from GSK about his upcoming study and was nervous. In my opinion, rightly so. There are many published reports of powerful pharmaceutical companies trying to suppress scientific information that is unfavorable and ruining the careers of researchers who are only trying to do what’s best for the public. He was so nervous, in fact, that he decided to record the encounter.
Let The Lies Begin
The amount of lying from the executives in this meeting is astounding. For example, executives in the meeting repeatedly said they would immediately begin a new analysis of the safety of Avandia. Three years later this study has yet to be published. They did, however, release the results of this study on their website, which of course were favorable for the drug. The fact that it has not been published means that it doesn’t hold up under peer review and was most likely an attempt to look like they were doing the right thing all the while making sure the numbers looked good too. It is an underhanded way of trying to get data to the public without the rigors of peer review.
“Also 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. In an interview, Dr. Nissen said the recording showed that the executives hoped to persuade him not to publish his study by suggesting that they had contradictory information they would share with him in a joint study.
‘In retrospect, it seems clear that neither statement was true,’ Dr. Nissen said. ‘They did not have contradictory data, and they never intended to cooperate in any analyses.'” (From the NY Times)
GSK said in response that they were not aware that Dr. Nissen was recording the interview and were disturbed that he did so without telling them. It’s probably a good thing that he didn’t tell them because it would have changed the entire meeting and we wouldn’t have this window into just how corrupt Big Pharma is.
GSK was sued in 2004 by the State of New York for not publicizing the results of studies that showed antidepressants led to an increase in suicide in teenagers. The settlement of the suit required GSK to post the findings on the internet. This crooked behavior was what fueled Dr. Nissen to record his meeting with these executives.
During the meeting the four executives spoke as if they were unaware of the results of the study Dr. Nissen has completed. It was clear they were lying about this as well because one week before the meeting these executives were faxed a copy of the study secretly and inappropriately. This was only later found out by Congressional investigators. Who would do something like this? A journal reviewer who also worked as a consultant for GSK. That’s right. The very same people who are supposed to review our literature and make sure it is accurate and without bias also work for Big Pharma. Talk about a conflict of interest.
At one point, the executives said that studies showed that Avandia had no impact on cardiac death rates. This is a fact they unequivocally knew was not true. Dr. Nissen’s study had concluded that the risk was increased by 64 percent. They then, again, spoke as if they did not know the results of Dr. Nissen’s study, which Congressional investigators have shown they did.
“I get different numbers on this, but we’ll talk about it later,” Dr. Nissen said.
“Hmm!” one executive responded. “I would like to hear more about that.”
Another executive said, “That would be interesting to see.”
“This is one that is important to us,” Dr. Krall concluded.
Dr. Nissen was clearly tired of the push he was getting because it was clear they wanted him to forgo publishing the study. He’d had enough.
“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.'”
Internal emails obtained by the Congressional investigation show that they company was well aware of the dangers of the drug despite what the executives were saying in this meeting with Dr. Nissen.
“‘There is no statistical reason for disregarding the findings’ of Dr. Nissen’s study. In another, Dr. Moncef Slaoui, head of research at GlaxoSmithKline, wrote that federal drug regulators, Dr. Nissen and the company’s own researchers all seemed to agree that studies of the drug showed that it substantially increased the risks of death and heart attacks, also known as ischemic events.'”
GSK has responded to Dr. Nissen’s study calling it flawed and with some serious limitations. They are saying these things even though their own studies have come up with similar numbers. This is entirely about the money that Avandia brings in for the company. Although its sales have dropped dramatically, it still made $1.9 billion last year. These executives, while MDs, and PhDs, ceased to care about the public the day their jobs became to get money into the pockets of their shareholders. And pulling a drugs that has been as successful financially as Avandia certainly will not endear them to the board members that make the decisions about their careers.
I will leave you with this. Thousands of people per year have unnecessary heart attacks and die by taking this drug, yet the executives at GSK want to cover up this evidence just to make more money. To me this is not just a failure of our regulation of drugs and the FDA, but also of health care in general. If “mainstream” doctors just understood more about nutrition and actual health and weren’t so quick to prescribe medication for a disease which, by all accounts, is most easily and successfully treated with diet and exercise, we wouldn’t be in this mess to begin with.