Avandia

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Contents

Background

Avandia or Rosiglitazone, is one of GlaxoSmithKline's blockbuster drugs for type 2 diabetes. It was raking in 4.6 million pounds a day in the early months of 2007, when an independent researcher who worked at the Cleveland Clinic in America, Steven Nissen, published a controversial meta-analysis of the drug in the New England Journal of Medicine (NEJM). Nissen added up heart problem data in all the previously published studies of Avandia in order to examine the drug’s safety profile. He concluded that users are 43 per cent more likely to have heart attacks and that there is an even higher increase in the risk of fatal heart problems.[1]

In April 2008, The Scotsman reported on NHS Scotland's reaction to Nissen's meta-analysis.[2]

Links to heart attack risks

After a two year inquiry, the US Senate Finance Committee issued a report in February 2010 stating Avandia's manufacturer, GlaxoSmithKline, knew of possible heart attack risks tied to its drug and 'tried to play down findings that the drug could increase cardiovascular risks while also working to minimize findings that a rival medication might reduce such risks'. [3] The senate asked the FDA to explain 'why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007'.[4] Two Food and Drug Administration (FDA) officials are recommending the drug is pulled from the market.[5]

Secret Tapes

According to The New York Times, Steven Nissen had a private meeting with four GSK executives 11 days before publishing the results of his meta-analysis and secretly recorded the discussion. During the meeting, the drug company's representatives 'repeatedly promised to begin a crucial analysis of the safety of Avandia “within days"'. Such a study has not been published in a medical journal. GSK's chief medical officer, Dr. Ronald L. Krall, also allegedly '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.'[6] According to the newspaper report:

'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.”'[7]

Conflicts of Interest

In March 2010, the British Medical Journal (BMJ) published research exploring 'a possible link between authors’ financial conflicts of interest and their position on the association of rosiglitazone [Avandia] with increased risk of myocardial infarction in patients with diabetes.' [8]

The authors concluded:

'Disclosure rates for financial conflicts of interest were unexpectedly low, and there was a clear and strong link between the orientation of authors’ expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies. Although these findings do not necessarily indicate a causal link between the position taken on the cardiac risk of rosiglitazone in patients with diabetes and the authors’ financial conflicts of interest, they underscore the need for further changes in disclosure procedures in order for the scientific record to be trusted.' [9]

Notes

  1. Nissen, S., and Wolski, K. (2007) Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes. The New England Journal of Medicine, volume 356:2457-2471.
  2. LYNDSAY MOSS and MARISA DE ANDRADE, Doctors Demand Freeze on use of diabetes drug for heart patients, The Scotsman, 7 April 2008, accessed 24 Feb 2010
  3. The Washington Post (Associated Press). 21 February 2010. Senate report ties GlaxoSmithKline diabetes drug Avandia to heart attack risks Accessed 23 February 2010.
  4. The Washington Post (Associated Press). 21 February 2010. Senate report ties GlaxoSmithKline diabetes drug Avandia to heart attack risks Accessed 23 February 2010.
  5. Harris, G. The New York Times Research Ties Diabetes Drug to Heart Woes Accessed 23 February 2010.
  6. Harris, G. The New York Times. 22 February 2010. A Face-Off on the Safety of a Drug for Diabetes Accessed 2 March 2010.
  7. Harris, G. The New York Times. 22 February 2010. A Face-Off on the Safety of a Drug for Diabetes Accessed 2 March 2010.
  8. Wang et al. BMJ 2010;340:c1344 Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review Accessed 21 March 2010.
  9. Wang et al. BMJ 2010;340:c1344 Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review Accessed 21 March 2010.
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