Internal Glaxo Emails Show Drug Company Was Concerned In 2007 About Avandia's Heart Attack Risks

Senator Grassley's Report On How Glaxo Defended Avandia In Wake Of 2007 NEJM Article By Nissen And Wolski Is Expected To Be Released Soon

(Posted by Tom Lamb at DrugInjuryWatch.com)

On May 21, 2007, in our post titled "Glaxo's Diabetes Drug Avandia May Cause Significant Heart Attack Risk", we reported about the Los Angeles Times publishing a May 21 article which broke the story about a new analysis of Avandia data that had been published online earlier this same day by the New England Journal of Medicine (NEJM).

This now relatively well-known NEJM Avandia article, "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death", was written by Steven E. Nissen, M.D., and Kathy Wolski, M.P.H.; it was published in the June 14, 2007 print edition of the NEJM.

It turns out, however, that GlaxoSmithKline PLC -- the drug company that makes Avandia -- had some (improper) advanced notice of the Nissen and Wolski NEJM article and (surprise, surprise) the drug company tried to do something about it. 

For the telling of this still-developing story, we turn to a January 14, 2009 Wall Street Journal (WSJ) article, "Glaxo's Emails on Avandia Reveal Concern", by reporters Alicia Mundy and Jared Favole.  We start by setting the stage:

The study by Dr. Nissen for the New England Journal was supposed to be kept under wraps until its release on May 21, but Glaxo obtained a copy on May 3 from a doctor, Steven Haffner of the University of Texas, who was reviewing it for the medical journal. Dr. Haffner had been a Glaxo consultant on Avandia since 2000 and received $433,000 from Glaxo between 2000 and August 2007. He confirms giving Glaxo the study, though he says doing so was "a terrible mistake."...

As soon as Glaxo got Dr. Nissen's draft, its researchers began a detailed analysis, according to the email excerpts. On May 4, one wrote, "There is no statistical reason for disregarding the [Nissen] findings as presented."...

In a May 8, 2007, email, Moncef Slaoui, the director of Glaxo research, told several executives: "FDA, Nissen and GSK all come to comparable conclusions regarding increased risk for ischemic events, ranging from 30% to 43%!"

The January 14 WSJ article suggests that there is more to come, soon, regarding Glaxo's conduct back in 2007, this time from Washington:

A leading Republican senator, Sen. Chuck Grassley of Iowa, has been pushing the FDA to ask Glaxo to withdraw the drug. He is preparing a report that may be released soon containing excerpts from Glaxo documents about the company's efforts to defend its drug from the New England Journal study, according to people familiar with the situation.

We will be watching for the release of Senator Grassley's report about Avandia and Glaxo.

If you know anything more regarding this apparent attempt by Glaxo to head-off the 2007 NEJM article by Nissen and Wolski that first revealed the increased heart attack risk associated with Avandia -- or you want to express an opinion about Glaxo's conduct in this instance -- please submit a Comment below.

(Posted by Tom Lamb at DrugInjuryWatch.com)

On May 21, 2007, in our post titled "Glaxo's Diabetes Drug Avandia May Cause Significant Heart Attack Risk", we reported about the Los Angeles Times publishing a May 21 article which broke the story about a new analysis of Avandia data that had been published online earlier this same day by the New England Journal of Medicine (NEJM).

This now relatively well-known NEJM Avandia article, "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death", was written by Steven E. Nissen, M.D., and Kathy Wolski, M.P.H.; it was published in the June 14, 2007 print edition of the NEJM.

It turns out, however, that GlaxoSmithKline PLC -- the drug company that makes Avandia -- had some (improper) advanced notice of the Nissen and Wolski NEJM article and (surprise, surprise) the drug company tried to do something about it. 

For the telling of this still-developing story, we turn to a January 14, 2009 Wall Street Journal (WSJ) article, "Glaxo's Emails on Avandia Reveal Concern", by reporters Alicia Mundy and Jared Favole.  We start by setting the stage:

The study by Dr. Nissen for the New England Journal was supposed to be kept under wraps until its release on May 21, but Glaxo obtained a copy on May 3 from a doctor, Steven Haffner of the University of Texas, who was reviewing it for the medical journal. Dr. Haffner had been a Glaxo consultant on Avandia since 2000 and received $433,000 from Glaxo between 2000 and August 2007. He confirms giving Glaxo the study, though he says doing so was "a terrible mistake."...

As soon as Glaxo got Dr. Nissen's draft, its researchers began a detailed analysis, according to the email excerpts. On May 4, one wrote, "There is no statistical reason for disregarding the [Nissen] findings as presented."...

In a May 8, 2007, email, Moncef Slaoui, the director of Glaxo research, told several executives: "FDA, Nissen and GSK all come to comparable conclusions regarding increased risk for ischemic events, ranging from 30% to 43%!"

The January 14 WSJ article suggests that there is more to come, soon, regarding Glaxo's conduct back in 2007, this time from Washington:

A leading Republican senator, Sen. Chuck Grassley of Iowa, has been pushing the FDA to ask Glaxo to withdraw the drug. He is preparing a report that may be released soon containing excerpts from Glaxo documents about the company's efforts to defend its drug from the New England Journal study, according to people familiar with the situation.

We will be watching for the release of Senator Grassley's report about Avandia and Glaxo.

If you know anything more regarding this apparent attempt by Glaxo to head-off the 2007 NEJM article by Nissen and Wolski that first revealed the increased heart attack risk associated with Avandia -- or you want to express an opinion about Glaxo's conduct in this instance -- please submit a Comment below.