Earlier this week news broke of yet another collection of secret emails, this time concerning the drug, Avandia.
In 2007, a Cleveland Clinic study conducted by prominent cardiologist Dr. Steven Nissen and published in the New England Journal of Medicine (NEJM) found that patients taking the diabetes drug experienced a 43-percent higher risk of suffering a heart attack. At that point GlaxoSmithKline argued against the findings.
According to the Wall Street Journal, the Glaxo emails prove its own researchers were worried its findings echoed that of Nissen’s. Glaxo’s senior consultant wrote in an email, “The numbers are the numbers, the analysis is very similar to our own.” He added that Glaxo couldn't "undermine" the figures but might find a way to explain them.
Sen. Chuck Grassley of Iowa, has been pushing the FDA to ask Glaxo to withdraw Avandia. He is apparently 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.
Steven Haffner of the University of Texas had already agreed to read it as part of the peer-review process for the New England Journal of Medicine but later went on to tell Glaxo of the 'confidential' paper before it was actually published. Haffner had been a Glaxo consultant on Avandia since 2000 and received $433,000 from Glaxo between 2000 and August 2007. Remarkable loyalty to his paymasters!
Nissen was paid a visit top Glaxo scientists, including the chief medical officer, just days before publication, they tried to get him to rethink his concerns. "They never revealed that they had obtained a copy of our manuscript and had concluded that our findings were irrefutable," he says. "Instead, they attacked the validity of the study and the motives of both the authors and the NEJM."
The Wall Street Journal hasn't yet viewed the full emails but one excerpt shows:
"There is no statistical reason for disregarding the [Nissen] findings as presented."
Why did Haffner show GlaxoSmithKline? Well, in his own words:
“Why I sent it is a mystery”
“I don’t really understand it. I wasn’t feeling well. It was bad judgment."
GlaxoSmithKline, as you would expect, have played it all down with some wonderful spin.
Nancy Pekarek, of GlaxoSmithKline, said:
Dr. Haffner had sent the article to the company on May 3, more than two weeks before the article was published in the New England Journal. He expressed concerns and questions regarding the methodology of the analysis, and sent the article to GSK for advice from experienced statisticians.
She added “We believe GSK acted appropriately and responsibly in responding to the situation.”
Here's what Alistair Benbow said when Glaxo were found to have withheld information on safety concerns for Seroxat:
""We firmly believe we acted properly and responsibly in first carrying out this important clinical trials programme..."
I'll leave it up to the readers of this blog to draw their own comparisons.
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