Glaxo Hid A Study On Avandia Risks For A Decade
4 CommentsBy Ed Silverman // July 13th, 2010 // 7:30 am
Nothing like dropping a bombshell on the morning of a crucial FDA advisory committee meeting. But GlaxoSmithKline quietly began a study in 1999 to determine if the cardiovascular risks of its Avandia diabetes pill were greater than with Actos, a similar drug, and instead of publishing the results, the drugmaker spent 11 years trying to cover them up, according to The New York Times.
The results were never provided to the FDA or posted on the Glaxo web site, the paper continues, citing these documents - please see Attachments A and E. “This was done for the US business, way under the radar,” Martin Freed, a SmithKline exec, wrote in a March 29, 2001, e-mail about the results. “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.” The study was actually begun by SmithKlineBeecham, which Glaxo acquired.
The latest disclosures indicate Glaxo had data hinting at Avandia heart risks almost as soon as the drug was introduced in 1999, but tried to hide that from the public, the paper writes. In one document, Glaxo tried to quantify lost sales if cardiovascular safety risk “intensifies.” The cost: $600 million from 2002 to 2004 alone, the document stated. Glaxo tells the paper it denies the allegations.
Glaxo also ran another trial comparing Avandia with older diabetes meds, but when Rhona Berry, a Glaxo exec, asked about publishing two of the trials, Freed wrote a July 20, 2001, e-mail saying: “Rhona - Not a chance. These put Avandia in quite a negative light when folks look at the response of the RSG monotherapy arm. It is a difficult story to tell and we would hope that these do not see the light of day. We have already published…better studies.” RSG is short hand for rosiglitazone, the generic name for Avandia.
UPDATE: In a statement sent us, Glaxo says the Senate committee “released a small subset of the 14 million pages of documents provided to plaintiffs’ counsel in the product liability litigationinclude drafts and other documents taken out of context, which therefore are incomplete and misleading. The documents do not offer new clinically relevant scientific information, and do not provide the full extent of GSK’s studies and evaluation of Avandia…Cherry-picking a handful of documents from more than 14 million pages of documents distorts the record and is misleading.”
The statement goes on to say that the study referred to by the Senate committee, which was called Study 175, “was an Actos (pioglitazone) -only study on LDL and triglycerides; it was not a study on Avandia (rosiglitazone) and heart attack. The results of this pioglitazone-only study were consistent with the pioglitazone label and thus did not contribute any significant new information. GSK has also examined the clinical effects of LDL increases experienced by some patients receiving rosiglitazone. The data, developed through multiple long-term trials, demonstrates that rosiglitazone treatment is not associated with the progression of atherosclerosis, which is a common cause of myocardial ischemia.”
Context
OK, Glaxo. Release the rest of the documents and explain the context.
Otherwise, it’s just the usual denial, denial, denial.
Justice in MI
For Context, and others,
I looked through the documents and GSK’s statement. While I could be wrong–it’s still selective, and parts are deleted–this would be my own summary:
Study 175–that “should not see the light of day”–was, indeed, purely a study of Actos, not Avandia.
But the reason for doing it appears to have been in order to decide whether to do a head-to-head study between the two drugs.
Given the 175 results, the decision was not to go forward. The documents suggest that, given what was already known, the “best result would be equivalence” and there appears to be a strong concern that Avandia would not fare well–particularly re: LDL and trigylcerides.
And so, as of these documents, the head-to-head was not pursued.
Beth Mahoney
These drug companies are ridiculous, they do not care if their products hurt or kill people, as long as they make a profit….thats all that matters. Something needs to be done about these companies, they are out of control.
ex-FDAer
Also for context. In spring of 2007 FDA OND issued policies that prohibited OND staff from discussing anything with OSE without it first going through the OND management. This is quite interesting in light of OND actions and what was occurring with Dr. Johann-Liang at that time.