GSK hid Avandia risks, Senate investigators say

An ongoing Senate investigation into GlaxoSmithKline's diabetes drug Avandia has discovered internal emails and other documents that suggest the drug maker actively promoted the medication at the same time as it failed to publish studies that identified "serious health risks."

"Among the documents the Finance Committee uncovered are internal emails showing that GlaxoSmithKline attempted to downplay scientific findings about the safety of Avandia as far back as 2000," a Senate Finance Committee release said.

The documents were forwarded to the FDA, which is conducting a review of Avandia. Studies have found the drug increases the risk of heart failure, stoke and heart attack compared with a competing drug, Actos. That two day hearing starting Tuesday could results in the FDA deciding to pull the drug off the market, restrict its use, strengthen warning on the label, or leave things as they are.

In one email dated July 20, 2001, then SmithKline scientist Martin I. Freed wrote a colleague at the company that became GlaxoSmithKline about the study data. "These put Avandia in quite a negative light … It is a difficult story to tell and we would hope that these do not see the light of day. We already published the better studies."

Glaxo has continued to defend the safety of Avandia. In today's New York Times, GlaxoSmithKline spokeswoman Mary Anne Rhyne said  the company had not provided the results of its study to the FDA because they "did not contribute any significant new information."

Also today Bloomberg News reported based on sources that Glaxo has agreed to settle 10,000 Avandia suits for $460 million. Check out that item here on Check Up.

In a statement emailed to Check Up GSK responded to the Senator's release of documents with a statement excerpted below:

"The Senate Finance Committee (SFC) has released a small subset of the 14 million pages of documents provided to plaintiffs' counsel in the product liability litigation.  They include drafts and other documents taken out of context, which therefore are incomplete and misleading." ...

"GSK has been diligent in providing its safety data on Avandia to the FDA and in publishing its clinical trial data in peer-reviewed journals or on its clinical trial website." ...

"Cherry-picking a handful of documents from more than 14 million pages of documents distorts the record and is misleading."

Last week, in the Journal of the American Medical Association published two studies  in advance of this week's FDA hearing. One of those studies led by FDA scientist David J. Graham examined data on 227,571 Medicare beneficiaries who took Avandia - also known as rosiglitazone - or a rival type 2 diabetes drug pioglitazone sold as Actos.

That study found Avandia "was associated with an increased risk of stroke, heart failure, and all-cause mortality and an increased risk of the composite of AMI (Acute Myocardial Infarction), stroke, heart failure, or all-cause mortality in patients 65 years or older."

The Senate committee probe was led by Sens. Max Baucus (D., Mont.) and Chuck Grassley (R., Iowa).

"What's happened with this drug further makes the case about the need to strengthen the office within the FDA that monitors drug safety after a drug is on the market and being sold to patients," Grassley said in a statement.  "A lack of accountability damages public confidence and hope in new drugs.  Trust can be rebuilt through the work of a more independent FDA."

"Patients and doctors have a right to know the risks of the medicines they use and prescribe, and drug companies have a responsibility to release data regarding safety concerns about their products," Baucus said in the statement. "We will continue working with the FDA on Avandia to ensure patients and doctors have the information they need to make safe, informed decisions about their medications."

The committee released a report on Avandia in February 2010.

A letter sent to the FDA Monday and documents uncovered by the investigators are available here.

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