A majority of the U.S. Food and Drug Administration's panel of outside experts voted to keep GlaxoSmithKline's (GSK) type 2 diabetes drug Avandia on the U.S. market, albeit with new restrictions. The vote is not a decision. The regulatory authority still has to make the final call, although it usually follows the advice of its panels.
For the five options under consideration, the 33 member panel voted as follows (one abstention):
None voted to allow marketing of the drug and removal of the warning;
Three voted to allow continued marketing with no label change;
Seven voted to allow continued marketing but add additional warnings to the label;
Ten voted to allow continued marketing but add additional label warning and restrictions on use;
Twelve voted to withdraw Avandia from the U.S. market.
While some may count the vote as favorable to GSK, with 20 panelists voting to keep Avandia on the market, it can be viewed as damning, with 22 members voting to either withdraw the drug or impose strict restrictions on its use. And according to Matthew Herper of Forbes, many of the panelists who voted for severe restrictions said they were close to voting for outright withdrawal. Either way, with all the bad publicity Avandia has received these days, it may not matter.
In an earlier vote, the panel found Avandia raised a heart attack concern compared with diabetes drugs in other classes and a rival product, Actos from Takeda, that's in the same class. However, the panelists voted that Avandia does not raise risk of death compared to older drugs or its competitor Actos.
Glaxo will continue to work with the FDA, Dr. Ellen Strahlman, GSK's chief medical officer, said in a statement. She added, "Patients taking Avandia should speak with their physician about their treatment and any questions they may have regarding the safety of the medicine."
Questionable Glaxo Behavior
The panel, which was convened Tuesday, heard conflicting opinions, reviewed hundreds of pages of data, and listened to testimonies from doctors and patients. One patient pleaded with the panel to keep Avandia on the market or it would mean a death sentence to him. Others claim the data is so consistent that it's time to pull the drug from the market. The panel's goal was to settle this three-year dispute over Avandia's safety.
But with the panel's review of Avandia, many other issues came to light -- mainly Glaxo's behavior. Senate Finance Committee Chairman Max Baucus (D-Mont.) and Ranking Member Chuck Grassley (R-Iowa) provided recent findings from their ongoing inquiry into Avandia to the FDA.
From reviewing internal GSK documents, the senators found that GSK withheld data from studies that found problems with the drug, and that Avandia was part of GSK's ghostwriting program -- "a practice by which drug companies initiate authorship of articles...that are then marketed to medical journals for publication under the names of doctors without public disclosure that the drug company sought the article in the first place," according to a statement released by the senators.
Among the findings sent to the FDA (in entirety here) are GSK executives' concerns about cardiovascular risks as early as one month after the drug was approved. Other findings also put the FDA conduct in a questionable light as the agency took more than two years to approve a black-box label warning regarding Avandia's risks.
GSK said that Avandia is one of the most extensively researched diabetes medicines. "The company has consistently shared data with the FDA and worked with the agency to update the label for Avandia as new data became available."
Avandia sales, which neared $3 billion in 2006, fell to $1.2 billion in 2009 following a study that suggested the drug poses increased risk for serious heart problems and after the FDA added the black-box label warning regarding the elevated cardiac risk in 2007. Avandia's U.S. sales were just 1.5% of Glaxo's 2009 revenues.
GSK shares closed up 1.76% and continued to climb over 1% in after-hours trading on the news as worries over more legal liabilities may have abated. According to Bloomberg, Glaxo quickly settled 10,000 of an estimated 13,000 suits for $460 million ahead of the vote.