FDA Official, Advisors Call GSK Letter About Avandia Review Misleading

A letter GlaxoSmithKline sent to doctors explaining the status of Avandia is being called misleading and deceptive by some federal drug officials and experts. 

The letter, dated July 28, was sent out by the company after FDA officials required the drug maker to explain the results of a recent FDA advisory committee hearing on the side effects of Avandia to doctors.

Following a meeting of independent experts last month, an FDA advisory panel determined that Avandia increased the risk of heart problems, but recommended that Avandia remain on the market with stronger warnings and restrictions. However, some FDA drug reviewers and members of the panel say that Glaxo’s letter to doctors paints far too rosy a picture of Avandia health risks and the panel’s determination.

The letter was sent to doctors who are taking part in a study called TIDE, which is designed to compare Avandia heart risks with those of Actos, a competing diabetes drug by Takeda Pharmaceuticals. The trial has come under attack by critics who claim it is unethical to expose human subjects to known heart attack risks, and earlier this summer the FDA suspended enrollment in the trial while it weighs whether TIDE should be stopped completely and whether there needs to be an Avandia recall.

According to a report in the New York Times last week, there is a building controversy over the contents of the letter. Some FDA advisory panel members, including Dr. Curt D. Furberg, Dr. Clifford J. Rosen and others called the letter deceptive and too friendly toward Avandia. They said that the letter, posted by the New York Times, downplayed the panel’s reservations about the validity of an earlier GlaxoSmithKline-sponsored clinical trial known as RECORD, which determined that Avandia was safe.

Dr. David Graham, an FDA drug safety reviewer who lead an Avandia study published earlier this year, said that the letter also fails to even mention the ethical problems and concerns over the TIDE trial, despite the fact that the point of the letter was to have them assess the ethics of the trial.

One panel member, Dr. Sanjay Kaul, disputed the view that the letter was deceptive, however, saying that it truthfully reflected the advisory committee’s deliberations, and GlaxoSmithKline officials say they believe the letter to be accurate. The drug maker indicates that the letter had to be written within one week and had to be kept brief, limiting the amount of information it could contain. 

Avandia (rosiglitazone) was first approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted following the allegations of an increased risk of heart attacks and congestive heart failure .

Avandia has come under harsh criticism in recent years by a number of experts, including some FDA drug safety reviewers, who have estimated that Avandia may be responsible for more than 100,000 heart attacks and deaths since it was approved. Critics have argued that an Avandia recall should be issued, as there is no reason to put patients at risk with the drug when there are alternative treatments that do not appear to carry the same heart attack risk as Avandia.

GlaxoSmithKline faced about 13,000 Avandia lawsuits filed by plaintiffs who accuse the company of failing to warn patients that of Avandia heart attack risks. Last month the company announced it had reached Avandia settlements in about 10,000 of those suits.