Washington, DCWhile patients wait for news about what the US Food and Drug Administration (FDA) will do about Avandia, more criticism about the way GlaxoSmithKline handled the drug and its studies has come to light. Some critics say a letter from GlaxoSmithKline ignores concerns about Avandia risks, potentially putting patients at risk.
According to a report in the New York Times on 8/19/10, the Food and Drug Administration (FDA) ordered GlaxoSmithKline to send certain doctors a letter describing a July advisory panel discussion of Avandia. Some doctors and at least one federal official claim the letter was misleading.
The letter was sent to doctors involved in a study called the TIDE (Thiazolidinedione Intervention in Vitamin D Evaluation) trial, which compares the safety of Avandia with that of rival drug Actos. During the advisory panel meeting, the FDA ordered GlaxoSmithKline to stop recruiting new patients for the study. Current participants in the study are allowed to continue with it.
The TIDE trial came under fire because critics said it was unethical to put patients at unnecessary risk of serious side effects, including heart attacks. Dr. David Graham, an FDA medical officer, argued at the advisory panel that the TIDE trial should be halted.
According to the New York Times, Graham says his comments were left out of GlaxoSmithKline's summary letter entirely. Furthermore, the ethical issues are not mentioned in the letter, even though the point of the letter was to help doctors determine whether or not the trial is ethical.
Meanwhile, some members of the FDA's advisory panel said the letter was biased and "Avandia friendly" and ignored criticisms of the validity of GlaxoSmithKline's studies. An advisory panel conclusion that Avandia has a higher risk of heart attack than Actos was also reportedly left out of the letter, which could raise ethical questions because the trial was designed to compare the safety of the two medications.
At least one panel member disagreed and said GlaxoSmithKline's letter was accurate.
An FDA spokesperson reportedly said that it was up to GlaxoSmithKline to send an accurate account of the meeting and that the FDA did not approve the content prior to the letter being sent out.
At the advisory committee meeting in July, advisory committee members were asked to vote on whether or not Avandia should be left on the market. Twelve members voted to withdraw the drug, 10 voted to severely restrict how the drug is marketed, seven suggested adding stronger warning labels and three voted to allow Avandia to be sold as is. One person abstained from voting.
The FDA now must decide whether to remove Avandia from the market or continue marketing it as is, with stronger warnings, or not at all.
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