Maryland Injury Lawyer Blog

As expected, an FDA advisory committee today ignored the urging of many leading researchers and consumer advocate groups and even one of its most influential scientists and voted 20-2 to keep the diabetes drug Avandia on the market. The FDA is not required to follow this recommendation but, almost invariably, it does.

Yesterday, Dr. David Graham, a leading FDA scientist and one of the FDA officials widely respected by both pharmaceutical companies and patients' rights advocates, said Avandia should be removed because of the risks and because Avandia was no better at controlling blood-sugar levels than similar diabetes medications such as Takeda's Actos (which might also increase the risk of heart disease according to a just published study).

Should Avandia be taken off the market? I don't know. Certainly, if a patient with serious life threatening diabetes is having a great result with Avandia, maybe the risk does outweigh the benefits for that particular patient. Perhaps the FDA should restrict Avandia for use in selected patients and brand Avandia with prominent and meaningful warnings referencing the studies that point to a greatly increased risk of a heart attack. But this is a different question than the real question Avandia lawyers are looking at with clients who have suffered a heart attack or stroke while on Avandia: what are the risks of Avandia are when did GlaxoSmithKline learn of these risks?

GlaxoSmithKline's stock price has fallen approximately 10% since a study published in the New England Journal of Medicine in May showed an increased risk of heart attack and other adverse cardiac events for patients taking the diabetes drug Avandia. Now shareholders are fighting back. A class action lawsuit has been filed against GlaxoSmithKline in the US claiming the company issued a series of "false and misleading statements" regarding Avandia, the group's blockbuster diabetes drug.

Avandia is still on the market, pending further research. The FDA has said it will issue a "black box" warning on Avandia,which means that studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. This warning and the media frenzy around Avandia is going to decrease sales and, of course, declining profits. This lawsuit alleges that Glaxo not only ignored its duty to Avandia users, it also ignored Glaxo shareholders.

Next week, a congressional subcommittee will investigate the FDA's watchdog role in evaluating the risks associated with the diabetes drug Avandia. One witness, scheduled to appear at the hearing, claims that Avandia’s maker, GlaxoSmithKline, attempted to silence his criticism of the drug. John B. Buse, a nationally recognized diabetes specialist, says that Glaxo engaged in tactics to intimidate the doctor to keep him from going public with his concerns.

The New York Times reports that the Senate Finance Committee investigators have been looking into “very serious” claims that Avandia’s manufacturer “silenced one or more medical professionals who attempted to speak out about the potential risk of heart attacks and other serious health consequences as the result of the use of Avandia.

The news on Avandia continues to get worse and worse for Glaxo...

Our lawyers are investigating Avandia, a diabetes drug which may significantly increase the risk of a heart attack. A study to be published in the “New England Journal of Medicine” found that Avandia may increase cardiac risk. The journal’s editor, Dr. Jeffrey M. Drazen, is quoted as saying that, “We view this as the best publicly available data on a very important question. It shows what we regard as a preliminary, but worrisome, signal about cardiovascular toxicity of this drug.”

This journal article does not necessarily mean that there is a products liability case against Glaxco, but the facts are emerging in a manner eerily similar to the Vioxx debacle. In fact, the finding that Avandia raises the risk of heart attack by 43 percent and aincrease the risk of heart-related death by 64 percent was based on a review conducted by Dr. Steven E. Nissen of the Cleveland Clinic, who was among the first doctors to raise questions about the cardiovascular risks associated with Vioxx.

The FDA has advised patients taking the drug, manufactured by GlaxoSmithKline, to seek advice from their doctor. The FDA intends to convene an advisory panel to investigate.

There is some question, however, whether the FDA is best suited to investigate. The New York Times reports that the FDA may have been aware of dangers associated with Avandia seven years ago. In a letter to the FDA on March 15, 2000, Dr. John B. Buse, chief of endocrinology at the University of North Carolina in Chapel Hill, who is about to become the president of the American Diabetes Association, expressed grave concerns about Avandia, citing “a worrisome trend in cardiovascular deaths and severe adverse events” among patients using the Avandia. Dr. Buse's letter was also critical of the Glaxo's marketing of Avandia, accusing the company of “pervasive and systemic” efforts to understate the Avandia’s risks and overstate its benefits.

Avandia, which has been on the market for seven years, is a big money maker for GlaxoSmithKline. Avandia is used by nearly a million people in the United States and two million people per year worldwide, for the treatment of Type 2 (adult-onset) diabetes. With $3.2 billion in worldwide sales last year, it was Glaxo’s second-biggest pharmaceutical product.

If you have had a significant cardiac event such as a heart attack or stroke, please call our Avandia attorneys at 800-553-8082 or click here for a free Internet consultation.