Avandia, was first approved in May 1999 by the FDA for the treatment of Type II (noninsulin-dependent) diabetes, and up to recently was one of the most prescribed drug for this condition. At the time of approval, Dr. Steven Nissen, a Cleveland Clinic cardiologist whose studies identified Avandia’s heart attack risks, said that the decision brought an end to “one of the worst drug safety tragedies in our lifetime,” adding that it was “essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future.” This “regulatory process” has been going on for 11 years, since Avandia was introduced in 1999.
One study estimated that from 1999 to 2009, more than 47,000 people taking Avandia needlessly suffered a heart attack, stroke or heart failure, or died.
The decision, on Avandia was reported in the New York Times . Because of Avandia, the F.D.A. announced in 2008 that it would no longer approve medicines simply because they help diabetics control blood sugar levels — the standard for more than 80 years. Instead, the F.D.A. now insists that drugmakers conduct trials lasting at least two years to show that their drugs do not hurt the heart and that they improve the quality or length of diabetics’ lives, far tougher tests.
The Avandia story also begins a new and unsettling period for pharmaceutical companies because Avandia’s risks became known well before FDA approval after Dr. Nissen analyzed data from clinical trials that GlaxoSmithKline, the maker of the drug, had been forced to post on its Web site as a result of a legal settlement. Such public postings mean that drugmakers can no longer easily hide or control scientific information about their medicines.
The agency’s decision to order restrictions on Avandia’s sales also demonstrates that the F.D.A. — given new powers over drugmakers and drug distribution in a 2007 law — intends to use those powers-three years later! The agency has now ordered that dozens of drugs be sold only with special restrictions.
Dr. Janet Woodcock, director of the F.D.A.’s drug center said, “We know that labels are often not read.” It was an extraordinary acknowledgment from a veteran of an agency that has relied for decades on label warnings to control drug use.
The suspension and restrictions all but ensure that Avandia’s sales — $1.19 billion last year and $3.2 billion as recently as 2006 should plunge. The drug has already been banned in the European Union. Avandia was once the biggest-selling diabetes drug around the world, despite the fact that there are over 117 other drugs available to treat type II diabetes. There were 600,000 people taking Avandia in the United States a few months ago.
GlaxoSmithKline responded that “the company continues to believe that Avandia is an important treatment for patients with Type 2 diabetes” and is working with the F.D.A. and European regulators “to implement the required actions.” The company promised that it would end Avandia promotions around the world.
The restrictions will take months to put in place. Patients now taking Avandia should continue to do so until they can consult their doctors, said Dr. Joshua Sharfstein, the F.D.A.’s principal deputy commissioner. ” WHAT?
But he said that doctors should now consider switching patients to other medicines.
FLASH: GlaxoSmithKline, the British drug giant, has recently agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant — the latest in a growing number of whistle-blower lawsuits that drug makers have settled with multimillion-dollar fines.
Question: Is there too much pressure from Big Pharm and Glaxo and its stockholders to take Avandia off the market as they did in Europe? The FDA is still giving excuses.