By Calvin Palmer
Drug regulators in Europe and the United States issued announcements today concerning Avandia, the controversial diabetes medicine made by British company GlaxoSmithKline.
The EU regulator, the European Medicines Agency, said the drug would no longer be available to patients in Europe, after recommending it be removed from the market.
In the US, the Food and Drug Administration decided to severely restrict the drug’s use but stopped short of an outright ban.
The FDA said it was taking the step after data suggested “an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia”.
Under the restrictions, the one-time blockbuster medicine will now only be available to new US patients with type 2 diabetes if they are unable to control their glucose levels through other medications.
Existing diabetes sufferers taking Avandia will be allowed to continue to take the medicine if they so choose, the FDA statement said.
“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA commissioner Margaret Hamburg. “We are seeking to strike the right balance to support clinical care.”
Avandia was once the biggest-selling diabetes medicine around the world, with sales reaching $3.2 billion in 2006. Its sales abruptly declined in 2007 after a study by Dr Steven Nissen, a Cleveland Clinic cardiologist, found that it increased the risk of heart attacks. An advisory committee in 2007 decided that Avandia did increase heart risks but voted to keep it on the market.
Further studies heightened the controversy and in July another FDA advisory committee meeting was held. This time, a majority of experts — many of whom had supported Avandia’s continued sales in 2007 — recommended it should stay on the market in the United States but with greater restrictions on its sale.
“Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug,” said Janet Woodcock director of the FDA’s Center for Drug Evaluation and Research.
Doctors will now have to attest that their patients are eligible to be prescribed Avandia, and the patients will have to acknowledge that they are aware of the risks.
The FDA said it would require Glaxo to develop a restricted access program for Avandia under a risk evaluation and mitigation strategy.
Avandia, known generically as rosiglitazone, was approved in 1999. It helps control blood sugar levels in diabetics by making patients more sensitive to their own insulin. It is one of a class of three drugs, the first of which, Rezulin, was withdrawn because it caused liver damage. Actos, the last remaining drug in the class, appears safe in part because it seems to affect a different set of genes than either Rezulin or Avandia.
Avandia’s risks became known only after Dr Nissen analyzed data from myriad trials that GlaxoSmithKline had been forced to post on its Web site as a result of a legal settlement.
The FDA has instructed GlaxoSmithKline to conduct an independent assessment of the Record trial, a landmark study of Avandia’s heart effects that an FDA medical officer found was riddled with what he said were unpardonable errors that seriously biased the trial’s conclusions.
The US watchdog also halted Glaxo’s clinical trial comparing Avandia to the other most popular diabetes drug Actos, as well as standard diabetes medication.
Senate investigators found that GlaxoSmithKline spent years hiding from regulatory authorities clear indications that Avandia increased heart risks. In July, GlaxoSmithKline took a $2.3 billion liability charge related to legal cases involving Avandia and another medicine, Paxil.
But today’s announcements may increase the company’s legal exposure.
Plaintiff’s lawyers must be rubbing their hands with glee at the prospect of rich pickings.
“If the manufacturers of Avandia had told the full truth about the drug’s harmful effects to the medical community or the users of Avandia, patients would have been able to make an informed decision about the potential health risks of using the drug,” said Robert Brown, the head of Baron & Budd’s Miami office.
“While we respect the FDA for repeatedly reviewing this drug, there has been a suggestion of bias on the advisory panel. Regardless, we cannot sit idly by while large pharmaceutical companies hide the truth about dangerous drugs,” said Brown.
Especially when he stands to make a lot of money from successful lawsuits.
How can patients make any informed decisions regarding their healthcare when the motivating force at work with many physicians and drug companies is greed?
Physicians may well protest their innocence in this sordid affair but let us not forget the inducements they are offered by drug companies to prescribe drugs. I am not saying all physicians accept these incentives but clearly the greedy ones do and make no mistake a good many doctors in America are motivated by personal wealth rather than patient care.
All a patient can hope for is that they find a doctor who strictly abides by the medical code, “Do no harm,” a doctor who puts patient care before his or her own financial gain.
Such physicians do exist in the United States, whether they form the majority of the medical profession is open to debate.