By Amir Khan
Did the Food and Drug Administration push through dangerous drugs due to influence from big pharma? That's the question that senior doctor Sidney M. Wolfe, MD, founder of the health research group Public Citizen, is asking in a new paper published in the journal BMJ after the FDA approved two weight-loss drugs that the European Medicine Agency (EMA), the European equivalent of the FDA, rejected due to concerns over side effects.
The drugs, Belviq and Qsymia, were both approved in the United States last summer, despite the concerns over side effects, including heart disease and depression, which led to both drugs being repeatedly denied by the EMA.
"Are Americans more resistant to the risks and more likely to benefit from certain drugs than Europeans?" Dr. Wolfe asks in the paper, "Or, on the contrary, is the European Medicines Agency more resistant than the U.S. Food and Drug Administration to the drug industry's desire to get approval for drugs with unique risks but without compensating benefits?"
Belviq showed a 16 percent increased risk of heart failure compared to a placebo, and resulted in 3 percent more weight loss, according to the paper. Similarly, 4.2 percent of patients on Qsymia experienced heart arrhythmia, compared to only 1.8 percent of patients on a placebo. The FDA noted these risks when they approved the drugs.
"There's probably not sufficient data at this time to rule out a clinically meaningful increase in the risk for valvular heart disease," the FDA said in their report when they approved Belviq.
Although the FDA approved the drugs, they did not push them through blindly. The FDA mandated further research on the negative heart effects of the drugs, but only after the drug hit the market. However, Gopal Chopra, MD, an associate professor of health sector management at Duke University in North Carolina, said those studies should have been performed first, even with the obesity rate rising rapidly.
"Obesity doesn't need an urgent solution, because it's not going to kill you in the next hour," Dr. Chopra said. "If we stop eating, we lose weight. The FDA should have been more judicious in approving these drugs."
But just because the drugs require further research doesn't mean that doctors shouldn't prescribe them, Chopra said.
"Every prescription needs to be tailored to the patient," he said. "Physicians need to balance the risks and benefits and figure out what's best for the patient."
Unfortunately, Chopra added, most doctors are unable to effectively understand all of the risks.
"I would prescribe the drugs, but I would prescribe them with a team," he said. "It needs more than just a prescribing physician. It needs a dietitian, an obesity specialist and other doctors all working together. If we all agree that the patient needs the drug, I would prescribe it."
The FDA did not respond to a request for comment.
"Anti-Obesity Drugs Should Not Have Been Approved, Expert Says" originally appeared on Everyday Health.