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Why did FDA approve two diet drugs banned in Europe?

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Belviq was “found by the [European Medicines Agency] to be too dangerous to be used for weight loss but [is] considered by the FDA to be ‘safe enough’ for Americans.”

Writing in the journal BMJ this week, Dr. Sidney Wolfe, a leading and outspoken consumer health advocate, asks why two prescription diet drugs that European regulators rejected were subsequently approved for use in the United States.

“Are Americans more resistant to the risks and more likely to benefit from certain drugs than Europeans,” asks Wolfe, “or, on the contrary, is the European Medicines Agency (EMA) more resistant than the US Food and Drug Administration (FDA) to the drug industry’s desire to get approval for drugs with unique risks but without compensating benefits?”

The question is meant to be rhetorical, of course. For as Wolfe, the co-founder, former director and now senior adviser to Public Citizen’s Health Research Group, makes clear in his commentary, he believes the European, not the American, regulators made the right choice. [Full disclosure: When I was a college student, I worked in the Washington, D.C., offices of the national Public Interest Research Group, which then included the Health Research Group.]

And Wolfe is far from alone in that assessment. Consumer Reports’ medical advisers, for example, have also determined that the risks of these drugs — lorcaserin (marketed in the U.S. as Belviq) and phentermine/topiramate (Qsymia) — outweigh their benefits.

To begin with, as Consumer Reports (and Wolfe) point out, the weight-loss benefits from the drugs are small. Studies show that people who take Belviq for a year can expect to lose only 3 to 3.7 percent of their weight, while those who take Qsymia can expect to drop a bit more: about 9 percent of their weight. And the lost weight may return. In one study, notes Consumer Reports, participants regained 25 percent of the pounds they shed on Belviq by the end of the second year.

More important, the drugs’ relatively small benefits come with significant side effects, ranging from headache, dizziness, nausea, fatigue and depression to potentially life-threatening cardiovascular problems, including heart-valve problems, heart attacks and strokes.

In fact, the FDA initially (in 2010) rejected Qsymia because of concerns about those risks, “and it is not clear why the FDA reversed course this time, since those side effects are still an issue,” writes Consumer Reports.

“When Qsymia was approved in July 2012, the FDA hailed it as another treatment option but decided that a study was needed to clarify the risks of major adverse cardiac events such as heart attack and stroke — but only after it was on the market,” writes Wolfe.

The FDA did something similar regarding Belviq, he adds: It required the company to conduct randomized clinical trials to evaluate the drug’s cardiovascular risk, including heart valve damage. But, again, it’s letting the company do these studies while the drugs are being widely sold.

By contrast, the EMA rejected both drugs, citing concerns about long-term health effects and noting that the drugs’ limited benefits did not outweigh those risks.

Belviq and Qsymia were “found by the EMA to be too dangerous to be used for weight loss but are considered by the FDA to be ‘safe enough’ for Americans,” writes Wolfe.

“This is not to say that the EMA is perfect,” he adds, “but rather that its recent record on drugs such as these puts the FDA to shame. It is not the resistance of Americans to the risks of these drugs but the intermittently dangerous malleability of the FDA that is the problem in the cases discussed here.”

“We’ve long cautioned against taking quick-fix weight-loss drugs like Belviq and Qsymia … as well as supplements, because their benefits are usually minimal, and their adverse effects can be troublesome,” Consumer Reports told readers earlier this summer. “Instead, skip the pills, and lose weight the safer, tried-and-true way — by eating less and exercising.”

You can read Wolfe’s commentary on the BMJ website. You’ll find Consumer Reports’ warnings about Belviq and Qsymia on its website.

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Comments (1)

  1. Submitted by Dimitri Drekonja on 08/23/2013 - 10:04 pm.

    Although I favor the EMA decision, there is one other issue to consider when asking why the American agency said yes, whereas the Europeans said no: obesity is a bigger issue here. Perhaps American regulators are willing to accept a bit more risk, given the extent of the problem.

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