Newspaper article

Why Did FDA Approve Two Diet Drugs Banned in Europe?

Newspaper article

Why Did FDA Approve Two Diet Drugs Banned in Europe?

Article excerpt

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. …

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