Diet Pill Dilemma: Why Is FDA Approving Drugs When Europe Isn’t?

By Karen Weintraub
Guest Contributor

We’ve all dreamt of popping a pill to help us safely lose weight, or at least eat that chocolate cake without guilt. But alas, even though the Food and Drug Administration has approved two new diet drugs in recent months, that dream probably isn’t any closer to reality.

2day929/flickr

2day929/flickr

In the current issue of the BMJ (formerly the British Medical Journal), Sidney Wolfe, founder of the advocacy group Public Citizen, slams the FDA for approving the drugs – lorcaserin (US brand name Belviq) and topiramate (called Qsymia). The FDA’s European counterpart rejected both of them because of heart risks that turned up during preliminary trials.

The FDA decided that the risks were relatively small and ordered the manufacturers to look for problems once they are on the market – basically, approving the drugs now and worrying later if they prove dangerous. Buyer beware.

The problem, Wolfe explained in a phone interview from Washington where he is preparing to testify at a National Institutes of Health meeting tomorrow, is that the reasons for hunger are complex and connected to many biological systems.

“When you give a drug powerful enough to effect hunger it is also going to affect other systems of the body,” most often the heart, he said.

In trials, compared to people taking placebos, people using lorcaserin lost about 3 to 3.7 percent more of their body weight and those on topiramate lost 6.7 percent more. That weight loss likely had health benefits.

But since a primary health risk of obesity is heart disease, Wolfe thinks the potential risk outweighs the benefits

Of course, some are more optimistic about the drugs. One letter writer on the BMJ’s website defends Belviq, made by Arena Pharmaceuticals, a company which he says he’s followed closely since he invested less than $15,000 in it four years ago.

“The pharmaceutical company went the extra mile in running comprehensive clinical trial procedures (echocardiographs) to ensure the likelihood that heart valve problems were not an issue,” posted Christopher G. Blood, an instructor at San Diego Community College. In three trials including more than 5,200 patients, there were no more heart valve problems among volunteers taking Belviq than those taking a placebo, he wrote.

Diet drugs are associated with heart problems, Blood argued, because the people who take them are obese and therefore unhealthy to begin with.

Another letter writer conjectures that the FDA approved the drugs and its European counterpart didn’t – not because Europeans are less susceptible to corporate pressure, but simply because the drugs are made by American companies.

Wolfe said he’s not sure why the FDA came to a different conclusion than its European counterpart, but he suspects it might have something to do with the $600-700 million the American pharmaceutical industry pays the FDA every year.

The bottom line is that Americans and Europeans will respond the same way to the drugs.

Whether they will help Americans lose weight safely remains to be seen, but Wolfe is dubious.

“I don’t believe in magic,” he said.

Karen Weintraub, a Cambridge-base health/science journalist, is a frequent contributor to CommonHealth. Follow her on Twitter @kweintraub.

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  • FrankLawrence

    Wow – the Qsymia drug you mention is not just topiramate but rather a combination of that with phenteremine. Big difference physiologically, psychologically, and risk wise. The EMA did not reject Belviq as you state but rather the drug developer pulled the application to allow more time I notice you include one writer’s conflict of interest statement but do not include Dr. Wolfe’s. Ms. Weintraub appears to have been in a big hurry in writing this piece. Reader beware.

  • X-Ray

    Alternate question: “Why is not Europe approving drugs already approved in the U.S.”? In other words, why should European opinion be preferred over that from the U.S.?

  • MrBlood

    Actually what Mr. Blood argued is that Sidney Wolfe misrepresented the heart valve data (there was no significant difference between placebo and Belviq) and that any small difference in self-reported depression rates must take into consideration that there was only a slightly lower rate of self-reported depression among the control group when compared to the Belviq group because they too were morbidly obese and that condition does not lend itself to optimal happiness.

  • gaucho25

    Mr Wolfe is against any weight loss drug since Phen Fen caused heart problems. So with his simple thinking than any drug for weight loss will cause heart problems. Belviq had 3 Phase III trials with 8000 participants and the most extensive heart monitoring of any drug with no heart problems. Wolfe is out to gain notoriety for himself and the media is given that quack a soap box.

  • Rudy Hassen

    People are always testifying before Congress that the FDA foot dragging is causing suffering! Drug lobbyists are always happy to second the sentiments. The Congress and FDA then cave. Science has little to do with what the FDA and USDA tell people they ought to be doing. Sad state of affairs from the people who saved the USA from the thalidomide mess in the 50s.