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

By: Pharma News | Views: 1844 | Date: 09-Sep-2013

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.


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


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.

Diet Pill Dilemma


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.


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