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Well it’s that time of year again. The time of year that we talk about cupids and Valentines and love and stuff. And, as a good friend of mine on facebook pointed out, we’ve also reached the golden moment where post-Valentine’s day chocolate is 50% off. It’s the time of year when we think about our hearts.
So in this spirit, I thought I’d write about a new controversy brewing over two new weight loss drugs/combinations that have recently been approved by the FDA. In 2012, the Food and Drug Administration approved two new sets of magic beans, I mean “weight loss drugs” lolorcaserin hydrochloride (brand name Belviq, manufactured by Eisai Inc.) and phentermine-topiramate (brand name Qsymia, manufactured by Vivus, Inc.).
People have been pretty excited about these coming out, especially since a number of other “weight-loss” drugs have been taken off the market due to concerns over cardiac side-effects. Now one might think, in light of the fact that we put thousands of people at risk with the previous round of “weight loss” drugs, that the FDA might be extra careful not to release a new round of weight loss drugs with the same problems.
Not so fast, say a pair of doctors in an editorial recently published in the February 10, edition of JAMA. In this article, Steven Woloshin, MD, and Lisa M. Schwartz, MD, point out that these drugs were approved by the FDA despite an alarming number of side effects. In the abstract for the piece the doctors state:
The drugs have been associated with serious harms: Both drugs’ labels include warnings about memory, attention, or language problems and depression; for lorcaserin, the label also warns of valvular heart disease and euphoria; and for phentermine-topiramate, the label warns of metabolic acidosis, increased heart rate, anxiety, insomnia, and elevated creatinine levels. Neither medication is marketed in Europe because of safety concerns.
And as I read these words, all I can think is, “Here we go again!” The drugs were approved under the condition that the drug manufacturers would conduct studies looking into the drugs’ heart risks. According to the FDA, waiting until such studies were completed to approve the drugs would “delay effective therapy” for obesity. The post marketing trials that were required to begin 16 months ago, do not appear to have begun. And even once those trials begin, those studies are not scheduled to be finished for another four or five years. And in the meantime we’re prescribing drugs known to potentially cause memory, language, attention, mood and serious vascular and inflammatory problems because some trials have shown short-term weight loss improvements of 3 to 7 percent over placebo. There are no studies indicating long-term weight loss improvements in those who take these medications. Nor, as Doctors Woloshin and Schwartz point out, is there any proof that these medications prevent disease or help us live any longer.
In the meantime we play with people’s hearts both literally and figuratively. In a culture and a society where many of us are taught that being overweight is the worst possible situation, doctors are peddling hope in the form of these pills. And rather than rule out potential cardiac and other serious heart attacks before the drugs are prescribed, doctors prescribe these pills to hundreds of people and “expose a lot of people to it while sorting it out,” said Woloshin.
So we can hope that the “post marketing studies” will actually begin and show no serious, long-term side effects like the permanent heart-valve damage we’ve seen from similar drugs in the past. We can hope that we won’t market these drugs as the next great hope for people hoping to escape the pain of weight stigma in our society just to have to pull them off the market a short time later.
But I fear this is yet another page in the weight-loss-fantasy playbook likely to leave a string of broken hearts.
Love, Jeanette (AKA The Fat Chick)