Consequences

One of the consequences of the over-hyped "obesity crisis" is that perspective gets lost. One would think that one of the goals of "health care" is guarding the health of patients yet that goal seems to fly out the window all too often when it comes to dealing with fat people.

Consider this: last week the FDA approved a second weight loss drug. It is not unreasonable to assume that given that physicians are supposed now to urge weight loss on fat patients, prescriptions for these drugs will rapidly take them up the scale of the widely prescribed. Even knowing what happened the Phen-Fen, this is likely to happen. How well informed will prescribers be about the cautions around this latest drug? How many of them will stop to consider whether the small weight loss is worth the risk?

The Consumer Reports Health blog has this to say about this drug:

According to the evidence submitted to the FDA, Qsymia appears to help people drop a few pounds. In studies, obese and overweight people who took Qsymia for one year lost 3.5 to 9.3 more pounds than those who took a placebo. But that small benefit is probably not worth the risks of birth defects, heart attacks, and strokes. In fact, two years ago the FDA rejected the drug, then called Qnexa, due to these concerns, and it is not clear why the FDA reversed course this time, since those side effects are still an issue.


The drug also carries a warning that it can increase heart rate and should not be used by people who have heart disease or have suffered a stroke. Due to the heart concern, Vivus, the manufacturer of Qsymia, is required to conduct a study to determine whether the drug poses a risk of major cardiovascular problems, including heart attack and stroke. Also too, pregnant women should not take Qsymia because it increases the risk of their children being born with a cleft lip or palate.

Mindful of the risks -- though one wonders in the face of them why the FDA approved this drug -- the FDA has set up some restrictions on it, at least initially.

Qsymia will only be available through specially certified pharmacies under a Risk Evaluation and Mitigation Strategy, or REMS, which is intended to inform doctors and patients about the possibility of birth defects.


"The very idea that a post marketing risk evaluation strategy was a condition required by the FDA for approval of this combination drug product seems like putting the cart ahead of the horse," says Marvin Lipman, M.D., chief medical adviser for Consumer Reports. "Such a study may very well result in preventable mortality and morbidity, a high price to pay in exchange for a few pounds of flesh."

And just in case you thought birth defects were the only concern, it also increases "the risk of glaucoma, kidney stones, mood problems such as anxiety and depression, and suicidal behavior or thinking about suicide". Nice, eh? Think that is a good trade off to achieve a weight loss of 3.5-9 pounds?

Could it be that the FDA has surrendered so to the obesity panic that they seriously believe that it is worth risking one's life with this drug just in order to achieve a weight loss so small as to not even be modest?

This trend is frankly scary.









© CHERYL FULLER, 2010. ALL  RIGHTS RESERVED.