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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Should the FDA Pull Meridia?

Posted in Misc. Drugs

If there is a Holy Grail among pharmaceutical companies, it isn’t a cure for cancer, AIDS, or another fatal disease.  It’s a weight-loss pill.  As any Fen Phen lawyer can tell you, the history of weight loss drugs has been mild weight loss and severe health risks.  Some are concerned that the Fen Phen story will repeat itself with Meridia:

Nearly all of Wednesday's discussion centered on results from a 10,000-patient study released last year, which showed patients with heart disease taking Meridia had a more than 11 percent risk of cardiovascular risks compared with 10 percent of those taking a placebo.

The study was designed to show that weight loss with Meridia led to improved outcomes for patients with heart disease, diabetes or both.

Because the study failed to show those benefits, some panelists questioned the rationale for keeping it on the market, considering its modest weight loss benefits. On average, patients lost 5 pounds while taking the drug and about 30 percent of patients achieved lasting weight loss while on the drug.

Source: The Associated Press: FDA panel split on withdrawing diet pill Meridia

Two things jump out at me.  First, the risk increases from 10 percent taking a placebo to 11 percent taking Meridia.  That evidence isn’t strong enough for an injured patient to prevail in federal court.  Generally, you need to show a doubling of risk; if people who took the drug were 20 percent more likely to have a cardiovascular event, that might work.

Second, the average weight loss was 5 pounds.  That’s not a significant amount of weight loss for any drug that carries with it a cardiovascular risk.  Want to lose ten pounds?  Eat 1,200 calories a day for a week and take a diuretic.  You’ll lose 5 to 7 pounds in a week.  Granted, it will all be water weight and will come right back within another week, but the point is that 5 pounds simply isn’t much weight.

I’m going to be keeping my eye on Meridia, if for no other reason than drug companies have a history of manipulating studies to show minimal risks.