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Public Citizen: FDA Reckless

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Despite a 20-2 FDA advisory committee panel vote this week to approve the diet drug Qnexa, Director of Public Citizen’s Health Research Group, Dr. Sidney Wolfe, called the approval “reckless.” Evidence shows the drug poses significant risks and little evidence of long-lasting weight loss, wrote Dr. Wolfe. He compares Qnexa’s approval to the diet drug lorcaserin (Belviq), which the FDA approved last month despite concerns about heart valve damage. Research shows Qnexa increases heart rate, and four patients in the clinical trial suffered heart attacks compared to no heart attacks for the placebo group.

Dr. Wolfe also writes, “It is magical and delusional thinking for anyone to believe that a drug will turn off hunger without hitting other targets where it will do harm, usually to the cardiovascular system.” Therein seems to lie the entire problem of Western medicine, the belief that a single pill can magically cure any ill.

Diet Drugs have Poor Batting Average

Is Qnexa destined to go the way of so many other so-called diet drugs? Dr. Wolfe mentions several previous ones that were withdrawn from the market because they increased cardiovascular risk – including sibutramine (Meridia), fenfluramine and dexfenfluramine (Redux) and ephedra. Everyone would like to see a magic pill fix obesity if such a thing were possible, but Dr. Wolfe says doctors, patients and the FDA are “desperate to the point where they are willing to risk patients’ lives.”

Other Qnexa Problems

Besides increased heart rate (a cardiovascular disease risk factor), several other Qnexa problems presented in clinical trials, including frequent metabolic acidosis or increased nephrolithiasis (kidney stones),  cognitive damage and birth defects (cleft palate/lip), which is well documented with human topiramate exposure.

Politics, Politics, Politics

Drug companies are forever lobbying to weaken the FDA by defunding and understaffing the agency, while at the same time trying to hide behind FDA approval to escape liability whenever a given drug or device proves to be less effective and more dangerous than advertised. One has to wonder how well such corporate pressure works to affect the agency’s decisions regarding drug safety.  One feels for FDA administrators and decision makers being pressured to approve questionable drugs (however worthy the given drugs’ goals), but if one takes such drugs and suffers serious injuries, one will probably feel less sympathetic toward those FDA officials who approved such drugs. On the other hand, if Qnexa proves to work for some, they can thank the 20 advisory committee members who voted for approval.

The Majority Rules 20-2

An FDA Advisory Committee recommended approval of  Qnexa by a vote of 20 to 2. The committee said Qnexa’s weight loss benefits for the chronically obese outweighed the risks of birth defects and cardiovascular problems that have been associated with the drug. An FDA advisory panel recommended against approval in 2010 over concerns about the drug’s side effects, and the FDA rejected it shortly after that. Then Vivus, the drug’s maker, submitted additional research.

The committee also recommended Vivus take several steps to prevent Qnexa from causing birth defects like cleft palate, including a possible warning label meant to reach women in their childbearing years. See the complete abc news story at:


by Matthews & Associates

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