Obesity Turkey, Vioxx Over-Reaction

I want to start this week with a bit of you-heard-it-here-first news that may help you enjoy more of your holiday meals.

Last March, Centers for Disease Control and Prevention chief Julie Gerberding announced that obesity caused 400,000 deaths annually in the U.S., a figure approaching the annual death toll for smoking. At the time, I criticized the statistic as “the kind you make up” rather than “the kind you look up.” ).

Then in September, I reported that researchers from the U.S. National Center of Health Statistics said that “many methodological and conceptual difficulties arise in attempting to estimate the number of deaths in the United States that are attributable to obesity” and that the CDC’s obesity casualty count may be overstated by as much as 200 percent.

The Wall Street Journal reported this week that the CDC plans to revise its obesity death toll downward, reportedly by about 80,000 fatalities — a good start, but an estimate that, in my opinion, remains way too high. CDC chief Gerberding acknowledged to the Journal that “there had been human errors in the [CDC’s] calculations.”

But instead of Gerberding blaming individual scientists for their “human errors,” it appears that the problem is more institutional in nature. As it turns out, “even before the disputed study was published, several scientists at the CDC expressed misgivings to their superiors about its methodology and findings…The dissenting scientists complained that their concerns were ignored and that the agency's rigorous standards governing scientific research hadn't been followed,” reported the Journal.

Though caught in an embarrassing situation, the CDC is hardly giving up. The agency has asked the National Academy of Sciences to consider the issue, knowing full well that an NAS panel with a pre-determined and CDC-friendly viewpoint can easily be assembled.

We’ll see what happens, but in the meantime, you can worry a little less about having that extra slice of pumpkin pie.

Vioxx (search) not a reason to gore the FDA

Exploiting the controversy over the withdrawn arthritis drug Vioxx, the Journal of the American Medical Association urged this week in an editorial that Congress consider establishing an “independent drug safety board” to track the safety of drugs after they’ve been approved for general use.

JAMA’s main argument in favor of the IDSB is that, because the Food and Drug Administration is responsible for approving drugs, the agency may be reluctant to take action against approved drugs that subsequently turn out to have safety issues.

While it’s certainly true that government agencies and their bureaucrats are famously reluctant to admit mistakes, Congress should think twice before creating an IDSB because of Vioxx.

Vioxx is a poor excuse for any drastic action as there has been a tremendous overreaction to the reports that the drug may be a heart attack risk. Merck, the drug’s manufacturer, probably erred and fed the frenzy by withdrawing Vioxx from the market completely. True, the Vioxx clinical trial launching the panic reported a doubling of the heart attack rate. But the baseline heart attack rate was relatively low (15 versus 7.5 out of 1,000 Vioxx users) and the increased heart attack rate was only apparent after 18 months of continuous Vioxx use (a period of time that constitutes overuse), as pointed out in the Wall Street Journal.

Merck should simply have re-labeled Vioxx with new warnings that the drug shouldn’t be prescribed to those with a history of cardiovascular and gastrointestinal problems, or for too long periods of time.

Congress should be leery of creating another federal program the sole mission of which is to find fault with easy-to-demonize businesses — especially at no risk to the program itself. We already have a government program like that. It’s the U.S. Environmental Protection Agency’s Superfund program for cleaning up hazardous waste sites — and it doesn’t work very well.

The basic problem with Superfund is that it has little to do and scores no political points unless it finds (or makes up) health risks at waste sites, blames the so-called “polluters,” regardless of the merits of the situation, and then punishes the polluters severely. There is little internal or external check or limitation on this fault-finding.

Similarly, an IDSB would look like it was doing nothing unless it found real or imaginary problems with approved drugs and took action against them and their manufacturers.

All drugs have benefits and risks. The FDA is fully capable of balancing them. This is not to say the FDA regulatory process is perfect. The agency often does the wrong thing. Generally speaking, though, the agency has at least some inherent institutional incentive to balance benefits with risks.

Congress should not make Vioxx hysteria any worse than it already is.

Steven Milloy is the publisher of JunkScience.com, an adjunct scholar at the Cato Institute and the author of "Junk Science Judo: Self-Defense Against Health Scares and Scams" (Cato Institute, 2001).

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