Jewish World Review Oct. 25, 2002 / 19 Mar-Cheshvan, 5763

Drs. Michael A. Glueck & Robert J. Cihak

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Consumer Reports


"Pediatric rule" guinea pigs


http://www.NewsAndOpinion.com | "Let's do it for the children."

How many times, over the last decade or two, have we heard the politicians intone that chant. But now that insufferably self-serving little mantra has a new variant.

"Let's do it TO the children."

Specifically, let's poison them. Or rather, have the federal government force drug companies to poison children.

Fortunately, there's still enough residual sanity in the federal court system to stop this recent regulatory nonsense.

Sort of. And perhaps only for a while.

By law, the Food and Drug Administration (FDA) must approve new prescription drugs as safe and effective before they can be released for sale or your doctor can prescribe them. We've written of the "zero risk/zero defects" bureaucratic mentality that has turned the drug approval process into an overlong, over-expensive nightmare that denies desperately ill people the drugs that might help them and keeps many promising drugs from ever reaching the public, or even being developed at all.

And we'll also say again, there's no absolute safety in this life. Perfection is impossible. Trade-offs affect almost every decision we make, in medicine as well as in other aspects of life.

Prior to 1997, compared with the excessive pre-clinical testing required of new drugs on adults, there was relatively little testing of these same drugs on children. Doctors tended to reduce dosages for children, and to prescribe on the basis of their own clinical experience and knowledge of individual patients. That year, however, Congress passed a law giving drug companies lucrative extensions of their exclusive marketing rights for specific drugs, if they studied their effects in children. Not surprisingly, they did.

Then in 1998, the Clinton FDA tried to outdo Congress and issued a "pediatric rule" requiring drug studies in children - even when that drug might never be used to treat a child; after all, not that many kids get Alzheimer's. The rule also meant that drugs would have to be tested on kids, even if it was clear that the drug would be ineffective and harmful to children. In such cases, drug researchers could apply for waivers, with the usual, expensive and time-consuming bureaucratic consequences.

Fortunately, on October 17th this year, the Federal District Court of Washington, DC, overturned the FDA requirement, http://www.dcd.uscourts.gov/00-02898.pdf in response to a lawsuit brought by the Competitive Enterprise Institute, the Association of American Physicians and Surgeons, and Consumer Alert.

The judge noted that the pediatric rule allowed the agency to tell drug manufacturers that they had "to study their product on pediatric populations, even if the product is not explicitly marketed for children's use."

In his ruling, Judge Henry Kennedy noted that "Congress adopted an incentive scheme while the FDA adopted a command and control approach. The two schemes differ in almost every possible regard." Congress offered a carrot; the FDA tried to brandish a very big stick. In effect, the FDA said the public can't trust anyone else to deliver good products or services; we can only trust the government.

Over-zealous government regulators are choking out common sense. It's impossible for the FDA - or anyone else - to get medical care or drug safety "just right" for every single child - out of tens of millions - in America. If it was so easy, or if an FDA official could figure this all out, then each of us could have our own "FDA Consumers' Guide to Medicine and Medical Care". We would look things up and take care of all illnesses on our own, with only an occasional call to our friendly federal government agent in the FDA.

Some members of Congress are now trying to overturn Congress' 1997 law that offers incentives - carrots - and are seeking further punitive, command-and-control power for the FDA - an even bigger stick. Senators Hillary Clinton (D-N.Y.), Mike DeWine (R-Ohio) and Christopher Dodd (D-Conn.) have proposed a new law that would give the FDA the big "pediatric rule" stick it wants.

Did we win a battle only to lose the war? Once again, we need to tell congress and the president: Don't give FDA regulators dictatorial powers over health care. Excessive agency control harms rather than helps our children's and our own health.

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Michael Arnold Glueck, M.D., is a multiple award winning writer who comments on medical- legal issues. Robert J. Cihak, M.D., is past president of the Association of American Physicians and Surgeons. Both JWR contributors are Harvard trained diagnostic radiologists. Comment by clicking here.

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