- The Washington Times - Monday, April 25, 2005

The Food and Drug Administration just yanked or restricted all but two of the nation’s top painkilling drugs, throwing patients requiring regular anesthesia into what Dr. Joshua Prager, head of the University of California-Los Angeles Pain Center, called “great confusion, not only among patients, but for physicians” about how to treat severe and chronic pain.

The only painkillers the FDA will recommend as working without long-term high-risk are aspirin and acetaminophen (Tylenol). Popular nonprescription drugs ibuprofen (Advil, Motrin, etc.) and naproxen (Aleve) will now require warnings against using more than two weeks. The prescription COX-2 inhibitor drug Bextra will be taken off the market and Celebrex (and Vioxx, if its manufacturer is willing to go back on the market) will require the maximum “black box” warning that its use could cause heart attacks and strokes.

Two days before the decision, Democratic Sens. Hillary Rodham Clinton of New York, Patty Murray of Washington and Edward Kennedy of Massachusetts confronted Dr. Lester M. Crawford, President Bush’s choice for permanent FDA administrator, and placed his nomination on “indefinite hold.”

Backed by the Ralph Naderite Public Citizen’s Health Research Group, supported by trial lawyers and endorsed by many other liberal legislators, the senators’ mission is to promote absolute safety via maximum political and bureaucratic regulation, unlimited access to health litigation against drug businesses and, ultimately, elimination of private medicine in favor of government-run health care.

Rule No. 1 for bureaucratic regulators is: What you do can get you in trouble with activists and politicians, what you deny no one can see. The ideal would be approving no drugs so no one could get hurt using them (nor blame the approving bureaucrat). The next best is to test them to death over the longest period possible in an effort to eliminate all risk.

Regulators, being statisticians, know it is impossible to eliminate all risk but can always rule on the side of caution. The only little problem is people die during the endless approval process. But no one can be sure they died from not having a drug not known to be available.

The FDA bias toward endless testing is most noticeable for patients with incurable diseases. The bureau insists experimental drugs for these patients must meet the tightest standards with thousands of patients tested under statistical methodology utilizing “blind” controlled experiments: Some patients receiving the full dose and some little or no dose at all.

Controlled experiments may make some sense for aspirin. But even the FDA should recognize the true control in terminal diseases is all patients will die if they get the sugar pill.

When a father started Abigail Alliance to save his little girls’ life by proposing a new expedited procedure without many controlled tests (as done in early phase tests) for terminally ill patients with no other recourse, the bureaucrats denied the request and defended the existing system for its efficiency, specifically mentioning the colon cancer drug Eloxatin.

Eloxatin was FDA-accelerated but not endorsed until 2003, by which time 56 nations had already approved it. France, the epitome of rigid bureaucracy, approved it 1996, saving colon cancer lives for the seven years it was unavailable in the U.S. Someone very dear to me was recently diagnosed with melanoma. While it is presently under control, she is refused vaccines stalled in clinical tests for years.

After 14 years as lead statistics professor for political scientists at the University of Maryland, your servant can testify there is no perfect, “objective” way to decide between control and test groups. Type I and Type II errors in statistics are inversely related to each other: The more one error type is reduced, the more the other increases. Statistics can help improve such judgments, but it is a subjective decision at the end. Human beings desire certainty. So the myths of purely objective science and absolute safety are very popular.

FDA’s actions are unsurprising. It must deal with a Congress and public that want certainty over science. FDA desperately needs a less bureaucratic process that gives patients choice.

Pain sufferers would not even have access to aspirin if it had to be tested under FDA procedures. Dr. Prager told NPR after the decision, “Aspirin would never be able to get through the FDA process today.”

Aspirin existed before FDA and did not pass through its bizarre bureaucratic process. Aspirin creates stomach problems for some, which is why other drugs were developed. If the FDA had existed when aspirin was developed, there simply would be no unrestricted pain medicine on the market today.

Donald Devine, former director of the U.S. Office of Personnel Management, is a professor at Bellevue University and editor of www.ConservativeBattleline.com.

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