The Quacks are Winning

(This column was first published in the March 31, 2003 issue of The Buffalo News.)

Today not many readers will recall a medical tragedy that occurred a half-century ago. In the early 1950s the drug thalidomide was introduced as a sedative prescribed for nausea and insomnia in pregnant women. Too late it was found to be the cause of severe birth defects in children whose mothers had taken it. Worldwide some 10,000 babies were born with seal-like arms and legs. Even in Canada there were well over a hundred victims. Fortunately for the United States an alert Food and Drug Administration (FDA) official, Dr. Frances Kelsey,* blocked the sale of thalidomide and thousands of children were saved.

It would be nice to believe that our government continues in this way to protect us from pharmaceutical harm.

Not so, as the recent death of Baltimore Orioles baseball pitcher Steve Belcher demonstrates.

A medical examiner has confirmed that Belcher's death was related to his taking the dietary supplement ephedra (or ma huang) in an over-the-counter product Xenadrine. Despite ephedra's widely known and long-term identification with high blood pressure and heatstroke, it has not been banned. So many problems due to its use have been reported that law firms advertise on the web for class action clients, yet about three billion doses are sold each year.

Why haven't bad pills like this been outlawed?

Because our federal representatives have so hamstrung our health agencies that they cannot carry out their oversight role.

Here is a partial history.

In 1976 despite widespread protest an amendment was enacted by attaching it to a "must bill", the Health Research and Services Act. This amendment bans the FDA from limiting the potency of dietary supplements to nutritionally acceptable levels or even requiring them to have any useful value. The then FDA Commissioner called this legislation "a charlatan's dream."

During the 1970s and 1980s court and political battles over the "anti-cancer" nostrum amygdalin (Laetril) put the FDA on the defensive. The agency has great difficulty controlling useless remedies like these that turn patients away from legitimate therapy. Similar problems exist today with quack AIDS products.

The most recent blow was the Dietary Supplement Health and Education Act passed in 1994. It adds herbal remedies to the dietary supplements over which our federal agencies have very little regulatory control and it further relegates the FDA to a defensive role. For example, this bill allows manufacturers to advertise nutritional benefits for their products without prior FDA approval; in fact, a product can be produced for a month before the government is even notified. Only if they promote their product as acting against a specific disease can it be regulated. Claims of an untested quack medicine to "maintain cardiovascular health" or "support the immune system", for example, cannot be monitored at all.

Meanwhile attempts by congress members like Claude Pepper to address legislative loopholes went nowhere.

The boogeyman behind all this is the powerful and extremely wealthy health foods industry. In the five years up to 2001, for example, health food companies and executives contributed almost $11,000,000 to candidates, parties and political action committees. Top recipients: Orrin Hatch (R), Robert Wexler (D), Dan Burton (R), Tom Harkin (D) and George W. Bush (R).

A tiny fraction of the FDA budget is devoted to combating health fraud, the most recent figure I have, .001 percent. Clearly we are not being protected.

Now I understand that something may be done about ephedra. What we really need is to unfetter our federal agencies so they can take aggressive action against all quack medicines.-- Gerry Rising

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* Despite her richly deserved awards for this act, one critic described Dr. Kelsey as a "delay-causing bureaucrat."