Hold Those Cheers for the FDA

The drug we should stop using "immediately" has been questioned for decades

Phenylpropanolamine is not a word in most people's vocabulary. Speaking for my spell-check and myself, we've certainly never heard of it.

But buried under the last-minute election news Monday was an item noting that the Food and Drug Administration is planning to ban phenylpropanolamine -- also known as PPA -- which turns out to be a not-so-benign drug that is the active ingredient in 35 brand-name medicines, mostly cold remedies and diet pills.

The FDA says PPA, a stimulant and decongestant, can cause strokes, especially in younger women, and it is asking drug companies to stop selling products containing it -- and Americans to stop using them -- while it proceeds with a formal ban. On the retail side, Walgreens and Rite-Aid, among others, are pulling items containing PPA from the shelves.

This is a bigger story than meets the vocabulary, because PPA is swallowed by millions of people taking such common over-the-counter remedies as Contac, Alka-Seltzer Plus, Comtrex and Robitussin. It's a bit of a shocker to have the FDA say, "We suggest you stop taking the drug immediately and use an alternative," when it comes to something as basic as common-cold medicine.

But an even bigger shocker -- at least to those of us not conversant with phenylpropanolamine -- is to learn that this shouldn't be such big news today. A trip down search-engine lane reveals that the FDA has a lot of chutzpah using the term "immediately" in connection with PPA.

Deadlines being what they are, I can't tell you at this writing who the next president of the United States is. But I can tell you who was president the first time the FDA began investigating phenylpropanolamine: That would be Richard Nixon, first term.

Yes, the first official suspicions go all the way back to 1972. But the warning of some physicians and scientists apparently paled next to the power of the pharmaceutical industry, and PPA not only survived but flourished as the use of diet pills exploded over the next quarter-century.

Fast forward to Feb. 13, 1982 -- but still as far back as the early Reagan years, presidentially speaking -- and consider what was already being reported in the New York Times. By then, the Center for Science in the Public Interest (a not-for-profit consumer group that's still around today, by the way) had made a formal request that the FDA ban the drug in diet aids. And it wasn't alone:

"The National Clearing House for poison control centers in August estimated that it handles each year 10,000 reports of phenylpropanolamine poisoning and that the drug forces at least 1,000 to seek emergency care. The Medical Letter, a nonprofit publication that keeps doctors abreast of the latest developments on drugs, is also skeptical about the effectiveness of chemical dietary aids, as is the American Medical Association.

"Despite this, products containing the PPA ingredient remain among the most widely sold drugs in America. In fact, last year alone nearly four million Americans consumed about 10 billion doses of products containing phenylpropanolamine."

A Georgetown University pharmacology professor warned back then that "the drug is dangerous and should be taken off the market." Pills with the PPA ingredient "are all risk and no benefit," she said.

There was, of course, another side to the story.

"The drug companies rejected all reports that the pills in recommended dosages cause hypertension, strokes or psychoses," the Times reported. "(One company spokesman) said "the benefits far exceed the risks for the vast majority of the American public. We're a very socially responsible company. It's one of our themes.'"

The battle raged on for years, with consumer groups and physicians warning that PPA was a dangerous decongestant that could increase blood pressure and cause chest pain or angina or strokes. The drug companies countered that PPA was as safe as safe could be in unclogging nasal passages and suppressing appetites.

Somehow the FDA managed, as recently as late 1990, to side with the drug companies after nearly two decades of research and controversy. The Washington Post reported:

"PPA is safe and there are no questions about its efficacy as a decongestant when taken as directed," said William Gilbertson, director of the FDA's over-the-counter-drug division, which reviewed the ingredient's safety.

Wonder what changed so dramatically in the past decade?

True, it was only recently that a five-year study by Yale University (with reluctant drug-company funding) showed that the wild-eyed critics of the '70s and early '80s weren't so wild-eyed after all: Young women had increased stroke risk of as much as 12 to 15 percent within just three days of taking their first dose of PPA.

But why did it take so long to vindicate the vocal critics from the medical, scientific and consumer communities? If the FDA can assert today that PPA is so dangerous that consumers should stop taking the likes of Contac and Robitussin "immediately," where has it been all these years?

This was great vindication for the drug-industry critics, who are too often dismissed as shrill in the "balanced" mainstream coverage of these issues. But don't expect any great lesson to be learned for the next time there is a major conflict between consumer health and the "socially responsible" drug companies' billions.

The big money will always have the upper hand.

And the FDA will move about as fast as you can say "phenylpropanolamine."

 
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