San Francisco Chronicle - March 13, 2000
Tom Abate

AIDS researchers, for instance, have used cancer remedies to fight HIV infections. These kind of off- label uses -- which the FDA has no power over -- sometimes provide the only treatments available.

But when physicians write about these off-label uses in scientific journals, drug companies want to mail reprints of these articles to other doctors -- subtly encouraging them to prescribe the drug in unapproved ways.

For years, the FDA and its opponents -- the drug lobby and some conservative legal groups -- have disagreed over whether the agency can regulate this drug company practice of publicizing off-label research.

Last month, a federal appeals court in Washington, D.C., decided the issue, but since each side claimed victory, the dispute remains murky.

A government source said the court reaffirmed FDA rules for mailing out reprints. A spokesman for the Pharmaceutical Research and Manufacturers of America called that assertion "ludicrous."

Though the rules themselves are arcane, the off-label dispute exemplifies an important philosophic divide in our pill-popping society.

On one side are those who want strong FDA rules, not just on off- label drugs but on herbal and botanical remedies, to protect consumers from "every quack and charlatan," in the words of Paul Stolley, an epidemiologist with the University of Maryland School of Medicine.

On the other side, an odd alliance of conservative groups and alternative medicine activists is doing the drug industry the favor of painting FDA bureaucrats as the enemy of medical choice.

"If doctors and patients really think something is worth trying, do we really want the FDA to say no?" argued Dan Troy, attorney for the Washington Legal Foundation.

It was the WLF that challenged the FDA's off-label rules in court, but its allies in the battle include the Competitive Enterprise Institute (CEI), a libertarian think tank that would like to diminish the FDA's power.

"If somebody who is sick reads about something and wants the therapy, they have the right not just to seek these remedies but be passionate about it," said CEI legal director Sam Kazman.

Although the off-label issue is the current focus of debate, Kazman applies this same patient choice philosophy to nonprescription botanical or herbal therapies.

Congress deregulated these products in 1994. Ever since, some medical experts have argued that these pseudo-drugs aren't adequately tested for safety or usefulness.

Kazman, arguing a point that would resonate with the alternative medicine advocates, wants to keep the FDA out of the herbal marketplace. "It's a matter of making up one's own mind versus having some bureaucrat in Washington make the rules," he said.

FDA defenders would agree with Kazman on one point -- the off-label dispute, and the simmering controversy over herbal remedies, are part and parcel of the same debate over how much power the FDA should have to regulate and approve health products.

"The FDA is not without fault, but it is a model for the world," Stolley maintained, arguing that the agency is "being weakened by well-meaning people who think that because something is a botanical it's safer, or that their personal freedom is infringed because some (off-label drug) has to be tested" before doctors put it into general use.

The Bay Area plays a role in this tug of war over the FDA. Stolley blames AIDS activists for "practically wrecking drug regulation by having special (FDA testing) standards set up to approve their drugs."

The Bay Area also remains a stronghold of alternative and herbal therapies that Congress removed from FDA pre-market testing.

At the same time, local biotech firms are churning out new prescription remedies -- and challenging the FDA to hurry its process for approving them. Given that the pace of discovery is increasing -- not to mention the growing consumption of medicines by aging Baby Boomers -- the FDA seems destined to perform a thankless job.

If it's slow in approving new prescription medicines, industry lobbyists and patient advocate groups hound it for being too cautious. But when it approves medicines that turn out to have deadly side effects -- as seems to be occurring with some of the new diabetes drugs -- consumer watchdog groups demand safety recalls and congressional investigations.

Some medical experts would like to see FDA-approved safety tests of deregulated herbal remedies, but conservative groups and counterculture activists would probably join forces to defeat any such move.

So we stand in the middle of a medical revolution -- several revolutions, in fact, from the development of gene-based drugs to the revival of ancient Chinese herbs. And to all but a few defenders, FDA officials seem to be the dowdy bureaucrats in the way.

--BLOWING BUBBLES: A couple of weeks ago, I suggested that the current bio-mania might be an unsustainable bubble, driven in part by momentum money flowing into biotech mutual funds.

In the past few days, biotech shares have gotten a bit of a comeuppance. The American Stock Exchange biotech, which reflects the performance of 15 larger firms, fell from 794 to 688, ending the week down 13 percent. The Nasdaq biotech stock index, which tracks 200 firms, posted similar losses.

But judging from mutual fund flows, it's not yet clear whether this is a temporary pause in a bullish sector or the start of a decline or plateau. Robert Adler, president of AMG Services, the mutual fund tracking agency, said $800 million a week was flowing into biotech mutual funds when we spoke a few weeks ago. That was a 2.5 percent weekly increase in the amount of money chasing biotech stocks.

As of March 1, the inflow had increased to $1.3 billion a week. "Assets are increasing 4 percent each week on average from new investor flows," Adler said.

The money had been flowing to the sector because of its hot performance, further inflating the price of biotech stocks. The question now is whether the inflow of money will stop as abruptly as it began.

There's a lag in the measurements, but I'll check back soon to see whether the current cooling in biotech has reversed the funds flow that has helped drive the rally -- or whether money continues to pour in, making a rebound likely.
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