Big Pharma's Politics Problem

- Jim Edwards

THE government's recent ban on over-the-counter sales of the contraceptive Plan B ought to give Big Pharma cause to re-examine its loyalty to the Republican party. The ban was based not on the drug's scientific claims, but on the squeamish feelings

that President Bush's managers at the Food and Drug Administration have regarding the sex lives

of underage girls, according to a report by the Government Accountability Office, the investigative arm of Congress.

Traditionally, drug marketers have been friendlier to Republicans than Democrats. About 65% of all the drug business' political donations—$150 million since 1997—have gone to Republicans, according to the Center for Public Integrity.

In return, the GOP has come out against drug-pricing controls; it opposes reform of our free-market healthcare system; and it has expressed dislike for the importation of cheap drugs from Canada.

The decision to prevent Barr Pharmaceuticals from selling Plan B, a so-called "morning-after" pill, as a nonprescription product raises the question of whether the Republicans' religious distaste for science has become a threat to marketers who want to promote new and useful drugs.

An FDA memo dated May 6, 2005, uncovered by the GAO, stated that Plan B should remain prescription-only because of the "immature" and "impulsive behavior" of girls aged 11 to 16. "[A]dolescence is known to be a time of rapid and profound physical and emotional change," it said.

The tone of the memo, from a senior FDA manager, suggests that if girls knew they could get Plan B at the local drug store they would be more likely to have sex. (The note did not distinguish between girls who have consensual sex and those who merely want to avoid becoming the underage mothers of their rapists' children.)

The GAO's report, released Nov. 14, indicated that the scientific data actually show the opposite: girls with access to contraception tend to engage in less risky behavior, not more.

The FDA's managers made their decision to reject Plan B before their own science panel finished its evaluation. Ultimately, the panel voted 23 to 4 in favor. It was then overruled by Bush's appointee, former FDA Commissioner Lester Crawford, who resigned in September.

The FDA cited no scientific worries about the drug's safety or effectiveness—in fact, a separate FDA memo praised

Plan B's "well-documented safety profile."

Thus, the decision was the first time the FDA rejected a drug application based not on science but on the feelings of

its managers.

The episode has added to the confusion surrounding Plan B, which many mistakenly believe is an abortion pill. It is not. It's a simple emergency contraceptive, containing a large dose of the hormones usually found in "the pill."

By itself, that ought to concern the drug business: what else in the pipeline might make Bush's FDA appointees blush? But Republicans have ignored science before.

Bush has had a longtime aversion to research on stem cells, which he regards as "embryos . . . with the unique genetic potential of an individual human being"—despite the presence of actual fully grown human beings struggling with Parkinson's symptoms as they beg Congress to allow the research to continue.

Bush has also come out against human cloning, which, despite the moral alarmists, is more likely to produce new organs for research or transplants than it is to create evil twins or armies of super-slaves.

And Bush has supported the move by some school districts to teach children that evolution has "gaps" and "problems" explainable by "intelligent design." That's a challenge to science as a whole. Viruses and bacteria by their nature evolve; if the government rejects evolution as a concept, then where are scientists to begin?

Politics aside, marketers may want to consider the business cost.

The pharmaceutical industry is dependent on good science. Among the international science community, the American habit of misunderstanding science encourages the brightest researchers to go elsewhere. Increasingly, that elsewhere isn't just Europe, it's points further East. Eventually, the brain drain will hurt us.

Already, India's Ranbaxy Laboratories has mounted an aggressive challenge to Pfizer's international patent rights on

Lipitor (it was successful in Finland but not in the U.S.). Israel's Teva Pharmaceutical Industries has gotten tentative FDA approval to market a generic version of the sleep drug Sonata in this country.

And European governments have displayed no major qualms about research on human tissue or cloning; both have been legal there for years.

As long as the American drug industry keeps its wagon hitched to a party that believes godless scientists cannot be trusted, then marketers in Europe, Asia and India will be happy to beat America to the market with new medicines and patents—and the riches they bring.



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