April 7, 2000 (Washington) -- Talk about being between the proverbial rock and a hard place: On April 10, an FDA advisory committee will publicly review data for a new drug that -- if approved by the agency -- may help a lot of American men with erectile dysfunction.
But it will give FDA staff a headache.
No, it's not a Viagra copycat -- Viagra works by increasing blood flow to you-know-where. This new drug, known as Uprima, is supposed to stimulate an erection through a mechanism in the brain. And men get the active ingredient into their bodies by putting a tablet under their tongues before intercourse. (That's right. Under their tongues.)
We might make light of such drugs, especially with former Sen. Bob Dole appearing all over TV talking about his erectile dysfunction. Dole has succeeded, for better or worse, in bringing public attention to a problem that men seldom discuss with anyone -- even their physicians.
The approval of Uprima, whose generic name is apomorphine and whose manufacturer is TAP Holdings in Deerfield, Ill., undoubtedly will be considered on the basis of the clinical data submitted by TAP. But if approved, everyone at the FDA knows what will happen. It will become another one of those so-called "lifestyle" drugs that is easily available via the Internet from overseas e-pharmacies that are almost impossible to regulate.
Selling lifestyle drugs -- those for conditions that are not really medical diseases in the traditional sense of the term, but nonetheless require a doctor's prescription -- has become a booming industry. In recent years, drug manufacturers have invested substantial sums in developing substances designed to enhance your quality of life.
And they've been successful. In the last decade, drugs for erectile dysfunction, baldness, and obesity -- although obesity can be a serious medical condition -- have come to market. And more are on the way.
Yet these products are now creating problems for the FDA because the aforementioned Internet sites heavily advertise such lifestyle drugs, and Americans have been obtaining them without a prescription or by providing minimal or no medical information.
The FDA was assigned by President Clinton the impossible task of shutting down these overseas pharmacies that service Americans, and this is now one of the agency's highest-profile priorities.
The U.S. Customs Bureau has an equally daunting task of trying to detain drug shipments at the borders -- now detaining nearly 10,000 shipments a year -- to protect the American public from the potential dangers of using Viagra and the baldness drug Propecia without the supervision of a doctor.
The challenge for the FDA will be to balance all these considerations as it grapples over the next few weeks with a decision that could give it still another headache -- approving the newest erectile dysfunction drug. Stay tuned. ...