From the Editor: Incurable - Pharmaceutical Executive

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From the Editor: Incurable


Pharmaceutical Executive


Patrick Clinton
I don't see the FDA ever approving a drug for a lifestyle improvement," says Cephalon CEO Frank Baldino in this month's cover profile. "And I don't know if I want to sell [one]. We entered this business to develop drugs for sick people—that's our purpose." Of course, we all like to hear that a pharma CEO wants to cure diseases. But on the subject of lifestyle drugs, I think Baldino—like many folks in the industry—may be kidding himself.

Let's be realistic. There are plenty of lifestyle drugs on the market already. Some of them, like Botox and birth-control pills, are approved for lifestyle indications (whether anyone wants to call them that or not). Others, including Baldino's own wakefulness drug,

Provigil, plus drugs like Viagra and human growth hormone, have off-label uses that are pretty clearly not about curing disease.

Will FDA eventually start routinely approving drugs meant primarily for lifestyle improvement—drugs that make us taller, slimmer, prettier, smarter, more muscular, less forgetful, and, yes, even younger? I imagine that there will be some kicking and screaming, but it's hard to see how the agency can ultimately resist. FDA's job is to ensure that drugs are safe and effective, not to limit them to the curing of diseases.

And why shouldn't lifestyle drugs be on the market? I can think of four more or less reasonable arguments:

Safety Drugs are intrinsically dangerous, this argument runs, and lifestyle improvements aren't sufficient justification to take substantial risks. That's plausible, but let's not forget that roughly 20 percent of American adults smoke. It's hard to justify letting them get away with that and depriving them of useful lifestyle improvements with far better safety profiles.

The Darwinian appeal We shouldn't improve ourselves with drugs and devices, which interferes with evolution's gradual honing of our genome. I, for instance, shouldn't wear glasses. By using them, I prevent myself from getting run over by a bus. That means I'll pass my nearsighted genes to my children, dooming them if civilization collapses, eyeglasses vanish from the earth, and saber-tooth tigers roam the ruined, smoldering streets of our cities. On the other hand, would it really hamper myself and my offspring to benefit some (no doubt) bozo with great eyesight?

Human nature We were born with certain defects, this case goes. They're part of who and what we are, and it's important for us to live with them, and experience pain and confront our limitations. A life of chemically-induced perfection is no life at all. I mostly believe this argument, but in a society devoted to plastic surgery, steroid-pumped athletes, and the delusional mind-set displayed each week on American Idol, I doubt that it can be the basis of public policy.

Fairness When we have drugs that enhance lifestyle, the rich will have them, and the poor, by and large, won't. The gaps that divide our society will grow larger, more visible, and more painful. Of course, they're already large, visible, and painful. A nation that can't bring itself to create equal access to healthcare is unlikely to worry about a few extra perks for the rich.

Eventually we're going to have lifestyle drugs, powerful ones that will make amazing differences in how we live. To judge by the way we cope with the drugs we already have today, we're nowhere near ready for them. We're not ready to assess their risks and benefits, to make them part of richly lived lives, or to keep them from tearing communities apart. We'd better learn soon. Like it or not, they're on the way.

Patrick Clinton
Editor-in-chief

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