- The Washington Times - Wednesday, July 21, 2004

Americans are not strangers to chemically altering their mental state. No, we don’t mean marijuana or ecstasy for recreational uses, but rather good old No-Doz caffeine tablets, or just a pot of coffee, to stay awake cramming for a final exam, or an over-the-counter sleeping pill to get some rest.

This field of “psychopharmacological enhancement” is growing in intensity and sophistication. Estorra, the first prescription sleeping pill you can take every night without becoming dependent, is expected to reach the market next year. Meanwhile, the military is studying the narcolepsy medication Provigil as a way to keep soldiers alert for long periods. Doctors have been flooded with requests from healthy people who want to use this stimulant to work and play harder. For example, many use it as an antidote to jet lag.

Thus, just as we’ve seen with steroids and growth hormones used by athletes to enhance physical performance, mind-altering drugs will certainly be used for ends that are not strictly therapeutic. But is that always a bad thing?

Some think so. As this science advances far beyond caffeine, the puritans and nanny-state advocates express concerns about such drugs. One member of the President’s Council on Bioethics, historian Francis Fukuyama, even wants new laws to allow use of these medications only for diseases such as Alzheimer’s and depression, while banning “healthy” people from taking them or any brain-boosting drug.

But to make such fine distinctions, federal regulators would have to eliminate doctors’ ability to write off-label prescriptions, that is, the use of approved medicines for purposes that don’t yet have Food and Drug Administration (FDA) approval. On the basis of information gleaned from medical journals and conferences, doctors prescribe this way more than 100 million times a year. If physicians lacked this authority, they would not be able to make the antidepressant Wellbutrin available to deter smoking, or to prescribe the blood pressure medication Tenormin to alleviate stage fright and other phobias without the drawbacks of conventional anti-anxiety drugs. Even the FDA recognizes that off-label prescriptions are sometimes necessary to good medicine.

Although Prozac-type antidepressants have long been prescribed to troubled individuals, they are now being tested to see whether they can improve the emotional well-being of psychologically “normal” adults. A few studies have shown these drugs can reduce negative feelings such as fear and hostility in healthy individuals. Unlike many patients with depression who complain that these medications blunt their emotions, these study volunteers reported no decline in their ability to experience happiness or excitement. They also appeared to cooperate more readily with others; for example, roommates found them less submissive, but no more domineering or belligerent.

Psychiatrists are prescribing these medications more often to post-depression patients to prevent a relapse, and even to clients who have never met the criteria for clinical depression. The trend suggests even healthy people will start taking them as social lubricants.

Even memory enhancement seems within reach, at least for older folks. One study found nine healthy middle-aged pilots who took the Alzheimer’s drug Aricept, an inhibitor of an enzyme involved in neuronal function, recalled flight-simulator lessons notably better than nine others who took a placebo. As the study’s lead author said, it’s almost as if the placebo group had hangovers, compared with the Aricept group.

While these results are interesting from an experimental standpoint, researchers don’t see Aricept, which has significant side effects, as a potential memory-booster for healthy individuals. Instead, they are focusing on other drugs, including a class that increases an intracellular protein known as CREB, which seems to promote long-term memory in animals with age-related learning deficits.

Who should dictate when and how such drugs can be used? U.S. regulators already impose stringent, hugely expensive testing requirements on the manufacturer of a drug before it can be marketed. Thereafter, it should be up to doctors and patients to decide about on- or off-label uses of the product.

We could soon see a new generation of important brain-boosting drugs, if only we can restrain the technophobic moralists, exactly the people who most need a “smart-pill.”

Henry I. Miller, a physician and former Food and Drug Administration official, is a fellow at the Hoover Institution. David Longtin is a free-lance writer.

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