TCS Daily

Pill, Anyone?

By Henry I. Miller - September 13, 2004 12:00 AM

Americans are no strangers to using chemicals for altering their mental state. No, we don't mean marijuana or ecstasy for recreational purposes, 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 that you can take every night without becoming dependent on it, 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.

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 people think so. As this science advances far beyond caffeine, the puritans and nanny-state advocates are voicing concerns about such drugs. One member of the President's Council on Bioethics, historian Francis Fukuyama, even wants new laws to allow the 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 over 100 million times a year. If physicians didn't have 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 for the practice of good medicine. According to the agency's website, "Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects."

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 that 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 to be less submissive, but no more domineering or belligerent.

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

Even the enhancement of memory seems within reach, at least for older folks. One study found that nine healthy middle-aged pilots who took the Alzheimer's drug Aricept, an inhibitor of an enzyme that is involved in neuronal function, did notably better at recalling flight-simulator lessons than nine others who took a placebo. As the lead author on this study said, it's almost as if the placebo group had hangovers when 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 make decisions about on- or off-label uses of the product. But paternalists such as Fukuyama want more regulation. In "Our Posthuman Future" (pp 213-214), he has written: "The FDA is not set up to make politically sensitive decisions concerning the point at which selection for characteristics like intelligence and height ceases to be therapeutic and becomes enhancing, or whether these characteristics can be considered therapeutic at all. The FDA can disapprove a procedure only on the grounds of effectiveness and safety, but there will be many safe and effective procedures that will nonetheless require [additional] regulatory scrutiny." He feels the FDA is unequal to this task, and sees "the need to create a new agency to oversee the approval of new medicines, procedures, and technologies for human health. In addition to having a broader mandate, this new authority would have to have different staffing. It would have to include not just the doctors and scientists who staff the FDA and oversee clinical trials for new drugs, but other societal voices that are prepared to make judgments about the technology's social and ethical implications."

At the very least, this scheme would impose yet one more level of regulation upon one of society's most highly regulated classes of products. The need to include new "societal voices" to make decisions about consumers' -- and physicians' -- ability to use demonstrably safe and effective products sounds ominously like the anti-libertarian tyranny of the nanny-staters.

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

Henry I. Miller, a physician and former FDA official, is a fellow at the Hoover Institution. David Longtin is a freelance writer.


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