Seminar Considers
Impact of Drug

It's 6:00 a.m. on a weekday and the beltways around the nation's major cities are packed with commuters. Were all these people asleep by 9:30 last night? Probably not. Most are over-booked, over-stimulated and over-tired.

Would they be tempted to use a drug that promised to keep them awake, and has no signs as yet of being addictive?

This was among the questions recently considered by Helene A. Emsellem, a sleep researcher, and Audrey R. Chapman, an ethicist and director of the AAAS Science and Human Rights Program, who joined interested members of the general public at AAAS on 19 September to discuss the implications of "off-label" use of the prescription drug Modafinil. An "off label" use is one that was not studied as a part of the FDA approval process.

Modafinil, (pronounced mo-DAF-i-nil), sold as Provigil by the pharmaceutical company Cephalon, is a drug that keeps you awake and alert. The FDA approved Modafinil as an aid to people who suffer from narcolepsy, a genetic disorder characterized by sleep attacks and profound sleepiness.

Modafinil is related to neither the caffeine nor amphetamine based stimulants that Michael J. Fox's character "Alex P. Keaton" took to stay awake and cram for finals in a memorable episode of "Family Ties."

Under the influence of caffeine, amphetamines and no sleep, Alex grew increasingly frantic and unable to function. Exhausted, he finally crashed and slept through his economics final. In a cathartic moment after a night of sleep, he promised America he would never cheat sleep with "off-label" prescription drugs again.

In recent years, however, America has embraced "off-label" uses of prescription drugs. Think Prozac. Think Viagra.

"Off-label" use of Modafinil was the focus of the discussion organized through the Program of Dialog on Science, Ethics and Religion at the American Association for the Advancement of Science.

Modafinil is currently available to the 150 to 250 thousand people in the US who suffer from narcolepsy. However, the potential demand for a drug that lets people pack more hours in the day is huge.

Emsellem, the former Director of the EEG Laboratory and Sleep Study Center at George Washington, noted some characteristics of Modafinil that could make it popular among the sleep-deprived masses.

"Modafinil promotes wakefulness with no effect on night time sleep. If you take it during the day, you can still sleep at night."

Emsellem continued, explaining that Modafinil has a low abuse liability. "It is not addictive, there is no subjective euphoria and no known lethal dose."

She also noted that there have been no long term studies on the effects of recreational use of Modafinil.

Ironically, it is this low abuse liability, combined with Modafinil's ability to keep people awake, alert and productive that caught the attention of Dr. Audrey Chapman, an ethicist interested in promoting informed dialog regarding humanity's position "on the edge of a neuro-pharmaceutical revolution."

Chapman asked the audience, "Does human nature have a fixed biological basis? If large numbers of people started taking Modafinil and sleeping less, would others be forced to follow just to keep up at work? Would structures and patterns in the work world change?"

Chapman paused and urged the audience to consider another scenario.

"Are Modafinil and other drugs being tested for potential 'off label' uses as a part of the FDA approval process? Should they be?"

In the Style Section of The Washington Post on 17 June 2002, Joel Garreau wrote an article chronicling his 43-hour Modafinil ride. With the public exposed to this kind of "off-label" press, the question lingers.

"Will Modafinil become as popular as Prozac?"

And if it does, what will it mean? Should we be worried?

— Daniel Kane

11 September 2002