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Fatigue-Beating Drug Induces Euphoria
March 12 2003
Maia Szalavitz

Modafinil raises questions about drug coverage

For its "Superman" series, Slate writer David Plotz tries modafinil (Provigil), a drug approved by the FDA for narcolepsy, but touted by the press and its manufacturer, Cephalon Inc., as a potential wakefulness drug without the potential for the addiction, mood crash and ensuing sleep deficit that follows use of other stimulants. The idea is that modafinil simply eliminates the need for sleep, allowing greater productivity, with no downside.

Earlier, The New Yorker had profiled the drug, claiming that it has a completely different mechanism of action than other stimulants, and acts only on the cells necessary to promote alertness - which secrete a substance called hypocretin (also known as orexin - the battle over which name should stick has not yet been won).

However, in people with narcolepsy, these cells are either in very short supply or non-existent; and the disease is thought to result from progressive loss of these cells or a congenital absence. In other words, if the drug worked only on these cells, it couldn't possibly effectively treat a condition in which they are missing or depleted. The thing is, it does.
Another hint that all is not as it seems comes in Plotz's article. He describes the drug with the luxuriant praise usually only seen in early accounts of addiction, before the worm turns.

The FDA has already warned Cephalon to stop making exaggerated claims about it. In its letter, the agency says that, as Plotz discovered, modafinil produces euphoria, just like other stimulants. In fact, tests found that it produced a euphoria level similar to that seen with Ritalin, a drug which is already known to have abuse potential.

The history of addiction is marked by ecstatic claims of new, non-addictive drugs which later prove to be trouble for some users. Heroin, for example, was introduced by Bayer as a non-addictive morphine. More recently, benzodiazepines like Valium were touted as alternatives to barbiturates. In that case, benzodiazepines did prove to be safer - but the risk of both addiction and overdose were only reduced, not eliminated.

The truth about modafinil remains to be seen. Media coverage of drugs is almost always filled with hyperbole - with both fears and potential benefits tending to be greatly exaggerated. The American Medical Association newsletter recently described Cephalon's latest studies, which support the use of the drug to help shift workers stay alert. If the FDA approves such use, the manufacturer could legally make claims that the drug can be used to fight ordinary fatigue.

America needs to ask itself whether it wants to accept the use of drugs for such "lifestyle" reasons - whether, for example, an alert late-night trucker is better than one who drowses and can potentially kill. The military, as many learned during a recent trial of several American pilots who accidentally bombed Canadian troops in Afghanistan, already believes that amphetamines - the use of which gets truckers arrested - improve pilot performance, and there is data to support their view.

The press needs to avoid both drug promotion and anti-drug hysteria - and be careful to examine the values inherent in judgments about risks related to drugs. Aside from this story in Reason, almost no one asked why some government agents devote their careers to putting speed-takers in prison, while others hand out virtually the same stuff to their top guns? Apparently, the military has recently become very interested in modafinil.



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