Cosmetic Neurology

Dear Friends and Colleagues:
Attached an interesting article from a recent edition of BusinessWeek reporting the emergence of cognition enhancers as the next financial goldmine for pharmaceutical companies seeking new applications for existing drugs.
I am categorically opposed to permit the expansion of the clinical application for these medications and look forward to your comments and response.
Happy Holidays, Merry Christmas, Happy Hanukkah.
Yours
Bernd

Bernd Wollschlaeger,MD,FAAFP,FASAM
President, Florida Society of Addiction Medicine


DRUGS December 18, 2008, 5:00PM EST
A Boom in Memory-Enhancing Drugs?
Some scientists predict boomers and college grads alike will fuel a boom in so-called cognition drugs. But at what risk?

By Ellen Gibson

Facing an important job interview, the college graduate searches her closet for the perfect outfit, then rifles through her medicine cabinet for just the right cognitive-enhancement pill. Adderall, perhaps, to help her concentrate. Or Provigil, for alertness...or maybe a beta blocker to combat jitters?

Doctors in the U.S. who track drug trends say scenarios like this could play out in a thousand variations as college students who grew up using prescription drugs as study aids enter the workforce. Many high-powered professionals are already popping such pills in secret. Within a few years they could be joined by millions of older adults, including baby boomers who decide there's nothing wrong with using "smart drugs" to ward off senior moments. The drug industry will benefit mightily if public opinion swings this way.

Many healthy people have trepidations about tinkering with the brain using addictive or otherwise risky pharmaceuticals. But those reservations are eroding for several reasons. A whole generation has come of age using attention-deficit drugs such as Adderall and Ritalin, a category valued at nearly $4.7 billion in 2007. A lot of teenagers have used them casually as study aids, often buying them on the Internet. And now, overworked professionals are seeing the appeal. "From assembly-line workers to surgeons, many different kinds of employee may benefit from enhancement and want access to it," wrote Martha J. Farah, director of the Center for Cognitive Neuroscience at the University of Pennsylvania, in a recent commentary in the science journal Nature. In the controversial essay, she and her co-authors, including Stanford Law School Professor Henry T. Greely, declared it's time for people to overcome their squeamishness: "Mentally competent adults should be able to engage in cognitive enhancement using drugs."

Cognition drugs are already a big market. Adderall XR, the extended-release version of the ADHD drug, brings Shire Pharmaceuticals (SHPGY) $1 billion a year. Pfizer's (PFE) Alzheimer's drug Aricept had U.S. sales of $1.6 billion in 2007—and it may give a boost to healthy people as well. In a small study, airline pilots on the drug showed some improvement in short-term memory. Then there's Provigil, a narcolepsy treatment that pulls in $840 million for Cephalon CEPH). Analysts say a fair portion of that comes from healthy people who use it to stay awake.

A half-dozen companies now have memory drugs in their research pipelines that the U.S. Food & Drug Administration will review initially as treatments for Alzheimer's or age-related dementia. But Steven Ferris, a neurologist and former committee member at the FDA, says there is huge potential for a memory treatment aimed at still-healthy baby boomers—and predicts that the FDA will ultimately condone such uses. "The first evidence-based memory treatment could be a $20 billion drug," predicts Ferris, who now runs an aging and dementia research center at New York University School of Medicine.

At the FDA, cognitive enhancement is barely on the radar right now. The majority of medicines the agency oversees are designed to treat diseases. Drug companies believe this could present a problem for smart drugs—a worry that may be inhibiting research spending in this area. "Regulators would have a hard time approving [cognition drugs] if they're not intended for a medical condition," in part because they have known health risks, says Shire spokesperson Matthew Cabrey.

Indeed, ADHD medications carry so-called black box warnings on their labels. Potential side effects of Adderall range from insomnia to cardiac events. Medical ethicists have a separate set of concerns. They worry poor people don't have the same access to these drugs as the wealthy.

What's more, if social concerns about smart drugs were to vanish, pressure to use them in the workplace might become irresistible. Under certain circumstances, "it is totally understandable for a manager to encourage people to change their work performance through drugs," Martha Farah said in an interview.

Her colleague Dr. Anjan Chatterjee, a neurologist at the University of Pennsylvania Hospital, raises another red flag. Creative insights often arise when the mind is allowed to wander, he says. If drugs that sharpen concentration become widespread in the workplace, they may nurture "a bunch of automatons that are very good at implementing things but have nothing to implement."

Chatterjee has thought deeply about this new class of drugs. In a famous 2004 research paper, he coined the term "cosmetic neurology," and he compares the current state of cognitive enhancement to the advent of cosmetic surgery. That specialty evolved as doctors struggled to help disfigured soldiers returning from World War I. It then morphed into a form of "elective self-improvement," he says. The same could happen with smart drugs. After all, the FDA currently regulates treatments for wrinkles, hair loss, and sexual dysfunction, which are not strictly medical in nature. Cognition drugs are the next obvious frontier. Says Chatterjee: "This is inevitable."

Gibson is an editorial assistant with BusinessWeek.