Brave Neuro World - Pharmaceutical Executive

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Brave Neuro World
Cosmetic neurology is a massive off-label market, but pharma has tended to look the other way. FDA may be about to change all that


Pharmaceutical Executive


Booming Consumer Trend

Public speculation that Obama uses Provigil is only the most novel evidence that cognitive enhancement (CE) has hit critical mass, both as an industry and as an issue. Surveys regularly show the use of ADHD drugs by the nation's exam-cramming college students at seven to 25 percent. In 2008, the journal Nature reported that in an informal tally of 1,400 readers, 20 percent said that they use Provigil, an ADHD drug, or a beta-blocker to "improve concentration" at work. Meanwhile, Tech Crunch, a Silicon Valley webzine, reported that local entrepreneurs increasingly equate Provigil with a competitive edge. Many users admit to acquiring the drug over the Internet or on the street, where quality and safety are a crap shoot.

The trend is a mainstay of the media in stories predictably registering either alarm or allure. The popularity of the practice has even introduced its own lingo, such as smart drugs, brain doping, mind hacking, and brain botox, reflecting other leading consumer obsessions.

The value of this market is the stuff that pharma dreams are made of. Steven Ferris, a psychiatry professor at New York University's school of medicine, estimates that a treatment for age-related memory loss alone could pull in $20 billion. "Pharma doesn't even have to build the market," says Chatterjee. "The market will come to pharma."

The value of this market is the stuff that pharma dreams are made of. Steven Ferris, a psychiatry professor at New York University's school of medicine, estimates that a treatment for age-related memory loss alone could pull in $20 billion. "Pharma doesn't even have to build the market," says Chatterjee. "The market will come to pharma."

Yet so far pharma, all too attentive to the many risks, has resisted. "As long as pharma doesn't step up to the plate, the charlatans will," Ferris says of the consumer treasure wasted on nutraceuticals making bogus claims of boosting brain functions, such as the billion-dollar "memory enhancer," ginkgo biloba. The market has also been flooded with technology like brain-fitness software, much of it aimed at Baby Boomers anxious about senior moments and worse.

The Social vs. Scientific Debate

In a seminal paper in a 2004 issue of Neurology, Chatterjee coined the controversial term cosmetic neurology to spark professional discussion about the medical and moral ramifications of a trend that he saw as inevitable. Since then, a mob of adherents ranging from opportunists to visionaries have mobilized around the cause, the social acceptance of which hinges on FDA regulatory approval.

Zack Lynch, executive director of the Neurotechnology Industry Organization and editor of its Brain Waves blog, works a keep-America-innovative angle. "Neurotechnology holds the promise of ... accelerating economic growth for entire countries," he says. "Think of millions of workers in India or China cognitively enhanced ... [to] boost productivity. Will the US be able to place these drugs off-limits and compete?"

Nick Bostrom, director of the Future of Humanity Institute at Oxford University, promotes an enhancement-as-evolution approach. "Human nature [is] ... a half-baked beginning that we can learn to remold in desirable ways: to live much longer and healthier lives, to enhance our memory and other intellectual faculties ... and generally to achieve a greater degree of control over our own lives," his homepage declares.

Still, scientific skepticism persists, starting with the fundamental assumption that a healthy human brain's performance can even be significantly enhanced. "In principle you can adjust your cognition pharmacologically if you are not operating at optimal levels, but the closer you are to optimal, the harder it is to improve," says Michael Minzenberg, associate professor of clinical psychology at the University of California at Davis.

"I don't believe that the current drugs can help people with healthy cognition," says Paul Solomon, professor of psychology at Williams College and founder of the Memory Clinic in Bennington, VT. "There's reason to believe that people with adequate levels of these neurotransmitters will never benefit."

The brain remains science's ultimate black box. Steady advances over the past three decades have shed light on the neuronal processes of memory, learning, and aging, while imaging techniques that map the brain's activity have deepened our understanding of drug effects. Yet the journey from bench to bedside is notoriously tortuous. Given that after a quarter-century of major investment, pharma has failed to develop a truly effective treatment for Alzheimer's, why should we expect steroids for the healthy brain?


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