The Ultimate Cure

One of Targacept's leading compounds is designed to improve cognitive activity in patients with Alzheimer's disease; another is for schizophrenia. Both are in human trials. So far, the drugs have worked well for those with the diseases, but the Alz�heimer's compound has also had an effect on healthy control subjects, whose scores on cognitive and memory exams improved significantly. The company also tested the compound on people who went to a memory clinic with mild age-associated memory impairment-the natural loss of memory that comes with normal aging. The mini-trial was a success: "People on 50 milligrams consistently said they remembered things better," deBethizy says.

Several other companies are developing meds that could treat brain-function slowdown in the elderly and might also enhance brain function in younger people. These firms include Memory Pharmaceuticals, Cortex Pharmaceuticals, and Lilly. "We are working on glutamate receptor medicines for memory and cognition," says Steve Paul, president of Lilly Research Laboratories. "This is a big future growth area for us."

But the drugs' success with healthy people raises a number of regulatory and ethical questions. The F.D.A. evaluates drugs based on how effectively they treat disease, not on whether they enhance healthy brains. Benedetto Vitiello, a psychiatrist and researcher at the National Institute of Mental Health who has also sat on neuropharma advisory panels for the F.D.A., acknowledges that many people face cognitive loss as part of normal aging. But the condition is often subtle and hard to quantify, he says. This may be one reason that the F.D.A. has been reluctant to list age-related cognitive loss as an official approved designation for new drugs, deBethizy suggests. He expects the F.D.A. to one day recognize it as an approved disease, "but right now," he says, "no one wants to spend the resources on a drug that may not be approved."

Yet mind-meds that can enhance mental functions are already used by healthy people. Through what's known as off-?label use, legal prescriptions are written for conditions the drugs weren't approved to treat. Physicians are allowed to prescribe any drug for any illness they see fit, but companies are barred from promoting drugs for unapproved uses.
A more recent drug being widely used off-label is Cephalon's Provigil. This high-tech medicine is approved for narcolepsy and a sleeping disorder that develops when people work odd shifts. Provigil, however, is widely prescribed for other conditions, ranging from depression and A.D.D. to jet lag. In late 2007, Cephalon agreed to pay a $425 million settlement to the government after the firm's sales force was accused of marketing Provigil and two other drugs to physicians to use for unapproved maladies. "It would behoove the federal government to get ahead of the enhancement issue now," says Zack Lynch. "Provigil is just the beginning."

A larger debate is percolating over what would happen if a pill could turn most people into brainiacs. "I don't believe in cognitive enhancement for people who are well," says memory expert and Nobel laureate Eric Kandel, a professor at Columbia University. "These should be pharma products for sick people." N.I.H. neuroscientist Jordan Grafman agrees: "If you manipulate the brain, it can change who we are."

Others say enhancers can't be stopped. "The record is clear. Wherever there have been new agents that enhance our functioning, mental or physical, even when they're risky like steroids, there are people who will use them," says U.C.L.A. bioethicist Gregory Stock, author of Redesigning Humans: Our Inevitable Genetic Future and a strident advocate for enhancement. "Why shouldn't people use them if they don't hurt us?"

Back in the less surreal world of their favorite San Francisco coffee shop, Zack and Casey Lynch tell me that their organization delisted four companies a mere three months after the neurotech index joined Nasdaq, highlighting the fact that those who would make money from our brains face a brutal reality. "It's a tough industry," Zack says with a sigh, as Casey crosses out the delisted companies and writes down the new ones on the chart they had given me. "But the future is clear," he says, quickly recovering his zeal, reminding me of Don deBethizy and the other neuro-cheerleaders. "This is going to work. The effects are going to be profound."

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