Smart Drugs and Drink May Not Be Smart

by Food and Drug Administration (FDA)

Ever since the days when snake oil salesmen crisscrossed the American frontier peddling miracle potions, unwitting consumers searching for a magic bullet have eagerly spent hard-earned cash on unproven drugs and useless concoctions.

During the early 1900s, many believed that "William Radam's Microbe Killer," which was 99 percent water, would cure all diseases. In the 1950s, hundreds of men and women suffering from various types of cancer turned to a horse-blood extract as the cure. And, most recently, thousands of young professionals have begun using so-called "smart" drugs and "smart" drinks as a way to increase energy, improve memory, and boost intelligence.

Some "smart" drugs are prescription medications approved to treat debilitating mental disorders, such as dementia and Parkinson's disease. Among the more popular are Hydergine (ergoloid mesylates), Eldepryl (selegiline hydrochloride), Dilantin (phenytoin), and Diapid (vasopressin).

Other "smart" drugs are medications not approved in the United States. These include piracetam (Nootropil), aniracetam (Draganon), fipexide (Attentil), vinpocetine (Cavinton), and Oxicebral (vincamine).

"Smart" drinks are made with amino acids, such as phenylalanine, choline, L- cysteine, and taurine, which are blended into juices and other nonalcoholic beverages.

But, like cure-alls of the past, no scientific evidence exists to show that "smart" drugs and "smart" drinks work, and FDA has not approved any drug or product to enhance memory or intelligence.

"The notion that "smart" drugs affect intellect is based on the belief that drugs designed to treat people suffering from dementia and other conditions that affect the mind can make normal people sharper," said Thomas Crook, Ph.D., a researcher with Memory Assessment Clinics, Inc., of Bethesda, Md. "But there is not scientific proof to back up this theory."

Crook, who headed the National Institute of Mental Health's geriatric psychopharmacology program from 1971 to 1985, said that no human studies objectively show that "smart" drugs can enhance the mental performance of normal individuals. No credible studies measuring subtle changes in normal individuals after taking "smart" drugs for a long period have been conducted.

"The research data I've seen was not based on well-controlled studies in which a 'smart' drug and a placebo were compared, and in which there was an objective measure of how successful the drug was, such as having to remember someone's name," Crook said.

"The clinical evidence relied on animal models, but animals and humans may not react the same. Individual people are different, too. A 25-year-old stockbroker won't react to certain stimuli in the same way that an older person would."

Safety Concerns

While efficacy of "smart" drugs is unproven, side effects associated with their use are well documented. Piracetam and Hydergine can cause insomnia, nausea and other gastrointestinal distress, and headaches.

Adverse reactions associated with Diapid include runny nose, nasal ulceration, abdominal cramps, and increased bowel movements.

Vincamine should not be used by pregnant women or children because it can cause gastrointestinal distress.

Although most of the known side effects are short-term, health professionals fear that the possibility of long-term side effects also exists.

"We just don't know what adverse effects there could be later," said James L. McGaugh, Ph.D., director of the Center for the Neurobiology of Learning and Memory, University of California-Irvine. "There haven't been enough studies conducted over a long period of time."

Further complicating the safety issue is the megadoses and different combinations of "smart" drugs users claim are needed to achieve the desired effects.

The effect of piracetam, according to "smart" drug enthusiasts, can be increased if taken in combination with Hydergine. Aniracetam, they say, works best if taken with choline. And no combination will work, say "smart" drug users, unless taken over an extended period.

"Based on theoretical evidence, you'd have to keep taking them to maintain the effect," said Crook. "When taken in combination over time, we don't know that they're safe."

"Smart" drinks, while consisting of amino acids, present similar safety concerns. If the drink contains a large dose of a substance or if many drinks are consumed, toxicity and short-term adverse side effects are possible, although small doses may also be toxic.

A recent report on amino acids prepared by the Federation of American Societies for Experimental Biology concluded that even healthy men who take single or incomplete mixtures of amino acids as dietary supplements are engaging in a potentially harmful practice. According to the report, other groups taking these supplements are at an even greater risk of possible adverse effects and should not use them without responsible medical supervision.

In large doses, phenylalanine may make some people irritable or cause insomnia. In addition, this amino acid should be avoided by people with phenylketonuria (PKU), a birth defect caused by the body's inability to metabolize phenylalanine. (Diet products made with aspartame [NutraSweet] contain phenylalanine at low, safe levels for people who don't have PKU and must bear labels warning people with PKU of the presence of this amino acid.)

Too much dietary choline can cause gastroenteritis and pancreatitis.

L-cysteine should not be used by children or pregnant women because it could possibly harm the fetus, and published studies show that taurine causes adverse effects in PKU patients, individuals with Wilson's disease — a potentially fatal genetic disorder caused by the body's inability to metabolize dietary copper — and persons taking MAO (monoamine oxidase) inhibitors, such as the antidepressants Parnate, Nardil, Marplan, and Eutonyl.

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.