Editorial:

Does the FDA Need Smart Drugs?

by Ward Dean, M.D.

The FDA’s Talk Paper on smart drugs is full of misinformation, distorted facts, and outright deception. It refers to smart drugs that are obtained “fraudulently through physicians’ prescriptions or imported for personal use.” This is clearly deceptive as there is nothing fraudulent about obtaining an approved substance for a legitimate use if it is prescribed by a physician. Nor is there anything fraudulent in obtaining an unapproved-but-legal substance for personal use when imported in compliance with U.S. laws [i.e., FDA Policy on Mail Importations, dated 20 July 1988].

The Talk Paper states that the “FDA is concerned about the safety of food-based products such as amino acids and vitamins.” The American public would certainly benefit if the FDA spent more time on this aspect of its charter than it does harassing citizens and nutritional supplement manufacturers and distributors. As a physician who prescribes prescription drugs as well as nutritional supplements and herbs, I can state without equivocation that I have seen many more adverse effects from prescription drugs than I have from non-prescription natural substances. My experiences are not unique, as can be seen in the table at the bottom of the facing page summarizing the relative safety of drugs vs vitamins [Loomis, 1992]. Loomis’ report is based on data obtained from annual reports of the American Association of Poison Control Centers. Since 1983, there has been only one vitamin-related death (attributed to niacin, but probably more related to an underlying cardiovascular disease for which the niacin was a treatment). On the other hand, there were more than 2500 deaths due to several common categories of prescription medications during the same period.

The FDA’s statement that “those [smart drugs] that are prescription drugs pose even greater risks” is misleading, for several reasons. First, we’d like to ask, “greater risk than what?” (since we have already established the relative safety of nutritional supplements, above). Second, prescription drugs that are used for cognitive-enhancement purposes are among the safest substances known. For example, there is no known toxic dose for Hydergine or Nootropil (piracetam), the two most widely prescribed cognitive-enhancing drugs in the world. Other substances such as Dilantin, Nimodepine, L-dopa, or selegiline (deprenyl) — which are approved for purposes other than cognitive enhancement — are used in much lower doses for cognitive-enhancing purposes than for their approved indications. Thus, potential side effects (that may be caused by these relatively safe substances when used for their usual therapeutic purposes) are minimized or non-existent when used for cognitive enhancing purposes.

The FDA’s statement that “the drugs are frequently imported from areas outside FDA jurisdiction and often do not meet quality-control standards commonly accepted in this country and enforced by the FDA” is misleading and pure baloney! Most of the foreign drugs that are imported for cognitive-enhancement purposes are manufactured by major international pharmaceutical companies like Glaxo, Sandoz, Pfizer, Parke-Davis, ICF, Ciba-Geigy, UCB, Riker, and others. There is no evidence that these companies use less-stringent manufacturing standards overseas than they do in the U.S. In fact, some medications that are sold in the U.S. by prescription are actually foreign-manufactured drugs that are repackaged with a U.S. label!

We agree with the FDA’s statement that “there are risks in using prescription drugs without the supervision of a physician.” However, nowhere in our book Smart Drugs & Nutrients do we encourage readers to take cognitive-enhancing substances without the supervision of a physician. In fact, to encourage physician supervision, we even provide the names and phone numbers of medical associations whose members are likely to be knowledgeable about such substances. We also provide complimentary copies of the book to physicians of readers of the book. In all fairness to this issue, we musn’t forget the risks of using prescription drugs with the supervision of a physician [see Loomis, 1992].

The FDA’s claim that there is “no adequate scientific evidence available to show that [smart drugs] are safe and effective” is just not tenable, and indicates the FDA’s lack of familiarity with the available scientific literature. Smart Drugs & Nutrients contains over 250 citations to the scientific literature. There is an even greater body of scientific literature which was not included due to the popular nature of the book. Interested investigators can easily access these data.

The statement in the Talk Paper that “even ordinary nutrients such as vitamins and amino acids can be highly toxic” [italics ours] is unfounded. Certainly, isolated cases of mild adverse reactions can be found to anything — including aspirin, and even water. However, the paucity of reported adverse reactions (despite the FDA’s repeated efforts to encourage physicians to report such adverse reactions) to even “megadoses” of vitamins and amino acids confirms that they are not “highly toxic.” Even tryptophan, which the FDA claims is toxic, isn’t. Prior to several bad batches manufactured by Showa Denko and imported into the United States, there was no reported toxicity from tryptophan use — despite 14 million users taking tryptophan regularly over a twenty year time period. The FDA’s “highly toxic” claim, even with tryptophan, is just an empty claim without scientific merit.

On the contrary, the Talk Paper confirms that “no injuries” have so far been reported to the FDA, by the over 100,000 estimated smart drug users in this country. However, the paper again unjustifiably implies that there is a question about the “actual identity” of cognitive-enhancing substances — despite the fact that they’re generally manufactured by reputable international pharmaceutical firms, as I have pointed out.

The FDA’s claim that “the popularity of smart drugs is due to ill-conceived and unfounded theories based on misconceptions about how drugs and other chemicals affect the body” is itself an ill-conceived and unfounded statement. For example, they claim that “one of the flawed concepts is that drugs used to help correct dysfunctional brain conditions such as epilepsy or dementia can somehow elevate normal brain function to a smarter, ‘better than normal’ state” — but does not explain how such a concept is allegedly flawed. We, on the other hand, cite documentation that such effects actually occur in normal individuals [Bonke and Nickel, 1989; Schoenthaler, 1991].

Another statement incorrectly asserts that “further misguided claims that smart drugs have anti-aging properties stem from the fact that U.S. drug companies are conducting research to develop drugs to benefit various conditions associated with aging including Alzheimer’s and Parkinson’s diseases.” The explanations for the anti-aging properties of several substances are, in fact, based on an understanding of their physiological and biochemical properties, results of human clinical studies, and extrapolation from lifespan studies that were conducted on animals. For example, deprenyl [Knoll, 1988], melatonin [Maestroni, et al., 1988], and DMAE [Hochschild, 1973] have all significantly extended the lifespans of experimental animals.

Another erroneous statement is that “another false [italics ours] rationale is that mental deterioration is a deficiency disease and can be prevented.” Again, this criticism is without substantiation, although there are a number of excellent studies that demonstrate improvement in cognitive performance with nutritional supplementation [Shoenthaler, 1991; Bonke and Nickel, 1989].

The Talk Paper’s reference to the numerous news features that discussed Smart Drugs & Nutrients as “promotions” is misleading. These news programs were no more promotions than the news programs that have featured Dr. Kessler promoting recent FDA enforcement actions.

The Talk Paper substantiated its attack on Smart Drugs & Nutrients by citing “scientists not involved in smart drug promotions who were being interviewed in press reports [who] attribute smart drugs’ reputed benefits to placebo effects or to misinterpretation of the actions of stimulant ingredients such as caffeine.” Why place such credibility on unsubstantiated anecdotal reports by scientists not associated with smart drugs? A better approach would be to discuss the subject with scientists who conducted the studies which were cited in Smart Drugs & Nutrients and Smart Drug News. Furthermore, we cite numerous studies which conclude that caffeine actually impairs cognitive performance, rather than enhancing it, as is commonly believed.

The FDA’s claim that “None of the claims for smart drugs have been subjected to testing in controlled clinical trials“ is absolutely false and demonstrates the FDA’s ignorance of the scientific literature. In fact, many such studies have been performed, in both normal and cognitively impaired subjects.

The FDA criticizes that “most marketers and promoters of smart drugs avoid putting their claims directly on the products’ labels.” This is obviously because such labeling would be in violation of FDA regulations and would subject the manufacturers to even greater persecution by the agency. It is no wonder that smart-drug marketers must depend on persuasive ads and sales pitches made by word of mouth through “sales reps” and organizations. Most incredible, however, of all the deceptive misinformation in the Talk Paper is the statement that, “Any product, regardless of its composition, that is clearly associated with smart drug claims — is illegal and subject to seizure or other actions by the [FDA] to protect the public health.” Does this mean that when somebody’s grandmother advises them to eat fish because it is “brain food,” that Granny can be arrested and the fish seized?

The final paragraph of the Talk Paper perpetuates the misconception that approved drugs can be used only for approved purposes. This is clearly in violation of the FDA’s own policy which states that “accepted medical practice often includes drug use that is not reflected in approved drug labeling” [FDA Drug Bulletin].

It is clear that smart drugs are the target of the latest FDA vendetta. A review of the available world literature on the subject clearly indicates that the FDA, by its obstructionist attitudes and policies — rather than protecting the health of the American public — has become the greatest single impediment to medical progress in this country.