The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 7 No.
1 • February 2004
The Federal Death Administration Strikes Again: Drug Standards Applied to a Food
Many neurological disorders are characterized by abnormal, insoluble deposits of protein aggregations, including Parkinson’s disease, Alzheimer’s disease, Huntington’s disease, and others. In the case of Huntington’s, the insoluble deposits are formed from polyglutamine aggregates (an abnormal expansion of CAG repeats in the huntingtin protein). In a new study, researchers report that various disaccharides (including the sugar trehalose) reduced the formation of polyglutamine aggregates in vitro and that this correlated with a decrease in cell death in a cellular model of Huntington’s disease. Moreover, oral feeding in vivo of trehalose to a transgenic mouse model of Huntington’s disease inhibited the formation of truncated huntingtin aggregates and improved the associated motor dysfunction. Hence, trehalose is potentially a therapeutic agent in human Huntington’s disease.
Trehalose is a food, available commercially for use in foods and dietary supplements. One would think, therefore, that if there is even a small chance that trehalose would be beneficial in the disastrous Huntington’s disease, human experiments should be begun forthwith. After all, there can be no question of its safety. As the comments on this study note, “The extremely low toxicity and high water solubility of this compound make this an attractive therapeutic approach, although the therapeutic effects seem to result from prevention of new aggregate formation, not from reversal of the pathology.”
So what’s the holdup? First, trehalose must be tested in a Phase I human trial, which is a test for safety, not for effectiveness in treating disease. Why spend millions on an entirely unnecessary Phase I human trial for a low-toxicity food? Because that is how the FDA’s rules say it must be done in order to be approved for drug use (i.e., to be permitted to put truthful information on the trehalose label concerning its relation to a disease), for example, as a possible treatment for Huntington’s disease. Trehalose can be sold legally as a food or dietary supplement, but only if you do not mention anything about a possible effect on disease. It is the information when placed on the label or labeling, not the substance, that is illegal. We argue in our ongoing suit against the FDA, Whitaker v. Thompson, that the FDA’s prohibition on the communication of truthful, nonmisleading information about a legal dietary supplement or a food (such as trehalose) is a violation of the First Amendment (“Congress shall make no law . . . abridging the freedom of speech . . .”).
Prohibiting the communication of information to the public (and even to doctors) about food substances unless the FDA says you can say it is the basis of the FDA’s approval process, which is biased in favor of drugs. If the First Amendment means anything, it means that you can communicate truthful, nonmisleading information to anyone you like without having to get the government’s permission. That is why Dr. Julian Whitaker and a few others of us are continuing this expensive battle all the way to the U.S. Supreme Court. You can follow this case, read all the briefs and court decisions, laugh and weep, and donate money (any amount will help), at www.emord.com. If you really want to live an extended lifespan (not to speak of living in a free society), this is a battle that we must win.
Ironically, new methods of producing trehalose are being developed commercially to reduce its price and to make it possible to use as a substitute for high-effectiveness carbohydrate sugars in mass-produced food products, especially low-carbohydrate foods. Once again, the FDA prohibits communication on labels of “forbidden” knowledge, at the point of a gun—knowledge that might reduce terrible pain and suffering for thousands.
- Tanaka et al. Trehalose alleviates polyglutamine-mediated pathology in a mouse model of Huntington disease. Nature Med 10(2):148-54 (2004).
- Katsuno et al. Sweet relief for Huntington disease. Nature Med 10(2):123-4 (2004).