In a move that has drawn criticism from leading researchers and the Alzheimer’s Association, the Canadian pharmaceutical company Bellus Health has begun to sell the would-be prescription drug tramiprosate (aka Alzhemed or homotaurine) over the counter as a nutritional supplement.
Last year, the compound, developed as an amyloid inhibitor, failed to gain FDA approval for treatment of Alzheimer disease based on a large North American trial carried out by Neurochem of Laval, Quebec (see ARF related news story). A few months later, Neurochem ended a separate European trial and announced it would market homotaurine, an amino acid that occurs naturally in seaweed, as a nutraceutical (see ARF related news story). With its stock price in the basement, last April Neurochem changed its name to Bellus Health. In September, the company began to sell homotaurine under the brand name Vivimind in stores around Canada and over the Internet, but not, so far, in the United States.
Based on information on the Bellus website, the product is billed as a “memory protective agent” and targeted to healthy aging baby boomers. The marketing material features selected data from the North American trial.
“They are using negative data from an Alzheimer’s trial to argue that the drug could work in people who do not have Alzheimer’s disease and may be worried about their memory,” said Lon Schneider of the University of Southern California. “The company is not going to let negative results stand in their way. They are marketing it in Canada because they can market it [there].” Due to differences in Canadian and U.S. law, homotaurine can be sold north of the border while the company goes through the Canadian government’s nutraceutical approval process, but separate approval is required to sell in the U.S. The company did not answer requests for more information about plans to introduce the product to the U.S. market.
Sam Gandy of the Mt. Sinai School of Medicine in New York added by e-mail, “In my opinion, the compound was established to be ineffective, at least in the trial design that was employed. One can argue that it might be effective as prevention, but that has not been proven. Bringing it to market does a disservice to patients, families, and clinicians.”
“It is amazing to me that in these days when we go to great time and expense to revisit old drugs that were never properly assessed in the past (e.g., hydergine as reported in the August 1990 NEJM by Thompson et al.), that a proper trial (like that of Alzhemed) fails, and yet those with financial interest re-brand it provocatively ("Vivimind") and market it cynically through what amounts to a regulation loophole,” Gandy wrote.
Paul Aisen of Georgetown University in Washington, DC, the principal investigator on the tramiprosate trial, wrote in an e-mail to ARF, “I do not think that compounds should be marketed for ‘protection of memory function’ unless they have been demonstrated to be effective and safe. The trials of tramiprosate did not demonstrate efficacy. (On the other hand, the same concern—no evidence of efficacy—could be made regarding most marketed nutraceuticals.)”
Finally, the Alzheimer’s Association has taken a strong stand against the use of homotaurine. In a written statement, the Association says it “does not support the use of the dietary supplement VIVIMIND—by people with Alzheimer’s disease or other dementia, family members of people with dementia, people worried about getting Alzheimer’s, or the general public.”
“Everyone wants better treatments for Alzheimer’s and dementia,” the statement says. “However, proof of the value of all interventions—including medical treatments, lifestyle changes, and dietary supplements—must precede new products into the marketplace. This product does not have that proof.” (See text of the complete statement [.pdf].)—Pat McCaffrey.
- FDA Deems U.S. Alzhemed Trial Results Inconclusive
- Philadelphia: European Trial of Alzhemed Ends, Marketing Morphs to Supplement
- Thompson TL, Filley CM, Mitchell WD, Culig KM, LoVerde M, Byyny RL. Lack of efficacy of hydergine in patients with Alzheimer's disease. N Engl J Med. 1990 Aug 16;323(7):445-8. PubMed.