(Boston)--Despite it being more than 30 years since the "fountain of youth drug" Gerovital H3 was banned in the United States, it may be making a comeback. In an editorial published in this month's Journal of the American Geriatrics Society BUSM researcher Thomas Perls, MD, points out that a few U.S.-based anti-aging and longevity clinics have begun to advertise Gerovital H3 in pill form and as intravenous infusions despite the fact that the U.S. Food and Drug Administration (FDA) banned it in 1982.
Gerovital H3 is the dental anesthetic procaine hydrochloride (novocaine), yet in the 1950s, this drug was abused among Hollywood stars. According to Perls governmental bodies such as the FDA are relied upon to protect their citizens from drugs that do not do what they are claimed to do or are unsafe, yet in communist Romania, the opposite occurred with the state-sponsored marketing of Gerovital H3. In 1956, a paper titled "A new method for prophylaxis and treatment of aging with Novocain-eutrophic and rejuvenating effects" was published in the now discontinued journal Therapiewoche by Ana Aslan, director of the Geriatrics Institute of Bucharest. As a result the communist regime established an anti-aging resort and clinic for foreigners.
Perls explains that by the 1970s, the National Institute on Aging commissioned a thorough evaluation of the studies and claims surrounding Gerovital H3. "The conclusion of that work was that, except for a possible mild monoamine oxidase (MAO) inhibitor effect that would potentially ameliorate depression, there was no scientifically credible evidence supporting the claims that procaine hydrochloride is beneficial in treating age-related diseases or syndromes," said Perls, professor medicine at BUSM and director of the New England Centenarian and Supercentenarian Studies at Boston Medical Center. Perls points out that a plausible explanation for why some subjects might have experienced some improvements in health was that, in addition to receiving Gerovital H3, they were receiving other interventions such as exercise, stress reduction and healthy nutrition. "Thus, a glaring problem for the demonstration of any benefit associated with Gerovital H3 or similar compounds is the absence of any double-blind, placebo controlled trials demonstrating a significant improvement in the outcomes that anti-aging doctors and entrepreneurs claimed," he added.
Additional studies were later performed to further investigate a possible MAO inhibitory effect from procaine hydrochloride and any subsequent neurocognitive benefit but there was no evidence that procaine and its preparations could treat or preventing cognitive impairment or dementia.
"Gerovital H3 appears to have experienced a recent rebound in marketing and sales in the United States, primarily because of Internet-based marketing. A search for "Gerovital H3" on Google or Yahoo! results in more than 300,000 hits. Inquiring patients and the public need to be informed about the approved and unapproved uses of procaine hydrochloride and aware that there is no scientific evidence supporting any systemic health benefits or "anti-aging" effects of the drug," said Perls.