Gerovital

Gerovital H3 is a controversial preparation, developed during the 1950s in Romania by Dr. Ana Aslan (1896?–May 20, 1988) It was and is promoted by its advocates as an effective anti-aging treatment. During Gerovital's "jet-set" heyday, Dr. Aslan's clinic gave Gerovital treatments to a stellar array of celebrities and dignitaries, reportedly including John F. Kennedy, Marlene Dietrich, Kirk Douglas, Salvador Dali. As of 2004 the mainstream medical view is that the preparation was seriously investigated in the 1960s and discredited, and that any promotion today is quackery. In the United States, the FDA bans Gerovital H3 from interstate commerce as an unapproved drug and, since 1982, has prohibited its importation.

A 1973 New York Times article said "cold water was thrown on [Gerovital]'s reputation years ago" by "three reports published simultaneously in British Medical Journal [that] found no merit for procaine hydrochloride for any of the problems of aging."

In the 1970s and 1980s, Gerovital H3 received some investigation as a treatment for clinical depression, but was never accepted as useful. Advocates, however, still suggest that Gerovital H3 acts as an MAO inhibitor.

In 1994, the U. S. FDA Consumer magazine said: "No health claims for Gerovital have been substantiated, and FDA considers it an unapproved new drug. It has caused low blood pressure, respiratory difficulties, and convulsions in some users." (Suppliers assert that the product is safe, and one cites a brief quotation from a newspaper article that says "while as early as 1973 Elmer Gardner of the FDA's Bureau of Drugs stated 'There is no safety problem with Gerovital H-3.'")

The main active ingredient is the well-known local anesthetic Procaine hydrochloride, (often referred to by the old brand name, Novocaine). It also contains small amounts of benzoic acid, potassium metabisulfite and disodium phosphate which are said to be important in the formulation, rendering it more effective by "stabilizing" it. Some advocates acknowledge that despite the stabilizers, the procaine in Gerovital H3 breaks down rapidly into DMAE and PABA, but ascribe the beneficial effects to these breakdown products.

From the 1950s until her death in 1988, Dr. Aslan promoted Gerovital H3 with great success. In the 1960s and 1970s her Romanian clinic, the Parhon Institute, became a mecca for celebrities seeking treatment, and an upscale tourist attraction. The New York Times referred to Gerovital's "jet-set aura," noting that Dr. Aslan had been covered in "society columns where such public figures as Nikita S. Khrushchev, Konrad Adenauer, and Ibn Saud have been listed among the multitudes said to have taken the drug." As late as 1988 an advertisement by the Romanian National Tourist Office lauded "the picturesque and exciting cities, scenic delights, famous resorts (including Gerovital H3 treatment centers), cultural and historic treasures that await the traveller to Romania."

Procaine itself is universally considered to be a drug. Older references by advocates Gerovital H3 always refer to it as a drug. Hoffer and Walker (1980) call it a "youth drug." Mircea Dumitru, Dr. Aslan's colleague and personal physician, describes it as "a complex drug acting like the procaine molecule... The addition of benzoic acid, potassium and disodium phosphate increase the effects of Gerovital-H3® biotrophic treatment." Web-based suppliers outside the United States that offer to ship the preparation to the U.S. generally characterize it as a "nutrient" or "vitamin," perhaps because of less strict legal treatment of nutritional supplements in the U. S. under the Dietary Supplement Health and Education Act of 1994.

Whether characterized as drug or nutrient, as of 2004, the FDA's 1982 automatic detention alert is still in effect and bans the import of Gerovital H3 into the U. S. as "a new drug within the meaning of 201(p), without an approved new drug application [Unapproved New Drug, Section 505(a)]." The ban includes

• Gerovital, GH3, KH3, Zell H3, GH3, GH3 Cream, etc.
• finished injectable or oral Procaine Hydrochloride
• bulk Procaine Hydrochloride

It is notable that virtually every company claiming to supply Gerovital H3 to the U. S. warns of widespread distribution of fake formulations. Each company suggests that products supplied by its competitors are phony (while asserting that they and only they are the only supplier of the real Romanian formula).

• One company says it sells "real" Gerovital H3 and warns that "the American market is flooded with fake GH3®."
• Another says it has "the ONLY ORIGINAL FORMULA BEING IMPORTED TO USA."
• A third says "Beware of the many phony GH3's... we are the only company willing and able to supply documented proof of our GH3's authenticity."

One Gerovital advocate states that the only way for a U. S. consumer to authentic Gerovital H3 is to have a compounding pharmacy in the U. S. prepare it from a doctor's prescription. He adds, "don't bother with a conventional doctor [who] will have the usual American medical establishment brain wash attitude."

2003 UK Trademark revocation In the U.K. the term "Gerovital H3" was formerly consideed to be a trademark of Prof  Dr A Aslan, registered to Gerovital Cosmetics SA, but in 2003 the trademark was successfully challenged by Societatea Comerciala “Farmec” SA and the trademark was revoked.

References

• "Disputed Drug Is Restudied for Use in Geriatrics," HAROLD M. SCHMECK Jr. New York Times, March 18, 1973
• "Our colorful TOUROMANIA booklet has it all," New York Times, March 6, 1988. (Gerovital treatments as a tourist attraction)
• Hoffer, Abram and Morton Walker (1980) Nutrients To Age Without Senility, Keats Publishing New Canaan, CT 1980; quoted at [1] (http://www.gerovital.homechoice.co.uk/gerovital-gh3-anti-aging1.htm): "this youth drug"; Charles De Gaulle, John F. Kennedy, Konrad Adenauer, Mao Tse Tung, Ho Chi Minh, Marlene Dietrich, Lillian Gish, the Gabor sisters, Charlie Chaplin, Kirk Douglas, Salvador Dali listed as having been treated at Aslan's clinic
• Mircea Dumitru, [2] (http://www.antiaging-systems.com/extract/geroh3.htm): "a complex drug"
• 1994 FDA Consumer article (http://www.fda.gov/bbs/topics/CONSUMER/CON00275.html)
• FDA quotes (http://www.realgh3.com/quotes.html) from a Gerovital supplier: "Elmer Gardner ... stated there is no safety problem."
• Gerovital-H3: a clinical trial as an antidepressant (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=376578&dopt=Abstract): no significant difference between the Gerovital and placebo groups
• Gerovital, by Ron Kennedy, M.D. (http://www.medical-library.net/sites/framer.html?/sites/_gerovital_(gh3).html) Advises preparation by a compounding pharmacy
• Automatic detention alert" IA#61-01 (http://www.fda.gov/ora/fiars/ora_import_ia6101.html) (FDA's import ban)
• Revocation of UK trademark (http://www.patent.gov.uk/tm/legal/summaries/2003/o20603.htm)

External links

• Read the package insert for Gerovital H3, including actions and indications (http://www.antiaging-systems.com/apruses/gerovitalH3.htm)
• Gerovital: "Anti-aging hoax" (http://www.netasia.net/users/truehealth/Gerovital.htm)
• Anti-Aging Medicine (http://www.anti-ageing.us)