Two-Billion Daily Doses Later, American Medicine Has Yet To Discover Ginkgo Biloba
by Bill Sardi by Bill Sardi
Imagine that ginkgo biloba, a widely sold herbal supplement, were an FDA-approved drug in the U.S.A.
Brian Williams, NBC’s evening news anchor, would likely lead off by saying: "Good evening, I’m Brian Williams with NBC’s Nightly News, brought to you by Tebonin® ginkgo leaf extract, the world’s leading remedy for circulatory problems in small arteries and veins."
Ginkgo biloba leaf extract is a drug in Europe. The approved ginkgo drug in Germany is Tebonin®, made by Dr. Willmar Schwabe GmbH & Co KG. It contains 120mg per tablet of EGb761® (ginkgo leaf extract).
Throughout the world, Tebonin is widely sold for relief of ringing in the ears (tinnitus) and dizziness (vertigo) and these very health claims are printed on the front label of a box of Tebonin. In the U.S., such advertising claims are not permitted.
Overseas pharmacies sell Tebonin EGb761 for about $1.00 per tablet. The same number of pills, providing the same standardized concentration of ginkgo leaf extract (24% ginkgo flavone glycosides and 6% terpene lactones), typically sells for about 35 cents per tablet in the U.S.A. In fact, one online source offers a major-brand standardized ginkgo biloba leaf extract for about 10-cents per tablet. But the days of economical dietary supplements like ginkgo may come to an end soon (see below).
Ginkgo overlooked in U.S.A.
Ginkgo biloba is a well-known dietary supplement that has gone largely overlooked by American medicine. Yet doctors in France, Italy, Germany and other European countries widely prescribe it for a variety of health conditions including memory and concentration problems, confusion, depression, anxiety, dizziness, tinnitus (ringing in the ears), headache, macular degeneration, narrowed arteries, prevention and treatment of cardiovascular disease, for oxygen-starved tissues (ischemia), blood clots, sexual dysfunction, mountain sickness, asthma, glaucoma, and retinal problems among diabetics.
Ginkgo biloba is particularly helpful in cases where small blood vessels (arterioles, venules, capillaries) have become narrowed or fail to widen (dilate).
Ginkgo sales falter
While retail sales of ginkgo biloba supplements exceeded $151 million in 1998, this herb has been forgotten or fallen into disfavor as some poorly-designed studies showed it may not be of significant benefit for early-stage Alzheimer’s disease. This is likely due to the fact that more cases of Alzheimer’s disease are caused by chronic inflammation rather than poor circulation. Ginkgo addresses the latter. American physicians prefer to prescribe acetycholinesterase inhibitors (acetycholinesterase is an enzyme that breaks down acetycholine, a brain chemical), a class of drugs which are of limited or no value to Alzheimer’s patients.
By prescription in Europe
Doctors in America generally don’t prescribe ginkgo, but throughout Europe it is a prescription drug and was the most commonly prescribed drug in Germany a few years ago. The World Health Organization has recommended the use of ginkgo for Raynaud’s disease, a disease of poor circulation in fingers and toes when exposed to cold. However, the U.S. Food & Drug Administration does not approve products containing ginkgo biloba as it is a dietary supplement even though it is widely used to treat disease in Europe.
In fact, during the past 20 years, 2 billion daily doses of 120 milligrams of ginkgo have been sold. Ginkgo extract entered the market in Germany in 1982, is now used by more than 10 million Europeans annually, is government approved, and is covered by insurance and the German national health care system, say researchers reporting in the March 2009 issue of the Puerto Rican Health Sciences Journal.
The recommended dosage of ginkgo is 120 to 240 mg daily taken in two to three doses. The dosage in patients with tinnitus (ear ringing) and poor circulation is no more than 160 mg per day, taken in two or three doses. Doses as high as 320 mg/day have also been studied. An initial period of six to 12 weeks is recommended to evaluate the effectiveness of ginkgo. Doctors are concerned that as a natural blood thinner, ginkgo may induce hemorrhages, but in a controlled study with aspirin it failed to do so. Persons with sensitivity to poison oak/ivy, mangoes or cashews should probably avoid ginkgo.
Supplements vs drugs
The wide difference in price and permissible health claims for ginkgo biloba extract here in the U.S.A. versus overseas is the Dietary Supplement Health & Education Act (DSHEA) of 1994.
Any legislation that would negate the freedoms and access to dietary supplements under DSHEA (there are 5 bills in committee in Congress that would do just that) would likely triple the price of ginkgo pills in the U.S.A.
Congress can pull any one of these bills out of committee onto the floor of the House of Representatives or Senate, late on a Friday night in the summer when Americans are away on vacation, and pass a bill that would invalidate DHSEA.
Power grab by Big Pharma
Even without new legislation, by employing section 912, subsection 301 (II) of the FDA Amendments Act of 2007, the FDA can, at any time, on behalf of Big Pharma, conduct a power grab and bar dietary supplements from interstate trade if they have been subjected to validation and review in published clinical studies. In other words, declare the most efficacious supplements to be drugs.
The FDA claims DSHEA handcuffs their ability to regulate dietary supplements. This is pure nonsense. The FDA serves as a censorship agency, blocking science-backed health claims for vitamin, mineral and herbal supplements.
Pharmaceutical companies have been the pet of Congress for the past few years. Now the threat of generics and patent expirations, as well as competitive bidding for drugs covered by the Medicare program, are likely to result in a decline in stock prices of leading drug companies.
To fully recognize how many drugs patents are expiring, see the list here of drugs expiring for the period 2007—2009 from Drug Topics Magazine.
In March of 2010 the biggest patent of them all, the $12.7 billion (global 2008 sales) for Lipitor (atorvastatin-Pfizer) patent expires. Lipitor’s manufacturer has struck a deal with Indian generics maker Ranxbury to delay copies of Lipitor for at least 5 months, adding billions to its sales. Lipitor sells in the U.S. for about $3 a day and would sell for about $1 a day as a generic.
The FDA has allowed all the statin drugs to remain on the market and make claims they reduce cholesterol despite the fact there is no evidence that these drugs lower mortality rates. [Lancet 2007; 369 (9557): 168—9] While millions of Americans take statin drugs, the incidence of heart disease and heart disease mortality rates remain about the same.
It is possible Congress could offer a big trade off with the drug industry. Medicare drugs would be placed up for bid and generics would be ushered in, in exchange for making dietary supplements drugs. Since the FDA and the pharmaceutical companies have hidden the fact that the biological action of most prescription drugs can be duplicated with vitamins, minerals, amino acids and herbal products, suddenly efficacious products like ginkgo, resveratrol, allicin (garlic), astaxanthin (algae), and arginine (amino acid), would be branded and would likely become television sponsors of the evening news.