The fact that the FDA does not mandate this warning on the package insert of statin drugs demonstrates the political nature of the agency’s decisions. The FDA pretends to be a consumer protection agency, but its actions clearly show that its primary function is to protect the economic interests of the drug industry. Statin drugs cause potentially lethal coenzyme Q10 deficiencies in millions of Americans, but drug company profits are obviously more important to the FDA than saving Americans’ lives.
Life Extension has filed a Freedom of Information Act request with the FDA seeking to ascertain the agency’s basis for not mandating the simple change to the labeling of statin drugs. Based on past experience, the FDA will ignore our Freedom of Information Act request, even though the law mandates that it respond.
What Makes Life Extension Foundation Different
Drug companies have a simple recipe for economic success. They find a molecule that can be patented, convince the FDA to approve it as a drug, and then market the new drug to physicians and the public. Even if the drug has serious side effects, pharmaceutical companies have been known to relentlessly market these drugs until the patent expires (or until they are forced to recall it).36
The Life Extension Foundation, on the other hand, has a commitment to maintain the health and well being of its members. Few consumers realize the extent to which Life Extension designs products to provide additional ingredients to protect against potential side effects of the active nutrient.
In a study of Parkinson’s disease patients, 360 mg a day of coenzyme Q10 was administered for only 4 weeks and there was a mild symptomatic improvement compared to placebo. More important, an established clinical test to measure Parkinson’s symptom function showed significantly better improvement of performance in the coenzyme Q10-supplemented patients compared with the placebo group.12 This new study helped corroborate a report last year that Parkinson’s patients consuming 1200 mg a day of coenzyme Q10 showed a 44% reduction in the decline of motor skills, movement, and mental function compared to the placebo group. Those receiving this high-dose coenzyme Q10 also demonstrated an improved ability to perform daily living tasks. What was remarkable about this 16-month study was that coenzyme Q10 slowed the progression of the disease, something that Parkinson’s drugs do not do.13
An example of the extra steps that Life Extension takes can be found in the oil-based coenzyme Q10 supplement it offers. While coenzyme Q10 has antioxidant properties, its cellular effect of boosting mitochondrial energy levels may result in the production of excess free radicals. Aging humans suffer from a variety of ailments related to mitochondrial exhaustion, and coenzyme Q10 is one of the most important nutrients to energize aging cells. In order to increase energy production, however, greater amounts of fatty acids have to be burned (oxidized) in the mitochondria. Recognizing that coenzyme Q10 intake could result in the generation of excess free radicals, Life Extension includes the most potent natural antioxidant (the tocotrienols) in the two most popular coenzyme Q10 supplements that it offers.
Tocotrienols are very expensive, but they provide a tremendous degree of natural protection against toxic free radicals. Brain cells produce very high levels of mitochondrial energy, and thus are particularly vulnerable to oxidative stress. The tocotrienols have demonstrated significant protective effects against oxidants (free radicals) that damage neurons. To our knowledge, no commercial supplement company fortifies its coenzyme Q10 with expensive tocotrienols.
The multiple benefits of alpha lipoic acid are well documented and it has become a popular dietary supplement. The only problem with alpha lipoic acid is that when more than 100 mg is consumed, it can compete with biotin and interfere with biotin’s activity in the body. Life Extension fortifies its alpha lipoic acid supplements with biotin to make sure that no one suffers a deficiency of this critical nutrient.
Folic acid is recognized by conventional medicine as the best-documented disease-preventing nutrient. There is a small risk that when people supplement with folic acid, it can mask a lethal case of pernicious anemia caused by a vitamin B12 deficiency. Life Extension therefore fortifies all of its folic acid supplements with potent amounts of vitamin B12 to guard against the manifestation of a serious anemic condition.
Chlorophyll is the most effective nutrient to protect against DNA gene mutation, but some people are concerned about the free copper that may occur naturally in chlorophyllin supplements. Life Extension adds a small amount of zinc to its chlorophyllin supplements to reduce the absorption of any free copper that may be present.
Drug companies obviously care little about the longevity of their customers, but a similar analogy can be drawn about commercial vitamin companies that sell supplements without providing added ingredients to guard against potential adverse reactions.
Warning Members of Potential Risks
When it is not possible to add an ingredient to protect against potential side effects of the active nutrients, Life Extension warns members to take additional nutrients to protect against potential adverse effects. For example, it is now clearly established that supplementing with the “alpha” tocopherol form of vitamin E depletes the critically important “gamma” tocopherol fraction. The latest study showed that when a group of human study subjects supplemented with 400 IU of alpha tocopherol daily, there was a 58% reduction in the gamma tocopherol levels in the body after only two months.38
Researchers at Johns Hopkins University have attributed the conflicting results obtained from cardiovascular and cancer trials using vitamin E to the gamma tocopherol deficit that occurs in response to alpha tocopherol supplementation. The Johns Hopkins researchers point out that gamma tocopherol has disease-preventive benefits and that supplementing with alpha tocopherol by itself may not make scientific sense.
What is truly ironic is that from 1985 to 1994, the FDA made a concerted effort to completely outlaw coenzyme Q10. One of the FDA’s arguments was that because coenzyme Q10 is sold as a prescription drug in Japan, it should not be freely available to Americans as a dietary supplement.
The FDA tried to embargo imports of coenzyme Q10 from Japan and launched criminal investigations against those who promoted it in the United States.
Life Extension’s CoQ10 supplements were seized twice (and won back both times in legal actions). The FDA’s excuse for the first seizure was that the cardiovascular health claims made by Life Extension turned the coenzyme Q10 into an illegal “drug.” During the second seizure, the FDA claimed that coenzyme Q10 was so “dangerous” that it posed an “imminent threat” to the health of the American public. These allegations were of course baseless, and fortunately federal judges eventually saw through the FDA’s charade.
The sad facts were that statin drugs (approved by the FDA) were killing Americans by causing lethal coenzyme Q10 deficiencies. Instead of addressing the statin drug issue, the FDA sought to ban CoQ10—the best antidote for statin drug toxicity.
The FDA continues to proclaim that it “protects” the health of Americans by denying “unproven” therapies. The FDA’s statements about “protecting” consumers’ health may go down in history as one of the greatest medical hoaxes of all time.
It took an enormous amount of effort by health freedom activists to derail the FDA’s efforts to deny Americans free access to CoQ10.
Most Foundation members take the Life Extension Mix multinutrient formula, which contains 400 IU of vitamin E (alpha tocopherol succinate). Gamma tocopherol, however, comes only in an oil base and cannot be added to the dry powder Life Extension mixes. Life Extension has repeatedly warned members about the dangers of taking alpha tocopherol without also supplementing with gamma tocopherol.
Because most members who take Life Extension Mix also take Life Extension Booster, gamma tocopherol was added to the Booster many years ago. Members can also obtain gamma tocopherol (and the tocotrienols) in a stand-alone formula.
In the Directory of Life Extension Nutrients and Drugs, numerous warnings are provided for dietary supplements. Commercial supplement companies pretend that there are no side effects to “natural” products and almost never warn about potential risks. Life Extension, on the other hand, has thoroughly reviewed the scientific literature in order to uncover potential problems that may be related to the ingestion of certain dietary supplements. While some people do not buy supplements after reading about potential problems, Life Extension remains vigilant in protecting its members’ health, as opposed to selling a product that might cause some individuals harm. Contrast this humanitarian policy with drug companies that do not warn statin drug users of the need to supplement with coenzyme Q10!
The Best Time to Buy Supplements
Long-time Foundation members often stock up on a 12-month supply of supplements each New Year. The combination of the regular member discount, the volume discount, and the Super Sale discount enables members to obtain their supplements at ultra-low prices.
Every once in a while, members will call to say they can buy a particular product from a commercial company for less money. We remind these callers that if Life Extension bought its ingredients from the lowest-priced Chinese suppliers, we too could offer those kinds of prices.
Life Extension purchases its ingredients from top-of-the-line European and Japanese pharmaceutical-grade suppliers. While the cost of these premium ingredients is higher than Chinese materials, we believe the proven biological effects of these pharmaceutical-grade nutrients justify using them. In the majority of cases, the pharmaceutical-grade supplements members obtain from Life Extension are priced lower than cheaper-grade Chinese ingredients that are increasingly saturating the American marketplace.
It is not just the pharmaceutical quality, however, that motivates those serious about their health to use Life Extension supplements. Life Extension has a policy of putting in slightly more active ingredients than what is actually stated on the label. The purpose of this is to guard against any loss of potency that might occur during shipping or longer-term storage. Commercial companies often put in the bare minimum, which can result in 5-10% less potency of the active ingredients.
As mentioned earlier in this article, Life Extension adds important ingredients (such as tocotrienols to coQ10) to deliver a scientifically balanced formula. Commercial companies often have formulation deficits that could result in potential adverse effects.
Unlike any commercial supplement company, Life Extension funds critical research aimed at extending the healthy human life span. Every time you buy a Life Extension product, you contribute to an ambitious scientific project aimed at abolishing human suffering and premature death.
For longer life,
Note: The 300 mg coenzyme Q10 capsules with perilla oil do not contain tocotrienols. The reason for this is to provide the maximum amount of CoQ10 at the lowest cost for those who need to take very high potencies of CoQ10. Those who use these 300 mg CoQ10 capsules are advised to take other antioxidants, especially the tocotrienols.