~ Cardiologists Overlook Lifesaving Discovery

William Faloon

Impressive research published in 2003 indicates that coenzyme Q10 may have broader clinical applications than originally identified. These new human studies further validate the efficacy of coenzyme Q10 in the adjuvant treatment of cardiovascular disease.1-9

In particular, a study of heart attack patients showed that compared to placebo, supplementation with 120mg a day of coenzyme Q10 reduced secondary cardiac events by 45% and significantly reduced the number of cardiac deaths. Many of these heart-attack patients were prescribed a "statin" drug to lower cholesterol levels. The major adverse effect of statin treatment was fatigue that occurred in 40.8% of the placebo group, whereas only 6.8% of the patients supplemented with coenzyme Q10 experienced fatigue.2

In newly published findings over the past year, positive results were shown when coenzyme Q10 was tested against disorders including macular degeneration, Parkinson's disease, viral myocarditis, and hereditary neurodegenerative diseases.10-21 Additional studies indicate that coenzyme Q10 deficiency is linked with disorders such as infertility and brain atrophy.22-23

The Problem With "Statin" Drugs

Massive advertising by drug companies has resulted in millions of Americans taking statin drugs every day. Because consumers are supposed to take these drugs possibly for the rest of their lives, statins have become the most profitable drug class in the world. While statin drugs do lower cholesterol, there is a controversy as to how effective these drugs are in extending overall life span.

Peter H. Langsjoen, MD, is the foremost authority on the use of coenzyme Q10 in the treatment of heart disease. His numerous research studies can be found in the world's most prestigious scientific journals.24-32

In 1990, the Proceedings of the National Academy of Science published Dr. Langsjoen's studies on the safety of statin drugs. Dr. Langsjoen explained that the mechanism by which statin drugs lower cholesterol also inhibits the natural biosynthesis of coenzyme Q10 in the liver. Dr. Langsjoen said that he conducted these studies because, "if lovastatin were to reduce levels of coenzyme Q10, this reduction would constitute a new risk of cardiac disease, since it is established that coenzyme Q10 is indispensable for cardiac function." Dr. Langsjoen then reported that his animal and human studies showed that lovastatin does indeed lower levels of coenzyme Q10.30 Dr. Langsjoen went on to describe case histories of his lovastatin patients who suffered from progressive cardiac degeneration, but whose heart function improved after oral administration of coenzyme Q10.

Move forward to July 8, 2002, and we find that Dr. Langsjoen has become a vocal critic of statin drugs and has published a new paper titled "Statin-Induced Cardiomyopathy." In an excerpt from this paper, Dr. Langsjoen describes his 17-year experience with statin drugs as follows:

"I have seen a frightening increase in heart failure secondary to statin usage, 'statin cardiomyopathy.' Over the past five years, statins have become more potent, are being prescribed in higher doses, and are being used with reckless abandon in the elderly and in patients with 'normal' cholesterol levels."33

Dr. Langsjoen attributes these heart failure cases as being caused by "statin-induced coenzyme Q10 depletion" that is preventable if statin drug users supplemented with coenzyme Q10.

The "Forgotten" Merck Patents

Pharmaceutical companies have long been aware that statin drugs can wreak havoc on cardiac patients and that taking coenzyme Q10 along with the statin drug would eliminate these side effects.

The evidence supporting coenzyme Q10 as an antidote to statin drug complications is so clear that in 1989 and in 1990 Merck patented the use of coenzyme Q10 in combination with statin drugs to both prevent and treat these complications. However, Merck has neither exercised these patents nor educated physicians or patients about the necessity of taking coenzyme Q10 along with statin drugs. One of the two Merck patents states that:

"Since Coenzyme Q10…is of benefit in congestive heart failure patients, the combination with HMG-CoA reductase inhibitors (statin drugs) should be of value in such patients who also have the added risk of high cholesterol."34

This patent was filed on behalf of Merck & Co on June 12, 1990. Now, almost 14 years later, most doctors and their patients remain ignorant that those taking statin drugs should also supplement with coenzyme Q10.

Last year, Life Extension made numerous calls to Merck's press and media office to discuss its patent of the statin-coenzyme Q10 combination and why this invention was never brought to market. Unfortunately, we were unable to obtain a response as to why all of this time, money, and research had been undertaken by a leading pharmaceutical company only to let their patents sit in a file cabinet. To this day, few doctors are aware of the coenzyme Q10 depletion problem caused by statin drugs, despite the extensive research undertaken by Merck, Dr. Langsjoen, and others.

Dr. Julian Whitaker Files a Petition Against the FDA

Based on this overwhelming body of evidence, Julian Whitaker, MD, filed a petition against the FDA that meticulously documented the many lethal effects that would occur if patients prescribed statin drugs were not supplemented with 100-200mg a day of coenzyme Q10. The objective of this petition was to force the FDA to mandate on the package insert that patients taking statin drugs should also take coenzyme Q10.

Dr. Whitaker's petitions state that statins deplete coenzyme Q10 stores in the body and increase congestive heart failure and cardiomyopathy risk. They call on the FDA commissioner to take immediate action to safeguard the millions of statin drug users.

Dr. Whitaker's petition explains that statin drug use may be inducing adverse effects in as many as 575,000 people worldwide. The petitions go on to state that statin drugs work by blocking production of cholesterol and coenzyme Q10 in the same pathway, and that consumption of 100-200mg per day of coenzyme Q10 can reverse depletion induced by statins.

Dr. Whitaker asserts that most patients and doctors do not realize that statin drugs block the production of coenzyme Q10. Dr. Whitaker went on to describe how coenzyme Q10 has been found to be essential for cellular energy production as well as for the functioning of the heart muscle. According to Dr. Whitaker:

"Statin drugs have proven in clinical trials to deplete coenzyme Q10, the 'sparkplugs' of the human body. Patients who take statin drugs without coenzyme Q10, particularly those with a history of heart disease, are especially prone to developing complications that can have fatal consequences."35

FDA Fails to Protect Statin Users

Dr. Whitaker's meticulously documented petition was filed on May 24, 2002. For the past 20 months, however, the FDA has ignored it. The result is that millions of statin drug users are needlessly being subjected to lethal side effects.

The failure of the FDA to amend the drug package insert to recommend that statin users supplement with coenzyme Q10 is a medical travesty. Since the underlying science is irrefutable, this is a blatant example of large drug companies influencing the FDA into not taking actions that would save lives.

Our opinion as to why drug companies may not want this label change is that it could reduce sales of their statin drugs. After all, if doctors told patients that statin drugs could cause heart muscle degeneration, many cardiac patients would refuse to take this class of drug. There is also an economic issue. Those covered by health insurance often have their prescription drugs subsidized, while government programs provide low-income people with free drugs. If these patients were told they had to buy coenzyme Q10 supplements if they are prescribed a statin drug, many would not be willing or able to bear this extra cost.

On the flip side, more statin drugs could be sold if there were fewer side effects encountered, such as muscle pain, fatigue, liver toxicity, heart failure, etc. A lot of statin drug prescriptions are not refilled because of side effects, so drug companies may be shortchanging themselves in the long run by not recommending coenzyme Q10 supplementation.

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 maintaining the health and well being of its members. Few consumers realize the extent to which Life Extension designs products that provide additional ingredients to protect against potential side effects of the active nutrient.

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 100mg 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.

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.

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!

Quality Control

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.

Note: The 300mg 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 300mg CoQ10 capsules are advised to take other antioxidants, especially the tocotrienols.

References

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2. Singh RB, Neki NS, Kartikey K, et al. Effect of coenzyme Q10 on risk of atherosclerosis in patients with recent myocardial infarction. Mol Cell Biochem. 2003 Apr;246(1-2):75-82.

3. Ohmoto N, Fujiwara Y, Kibira S, Kobayashi M, Saito T, Miura M. Cardiomyopathy showing progression from diffuse left ventricular hypertrophy to dilated phase associated with mitochondrial DNA point mutation A3243G: A case report. J Cardiol. 2003 Jan;41(1):21-7.

4. Fosslien E. Review: Mitochondrial medicine—cardiomyopathy caused by defective oxidative phosphorylation. Ann Clin Lab Sci. 2003 Fall;33(4):371-95.

5. Engelsen J, Nielsen JD, Hansen KF. Effect of coenzyme Q10 and ginkgo biloba on warfarin dosage in patients on long-term warfarin treatment. A randomized, double-blind, placebo-controlled cross-over trial. Ugeskr Laeger. 2003 Apr 28;165(18):1868-71.

6. Singh RB, Kartik C, Otsuka K, Pella D, Pella J. Brain-heart connection and the risk of heart attack. Biomed Pharmacother. 2002;56 Suppl 2:257s-265s.

7. Sarter B. Coenzyme Q10 and cardiovascular disease: a review. J Cardiovasc Nurs. 2002 Jul;16(4):9-20.

8. Piotrowska D, Dlugosz A, Pajak J. Antioxidative properties of coenzyme Q10 and vitamin E in exposure to xylene and gasoline and their mixture with methanol. Acta Pol Pharm. 2002 Nov-Dec;59(6):427-32.

9. Tran MT, Mitchell TM, Kennedy DT, Giles JT. Role of coenzyme Q10 in chronic heart failure, angina, and hypertension. Pharmacotherapy. 2001 Jul;21(7):797-806.

10. Feher J, Papale A, Mannino G, Gualdi L, Balacco Gabrieli C. Mitotropic compounds for the treatment of age-related macular degeneration. The metabolic approach and a pilot study. Ophthalmologica. 2003 Sep-Oct;217(5):351-7.

11. Blasi MA, Bovina C, Carella G, et al. Does coenzyme Q10 play a role in opposing oxidative stress in patients with age-related macular degeneration? Ophthalmologica. 2001 Jan-Feb;215(1):51-4.

12. Muller T, Buttner T, Gholipour AF, Kuhn W. Coenzyme Q10 supplementation provides mild symptomatic benefit in patients with Parkinson's disease. Neurosci Lett. 2003 May 8;341(3):201-4.

13. Shults CW, Oakes D, Kieburtz K, et al. Effects of coenzyme Q10 in early Parkinson disease: evidence of slowing of the function al decline. Arch Neurol. 2002 Oct;59(10):1541-50.

14. Beal MF. Mitochondria, oxidative damage, and inflammation in Parkinson's disease. N Y Acad Sci. 2003 Jun;991:120-31.

15. Beal MF. Bioenergetic approaches for neuroprotection in Parkinson's disease. Ann Neurol. 2003;53 Suppl 3:S39-47; discussion S47-8.

16. Kishimoto C, Tomioka N, Nakayama Y, Miyamoto M. Antioxidant effects of coenzyme Q10 on experimental viral myocarditis in mice. J Cardiovasc Pharmacol. 2003 Nov;42(5):588-92.

17. Jauslin ML, Meier T, Smith RA, Murphy MP. Mitochondria-targeted antioxidants protect Friedreich Ataxia fibroblasts from endogenous oxidative stress more effectively than untargeted antioxidants. FASEB J. 2003 Oct;17(13):1972-4. Epub 2003 Aug 15.

18. Sandhu JK, Pandey S, Ribecco-Lutkiewicz M, et al. Molecular mechanisms of gluta- mate neurotoxicity in mixed cultures of NT2-derived neurons and astrocytes: protective effects of coenzyme Q10. J Neurosci Res. 2003 Jun 15;72(6):691-703.

19. Chuang YC, Chan JY, Chang AY, et al. Neuroprotective effects of coenzyme Q10 at rostral ventrolateral medulla against fatality during experimental endotoxemia in the rat. Shock. 2003 May;19(5):427-32.

20. Shults CW. Coenzyme Q10 in neurodegenerative diseases. Curr Med Chem. 2003 Oct;10(19):1917-21.

21. Kishimoto C, Tamaki S, Matsumori A, Tomioka N, Kawai C. The protection of coenzyme Q10 against experimental viral myocarditis in mice. Jpn Circ J. 1984 Dec;48(12):1358-61.

22. Mancini A, Milardi D, Conte G,. et al. Coenzyme Q10: another biochemical alteration linked to infertility in varicocele patients? Metabolism. 2003 Apr;52(4):402-6.

23. Lamperti C, Naini A, Hirano M, et al. Cerebellar ataxia and coenzyme Q10 deficiency. Neurology. 2003 Apr 8;60(7):1206-8.

24. Langsjoen PH, Langsjoen A, Willis R, Folkers K. Treatment of hypertrophic cardiomyopathy with coenzyme Q10. Mol Aspects Med. 1997;18 Suppl:S145-51.

25. Langsjoen P, Langsjoen P, Willis R, Folkers K. Treatment of essential hypertension with coenzyme Q10. Mol Aspects Med. 1994;15 Suppl:S265-72.

26. Langsjoen H, Langsjoen P, Langsjoen P, Willis R, Folkers K. Usefulness of coenzyme Q10 in clinical cardiology: a long-term study. Mol Aspects Med. 1994;15 Suppl:s165-75.

27. Langsjoen PH, Langsjoen PH, Folkers K. Isolated diastolic dysfunction of the myocardium and its response to CoQ10 treatment. Clin Investig. 1993;71(8 Suppl):S140-4.

28. Folkers K, Langsjoen P, Langsjoen PH. Therapy with coenzyme Q10 of patients in heart failure who are eligible or ineligible for a transplant. Biochem Biophys Res Commun. 1992 Jan 15;182(1):247-53.

29. Folkers K, Hanioka T, Xia LJ, McRee JT Jr, Langsjoen P. Coenzyme Q10 increases T4/T8 ratios of lymphocytes in ordinary subjects and relevance to patients having the AIDS related complex. Biochem Biophys Res Commun. 1991 Apr 30;176(2):786-91.

30. Folkers K, Langsjoen P, Willis R, et al. Lovastatin decreases coenzyme Q levels in humans. Proc Natl Acad Sci U S A. 1990 Nov;87(22):8931-4.

31. Langsjoen PH, Langsjoen PH, Folkers K. A six-year clinical study of therapy of cardiomyopathy with coenzyme Q10. Int J Tissue React. 1990;12(3):169-71

32. Langsjoen PH, Folkers K, Lyson K, Muratsu K, Lyson T, Langsjoen P. Pronounced increase of survival of patients with cardiomyopathy when treated with coenzyme Q10 and conventional therapy. Int J Tissue React. 1990;12(3):163-8.

33. Available at http://www.redflagsweekly.com/features/2002_july08.html. Accessed December 1, 2003.

34. Brown MS. Coenzyme Q. sub. 10 with HMG-CoA reductase inhibitors. United States Patent 4,933,165. June 12, 1990.

35. Whitaker JM, MD. Citizen petition before the department of health and human services Food and Drug Administration, November 24, 2002.

36. Dangerous prescription [transcript]. "Frontline." PBS television. November 17, 2003.

37. Chris Adams, Alison Young. Prescription for trouble: FDA loses hold on marketing by drugmakers, November 5, 2003, Detroit Free Press Washington Bureau.

38. Huang HY, Appel LJ. Supplementation of diets with alpha-tocopherol reduces serum concentrations of gamma- and delta-tocopherol in humans. J Nutr. 2003 Oct;133(10):3137-40.


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