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statistics, faulty interpretation of the data voices are silent on this possibility. For the cular literature and Aristotles lessons on and faulty presentation of the risk/benefits record, I believe the case is not closed on logic, they concluded that carnitine is the of the drugs. It, indeed, was a critical career this issue. culprit. Not so. The high levels are a warnlesson for me. Heres another eye-opener. It was, and ing sign or biomarker of a distressed heart, Examples of medical-media complex still is, very widely accepted and historical- be it coronary artery disease or cardiomycausing confusion ly supported by opathy, or weak heart. Since I am the docmany. For are and tor who brought carnitine into the United laboratory It will surprise you to know example, I am an clinical studies, States way back in 1965, I have a personal that the application of statistics endocrinologist that HDL choles- interest in this study and issued a press doesnt prove anything, it only deals and clinical pharterol is cardiopro- release exposing its faults and clarifying with probability. macologist (an tective by remov- the truth. It is now posted on the FIM, The expert in clinical ing cholesterol Foundation for Innovation in Medicine research). Yet, I am still not sure of the risk- from artery walls. The higher the concen- website (www.fimdefelice.org). benefit of hormonal management of post- tration in the blood, the safer you are from There have been several published studmenopausal women. For many years, it the ravages of caries, warning us was believed that the benefit was obvious. diovascular disabout faulty cliniFactors contributing to Women felt better and, based on soft clini- ease. Not necescal studies which faulty clinical trials: cal data, it was believed that it decreased sarily so. In a more have been inex1. Poor study design the incidence of cardiovascular disease. definitive or conplicably and irre2. Poor statistics Then a large scale published study report- trolled s p o n s i b l y clinical 3. Poor overall interpretation of the results ed that hormonal therapy in post- study which evaluignored by the 4. Poor presentation of the risk/ benefit menopausal women increased their car- ated a drug that medical-media ratio (to consumers and physicians) diovascular risk. There understandably was elevated HDL, the complex. For a general response of grief and disbelief, results did not example, the even among doctors. Then a reanalysis of support this belief. Strangely enough, Greek physician, John Ionnidis, is perhaps the data was done, reporting that the clini- expert doctors in this field and the media the worlds authority on faulty conclusions cal design and stahave hardly cov- of clinical studies. He has published well tistical analysis of ered these find- over 1,300 papers with co-authors from According to one leading it were faulty and ings. For this rea- over 500 institutions in 43 countries. He authority, 90 percent of the only applied to son the vast has found that 90 percent of the concluconclusions of clinical studies, even in women who took majority of peo- sions of clinical studies, even in the most the most prestigious the hormones ple still are anx- prestigious medical journals, are somewhat medical journals, are somewhat flawed later on in the ious to know flawed and, oftentimes, incorrect. and, oftentimes, incorrect. post-menopausal So where does that leave us? about, and feel phase. The benesafer, when they Unfortunately, it is an unresolvable dilemfits only applied to women treated at an learn that their HDL blood levels are high ma, and we must live with it. The only soluearlier age. The result? Along with most of and embrace any substance that elevates tion is to cure the diseases and disabilities my colleagues and their patients, I am not them. How about you? that ail us, which would eliminate the need sure of the true risk/benefit of this therapy. for these studies. FIM has proposed the etting back to the Cleveland Clinic Doctornaut Act to accelerate the discovery There has been an insufficient attempt to study which claims that carnitine of such cures, as well as reduce health care explain to doctors and patients a clear prescauses atherosclerosis: As I said costs. For more information, take a look at: entation of the risks versus benefits of takbefore, the media went hog wild, spreading www.fimdefelice.org and watch the new ing such hormones. Lets take vitamin E as another example: faulty information and scaring lots of folks, FIM video about Doctornauts. Study after study reported that it was car- including not only patients who are carnidioprotective. Even doctors were con- tine takers, but parents of youngsters who ABOUT THE AUTHOR: vinced. Then a more controlled clinical have been on carnitine for years. This medStephen L. DeFelice, M.D., founded FIM, the study showed no such effect. All four fac- ical-media event is a classic and obvious Foundation for Innovation in Medicine, in 1976 tors are clearly in action in this case, and example of the negative side of the med- with the mission to accelerate medical discovery. the possibility that this vitamin being car- ical- media complex. The investigators FIM is now involved in the Cure Care vs. Health dioprotective still exists. However, medical measured carnitine blood levels in over Care initiative and the Doctornaut Act. Dr. DeFelices 40 year pioneering research on carnitine 2,000 patients and found that high levels led to its FDA approval as an orphan drug and were associated with cardiovascular dis- worldwide recognition. He also coined the term ease. Ignoring the vast carnitine cardiovas- nutraceutical, which is now in many dictionaries.