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  • Running The FDA’s Gauntlet With An Anti-Aging Pill

    August 7, 2013: by Bill Sardi

    Friday, August 9, 2013: Bill Sardi interviews Emmy-Award Winning Journalist George Knapp On KLAV-Radio

    Tune in Friday at 9:00 AM Pacific Time, via the internet (also archived for later listening), or locally in Las Vegas at 1230AM on the radio dial, for a scintillating interview with the reporter who took on Big Pharma and brought public attention to Longevinex®.

    Managing a dietary supplement company as I do, I have been in a unique position to launch, for the first-time, an effort to circumnavigate the Food & Drug Administration’s onerous grip over dietary supplements.

    Oh, I am not attempting to avoid FDA’s push for more regulatory oversight even though this appears unwarranted, or to ignore the FDAs insistence that dietary supplements like generic vitamin C and D cannot be labelled as curative or preventive for scurvy or rickets, as outlandish as that may be.

    Nor am I saying any dietary supplement should be given the go-ahead to make any health claim their makers wish without adequate substantiation.

    What I am talking about is an attempt to fully comply with the FDA’s regulations, to restrict any health claims to those permissible — to promote health in structures and functions in the human body and avoid any claims the product I am associated with (Longevinex®) prevents, cures or treats any disease.

    What I am talking about is completion of toxicity testing (now published) the FDA has been harping about to prove dietary supplements are non-toxic, even though many of them have been on the market for years with a high safety profile.

    What I am talking about, where possible, is publication of small preliminary human trials that reveal the potential Longevinex® has to rescue humanity from the ravages of aging – diminished vision, lost control of insulin, blood sugar and blood pressure, and even abolition of malignancies and mortal heart stoppages.

    Track record of the only proven anti-aging pill

    In regard to the above, a small human trial reveals Longevinex® abolishes the first sign of blood vessel aging (twice as well as plain resveratrol).

    Longevinex® has also been shown to inhibit invasion by vision-destructive blood vessels at the back of the eyes, actually reversing vision loss and rescuing 16 of the first 17 treated patients from permanent blindness.

    Because Longevinex® inhibited the formation of abnormal blood vessels at the back of the human eye after an FDA-approved medication failed to do so, and that failed drug was originally approved by the FDA to recede new blood vessels that feed growing tumors, it could be inferred Longevinex® is potentially a stronger anti-cancer agent than currently available anti-angiogenic anti-cancer drugs.

    A small-group study has also been launched at a major university to determine if Longevinex® is beneficial for patients with metabolic problems — to help maintain their blood sugar and insulin levels within the normal range.  The results of that study may be available before the end of 2013.

    Furthermore, in lieu of a conclusive 5-year $50 million human study to see whether a pill like Longevinex® would prevent mortal heart attacks (a study that only the National Institutes of Health could possibly fund and commission), Longevinex® demonstrated ability to protect animal hearts from damage (scarring) caused by an laboratory-induced heart attack to the point of preventing “cardiac death” (stoppage of a pumping heart).

    Longevinex® worked twice as well as plain resveratrol in this published study, as confirmed by microRNA analysis performed by National Institutes of Health researchers.   Given there is currently no effective prescription or non-prescription agent that is proven to prevent mortal heart attacks (not statin drugs or aspirin), the importance of this is huge.

    What Longevinex® has achieved to date has largely been ignored by modern medicine, plagiarized by 430 competing brands of resveratrol pills, and sadly, substituted with other unproven and poorly formulated red wine pills by foolish price-conscious consumers.

    Lament over lost opportunity

    This lament is not shared here over lost commercial gain but rather the failure of the public to embrace a dietary supplement that could provide an answer to the question of whether there really is a proven anti-aging pill.

    Longevinex® could serve as an example of the potential natural medicine has for slowing biological aging.  Furthermore, Longevinex® could serve as the very first nutriceutical to break the grip of Big Pharma and its arrogant claim that its products are the only one’s proven to be safe and effective.  (Last time I looked, vitamins C and D were safer and work better than any prescription drug.)

    If Longevinex® is shown to prevent, treat or cure any disease, it will be classified as a drug, even if no new drug application has been filed with the FDA.  If Longevinex® remains a dietary supplement, it will continue to be affordable.  If it is forced to become a drug, it will likely cost quite a few dollars a day.  The intention here is to keep Longevinex® as an affordable dietary supplement but conduct human clinical trials as if it were a drug.

    While a small company like Longevinex® could not possibly sponsor large-group long-term studies, it could use markers of aging like red blood cell width and labile iron to provide partial confirmation of a claim it is an anti-aging product.  Longevinex® has already been demonstrated to switch 81% of longevity genes in laboratory animals in the same direction as a calorie restriction diet.  Limited calorie diets are known to double the lifespan and health span of laboratory mice.

    The end of modern pharmacology?

    If there were truly a free market and pharmaceuticals had to compete on an even basis with vitamins, minerals, amino acids and herbals, natural medicines could put an end to the era of allopathic medicine, avoid the accompanying morbidity and mortality associated with prescription drug use, and save many billions of healthcare dollars.

    All that need happen is for the public to broadly embrace such an anti-aging pill, utilize it en mass, and turn the disreputable pharmaceutical industry on its rear end.  Then watch whether such a pill, which targets such a broad number of “longevity” and “health” genes, eliminates the need for multitude of drugs to treat each and every disease.

    To cure all, address aging

    It is age-related chronic disease that predominates in a longer-living society.  The pharmaceutical companies have plundered insurance pools to abscond with billions of undeserved dollars while never addressing the true cause of aging, which is accumulation of minerals (largely iron, copper and calcium) in aging tissues.

    It is tragic to see pharmaceutical companies sell pills that address mental depression like Elavil, Paxil, Lexapro and Zoloft when oftentimes a depressed mood is simply caused by a shortage of folic acid (believed to represent about a third of diagnosed cases).

    It is literally heart-breaking to see 25 million healthy Americans take statin cholesterol-lowering drugs that do not reduce the death rate for coronary artery disease.

    Free market choice in health care

    A free market in pharmacology does not exist.  The FDA gives exclusive approval to patentable man-made molecules, or to natural remedies that have conducted expensive human trials and have thus become “drugs.” (The fish oil supplement Lovaza, FDA approved for reduction of triglycerides, is an example of the latter.  It costs ~$8.00 a day.)

    The FDA bestows upon synthetic molecules a monopoly that raises prices to the point of unaffordability and increases the risk for side effects.

    While it cannot be said all of mother nature’s molecules are safe (example: an extract from hemlock is poisonous), generally speaking, natural molecules, particularly those that have been found to be essential for life, are geared by nature to produce beneficial effects in humans without side effects when consumed in reasonable doses.

    Why is it that FDA-approved drugs are documented to kill hundreds of thousands while the Poison Control Centers of America has not documented a vitamin or mineral-related death for properly dosed dietary supplements in years?

    Jeffrey Bland PhD says the pharmaceutical system that is being protected is “not working to reduce chronic disease.”  Dietary supplements do not need “black box warnings” like FDA-approved drugs do, says Dr. Bland.

    Another pill is ignored

    More than one party has attempted to win over the public’s confidence and break the grip the FDA/Big Pharma/physician troika has over the medicines Americans are offered.

    Dr. Matthias Rath along with Linus Pauling were originators of the collagen theory of heart disease and conclusively demonstrated that arterial disease is remedied by vitamin C and two amino acids (lysine and proline).

    Drs. Pauling and Rath discovered that the lost ability to internally synthesize vitamin C is reason why humans develop arterial disease and most animals don’t.  (Humans lost the ability to internally produce vitamin C in their liver many many generations ago due to a gene mutation in the liver.)

    Dr. Rath was granted a patent on a vitamin C-amino acid based multivitamin that would eradicate heart disease.  He was momentarily ecstatic, I am told.  Did he become a billionaire?  Did his product save millions of people’s lives?  Was heart disease eradicated?

    Even though Dr. Rath’s product became a reality, it never lived up to the hopes he had for it.  The public largely ignored it and opted for doctor-prescribed statin drugs.

    Did the dietary supplement industry embrace Dr. Rath’s product?  No, it chose to embrace pseudo-scientific elixirs such as coral calcium a bogus multivitamin called SeaSilver that were eventually put out of business by the Federal Trade Commission for making unfounded health claims.  A subsequent analysis validates Dr. Pauling and Rath’s discovery.   In the interim, millions prematurely died of heart disease.

    What does the public want?

    What many patients want is for doctors to prescribe vitamins and red wine pills and for insurance to pay.  That day may never come.

    A Pew Research Survey, the largest public opinion survey ever conducted on aging, medical advances and life extension, has just been published.  The survey reveals most Americans (56%) would not embrace super longevity personally.  Only 25% of those Americans surveyed said they believe people will live to 120 years by the year 2050, and nearly 8 in 10 said they believed any technology that radically extends human life will only be available to the wealthy.  Only 4% of Americans said they would like to live 120 years and beyond.  Most Americans surveyed doubt such a breakthrough in longevity will occur anytime soon and only 7% of Americans said they had heard or read a lot about the possibility that people could live much longer.

    If the above poll is indicative of the public’s sentiments regarding anti-aging pills, the masses simply aren’t searching for such a pill.   Rather, the masses have been deceived to believe cholesterol-lowering statin drugs are modern medicine’s longevity pill, despite the lack of evidence for that claim.

    Without “doctor prescribed,” “FDA approved,” and “paid by insurance,” it doesn’t look like any anti-aging pill is going to run the FDA gauntlet.  And the medical establishment is not about to put itself out of business either.

    Poignantly, one wonders if humanity would derive greater benefit by paying the public to take such a pill, thus averting trillions of dollars of future health care costs.  Even that idea would likely be corrupted as the government-issued anti-aging pills would likely be sold on the street for a bottle of beer.

    Whether any of this becomes reality appears to be in the hands of the public.  It is possible such a technology already exists in the form of a red wine pill.  Conclusive evidence would require 100-year human study, which is costly and impractical and would serve no purpose to answer questions for this generation.  The best available evidence points to limited calorie diet, which only a small number are likely to adopt, or a molecular mimic of the same.

    Currently the FDA only approves drugs for diseases, not for longevity.  While the FDA prohibits dietary supplements from claims they prevent, treat or cure any disease, aging itself is not classified as a disease.

    A more pointed question remains for readers of this report.  What do YOU want to do?  Sit around and wait for your doctor to back away from prescribing drugs and wait till insurance pays for vitamins and red wine pills?

    ©2013 Bill Sardi,

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