Alzheimer’s Disease is an ailment more dreaded and feared than most illnesses, including cancer. The mere thought of losing ones mind, of having a brain with less capacity than of a helpless newborn, is very scary, to say the least. The severe stage of dementia robs the victim of all thought processes, memories, and intelligence, leaving the person in total mental darkness, oblivious of his environment and the people around him.
Inspired by this, enterprising businessmen around the globe have marketed medications they label as “food supplement” which they advertise as beneficial for the prevention or for cure of brain deterioration or dementia, obviously targeting Alzheimer’s.
One particular company, Quincy Bioscience Manufacturing Inc., of Madison, Wisconsin, has been marketing a Prevagen pill as the “[F]irst and only dietary supplement that…protects the brain cells from death…. If you do just take one supplement, this may be the one to consider to protect and preserve your brain.”
A bold and serious claim, indeed. But is there a genuine scientific basis to support this assertion?
No, there is none. The other issues with Prevagen, as with all unapproved medications, especially with “food supplements and herbals,” are unproven efficacy, questionable safety, and possible complications, some life threatening.
Hiding behind the label
Most, if not all, manufacturers of the so-called “food supplements,” label their products as such in order to avoid the very costly and stringent medication testing procedures, requirements, and standards, which all US-FDA approved drugs have undergone and satisfied.
While claiming to be “food supplements,” these products are actively and blatantly advertised, some more subtle and indirect, that they provide medicinal or curative effects. The most fraudulent of them even claim to treat and cure all diseases from a to z.
There are hundreds of them out there in the market and consumers must be educated, warned, and protected by the government and those who know better.
It is bad enough for these “food supplements” to be ineffective, useless, and a waste of money, it is another for their complications to cause irreparable harm to our body in the long run. There have been organ failures and some deaths reported from the use of “food supplements” and herbals.
This US-FDA investigation on Prevagen, which started more than 6 years ago and still ongoing, is a typical example.
According to the published reports, the Public Health Services of the Food and Drug Administration of the United States issued the following scathing comments and warnings to Mark Y. Underwood, President of Quincy Bioscience in Wisconsin the manufacturer of Prevagen:
Based on the investigation of the various websites for Prevagen, “the agency has determined that your products Prevagen, Prevagen Extra Strength, and Prevagen Professional are being promoted for conditions that cause these products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1)(B). The therapeutic claims on your websites (see “Unapproved New Drugs” section below) establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. In addition, statements on your www.hopetrials.com website establish that Quincy Bioscience has been sponsoring clinical trials to investigate the use of apoaequorin to treat or prevent disease for which there is no investigational new drug application (IND) in effect. The investigation and marketing of your products for these uses violates the Act.”
Under 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Apoaequorin is not approved as a drug for marketing in the United States, and is not exempt from this requirement pursuant to 21 U.S.C. § 355(i), which governs the use of investigational new drugs.
It has also come to our attention that the apoaequorin used in your Prevagen products is produced synthetically. Therefore, the synthetically produced apoaequorin used in your Prevagen products is not a dietary ingredient as defined in section 201(ff)(1) of the Act. Accordingly, your Prevagen products could not be marketed as dietary supplements.
Regarding the use of pictures and videos on your websites, we remind you that an image may be considered a claim to diagnose, mitigate, treat, cure, or prevent disease if, in the context in which it is presented, the image suggests that the product has an effect on a disease or diseases.
“Your website www.prevagenreviews.com also contains claims in the form of personal testimonials,” implying Prevagen was medically beneficial “in preventing or treating brain cell damage.”
Your Prevagen, Prevagen Extra Strength, and Prevagen Professional products are not generally recognized as safe and effective for the above referenced uses.
Specifically, you failed to report to FDA adverse events like seizures, strokes, and worsening symptoms of multiple sclerosis that had been reported to your firm as being associated with use of Prevagen products. Some of these adverse events resulted in hospitalization. In total, our inspection found records of more than 1000 adverse events and product complaints that had been reported to your firm between May 2008 and December 1, 2011. Some of these involved heart arrhythmias, chest pain, vertigo, tremors, and syncope (fainting), in addition to the seizures, strokes, and worsening of multiple sclerosis already mentioned.
Public ignorance and gullibility
In their natural desire to be healthy, or in their search for Ponce de Leon’s Fountain of Youth, most people in general are eager to try almost anything, sometimes, at any price. The flourishing trillion dollar industry for “food supplements,” herbals, and products that “stop or slow” aging and remain yourthful is a testament to this.
Most unfortunately, the ultimate tragedy here falls on many ignorant and unsuspecting consumers who could hardly make ends meet, who are at the victims of these unconscionable companies.
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Philip S. Chua, MD, FACS, FPCS, Cardiac Surgeon Emeritus in Northwest Indiana and chairman of cardiac surgery from 1997 to 2010 at Cebu Doctors University Hospital, where he holds the title of Physician Emeritus in Surgery, is based in Las Vegas, Nevada. He is a Fellow of the American College of Surgeons, the Philippine College of Surgeons, and the Denton A. Cooley Cardiovascular Surgical Society. He is the chairman of the Filipino United Network – USA, a 501(c)(3) humanitarian foundation in the United States. Email: [email protected]
