No Consumer Protection

William Faloon

The ABC Nightly News has reported that over 150,000 Americans regularly use s-adenosyl-methionine (SAMe). The problem is that many people are not deriving any benefit because unscrupulous manufacturers are selling products that contain virtually no SAMe.

A blatant example of consumer fraud was brought to our attention when we assayed a SAMe supplement that was selling at an impossibly low price. We found that each tablet of this counterfeit product contained 5.1 mg of SAMe, yet the label claimed that each tablet provided 200 mg. This is not an isolated problem. Previous assays have shown that our brand1 and Nature's Made's brand are the only ones that contained the proper amount of SAMe.

You might expect that ABC News would have reported on the problem of mislabeled SAMe, but this was not the case. The testing lab ABC News used apparently did not know how to accurately assay for SAMe and they mistakenly reported that our brand and Nature's Made brand contained 40% more SAMe than what is claimed on the label. We know this not to be true for two reasons. First of all, we have regularly assayed our brand and Nature's Made brand, and they consistently come out at 100% label potency, not 140%. Secondly, SAMe is so expensive, that if we put in 40% more active ingredient than what the label claims, we would lose money on each box sold.

 

What this ABC News report really showed is that brands they endorsed as meeting label claim potency where actually 40% deficient in SAMe. We don't fault ABC News for these discrepancies as SAMe is an extremely difficult substance to test for. That's why Newsweek magazine asked us to test major brands of SAMe for them because no commercial assay lab would guarantee accurate results. As the first organization to offer SAMe in the United States, we had to develop an accurate method to verify that the SAMe we were putting into our tablets was maintaining 100% stability. SAMe is inherently unstable, and this is one reason why many commercial SAMe products contain little active ingredient by the time the consumer ingests them.

In order to help protect consumers, The Life Extension Foundation has contacted the company recently identified as selling bogus SAMe and advised that they should recall the product. Previous letters like this have resulted in commercial companies withdrawing their sub-potent products or re-formulating to make a product that meets label claim.

We aren't the only organization seeking to protect consumers against fraudulent products. An organization called ConsumerLab recently assayed commercial SAMe supplements, and found that six out of thirteen brands tested failed to meet label claim.

There are consumer activists that argue that FDA regulation is the solution to these kinds dietary supplement problems. The fact is that the FDA lacks the resources to adequately test the tens of thousands of supplements sold on the American market. Furthermore, the FDA's objectives are not to guard the consumer against sub-potent supplements, but rather, the agency's focus is on protecting the pharmaceutical industry against the competition that dietary supplements pose to prescription drugs. It actually helps the pharmaceutical industry when counterfeit SAMe products are sold to Americans. Since these bogus products fail to produce anti-depressive effects, the consumer resorts to FDA-approved anti-depressant drugs and loses confidence in alternative therapies.

The FDA remains biased against alternative medicine, and this can be seen in the agency's proposal to seek ten million tax dollars a year to regulate Internet pharmacies and health sites. As we reported three months ago, one of the FDA's excuses for seeking this annual tax payer subsidy is to keep Americans from being able to order Viagra without a prescription. A new report, however, shatters the FDA's argument that Viagra can be safely used when prescribed by a physician.

This study shows a higher number of deaths and serious cardiovascular events associated with Viagra than what were previously thought. These findings were presented at the March 14, 2000 meeting of the American College of Cardiologists in Anaheim, CA. In this analysis of 1,473 major adverse events related to Viagra, 522 people died, the majority due to cardiovascular causes. According to the study's senior author, the majority of deaths were associated with standard Viagra dosages (50 mg) and were due to cardiovascular causes that appeared to be clustered around the time of dosing (most deaths occurred within four to five hours of taking Viagra). These 522 deaths are sharply higher than previous estimates.

 

What is most striking is that the majority of deaths occurred in patients who were less than 65 years of age, and who had no reported cardiac risk factors. You may remember that after men started dropping dead after taking nitrate drugs and Viagra, the FDA responded by mandating new labeling that warned against prescribing Viagra to those whose underlying cardiovascular disease might predispose them to an advers reaction. However, this new study showed that most deaths (88%) actually occurred in patients who were not taking nitrates, leading investigators to speculate whether there are some susceptible individuals who are vulnerable to Viagra's lethal side effects even if they don't take nitrate drugs.

The question begging to be answered is how the FDA could have missed these lethal side effects after spending so many years and dollars evaluating Viagra for safety. As a consumer, you are paying $8 to $10 a tablet for Viagra, and the drug company justifies this outrageous price by factoring in the high FDA-approval costs. The FDA, however, failed to detect Viagra's lethal side effects, 522 people have died to date and Americans are still being deceived into believing that the FDA "protects" the public's health.

While the FDA has no plans to restrict sales of Viagra, it still classifies natural testosterone as a "scheduled drug," which makes it more difficult for physicians to prescribe it. Natural testosterone is more effective in restoring lost libido than Viagra, and is completely safe (for men who do not already have prostate cancer)2. Alternative medicine has been extolling the virtues of natural testosterone replacement therapy for years, while misguided FDA policies have suppressed this safe, non-patented libido-enhancing therapy.

It is difficult to ascertain how the FDA can claim to be guarding the public against dangerous drugs when 522 men have died after taking Viagra and many more have encountered "major adverse events." Under the guise of protecting the consumer from unsafe products, the FDA has instead created a multi-billion dollar monopoly for the manufacturer of Viagra. The consumer pays for this non-existent "protection" every time they buy an exorbitantly priced FDA-approved drug.

There are free market solutions that would allow Americans to safely and quickly gain access to new life saving therapies. Change, however, no matter how practical, comes slow to Washington politics. That's why membership in The Life Extension Foundation is so critical to those who are concerned about maintaining optimal health today. Our organization exists solely because we provide members with substantive health benefits, unlike the government protected drug monopoly that uses FDA "approval" to sell expensive, dangerous and sometimes worthless products.

We are again asking members to protest the FDA's intensified efforts to persuade Congress to grant the agency ten million dollars a year to censor Web pharmacies and health sites. Following this article is a new form letter that can be torn out of this magazine or photocopied and mailed to your Representative and two Senators in Congress.

Another form letter in this issue enables you to voice your support for a bill that is now in both the House and Senate that would enable Americans to purchase FDA-approved drugs from offshore pharmacies at far lower prices. This bill is gaining enormous bi-partisan support, as the American public is aggressively lobbying their members of Congress to allow them to purchase identical medicines at lower prices from other countries. The FDA and pharmaceutical industry, on the other hand, want to deny Americans the right to purchase these lower cost medications. You can read an update to this epic battle between the American consumer and the pharmaceutical industry in the article entitled "Big Bucks" in this month's issue.

As a health consumer, your best protection lies in a free market environment, as opposed to the current system whereby giant pharmaceutical companies work hand and hand with the FDA to ensure than Americans pay the highest drug prices in the world. Under existing rules, Americans are denied access to life saving therapies while the FDA pretends to protect consumers against dangerous and ineffective products. The facts are that the FDA approves dangerous drugs that kill over 125,000 Americans a year while simultaneously suppressing innovative therapies that could save many lives. Despite these abysmal facts, the FDA continues to put forth a charade that it functions as a "consumer protection" agency. The Life Extension Foundation has long contended that the FDA acts to protect the financial interests of the large drug companies, at the expense of the American consumer's health and pocketbook.

For longer life,

William Faloon

References

1. Our brand is sold by some other distributors under different labels
2. Safety and efficacy of natural testosterone discussed in: Maximize Your Vitality and Potency (Jonathan V. Wright, M.D.) The Testosterone Syndrome (Eugene Shippen, M.D.) Disease Prevention and Treatment (Life Extension Foundation)

Date:________________________
To the Honorable ____________________
U.S. Senate
Washington, D.C. 20510

At a hearing of the Senate Health, Education and Pensions Committee, held on March 20, 2000, the FDA sought a ten million dollar annual appropriation beginning in Fiscal Year 2001 to police the Internet. I am vehemently opposed to my tax dollars being used to fund the FDA, an agency that I believe does not protect the public like it pretends to do.

In the FY 2001 budget proposal, the FDA is asking Congress to pass a new law that would give the agency repressive powers that would restrict the free flow of information on the Internet. I ask that you vote against any proposed law that gives the FDA more control over what I am allowed to read and put in my body. Some of the unconstitutional authority the FDA is seeking includes:

1. Issuing subpoenas without a court order. Giving the FDA this new power will create a litigation monster whose annual appetite will rapidly exceed the ten million dollars a year they are now seeking.
2. Fining Internet pharmacies $500,000.00 every time they sell a drug that does not meet the FDA's definition of a legal prescription. This type of excessive fine will enable the FDA to arbitrarily bankrupt any online pharmacy it decides to target.
3. Setting up "a rapid response team" to identify, investigate and prosecute websites, i.e., the FDA is seeking to establish a private army of storm-troopers to summarily shut down any website it chooses.

Please do not be mislead by the FDA's pathetic attempts to convince you that they are trying to protect the health of the public by regulating the Internet. According to the April 15, 1998 issue of the Journal of the American Medical Association, adverse reactions to legally-prescribed FDA-approved drugs are the fourth to sixth leading cause of death in the United States. Since this article was published almost two years ago, the FDA has done nothing to reduce the number of Americans dying from dangerous drugs, yet the FDA now seeks ten million tax dollars a year to attack alternative health and pharmacy websites.

If the FDA convinces Congress to grant it more power and money to attack health websites, American consumers will be denied access to innovative therapies and pay a lot more for their prescription drugs. I therefore ask that you write me with your position on this issue so I will know how to case my ballot this November.

Sincerely,

Name___________________________________________
Street___________________________________________
City_______________________ST_______Zip__________

cc: House Representative