| LE Magazine July 2000
 
No Consumer Protection
By 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.
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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.
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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 adverse
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.
William Faloon
Vice President, Life Extension Foundation
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) |