Please refer to both of the
articles below for some of the latest news on the
Durbin Implications.
The Other
Shoe Drops
by Scott Tips
June 2003, Whole Foods Magazine
Dick Durbin is a
reverse Cassandra. Cassandra, as you may recall from Greek
mythology, was the seer who was cursed by the Gods with the
gift of accurately foretelling the future only to be
disbelieved by everyone. Senator Richard Durbin (D-Ill.) and
his fellow travelers, on the other hand, have absolutely no
gift for foretelling the future but are believed by everyone.
Or at least by most.
We certainly do not believe Mr. Durbin when he tells us that
Americans urgently need to be protected from dietary
supplements with his newly introduced “Dietary Supplement
Safety Act” (S.722). Dietary supplements, he proclaims, are
accidents waiting to happen unless they are safely
manufactured and controlled through his amendment to the
FDA-hated “Dietary Supplement Health and Education Act of
1994” (DSHEA). And for those Americans who have been
conditioned by the media articles and news reports continually
thrown at them for many years now about the “hazards” of
vitamins, minerals and herbs, the long-expected other shoe is
now dropping with Mr. Durbin’s “solution” to the “problem.”
Like a pre-attack bombardment, all of those newspaper and
magazine articles about vitamin overdoses, ma huang ephedra
concerns, and hormone-precursor issues were meant to soften us
up for the kill: Durbin’s heavy-armor strike is the follow-up
in a concerted effort to rollback the health victory of 1994.
Mr. Durbin and the usual rogues’ gallery of statists mask
their true anti-freedom intentions behind the by-now trite
proclamations of concern for the safety of Americans. Of
course, the establishment Consumer’s Union, forever abysmally
ignorant of health matters, asks its readers to promote
increased health safety by supporting Durbin’s bill. Yes, we
are all concerned about the safety of Americans, but not from
dietary supplements – rather, from the Food and Drug
Administration and legislators like Durbin who would literally
kill us with their supposed good intentions.
The so-called “Dietary Supplement Safety” Act proposes to
protect us by requiring that dietary supplement manufacturers
submit Adverse Event Reports (AERs) to the FDA within 15 days
of receiving such reports from the public or health
professionals. At an estimated cost of $10 million per year,
the FDA would then be required to clinically evaluate each
serious adverse event and develop systems and procedures to
collect, store, and access such adverse data. Although
Durbin’s bill does not require that the AER information be
published on the FDA's website as is done currently with
prescription-drug AERs, that can come later after the industry
and public accepts this initial step. The legislation also
requires manufacturers of “stimulant” dietary supplements
(products that speed up a person's heart or affecting a
person's central nervous system) to submit proof that their
products are safe prior to bringing those products to market
and would place anabolic steroids (including DHEA) under the
Controlled Substances Act. Durbin’s bill also expands FDA's
authority to require proof of safety from any dietary
supplement maker if the agency has received reports suggesting
that the product is deadly or causing other serious adverse
health effects. If a manufacturer cannot show its product to
be safe to FDA’s satisfaction, then the FDA could take that
product off the market. This bill is yet another step towards
regulating dietary supplements like drugs. While Durbin
proceeds with this proposed post-market regulation of the
tracking and sale of dietary supplements, the FDA itself has
issued its first set of proposed regulations to regulate the
manufacturing of dietary supplements like pharmaceutical
drugs. (See Tips Article on cGMPs.) Durbin’s bill has been
referred to the Senate Health, Education, Labor and Pensions
(HELP) Committee for study.
Yet, dietary supplements have an enviable and exceptional
safety record. According to the U.S. Center for Disease
Control (CDC), deaths from dietary supplements have averaged
fewer than five confirmed deaths per year over the last 25
years in the United States. And most of those deaths came from
the single batch of contaminated, genetically engineered
tryptophan introduced into the United States from Japan in the
1980s.
In contrast, “properly” tested, approved, regulated, and
prescribed drugs are the fourth most common cause of death in
the United States. According to the Journal of the American
Medical Association, such drugs cause from 90,000 to 160,000
deaths per year in the United States. Another 100,000 or more
are killed in hospitals because of medical errors. And more
than two million people require hospitalization every year
because of adverse reactions attributable to prescription
drugs. The unreported numbers are estimated to be much larger.
Even food is vastly more dangerous than dietary supplements.
Food poisoning causes 5,000 to 9,000 deaths per year according
to the CDC. Those numbers, too, are eclipsed by the 76 million
Americans who get sick from food every year as well as by the
300,000 who are hospitalized annually because of food borne
illnesses. In fact, Americans are less likely to die from
dietary supplements than they are to die from bee stings,
sports injuries, lightning strikes, animal bites, and horse
riding. I must confess, though, that dietary supplements
probably do account for more annual deaths than meteor strikes
or spontaneous combustions.
Of course, there are always those naïve ones who will say that
no cost is too high to prevent the some five deaths a year
attributable to dietary supplements. Assuming for the moment
that any of the current steps proposed by the FDA and Mr.
Durbin will prevent even one of those deaths, which I do not
believe they will, the tradeoff cost of such regulations is
actually more human pain and loss of life. Hard to believe?
Believe it because as increasing regulation of the
dietary-supplement industry heaps ever more costs upon them,
dietary-supplement prices will also go up – and markedly so,
placing these vital substances beyond the affordable reach of
many consumers. As it is now, many important vitamins and
minerals cost more dollars than consumers are willing to pay.
Imagine when these and other dietary supplements begin to
approach the price levels of drugs – many more persons will
forego the true benefit of prevention for the false allure of
drug cures. And pricing is just one aspect of the problem.
Consider also the disincentive that such increased costs and
regulation will place upon the introduction of newly
discovered health products. Truthfully advertised and properly
marketed, dietary supplements have the potential to reduce
cancer and other deaths by some 50-75 percent; but if they
become as costly as drugs without any corresponding right to
make drug claims, then they will be shunned by consumers.
Equally wrong, Durbin’s bill would classify as controlled
substances some dietary supplements, such as DHEA, that would
help individuals live richer and longer lives. And, his bill
is sexist, favoring women over men since it would discriminate
against users of testosterone while still permitting the use
of estrogen, perhaps on the outdated notion that somehow
testosterone is more dangerous than estrogen.
Right now, nutrients such as saw palmetto compete favorably
with Proscar for helping men with benign prostate hypertrophy,
melatonin competes favorably with sleep aids and medications,
and glucosamine sulfate with prescription and over-the-counter
arthritis drugs. Moreover, these nutrients are far safer than
their drug alternatives. Yet, high-level FDA regulators,
perhaps looking to their future high-paying jobs with large
pharmaceutical companies, know that such jobs are threatened
by these natural products and they will act to protect their
future income by eliminating or restricting the natural
competition.
Some have suggested that by the use of anonymous case reports,
selective reporting of anti-dietary supplement “studies”
funded by certain pharmaceutical companies along with biased
press reports from the public-affairs office of the FDA, the
anti-freedom regulators will succeed in “manufacturing” the
consent that they need to pass these new laws and regulations.
Durbin’s bill is one important step in treating healthy
dietary supplements like harmful drugs. In doing so, the FDA
will begin the process of holding dietary supplements to
drug-safety standards. Once those standards are in place, the
United States will have no argument against applying the
excessively restrictive international standards of the Codex
Alimentarius Committee (i.e., upper and lower limits, positive
and negative lists, etc.) because the only lawful basis by
which the United States can avoid a Codex standard is on the
basis of safety. And when dietary-supplement safety is
unnecessarily held to rigid drug-like standards, then
eventually Codex’s other drug-like restrictive standards will
also apply.
Write your legislators. Durbin’s anti-freedom bill must be
defeated.
The
age-old, surefire call to regulate is being trumpeted once
more in the interest of "public safety." This time it is to
keep the public safe from those infamous killers - vitamin
pills. Sen. Richard Durbin (D-Ill.) has introduced legislation
that effectively would give the Food and Drug Administration
(FDA) the authority to remove from the market any dietary
supplement it chooses, including vitamins E and C. Opponents
of the bill say the senator may be deficient in his
understanding of natural supplements and has overestimated the
daily allowable dose of federal regulatory intervention that
Americans will swallow.
Durbin's Dietary Supplement Safety Act of 2003 (S 722),
cosponsored by Sens. Hillary Clinton (D-N.Y.), Charles Schumer
(D-N.Y.) and Dianne Feinstein (D-Calif.), is said to result
from the growing number of deaths allegedly associated with
the use of dietary products containing the natural supplement
ephedra, including that of Baltimore Orioles pitcher Steve
Bechler on Feb. 17. While fatal use by a few high-profile
athletes has focused attention on dietary supplements
containing natural stimulants, Durbin says it was the death of
his 16-year-old constituent Sean Riggins, who died from an
ephedra-induced heart attack on Sept. 3, 2002, that pushed the
senator to fight for a federal prohibition of the supplement
and to get ephedra banned in Illinois, the only state in the
nation to take such a step.
What Durbin says he hopes to do, in the name of public safety,
is to require manufacturers of dietary supplements to prove
the product is safe before marketing it. The Durbin bill would
expand the FDA's authority to require exotic proof of safety
from any dietary-supplement maker if the agency has received
so much as a single report of an adverse reaction (AR). If the
manufacturers fail during hideously expensive tests to prove
that the product is safe, the commissioner of the FDA can
remove it from the market.
The legislation would require manufacturers of dietary
supplements to report to the FDA, within 15 days, any and all
serious adverse health events by anyone using their products,
something critics say is almost impossible to do as a matter
of simple practicality. Even so, the Durbin claims about
dangers seem nothing if not wildly exaggerated. Although the
Illinois senator claims "scientific reports have linked
ephedrine and similar dietary supplements to 117 deaths and
more than 17,000 other health-related problems," in 2001 the
Department of Health and Human Services (HHS) received just 10
adverse-event reports from manufacturers for all
dietary-supplement products combined. Durbin's take on the
disconnect between HHS and other alleged scientific reports is
that "the voluntary-reporting system under current law is
clearly not working."
What is interesting about the legislation is that, even though
the senator spotlights ephedra and other "stimulant" products
to excite interest in his case for added federal regulation on
natural supplements, the word "ephedra" does not appear
anywhere in the eight-page bill. Critics say this is because
the senator wants to impose on manufacturers of natural
dietary supplements the same exorbitant costs as have been
imposed on drug manufacturers to make prescription medicines
prohibitively expensive for so many Americans. Apparently
Durbin thinks that is the only way the public can be
protected.
Consider some of the drug products long regulated by the FDA -
drugs that already must be "proved safe" before being brought
to market. Take for example the chemical stimulant Ritalin,
which is taken by tens of millions of school-age children
every day. According to the FDA, between 1990 and 1997 there
were 160 deaths associated with methylphenidate (Ritalin) and
569 hospitalizations, 36 of which were life-threatening. And
it is widely accepted that the FDA formally receives less than
1 percent of suspected serious ARs.
Furthermore, the adverse side effects of the natural ephedra
and the pharmaceutical Ritalin, both popular stimulants, are
all but identical. Yet neither Durbin nor any other federal
lawmaker has called for the removal of Ritalin from the
market. Consider these warnings of potential adverse
reactions. Ephedra: nervousness, dizziness, tremor,
alterations in blood pressure or heart rate, headache,
gastrointestinal distress, chest pain, myocardial infarction,
stroke, seizures, psychosis and death. Ritalin: nervousness,
dizziness, irregular or fast heartbeat, chest pains, high
blood pressure, severe headache, palpitations, angina, cardiac
arrhythmia, abdominal pain, unusual bleeding, tics, blurred
vision, insomnia, toxic psychosis, death.
Advocates of natural medicines say the antidepressant Prozac,
made by pharmaceutical giant Eli Lilly, is another interesting
case Durbin may want to review before putting all his
"public-safety" eggs in the FDA basket. As of September 1993
there had been nearly 30,000 AR reports associated with Prozac
filed with the drug agency, including side effects such as
delirium, hallucinations, convulsions, violent hostility and
psychosis, plus 1,885 suicide attempts and 1,734 deaths -
1,089 by suicide. And according to Thomas G. Whittle and
Richard Wieland, critics who obtained documents under the
Freedom of Information Act, "both Eli Lilly and officials of
the FDA were aware that at least 27 deaths had been linked to
the use of Prozac prior to the drug being released on the
market."
These figures are 10 years old, and yet the FDA has not pulled
Prozac from the market. Despite tens of thousands of AR
reports detailing adverse reactions, the federal agency tasked
with overseeing the public safety of drugs has not required
Eli Lilly to "prove" that Prozac is safe. In fact, according
to Whittle and Wieland, "a 1986 FDA safety review [of Prozac]
... discovered that Eli Lilly had failed to report information
about the onset of psychotic episodes in people during
Prozac's testing." And still the FDA took no action against
the drugmaker.
But, when it comes to natural dietary supplements, here is
Durbin doing his part to protect the public by setting a
standard that critics say is far above that for
pharmaceuticals. "It is impossible," Durbin says, "for anyone
to calculate exactly how many people have had their lives
ended or their health ruined by ephedra during the months
since I first raised the issue, but whether it was 500 or
five, it was too many. We can lead the country in protecting
our kids by imposing reasonable safety restrictions on these
dangerous drugs; this experience with ephedra should convince
everyone the law should be changed in order to protect the
American consumer."
Given the enormous number of AR reports filed about Ritalin
and Prozac, to name just two pharmaceuticals, critics wonder
aloud why, given the senator's concern about public safety, he
has submitted no legislation to ban the use of those products,
especially since Ritalin and ephedra both are stimulants and
there is virtually no difference between the adverse reactions
reported with their use. Apparently the guiding Durbin
principle that says, "whether it was 500 or five, it was too
many," doesn't apply when it comes to highly profitable drugs
pushed by the pharmaceutical giants, according to holistic
practitioners who prefer natural remedies.
Julian Whitaker, a medical doctor who is founder and director
of the Whitaker Wellness Institute in Newport Beach, Calif.,
tells Insight that "this legislation isn't about safety at
all. It's about loss of control that the FDA has experienced
over the last seven or eight years when it comes to regulation
of the nutritional-supplement industry with passage of the
1994 Dietary Supplement Health and Education Act (DSHEA). It
basically said the FDA no longer could rule arbitrarily on the
nutritional-supplement industry by denying publication of
truthful information on supplements. The 1994 law gave the
nutritional-supplement industry a safe harbor that kept its
products from being designated as drugs subject to
prohibitively expensive regulation, and the industry has a
safety record that reportedly is the best of any
consumer-product company in the United States. This is
especially important when you realize there are 5,000 deaths
attributed to aspirin every year, 30,000 deaths known to be
caused by over-the-counter drugs and 240,000 deaths from
prescription pharmaceutical drugs used correctly."
Whitaker, the author of nine books on nutrition, is just
getting warmed up. "We don't know the deaths that come from
vitamins, particularly ephedra, were the result of abuse," he
says. "When over-the-counter drugs are responsible for deaths
no one cares even to write about it, but if a baseball player
dies from a heat stroke and he's got ephedra in his system
they blame the ephedra. Suppose, though, that he had Sudafed,
Tylenol or alcohol in his bloodstream. Are they going to take
those products off the market? Look at it this way: We have
millions of people suffering from alcohol-related health
problems because of alcohol abuse. Is Congress going to take
alcohol off the market?"
David Seckman, executive director of the National Nutritional
Foods Association, the oldest and largest trade association in
the United States representing natural products, including
retailers, manufacturers and wholesalers, tells Insight, "This
legislation is a bad idea and there are some provisions that
we're very concerned about. It mandates that manufacturers
submit adverse-reaction reports for supplements, and it
defines products like stimulants that won't be allowed to be
used as supplements. Naturally the bill explicitly excludes
things like caffeine from the list. This is because, if you
look at the definition of what a stimulant is, you learn that
it is anything that increases the heart rate - which is just
about anything. The commissioner of the FDA, after just one
adverse-reaction report, would have the discretion to make the
manufacturer of the targeted product prove it is safe before
it again can be marketed."
Seckman says, "Our concern is that we're talking about
products that have been used safely and effectively for
thousands of years that now can be pulled from the market
because of just one report. People will be able to call in
with an adverse reaction to multivitamins and the commissioner
will have the authority to make the manufacturer prove that
multivitamins are safe. Under the 1994 DSHEA, supplements were
classified as foods and under a totally different category
than drugs. Drugs require premarket approval and are granted a
patent. You're not going to be able to do that with vitamin C
and other such natural products. It's just going to put the
commissioner in a precarious situation to make determinations
about the safety of natural products."
As Seckman notes, "Under the current law the FDA already has
the ability to ban any product that it finds is not safe. Our
contention is that if the FDA commissioner finds a product
that is unsafe, and can prove it, then that product should be
banned. We don't think the congressional intent was or is that
every time there is an issue with a supplement we need
Congress to decide whether vitamin C or any other natural
supplement should be banned. The language is already there.
Look at garlic, for instance. Should you have to prove that
garlic is safe before you put it on the market? This is a
possibility under the proposed legislation. And you always are
going to find people who have adverse reactions to something
they take, even things like vitamin C and garlic. We don't
think this legislation is wise."
Len Horowitz, an internationally known public-health authority
and author of more than a dozen books, including Emerging
Viruses and Death in the Air: Globalism, Terrorism and Toxic
Warfare, isn't buying the public-safety mantra. "This isn't a
public-safety issue," Horowitz explains. "It may be disguised
as one, but it has nothing to do with public safety.
Everything is tremendously regulated to the detriment of
society, and I believe that the pharmaceutical industrialists
have their hand in every aspect of the regulations and
legislation."
Horowitz continues, "You know, people are overdosing on coffee
every day, but you don't see Congress regulating Starbucks.
This argument has to be understood within the context of the
fear mentality generated by the media on behalf of the
pharmaceuticals who don't want to tell you that the third
leading cause of death in the U.S. is drug-induced,
physician-prescribed, hospital-prescribed medications. You
don't see the intensity over that, but you do see it over and
over again when someone overdoses on ephedra."
He asks, "Are supplements dangerous? What isn't dangerous?
Water is dangerous. Try hyperventilating for five minutes and
you'll pass out. That's dangerous. This is about an induction
of phobia - a fear that is disproportionate to the actual size
of the threat. Saying that one case or even 100 cases of
people overdosing from too many vitamins, [that] amounts to
trying to induce a phobia to push legislation - dreaming up
justification for insane regulations."
Opponents argue that the numbers don't come anywhere near
showing a need for what they regard as legislative overkill.
Especially when one considers that, according to the FDA,
adverse reactions to dietary supplements represent less than
one-half of 1 percent of all substance-adverse events. Of
course, Sens. Durbin, Clinton, Schumer and Feinstein disagree.
Kelly Patricia O'Meara is an investigative reporter for
Insight.
