Regulating Vitamins

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Regulating Vitamins

 

http://www.insightmag.com/news/455042.html

 

Regulating VitaminsBy Kelly Patricia O Meara

 

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.