Regulating Vitamins

[Guest guest]

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.