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The Other Shoe Drops
By Scott Tips
June 03, 2003

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.

Please click on the appropriate links below to read the following information or right click and choose "Save Target As..." to save this to your file directory for future use and reference.  The following files are all in .pdf format requiring Adobe Reader which can be downloaded for your system by clicking the icon at the bottom of this text:

Introduction to the Dietary Supplement Safety Act

The Dietary Supplement Safety Act Legislation (the actual bill, S. 722, in its entirety)

(Petition) Targeted Congressional Member Letter to oppose S.722

List of Targeted Members of Senate Health, Education, Labor and Pensions Committee to oppose S.722

Regulating Vitamins

by Kelly Patricia O'Meara

September 2003

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.