US Supplement Industry "Tarred and Feathered" by Annonymous Case Reporting "Data

To: IAHF List
Subject: US Supplement Industry "Tarred and Feathered" by Annonymous Case Reporting "Data" Cited by IG Report in AP "Story"
From: "International Advocates for Health Freedom" jham@iahf.com
Date: Thu, 19 Apr 2001 18:13:32 -0400

IAHF List: See the horribly biased AP News story below my comments which attacks the supplement industry unfairly calling for "tougher regulations" By allowing annonymous case reports to be logged against vitamins in their "Medwatch Adverse Reaction Reporting System" FDA is "proving" vitamins are dangerous, and a biased HHS Report is calling for "tough new rules" for safe vitamins. Send this to your Senators and Congressmen to complain.

At 11:10 AM 4/19/01 -0400, you wrote:
http://www.intelihealth.com/IH/ihtPrint/WSIHW000

This story about the IG Report from HHS indicates to me that the IG Report is very slanted against us because it attempts to cast dietary supplements in a negative light, in an effort to insinuate that they are "as dangerous" as OTC or prescription drugs. In this country dietary supplements are regulated as foods, with adverse reaction reporting system no different than that which FDA has for other foods, and foods are far more dangerous than dietary supplements by any objective measure. CRN angers me greatly, and in general I distrust them hugely, but aside from the fact that CRN said nothing about the problem of FDA allowing annonymous case reports to be used against vitamins (a curious and HUGE ommission wouldn't you say?) I AGREE with their criticisms of the draft of the IG Report which you can read at http://www.crnusa.org (CRN is demanding that the report undergo extensive changes before being publicly released.)

FDA currently allows annonymous case reports for alleged "Adverse reactions" and anyone can fabricate them and call them in. I suspect strongly that the main reason the FDA wasn't able to get the information they sought via their "Medwatch" program is that many of the adverse reaction "reports" on supplements were phony. There is no question in my mind that the Cartel has logged bogus reports on the Medwatch "system". Before he killed himself, Brian Leibovitz,PhD, tried hard to call attention to the fact that FDA's annonymous case report "Adverse Reaction surveilliance system" for dietary supplements to be the ultimate fraud.

With annonymous case reports, you can say anything about anything and nothing can be verified. Its the only way you can "prove" vitamins are "dangerous". Brian intentionally called in a handful of phony, (and highly absurd) case reports just to illustrate how crooked FDA's Medwatch program is. He wanted to see if his phony reports would get included in FDA's database (they were). Then he called them up to tell them what he'd done, demanding that the phony reports be removed (they weren't). So he called back again to complain that they hadn't been removed, called this to the attention of his Senators and Congressman, and demanded to be arrested for issuing these phony reports. (He wasn't, they realized he was after publicity that he would have used against the FDA.)

Brian wanted to sue the FDA over their fraudulent Medwatch system, but could never get anyone to help him besides me. I tried to get this idea out to people the best I could. Brian killed himself in part due to depression caused by this deep corruption. He discussed his concern about FDA's phony Medwatch system re vitamins in the last radio interview he ever did which you can hear at http://www.citizensvoice.org/index2.html His loss to our movement was immense. He once worked with Linus Pauling doing research on antioxidant vitamins. Given that the FDA is housed within the Dept. of Health and Human Services where this bogus IG Report originated, all I can say is "consider the source." FDA has a huge press office and the ability to get garbage like this distributed via the AP wire at will.

April 18,2001

WASHINGTON (AP) - Tough new rules are needed to monitor the sale and use of dietary supplements, the vitamins and herbs now used by about 60 percent of Americans, a government study says.

A draft report of the study by the Department of Health and Human Services inspector general's office said federal regulations now do a poor job of protecting the public from the risks of dietary supplements.

The report said supplements do not undergo premarket safety approval procedures of the Food and Drug Administration, and manufacturers are not required to report adverse health effects experienced by people taking the supplements.

Instead, the report said, the FDA relies on voluntary reports of adverse health effects and ``rarely reaches the point of knowing whether taking a safety action is warranted'' for a dietary supplement.

The study urged regulations requiring supplement manufacturers to register themselves and their products with the FDA and to report any adverse health results to the agency.

A recent FDA study, the report said, estimated that the agency learns of fewer than 1 percent of adverse events involving dietary supplements, even though some, such as ephedrine alkaloids or ginkgo biloba, have been linked to serious side effects.

Often the FDA is unable to determine the ingredients in products mentioned in adverse event reports, because labels are missing from 77 percent of products mentioned in such reports, the study found. Even the city and state where the products were manufactured was missing from 71 percent of the products named in adverse reaction reports, the study found.

``Our evaluation of FDA's dietary supplement adverse event report system leads us to conclude that ... the potential of the system to serve as a consumer safeguard is inherently limited,'' the draft report said. It said the current system ``cannot serve as an adequate safety valve.''

The report said dietary supplements are "increasingly popular," used daily by about six out of 10 Americans.

Dietary supplements include vitamins, minerals, herbs and amino acids. Such supplements can be beneficial, but they can also carry health risks, the report notes. In the past, the FDA has warned about ephedrine, which can cause strokes, and about some herbal products marketed as sleep aids or weight control formulations that caused heart attacks, strokes, even death.

The Council for Responsible Nutrition, a trade organization of dietary supplement manufacturers, said the report was seriously flawed and demanded extensive revision of the draft before the report is made public.

"The report paints a negative picture of the dietary supplement industry, implying that many companies are fly-by-night operations that FDA has difficulty locating," said a letter to the inspector general's office from Annette Dickinson, the council's vice president.

Instead, she said, 65 manufacturers known to the agency account for about 75 percent of the dietary supplement products on the market.

Dickinson said the trade group worries about "the negative view of dietary supplements that we believe pervades the IG's report" and asked that extensive changes be made before the report is completed.