Now playing: Stop the FDA!

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By Kerry Grens

Now playing: Stop the FDA! Group claims the agency violates free speech, and it's made a movie to explain why. Is Congress listening? [Published 29th June 2007 09:53 AM GMT]

Seated in a leather arm chair beside a stone fireplace, actor Terrence McNally speaks to the camera about his vision of an ideal world, one in which people have the right to save themselves from disease. Where grocery aisles contain signs that gently shepherd shoppers to the supplements that target their particular health concerns, such as omega-3s for people with existing cardiac problems. Yet, as McNally explains, an oppressive force is getting in the way of this utopia. "At the very point of sale the federal Food and Drug Administration stands as a roadblock to truth," McNally says. Anyone who watched US television in the 1980s would likely recognize McNally. He had guest roles on Mork & Mindy, Dynasty, LA Law, and the Love Boat, among other then-hits. (He also produced Earth Girls are Easy, incidentally.) Set to patriotic music, digital images of the Statue of Liberty and the scales of justice swirl in front of a starry sky. Engraved on a massive gavel are the words Freedom of Speech. As the music fades and the scales slide from view, the camera zooms in on McNally as he interviews a parade of supplement advocates and manufacturers, all claiming the FDA violates free speech by preventing supplements from carrying particular health claims. The agency has no provisions to evaluate or approve dietary supplements before they're sold. Supplement manufacturers can say a product maintains overall health, or a category as broad as "heart health," but cannot claim it treats or prevents a specific condition. According to the FDA Web site, a supplement labeled as effective for a specific condition "would be considered an unapproved--and thus illegal--drug." The movie asks the question: If you can sell a product without saying it's safe, and claim it offers some specialized protection, why not mention it may prevent or treat a more specific condition, if that claim is supported by research data? The movie, by a group called StopFDACensorship.org, includes Julian Whitaker, a doctor who runs a wellness institute in Newport Beach, California and sells nutritional supplements online; Steve Wallach, marketing director for a supplement company; and authors and supplement designers Durk Pearson and Sandy Shaw. Washington D.C. attorney Jonathan Emord, also interviewed in the movie, said the costs were minimal because producer Bill Kole, president and head writer for Mission Control Music & Post, donated most of the work. Our movie theaters have become platforms to call for political change - take the work of filmmaker Michael Moore (of the upcoming Sicko, about the state of US healthcare), and former Vice President Al Gore, who raked in millions by arguing that climate change has placed the planet on the verge of a catastrophe. This 30-minute movie is done on a much smaller scale, and interviewees have enormous financial stakes in the outcome. It's also unlikely to ever hit theaters, but Emord says his office has distributed thousands of the film's DVDs. Congress may be watching. Last month, representatives introduced the Health Freedom Protection Act, which would allow manufacturers to include language on the benefits of a nutrient for treating a particular disease or condition on its label. For example, the bill would authorize labeling such as: "Omega-3 Fatty Acids may reduce the risk of coronary heart disease." Emord has won several cases against the FDA for violating free speech, including a 2001 decision that permitted language that says folic acid helps prevent birth defects. It was a "moral necessity," Emord says of the case. According to StopFDACensorship.org, "FDA's censorship contributed to a preventable 10,000 neural tube defect births." However, in 2004 the Court of Appeals upheld a District Court's decision to dismiss a case regarding supplement labeling with saw palmetto health claims. The FDA's response to queries about StopFDACensorship.org was to reference the agency's Web site describing labeling regulations. Additionally, a spokesperson for the FDA told The Scientist in an Email, "FDA does not comment on lawsuits." Charles Simone, a member of StopFDACensorship.org and founder of the Simone Protective Cancer Center, a research and treatment facility in New Jersey, was also interviewed in the movie. He says he has no financial ties to the nutritional supplement industry. "All we're trying to do is very simple: allow people to state truthful statements," Simone says. Obviously, not everyone agrees. "There are good reasons why the FDA doesn't allow" labeling supplements as treatments for particular conditions, says Wallace Sampson, a fellow with the Committee for Skeptical Inquiry, which evaluates "fringe science" claims. The literature is full of mixed data about the effects of supplements. For instance, large amounts of folic acid can mask the symptoms of pernicious anemia. Saw palmetto may be no better than placebo to treat the symptoms of benign prostatic hyperplasia, and the effects of glucosamine chondroitin on knee pain from osteoarthritis are unclear. The proposed bill would authorize health claims for all three supplements on labels for products that contain them. Last week, the Center for Science in the Public Interest asked the FDA to prohibit egg sellers from marketing omega-3 rich eggs as heart-healthy. The health advocacy group argued that eggs are high in cholesterol, and often contain different forms of omega-3s, not just the beneficial types. "There's something to be said for freedom and excessive regulation, which stultifies the economy in some ways," says Sampson. "But there's nothing to be said for false advertising." The Health Freedom Protection Act currently sits in the House Committee on Energy and Commerce. A previous iteration of the bill was introduced in Congress in 2005, but never came to a vote. Do you think the FDA should okay marketing supplements to prevent or treat a specific condition? Will this movie sway anyone's opinion? Tell us here. Kerry Grens mail@the-scientist.com Links within this article: Terrence E. McNally http://www.imdb.com/name/nm0573646/ M.L. Phillips, "Getting omega-3s from pigs," The Scientist, March 27, 2006. http://www.the-scientist.com/news/display/23249/ K. Grens, "For sale: Stem cell enhancers," The Scientist, May 15, 2007. http://www.the-scientist.com/news/display/53194/ Food and Drug Administration, Overview of Dietary Supplements http://www.cfsan.fda.gov/~dms/ds-oview.html#regulate StopFDACensorship.org http://stopfdacensorship.org Julian Whitaker http://www.drwhitaker.com Steve Wallach http://www.youngevity.com/index.php Durk Pearson and Sandy Shaw http://en.wikipedia.org/wiki/Durk_Pearson Attorney Jonathan Emord http://www.emord.com Bill Kole http://www.missioncontrolmusicandpost.com Health Freedom Protection Act http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117 US District Court Opinion in Pearson v. Shalala http://www.emord.com/docs/Memo%20Opinion%202-2-011.pdf L.J. Williams et al., "Decline in the prevalence of spina bifida and anencephaly by race/ethnicity: 1995-2002," Pediatrics, 115:580-6, 2005. http://www.the-scientist.com/pubmed/16140696 Charles Simone http://www.drsimone.com T.A. Jacobson, "Secondary prevention of coronary artery disease with omega-3 fatty acids," The American Journal of Cardiology, 98:61i-70i, 2006. http://www.the-scientist.com/pubmed/16919518 R. Dalton, "Quackbusters Inc: Hot on the heels of medical hucksters," The Scientist, May 16, 1988. http://www.the-scientist.com/article/display/8412/ Committee for Skeptical Inquiry http://www.csicop.org/about/ M.S. Morris et al., "Folate and vitamin B-12 status in relation to anemia, macrocytosis, and cognitive impairment in older Americans in the age of folic acid fortification," The American Journal of Clinical Nutrition, 85:193-200, 2007. http://www.the-scientist.com/pubmed/17209196 S. Bent et al., "Saw palmetto for benign prostatic hyperplasia," New England Journal of Medicine, 354:557-66, 2006. http://www.the-scientist.com/pubmed/16467543 D.O. Clegg et al., "Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis," New England Journal of Medicine, 354:795-808, 2006. http://www.the-scientist.com/pubmed/16495392 "Egg producers deceive consumers, violate law with bogus omega-3 claims," CSPI, June 21, 2007. http://www.cspinet.org/new/200706211.html

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FDA CENSORS ALL NUTRIENT-DISEASE INFORMATION

by Sheryl Morley

[Comment posted 2007-09-30 09:18:33]

People seem oblivious to the fact that FDA censors every claim that a nutrient treats or prevents a disease, not just those that are false. Consequently, even the claim that prune juice is a treatment for chronic constipation is prohibited; in fact, if the claim were made, the makers of prune juice could be prosecuted under the civil and criminal laws, even incarcerated. The censorship is so broad that it keeps from the market vital health information that can enable consumers to choose among foods and supplements based on accurate data about their disease prevention and treatment effects. Do we let government censor all information on the theory that some of it is false? Of course not, yet that is precisely what the FDA does in the case of nutrient-disease claims for foods and supplements. Moreover, very little information is provable to a conclusive degree but we depend upon that less than conclusive information nonetheless in the making of every day decisions. The fact that it is more probable than not that omega-3 fatty acids reduce the risk of sudden death heart attack is enough to justify allowing that information on fish and supplements, but FDA prohibits it. The First Amendment is based on the assumption that the individual is best left to decide what is in his or her own interest, if only well enough informed. Freedom depends on acceptance of that proposition. In the case of foods and supplements (but not drugs!), the FDA starts from the premise that no information is better than some accurate information and that nothing except that which is proven true conclusively should ever reach the eyes or ears of consumers. That is Big Brother in the worst way. It offends the very core principles of our First Amendment in ways that sacrifice human health and life. FDA has proven itself a great enemy of liberty in ways that threaten health and favor drug monopolies. We should never have let that agency become a captive of the largest drug companies in the world and we should never have let that captive entity dictate what health information we receive: The result has been government creation and defense of a drug monopoly on treatment information at the expense of truthful treatment information concerning certain key nutrients. FDA will defend even unsafe drugs, like Vioxx, at the expense of tens of thousands of lives but when it comes to allowing expectant mothers to receive information that an inexpensive B-vitamin, folic acid, if taken daily by women of childbearing age can dramatically reduce the incidence of neural tube defects, FDA censors it year after year until the courts dictate otherwise. The price of liberty in the food market may be a mistaken choice. The price of censorship of all treatment information, except when made for drugs, may be your life.

FDA CENSORSHIP

by BETH LOYD

[Comment posted 2007-07-04 02:46:57]

I FEEL THAT THE FDA SHOULD INDEED LIGHTEN UP ON ALOT OF THEIR ISSUES AND NOT BE SWAYED BY THE ALMIGHTY DOLLAR. HOW COME SO MANY OF THE NEW DRUGS ARE SO EXPENSIVE?
THE PHARMACEUTICAL COMPANIES HAVE A BIG PART IN WHAT DRUGS GET APPROVED BY THE FDA. THERE ARE PLENTY OF LOW COST ALTERNATIVE DRUGS THAT ARE GETTING OVERLOOKED BECAUSE THEY WILL EITHER PUT AN EXPENSIVE DRUG OUT OF BUSINESS, OR THE COMPANIES THAT MAKE THEM OR CONDUCT THEIR CLINICAL TRIALS ARE NOT GETTING THE FUNDING AND BACKING THAT THEY DESERVE. IT IS A GREAT DISSERVICE TO THE PEOPLE THAT SUFFER FROM DISEASE, AS MOST DO NOT HAVE INSURANCE OR ADEQUATE FUNDS TO OBTAIN THE CURRENT DRUGS ON THE MARKET.

Claims supported by reasonable scientific evidence are OK

by Herb Ruhs, MD

[Comment posted 2007-07-03 15:29:34]

We are witnessing a struggle for market share between the so called "ethical drug industry" and marginalized producers of non-patentable products. The FDA is clearly on the side of the big drug companies here. The corruption at the FDA is outrageous. A decent government (the starting point for any contemplation of reform) would be open to scientifically based claims for all products under their supervision. As it is we are just being shucked and jived by the morally impaired.

Open Access Database Proposal

by Gary Anderson

[Comment posted 2007-07-02 12:58:54]

While the idea of an open access database to collect experience may sound like a solution, it is not. Such an uncontrolled, unregulated system would be no better than the current word of mouth and testimonial approach favored by supplement manufacturers and alternative advocates. Someone once said, "The plural of anecdote is not data."

Relying on busy practitioners of medicine to enter cases in a database, without compensation, one assumes, is naive at best, but most likely merely useless.

Now playing! Stop the FDA

by Betty

[Comment posted 2007-07-02 12:53:51]

If well controlled clinical trials have been conducted to support the labeling and the results published in a peer reviewed journal then I have no problem with wording being added to supplements to indicate that they may help treat or prevent a disease.

The FDA kills Americans by the 100s of 1000s

by Lew glendenning

[Comment posted 2007-07-01 19:47:30]

The FDA released about 20 drugs last year.

Europe has 500 - 1000 drugs in common use which are not available to US physicians.

There are now serious academic studies concluding that the costs of the FDA's regulations outweigh the benefits, that while we no longer die so often of bad food or drugs, we very often die of too-expensive or non-existant drugs.

Latest figures indicate that it costs about $1B for every new drug that makes it through the regulatory system, therefore requiring a $2B annual market to justify the effort. There are NOT THAT MANY $2B / year drugs, either for the US / European market or for 3rd world countries.

We have the worst of both worlds: An FDA with heavy regulatory costs and a product-liability system with uncertain, but usually heavy, costs.

There is no possibility of a universally-safe or -effective drug, so both approaches are flawed at their base.

Both could be replaced with an open-access database: After initial animal studies, a drug would be made available. Every MD using a new drug protects himself by entering the data for his patient and consulting the summaries for prior patients of that time. This would provide both more complete and more timely information.

That is also the information that patients need to make informed decisions, and to assume their share of the risk in return for the benefits of new drugs.

FDA control

by Denver Smith

[Comment posted 2007-07-01 08:23:39]

Truth in disclosure as to the actual benefits of a supplement is important while the use of supplements by consumers to enhance their physical wellness is all important. Guidelines to protect both against false advertising and consumer interest need to be in place so I believe the FDA has a role to play to protect although the FDA should have a checks and balance system to verify their own decisions as to prevent them from infringing on our legal rights.

FDA: Marketing of food supplements

by K. Workman

[Comment posted 2007-07-01 06:52:49]

This is a two-edged sword. There are many "magic cures" being marketed that are ineffectual or worse. Food supplements may provide health benefits, but often these benefits/risks are a matter of controversy. Who is to sort out the claims from the facts? The industry has repeatedly proven it cannot "self-regulate". No, I fear some form of regulation is needed. I hate to see the FDA - a proven inefficient and effectual organization - get involved. I do not have the answer except to say that some national organization (CSPI?) should be able to prevent the facts and then let the consumer decide. I am adamantly against the Government or any other organization or person protecting people from themselves.

Potency and Labels, Rights without Responsibility?

by S. Clark

[Comment posted 2007-06-29 20:59:39]

Regulated drugs must have implemented analytical approaches that demonstrate that the drugs have the claimed activity, and that the activity can be maintained in each manufacturing run. In this manner, we have some level of confidence that 200 mg of ibuprofen is of similar benefit (and risk) whether in Advil or in a generic tablet. The labels of regulated drugs carry quantitative information. It is not in my or societies best interests to allow any manufacturers a 'free-speech right' to make up potency information (if they do no rigorous testing, how can I know it is not made up?).

Supplement manufacturers do not have the potency requirement placed on them. If they want the 'free-speech right' to make efficacy/potency claims, then they should accept the RESPONSIBILITY of measuring, demonstrating, and continuously demonstrating the potency of what they manufacture. This is a part of the whole IND (FDA's investigational new drug) process. But it costs a lot of money. Supplement manufacturers do not have to bear this cost at present. I think they would be wise to not rock the boat, unless they want to pay the price of potency/efficacy claims. Already, I expect that the consumer bears the cost of the lack of potency in their supplements.

Mandatory Clinical Trials for Supplemnts

by Eric Olsen

[Comment posted 2007-06-29 19:53:58]

Food supplements must, as do prescription drugs, uhdergo clinical trials involving the specific health claims made for the supplement, and then have the results of those trials peer reviewed prior to FDA approval for any claims made as a part of the product labeling.
I do not support the general concept held by those who endorse claims made for food supplements as these claims usually are not backed by broad scientific studies. My personal experience with supplements has not seen any specific long term improvement of any chronic condition of my health.
Supplements, just as acupuncture, are very temporary treatments. Yet, manufacturers and health gurus promote specific products as paneceas for various conditions- indeed treating a syndrome of conditions,
Prescription drugs are designed to interact with more specific biochemical targets. Supplements have much broader targets. Therefore, I believe that ultimately only a few food supplements will ever pass muster with the FDA. That is as it should be, while freedom of speech is again erroneously adopted by activists as the issue and the real issue, science, is relegated to the sidelines.

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