Now playing: Stop the FDA!

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.comLinks 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#regulateStopFDACensorship.org http://stopfdacensorship.orgJulian Whitaker http://www.drwhitaker.comSteve Wallach http://www.youngevity.com/index.phpDurk Pearson and Sandy Shaw http://en.wikipedia.org/wiki/Durk_PearsonAttorney Jonathan Emord http://www.emord.comBill Kole http://www.missioncontrolmusicandpost.comHealth Freedom Protection Act http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117US District Court Opinion in Pearson v. Shalala http://www.emord.com/docs/Memo%20Opinion%202-2-011.pdfL.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/16140696Charles Simone http://www.drsimone.comT.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/16919518R. 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/17209196S. Bent et al., "Saw palmetto for benign prostatic hyperplasia," New England Journal of Medicine, 354:557-66, 2006. http://www.the-scientist.com/pubmed/16467543D.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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