Industry Groups Warn Against Anthrax Claims

WASHINGTON--Natural products have many benefits to the immune system--garlic and oil of oregano have been studied for their antibacterial qualities, while herbs such as echinacea and goldenseal gently stimulate immune function. However, natural products industry groups are publicly reminding retailers, manufacturers and consumers that dietary supplements are not designed to replace medical care, particularly in the face of biological attacks.

The National Nutritional Foods Association (NNFA), for example, issued a member update after receiving inquiries from retailers about products that were being marketed as alternative preventatives and treatments for anthrax. "Let's be very clear," David Seckman, NNFA (www.nnfa.org)executive director, said in the statement, "no dietary supplement or other natural product has been approved for the treatment of anthrax. Even the most vague intimation that a product or combination of products will ward off or cure anthrax infection will be widely viewed as preying on the fears of a frightened public." The statement also reiterated that under the Dietary Supplement Health and Education Act (DSHEA), dietary supplements may not be positioned to "diagnose, mitigate, treat, cure or prevent" any disease. Seckman later commented that the industry faces a dangerous time. "When it comes to the threat of bioterrorism and the promotion of natural remedies to ward off or treat infections, the industry must remain above board and stay strictly within the letter of the law, or we--as an industry--will be facing a public relations nightmare," he said. "Any company that is viewed as preying on a frightened public--regardless of that company's industry--will reap not only disapprobation from regulatory agencies, but public condemnation, as well."

The alternative and complementary medicine community also developed a statement after the Centers for Disease Control (CDC) issued its first Clinician Advisory on Oct. 18. "The CDC focused its efforts on the traditional medical community, and we wanted to reiterate that message to our community," said Michael McGuffin, president of the American Herbal Products Association (AHPA). In a message to the natural health care community, AHPA, the Acupuncture & Oriental Medicine Alliance, the American Association of Naturopathic Physicians, the American Association of Oriental Medicine and the American Herbalists Guild advised their practitioners to recommend that patients who may have come in contact with anthrax seek standard medical treatment and that they report the exposure to local health authorities. "There are natural therapies that have much to offer in terms of enhancing general immune resistance and in dealing with stress in this time of great anxiety," the statement reads. "In addition, your patients may ask you to provide supportive therapy during or after antibiotic therapy. There are not, however, any defined natural healing protocols for the treatment of any form of anthrax infection."

One product that is available over-the-counter (OTC) and is being covered in the press is the homeopathic remedy Anthracinium, a nosode made from anthrax bacteria. A story from Channel2000.com noted that Medrial International, a supplier of anthracinium, said sales of the remedy are skyrocketing despite the company's statement that oral intake is "not the recommended use." According to Steven Brynoff, vice president of sales and marketing with Medrial, the company is seeing increased sales of the remedy, but is including a special flier in all orders to explain the proper use and indications of the remedy. The flier states: "Please note that the literature does not support use as either prophylaxis for or treatment of infections caused by Bacillus anthracis [anthrax]. Such indications are prescription in nature and are an inappropriate use of this product. If you believe that you require prevention of, or treatment for, symptoms of infection caused by Bacillus anthracis, please see a licensed health care provider immediately."

According to the National Center for Homeopathy (NCH), the primary clinical indication for anthracinium is for carbuncles and malignant ulcers. "Nothing in the literature suggests that homeopathic Anthracinium may be useful for pulmonary anthrax--the more fatal manifestation," J.P. Borneman wrote. "Thus, the indiscriminate application of homeopathic Anthracinium as prophylaxis for, or treatment of, pulmonary anthrax is not indicated."

Despite warnings from industry and federal agencies, some individuals and companies are promoting natural products for anthrax treatment or to bolster the immune system. On the Howard Stern radio show, for example, health writer Bill Sardi was interviewed Oct. 30 on "natural antibiotics for anthrax," including oil of oregano and garlic. An article on Sardi's Web site (www.askbillsardi.com) noted that while commercial antibiotics are losing effectiveness, "FDA makes no mention of natural, non-patentable antibiotics which do not induce resistance, some of which exhibit a 100 percent kill factor for anthrax and a wide range of other germs." The primary study Sardi referenced on the antibacterial action of compounds including oregano, garlic and allspice was conducted at Cornell University and published in the Quarterly Review of Biology in 1998. The lead researcher, Paul W. Sherman, said the study did show that spices used in many types of cuisine kill or inhibit food-spoilage microorganisms. However, he told INSIDER that the results do not mean that the products are a treatment for inhalation anthrax. "Absolutely not," he said. "It is fair to say that spices have some antibacterial activity, and some have been effective in a laboratory setting at killing some species of Bacillus. But that's not a health recommendation."

In an E-mail exchange with INSIDER, Sardi noted that consumers should be made aware of these natural antibiotic agents. "While natural products are not, and cannot, be labeled to kill anthrax, utilizing freedom of speech under the U.S. Constitution, it is important for consumers to know that natural antibiotics may provide a back-up or fall-back level of defense against anthrax," he wrote. "Natural antibiotics may buy an anthrax victim time until the immune system kicks in or antibiotic drugs become available."

Healthnotes Newswire released a story Nov. 1 by Alan Gaby, M.D., reviewing Sardi's online article about natural remedies and bioterrorism. "In the face of widespread fear and uncertainty, the public will no doubt be interested in a new online article claiming that a number of natural remedies can be used in the fight against biological and chemical terrorism," Gaby wrote. "However, virtually all of the research cited is taken out of context or misrepresented, and the conclusions drawn from this research are unwarranted and potentially dangerous." (For the complete article, see www.naturalproductsinsider.com/articles/1a1hot.html.)

Other companies are promoting dietary supplements designed to boost immune function. "Our anthrax protocol was put together by a medical student to bolster the immune system," said Scott Brown, owner of Ionic Minerals in Phoenix. "We can't make a claim about it, but we use the words disease and treatment [in the description] because people are searching on the Internet for anthrax treatments. Those are buzzwords to draw hits, but we explain our mineral deficiency program is to help the body heal itself." The protocol includes such ingredients as silver, zinc and stabilized oxygen. "Unless something works in a clinical trial . FDA says we can't recommend it or say it's safe," Brown added. "Too often we're painted as a bunch of wackos out there to make a buck and confuse you. People are looking for something to take care of problems without drugs that have side effects."

Another company, Largo, Fla.-based Go2Pharmacy Inc., introduced a new product called Thraxide. Product literature says the product is designed to "help the body boost the immune system while aiding in cleaning out the toxic byproduct of [biological attacks]." Go2's president, Kotha Sekharam, told the St. Petersburg Times that the company is not trying to prey on consumer anxiety. "That's not our purpose," he was quoted as saying. "This is just like using vitamin C in cold season."

Industry members say the high profile of the bioterrorism scares means extreme caution should be exercised by marketers. "Anyone in the natural products industry who would encourage people who are legitimately afraid of anthrax exposure to do anything other than see a licensed health professional and instead to use traditional immune enhancing supplements is acting in a grossly irresponsible manner," said Marc Ullman, partner in the New York based legal firm Ullman, Shapiro & Ullman. "Anyone who attempts to bolster sales by taking advantage of people's fears, shame on them. And anyone who thinks they can hide code words in metatags and give interviews touting their products as effective against bioterrorist weapons but not put a disease claim on their label risks hearing from FDA's Office of Criminal Investigations."