By Joel Preston Smith
Swine flu is now widespread in 48 U.S. states, according to the U.S. Centers for Disease Control and Prevention. Margaret Chan, director-general of the World Health Organization, told health officials in Mexico July 3, that the “the virus is now unstoppable.”
Add the scarcity of H1N1 vaccine, distrust over the safety of the vaccine itself, and growing demand for alternative or self-prescribed medicine, and it all adds up to an excellent marketing op for unscrupulous businesses preying on a fearful, and suspicious public. Consequently, herbal remedies for swine flu are all the rage on the Internet, with marketers claiming to offer products to boost the immune system, awaken one’s “inner warrior,” or outright cure the disease.
Gary L. Coody, National Health Fraud coordinator for the U.S. Food and Drug Administration, says that in response to the rise of fraudulent product claims related to the H1N1 virus, his agency launched what may be an unprecedented anti-fraud campaign in its history.
“With H1N1, we knew there would be people who took advantage of other people’s fears,” Coody explains. “One of our main concerns is that these products can give the buyer a false sense of security that they’re being protected in some way, when there’s really no scientific basis on which to make a claim that the product prevents or treats the influenza virus.”
Coody’s staff, under the FDA’s Office of Enforcement, began an intensive search of the Internet in April, tracking websites that offered farcical products or trumpeted unverifiable claims about treating or preventing swine flu.
Given the production lags with H1N1 vaccine, and fears about its safety, combined with pervasive distrust of the mainstream medical community, it seemed inevitable that the public would turn to the Internet, and self-prescribed products, for salvation. As of November 9, 2009, Coody’s office had netted 80 websites posting fraudulent claims, and a total of 141 suspect products.
The FDA has approved only two drugs for treating acute, uncomplicated H1N1-type influenza—Tamiflu and Relenza. There are no FDA-approved generic substitutes for either medication, but websites claiming to offer cures and preventives seem to replicate like the virus itself. They also bilk consumers out of an effective treatment—if a given company actually sells what it claims to sell—by marketing products that would only arrive after the flu has run its typical five-day course.
Canada Pharmacy, (canadapharmacy.com,) offers a product titled Tamiflu, and also sells non-FDA-approved generics, Ayurvedan herbal remedies and cold and sinus-relief formulas. A representative from the company noted that Tamiflu products take two to three weeks to ship to the U.S.
Coody said his office purchased several products purported to be Tamiflu in late May and June, and tested the products at the FDA’s Forensic Chemistry Center in Cincinnati, Ohio. One of the $209 samples,—from a “Canadian health care” website—arrived wrapped in a plain brown envelope, postmarked from India. The package contained 20 pills glued between sheets of white paper, bearing no label or information regarding how the “medication” should be used.
The forensics lab determined that “the pills had no active Tamiflu ingredient,” Coody notes, “just acetaminophen and talc.” Coody says the website vanished shortly after the purchase was made.
The FDA recommends that consumers buy medicines only from sites that are accredited by VIPPS, Coody says. Accredited websites carry the VIPPS seal and should also be licensed in the U.S. with a state Board of Pharmacy, he adds. VIPPS, for Verified Internet Pharmacy Practice Sites, is a consumer-protection function of the National Association of Boards of Pharmacy, founded in 1999 to provide a measure of assurance to Internet shoppers and help circumvent pharmacy scams worldwide.
Wary consumers might shy away from foreign-based Internet marketers, but might not be so cautious if the supplier is a licensed health-care provider based in the U.S. As with any Internet marketing site, caveat emptor still applies—buyer beware.
One of the websites nailed in the FDA sweep, Agelessherbs.com, is owned and operated by Catherine Browne, an acupuncturist and herbalist in Hamptonville, N.C.
Agelessherbs offered two herbal products which claimed to treat H1N1, according to the FDA. Great Protector Formula was an “anti viral herb remedy for influenza natural prevention of swine/bird flu.” Curing Pills offered an over-the-counter treatment “for the nausea, diarrhea and vomiting aspect of this virus.”
Coody’s office sent a statement to Browne stating in part “We request that you immediately cease marketing unapproved, uncleared, or unauthorized products for the diagnosis, mitigation, prevention, treatment, or cure of the H1 N1 Flu Virus,” and gave Browne 48 hours to comply.
When website owners/operators fail to remove fraudulent claims within 48 hours, the agency can seek civil penalties, seize products on site, request a court injunction to stop the sale of the products, and/or issue criminal charges against the perpetrator.
“We’re taking this very seriously,” Coody remarks.
More than 80 percent of those warned by the FDA have removed fraudulent H1N1 claims or products from their websites.
Browne declined to answer questions about her products, but emailed a statement, saying, “While I am guilty of trying to provide information and natural solutions for people wanting to approach the flu, I certainly believed in our product and did not intend to be misleading.” Agelessherbs, now offers Evil Airborne Warrior Formula, as an “anti viral” treatment for people “going into crowded places.”
Roger W. Wicke, Ph.D., says that the problem with marketing herbal remedies as a whole is “like shooting a gun in the dark and hoping to hit your target.” Wicke, director of the Rocky Mountain Herbal Institute in Hot Springs, Mont., argues, “herbs are often advertised as being good for specific health conditions. Frankly, from the FDA’s perspective, that’s deceptive. Patients choose herbs for themselves based on very simplistic methods. ‘Take herb X for disease Y’ is a very crude way of looking at an illness.”
The U.S. government opened the floodgates to health fraud with the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), according to Robert S. Baratz, M.D., president of the National Council Against Health Fraud, headquartered in Newton, Mass. DSHEA allowed manufacturers to offer dietary supplements without pre-market approval by the FDA—as long as the products do not purport to prevent or treat diseases in the absence of verifiable scientific data to support the claim.
“Companies can now market a product with the claim, “It supports a healthy immune system,” observes Baratz, assistant clinical professor of medicine at Boston University Medical School. “Well, so does air and water. Breathing supports a healthy immune system. The Act (DSHEA) basically prohibits the FDA from doing anything until there’s a body count.”
Baratz adds, “Virtually anything can pass as a supplement. If it’s any vitamin of any kind, an amino acid, any herb, in any quantity. As long as it has one of those, you can call it a supplement. I can go out and get lawn clippings and put them in little capsules and sell them as an herbal supplement. I can claim it ‘supports breast health’ and the FDA can’t touch me.”
Americans spent $33.9 billion out-of-pocket on complementary and alternative medicine during a 12-month period from 2006 to 2007, according to a 2007 study by the National Center for Health Statistics. The figure represents about 1.5 percent of total health care expenditures for that period in the U.S.
Monitoring fraudulent product claims typically falls under the purview of the Federal Trade Commission. Richard Cleland, Assistant Director of the FTC’s division of advertising practices, says his agency’s principal focus—like the FDA—is now centered on fraudulent claims about Swine flu treatments. “We’ve seen this kind of opportunism in Anthrax scares, with the SARS virus,” Cleland explains. “Whenever there’s anything in the news about a health threat, there will be an increase in herbal cure-alls to deal with it. A lot of products (the FTC is seeing hawked over the Internet) have been around for centuries. They just slap the latest condition on it and put it up for sale.”
Cleland notes, for example, a rise in the marketing of colloidal silver as an herbal remedy for flu symptoms. The metal, suspended in microscopic form in an oil, is often marketed as an antiseptic. According to the National Center for Complementary and Alternative Medicine, a division of the National Institutes of Health, “there is no scientific evidence” to support the safety or effectiveness of colloidal silver products.
“We’ve never found anything in the scientific literature that substantiates the claim that the product does anything positive in humans,” Cleland notes. “One thing is true, though. If you have a petri dish filled with bacteria and you put enough silver in there, you’ll kill them. It’s called heavy metal poisoning.”
While marketers of herbal products don’t advertise heavy-metal poisoning as one of the possible side effects of using botanicals to treat or cure the flu, the possibility is a growing concern in the U.S. medical community.
A study by researchers at Boston University School of Medicine concluded that one fifth of Ayurvedic herbal-medicine products produced in South Asia, and available over the Internet, contained potentially harmful levels of lead, mercury or arsenic. The study, published in the Aug. 27, 2008 Journal of the American Medical Association, noted that 75 percent of the websites selling tainted medicine claimed to be following Good Manufacturing Practices, or testing their products for heavy metals.
“How can we give our patients herbs if they have contaminants?” asks Elizabeth Goldblatt, vice president of the American College of Traditional Chinese Medicine, in San Francisco, Calif. Goldblatt, who served as president of the Oregon College of Oriental Medicine from 1988-2003, says she and colleagues are launching a survey of U.S. vendors and manufacturers of traditional Chinese herbal medicines, in an effort to determine which are testing for contaminants on a regular basis. “I think using herbal products can be very useful in one’s overall health,” she adds, “but on the other hand, people are rightly concerned about the safety of these products.”
Kevin D. Wilson, a naturopathic doctor and legislative chair for the Oregon Association of Naturopathic Physicians, also cautions against using over-the-counter formulations for flu or any illness without the advice of a physician. “I do believe that there are herbal products that are effective in treating diseases,” Wilson says, “but they have to be used in the context of each individual’s health status. Herbs are not cookie-cutter medicines for everyone.”
Not all practitioners of mainstream medicine are opposed to the use of alternative medicine to treat flu (or at least address its symptoms) and other illnesses. Like any person charged with the care of the public, however, they do object to the sale of snake oil.
“Certain herbs are accepted in the medical community as having some benefit,” Baratz notes. “Peppermint is good for an upset stomach. Digitalis, belladonna, atropine, quinine—they’re all natural products whose pharmacology was deduced and elucidated to the extent that they’re now useful. But that doesn’t mean every natural product is good for you. Snake venom isn’t good for you, but it’s effective if you’re a snake.”
Joel Preston Smith is a Portland-based writer and well-traveled photojournalist. See www.joelprestonsmith.com.