Journal of the National Cancer Institute Advance Access originally published online on August 26, 2008
JNCI Journal of the National Cancer Institute 2008 100(17):1200-1202; doi:10.1093/jnci/djn317
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© Oxford University Press 2008.
NEWS |
Crackdown on Unproven Cancer Treatments Focuses on Internet Marketers
In June, the U.S. Food and Drug Administration announced that it had sent warning letters to 25 companies that peddle unapproved cancer treatments on the Internet. The companies, identified through consumer complaints and a daylong Web search by employees of the FDA, the Federal Trade Commission, and Canadian government agencies, were given 15 days to address the violations outlined in the letters.
The companies’ products—including shark cartilage; the botanicals bloodroot and Cat's Claw; ellagic acid, an antioxidant found in pomegranates; and an herbal tea called Essiac—are legal to sell in the United States, said Gary Coody, the FDA's national health fraud coordinator. The problem lies in the claims that the companies make about their products’ intended uses and benefits. Many of the products cited in the warning letters are marketed as "dietary supplements" and are regulated under the 1994 Dietary Supplement Health and Education Act. Supplements are exempt from the rigorous testing and approval procedures that the FDA requires of new drugs, but marketers are prohibited from claiming that their wares prevent, treat, or cure any disease.
Thus, the FDA warned Precision Herbs LLC, an Ohio-based company, against describing its herbal remedy CancerGene as "historically used to help switch on all three genes that inhibit cancer." And Ageless Cures LLC of Houston was warned against claiming that its product Curcumin "causes cancer cell apoptosis (programmed cell death)." When companies make statements such as these, their products are considered to be unapproved new drugs, which are illegal to sell in the United States. Crossing back into legal territory usually involves removing the problematic claims, which may include the name of the product, Coody said.
Although the sale of unproven cancer remedies is not a new phenomenon, the FDA's action points to a recent shift in strategy for both companies and researchers: the aggressive use of the Internet to make claims about alternative therapies on the one hand and an increase in government-funded studies on many of the same medicines on the other.
The FDA's actions are part of a larger international project directed by the Mexico–U.S.–Canada Health Fraud Working Group (MUCH) to crack down on health fraud. MUCH has representatives from FDA, Health Canada, and Mexico's Federal Commission for Protection from Sanitary Risks (COFEPRIS). Because of the commercial aspects of health fraud, MUCH also includes the U.S. Federal Trade Commission and Canada's competition authority, Competition Bureau Canada. The health agencies enforce their rules concerning what is or is not a drug and their standards for proving safety and effectiveness, whereas the trade agencies approach the problem from a truth-in-advertising standpoint, said Adam Zimmerman, of the Competition Bureau.
The three countries assist each other mainly by sharing information, including the results of Internet sweeps for companies that are in violation of the law and by coordinating enforcement efforts whenever possible, he said. Like the FDA, the Competition Bureau has conducted a thorough Internet search and has sent warning letters to companies that were fraudulently marketing cancer remedies. More than 90% of the letter recipients responded by changing their misleading claims or by shutting down their Web sites. Many companies have also responded to the FDA's action, Coody said. However, those that fail to respond could face an injunction, a court order to halt specified activities; seizure of their inventory; or even criminal prosecution.
The anti–cancer fraud initiative was mainly the work of U.S. and Canadian authorities. The Mexican members of MUCH received the list of Internet sites gathered by the U.S. and Canadian sweeps, but because none of the flagged companies was located in Mexico and because cracking down on cancer fraud is not currently a major activity within the Mexican government, they took no further action, said Patricia Pineda, manager of international affairs for chemical agents at COFEPRIS.
Wild West Online
Health fraud is much older than the Internet. In fact, the 1906 Food and Drug Act that established the FDA was passed, in part, because of the widespread sale of "snake oil" medicine products. "There were cancer cures back then, too," Coody said. Purveyors of unproven medicines reached their customers through mail, traveling "medicine shows," roadside signs, and ads in magazines and newspapers.
More recently, products that purportedly treated disease were sometimes advertised in television infomercials. However, the Internet has made it much easier to reach people. Zimmerman estimates that 9 million Canadians (approximately one-third of the adult population) turn to the Internet for health information. In the U.S., the figure is even higher. Recent surveys report that approximately half of adult Americans have researched health-related topics on the Internet.
"The Internet has become the Wild West, so to speak," he said. "Fraudsters are really able to take hold of the new media and get out there in ways they hadn’t before to take advantage of people. The Internet has made it a world market."
Zimmerman emphasized that MUCH is not categorically opposed to alternative medicine. "We don’t want to say that just because it's not science-based medicine that it is automatically fake or a scam," he said. "There are established treatments that have been out there for hundreds of years. At the same time, there are those treatments that people claim have been out there for hundreds of years that do absolutely nothing. The catch is, just because it's been around for hundreds of years doesn’t mean it works or it's safe to use or that it's been approved for use as a treatment."
Science at an Early Stage
Teasing apart alternative therapies that are effective from those that are not is one of the missions of the U.S. National Center for Complementary and Alternative Medicine (NCCAM), part of the National Institutes of Health. According to Barbara Sorkin, Ph.D., the program officer in charge of the center's extramural cancer projects, researchers are interested in the anticancer potential of some of the natural products that were targeted in the FDA's action. But most of the work is at a very early stage, she said.
At the NCCAM-funded Center for Excellence in Pancreatic Diseases at the University of California, Los Angeles, investigators are studying the effects of the antioxidant ellagic acid on pancreatic cancer cells, and they may extend the research to animal models of pancreatic cancer and pancreatitis, as they search for possible mechanisms of action.
NCCAM has also supported a pilot study of the herbal tea Essiac. However, the results suggested that Essiac might do more harm than good. Lead investigator Kristen Kulp, Ph.D., of the Lawrence Livermore National Laboratory in Livermore, Calif., reported in Breast Cancer Research and Treatment in 2006 that the tea stimulated the growth of a human breast cancer cell line. Several other studies on Essiac, not funded by NCCAM, have had mixed results, Sorkin said. "Most of them have not looked promising to the extent that people would be pursuing clinical research," she added.
One supplement that has been tested in human clinical studies is shark cartilage. Initially, interest in shark cartilage as an anticancer agent arose because many people believed that sharks did not get cancer. Although that turned out to be incorrect, research on shark cartilage revealed that it contains several substances that inhibit angiogenesis, or blood vessel growth. Tumors cannot grow beyond a few millimeters unless they secure their own blood supply through angiogenesis. Angiogenesis inhibitors from other sources have shown some promise in fighting cancer. NCCAM and the National Cancer Institute jointly sponsored two clinical trials—one in patients with breast or colon cancer and the other in patients with lung cancer—which tested the effects of adding a shark cartilage preparation to standard therapy. Both studies concluded that shark cartilage did not increase survival; the breast and colon cancer study further concluded that the cartilage did not reduce treatment side effects or improve patients’ overall quality of life.
At least one of the products on the FDA's list, bloodroot, has been linked to adverse outcomes in cancer patients. Bloodroot, sold as a remedy for skin cancer and other skin lesions, is a caustic agent; it burns through the skin, destroying tissue and causing significant scarring. There are several reports of patients with nonmelanoma skin cancers, usually curable with a simple surgical procedure, who experienced complications after attempting self-treatment with topical preparations of bloodroot. In one case, the bloodroot successfully treated the skin cancer but left behind a disfiguring scar. In another case, the cancer recurred but was masked by scar tissue, leading to a delay in appropriate treatment. In a third case, bloodroot did not eradicate the cancer, which eventually metastasized.
In Oncologists’ Offices
The growing popularity and easy availability of cancer-related alternative medical products has made them a common topic of discussion in oncologists’ offices. Samantha Seaward, M.D., chief of radiation oncology at Kaiser Permanente Santa Clara Medical Center in California, asks all her patients if they are using or thinking of using any complementary or alternative therapies; about 15% say that they are. Most, she said, are taking vitamins or nutritional supplements. Others are interested in practices such as herbal medicine, chiropractic, and acupuncture.
If she is not familiar with a product, Seaward will ask the patient to bring it in so that she can inspect the ingredient list. "The majority of compounds that patients are taking are not harmful and do not interfere with treatment," she said. However, there are exceptions. For example, high doses of antioxidant vitamins can interfere with the effectiveness of radiation and chemotherapy, she said. Seaward advises patients to stop taking or at least reduce their dose of such vitamins before beginning conventional treatment.
Seaward occasionally encounters patients who want to abandon mainstream medical therapy in favor of an alternative treatment. In those instances, she said, "I try to encourage them to pursue their therapy of choice as a complementary therapy in addition to conventional treatment." She discusses the pluses and minuses of declining standard treatment, as well as the lack of data on most alternative therapies. To support her case, she sometimes shows her patients pages from Quackwatch, a nonprofit Web site run by Stephen Barrett, M.D., that details the shortcomings of many alternative medical treatments.
Many patients ultimately agree to stick with their prescribed course of treatment, but a few do not. Seaward recently saw a young patient with breast cancer. The woman had surgery to remove the tumor but refused follow-up radiation treatment, choosing instead to pursue an alternative treatment. She faces a 30%–40% chance that her tumor will recur, Seaward said; if she had opted to have radiation therapy, her risk of recurrence would have been 5%–8%.
"It's hard when people are not medically educated," said Seaward. "All treatments sound equally good to them. You can’t fault them for that."
Hoping to raise awareness of cancer fraud, the U.S. and Canadian governments are working on public education efforts, including their own active use of the Internet. The Competition Bureau, for instance, launched Project False Hope, which includes two interactive Web tools to teach consumers how to identify health scams. The first, Anatomy of an Online Health Scam, is a mock Web site advertising a fake cancer cure called Natural Herbal Formula. As readers scroll over the text, pop-up bubbles highlight tactics that marketers use to reel in unsuspecting consumers. The second Web tool is a Cancer Fraud Awareness Health Quiz that people can use to test their health fraud savvy. But both Coody and Zimmerman emphasize that the most important thing patients can do to protect themselves from health scams is to consult a qualified medical practitioner before beginning any treatment. Said Zimmerman, "Our key message is ‘Talk to your doctor first.’"
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