FDA Cracks Down on Fake Mesothelioma Treatments
- Legislation & Litigation
- May 2, 2017
Stories abound of a “cancer-curing” tea from the forests of Canada. Herbal blends claim to “attack cancer at the DNA level.”
For many years, mesothelioma patients have turned to alternative medicines like these as treatment options for the rare asbestos-related cancer.
Sometimes these options are a last resort, after traditional treatments fail. They may be used in conjunction with standard treatment (complementary medicine) or on their own as the main approach.
But the U.S. Food and Drug Administration (FDA) recently issued warning letters to companies that manufacture or market products claiming to prevent, diagnose, treat, mitigate or cure cancer.
The letters addressed 14 U.S.-based companies illegally selling more than 65 products that fraudulently make these claims. Many of these illegal cancer treatments are marketed and sold on websites and social media platforms, according to the FDA.
Mesothelioma and other cancers do not have a definitive cure, and it is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that make unproven anti-cancer claims without first receiving FDA approval for the labeled uses.
“We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work,” Douglas W. Stern, director of the FDA’s Office of Enforcement and Import Operations, said. “Patients should consult a health care professional about proper prevention, diagnosis and treatment of cancer.”
Alternative Medicine Use for Mesothelioma Patients
The National Institutes of Health defines complementary and alternative medicine (CAM) as “a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine.”
In 2008, the National Center for Complementary and Integrative Health (NCCIH) and the National Center for Health Statistics (part of the Centers for Disease Control and Prevention) reported more than one-third of American adults used some form of CAM treatments.
The prognosis for many mesothelioma patients is bleak. Surgery is not always an option — especially for late-stage patients — and other traditional cancer treatments, such as chemotherapy and radiation therapy, may have little to no effect on life expectancy.
Because of this, many people diagnosed with mesothelioma turn to complementary medicine and therapies that may lessen cancer symptoms, enhance traditional treatments and help the body recover quicker.
Others take a complete alternative approach, relying solely on supplement pills, topical creams, oils, teas and other products or practices to treat their cancer instead of conventional drugs and treatments.
Some mesothelioma survivors who took alternative treatment approaches:
- Ruth Phillips embraced nontraditional treatments at the Immune Augmentative Therapy Centre in the Bahamas. Her philosophy of strengthening her immune system to fight the cancer has allowed her to live more than 17 years past her original eight-month life expectancy.
- Pleural mesothelioma survivor Andy Ashcraft is one of a growing number of cancer patients who relies on cannabis oil treatments. Because breathing and chronic coughing are common symptoms of pleural mesothelioma, many patients turn to cannabis oil — a derivative of the marijuana plant — to help manage symptoms such as pain and anxiety. Twenty-eight states and the District of Columbia have passed some form of medical marijuana legislation despite the fact it is still listed as a Schedule I controlled substance by the U.S. Drug Enforcement Administration and not approved by the FDA.
- In 2013, James B. turned to the Budwig Protocol, a radical change in diet that claims to shrink or completely eliminate tumors. The diet consists of a combination of cottage cheese, flaxseed oil and fruit. James began the so-called anti-cancer diet after doctors recommended hospice care as the best option available to treat his pleural mesothelioma.
Although these and other alternative treatments have worked for mesothelioma survivors, there is no definitive cure for the asbestos-related cancer or a promise of longevity. Patients should always consult their doctor and oncology team before pursuing alternative treatments or therapies.
Essiac Tea, Revivin Among Products in Warnings
The label for Sunstone’s Essiac Tea claims “it has been used for cancer, cancer prevention, AIDS, diabetes…” and that “cancer and AIDS sufferers or other ill people may wish to take 2 fluid ounces of the tea twice daily on an empty stomach,” according to the FDA warning letter.
Essiac herbal tea recipes have a long-rumored history of cancer cures and prevention, dating back to the 1920s. The organic tea gets its name from Canadian nurse Rene M. Caisse (the reverse spelling of her last name), who held and protected the only recipe until just before her death.
Versions of the tea have been sold under a variety of brands and promoted as an alternative treatment for cancer and other illnesses.
Some of Sunstone’s other products, including Chelated Boron and Circulatory Detox & Support Syrup, bill themselves as a cancer preventative.
BioStar Technology International in Los Angeles had five products in question in their warning letter. The company’s Asparagus Extract label claims it should be taken by everyone for heart, cancer prevention,” while BioStar’s Revivin product flyer claims it the herbal supplement “attacks cancer at the DNA level.”
“This results in a more comprehensive cancer inhibition therapy,” the Revivin label claims, according to the FDA warning.
The FDA also issued online advisory letters to four companies who market or sell products defined as drugs under the agency’s code. FDA officials gave the companies 30 days to correct the violations, including removing information on product websites or labeling that promote unapproved uses.
Products mentioned in the advisory letters that claim to prevent or treat cancer include:
- Versions of Landis Revin LLC’s Trevinol enzyme supplements
Consumers Should Be Aware of Unproven Treatments
The FDA requested responses from the 14 companies in violation of the Federal Food, Drug and Cosmetic Act as to how they plan to correct the issues.
Failure to respond within 15 days may result in legal action, including product seizure, injunction and criminal prosecution.
Over the past 10 years, the FDA has issued more than 90 warning letters to companies marketing hundreds of products that make fraudulent cancer claims. Many of these companies have stopped selling these products, but some remain on the market through the ease of moving marketing operations to new websites or by using online marketplaces such as Amazon and eBay.
The FDA encourages consumers to report adverse reactions associated to these products to the agency’s MedWatch program.
And while some alternative medicines have shown promising results for mesothelioma patients, Stern cautions cancer patients considering one of the more than 65 products in question.
“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,” Stern said.
Matt Mauney is an award-winning journalist with nearly a decade of professional writing experience. He joined Asbestos.com in 2016, and he spends much of his time reading, analyzing and reporting on mesothelioma research articles to ensure people in the mesothelioma community know the latest medical advancements. Prior to joining Asbestos.com, Matt was a reporter at the Orlando Sentinel. Matt also edits some of the pages on the website. He also holds a certificate in health writing from the Centers for Disease Control and Prevention.
- U.S. Food & Drug Administration. (2017, April 25). FDA takes action against 14 companies for selling illegal cancer treatments. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm554698.htm
- U.S. Food & Drug Administration. (2017, April 25). Illegally Sold Cancer Treatments. Retrieved from https://www.fda.gov/ForConsumers/ProtectYourself/HealthFraud/ucm533465.htm#T1
- U.S. Food & Drug Administration. (2017, April 17). BioStar Technology International, LLC 4/17/17. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm554127.htm
- U.S. Food & Drug Administration. (2017, April 17). Sunstone, Inc. 4/17/17. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm554034.htm
- McGinley, Laurie. (2017, April 26). FDA cracks down on companies pushing vegetable extracts and creams as cancer cures. Retrieved from https://www.washingtonpost.com/news/to-your-health/wp/2017/04/25/fda-cracks-down-on-companies-peddling-fraudulent-cancer-treatments/?utm_term=.07c07b0b3a1f