Your Weekly Update of News and Reviews
April 22, 2010
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., with help from William M. London, Ed.D., M.P.H. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.
“60 Minutes” blasts stem cell therapy clinic. CBS’s “60 Minutes” has aired a half-hour report about stem-cell treatments claimed to cure cancer, amyotrophic lateral sclerosis (ALS), multiple sclerosis, and Parkinson’s disease. The treatment is marketed by Lawrence Stowe at Stowe Bio Therapy in La Mesa, California and administered in Mexico at the “Rio Valley Medical Center” operated by operated by Frank J. Morales, whose medical degree came from CETEC, a Caribbean school that was later shut down for selling diplomas. After a hidden camera taped them trying persuade an ALS patient to pay $125,000 for a”permanent fix,” a CBS producer confronted the pair about what happened. [21st century snake oil: “60 Minutes” cameras expose medical con men who prey on dying victims. CBS News, April 18, 2010]
The program exposes Stowe as a psychopath who lies without batting an eyelash about the treatment and alleged credentials and affiliations. It is probably the finest character study of a quack in action ever broadcast. After learning about the situation, the FDA announced that it would investigate.
Stem cell therapy has great potential, but no commercial clinics should be regarded as trustworthy. A researcher affiliated with the International Society for Stem Cell Research has found more than 200 of them marketing through the Internet. Stowe promotes his treatments through the Stowe Foundation, a nonprofit corporation, founded in 2003 and “dedicated to the study of the human immune system and the body’s natural ability to heal itself from chronic illness.” In a brochure apparently intended to raise $10 million from private investors, Stowe Biotherapy Inc. falsely claimed to have an “FDA-approved stem cell based approach to regenerative healing” and projected a net income of $71 million by its third year of operation. Dr. Morales is a codefendant with Immunosyn Corporation and others in a class-action suit alleging that he sold the plaintiff an alleged multiple sclerosis cure that turned out to be water or a dilute salt solution with no active ingredients.
Supplement marketers plead guilty. Charles C. Thao, his wife, Mai Lor, and Tony T. Pham, have pled guilty to various charges in connection with the marketing of dietary supplements through the Internet. Government press releases indicate:
- In 2005 and 2006, their operation sold more than $17.4 million worth of dietary supplement products with false claims that clinical testing had proven them effective against diabetes, irritable bowel syndrome, gout, high cholesterol, high blood pressure, heartburn and diarrhea.
- The marketing activities included the use of fraudulent testimonials, nonexistent credentials, and endorsements, that included one from a nonexistent physician.
- Pham operated Web sites that were configured to display a sanitized version of the sites (no illegal claims) when accessed from FDA network computers. [Supplement marketers indicted. USDOJ news release, Feb 28, 2008]
- Thao’s guilty plea included an agreement to forfeit to the government $17,421,059 (for which he and his co-defendants are jointly and severally liable), which represents the amount of proceeds obtained as a result of the offenses, three real estate properties in Springfield, three vehicles and the funds credited to various bank accounts. [Springfield business owner pleads guilty to $17 million fraud scheme. USDOJ news release, March 18, 2010]
The number of people marketing dietary supplements with illegal claims vastly exceeds the government’s ability to stop them on a case-by-case basis. However, this case illustrates that illegal claims for serious disease can trigger criminal prosecution with severe penalties.
New ethics code intended to reduce conflicts of interest. The Council of Medical Specialty Societies (CMSS) issued a new voluntary Code for Interactions with Companies. The 25-page document provides detailed guidance to member groups on appropriate interactions with drug companies and other health-related for-profit companies. The code is intended to ensure that societies’ interactions with companies are independent and transparent and advance medical care to benefit the public. CMSS represents 32 leading medical professional societies with a collective membership of more than 650,000 U.S. physicians. The code addresses:
- Financial disclosure: Donations and support received from for-profit companies and Board members’ financial and uncompensated relationships with companies should be publicly disclosed.
- Independent program development: Publicly available policies and procedures should ensure that educational programs, advocacy positions, and research grants are developed independent of industry supporters.
- Independent leadership: Society leaders (presidents, CEOs, and editors-in-chief of society journals) may not have direct financial relationships with relevant for-profit companies in the health care sector.
Thirteen groups have already adopted the code. Others plan to do so in the near future. Many already have policies that meet or exceed some of the principles in the code.
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