Consumer Health Digest #03-34
Your Weekly Update of News and Reviews
August 26, 2003
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., and cosponsored by NCAHF and Quackwatch. 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.
Bills introduced to strengthen supplement regulation. Senators have introduced two bills intended to strengthen the FDA's ability to regulate herbs and dietary supplements. The Dietary Supplement Safety Act of 2003 (S.722), introduced by Sen. Richard Durbin (D-IL), would amend the Federal Food, Drug, and Cosmetic Act to:
- Require manufacturers and distributors of these products to report adverse events.
- Enable the Secretary of Health and Human Services (HHS) to conduct safety reviews and approve or disapprove continued marketing of suspect products. To gain approval, a manufacturer would have to demonstrate that the product is safe under ordinary or frequent consditions of use.
- Require premarket approval of "stimulant supplements," products that speed metabolism, increase heart rate, constrict blood vessels or cause the body to release adrenaline.
- Removes products that promote muscle growth or are advertised to promote muscle growth from the definition of "dietary supplement," which means that they have more stringent requirements to market.
- Eliminates a provision of the Act requiring the United States to bear the burden of proof to show a supplement or ingredient in a supplement is unsafe.
The DSHEA Full Implementation Act of 2003 (S. 1538), introduced by Senators Tom Harkin and Orrin Hatch, would:
- Authorize additional money to assist the FDA in carrying out the regulatory requirements of the 1994 Dietary Supplement Health and Education Act (DSHEA). The amount would rise from $20 million for fiscal year 2004 to $65 million for fiscal year 2008, approximately what the FDA has indicated it would need to fully implement DSHEA.
- Require the FDA to report how many complaints it gets, how often it requests substantiation from manufacturers, the number claims it determines to be misleading or unsubstantiated, and any recommendations it has about supplement regulation.
The National Nutritional Foods Association (NNFA), which represents manufacturers and retailers of "natural products," opposes S. 722 and supports S. 1538. According to NNFA, S. 722 would grant the FDA "new and unprecedented authority to subject safe and beneficial products to additional and unnecessary scrutiny," whereas S. 1538 would "eliminate the Food and Drug Administration's favorite excuses that it doesn't have enough staff, money, or power to regulate supplements." [NNFA action alert, accessed Aug 25, 2003]
The true purpose of DSHEA, which Harkin and Hatch spearheaded, was to cripple the agency's ability to regulate the herbal and dietary supplement marketplace. Before its passage, manufacturers bore the burden of proving products were safe. DSHEA requires the FDA to prove that a product is unsafe in order to ban it. S. 722 would enable the FDA to require proof of safety if adverse effects were reported as they have been with ephedra products. S. 1538 would enable the FDA to increase certain activities, but DSHEA will still prevent efficient regulation. DSHEA passed because the health food industry used misleading scare tactics to generate an avalanche of communication to Congress from sellers and consumers who expressed fear that their freedom to buy various products needed protection. NNFA and its allies are using similar tactics to attack S. 722 and promote S. 1538. NNFA's counter card, for example, falsely suggests that S. 722 could lead to bans of vitamin C, calcium, and multivitamins.
Matthias Rath cancer treatment criticized. The Swiss Study Group for Complementary and Alternative Methods in Cancer (SKAK) and the Swiss Cancer League (SCL) is warning against the theories and products of Matthias Rath, M.D. According to the report, Rath claims that:
- Diseases arise when the balance between mechanisms breaking down and building the connective tissue shifts towards breakdown. If disease organisms or cancer cells can dissolve the surrounding connective tissue, a disease may spread in the body.
- The plasminogen activator/plasmin system plays a critical role in this process: the reaction chain results in the activation of collagenase, which breaks down collagen. By gaining access to the blood vessels, cancer cells can then spread in the circulatory system.
- The body can normally block enzymes that destroy connective tissue by means of two mechanisms: with the intrinsic enzymatic block or with the help of nutritional supplements.
- Nearly all people suffer from a chronic vitamin deficiency.
- Almost all diseases are caused by a lack of lysine and vitamin C. Lysine can allegedly suppress the plasmin-induced proteolysis by occupying the binding sites on plasminogen. In diseases, the body's production of proline becomes insufficient, which is why this amino acid also has to be consumed. The name "Cellular Health" was chosen because the nutritional supplements target the body's cells as their active site.
- The mechanism of cancer spread that he has identified is the decisive breakthrough in blocking cancer and a breakthrough in the struggle against infectious diseases (including AIDS) and virtually all other diseases.
The SKAK/SCL report concludes that Rath's underlying assumptions have never been scientifically tested and, based on current state knowledge, a cancer-preventing or -curing action is not proven for any of his products, which cannot be legally marketed in Switzerland. [Dr. Matthias Rath's Cellular Health. Berne, Switzerland: Swiss Cancer League, 2003]
Rath also claims that conventional cancer therapy has never demonstrated a life-prolonging effect and often accelerates the disease's progress. This statement is false. Ads he has placed in many large newspapers have praised "natural health" methods and described the war against Iraq as part of a conspiracy to create a climate of fear that would enable the "drug cartel" to remain viable.
FTC settles medical billing scam case. Charles Lloyd and his company, Healthcare Claims Network, Inc., doing business as Med Data Solutions, are banned from promoting or selling medical billing work-at-home opportunities, as a result of a settlement with the Federal Trade Commission. The complaint against the defendants was filed in June 2002 as part of the "Project Busted Opportunity" sweep. The settlement requires that the company be liquidated and that Lloyd pay $10,000. In addition, the settlement prohibits the defendants from making any deceptive claims in connection with the sale of any goods or services. Two other defendants named in the complaint (Anne and Stanford Miller) settled in February 2003. According to the FTC, the defendants promised that, for $485, they would provide consumers with everything necessary to perform medical billing services from home, including training, a list of doctors needing home-based medical billers, and the software to perform the work. Instead, the defendants provided inadequate training and software that many buyers were unable to use. In addition, the doctors on the defendants' list had no need for at-home billing services. As a result, the buyers were unable to earn any income using the defendants' medical billing packages. [Med Data defendants banned from selling medical billing work-at-home business opportunities. FTC news release, Aug 26, 2003]
India considering severe penalties for peddling fake drugs. India plans to introduce the death penalty for the sale and manufacture of fake and counterfeit medicines that cause grievous harm. The move follows widespread concern that existing regulations pose little deterrence to unscrupulous drug vendors. An expert committee has recommended stiffer penalties and improvements in the nation's drug regulatory infrastructure. The committee recommended changing the maximum penalty from life imprisonment to death and the minimum prison sentence from 5 years to 10 years. The committee has also called for higher fines. Commenting that "Profiting from spurious drugs that might harm or kill innocent people is equivalent to mass murder," India's health minister Sushma Swaraj pledged to accelerate the process of enacting the changes. Last year, government inspectors found that 9% of samples were of poor quality and 0.3% were fakes. The common fake drugs are antibiotics, drugs for tuberculosis and malaria, and cough syrups. [Mudur G. India to introduce death penalty for peddling fake drugs. British Medical Journal 327:414b, 2003] The problem is worldwide. On July 16, the U.S. Food and Drug Administration announced new countermeasures. [FDA announces initiative to heighten battle against counterfeit drugs. FDA news release, July 16, 3003]
FTC Do-Not-Call list swells. The transfer of 14 state do-not-call lists has brought the total of registered phone numbers on the FTC Do-Not-Call list to 41.7 million. As of October 1, telemarketers must avoid improper calls to everyone listed by August 31st. [41.7 million telephone numbers registered on Do Not Call List: Data transfer by 14 States increases number by 9 million. FTC news release, August 26, 2003] Consumers may still receive calls for 18 months from businesses from which they have made a purchase or payment. If a consumer has requested information from a company, that company may call for three months. Charities, political organizations, and organizations conducting surveys are not covered by the list rules.
This page was posted on August 26, 2003.