Consumer Health Digest #06-11
Your Weekly Update of News and Reviews
March 14, 2006
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.
New rules for drug package inserts. The FDA has unveiled a major revision to the format of prescription drug information (commonly called the package insert) to give healthcare professionals and patients clear and concise information. [FDA announces new prescription drug information format to improve patient safety. FDA news release, Jan 18, 2006] The new rules, which take effect on June 30, are intended to help manage the risks of medication use and reduce medical errors. The first major revision in more than 25 years, the new format requires a summary of the most important information about a product to be prominently displayed at the top of the page. Other notable requirements include:
- A "Highlights" section that provides the most important information about benefits and risks.
- A "Patient Counseling Information" section to help doctors advise patients about uses, limitations and risks.
- A table of contents for easy reference to detailed safety and efficacy information.
- The date of initial product approval to help indicate how long a product has been on the market.
- A toll-free number and Internet contact information to encourage more widespread reporting of suspected side effects.
All drugs approved within the past five years will gradually be required to adopt the new information format, but the FDA is encouraging earlier compliance on a voluntary basis. The Center for Drug Evaluation and Research site has additional information. Each year the FDA approves about 30 brand-new drugs and more than 100 new or expanded uses for existing medications.
FTC nails Garden of Life. Garden of Life, Inc., of West Palm Beach, Florida and its founder and owner, Jordan S. Rubin, have settled FTC charges that they made unsubstantiated claims that their dietary supplements were effective against a long list of ailments, ranging from colds to cancer. [Dietary supplement maker Garden of Life settles FTC charges: Claimed clinical studies backed Primal Defense, RM-10, Living Multi, and FYI. FTC news release, March 9, 2006] Under the settlement, Rubin and the company:
- Must pay $225,000 in consumer redress. If it is found they misrepresented their financial status, they will be responsible for more than $47 million—the total gross sales of the four products.
- Are barred from making unsubstantiated claims about the health benefits, performance, efficacy, safety, or side effects of any food, drug, or dietary supplement, or any program that includes such a product.
- Are prohibited from misrepresenting the results of any test or study.
In 2004, the FDA ordered Garden of Life to stop making unsubstantiated claims for several products. [Singleton ER. Warning letter to Robert U. Craven. May 11, 2004] During that year, Rubin's book, The Maker's Diet, made the New York Times list of best-selling hardcover advice books. The book claims that Rubin cured himself of a long list of diseases and conditions. Quackwatch has additional information about Rubin.
FDA trying to stop sale of steroid-containing "dietary supplements." The FDA has warned four manufacturers and distributors of unapproved drugs containing steroids that continued distribution and sale of these products without FDA approval could result in regulatory action including seizure and injunction. The agency is concerned that these products, which are marketed as dietary supplements and promoted for building muscle and increasing strength, may cause serious long-term adverse health consequences. These products claim to be anabolic and problems associated with anabolic steroids include: liver toxicity, testicular atrophy and male infertility, masculinization of women, breast enlargement in males, short stature in children, adverse effects on blood lipid levels, and a potential to increase the risk of heart attack and stroke. The products are:
- Anabolic Xtreme Superdrol, manufactured for Anabolic Resources LLC, Gilbert, Arizona, and distributed by Supplements To Go, Cincinnati, Ohio
- Methyl-1-P, manufactured for Legal Gear, Brighton, MI and distributed by Affordable Supplements, Wichita, Kansas
The FDA advises consumers to stop taking them any such products and return them to their place of purchase. [FDA warns manufacturers about illegal steroid products sold as dietary supplements. FDA news release, March 9, 2006] In March 2004, FDA sent warning letters to 23 manufacturers and distributors of products containing androstenedione.
Mannatech class-action suits consolidated. Several class-action lawsuits filed by Mannatech investors have been consolidated. The suits charge that the company caused Mannatech's shares to trade at artificially inflated levels by misrepresenting the company's prospects and permitting its "independent distributors" to make improper claims for products. The plaintiffs seek to recover damages on behalf of all persons or entities who acquired Mannatech securities between August 10, 2004 and May 8, 2005. The 125-page consolidated complaint, which is posted on Casewatch, provides amazing details of illegal product claims and other alleged wrongdoing obtained from former high-level employees, consultants, and distributors.
Pennsylvania Attorney General stops prescription drug plan scam. Michael and Dora Markle and their business Pro-Tel Planning, LLC of Red Lion, Pennsylvania have signed an Assurance of Voluntary Compliance under which they have promised to issue refunds, pay penalties, and get out of the health care business. [Attorney General Corbett takes action against PA company accused of deceptively advertising prescription drug plan; Consumers have until March 21, 2006 to obtain refunds. Pennsylvania Attorney General news release, Feb 24, 2006] Pro-Tel had charged consumers a $60 fee per prescription per year to fill out applications and other documents. The alleged deceptions included:
- Falsely claiming that it is "impossible" for physicians to offer their patients help in obtaining free prescription medications because they would be bogged down in paperwork with no time to see patients.
- Failing to make consumers aware that the same information and forms are offered free of charge via the Internet or by calling toll-free numbers.
- Falsely representing that consumers had to purchase a life insurance policy from United American Insurance Company in order to "qualify" for preferred services.
- Falsely claiming that the company used "state of the art" computer software programs to track consumers' prescriptions and eligibility information when the software used was standard and common in the industry.
Under the terms of the Assurance, the defendants denied the allegations but agreed to:
- Refund a portion of the fees to consumers who file complaints with the Attorney General's Office.
- Dissolve Pro-Tel Planning and stop engaging in the sale of their assistance services in Pennsylvania
- Stop engaging in all health care business that is not directly related to the sale of insurance.
- Pay more than $7,500 in civil penalties and investigation costs.
This page was posted on March 14, 2006.