Consumer Health Digest #08-39
Your Weekly Update of News and Reviews
September 23, 2008
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.
Enrollment stopped in dubious chelation therapy study. Enrollment into the $30 million NIH-sponsored Trial to Assess Chelation Therapy (TACT) has been suspended. The clinical trial, which began in 2003 and was scheduled for completion in 2009, is intended to test whether intravenous disodium EDTA is effective against coronary artery disease. In May, Medscape General Medicine published a lengthy report calling for the study's immediate termination because:
- There is no reliable preliminary evidence or logical reason to believe that the treatment will work.
- Chelation proponents used political connections to pressure the NIH to fund the study.
- The application for the trial misrepresented previous data and concealed evidence of risks.
- The study lacks precautions necessary to minimize risks.
- The consent form reflects these shortcomings and fails to disclose apparent proprietary interests, including the fact that more than half of the investigators make money by selling chelation treatment to patients.
- Many of the doctors administering the chelation therapy have been in regulatory trouble and are untrustworthy.
- The trial's outcome would be unreliable and almost certainly equivocal, thus defeating the study's stated purpose.
NIH has made no public announcement about the suspension, but an astute reporter learned that the federal Office for Human Research Protections had opened an investigation after concluding that a complaint by the Medscape article authors had merit. TACT's principal investigator, Gervasio Lamas, M.D., of the University of Miami Miller School of Medicine, told the reporter that doctors who had been disciplined by state boards or have criminal records were asked to drop out. [Marchione M. Government probes chelation-heart disease study. Associated Press, Sept 25, 2008]
Earlier this year, after the FDA expressed safety concerns, the two companies that sold disodium EDTA in the United States stopped selling it, which means that it is no longer legally available in the United States. [Barrett S. FDA issues chelation therapy warning. Chelation Watch, Sept 26, 2008] Chelation Watch has additional details plus links to key documents.
PBS fundraisers draw complaints. PBS ombudsman Michael Getler has called attention to the fact that PBS broadcasts some programs that it neither produces nor endorses and that the outside origin of the programs may not be conspicuously disclosed. [Getler M. Caution: That program may not be from PBS. PBS Web site, May 15, 2008] Such programs have include fundraising specials that promote the questionable health theories and practices of Gary Null, Nicholas Perricone, M.D., and Daniel Amen M.D. Getler's column was written in response to recent complaints about programs that promoted Amen's claims related to curing attention deficit/hyperactivity disorder, "balancing the brain, " and preventing Alzheimer's disease.
FTC strengthens unwanted phone-call rules. The Federal Trade Commission has added several more requirements to its Telemarketing Sales Rule. The current rule bans the use of recorded messages unless the prospective customer has a previously established business relationship with the caller. The amended rule changes this in three ways.
- As of December 1, 2008, although such calls will still be legal, the caller must provide an automated keypress or voice-activated opt-out mechanism and include a toll-free number that consumers can use to stop future calls if messages are left on their answering machines.
- As of September 1, 2009, no recorded sales calls will be permissible unless the recipient has provided written consent to receive them. Charitable calls made by for-profit telemarketers on behalf of non-profit charitable organizations to members or previous donors will be permitted but must have an opt-out mechanism and must stop when people opt out.
During the public comment period that preceded the enactment of this rule, the FTC received thousands of complaints that that prerecorded sales calls are abusive invasions of consumer privacy. [Federal Trade Commission. The FTC's Do-Not-Call Registry now contains more than 150 million numbers. Telemarketing sales rule: Final rule amendments, 16 CFR Part 310. Federal Register 73:51164-51204, 2008]
This page was revised on September 26, 2008.