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Anti-Aging Products: A Health Hazard?
by Richard A. Sherer
Geriatric Times March/April 2002 Vol. III Issue 2
Univera Pharmaceuticals' Anabolic/Catabolic Index Test can detect anabolic metabolites in a urine sample and determine the current level of a subject's metabolic efficiency. It costs a pittance: $124. The test is used in conjunction with Longevity Signal Formula, a supplement that can enhance energy, strength and stamina; support hormonal balance; bolster immune defenses; and support the subject's mental and physical performance. It can also slow signs of aging. A 30-day supply of the formula is available for only $79.
One other thing: The government says neither of them works.
And, while the distributor of both the test and the formula has signed a consent decree agreeing not to market the products, a search engine can quickly find more than 300 Web sites where they are still being promoted.
The Internet appears to have replaced late-night television as the primary source of information for patients in search of miracle cures. Entering the term anti-aging on one prominent search engine turned up 160,000 results in 0.45 seconds. Cancer cures, arthritis cures and virility enhancements are all available at the click of a mouse. In 2000-2001, a site offering a Viagra-like product received 15,000 hits.
"What the Internet changed was that it made every local practitioner into a potential national marketer," explained Richard Cleland, senior attorney in the division of advertising practices for the Federal Trade Commission (FTC). He told Geriatric Times, "I've been looking into the health fraud area for almost 20 years. There have always been longevity products and arthritis and cancer cures. But a lot of it 15 years ago was local promotion. It depended on word of mouth and on local practitioners."
Last fall, the U.S. Senate Special Committee on Aging held a daylong hearing looking into the marketing of anti-aging products to seniors. Committee chair Sen. John Breaux (D-La.) said at the hearing:
It is estimated that $27 billion or more is spent on supplements and that 60% of these consumers are older Americans. Individuals who are both healthy and ill take supplements for a variety of reasons. Some take supplements to increase energy, build muscles or lose weight...others have begun taking them as alternatives to traditional medicine and escalating prescription drug costs. More and more, our nation's seniors are turning to these supplements.
A report by the U.S. General Accounting Office (GAO), which was released at the hearing, was unequivocal in its findings:
"Dietary supplements marketed as anti-aging therapies may pose a potential for physical harm to senior citizens," it concluded. "Evidence from the medical literature shows that a variety of frequently used dietary supplements can have serious health consequences for seniors."
Martin T. Gahart, who prepared the GAO report, told GT that the real problem is one of trust. "Many people assume that if something's on the shelf, somebody has checked it out. That's not the case. The way the system is now, it puts the burden on individuals to understand what the products contain."
By and large, seniors get their information about the products they take from sources other than their physicians, and, the GAO reported, "About half of seniors who use a dietary supplement do not inform their doctor."
The report noted that some of these products show potential health benefits and that the National Institutes of Health are beginning to provide funding and research support to evaluate the safety and efficacy of alternative treatments for major conditions. In the meantime, however, contraindications have been identified in the literature for several supplements.
In addition, the report cited the increasing number of possible interactions with prescription medications that have been identified. For instance, the GAO reported, "evening primrose, ginkgo biloba, ginseng, glucosamine, and St. John's wort magnify the effect of blood-thinning drugs such as warfarin or coumadin." The report, including a complete listing of commonly used products and their contraindications, can be found online at <www.gao.gov>.
Physicians and others who have regular contact with patients could provide much-needed information about the risks of supplements, but they may not be taking a proactive position in finding out what supplements their patients are using. "As more literature and advertisements for these products become more widespread, it's something we have to focus on, clinically and educationwise," James E. Fanale, M.D., chair of the board of the American Geriatrics Society (AGS), told GT. "As we work with residents, we focus on teaching them to ask what kinds of over-the-counter medications their patients are taking. Now they also need to ask about what other remedies they are taking."
The FTC's Cleland pointed out that some patients will make a conscious decision to withhold information from their physicians. "One of the unfortunate situations that has arisen is that people have the feeling that I've got traditional medicine over here and all these complementary and alternative products over here -- some of which may make sense and some of which are complete quackery. I'm not going to tell my traditional provider about the alternative products I'm using. Those people lose an independent source of information."
Some marketers of anti-aging products dress up their sales efforts by creating fake organizations with official-sounding names or publishing seemingly authoritative journals. Breaux said he initiated the hearing after his wife received a magazine called the Journal of Longevity. "At first glance it appeared to me to be a scientific journal extolling the virtues of supplements, focusing on those that have alleged 'anti-aging' effects," the senator said. "I was drawn in and amazed by the startling new discoveries to slow the aging process...until I realized that the mailer was simply a fancy advertisement for one company's products."
The president of that company, Almon Glenn Braswell, invoked his Fifth Amendment right against self-incrimination at Breaux's hearing. He had previously been convicted of mail fraud relating to a hair-loss product and was pardoned by President Bill Clinton in early 2001.
Meanwhile, the products proliferate despite the efforts of both the FTC and U.S. Food and Drug Administration to stem the tide. The two federal agencies have overlapping jurisdictions and have been working together, along with Canadian health authorities, to identify questionable products and remove them from the marketplace.
In 1997, the agencies launched Operation Cure.All, designed to track unfounded health claims for products on the Internet -- AIDS and cancer cures, virility enhancements, anti-aging products, and arthritis treatments. Since then, the FTC has filed a total of 16 cases against manufacturers and distributors. The FDA has issued several dozen so-called cyber-letters against Web sites that made unsubstantiated claims about supplements.
The GAO found that Operation Cure.All has had limited effect. "In 1997, an estimated 13 percent of notified companies withdrew their claims or Web site, while 10 percent made some changes. In 1998, an estimated 28 percent of notified companies withdrew their claims or Web site, while 10 percent made changes. By comparison, the percentage of companies that made no changes in both years exceeded 60 percent."
Since 1998, the FTC has filed over 30 dietary supplement cases. And even in these limited efforts, the focus has not been on anti-aging products per se.
"With regard to claims that a product can reduce or reverse aging, we've filed one case in the last year," Cleland said. "We're more likely to be focusing on diseases or health conditions associated with aging, such as arthritis and cancer."
The one FTC complaint regarding anti-aging products was against MaxCell BioScience Inc., marketer of the Longevity Signal Formula and Anabolic/Catabolic Index Test.
Critics say the agencies are hampered by restrictions in the law and by limited resources. "The FDA requires manufacturers of prescription drugs to prove their effectiveness," Gahart pointed out. "But for dietary supplements, the FDA is required to prove they're dangerous before it can take action. The hurdles are very high, and the FDA has never tried to prove a product was dangerous in court."
In addition, he said, unlike the makers of prescription products, "Manufacturers of dietary supplements are not required to report adverse events to the FDA."
The FTC has stepped up its efforts in consumer education with a series of Web sites designed to look like those that market supplements and miracle drugs to consumers. One of those sites, promoting a product called Virility Plus, has received more than 15,000 hits since it was launched in 2000. When the visitor clicks on the link for more information, they are taken to a page that announces, "You could have been scammed!" and given a crash course in how to identify phony products on the Internet.
But by and large, the efforts to protect seniors and other consumers are falling behind. Breaux has asked the inspector general of the U.S. Department of Health and Human Services for a report on labeling laws for dietary supplements. That report is due late this year, when it may be overshadowed by congressional elections.
"These are clearly cases of 21st century snake oil salesmen," Breaux told the press following the hearing. And so far, it looks as if they will be able to continue peddling their wares for the rest of the century.
