Unproven Medical Treatments Lure Elderly : Part 3

by Food and Drug Administration (FDA)

(Page 3 of 3)

Magnetism: Pressure dots with tiny magnets affixed to adhesive strips and worn over the arthritic area are promoted for curing arthritis; a magnet in men's briefs is purported to cure impotence; and a magnet used as a suppository is promoted for curing hemorrhoids. There is no scientific basis for any of these claims.

Retin-A has been approved by FDA as a topical treatment for acne. The agency, however, has not determined whether it is safe and effective as a wrinkle remover.

RIFE generator promoters claim that they can insert a person's photograph into their device and diagnose medical conditions. FDA has not approved the marketing of this device, nor is there any scientific basis for this claim.

RNA, or ribonucleic acid, a natural body chemical that carries genetic information, is a common ingredient in anti-aging compounds and is also promoted for Alzheimer's. Promoters claim it rejuvenates old cells, improves memory, and prevents wrinkling. But there have been no controlled scientific studies to back up these claims.

Superoxide dismutase (SOD) is a normal body chemical, promoted to slow aging and treat Alzheimer's. According to the National Institute on Aging's Schneider, writing in the New England Journal of Medicine, some studies have shown higher tissue levels of SOD in longer- living species. A survey of a large number of different animal species revealed, in fact, that the longest-lived species, human beings, had the highest tissue levels of superoxide dismutase. But there is no evidence that SOD works to delay aging or prolong life, nor is there any evidence that taking SOD tablets raises blood or tissue levels of SOD.

Avoiding Fraud

According to FDA, these red flags should make you think twice about remedies not prescribed by your doctor:

• celebrity endorsements
• inadequate labeling (a legitimate nonprescription medication is labeled with indications for use, as well as how to use it and when to seek medical help)
• claims that the product works by a secret formula
• promotion of the treatment only in the back pages of magazines, over the phone, by direct mail, in newspaper ads in the format of news stories, or 30-minute commercials in talk show format.

The Arthritis Foundation says the following claims are also warning signs that a "cure" has but questionable therapeutic value:

• It's effective for a wide range of disorders, such as cancer, arthritis and sexual dysfunction. (But," says FDA's Aronson, "don't misinterpret this and believe a product promoted for only one disease is safe and effective.")
• It's all natural.
• It's inexpensive and has no side effects.
• It works immediately and permanently, making a visit to the doctor unnecessary.

Older Americans, along with younger folks, should remember that falling victim to health fraud is "not a matter of being weaker or foolish," says Renner. "It is a matter of being in pain or having more than one chronic illness — or both."

Barrett offers a final word of advice: "When you feel your physician isn't doing enough to help, don't stray from scientific health care in a desperate attempt to find a solution." Instead, ask your physician to provide a more detailed explanation or to refer you to another doctor. Kristine Napier is a registered dietitian and writer in Mayfield Village, Ohio.

Hearing Aids

FDA is taking action to improve the patient care of people who buy hearing aids. Though hearing aids have significantly improved the quality of life for many older Americans, the agency is concerned that some manufacturers are making unsubstantiated claims about their devices and are giving inaccurate portrayals of their devices' risks and benefits.

The agency last November proposed changes to hearing aid regulations to require a hearing assessment in all cases before a person is sold a hearing aid. The regulation will also require that this assessment be done by a qualified health professional licensed by the state. A public hearing on the proposal was held Dec. 6 and 7 near FDA headquarters in Rockville, Md.

Although a 1977 regulation restricts hearing aid sales to people who have had a hearing evaluation by a doctor within six months, FDA Commissioner Kessler pointed out that the "regulation also included a provision allowing fully informed adult patients to waive the medical examination." Kessler said this waiver has been "overused and misrepresented."

Before proposing the regulation changes, FDA reviewed promotional materials for a number of hearing aids and found that several manufacturers were making unsubstantiated and misleading claims that created unrealistic expectations about the performance of the devices. In addition, the materials failed to disclose significant information and did not accurately disclose the device's potential risks and benefits.

At press time, FDA was reviewing public comments on the proposed regulation changes.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.