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For a Proven Product, Blurry Claims


By: Christopher Wanjek
Washington Post, April 23, 2002

 

Eye care company Bausch & Lomb is marketing a dietary supplement with bold claims that it is "the only eye vitamin proven effective by the National Eye Institute" (NEI), saying a study showed it helped "preserve the sight of people most at risk for age-related vision loss."

While these statements are correct – and indeed reflect the results of high-quality, government-sponsored research – they don't precisely relay what the vitamin can (and can't) do. And the campaign illustrates how even the most resolute attempts to abide by the policies of the Food and Drug Administration (FDA) regarding the marketing of dietary supplements can lead to confusion.

In the most comprehensive study to date on nutritional supplements and vision loss, the 10-year Age-Related Eye Disease Study, or AREDS, found that a certain combination of antioxidants and minerals significantly reduced the risk of permanent vision loss for some people with age-related macular degeneration, a leading cause of blindness. That dietary supplement mix – beta carotene, vitamins C and E, and zinc – was prepared by Bausch & Lomb especially for the study, which was funded largely by the NEI, part of the National Institutes of Health.

PreserVision is indeed good news for the millions of people (including 33 percent of those over age 75) who have age-related macular degeneration, a disease with few treatment options and a common cause of blindness. Patients with the condition often develop globular growths called drusen on their maculae, the retina's region of maximum visual sensitivity. Over time, the retina's cells die and more drusen form, slowly blurring vision to the point of blindness. The cause is unknown.

Results of the study showed that intermediate-stage patients who took the supplement were 25 percent less likely to progress into the advanced stage and 19 percent less likely to lose their vision completely compared with the placebo group.

But that's all the PreserVision formula did. The nutrient mix did not prevent the progression of macular degeneration for those patients in the beginning stages of the disease, said Frederick Ferris, director of clinical research at NEI and the chairman of the AREDS. Nor was it helpful in preventing cataracts, another age-related eye disease. And as the NEI stresses in its brochure and on its Web site, no food or dietary supplement has ever been shown to improve vision.

Ferris calls the research into the formula's benefits "a huge step in the right direction," given the fact that many Americans are popping all kinds of supplements without knowing the consequences. "We feel pretty good about bringing science to a field [dietary supplements] that hasn't had a lot. But these are pharmacological doses, not food doses," of the vitamins and minerals involved.

PreserVision contains, among other ingredients, 80 mg of zinc and 15 mg of beta carotene (which converts to vitamin A), six and three times the government's daily recommended intake, respectively. The long-term risks of high doses of antioxidants are not known, according to Lee Jampol, of the Department of Ophthalmology at Northwestern University Medical School in Chicago, whose editorial accompanied the published results of AREDS last year. Beta carotene may be associated with a higher risk of lung cancer in smokers and yellowing of the skin; zinc interferes with medications and may lead to a copper deficiency and stomach problems.

Many ophthalmologists do not recommend dietary supplements for people in the early stages of macular degeneration, let alone for baby boomers concerned that someday their healthy eyes might fail – and who may be tempted by PreserVision's broad marketing claims. Even though a prescription is not needed for the supplement, a spokeswoman for Bausch & Lomb said the company has been very careful to advise consumers to ask their eye doctor if PreserVision is right for them.

Ironically, while Bausch & Lomb might like to explain to the consumer exactly what PreserVision is good for, by law it cannot.

Because PreserVision is being sold as a dietary supplement rather than a drug – and therefore did not need or receive FDA approval – Bausch & Lomb cannot make any claims that PreserVision treats, cures or prevents any specific disease. But in the NEI study, doctors did indeed treat patients with AMD; and this did indeed prevent vision loss in some patients. Read the PreserVision label and advertising, however, and you will learn that the supplement can "help preserve the sight of people most at risk for age-related vision loss." This statement is correct and legal, but it invites an overly broad inference about its value. A clear statement that the formulation helps some people with intermediate macular degeneration preserve their vision would be more accurate and helpful but prohibited.

So as science finally begins to provide an element of legitimacy for a dietary supplement, consumers may remain in the dark about what really works.

 


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