Is AREDS Changing Practice Patterns?
Many doctors say yes, but also see a need for better patient education.
By Robert Israel, Contributing Editor

Reported in the October 2001 Archives of Ophthalmology, AREDS evaluated the effect of high-dose vitamins C and E, beta carotene, and zinc supplements (Bausch & Lomb's Ocuvite PreserVision) on AMD progression and visual acuity. The study followed 3,640 patients between the ages of 55 and 80 with AMD of varying severity over a period of 6.3 years. Among the findings: Patients at high risk for developing advanced stages of AMD lowered their risk by approximately 25% when they were treated with high doses of zinc and antioxidants.

That and other findings from the study have had a distinct impact among ophthalmologists. Some doctors interviewed for this report feel that the study indeed represents a breakthrough in the treatment of the disease. They applaud AREDS and credit it for prompting them to change how they treat their patients. Other doctors remain skeptical. They contend that the findings aren't conclusive enough to convince them to change how they treat patients.

There is, however, a constant among all the doctors interviewed: Clear and accurate communication with their patients is crucial. It's imperative, they said, to educate patients and to clearly disseminate the facts uncovered by the study. Many also said they see a need to rebut the sometimes misleading and confusing claims that have appeared in numerous media outlets. Patients, they say, have become confused by misinformation in newspapers, magazines and sometimes by the plethora of advertising from drug companies that has appeared in the wake of the study's publication.

Providing the right answers

The study's chairman and principal investigator is Frederick Ferris, M.D., director of clinical research at the National Eye Institute. Dr. Ferris said that the study "contains important news for all of the people needing treatment. The treatments are effective for those that do progress with the disease. The good news is that the vitamin supplements are not terribly expensive, and there are no side effects. People that smoke should avoid the beta-carotene supplement, which has been known to increase their chances to get cancer."

Dr. Ferris, too, expressed concern when asked about news of misleading and inaccurate reports that have appeared in the media. "It is absolutely crucial that the correct information reaches doctors and their patients," he said. "The NEI is currently undertaking a national effort to educate and disseminate information about AREDS to ensure that information is communicated correctly."

That's good news to another principal investigator of the study, Aaron Kassoff, M.D., of the Eye Center at Memorial in Albany, N.Y., who has undertaken a communication effort of his own. "This study is indeed a breakthrough in the treatment of AMD, and I believe it is crucial to publicize the findings, to make the findings known to lay and professional people, who should recognize the importance of the study," Dr. Kasoff said.

Dr. Kassoff said he spoke to reporters at three of Albany's television stations, as well as to the daily Albany Times-Union newspaper, to communicate the study's findings and to share "not only the civic pride I feel that over 400 people from the Albany area participated in the study, but also to get the right information about the study out there to those it can best help."

That was also the stated intention of an advertising supplement to New York Times Magazine on May 5, Dr. Kassoff noted, that he felt missed the mark. "While the intention of the advertising supplement in the Times magazine is a good one, there was an error in the copy, and one error can lead to many misconceptions," Dr. Kasoff said. "On one side of the advertising supplement, for example, the copy reads that there is no known treatment for AMD, while on the opposite side of the page, a full-page advertisement states that there may be a cure. It confuses patients looking for straight answers."

In order to provide straight answers to his patients about AMD, K. Bailey Freund, M.D., a retina specialist at Vitreous-Retina-Macula Consultants of New York, has set up a Web site (http://vrmny.com/AMD&Vitamins.htm) explaining the results of the ARED study and his recommendations for adopting them in his practice.

"We have a responsibility to educate and explain," Dr. Freund said. "The literature that is published in advertisements can sometimes be confusing. It takes a lot of time to explain the truth to patients, but it is worth it. The AREDS study has indeed changed my practice because it is a good study, and it can push back the disease a few years for patients who are suffering from the disease. By posting the correct information up on a Web site, I can actively clarify misconceptions patients raise."

Dr. Freund said he tells all of his patients about the study. "I explain that the statistical power of the trial was not sufficient to show whether patients with early findings or simply risk factors ­ a family history, smokers ­ will benefit from long-term supplementation. The study was not of sufficient length to document long-term (more than 6 years) safety of the supplements. After I explain this, the patients still ask whether they should take them. I tell them that my "gut feeling" is that any patients with AMD or at risk for AMD will probably lower their risk by taking the supplements, and the risks in terms of side effects are probably small but not really known."

Michael J. Elman, M.D., who is in private practice as well as active in research at Johns Hopkins in Baltimore, agrees. He lauds AREDS as a breakthrough and a major finding in public health. "The more you can help patients take steps to help themselves, the better," he said. He, like Dr. Freund, intends to use his Web site to educate his patients because he, too, has seen evidence of misinformation.

"A patient came to me recently," Dr. Elman said, "and she told me she had read about a cure for macular degeneration in a newsletter she pays $50 to subscribe to. I spent time with her in an effort to refute several of the claims of this newsletter. Patients believe that if they read it, if it appears in print, it has to be true. That is simply not the case. We in the medical profession have the responsibility of telling patients what is real and what is not."

Harry W. Flynn, M.D., who serves as president of The Retina Society, said that to a certain extent, AREDS has changed practice patterns. "We're now recommending the multivitamin tablets to high-risk patients with macular degeneration. We've read the journals, understand the results, and are doing what's necessary. I cannot speak for the membership of the Retina Society in general, but I feel it is a commonly accepted practice."

He underscored the importance of clear communication to patients. "There are marketing companies out there who make money when they confuse the public," Dr. Flynn said. "As professionals, we have to get important information to patients beyond the marketing campaigns."

Awaiting more answers

Other doctors aren't as impressed with the AREDS results. Eddie Kadrmas, M.D., a retina specialist in private practice in Plymouth and Dartmouth, Mass., said he's "underwhelmed" by the study.

"Patients have come to me with articles from The Boston Globe, and they want a magic potion, a cure, they want something they can do to stop the disease, which is progressive, no matter what we do," Dr. Kadrmas said. "I have to temper their expectations and explain that we need more research, more data. My fear is that when patients read that the taking of a zinc supplement is helpful, they might begin to take it on their own, without consulting a doctor. They are so intent on taking something that can stop the disease. But there are still many unanswered questions. For example, patients want to know if the disease is hereditary, and if it is, should their children start taking the vitamins now in order to prevent macular degeneration? We don't have the answers to these kinds of questions yet."

Jay Duker, M.D., of the New England Medical Center in Boston, agrees. "It is important to tell patients that the study is a work-in-progress, and we have a lot more work to do," Dr. Duker said. "There are a lot of other considerations that the study has not touched upon with regards to macular degeneration, namely a patient's attitude, needs, and social relationships. It is not just about taking vitamins."

Indeed, most doctors interviewed said that the psychological effects of macular degeneration are contributing factors to the treatment of the disease. Dr. Freund said if a patient he is seeing gets assistance to go about his or her life and is able to maintain a measure of self-reliance, "the taking of vitamin supplements is a boon. But I have other patients who struggle daily to maintain their independence, who don't have someone to help them shop or get to medical appointments, and for these patients, news of the AREDS study and its implications seems moot."

Yet the study is important, Dr. Kadrmas said, because "a study is supposed to stimulate discussions, and this study has indeed done that. I applaud the study, but we have a long way to go in our communication and treatment of patients with AMD."

Robert Israel is a freelance journalist based in Arlington, Mass.