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  itemPink (1K) PRESS RELEASE

At Capitol Hill Briefing, Scientists and Patients Weigh In On Drug Safety, Recall Issues
AARDA Releases Official Position Paper, Citing Need for Greater “Patient Voice and Choice”
WASHINGTON, D.C., July 20, 2005 – When a drug, either in clinical trial or on the market, is halted, recalled or facing recall, patients whose quality of life and disease status are directly related to the drug in question must be part of thediscussion/decision-making process,along with the Food and DrugAdministration (FDA), Congress, the pharmaceutical industry and consumer groups.

This overriding need for greater “Patient Voice and Choice” in prescription drug issues is the official position released today by the national patient advocacy organization, American Autoimmune Related Diseases Association, Inc., (AARDA). Speaking about the issue at a briefing on Capitol Hill, Abby Bernstein, member, AARDA Board of Directors, outlined the organization’s position for members of the U.S. Senate and House of Representatives and their staffers. She said AARDA takes this position because:

---One drug does not fit all. This is particularly true in the case of patients with difficult-to-treat diseases such as autoimmune disease which often require treatment with off-label indications and/or a complex drug regime. Just as the generalization cannot be made that no one drug will be effective for everyone, neither can it be said that a drug will have the same safety issues and/or side effects in all treated individuals.

___Patients’ needs must be part of the “risk/benefit equation.” They are entitled to speak out about their ability and right to work with their physicians to make the right treatment choices to best manage their difficult diseases.

---Consumer groups have a voice when it comes to drug recalls, yet consumers are not necessarily patients. Therefore, patients, with the help of their physicians, need to be entrusted with the responsibility to make decisions regarding their health care.

About the Capitol Hill Briefing

Hosted by AARDA, Friends of Cancer Research and several other national non-profit organizations representing a broad spectrum of diseases and patients, the briefing featured scientists who research drugs and patients who depend on them for their life and health. Together, they discussed their perspectives about drug safety and efficacy issues, and presented their top concerns as Congress continues to examine this pressing issue.

About Autoimmune Disease and AARDA There are more than 80 known autoimmune diseases including multiple sclerosis, juvenile diabetes, rheumatoid arthritis, scleroderma, lupus, Sjögren disease and Graves disease. Autoimmunity is the underlying cause of these diseases. It is the process whereby the immune system mistakenly recognizes the body own proteins as foreign invaders and begins producing antibodies that attack healthy cells and tissues, causing a variety of diseases.

According to the National Institutes of Health (NIH), there are 23.5 million Americans who suffer from autoimmune disease. However, there are likely millions more who have not been diagnosed. Every year a person remains undiagnosed and untreated, they are at an increased risk for organ damage and premature death. Collectively, autoimmune disease is one of the top 10 leading causes of death of children and women under 65, yet less than six percent of American surveyed in a recent Roper poll could identify an autoimmune disease.

AARDA is the nation only organization dedicated to bringing a national focus to autoimmunity as a category of disease and a major women health issue, and promoting a collaborative research effort in order to find better treatments and a cure for all autoimmune diseases. For a full copy of the position paper titled, “A Greater Need for ‘Patient Voice and Choice,’” or for more information, please visit AARDA’s web site at www.aarda.org anc click on Advocacy Issues or call 1-888-856-9433. - # # # -