A changing framework for MS treatment: more choices mean more responsibility.

For the past 12 years we have been extremely fortunate that the FDA-approved agents for treating MS have been extraordinarily safe. Similar degrees of safety are not seen among the medications available for treatment of most other autoimmune diseases. While we are grateful for the degree of efficacy provided by our currently available drugs, there is need for improvement. Such improvement is likely to come from both the use of combinations of existing medications and the development of entirely new drugs.

Among the medications approved by the FDA for use in autoimmune diseases such as rheumatoid arthritis, Crohn's disease, systemic lupus erythematosus, psoriasis, ulcerative colitis, and ankylosing spondylitis are several with significant degrees of risk up to and including fatalities. Enbrel, Humira (adalimumab), Kineret (anakinra), Remicade (infliximab), methotrexate, azathioprine, and Celebrex are among them. People with these diseases, along with their physicians, have been learning to weigh potential risks and benefits when making their treatment decisions.

In treating MS, we may soon face decisions about therapeutic options and possible toxicity similar to those that people dealing with other autoimmune diseases have been addressing for years. Our paradigm, or frame of reference, will now need to be more in line with theirs. We have much to learn from their experiences. Informed decisions require significant effort by individuals with MS and their health-care professionals. Everyone concerned must become educated about each drug.

This obligation is true not only with regard to Tysabri but will likely be the case with other drugs currently in the MS pipeline.

MS is such a diverse disease, there may never be a "one size fits all" treatment strategy. Any decision about whether to take a given therapy should be made after careful discussion between patient and physician.

The choice of Tysabri carries with it the potential for powerful benefits and the risk of developing PML (progressive multifocal leukoencephalopathy), an often fatal disease of the central nervous system. The side effects of using Tysabri for an extended time are not yet known. If new cases of PML or other serious events occur, the National MS Society will monitor the situation and disseminate the information as soon as it is available. If the risk of this or any other medication were to rise significantly in clinical use, it would be important to recognize it immediately, assess the situation quickly, and take appropriate action.

Among all of these unknowns there are some guarantees: The National MS Society will partner with health-care professionals and the individuals and family members who are directly affected by MS. We will be here to provide analysis, professional opinion, education, counseling, and advocacy action if necessary. We will shine as bright a light on the issues as we can. The FDA hearings in March showed how important it is to work together to reach the wisest possible decisions.

Together we can share the obligation to weigh the risks of any given new treatment against the risk of maintaining the status quo.

RELATED ARTICLE: Driving MS research forward.

Since 1946, the National MS Society has spent more than $500 million on MS research. It has been a key player in virtually every major breakthrough in understanding and treating the disease since that time. Basic research helped lead to the development of our current disease-modifying therapies and over the past 20 years the Society has funded 61 clinical studies of potential new MS drugs.

The Society initiated and funded research into the interferons now known as Betaseron, Avonex, and Rebif. (See page 22 of this issue for the story on William Sibley.) As early as the 1970's we were funding research on glatiramer acetate, originally called co-polymer 1, now known as Copaxone. Similarly, basic research on the significance of the integrin molecule led to the development of Tysabri.

Because of this groundwork, people with MS and their physicians now have more choices--and more responsibility. This will only increase as we move forward.

Dr. John Richert is vice president for Research and Clinical Programs at the National MS Society.