March 7, 2006 .. as of the day of the Advisory Committee hearing, March 7, 2006, exactly 372 days will have passed since the February 28, 2005 suspension of Tysabri.

What has this meant to MS patients? Looking at just the approximately 8,000 patients who were on Tysabri (commercial distribution plus approximately 3,000 patients who decided to continue on Tysabri in the clinical trials), plus approximately 20,000 patients who had applied through their doctors for insurance reimbursement for Tysabri, approximately 28,000 patients would have been using the drug for about a year. Indeed, more patients were choosing Tysabri every day, but let’s look at just the group of patients who had already made a decision as of February 28, 2005.

Let’s follow this group, using some generally accepted guidelines for the frequency of MS relapses over the course of time. Since Tysabri has not been available since February 28, 2005, about 25,200 patients (90%) of these 28,000 patients might have elected to receive one of the available, older less effective therapies, and approximately 2,800 patients (10%) might have elected to receive no MS therapy, waiting for Tysabri to be reinstated. The patients receiving the less effective therapies would have an average relapse rate of approximately 50% (one relapse, on average, every two years), so approximately 12,842 of these patients, on average, would have suffered one relapse during this period. The patients on no therapy would have a slightly higher average relapse rate, approximately 0.74 relapses/year off therapy, so approximately 2,112 relapses among this group, for a total estimated number of relapses of 14,953.

If all of these patients were on Tysabri, with an estimated average relapse rate of just one relapse every four years (0.25 relapses/year), an estimated 7,134 relapses would have occurred, meaning that an estimated 7,819 relapses could have been avoided. An estimated 2,580 of the patients suffering from these avoidable relapses would be expected to require a cane, walker or wheelchair, and an estimated 1,290 of the patients suffering from these avoidable relapses would never completely recover from their relapses, suffering permanent disability.

Of these AVOIDABLE exacerbations, one-third would have been moderate or severe, requiring five days or so treatment with IV steroids. Half of these 1,290 exacerbations will never completely recover. Some of these exacerbations were at the top of the cervical spine. An estimated 109 of these patients might lose their ability to walk while they were relapsing, and 65 might never walk independently again.

Tick Tock Tick Tock

Over a year will have passed by the time the Advisory Committee meets on March 7, 2006, and these numbers show that thousands of MS patients and tens of thousands of family members, friends, employers and co-workers will have been adversely affected. Concerns are raised about “risk,” but is the risk of not having an effective drug being considered? Does anyone care?

Tick Tock Tick Tock

With every passing day, more avoidable relapses, more patients permanently in wheelchairs, more patients legally blind, more patients now incontinent and more patients with significantly lower IQs.

MS is impatient, it will not wait for the FDA.