Spade Kitty Wrote:
Can you elaborate? I have a very close friend whose mother has really progressed MS and is in the midst of a two year attack.
Tysabri is a drug that was pulled off the shelves last year because a few MS patients died after taking it. This past week, the FDA held hearings whether to bring back the product.
This is a testimonial by our VP of Research and Clinical Programs.
"John R. Richert, MD
National Multiple Sclerosis Society
Testimony as submitted on Thursday, March 2 for FDA Open Hearing on March 7, 2006
Tysabri® (natalizumab) External Advisory Panel
Thank you for the opportunity to speak at this hearing. My name is Dr. John Richert and I serve as Vice President for Research and Clinical Programs at the National Multiple Sclerosis Society. Prior to assuming this position one year ago, I was on the faculty at Georgetown University Medical Center , where I served as an investigator in the Sentinel trial of Avonex plus Tysabri. I currently serve on the Data and Safety Monitoring Boards for the Phase III trials of Novartis' FTY720 and Acorda's Fampridine.
The National MS Society has been in existence since 1946. The mission of the Society is to end the devastating effects of MS. We are relentless in this effort. In 2005 alone, we invested $40 million to stimulate scientific discovery that will increase our understanding of MS and lead to the discovery of new treatments. It is essential that people with multiple sclerosis have more choices for safe and effective treatments. We are grateful to the FDA for granting expedited review of this application in order to weigh the benefits and risks of the drug Tysabri.
Determining the relative risks and benefits for Tysabri is a complicated matter. There are data that are being considered by the Advisory Panel that have not generally been in the public domain. There are also issues of risk for which there are no answers at this time. The National MS Society's position has been to pursue all possible avenues to assure that the FDA brings together the expertise required to evaluate all of the data and to come to the best possible decision. In this effort, we submitted a recommended list of reviewers who, in our opinion, bring to the table a comprehensive and balanced understanding of the issues associated with the return of Tysabri to the market. We also provided recommendations on clinical and scientific experts, as well as people with MS, to speak at this open public hearing.
In order to assure that the FDA received feedback from every individual who wished to be heard on this issue, we dedicated a month-long front-page link from our website, which attracts over 14.5 million visits a year, to the FDA comment page. We also provided information on submitting testimony and participating in the hearings in person.
In order to make sure that the hopes and concerns of people with MS were being heard in the FDA process, in December 2005, the National MS Society commissioned an online survey of a random sample of over 800 people with MS seeking their opinions on Tysabri, with particular emphasis on determining the amount of risk that they would be willing to accept and still take this drug. The study was coordinated by International Communications Research with Harris Interactive Online.
We have made the results of this survey available to the FDA, have provided a brief summary on our website, and will provide the full report of the results on our website after the FDA reaches its decision on Tysabri. The survey found that only 50% of respondents had heard of Tysabri. Of those who had heard of Tysabri, approximately 25% had a positive impression of the drug, 25% had a negative impression, and approximately 33% expressed a neutral opinion, wishing to have more information before making up their minds. The remaining respondents had no opinion.
Twenty-six respondents had received Tysabri during its period of availability. Of these, approximately 76% wished to receive it again, 12% did not wish to receive it again, and 12% were undecided. Among all survey respondents, approximately 1/3 wished to have Tysabri available and half wished to have more information before making a decision.
In this survey, questions about acceptable degrees of risk were phrased in a manner such as: Would you wish to take this drug if the risk of dying from PML within 3 years is one in a thousand, or 1%, or 10 %, and so on, right up to a 100% risk of dying from PML. The responses were spread relatively evenly throughout the range, without a cut-off at any particular degree of risk.
For the past 12 years we have been extremely fortunate that the approved disease modifying agents for MS have been extraordinarily safe. Similar degrees of safety are not seen among the medications available for treatment of most other autoimmune diseases. Medications approved by the FDA for use in the treatment of rheumatoid arthritis, Crohn's disease, systemic lupus erythematosus, psoriasis, ulcerative colitis and ankylosing spondylitis include those with degrees of known risk that include fatalities. These medications include Enbrel, Humira (adalimumab), Kineret (anakinra), Remicade (infliximab), and Celebrex.
Patients suffering from these autoimmune diseases, along with their physicians, are learning to weigh the potential risks and benefits when making their treatment decisions. Informed decisions require a significant effort on the parts of both patients and physicians to become well-educated on the merits and risks of each drug. It is likely that our frame of reference for MS drugs will need to change to be more in line with the toxicity risks that are recognized in the treatment of other autoimmune diseases.
Similarly, the amount of effort required on the part of patients and their physicians to become knowledgeable about their treatment options will need to become more in line with what people dealing with other autoimmune diseases have been facing. There are a number of other drugs that are currently in the MS pipeline, including several new oral medications. The kinds of decisions being faced today with Tysabri will likely be faced again and again as new generations of medications are developed. The risks of the medications will need to be weighed against the risk of doing nothing.
If, after this safety review is complete, the FDA recommends Tysabri's return to the market, we will applaud the addition of this treatment to our arsenal. If the FDA does not approve Tysabri's return to the market, or if it does so with significant restrictions, we will work tirelessly to find ways to satisfy the safety concerns so that more effective treatments can be readily available for the benefit of people with MS.
Thank you very much for your thorough and thoughtful consideration on this issue of vital importance to people affected by MS."
