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Wednesday, August 27, 2008

Participating in a Clinical Trial? Talk to Your Neurologist

by Dr. Kantor - as found on MS Central .com

Wednesday, August 13, 2008

We are getting closer the release of the first oral medicines in the treatment of Relapsing-Remitting MS (RRMS) with the goal of preventing relapses (and hopefully progression and disability). Altruistic patients worldwide are taking part in multiple clinical trials testing the safety and efficacy (effectiveness) of these new forms of medicines.

These newer medicines are giving the MS Community hope because they do not involve needles, but also because they may be found to work even better (higher efficacy) than our older medicines. Unfortunately, however, two patients in one of the trials passed away recently from infections.

MS is an autoimmune disease, and so the body attacks itself (the myelin covering the nerves and the nerves themselves), much like in Diabetes mellitus type 1 (childhood diabetes) where the body attacks the pancreas (the organ which releases insulin). Because MS involves the immune system being hyperactive, many of the medicines to treat MS are immunosuppressants to try to push the immune system down. Immunosupression also makes it harder for the body to fight off infections.

Fingolimod (also called FTY720) is a novel oral medicine being tested in three Phase 3 trials both in the United States and worldwide). Phase 3 trials are large trials where patients either receive the medicine being tested (in this case, Fingolimod) or another standard medicine (or placebo). Fingolimod is being tested in two placebo-controlled Phase 3 trials (one in the United States and the other in the rest of the world) and in one Avonex®-controlled Phase 3 trial) where patients receive a daily pill and weekly injections into the muscle and they do not know if they are receiving the real pill and a fake injection or a fake pill (placebo) and a real injection (Avonex®). The idea of this trial is to compare the safety and efficacy of the new medicine Fingolimod with an older well-established medicine (Avonex®).

The patients volunteering for these trials are true heroes – they are pioneers leading the way for the development of new medications and making it possible for the entire MS community to have greater access to new medicines. Just as the patients who were in the original trails of Avonex®, Betaseron®, Copaxone® and Rebif® blazed the way for hundreds of thousands of MS patients to lead better lives, these patients in the newer clinical trials should be applauded and thanked for their commitment to helping all MS patients and families.

Being in a clinical trial, however, carries with it risk. If we knew everything about the safety and efficacy of the medicine being tested, then we wouldn’t need these trials. Therefore, there may be risks which are not discovered until something bad happens.

This summer, Novartis (the makers of Fingolimod) announced that a patient in Italy receiving FTY720 in the clinical trial, developed disseminated Varicella Zoster (the infection of chickenpox and shingles) and passed away. Another patient in South Korea developed herpes encephalitis (an infection of the brain by the herpes virus) and also passed away.

The hearts and thoughts of the entire MS community go out to the families and friends of those heroes.

The MS research community is remaining vigilant in the earlier detection and diagnosis of potentially fatal infections while patients are being exposed to immunosuppressants. Patients in the Unites States are still enrolling in the placebo-controlled trial of FTY720 for the treatment of relapsing MS. Patients and doctors are keeping an eye out for any further infections, and the earlier they can be found, the better we can treat them with antibiotics and antiviral medications.

The recent deaths reemphasize the need to have an open dialogue with your neurologist, whether you are in a clinical trial or not, and to retain and claim your true position as the center of the MS Team in M*STAR (the Multiple Sclerosis Team Approach Rule).

Leaving comments is a great way to get others involved with the topic.
Please feel free to leave your comment(s) for any of the postings found on this blog.


Paul is a Hermit said...

It is good to remember these people. Because it is not simply a matter of living or dying, at worst. It is possibly more pain and illness than they could ever have imagined, regardless of the pages of warnings given. These people, perpetually nameless and faceless, give the scientists what they need, what could eventually make fortunes for sponsoring drug companies, what they need for FDA approval, a live, human body.

I'm glad to see them receive this attention; someone rembering. Wish something could be found without any health tradeoff.

Anonymous said...

Thank you to the person who left the previous comment for your kind remarks. I am (was) in this trial (FTY720 vs. Placebo) and had to drop out because my immune system was basically wiped out. I acquired so many oppotunistic infections and so many bizarre side effects, it is amazing I'm still kicking. I have lost so much weight, I can wear my 6-year old's t-shirts (and I'm a 34 yr old, 5'4 woman). When all was going well, I was very well liked, but as soon as the adverse events began, I was "persona non-grata" at the trial center. They would not return my calls, emails nor would they call back my personal drs. who are trying to take care of me.

Thankfully, my immune system is slowly building back up, but I'm not gaining back body weight, in fact I still can't eat much at all and no one can seem to figure out why. I see this med seems to help a lot of people and for that I'm glad. I really did join the study in hopes of finding a good MS treatment for myself, but also becaus I have so many friends that are worse off than me and wouldn't it be nice if I could tell them how I helped find something that would help them too... Oh well, how about that, huh?

In the end, I had no choice but to report this to the FDA. I finally got a call 2 days ago from the center... to check on me and offer me a "follow up appt". Too little too late.

So thank you again for remembering those patients in Europe and Korea. The ones they didn't want to talk to me about when the press releases came out. I can assure you, I WILL NOT forget them.