Thursday, April 16, 2009

From my google alert email yesterday...

I like the news I just posted about fingolimod from the Rocky Moutain MS Center's newsletter...

I don't so much care for this news that broke yesterday on Reuter's:

Patient on Novartis’ MS Drug FTY720 Gets Hemorrhaging Focal Encephalitis


April 14, 2009

Novartis (NVS) is reporting that one of its shining star drugs in development may be in trouble. Doctors in the trial for FTY720, also known as Fingolimod, have reported a case of hemorrhaging focal encephalitis in one patient. The company said the patient concerned was recruited into the study seven months before hospital admission for the reported event, before which no new disease activity had occurred.

Eric Althoff from Novartis commented on the scenario:

“As per normal procedures, this particular case was communicated in a timely fashion to health authorities and study investigators. It is difficult to interpret an isolated case report without the benefit of the full Phase III data set. At this stage, a relationship with FTY720 can neither be excluded nor confirmed.”

FTY720 works as an immunosuppressant, causing lymphopenia by preventing lymphocytes from leaving lymph nodes. The drug has already demonstrated superiority over Biogen’s Avonex and is currently in an ex-US Phase 3 study called FREEDOMS I. The trial is comparing two doses of the drug vs placebo in 1,272 MS patients.

The drug is a potential star because it is given orally (all MS drugs on the market are injection) and has already demonstrated superior efficacy over Avonex. The main concern is safety, safety and safety. Up until now, the known safety issues had been transient heart rate reductions, elevated liver enzymes, skin cancer, infections (there have already been two fatal viral infections) and minor increases in blood pressure. This is the first serious brain inflammation case in the trial which would put concerns about the drug’s safety right up there with Tysabri.

The safety issue might be a positive for Merck’s cladribine which is in a race with NVS to become the first oral MS therapy. Cladribine also had some issues earlier this year when the company reported four patients had died of cancer.

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It's weird. Even though I'm a full-fledged, professional, card-carrying Hypochodriac, the news of the bleeding brain infection (as far as I can figure, that's what Hemmorhaging Focal Encephalitis means) does not stun me into a frozen state of panic whereby I am unable to ingest my daily pill.

On the contrary, I get up and yawn and stretch with eyes still half closed (regardless that it's the crack of 9a.m.) and slug my little capsule down with a swig of decaf. Oblivious to any idea that should be swelling up in my subconscious that my brain may get infected and bleed.

I just can't seem to muster the fear. I guess it's because I tell myself that when complications like this arise, I don't know the full back story and the poor person that had these complications obviously was not well by definition since we all (in these clinical trials) have a MS diagnosis. I feel like since I quit smoking, started eating better and got on this trial, my MS has been whipped into submission and I'm actually quite healthy.

That reminds me of the one time I saw an eye doctor in the study. I forget how it came up, but I replied to whatever the question was with : "other than having MS I'm healthy as a horse."

He just stared at me before bursting out laughing. I, at first, couldn't see the humor, but I guess to someone who doesn't HAVE MS, the diagnosis must seem like the ultimate branding of Incurable Illness. I tend to see it as an annoyance and a Life Obstacle. We all have them. Mine just happens to be MS. That doesn't mean I can't be *otherwise healthy*.

So, while this isn't the greatest news for the clinical trial, I'm not personally freaking out or losing sleep or pausing before tossing back my pill.

Read the packaging insert that comes with your aspirin. Even that stuff can cause death. Everything in life is a gamble. And I'm all in on this hand.

4 comments:

  1. I'm with you. Until all facts are known, freaking out doesn't do any of us any good. The cause will be found and if any additional testing needs to be added to the study protocol, it will be.

    Regardless of whether I'm on placebo or not, I feel better than I have in ages and the only way I'll give them back is to have them pried out of my cold, dead hands.

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  2. You very much have the right attitude towards life. I admire it, a lot.

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  3. Hey, Fingohead!! I've missed you (by no fault of yours, actually...I'm a lazy blog-reading beauch lately)

    Yeah...aspirin kills more people annually than the med you are on! Good on ya for not getting knotted panties over this one. LOL

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  4. I am another "guinea pig" on the FTY 720, based at the Frenchay in Bristol. I have been certain since the day I was randomized that I am on one of the doses of the drug and not the placebo; this has been borne out by the fact that my health has improved to the degree that I have returned to work and have a full and mostly healthy life now. I agree with you completely about reacting to the news of this new side effect. To be able to live largely without the constant fear of having an MS attack is totally worth the risk of side effects from the new drug, in my opinion. I'd rather live less long, but well, than live for a long time with the threat of MS attacks hanging over me all the time.

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