Thursday, June 5, 2008

Novartis says FTY720 trial continues despite death

This article was just brought to my attention regarding the serious infections experienced by two clinical trial patients and the subsequent death of one.

Click here to read the full article.

This trial, it must be remembered, is the largest clinical trial for MS patients ever and includes upwards of 1250 patients in the head to head comparison of Fingolimod to Avonex alone. There are several other trials running concurrently and extension phases of prior trials. People die for all kinds of reasons. It doesn't necessarily mean that fingolimod was the cause of, or contributing factor in, the patient's death.

While the news of serious infection and death is not something I take lightly, these are the risks we take when we agree to test out medicine that's experimental.

I know I have personally suffered an increase in UTIs and upper respiratory infections this past year, but nothing that drinking more water and avoiding crowds during flu season along with more rigorous hand washing hasn't kept in control.

There are risks with any medication. The trick is to weigh the risk vs. the efficacy. I still believe Fingolimod will go to market -- they haven't even stopped the trial over this news -- and when it does, we will each have to make our own informed and personal decision about whether to take it (or any other disease modifying drug) or not.

This news scares me, naturally, but my faith in the miracle FTY720 has brought me cannot be squelched that easily.

My condolences to the family of the patient who died. My sincerest thanks for their participation in this trial. It was a noble cause and they did not die in vain. The fact that they were a contributing member of a group who are giving of themselves (and in their case, their very life!) for the greater good of all the MS community speaks volumes about the type of person they were.

I seriously hope it wasn't PML and that it wasn't related to the use of the drug.

2 comments:

  1. I say, if it's working for YOU, then at least one person is benefiting and it is worthwhile. You're right...all of these drugs can cause DEATH...that's why it's listed on the WARNING part of the box! Hang in there...and I, too, am hoping you're getting the real McCoy...

    Linda D.in Seattle

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  2. I am currently one of many that are on this experimental study drug. I have been on the study since 2004. I have not had a relapse since. We are well monitered and go through many different tests every 3 months. I am glad to be a part of this amazing study!!

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