the trials of a trial

So we received the following email from one of our group members who has IBM and was interested in the upcoming BYM338 trial. Here’s what he had to say about his experience –

I called Dr. Sivakumar’s office in Phoenix as soon as I read the information regarding the trial and locations. I was told to get the doctor who has been seeing me for my IBM for the last twelve years to submit my diagnosis and treatment history to them.  I was also asked to fax them my personal history as well as any medications and supplements I was taking.  After a few days I called them back to make sure they had received all of the requested information.  They said they had and would get back to me within a week.  After a week I called them back …. many, many times and left messages each time.  After three weeks of calling I finally reached Mr. Willner who is assisting Dr. Sivakumar.  I was told that I was fourteenth on the list and they would eventually go forward with nine or ten for the trial. I asked him many questions and here is a little of what I found out.

1.  This will be a double blind trial which means you may be getting a placebo and not BYM338.
2.  Initially, you will have to be in Phoenix for five weeks as they begin the infusions.
3.  You will then have to come back to Phoenix once a month for the next two years for the infusions.
4.  At the end of two years all of the patient information and findings will be submitted to the FDA for
consideration and evaluation.
5.  It could be possibly another two years before the FDA approves BYM338 for approval and
availability.
6. Here’s the best for last.  After the two years of being on the drug there is no guarantee that the FDA
will allow patients in the trial to continue to get the infusions while they are analyzing the results.  So,
even if the drug is doing what everyone hopes it will you may or may not be able to continue to take it
until the FDA gives their approval.

Basically, I wasn’t very pleased with the way they handled their communication with me.  I was told they would call me back and that just never happened.  For myself I am not interested in participating in a trial where there would be a chance that I would be getting the placebo … and I do understand why they do it that way.  Additionally, I would not be able to handle the expense of going to Phoenix once a month for the infusions. I am hoping that, possibly, in the near future there might be a trial available at Anchutz or somewhere closer to the Denver area.

Just thought I’d let you know of my experience.

We know that getting into clinical trials is difficult and a pretty expensive proposition for most. We’d love to hear anyone else’s experiences with getting into a trial – good, bad, or ugly. Let us know!

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