Monday, May 7, 2012

A recap of my ms experience - Part 3 - joining the clinical trial

If you're just joining us, you can read parts 1 and 2 here to get up to speed:

Part 1: Diagnosis
Part 2: Starting Therapy

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I stayed on Copaxone for the next eight years. The whole time I continued relapsing 3-4 times a year with such terrible relapses it often took a good three months to recover, so I was basically in one stage of a relapse or another continually.

My neurologist, whom I trusted implicitly with my ms, did not seem alarmed by my relapse rate, nor did he suggest I try switching therapies. He just insisted I had an aggressive case of ms and I should stay on the Copaxone and treat acute attacks with IV steroids. I didn't know any better, so I went along with the plan.

Then one day my neuro I'd been with all along had a stroke. His practice abruptly shut down while he struggled to recover. I was without a neurologist.

Since my small town only had one other neurologist who wasn't seeing new patients, my primary care physician (PCP) became my ms lifeline. Every time I'd feel some new numbness, weakness or burning, I'd run to him. He kept insisting that the things I was coming to him with were ms related and I really needed a new neurologist. The catch was, in order for me to see a new doctor, I would have to drive out of town to do so. That terrified me. I hate trying to navigate in strange places almost as much as I fear driving on the interstate. I was defiant. 

One day he just put his foot down and, before I had left his office, he had his nurse schedule me an appointment with a neurologist out of Jacksonville, FL. A Dr. Kantor I'd never met.

The appointment was a good month away and in the meantime I got an Momentum magazine in the mail. In the back of the magazine is a section that outlines all the promising therapies coming down the pipeline. All the stuff currently in clinical trials. I read about a trial that was soon going to be recruiting patients called the TRANSFORMS trial to test efficacy and safety of a new drug called Fingolimod. What was exciting to me about this trial was the fact that it lacked a placebo. Rather it would be testing 2 different doses of Fingolimod in a head to head comparison study with FDA approved Avonex.

 It was to be a double blind study meaning neither patient or study center would know what the patient was on. In order to accomplish the blinding, it would be necessary for the study patient to take a pill once a day AND do a shot once a week. Either the pill or the shot would be the "placebo", but not both. So the patient would either take a sugar pill all week while giving themselves a shot of Avonex once a week, or they would be taking Fingolimod all week while giving themselves a shot of sterile water once a week.

Around the same time that I got that Momentum magazine, I also got a flyer in the mail from the local ms support group. I was excited to see their upcoming guest speaker was going to be my new neuro. How convenient! I could go meet him before I had my appointment and maybe get a little one on one time with him and ask him about the clinical trial.

Turns out I didn't have to ask. When he spoke at the support group meeting, Dr. Kantor was full of energy and very excited to talk about many things -- including the fact that he was lead investigator for the TRANSFORMS trial that was currently recruiting.

When I had my appointment, finally, we discussed all the things unique to being in a clinical trial and in particular the known risks associated with Fingolimod. I met with the study coordinator who gave me a thick stack of papers call the "informed consent" to take home and read through. It basically outlined what the study would be about and then went on to list any and all possible side effects or adverse reactions that were known to be associated with the medicine. Since Fingolimod had been trialed earlier in kidney transplant patients (at a much higher dosage), there were many known possible risks to consider.

It was a very intimidating and scary document considering I can't even take a Tylenol without reading the package insert and wondering how many of the possible side effects I might suffer. (Hence the "hypochondriac" in my blog's tag line.)

I ended up signing it and before I knew it I was under the microscope. Not literally, of course, because that would have to be one big microscope, but I felt like I was being thoroughly poked and prodded and constantly monitored. I had never had such acute attention paid to the minute details of my health and I felt surprisingly "safe" within the clinical trial.

This is where I have to leave off so you can catch a break and get on with your day...

I will try to finish this up and condense the trial into a single blog post only recapping the highlights. Not an easy task for someone fond of huge, paragraph-ish run-on sentences.

That's why I can't do Twitter. I can't get to the point in 140 characters or less.


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