Clinical Trials ~ No Thank You!

Previously, I began tackling the results from Survey Says ~ Wednesday question: Clinical Trials…Sign Me Up!  We took a look at the popular response, “Maybe.”  Today, let’s look at “No.”

We know there is no cure for MS (and many other diseases) or options for patients with progression.  We have symptom management treatments at best.  Having said that, we do know, with certainty, that the first type and most common diagnosis of MS is RRMS (Relapsing Remitting MS).  Today, patients have 13 treatment options available as a first line of defense for RRMS. Currently, there is nothing for progressing forms.  Having said that, it is my belief that the researchers have an opportunity to find something, anything to help the varying classes of progression. Financially, this area of treatment will indeed have great returns for an empty market.

So now what?

Wait, wait, and wait some more.  Clinical trials are the golden standard for medical research.  Each pharmaceutical drug on the market in the US receives FDA approval only after clinical evidence (data) shows it’s effective and safe for patients. That’s a good thing! Gives me time to work on patience…again! 🙂

Clinical Trials…No!

clinicaltrialI was traveling to John Hopkins Multiple Sclerosis Center in Baltimore, Maryland, with the hope to participate in a clinical trial.  John Hopkins is know as a premiere MS Center with cutting-edge treatment and research. I felt the need to see if I just might qualify for potential trials.Afterall, I’m progressing with no other options to stop and/or repair neurological functions. What did I have to lose?

I did qualify for one trial:  A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients.  At my visit, my doctor was very confident this would be a good trial for me.  Potential to “stop brain atrophy and get rid of B-cells.”  The idea of the trial was to inject the medication (Rituximab) via the spine (intrathecal). It was the hope this method of administration would “allow the medication to cross the blood brain barrier and arrive directly in the brain.”

Of course, her list of side effect cautioned me…post spinal injection, you may feel nauseated, temporary paralysis, headache, possible spinal infection, to name a few.  This procedure would be done every two weeks for three months. MRIs would monitor activity each month.  I’m certainly not one to say yes immediately.  My doctor provided me with an 14-page informed consent to read over, sign, and ask questions if needed.  Let the research begin.

Needless to say, I couldn’t wait to discuss with hubby.  We went through the consent, researched, and made a list of questions to ask the doctor when they called:

  • What happens to the “B-Cells” when trial period is complete?  “They may come back.” “We will monitor with MRI a year later to learn more.”  “The trial will reveal if eliminating B-Cells slows down brain atrophy.” (keep in mind this happens naturally as we get older, however, faster with MS patients.)

  • Does this attack T-cells too since we know these guys cause a lot of trouble? “No.”

  • Side effects/injury, will you treat if they happen?  “Your medical team at home would manage your care.”

  • Will I be responsible for any expenses?  “Yes, what your insurance does not cover is your responsibility.”

  • PML (progressive multifocal leukoencephalopathy) is a rare and usually fatal viral disease characterized by progressive damage (-pathy) or inflammation of the white matter (leuko-) of the brain (-encephalo-) at multiple locations (multifocal).** Today, a simple blood test reveals if you carry this virus.  My questions was this: Do you test for PML?  “No.”  What!?!  A simple blood test will show if you carry PML virus.  This made absolutely no sense to me!

After a lengthy discussion and our questions addressed,  several factors made this an easy decision to make.  My answer was a firm, “No thank you.” The benefits did not outweigh the potential risks.

Clinical trials can be a wonderful option if current treatments have/are failing. Remember, it is very important to take your time, do your research, read the informed consent carefully, and ask plenty of questions.  You, as a patient, will make good educated decisions for your care as you weigh the benefits and potential risks involved!

“Count Your Blessings”

**wikipedia

Disclaimer:  This is my personal experience and decisions made. If you have any questions or concerns, please reach out to your physician to see what the best option is for you.

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3 Comments

  1. Thanks for sharing your experience. I have found that, almost always, the risks far outweigh the possible benefits. I was close to saying yes once, but it came down to the inconvenience for family members. There are so many appointments already that adding more, even in the name of research, is not practical.

    • Great comment! What’s nice with the clinical trials are the options to get meds that may help before FDA approval, but it has to be a good fit considering all of our appointments, etc. 🙂 Help is a coming for sure as we hold on for advancements giving us hope! Have a great weekend!

  2. Brenda

    🙂

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