ALS Advocacy

ALS Advocacy
Lou Gehrig's Disease - Motor Neuron Disease - Amyotrophic Lateral Sclerosis
Thought it had been cured by now? Still no known cause. Still no cure. Still quickly fatal. Still outrageous.

Thursday, March 13, 2014

Is This Not A Draconian Charade?

During a recent webinar on clinical trial enrollment, the daughter of a man with ALS explained how some stem-cell trials they considered were actually doing a placebo surgery.  All patients accepted in the trial will undergo major surgery to access their spines and brains.  Some will get stem cells. Some will get fake placebo stuff.  Let's sew them up and see how they do, eh, doc?

I was amazed that a surgeon who took the oath about "first do no harm" would even consider this.

I was amazed that volunteers would be subjected to such a cruel risk, especially in a clinical trial system that is so risk-averse about so much.

Let the conversations begin.  Is this the best we can do to evaluate safety and efficacy?

http://www.clinicaltrials.gov/ct2/show/NCT02017912?term=brainstorm&rank=3

People with ALS deserve better than risky fake surgeries and scars that are painful in many ways.


4 comments:

  1. It's BS. Cancer trials are run much differently. Look up the I-SPY cancer trials. There is no placebo. Different treatments are tested of different participants, instead of having a placebo control group. Patients are swapped out of a treatment that is clearly not working and switched onto a new treatment. It is amazing. And should be done in every trial.

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  2. Not true. Brainstorm's procedure does not entail surgery, only intramuscular and intrathecal injection. Get your facts straight.

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  3. Point well taken. Not a surgery with staples. Still seems like a major procedure to me and Draconian to insert placebo this way. Thanks for comment.

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  4. While I wish them godspeed and success, the real question to be asked is how Neuralstem will treat patients as it seems almost certain that repeat procedures will be necessary. Surely, the average ALS patient cannot endure this.

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