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The Cruelty of Anti-Patient FDA Rules

Are you or a loved one interested in receiving stem cell treatment? For free information, please fill out our treatment form or email me don@repairstemcells.org and just put TREATMENT in the subject box and the MEDICAL CONDITION in the message.

Right now there are millions of individuals whose lives are directly dependent on the rate at which new drugs come to market. I'm one of them. I'm fighting for my life.

To date, half of my intestine has been removed to manage Crohn's disease. Last year, at age 23, I enrolled in a clinical trial for a treatment that could save my life: an adult stem-cell therapy that helps damaged intestinal tissue regenerate from the relentless inflammation and scarring caused by Crohn's.

The sponsor, Osiris Therapeutics, reported that Crohn's patients in the therapy's Phase II trial all experienced clinical improvement after receiving the cells. A Phase III trial for the treatment is now nearing completion, but Food and Drug Administration (FDA) approval could be years away, despite its FDA "fast track" designation.

In accordance with antiquated FDA policies, the Phase III trial is randomized with three groups of patients, and double-blinded, which means neither the doctors nor patients are told what treatment is being administered. One group received full-strength stem cells, another received half-strength, and a third got a placebo (the proverbial "sugar pill"). It appears I got the placebo.

Foregoing all other treatments, I received the four scheduled infusions, and yet my disease progressed with a vengeance. In a matter of weeks, I became dangerously malnourished. I've since been readmitted to the hospital countless times, as my doctors continue to plead with Osiris for information. But Osiris has refused, citing adherence to FDA protocol.

I am now a lab rat. I have no right to know what happened to me in the study, nor do I have a right to try the promising treatment as my health deteriorates. It doesn't have to be this way.

To which I RESPOND:

Sorry, young man, we are all lab rats for the billionaires who profit from this “pills only” medical system.  There isn’t a clinical trial for any drug approved THIS CENTURY that is honest.  They just make up the data, get approval from the FDA, which they own, and wait for the deaths of us lab rats to decide whether or not stopping the deaths is worth losing their profits.  At one time 25 or so years ago, big corporations worried about lawsuits, but since they now control what used to be a legal system, lawsuits are not a problem—they own that system too. 

Don’t believe it?  Five years after the Vioxx criminally fraudulent clinical trials killed over 50,000, guess how many widows actually got a lawsuit filed?  Sorry, wrong number.  It was 18.  Simple.  Just change the rules with a congress you own and all the giants have to do is delay, delay, delay.  Of course the fully controlled Supreme Court hasn’t ruled against a big corporation THIS CENTURY.

So, dear Vioxx widow, your choice is simple—settle for the $10,000 we value your late husband’s life at, or your grandchildren will accept the $5000 we offer them in 2034.


Posted: 4/13/2010 11:49:29 AM by Don Margolis | with 0 comments
Filed under: Crohn's, Intestinal, Research, Stem Cells, Therapy, Treatment

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