ESSAY - The FDA is killing Crohn's patients

[Guest guest]

The Wall Street Journal

30 Dec 2008

By GIDEON J. SOFER

The FDA Is Killing Crohn's Patients

Science didn't require that I get a placebo.Article

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.

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Read the full article here:

http://online.wsj.com/article/SB123059825583441193.html?mod=sphere_ts & mod=sphere\

_wd

Not an MD