Repeal and Replace

…the Food and Drug Administration.  I’ve written before about the FDA’s shameful obstruction of an experimental drug that showed great promise—before the FDA’s obstruction, so those persons knew all about it—in mitigating Duchenne Muscular Dystrophy to the permanent detriment of the boys who have that ultimately fatal disease.

Here’s another shameful example of the FDA’s lethal obstruction, provided by Marc Thiessen in an end of the year piece for The Washington Post.  Amyotrophic lateral sclerosis, Lou Gehrig’s disease, is another fatal disease of the nervous system, this time one that destroys motor neurons in the spine so that muscles atrophy, including ultimately those that power the lungs, and the victim dies.  ALS is 100% fatal—or was until an experimental procedure was developed by the folks at the Center for ALS at the Emory University School of Medicine.  The procedure those folks developed involved injecting neural stem cells directly into the spinal regions where masses of the motor neurons affected by ALS are located.

Thiessen’s friend, afflicted with ALS, was fortunate to be able to have access to this procedure—which was so early in its development that the friend’s participation was in a trial stage whose purpose was nothing more than to show that the procedure was safe; it wouldn’t kill the receiving patients.  The procedure didn’t kill Thiessen’s friend.  Maybe it cured him (he died of brain cancer six years after his diagnosis of ALS, a post-treatment life span too short to say “cured” but plainly long enough to say “positive effect in putting the ALS into remission.”

That remission was the watchword is demonstrated by the fact that the man went from being unable even to walk to his mailbox for his mail to being able to walk Atlanta’s two-and-a-half-mile Walk to Defeat ALS four years in a row, and to do each with no problem.

Slam dunk for the procedure to go to final stage testing and production, right?

No.  Not with our FDA.  Thirty-two ALS victims have been allowed by the FDA to try the procedure in a time span during which 24,000 Americans have died of this disease.  Because the FDA demands proof of effectiveness through a Byzantine “testing and trial” sequence of experiments that only bureaucrats could find useful before it will approve a drug or a medical procedure.

It’s time to disband the Food and Drug Administration altogether and replace it in toto with an agency that will oversee such things, but that will approve on a showing of “does no harm.”  The efficacy of a drug or procedure belongs solely in the free market, with the doctor and patient making the use decisions.  This is not an area for Government, or Government’s bureaucrats, to interfere.

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