FDA Not Satisfied with Just 25 Percent of the U.S. Economy

Ronald Bailey|Aug. 8, 2012 11:08 am

The agency now aims to regulate your body's cells. Some researchers and physicians have been taking adult stem cells from individual patients and reinjecting them to treat various medical conditions. While certainly not the standard of care yet for treating many ailments, progress is being made. For example, European surgeons have grown and transplanted tracheas using stem cells taken from individual patients. One stunning success is the case of Ciaran Finn-Lynch who received a transplant of a  trachea grown using his own stem cells. That operation did not take place in the U.S.

Now the Food and Drug Administration has won a federal court case that allows the agency to regulate adult stem cell treatments as though they are pharmaceuticals. This will do for stem cell research what FDA regulation has done for drugs - slow progress and make treatments much more expensive. As former FDA deputy commissioner and physician Scott Gottlieb and attorney Colleen Klasmaier explain in their Wall Street Journal  op/ed [sub required] today:

At issue are cells taken from our own bodies and then re-implanted with the purpose of treating medical problems. The most inspiring work involves adult stem cells, although the court's ruling in principle extends FDA oversight into things as common as in-vitro fertilization—basically turning reproductive cells into "drugs" under the law.

The adult stem cells can differentiate into many kinds of finished tissues. This enables doctors to use these cells to renew damaged body parts. This science of regenerative medicine has promise across many fields of medicine, from cardiology to brain diseases to orthopedics...

How, for instance, would you run a large-scale, randomized trial and ensure consistency from one use of a drug to another, where the "drug" is really a medical procedure that must vary from one patient to the next because it involves their own unique cells? The FDA requirements, designed for products manufactured and sold on a mass scale, can't be readily satisfied when it comes to treatments that are personalized to individual patients.

When the FDA seeks to hold physician procedures to the same rules as pharmaceutical manufacturers, invariably the doctors have no choice but to bow to regulatory pressure, stalling progress. Regenerative Sciences, the defendant in the case, has moved some of its labs to the Cayman Islands. Most of the science of using adult stem cells for regenerative medicine is unfolding in Britain, Singapore and Israel precisely because of the FDA's bent to hold with misgiving anything novel in medicine...

...it can be deadly when it comes to the agency's impulse to regulate, and thus forestall, cell therapies used to help repair damaged body parts.

As I have pointed out before, speeding new treatments to patients saves lives, delays kill:

A 2005 National Bureau of Economic Research study found that, on balance, the faster FDA drug approvals made possible by new funding legislation passed in the 1990s saved far more lives than they endangered. In fact, new drugs saved up to 310,000 life-years compared to 55,000 life-years possibly lost to the side effects of drugs that were eventually withdrawn from the market.

Both Gottlieb and Klasmaier disclose that they work with companies that are developing cell-based therapies. For more background on FDA overregulation and overcaution, see my columns, "Timid Bureaucrats Kill People," and "Building a 21st Century FDA."

 

http://reason.com/blog/2012/08/08/fda-not-satisfied-with-just-25-pe...

 

Science Correspondent Ronald Bailey is the author of Liberation Biology (Prometheus).

Views: 72

Comment

You need to be a member of 12160 Social Network to add comments!

Join 12160 Social Network

"Destroying the New World Order"

TOP CONTENT THIS WEEK

THANK YOU FOR SUPPORTING THE SITE!

mobile page

12160.info/m

12160 Administrators

 

Latest Activity

Doc Vega posted blog posts
yesterday
Doc Vega commented on Doc Vega's blog post Plausible Explanation Behind Recent Cryptid Sightings in the Wild!
"cheeki kea I was wrong Emperor Penguins are big and powerful but still alive but this,  A size…"
yesterday
Doc Vega commented on Doc Vega's blog post Plausible Explanation Behind Recent Cryptid Sightings in the Wild!
"Cheeki kea here's another that they say there have been modern sightings of!  The name of…"
yesterday
Doc Vega commented on Doc Vega's blog post Plausible Explanation Behind Recent Cryptid Sightings in the Wild!
"cheeki kea, did you ever hear of the giant Imperial Penguins? They were about 6 feet tall and could…"
yesterday
Doc Vega commented on Doc Vega's blog post Plausible Explanation Behind Recent Cryptid Sightings in the Wild!
"cheeki kea I do not think these giant two legged birds would need to have a bad attitude as long as…"
yesterday
Olivia Brooks updated their profile
yesterday
John Miller was featured
yesterday
tjdavis's 2 blog posts were featured
yesterday
Zfort Group's blog post was featured
yesterday
Doc Vega's 6 blog posts were featured
yesterday
Burbia commented on tjdavis's video
Thumbnail

“What’s His Motive?” - Inside The Mind of George Soros

"Trump calls for George Soros and son to face federal…"
Tuesday
Burbia commented on tjdavis's photo
Tuesday
Profile IconSeeta Sathe and Olivia Brooks joined 12160 Social Network
Tuesday
tjdavis posted a video

Mossad, Terrifying CIA Technology, Blackwater & The Most Secret CIA Unit | John Kiriakou

John Kiriakou served 15 years in the CIA as a Case Officer (Spy) and as CIA's Head of Counterterrorism Operations in Pakistan where he lead the raid that cap...
Monday
tjdavis posted a photo
Monday
tjdavis posted a video

A Critique of the Tavistock Institute - The Mother Of All Conspiracy Theories

An examination of the Tavistock Institute, a theory which seeks to explain how Western societies have been brainwashed by a cabal of social scientists and th...
Sunday
tjdavis posted a video

“What’s His Motive?” - Inside The Mind of George Soros

In this short clip, Patrick Bet-David, Sebastian Gorka Adam Sosnick, and Tom Ellsworth George Soros and what motivates him to do the things he does. FaceTime...
Aug 27
Doc Vega posted blog posts
Aug 27
cheeki kea favorited Bob of the Family Renner's photo
Aug 26
cheeki kea commented on Doc Vega's blog post Plausible Explanation Behind Recent Cryptid Sightings in the Wild!
"If you're ever out there Doc V and notice giant two legged birds roaming the wilderness be…"
Aug 26

© 2025   Created by truth.   Powered by

Badges  |  Report an Issue  |  Terms of Service

content and site copyright 12160.info 2007-2019 - all rights reserved. unless otherwise noted