4 ms·
And absent the FDA, first generation therapies based on stem cell transplants would have been available in the US for much of the past decade, and we'd have had
by reasonattlm 14y ago
And absent the FDA, first generation therapies based on stem cell transplants would have been available in the US for much of the past decade, and we'd have had a few years of second generation therapies devoted to small patient populations like this one.
Meanwhile, the large patient populations (e.g. heart disease) continue to have to leave the country to find stem cell therapies. The FDA makes it prohibitively expensive to develop therapies, steps on groups that try to offer stem cell treatments akin to those widely available elsewhere in the world, and thus encourages a black market:
http://www.fightaging.org/archives/2011/11/an-unusually-clear-example-of-the-cost-of-the-fda.php http://www.fightaging.org/archives/2011/11/an-unusually-clea...
http://www.fightaging.org/archives/2011/12/when-you-make-medical-progress-illegal-what-results-is-a-black-market-in-medical-progress.php http://www.fightaging.org/archives/2011/12/when-you-make-med...
http://www.fightaging.org/archives/2012/01/research-and-clinical-development-industries-in-the-us-must-start-to-extend-beyond-the-us.php http://www.fightaging.org/archives/2012/01/research-and-clin...
http://www.fightaging.org/archives/2010/08/fda-tries-to-shut-down-regenerative-sciences.php http://www.fightaging.org/archives/2010/08/fda-tries-to-shut...
Regenerative Sciences, Inc., a Colorado medical practice that specializes in the use of a person's own stem cells to help patients avoid more invasive orthopedic surgery, announced today that the US Food and Drug Administration (FDA) is seeking to enjoin the clinic physicians from practicing medicine using patients' own stem cells. The lawsuit will allow Regenerative Sciences to question the FDA's policy that adult stem cells can be classified as drugs when used as part of a medical practice. ... The FDA will finally answer our questions, in court, about their claims and jurisdiction as opposed to doing everything in their power to avoid the issue that we are not a drug manufacturer, but simply a medical practice.
- sp332 14y agoThis is mentioned in the article. So why does a company based in Dulles, VA have to go to Canada to get approval? Well, as promising the results are, they no doubt are surprising to some. In 2009 Prochymal suffered a major setback as two separate trials showed that, while the drug was safe, it failed to improve the condition of patients with graft-versus-host disease. This treatment was shown twice to be ineffective, and therefore not worth the risk of injecting yourself with an experimental batch of processed stem cells. Also, even with the failed 2009 trials, the FDA isn’t dragging its feet. Prochymal is currently being tested in trials that will assess, not only its ability to mitigate graft-versus-host disease, but Crohn’s Disease as well.