The Slow Advance of Stem Cell Therapies

In countries like the US, the bulk of the cost in time and resources of producing therapies from scientific advances lies in satisfying regulatory bodies - a useless cost, a waste, in other words. Money that could have gone to making a better, safer product is instead squandered on hoop jumping. In the US, the Food and Drug Administration is draconian now and becoming worse with each passing year. All the incentives for political appointees and government employees at the FDA are aligned towards blocking new therapies rather than allowing them through. They will not be much blamed for an absence of new approvals - the unseen cost of regulation is not what is, but what might have been - yet will be greatly blamed for any new approval of a therapy that proves even slightly more risky than estimated. So the bar for new therapies is raised and raised, a little at a time.

Stem cell therapies are a good example of a working class of medicine that is essentially forbidden in the US. Stem cell treatments presently illegal to provide in the US have been available elsewhere in the world for some years now, offered by responsible providers who have worked to bring the best they can offer to customers. Regulation of medicine serves no purpose other than to prohibit what might be available; it is control for control's sake. But of course, you'll rarely read about therapies available elsewhere in the world in the US press - or at least not in the context of what is also presently forbidden by the FDA. Here is an example of a general interest article on the progression of stem cell therapies:

If you've just had your first heart attack, doctors may one day be able to reverse the damage done with stem cell therapy. An intravenous method of injecting stem cells into patients who had experienced heart attacks within the previous 10 days suggested that this method works to repair - not just manage - heart damage, a recent study found. The study is a step forward in a field in which a lot of approaches have been tried in animals and preliminary human trials, but none has been approved for widespread clinical use for heart patients.

...

The research, published in the Journal of the American College of Cardiology, were part of a phase I study that set out to show safety. The trial has moved on to phase II, which is taking place in 50 hospitals in the United States, said Dr. Joshua Hare, director of the Interdisciplinary Stem Cell Institute at the University of Miami's Miller School of Medicine and lead author of the study. "We're looking on the time frame here of five years, in the best-case scenario, to have approved cardiac stem cell therapies," Hare said.

Five years ago, the first tentative therapies of this nature were already taking place in Asia. Theravitae, based in Israel, Canada, and Asia, has treated hundreds with its similar Vescell technology over the past few years. There is no good reason why these technologies are illegal to provide in the US - only prohibition for its own sake. And this is one very small slice of the larger picture; a hundred advanced medical technologies delayed and not developed in the US because of the FDA.

Present circumstances and trends strongly suggest that medicine in far countries will be consistently more advanced than that available in the US in the decades to come. Plan on medical tourism for your future.

Comments

I understand over regulation can be harmful for future progress because the FDA is biased for political reasons.

I do not understand the tone of the article. Where are the hard facts to back up the claims? I don't mean this pejoratively. I follow this blog off and on for years now.

If you are just venting, that I do understand.

Posted by: Matthew at December 18th, 2009 6:12 PM

I agree with Matthew. This sentence in particular stands out as being obviously false:

"Regulation of medicine serves no purpose other than to prohibit what might be available; it is control for control's sake."

It's quite obvious that this control exists to protect people from snake oil treatments and other unscrupulous chicanery. That should be especially obvious to someone interested in fighting ageing, since the promise of longer life is still used to sell ineffective or outright bogus supplements and doubtless all kinds of other junk.

Is the regulatory system in the US, broken? Maybe so, but I think it's of limited relevance to the content of this post and this blog generally. Doubly so for readers outside of the US.

Posted by: Ben at December 18th, 2009 7:13 PM

I think FDA regulation will become superfluous in the near future. It is not only medical tourism that will make U.S. availability of such therapies irrelevant, but the fact that if they do become available in the U.S., they would be way more expensive than in other countries.

If the U.S. government attempts to make it illegal for Americans to travel internationally for medical treatment, that will be the time that we need to destroy our government and replace it with something more reasonable.

Posted by: kurt9 at December 18th, 2009 10:59 PM

Oh yes I'm sure the money saved would have gone into making the drugs safer, like it does in all unregulated markets...

Honestly, do you not remember the world of buyer beware...

Posted by: David at December 19th, 2009 12:36 AM

David,

Why would you trust a government regulatory agency that refuses to consider the aging process a treatable condition with safe guarding your health? I would think that such an agency would be a threat to my long-term health and well-being, not any form of protection at all.

I think its just insane to trust any "deathist" or "deathist"-run organizations with your long-term future.

Posted by: kurt9 at December 19th, 2009 3:56 PM

As a stem cell scientist in Australia, I can guarantee that stem cell therapy is a long way off. Stem cells are actually very dangerous. Would you trust any drugs approved by an FDA that approves cells that can give you cancer? It is important to have a regulatory body.
Overseas treatments are not scientifically proven. This far, there has onl been one clinical trial involving embryonic stem cells. "Clinics" in Russia and Bangladesh have not published any of their work to any peer-reviewed journals. All patients have to go on are testimonials on fancy websites. If the therapy is as good as they say, then it should be published straight away. Then it can be approved. A lack of peer reviewed material means that these clinics are only guessing that the stem cell treatments they deliver will have any beneficial effect whatsoever, and hoping that they do not harm people.
Considering the worst consequences of stem cell treatment, it is worth waiting until the FDA approves such practices.

Posted by: Nick at January 28th, 2010 7:18 PM

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