Stem cell treatment availability in the US, FDA regulations, ASCTA, Freakonomics and Roe V. Wade

You Can't Get There From Here

Adult Stem Cell Treatment Availability in the US

There are precious few adult stem cells treatments available in the US, consisting mostly of a few small clinical trials and the transplants used over the past 40 years for leukemia and other cancer patients. But these transplants are bone marrow transplants and not treatments for the 130+ disease that ARE currently being treated with a great deal of success around the world.

The stem cells being used to treat MS etc at Duke and Northwestern if I remember correctly are studies and trials and the unfortunate reality is that actual commercially available stem cell treatments for diseases will not be available in the US for a decade or so. We lose 1.5 million Americans per year to the top 4 diseases (Cancer, Diabetes, Cardio Vascualar and our own health care system – in no particular order) and that is more than a shame; it is a travesty.

Are FDA regulations a NECESSARY EVIL?

If you argue that these deaths are a necessary evil required to follow the cautious path of proper procedures and clinical trials in order to protect future patients than I will respect your position but I can’t possibly agree with you. I can’t help but think that there must be another way. I am not an expert on medical legality but perhaps there are techniques we may employ to speed the process by which people in the US may be treated sooner.  We can begin by labeling these treatments as experimental… getting detailed yet clear waivers signed by the patient…ensuring that the patients have been educated about all of the available statistical data…and…and… maybe you can add more to this list; I would love to hear your suggestion.

One way or another, they are going to do it...whether safe practice is available here or not

Disclaimer: This next paragraph is a purely socio-economic illustrative device. I have no interest in engaging in ethical or religious discussions.

With the lack of availability of stem cell treatments in the US for disease, I am reminded of the religious inspired attempt to curtail teen-sex by removing condoms from availability and by teaching abstinence. We all know how well that worked. The instinct to perpetuate the species and the associated hormone release during teen years are virtually impossible to supplant with logically instruction. Pre-marital teens still ended up engaging in sexual activity; they just had a more difficult time getting condoms to protect themselves from STD’s and avoid pregnancy.

Likewise, people will get adult stem cell treatment regardless of how strict our regulations are or how long it takes them to be available in the US.  They will get them here if they can through local safe practice treatment centers or they will make the trip outside of the US if it is not available…there is no stopping it. Like the perpetuation of the species, our instincts for survival are a huge motivating force.  Don’t we owe it to our population to provide this service with the highest possible standards in the US now so they don’t have to travel outside our country? Shouldn’t we revise the FDA standards so our dying million don’t have to wait 10 years in vain to receive adult stem cell treatments that have over a half decade of success with minimal if any side effects outside of the US?

Time for a fresh set of eyes on FDA regulation of adult stem cell therapies

There is a growing number of voices in the US who have expressed their desire to replace the FDA’s outmoded drug specific regulations that is in itself self-serving and has a long history of failures (from Vioxx to the recent pulling of the drug psoriasis drug Raptiva which resulted in serious brain infection and death of 3 out of 4 patients who contracted it from the FDA approved drug).

The growing number of “ADULT STEM CELL THERAPIES NOW!” activists are calling for a comprehensive tissue and procedural specific set of protocols and guidelines that directly address the unique qualities of adult stem cell treatments.  No one (of the conscientious and positively motivated doctors & scientists I am referring to) is advocating a carte blanche and wild west approach to stem cells.  No one feels that there should be indiscriminate availability of adult stem cells issued from unregulated street corner vendors.  What is being called for is merely a fresh pair of eyes to look at these new treatments developing from a new science.

Stem cells are indeed an incredibly powerful tool with a huge potential for benefit to the ill and suffering. Can’t we come up with something besides sending 1.5 million per year home to die? It is a fine line, no doubt and the road to hell is paved with the best of intentions.  What one can take advantage of to help countless patients, another can utilize to take advantage of them.

Alexander the Great Cuts the Gordian Knot

This is the Gordian Knot at the center of the problem and as with any incredibly powerful tool, device, treatment it can be used for good or for evil.  A forum poster named Eric S. (on the Carecure forum) so excellently and succinctly stated: “Is there no happy medium which ensures safety but at the same time doesn’t slow progress (, the availability of treatments) and balloon the cost of producing therapies?”  Let us combine our ideas and efforts and together uncover the Alexandrian solution (legend has it that Alexander the Great sliced through the Gordian Knot with his sword).

The point is, I agree that there must be a standardized set of guidelines and protocol that must be established, maintained and overseen and many doctors and scientists feel this way as well.  I recently became introduced to Dr Centeno of the American Stem Cell Therapy Association (ASCTA) – http://www.stemcelldocs.org/Home_Page.html – and  this is EXACTLY what those scientists are advocating.

“The ASCTA is a physician run organization dedicated to establishing best practice lab and clinical guidelines for adult stem cell use.  The ASCTA considers the clinical use of the patient’s own adult stem cells which have been minimally culture expanded to be the practice of medicine.”

There is also an associated patient driven “Safe Stem Cells Now movement” which is a mirror and off shoot of the ASCTA – http://www.safestemcells.org/Home_Page.html

“This patient driven movement is dedicated to empowering our U.S. physicians to safely use stem cells in daily treatment…The goal to is let patients know that their ability to access safe stem cell treatment is being heavily restricted by the big pharmaceutical giants and the FDA.”

As the world around us changes, so too must we. The regulations and laws of yesterday do not apply to the situations and cases of tomorrow. In many cases, the regulations and laws of yesterday even become detrimental to the goals of society. This is why we are constantly reinventing them. That is what is happening now.  That is all that is being recommended here.

What kind of impact did Roe v. Wade have on violent crime?

Levitt and Dubner (Freakonomics) made a very interesting observation about declining crime in the 90’s, attributing it to Roe V. Wade in 1973. After the constitutional right of abortion became enforced in the Supreme court, many more mothers received abortions and many more “unwanted” children were not brought into this world. His contention was that 18 years later, there was a huge reduction of “unwanted” children and these children were more likely to be brought up in broken homes with less education, positive role models, etc.  The significant reduction of the demographic consisting of “persons with a higher potential of a criminal future” resulted in an associated significant reduction of crime at the time when those children would be reaching their “criminal prime” and young adulthood.

Hind sight is a very powerful device.  I wonder what would happen if we trained Levitt and Dubner’s expert eyes on the sociological phenomena surrounding US and world adult stem cell treatment availability.  What would he see 18 years from now when looking at the state of stem cell treatments around the world? What will the availability of stem cell treatments (or lack there of) produce in societies around the world? What will the lack of availability in the US create?

How will mortality and morbundity rates be affected? Will the US be the only country in the world that is not starving itself to death and facing  severe water shortages because all of our sick will have quickly succumbed to their diseases while the rest of the world will face a huge crisis of overpopulation due to their stem cell granted life extensions of 5, 10, 20 years? Will unyielding FDA restrictions force us to walk the path of the lemmings?

Who knows. We can only wait and see.

Will we be forced to follow the path of the lemmings?