Now don’t get me wrong. If someone put a gun to my head and forced me to choose between an embryonic stem cell therapy and an adult stem cell therapy in an experimental attempt to cure a bone disease which I may suffer, I would, hands down, choose adult stem cell therapy. Adult stem cell therapy, by all probability, would be safer.But remember, I had a gun to my head. If I had a free choice, I most likely would turn, high tail it quickly toward the nearest exit, choosing neither option, unless a sound clinical trial had been performed and I had access to the results of such trial.
But back to the gun at my head….
Adult stem cell therapy is generally considered to be safer than embryonic stem cell therapy since it does not have the potential to create a teratoma, infamous for embryonic stem cell therapy gone wild, gone wrong. Teratomas are the ying of the embryonic stem cell potential, the yang being pleuropotency, the potential to form any cell in the body.
But this decreased risk using the adult stem cell does not necessarily indicate that adult stem cell therapy is safe, free of dangers. Even if the adult stem cells are harvested from one’s own body, serious problems and dangers can present if those cells are not handled safely, appropriately controlled or have undergone any chemical or genetic manipulated while in culture.
In vitro (i.e. in culture) manipulation of adult stem cells can lead to dangerous and unpredictable changes within the adult stem cell or lead to a contamination that could cause great harm to a patient, even death. Adult stem cell therapies should be regulated with GMP standards. Scientific technicians should be certified and trained to do this work. Well, at least that is what I would demand.
The other danger with using any stem cell treatment (that being adult or embryonic) is what I call “positional effects”. That is, where the stem cell is placed back in the body of the patient could negatively impact safety of the patient. Try shooting a syringe full of adult stem cell osteoblasts inside a human brain and let’s see how safe that will be. Not on me you won't.
Adult stem cell therapies can be used to potentially treat a variety of diseases in different ways in different forms. To ensure patient safety and enhance scientific discovery, much research is still needed to understand the science behind adult stem cell therapy and how, what, where and why it will be used. This requires formal clinical trials. Period.
A sudden pool of pro-adult stem cell proponents (most likely linked to the industry of “physicians gone biotech” and their ties to desperate patient advocacy groups) have entered the blogosphere recently in numerous numbers, vocally advocating with resounding stomping of feet, that adult stem cells are proven safe and should not be regulated. This is another ploy by the scientific community to mislead the public in order to avoid any type of regulation within the biological research sciences. It is getting to be absurd and truly is dangerous. It exploits the public, especially those with serious debilitating illness, leading many to sign up for dangerous unregulated clinical trials. It’s bad science.
The FDA is on the prowl and not happy about this. I don’t blame them. The FDA is not perfect. But this time they are right in their argument. Adult stem cell therapy should be regulated. It has not been proven safe.
Just because adult stem cell therapies are offered in other parts of the world doesn’t prove that they are safe or effective. Adult stem cell therapy offers a safer and better ethical alternative than embryonic stem cell therapy. But adult stem cell therapies are used in many different ways, requiring oversight to ensure patient safety and do good science.
Is there someone out there advocating for unsafe adult stem cell treatments? I don't think so. There are many U.S. doctors advocating for safe treatments using adult stem cells for all applications. These aren't rogue physicians. The FDA has declared our own stem cells drugs. What nonsense. I think I smell big pharma, not physicians gone wild. I believe a person that is faced with a terminal or chronic illness should be able to have the choice of autologous treatment available to him or her without having to leave the U.S. You my friend are obviously healthy and can wait 10 years while the FDA and big pharma figure out how to get their piece of the pie. I will gladly sign my name to this post. You can classify me as a desperate advocate if you want, but as I stated you must not have any health problems, work for big pharma or the FDA or simply have a death wish for those of us not as fortunate as you.
ReplyDeleteI wouldn't trust the FDA with my health and safety any more than I would trust Wall Street with my money. Regulation and oversight are important, but the FDA is overstepping their bounds. My stem cells are not drugs, they are natural parts of my human tissue and the FDA has no business regulating them. I have every right to use them to treat a disease or condition that affects me. It is my right to choose. That's great if you would not choose stem cell therapy as an alternative. Fine. But don't lobby to have my right to use it taken away.
ReplyDeleteHolly Hamann
By the "FDA", are you refering to the Fraud and Death Administration?
ReplyDeleteNo "FDA" Future Death Advisors. I agree with Barbara. I am a healthy man, but see her points. We are not in her position. It isn't like they are trying to use stem cells for chronic Diarrhea. It's for diseases that are more than likely deadly to the person advocating stem cell therapy in the first place. So what's it to you. You have stock in a drug company?
ReplyDeleteSo lets see... The FDA has put their stamp on oxygen- the stuff that keeps us alive. Now they are going after our own cells? What's next, our blood and skin? Will we someday all be walking around with a "Stamp" on our bodies saying, "This product IS or IS NOT approved by the Food and Drug Administration"?
ReplyDeleteAdult Stem cell treatment availability in the US, FDA regulations, ASCTA, Freakonomics and Roe V. Wade
ReplyDeleteThere 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.
http://repairstemcell.wordpress.com/2009/04/10/re-the-prior-post-about-the-patient-organization/
"The FDA is on the prowl and not happy about this. I don’t blame them. The FDA is not perfect. But this time they are right in their argument. Adult stem cell therapy should be regulated. It has not been proven safe."
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"The Food and Drug Administration was also negligent in the Vioxx case," said Grassley, who has proposed making the drug safety office more independent. "Those running the nation's public safety agency repeatedly dismissed the concerns of their own scientists and seemed to do everything possible to keep the public in the dark about emerging problems with Vioxx."
Sen. Charles E. Grassley - Washington Post
http://www.washingtonpost.com/wp-dyn/content/article/2005/08/19/AR2005081900256.html
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Documents released through the Freedom of Information Act, detail the transcript of a meeting held in June of 2000 between members of the CDC, the FDA, and representatives from the vaccine industry.
The group discusses the results of a February 2000 study that finds a significant association between exposure to thimerosal-containing vaccines, and developmental issues like autism in children.
Some of the comments--
"There are just a host of neurodevelopmental data that would suggest we've got a serious problem."
"My gut feeling? It worries me. I don't want my grandson to get a thimerosal-containing vaccine until we know better what's going on."
"We are in a bad position from the standpoint of defending any lawsuits."
"We have asked you to keep this information confidential."
And that's what happened. Three years later, the CDC published a study in the November 2003 issue of "Pediatrics" contradicting the earlier results, and clearing thimerosal of any link to neurological problems in children.
Firstcoastnews
http://www.firstcoastnews.com/news/news-article.aspx?storyid=14764
When the FDA grants approval on products marketed to consumers, the vast majority of Americans feel comfortable that the agency has performed its due diligence and the risk of injury or harm is non-existent.
ReplyDeleteSince its inception in 1906 as the Bureau of Chemistry, however, the FDA has been mired in an incestuous conflict-of-interest culture. Despite horrific reports on approved drugs harming and killing thousands of Americans, the public at large remains unaware of the agency's corrupt history.
FDA: Another Government Regulatory Disaster -- II of III
Article Continues: http://www.huffingtonpost.com/deirdre-imus/fda-another-government-re_b_130279.html
Some people enjoy saying "I told you so." I cannot under these circumstances. What you are going to read is too barbaric for me to brag that we knew it was going on all along.
ReplyDeleteBack in the early 1980s, Life Extension predicted horrific tragedies if government control over health care was not abolished. The heartbreaking fact is that tens of millions of Americans have needlessly suffered and died because of FDA incompetence. and the FDA now admits its own incompetence!
These tens of millions of lives lost are not statistics of strangers. Virtually everyone reading this column has family or friends who have been victimized by dangerous drugs or denied access to life-saving ones.
The FDA indicts itself
Atrticle Continues: http://findarticles.com/p/articles/mi_6839/is_2008_July/ai_n30938530/
The Safe Stem Cells NOW movement was started by the American Stem Cell Therapy Association (ASCTA). The goal is to let patients know that their ability to access safe stem cell treatment is being heavily restricted by the big pharmaceutical giants and the FDA. This patient driven movement is dedicated to empowering our U.S. physicians to safely use stem cells in daily treatment. The ASCTA is currently putting forth guidelines for the safe use of your stem cells in doctor run, state of the art labs.
ReplyDeletePatient Site: www.safestemcells.orgPhysician Site: www.stemcelldocs.org-