Ask the Expert with Michael Freeman PhD MPH DC
Forensic Epidemiologist
Q: As a forensic scientist, how does one go about investigating deaths that have occurred during or after stem cell therapy?
A: The standard for an opinion in a forensic setting (like a court case) is "what is more probable than not" which means that the suspected cause (in this case the stem cell treatment) accounts for more than 50% of the explanation for the death, and if you removed the suspected cause that the death wouldn't have happened, at least not at the time that it did (everyone dies eventually). So the death can be due to some direct action of the stem cells - like they clumped together and formed a clot in the lungs, or due to the treatment that is intended to harvest or deliver the stem cells (infection, etc) or it was a coincidence to the treatment. One of the important things to keep in mind, particularly with some of the offshore facilities, is that they attract very sick patients, and very sick patients often die regardless of treatment.
Q: I am still trying to get someone to tell me how stem cell treatments might be helpful for a decline in diffusion associated with emphysema. Would you be able to give me an answer?
A: No, this is the kind of question that would have to be addressed by someone who is doing research in the area. My field of stem cell therapy research is in treatment for orthopedic conditions, largely.
Q: It seems like the FDA is not wanting the U.S. to move forward in the area of actual stem cell treatments for patients. There is lots of research going on, but most of it seems to be with rodents. Millions of people with chronic and terminal diseases could benefit from having treatment with their own stem cells. Why isn't more being done to pressure the FDA into easing the regulations they are trying to impose on clinics that dare to try to help people such as Regenexx?
A: The FDA is tasked with safeguarding public safety with regard to mass-production of medical therapeutics - this works well for manufacture of a drug at a central location, as the actions of the FDA inspectors can protect many people. Stem cell therapy is a one to one procedure, like having a crown made for a tooth, or a drug combination made for an individual at a formulating pharmacy. The physician who performs the procedure is responsible for the appropriate use and handling of the patient's stem cells, and never uses them on any other patient. The FDA cannot practically oversee individual procedures, and this is why physicians are subject to state laws regarding minimum competency, education, residencies, and licensure; so that they can be trusted to know what they are doing without having someone looking over their shoulder all of the time. Regardless, the FDA has taken the bizarre and unjustifiable position that if a patient's stem cells are removed from their body and put back in another part of the body that this constitutes the manufacture of a drug. If this was true then in vitro fertilization and dozens of other procedures would immediately come under the regulation of the FDA. This has not happened, however, and this contradictory position of the FDA pertaining only to adult autologous stem cells will become apparent with time. I can't tell you exactly why the FDA has taken the position they have with regard to stem cells, but I can tell you that the issue is getting a lot of attention right now, and some changes or clarification are likely coming in the near future.
Q: Where can I find information on the theoretical effectiveness of stem cells on adults? I am very interested in reading about current theories on stem cells for adults with cerebral palsy. Everything seems to be about children that I can find.
A: The internet is an amazing source of information and misinformation on stem cells, and it is likely the first place to start looking. Go to Google Scholar and then Pubmed and just play around with the search terms. With something as new as stem cell therapy for neurologic problems this is a good place to get a feel for what is being done, what is coming, what is controversial, and what may or may not work in the future. At the present time, the stem cell consumer has to be better informed than the average patient seeking care - there are sincere, smart, ethical and knowledgeable docs providing care, and there are opportunists looking to make a buck. The ICMS has done its best to help educate patients on what is out there, but ultimately everyone has to look at for their own health and welfare.
Q: If stem cell treatments are someday going to be routine for treating disease and even anti-aging, what role do you see Big Pharma taking? I can't imagine them wanting us all to get well and stay well using our own stem cells.
A: Good question. I don't think there is any doubt that autologous stem cells will be routinely used for many degenerative conditions that we don't treat very successfully currently. "Big Pharma" is like a shark in that it has to keep moving forward or it will die. This means continued development of products that will sell well. At its best, the pharmaceutical industry is saving lives with new drugs that it is supplying reasonably to those in need; at its worst, the public gets sold expensive new drugs that are marginally or not at all better than what they replace, with hidden or yet to be known side effects that kill. I think that examples of both can be found, but for the most part the actions of Big Pharma fall between the two extremes. I think that the best place in the future for the pharmacy industry will be in supplying supportive products for the clinical practice of stem cell therapy, but that the cells themselves will always come from the patient, and be free for the patient to use as he or she sees fit. This concept will likely get some resistance from Big Pharma, but eventually they will get it (hopefully).
Q: What amount of cost savings might be involved if cures for diseases are available someday using stem cell therapy? How many years down the road could this be a reality?
A: I can tell you that a recent analysis that I performed, looking at just knee replacement costs and mortality in the Medicare community, indicated that a gradual replacement of up to 25% of knee replacement surgeries over a 5 year period would save around 8,000 lives and more than US$10 billion. Quite frankly, if stem cell therapy lives up to its potential, the cost savings alone could potentially save the Medicare program and bring the US Healthcare system from the brink of financial disaster to an indefinitely sustainable sector of the economy. The biggest losers would be the corporations that make the drugs and devices that would become largely obsolete.
Q: Why is so much research duplicated? It seems that scientists should try to get it together instead of each one doing a repeat of something that has already been done. It seems like such a waste of time and money.
A: Unfortunately, there is good incentive in the academic research community to study and only possibly solve small problems a little at a time. Researchers are dependent upon grants, and grants are awarded based on what other researchers think of research proposals. Studies that promote huge leaps are often not funded because this just isn't the way that it's done oftentimes. On the other hand, just about every week a new study is published that describes really innovative and clever research. So there is progress, but it's not always as fast as it could be or should be.
Q: Do you think that stem cell treatments will become so routine that eventually a person can have one done at their doctor's office?
A:Without reservation I would say 100% yes.
Q: Why is it that some hospitals can give stem cell treatments and a handful of clinics as well in the U.S., but for the most part the FDA seems to have scared a lot of doctors/clinics from even trying to do treatments? It makes no sense to me seeing that I can legally get things like a blood transfusion.
A: Doctors and hospitals and clinics should be scared of the FDA - they are empowered to make allegations that can keep you in court for 10 years defending yourself, and bankrupt you with the legal fees, with no financial recourse even if you win. The folks who are willing to stand up to such a powerful opponent are relatively few and far between.
Q: What is the favorite part of your job? You seem to have a lot of things going on.
A: I would have to say it is the wonderful variety of what I get to do. I investigate death and injury in forensic settings most of the time, I teach students and residents at the medical school some of the other time, and I get to participate in fascinating research like the stem cell studies that I have been involved with in the rest of the time. I feel fortunate that I never have to complain of boredom.
Thanks for the great questions!
About Michael Freeman
Michael D Freeman PhD MPH DC
Forensic Epidemiologist
Mailing address:
1234 SW 18th Ave, Suite 102
Portland, OR 97205
T 971-255-1008, F 971-255-1046
C 503-871-0715
forensictrauma@gmail.com
Forensic Epidemiologist
Q: As a forensic scientist, how does one go about investigating deaths that have occurred during or after stem cell therapy?
A: The standard for an opinion in a forensic setting (like a court case) is "what is more probable than not" which means that the suspected cause (in this case the stem cell treatment) accounts for more than 50% of the explanation for the death, and if you removed the suspected cause that the death wouldn't have happened, at least not at the time that it did (everyone dies eventually). So the death can be due to some direct action of the stem cells - like they clumped together and formed a clot in the lungs, or due to the treatment that is intended to harvest or deliver the stem cells (infection, etc) or it was a coincidence to the treatment. One of the important things to keep in mind, particularly with some of the offshore facilities, is that they attract very sick patients, and very sick patients often die regardless of treatment.
Q: I am still trying to get someone to tell me how stem cell treatments might be helpful for a decline in diffusion associated with emphysema. Would you be able to give me an answer?
A: No, this is the kind of question that would have to be addressed by someone who is doing research in the area. My field of stem cell therapy research is in treatment for orthopedic conditions, largely.
Q: It seems like the FDA is not wanting the U.S. to move forward in the area of actual stem cell treatments for patients. There is lots of research going on, but most of it seems to be with rodents. Millions of people with chronic and terminal diseases could benefit from having treatment with their own stem cells. Why isn't more being done to pressure the FDA into easing the regulations they are trying to impose on clinics that dare to try to help people such as Regenexx?
A: The FDA is tasked with safeguarding public safety with regard to mass-production of medical therapeutics - this works well for manufacture of a drug at a central location, as the actions of the FDA inspectors can protect many people. Stem cell therapy is a one to one procedure, like having a crown made for a tooth, or a drug combination made for an individual at a formulating pharmacy. The physician who performs the procedure is responsible for the appropriate use and handling of the patient's stem cells, and never uses them on any other patient. The FDA cannot practically oversee individual procedures, and this is why physicians are subject to state laws regarding minimum competency, education, residencies, and licensure; so that they can be trusted to know what they are doing without having someone looking over their shoulder all of the time. Regardless, the FDA has taken the bizarre and unjustifiable position that if a patient's stem cells are removed from their body and put back in another part of the body that this constitutes the manufacture of a drug. If this was true then in vitro fertilization and dozens of other procedures would immediately come under the regulation of the FDA. This has not happened, however, and this contradictory position of the FDA pertaining only to adult autologous stem cells will become apparent with time. I can't tell you exactly why the FDA has taken the position they have with regard to stem cells, but I can tell you that the issue is getting a lot of attention right now, and some changes or clarification are likely coming in the near future.
Q: Where can I find information on the theoretical effectiveness of stem cells on adults? I am very interested in reading about current theories on stem cells for adults with cerebral palsy. Everything seems to be about children that I can find.
A: The internet is an amazing source of information and misinformation on stem cells, and it is likely the first place to start looking. Go to Google Scholar and then Pubmed and just play around with the search terms. With something as new as stem cell therapy for neurologic problems this is a good place to get a feel for what is being done, what is coming, what is controversial, and what may or may not work in the future. At the present time, the stem cell consumer has to be better informed than the average patient seeking care - there are sincere, smart, ethical and knowledgeable docs providing care, and there are opportunists looking to make a buck. The ICMS has done its best to help educate patients on what is out there, but ultimately everyone has to look at for their own health and welfare.
Q: If stem cell treatments are someday going to be routine for treating disease and even anti-aging, what role do you see Big Pharma taking? I can't imagine them wanting us all to get well and stay well using our own stem cells.
A: Good question. I don't think there is any doubt that autologous stem cells will be routinely used for many degenerative conditions that we don't treat very successfully currently. "Big Pharma" is like a shark in that it has to keep moving forward or it will die. This means continued development of products that will sell well. At its best, the pharmaceutical industry is saving lives with new drugs that it is supplying reasonably to those in need; at its worst, the public gets sold expensive new drugs that are marginally or not at all better than what they replace, with hidden or yet to be known side effects that kill. I think that examples of both can be found, but for the most part the actions of Big Pharma fall between the two extremes. I think that the best place in the future for the pharmacy industry will be in supplying supportive products for the clinical practice of stem cell therapy, but that the cells themselves will always come from the patient, and be free for the patient to use as he or she sees fit. This concept will likely get some resistance from Big Pharma, but eventually they will get it (hopefully).
Q: What amount of cost savings might be involved if cures for diseases are available someday using stem cell therapy? How many years down the road could this be a reality?
A: I can tell you that a recent analysis that I performed, looking at just knee replacement costs and mortality in the Medicare community, indicated that a gradual replacement of up to 25% of knee replacement surgeries over a 5 year period would save around 8,000 lives and more than US$10 billion. Quite frankly, if stem cell therapy lives up to its potential, the cost savings alone could potentially save the Medicare program and bring the US Healthcare system from the brink of financial disaster to an indefinitely sustainable sector of the economy. The biggest losers would be the corporations that make the drugs and devices that would become largely obsolete.
Q: Why is so much research duplicated? It seems that scientists should try to get it together instead of each one doing a repeat of something that has already been done. It seems like such a waste of time and money.
A: Unfortunately, there is good incentive in the academic research community to study and only possibly solve small problems a little at a time. Researchers are dependent upon grants, and grants are awarded based on what other researchers think of research proposals. Studies that promote huge leaps are often not funded because this just isn't the way that it's done oftentimes. On the other hand, just about every week a new study is published that describes really innovative and clever research. So there is progress, but it's not always as fast as it could be or should be.
Q: Do you think that stem cell treatments will become so routine that eventually a person can have one done at their doctor's office?
A:Without reservation I would say 100% yes.
Q: Why is it that some hospitals can give stem cell treatments and a handful of clinics as well in the U.S., but for the most part the FDA seems to have scared a lot of doctors/clinics from even trying to do treatments? It makes no sense to me seeing that I can legally get things like a blood transfusion.
A: Doctors and hospitals and clinics should be scared of the FDA - they are empowered to make allegations that can keep you in court for 10 years defending yourself, and bankrupt you with the legal fees, with no financial recourse even if you win. The folks who are willing to stand up to such a powerful opponent are relatively few and far between.
Q: What is the favorite part of your job? You seem to have a lot of things going on.
A: I would have to say it is the wonderful variety of what I get to do. I investigate death and injury in forensic settings most of the time, I teach students and residents at the medical school some of the other time, and I get to participate in fascinating research like the stem cell studies that I have been involved with in the rest of the time. I feel fortunate that I never have to complain of boredom.
Thanks for the great questions!
About Michael Freeman
Michael D Freeman PhD MPH DC
Forensic Epidemiologist
- Affiliate Professor, Department of Public Health and Preventive Medicine
Oregon Health and Science University School of Medicine http://www.ohsu.edu/xd/education/schools/school-of-medicine/departments/clinical-departments/public-health/people/michael-d-freeman-phd-mph-d.cfm
- Adjunct Associate Professor of Forensic Medicine and Epidemiology,
Institute of Forensic Medicine, Faculty of Health Sciences, Aarhus University Aarhus, Denmark
Mailing address:
1234 SW 18th Ave, Suite 102
Portland, OR 97205
T 971-255-1008, F 971-255-1046
C 503-871-0715
forensictrauma@gmail.com