Why was STEMSO formed?
by host Doug Hammond
My first impression about the state of the stem cell industry came from friends and acquaintances that have had to travel abroad for medical treatment and others that would like to, but cannot, due to the expense, fear of travel or that they are simply not ambulatory among other factors.
I am still surprised how many people that I meet who know nothing of how their "own" stem cells are helping people get well.
I was astonished when I found out that my own stem cells were regulated as a drug by the FDA and as a result, read about the proliferation of off-shore treatment options and jobs, money, patients leaving the USA, American patients, caregivers going to Mexico to receive medical treatment!
Disbelief would describe my state of mind better.
I asked myself, where was the industry representation to address these issues? What are the economic impacts of NOT treating patients in their home country? What organization was advocating for the medical practitioners and patients access to their own tissue? A" trade association" is the perfect tool to address these issues and one did not exist.
There are plenty of non-profit charities 501 c 3s but no non-profit Trade associations 501 c 6s for adult stem cells.
That was how STEMSO was started .
Douglas Hammond
President
International Stem Cell Society
STEMS
rg
704-650-6158
Questions and Answers
Q: Can you please elaborate on what your group is hoping to accomplish?
A: “The International Stem Cell Society, STEMSO, is a member based, international, non-profit 501(c) 6 trade association for the purpose of promoting the interests of the global, adult stem cell healthcare industry while linking patients and stakeholders with member medical organizations. STEMSO provides information, education, resources, advocacy and public awareness for the advancement of the adult stem cell industry”
Q: Can individuals join STEMSO? How is it possible to overcome the apathy the public has towards sick people? I don't think most people have a clue what is going on. I am thinking about what has been done to make the public aware of breast cancer for instance. The disease affects relatively few in comparison to the numbers of people with diseases that stem cell treatments might help and yet it gets a huge share of funding and recognition. It's been a brilliant strategy. I am wondering if stem cell treatment is too political to do something similar.
A: Individuals, at this time, may not join STEMSO. Our structure as a trade association is geared towards organizations for membership. This may change in the future.
……and yes, it is possible to overcome apathy. The Breast Cancer Awareness Campaigns are fine examples of how “associations” have helped to accomplish public awareness and generate millions for research. I might add that the NFL is a 501 (c) 6 nonprofit trade association, and their collaboration with 501 (c) 3 cures-related charities (pink ribbon) is important for their success.
…..I agree. While Breast Cancer effects smaller numbers of patients relative to heart disease or diabetes, if you or your family member has/had breast cancer, the relative, statistical issue quickly becomes irrelevant. It has nothing to do with one disease being less important than another.
The breast cancer association’s financial and public awareness campaign successes are a result of hard work, collaborations, a positive message, creative public outreach and marketing ideas. The lesson here is that the association/society model can utilize a powerful team effort in order to effect change.
The pharmaceutical companies have their associations, and they put their competitiveness aside when it comes to regulatory issues. We would be wise to adopt all the aforementioned strategies.
The clinicians and patients related to point of care therapies have failed to do this. Frankly, they sometimes put-out a confrontational, unfocused message, and reactionary statements versus a true, planned, original and positive message about Stem Cells.
The adult stem cell clinicians and patients who are advocating for the right to receive their own cells need a public relations make-over. Some organizations let their “perceived competition” define who they are because they are reacting to statements that they do not want to hear or because it does not support their position.
STEMSO is taking the lead with defining a new, and more positive, message and this will assist STEMSO’s purposes, to have a political and regulatory impact.
Secondly, as a non-profit “trade” association, STEMSO will demonstrate that there are huge economic opportunities for clinical applications of stem cells and job creation that can be implemented now.
We do need, however, to make research papers and clinical studies available which support this position. In order to help us, any information that supports this position should be forwarded to STEMSO.
In addition to the health benefits, another priority of STEMSO is to show our political representatives these economic upsides for investment, job creation and, of course, the health benefits. This will get them to listen.
I disagree about funding-- there has been billions of dollars pouring into research organizations and universities and much of this amount is derived from Non-profit related cure organizations, Pharma investment and federal tax dollars. The problem is that very little of this revenue goes to Stem Cell awareness/education for the general population or towards economic development of clinical point of care models. Most goes to fund research and very little to benefit large patient populations as it relates to stem cells.
There are opportunity costs, investment revenues, tax dollars wages and quality of life issues being lost by not treating patients/caregivers effectively with point of care/autogolous stem cell therapies now. See the Global Economic Burden of Non-communicable Deceases, a Harvard study under advocacy www.STEMSO.org
I believe that the vast majority of Americans have NO clue what Adult stem cells are, how they are working now in clinical practice or that their own cells are regulated as drugs by the FDA and European counterpart, the EMA.
Q: There have been several bills introduced to help patients, such as H.R. 6288 - The Patient Choice Act of 2012, H.R. 6342 - The Compassionate Freedom of Choice Act of 2012, S. 3506- The Ethical Pathway Act of 2012. I hear of such legislation when it is introduced and then somehow never seem to hear much more about such bills. Will STEMSO be helping push through any of this legislation if the bills are still alive and will it include stem cell treatment?
A: No, STEMSO will not take this approach. These bills died and are at present languishing in committee for a reason.
The Feds already relegated much of their power and authority to the FDA to write the guidelines that are in effect “the law”.
The current paradigm does not seem cost effective, however, given the billions spent on research. Furthermore, if patients seek underground, alternatives providers (which they are) with no oversight, this insures lack of follow-up, no recording of outcomes and potential problems with safety and efficacy and, of course, jobs, patients, and dollars going to less restrictive countries.
We have no choice but to work with state legislation and to work directly with the FDA to modify current guidelines.
A prominent and respected surgeon put is this way, and I paraphrase. When you look historically at novel therapies such as transplant medicine, IVF and ICSI, took a great deal of prefacing and collaborative consensus building that was needed to form cogent regulations to monitor safety. This allowed the fields to move forward. This process is lacking in the adult mesenchymal stem cell realm and in particular adipose derived stem cells (ADSC).
STEMSO is planning a policy forum in DC to address this and will invite the FDA or we will go see them.
Q: How does STEMSO get funding?
A: We receive the vast majority of our funding from organizational member dues, sponsorships and conferences.
Q: Have you had any interest from religious organizations that oppose embryonic stem cell research in helping STEMSO? I would think they would want to hop on board.
A: Surprisingly, no, we have not had any such groups approach STEMSO. We are advocating for adult stem cells and related therapies. STEMSO’s mission is to educate people about adult stem cells and point of care therapies that are available now.
This issue and ongoing debate concerning embryonic stem cells has hurt the public awareness and stolen the debate and attention away from the “other” types of stem cells that can and are having an immediate impact on patient wellness.
Q: Is STEMSO a similar organization to ICMS? Are you working towards establishing a national registry for patients that could be used to track them after treatment? That was something ICMS was trying to do.
A: No, STEMSO is not like ICMS. ICMS is a 501(c) 3 charity and STEMSO is a 501 (c) 6 Trade association, which has a very different non-profit tax structure and treatment by the IRS. STEMSO will not be creating a patient registry, an IRB or oversight for clinics or research organizations. Other organizations have already done this. There is no need to reinvent the wheel. This is not to say we are opposed to registries.
We are not planning to put forth guidelines or process requirements for our members to follow.
Q: There is always so much negativity from some vocal members in the research community about advocacy groups. They claim to be supportive of patients, but only as far as warning patients of risks and the importance of waiting for FDA approved clinical trials. Does STEMSO plan to try to get the FDA to lift the regulations that it has imposed on our stem cells or will your group try to work with researchers and the FDA to expedite clinical trials? I guess my question is, what direction is your group planning to take?
A: Yes, I agree there is “too much negativity” and mudslinging going on from both sides, and, unfortunately, this has been made very public. I believe those Stem Cell Clinics which claim cure-alls are bad for the industry. Conversely, blanket statements that all clinicians and stem cell therapies have no basis in science or that they not safe or effective are also misleading, for the same reasons.
Yes, We will work with the FDA to modify the regulations and advocate for processes to speed up trials and allow for more participants. Both strategies must be deployed.
Q: Is it feasible to try to get all the separate advocacy groups together under one umbrella such as STEMSO? There are so many different groups representing a multitude of issues, diseases, and interests. I imagine this would be difficult, but in this fight for our lives, a big army is needed.
A: I doubt it would be possible to get all of the groups under one umbrella. It is feasible, however, for some organizations to work together and combine resources in order to accomplish collaborative goals.
Q: How can STEMSO lobby effectively when you have to compete with Big Pharma's money? Will you be working more on a state level rather than a national level or what are your plans?
A: Money is always a problem for an organization like ours. Federal legislative lobbying can be very costly; relative to state grassroots efforts, which can be done successfully and for relatively less money. This is why we will initially focus on state legislation.
In addition, this also creates opportunities for much needed public awareness and education concerning adult stem cells, more specifically, autologous adult stem cells.
This does not mean we will ignore the FDA. We are in process of creating a comprehensive policy document which would include recommendations that may be addressed by the EMA and FDA so as to influence adult stem cell therapies regulation. The fact is the FDA is not going away. We must work with them, not against them.
Q: What is the most important thing a person can do to help in this cause?
A: Support STEMSO publicly and privately. Talk about the good things adult stem cells can do for all us. When you come across a group, company or association, remember to tell them that there is one association trying to change the status quo. Point people to www.stemso.org for more information. Contact your state legislators, meet with them, and tell them the good things happening at the clinical level.
by host Doug Hammond
My first impression about the state of the stem cell industry came from friends and acquaintances that have had to travel abroad for medical treatment and others that would like to, but cannot, due to the expense, fear of travel or that they are simply not ambulatory among other factors.
I am still surprised how many people that I meet who know nothing of how their "own" stem cells are helping people get well.
I was astonished when I found out that my own stem cells were regulated as a drug by the FDA and as a result, read about the proliferation of off-shore treatment options and jobs, money, patients leaving the USA, American patients, caregivers going to Mexico to receive medical treatment!
Disbelief would describe my state of mind better.
I asked myself, where was the industry representation to address these issues? What are the economic impacts of NOT treating patients in their home country? What organization was advocating for the medical practitioners and patients access to their own tissue? A" trade association" is the perfect tool to address these issues and one did not exist.
There are plenty of non-profit charities 501 c 3s but no non-profit Trade associations 501 c 6s for adult stem cells.
That was how STEMSO was started .
Douglas Hammond
President
International Stem Cell Society
STEMS
rg704-650-6158
Questions and Answers
Q: Can you please elaborate on what your group is hoping to accomplish?
A: “The International Stem Cell Society, STEMSO, is a member based, international, non-profit 501(c) 6 trade association for the purpose of promoting the interests of the global, adult stem cell healthcare industry while linking patients and stakeholders with member medical organizations. STEMSO provides information, education, resources, advocacy and public awareness for the advancement of the adult stem cell industry”
Q: Can individuals join STEMSO? How is it possible to overcome the apathy the public has towards sick people? I don't think most people have a clue what is going on. I am thinking about what has been done to make the public aware of breast cancer for instance. The disease affects relatively few in comparison to the numbers of people with diseases that stem cell treatments might help and yet it gets a huge share of funding and recognition. It's been a brilliant strategy. I am wondering if stem cell treatment is too political to do something similar.
A: Individuals, at this time, may not join STEMSO. Our structure as a trade association is geared towards organizations for membership. This may change in the future.
……and yes, it is possible to overcome apathy. The Breast Cancer Awareness Campaigns are fine examples of how “associations” have helped to accomplish public awareness and generate millions for research. I might add that the NFL is a 501 (c) 6 nonprofit trade association, and their collaboration with 501 (c) 3 cures-related charities (pink ribbon) is important for their success.
…..I agree. While Breast Cancer effects smaller numbers of patients relative to heart disease or diabetes, if you or your family member has/had breast cancer, the relative, statistical issue quickly becomes irrelevant. It has nothing to do with one disease being less important than another.
The breast cancer association’s financial and public awareness campaign successes are a result of hard work, collaborations, a positive message, creative public outreach and marketing ideas. The lesson here is that the association/society model can utilize a powerful team effort in order to effect change.
The pharmaceutical companies have their associations, and they put their competitiveness aside when it comes to regulatory issues. We would be wise to adopt all the aforementioned strategies.
The clinicians and patients related to point of care therapies have failed to do this. Frankly, they sometimes put-out a confrontational, unfocused message, and reactionary statements versus a true, planned, original and positive message about Stem Cells.
The adult stem cell clinicians and patients who are advocating for the right to receive their own cells need a public relations make-over. Some organizations let their “perceived competition” define who they are because they are reacting to statements that they do not want to hear or because it does not support their position.
STEMSO is taking the lead with defining a new, and more positive, message and this will assist STEMSO’s purposes, to have a political and regulatory impact.
Secondly, as a non-profit “trade” association, STEMSO will demonstrate that there are huge economic opportunities for clinical applications of stem cells and job creation that can be implemented now.
We do need, however, to make research papers and clinical studies available which support this position. In order to help us, any information that supports this position should be forwarded to STEMSO.
In addition to the health benefits, another priority of STEMSO is to show our political representatives these economic upsides for investment, job creation and, of course, the health benefits. This will get them to listen.
I disagree about funding-- there has been billions of dollars pouring into research organizations and universities and much of this amount is derived from Non-profit related cure organizations, Pharma investment and federal tax dollars. The problem is that very little of this revenue goes to Stem Cell awareness/education for the general population or towards economic development of clinical point of care models. Most goes to fund research and very little to benefit large patient populations as it relates to stem cells.
There are opportunity costs, investment revenues, tax dollars wages and quality of life issues being lost by not treating patients/caregivers effectively with point of care/autogolous stem cell therapies now. See the Global Economic Burden of Non-communicable Deceases, a Harvard study under advocacy www.STEMSO.org
I believe that the vast majority of Americans have NO clue what Adult stem cells are, how they are working now in clinical practice or that their own cells are regulated as drugs by the FDA and European counterpart, the EMA.
Q: There have been several bills introduced to help patients, such as H.R. 6288 - The Patient Choice Act of 2012, H.R. 6342 - The Compassionate Freedom of Choice Act of 2012, S. 3506- The Ethical Pathway Act of 2012. I hear of such legislation when it is introduced and then somehow never seem to hear much more about such bills. Will STEMSO be helping push through any of this legislation if the bills are still alive and will it include stem cell treatment?
A: No, STEMSO will not take this approach. These bills died and are at present languishing in committee for a reason.
The Feds already relegated much of their power and authority to the FDA to write the guidelines that are in effect “the law”.
The current paradigm does not seem cost effective, however, given the billions spent on research. Furthermore, if patients seek underground, alternatives providers (which they are) with no oversight, this insures lack of follow-up, no recording of outcomes and potential problems with safety and efficacy and, of course, jobs, patients, and dollars going to less restrictive countries.
We have no choice but to work with state legislation and to work directly with the FDA to modify current guidelines.
A prominent and respected surgeon put is this way, and I paraphrase. When you look historically at novel therapies such as transplant medicine, IVF and ICSI, took a great deal of prefacing and collaborative consensus building that was needed to form cogent regulations to monitor safety. This allowed the fields to move forward. This process is lacking in the adult mesenchymal stem cell realm and in particular adipose derived stem cells (ADSC).
STEMSO is planning a policy forum in DC to address this and will invite the FDA or we will go see them.
Q: How does STEMSO get funding?
A: We receive the vast majority of our funding from organizational member dues, sponsorships and conferences.
Q: Have you had any interest from religious organizations that oppose embryonic stem cell research in helping STEMSO? I would think they would want to hop on board.
A: Surprisingly, no, we have not had any such groups approach STEMSO. We are advocating for adult stem cells and related therapies. STEMSO’s mission is to educate people about adult stem cells and point of care therapies that are available now.
This issue and ongoing debate concerning embryonic stem cells has hurt the public awareness and stolen the debate and attention away from the “other” types of stem cells that can and are having an immediate impact on patient wellness.
Q: Is STEMSO a similar organization to ICMS? Are you working towards establishing a national registry for patients that could be used to track them after treatment? That was something ICMS was trying to do.
A: No, STEMSO is not like ICMS. ICMS is a 501(c) 3 charity and STEMSO is a 501 (c) 6 Trade association, which has a very different non-profit tax structure and treatment by the IRS. STEMSO will not be creating a patient registry, an IRB or oversight for clinics or research organizations. Other organizations have already done this. There is no need to reinvent the wheel. This is not to say we are opposed to registries.
We are not planning to put forth guidelines or process requirements for our members to follow.
Q: There is always so much negativity from some vocal members in the research community about advocacy groups. They claim to be supportive of patients, but only as far as warning patients of risks and the importance of waiting for FDA approved clinical trials. Does STEMSO plan to try to get the FDA to lift the regulations that it has imposed on our stem cells or will your group try to work with researchers and the FDA to expedite clinical trials? I guess my question is, what direction is your group planning to take?
A: Yes, I agree there is “too much negativity” and mudslinging going on from both sides, and, unfortunately, this has been made very public. I believe those Stem Cell Clinics which claim cure-alls are bad for the industry. Conversely, blanket statements that all clinicians and stem cell therapies have no basis in science or that they not safe or effective are also misleading, for the same reasons.
Yes, We will work with the FDA to modify the regulations and advocate for processes to speed up trials and allow for more participants. Both strategies must be deployed.
Q: Is it feasible to try to get all the separate advocacy groups together under one umbrella such as STEMSO? There are so many different groups representing a multitude of issues, diseases, and interests. I imagine this would be difficult, but in this fight for our lives, a big army is needed.
A: I doubt it would be possible to get all of the groups under one umbrella. It is feasible, however, for some organizations to work together and combine resources in order to accomplish collaborative goals.
Q: How can STEMSO lobby effectively when you have to compete with Big Pharma's money? Will you be working more on a state level rather than a national level or what are your plans?
A: Money is always a problem for an organization like ours. Federal legislative lobbying can be very costly; relative to state grassroots efforts, which can be done successfully and for relatively less money. This is why we will initially focus on state legislation.
In addition, this also creates opportunities for much needed public awareness and education concerning adult stem cells, more specifically, autologous adult stem cells.
This does not mean we will ignore the FDA. We are in process of creating a comprehensive policy document which would include recommendations that may be addressed by the EMA and FDA so as to influence adult stem cell therapies regulation. The fact is the FDA is not going away. We must work with them, not against them.
Q: What is the most important thing a person can do to help in this cause?
A: Support STEMSO publicly and privately. Talk about the good things adult stem cells can do for all us. When you come across a group, company or association, remember to tell them that there is one association trying to change the status quo. Point people to www.stemso.org for more information. Contact your state legislators, meet with them, and tell them the good things happening at the clinical level.