Just when numerous articles are surfacing that lots of medical studies are junk, CIRM is running out of money and the FDA may have a new commissioner favorable to allowing stem cell clinics to treat patients as a practice of medicine, the all knowing guru of kindness and compassion for patients, Paul Knoepfler, has written a blog piece which I'm sure he hopes will help shoot down any chances of legislation passing which is favorable to patients in Texas. As for the broader opposition from ISSCR, that's a hoot. The quote from Sally Temple is a tired example of how out of touch this group is with real patients. Give me a break conflicted academics !!!! Get some new jargon other than snake oil, dubious, unproven and unlicensed. Talk about an unimaginative group of pinheads to use Bill O'Reilly's name for those who just seem to live in their own little world. And why doesn't he mention those who are for the bills? Many people I know put a lot of hard work into this and actually met with legislators. He prefers to just give us all a sermon from afar and like the first person who commented (see below), patients are fed up with it.
David Bales is on the record as being neutral. That's strange considering the quote on Knoepfler's blog. A very reliable source heard him state he was neutral.
As far as I'm concerned, Knoepfler crosses the line into self conflicted unreality so often that I just have to put him down in my books as one more looney left professor. That is just my opinion and not his as he believes he is one of the top experts in the stem cell industry. There seems to be an abundance of professors just like him lately on college campuses pushing their own agendas. He even weaves the Russians into this article.
The last paragraph is very telling about his one sided assessment of what actually constitutes patient endangerment in my opinion. I believe his rhetoric and actions endanger patients as their choices dwindle and they are forced offshore for treatment. These bills are a step in the right direction. I find it highly amusing that he apparently didn't know about them much earlier as this is the first warning he's issued. I smell panic. He is right about helping to make a difference though. If you live in Texas let your legislators know that you want them to pass these bills.
3 Dangerous Texas Bills Would Boost Stem Cell Clinics
Posted on May 8, 2017
ipscell.com/2017/05/3-dangerous-texas-bills-would-boost-stem-cell-clinics/
The Calexit and Texit state secession campaigns for California and Texas to leave the union, which are linked to Russian President Putin, are never going to be successful. However, if some Texas lawmakers and stem cell clinics there have their way, Texas would take a big step away from the rest of us on the stem cell front, endangering patients. Such a development would strongly contrast to all the great, cutting edge stem cell research going on in labs across that state. Somehow this major development has not been covered yet by national or even Texas media.
What’s the scoop?
Three bills are pending at the Texas Capitol that if passed and signed into law would pave the way for unproven, risky stem cell therapies to be sold much more readily to patients by clinics. The Texas stem cell bills include HB 661 and HB 810 by Rep. Tan Parker, and HB 3236 by Kyle Kacal. You can learn more about the bills by following direct links to each bill here http://www.capitol.state.tx.us/tlodocs/85R/billtext/pdf/HB00661I.pdf#navpanes=0 , here, http://www.capitol.state.tx.us/tlodocs/85R/billtext/pdf/HB00810I.pdf#navpanes=0 and here.http://www.capitol.state.tx.us/tlodocs/85R/billtext/pdf/HB03236I.pdf#navpanes=0
HB 661 seems to be a very loose kind of right to try effort that concerningly would extend it from restricted just to patients with terminal illnesses to also those with chronic conditions that could be just about anything. In a sense, a stem cell clinic’s own doctor perhaps could decide whether their patient/customer has a chronic disease that is eligible. How often would the clinic doctor say “no” since that would mean the patient would not get the treatment and so would not pay them big bucks?
HB 810 is a stem cell-specific kind of right to try bill that would greatly lower oversight standards and put patients at greater risks. The third bill, HB 3236, is what I call “Right to Profit” for the clinics because if that bill passes then the clinics would have free rein to make millions in profits from vulnerable patients. How would that be a good thing for most Texans? It wouldn’t. In fact, I see it as a consumer ripoff bill.
Other than stem cell clinics, it’s hard imagine many fans of these bills. Most people I have talked to strongly oppose them including top stem cell scientists in Texas. The organization Texans for Cures, which has been very balanced, sensible and supportive of stem cell-based regenerative medicine for many years, strongly opposes these bills too. Here’s a statement from its Chairman David Bales:
“After careful examination of HB 661, HB 810 by Rep. Parker and HB 3236 by Texans for Cures Medical Advisory Committee, which includes leaders like Dr. Doris Taylor and Dr. William Decker, we decided to vigorously oppose all three bills because they jeopardize patient safety and responsible research in the State of Texas”.
There’s broader opposition too. For instance, the largest global stem cell research organization, ISSCR, is opposed to these stem cell bills. You can read more about ISSCR’s viewpoints in a letter from its President Sally Temple to Texas lawmaker Todd Hunter. Here’s a big picture quote from the ISSCR letter:
“…these bills will allow snake oil salesmen to sell unproven and scientifically dubious therapies to desperate patients.”
What businesses exactly would stand to benefit mostly at the expense of patients?
In our survey last year, Leigh Turner and I found 71 stem cell businesses in Texas that did not appear to have FDA approval for selling stem cells to consumers so these kinds of companies would likely stand to profit from the trio of stem cell bills under consideration. When I think of stem cell clinics in Texas, one called Celltex specifically comes to mind. It is most famous for having transplanted experimental stem cells by the billions into then governor Rick Perry. I was fortunate to have the chance to have met in a small group with Perry some years ago here in California. It was clear he genuinely felt that the infused Celltex stem cells had made a positive difference for him, but collecting and impartially analyzing data from a large group of patients including experimental controls is the only way to be sure about this kind of still unproven clinical science.
What’s the back story on Celltex? Celltex was one of the first high-profile stem cell clinics in the U.S. Despite its friendly relationship with Perry, it ran afoul of the FDA some years back. After that it headed south for the border to do its clinical transplants in Mexico even as it remained HQ’d in Texas. I’ve covered Celltex on this blog in the past and you can see archived posts here. Over the years of blogging occasionally about Celltex I’ve been verbally attacked and even threatened by some of their supporters so there are clearly strong feelings out there.
Since federal law trumps state law it’s unclear what would happen if these bills pass. However, with Donald Trump and Rick Perry, who is now DOE Secretary, both in power at the federal level, and uncertainty about the views of future FDA leadership on stem cells, maybe the feds would back down on stem cells if Texas pass these laws? That’s probably what the folks backing these bills are daydreaming about as they imagine the future. Their wish is likely that Trump & Perry will lean heavily on the FDA to back off. Such political pressure on the FDA is possible and in theory could work, but it would be a really bad thing for both patients and the FDA itself in terms of its reputation if it backed down.
“Now, hold on, Paul,” you might say, “these laws are only about making promising stem cell therapies available to needy patients!” As much as that sounds good, I believe that’s not true. No one is more bullish on stem cells than me, but despite their great longer-term potential both for healing patients and boosting the economy, mostly they are not ready.
The stem cell field has good momentum now and I believe new game-changing therapies are coming via several types of stem cells including adult stem cells, but unfortunately it takes time so if you take shortcuts you can royally mess things up and harm many people. Today most of what is offered for sale on the stem cell front directly marketed to patients by clinics is more hype than hope. These Texas bills would end up just helping the clinics and risk harming patients with new health risks and big hits to their wallets. The US stem cell field, including physicians and scientists working hard every day especially in Texas labs, but also all across America, also stands to be harmed by these bills.
If you are a Texan and find this situation concerning please call your representatives and tell them to oppose these bills. There is a reasonable chance that these bills will never become laws, with them particularly likely facing opposition in the Texas Senate, but you never know. Make a difference by helping to make sure this ends right.
Comments:
Daniel on May 8, 2017 at 2:38 pm said:
Patients are doing stem cell therapy anyway and having to fly overseas just to get their cells introveniously back in them. I’ve not heard of any negative experiences from the patients themselves about CellTex. We the patients should have the right to try. If it’s left up to the FDA and big pharma, there’s no hope for us until they decide to develop a drug that they can sell which is just not starting for regenerative therapy.
After reading several of your articles, it’s clear to me that you actually have no clue what you’re reporting on especially when it comes to these house bills. It seems your goal is to place fear in patients and steer them clear of the future of stem cell and the potential that it has for patients today. You just make subtle remarks making jabs at clinics that are actually doing cleared trials such as CellTex. With that being said, your reporting only angers me to the point of feeling the absolute need to comment, which I rarely ever do and so far, have done twice on your fake news reports. So, this is the last report of yours I will ever read and hope people actually research some of these clinics for themselves before drawing a conclusion based on your fake reports.
Reply ↓
admin
on May 8, 2017 at 3:23 pm said:
@Daniel,
As I write this blog, I have to call it like I see it (on opinions I write) and I’m careful about researching what I write about on the more factual/news side.
When it comes to this “news” element of any particular piece, I aim to be completely factual in a way that is independently verifiable. If you have questions about the factual nature of specific things that I write about, let me know. Of course I can be mistaken at times.
By instead saying inflammatory things like “you have no clue” and “your fake news”, what does that achieve?
As to opinions, I don’t think we are going to see eye-to-eye and I understand that you disagree with my views.
Paul
Jeanne A. Pawitan on May 8, 2017 at 11:08 pm said:
Dear Paul,
In my opinion, to prevent desperate patients becoming prey is to educate them how to sue when bad things happen, and be careful when they are signing the informed consent.
Be careful, not to sign that they will not sue. Be aware, what is their right, what are the promises, and what if the promises are not fulfilled.
I think that it will be very valuable if you can make a blog about this, to educate the patients to be.
I do not think that there were clinics that wanted to be sued. This will make them to take more care about the safety and efficacy.
David Bales is on the record as being neutral. That's strange considering the quote on Knoepfler's blog. A very reliable source heard him state he was neutral.
As far as I'm concerned, Knoepfler crosses the line into self conflicted unreality so often that I just have to put him down in my books as one more looney left professor. That is just my opinion and not his as he believes he is one of the top experts in the stem cell industry. There seems to be an abundance of professors just like him lately on college campuses pushing their own agendas. He even weaves the Russians into this article.
The last paragraph is very telling about his one sided assessment of what actually constitutes patient endangerment in my opinion. I believe his rhetoric and actions endanger patients as their choices dwindle and they are forced offshore for treatment. These bills are a step in the right direction. I find it highly amusing that he apparently didn't know about them much earlier as this is the first warning he's issued. I smell panic. He is right about helping to make a difference though. If you live in Texas let your legislators know that you want them to pass these bills.
3 Dangerous Texas Bills Would Boost Stem Cell Clinics
Posted on May 8, 2017
ipscell.com/2017/05/3-dangerous-texas-bills-would-boost-stem-cell-clinics/
The Calexit and Texit state secession campaigns for California and Texas to leave the union, which are linked to Russian President Putin, are never going to be successful. However, if some Texas lawmakers and stem cell clinics there have their way, Texas would take a big step away from the rest of us on the stem cell front, endangering patients. Such a development would strongly contrast to all the great, cutting edge stem cell research going on in labs across that state. Somehow this major development has not been covered yet by national or even Texas media.
What’s the scoop?
Three bills are pending at the Texas Capitol that if passed and signed into law would pave the way for unproven, risky stem cell therapies to be sold much more readily to patients by clinics. The Texas stem cell bills include HB 661 and HB 810 by Rep. Tan Parker, and HB 3236 by Kyle Kacal. You can learn more about the bills by following direct links to each bill here http://www.capitol.state.tx.us/tlodocs/85R/billtext/pdf/HB00661I.pdf#navpanes=0 , here, http://www.capitol.state.tx.us/tlodocs/85R/billtext/pdf/HB00810I.pdf#navpanes=0 and here.http://www.capitol.state.tx.us/tlodocs/85R/billtext/pdf/HB03236I.pdf#navpanes=0
HB 661 seems to be a very loose kind of right to try effort that concerningly would extend it from restricted just to patients with terminal illnesses to also those with chronic conditions that could be just about anything. In a sense, a stem cell clinic’s own doctor perhaps could decide whether their patient/customer has a chronic disease that is eligible. How often would the clinic doctor say “no” since that would mean the patient would not get the treatment and so would not pay them big bucks?
HB 810 is a stem cell-specific kind of right to try bill that would greatly lower oversight standards and put patients at greater risks. The third bill, HB 3236, is what I call “Right to Profit” for the clinics because if that bill passes then the clinics would have free rein to make millions in profits from vulnerable patients. How would that be a good thing for most Texans? It wouldn’t. In fact, I see it as a consumer ripoff bill.
Other than stem cell clinics, it’s hard imagine many fans of these bills. Most people I have talked to strongly oppose them including top stem cell scientists in Texas. The organization Texans for Cures, which has been very balanced, sensible and supportive of stem cell-based regenerative medicine for many years, strongly opposes these bills too. Here’s a statement from its Chairman David Bales:
“After careful examination of HB 661, HB 810 by Rep. Parker and HB 3236 by Texans for Cures Medical Advisory Committee, which includes leaders like Dr. Doris Taylor and Dr. William Decker, we decided to vigorously oppose all three bills because they jeopardize patient safety and responsible research in the State of Texas”.
There’s broader opposition too. For instance, the largest global stem cell research organization, ISSCR, is opposed to these stem cell bills. You can read more about ISSCR’s viewpoints in a letter from its President Sally Temple to Texas lawmaker Todd Hunter. Here’s a big picture quote from the ISSCR letter:
“…these bills will allow snake oil salesmen to sell unproven and scientifically dubious therapies to desperate patients.”
What businesses exactly would stand to benefit mostly at the expense of patients?
In our survey last year, Leigh Turner and I found 71 stem cell businesses in Texas that did not appear to have FDA approval for selling stem cells to consumers so these kinds of companies would likely stand to profit from the trio of stem cell bills under consideration. When I think of stem cell clinics in Texas, one called Celltex specifically comes to mind. It is most famous for having transplanted experimental stem cells by the billions into then governor Rick Perry. I was fortunate to have the chance to have met in a small group with Perry some years ago here in California. It was clear he genuinely felt that the infused Celltex stem cells had made a positive difference for him, but collecting and impartially analyzing data from a large group of patients including experimental controls is the only way to be sure about this kind of still unproven clinical science.
What’s the back story on Celltex? Celltex was one of the first high-profile stem cell clinics in the U.S. Despite its friendly relationship with Perry, it ran afoul of the FDA some years back. After that it headed south for the border to do its clinical transplants in Mexico even as it remained HQ’d in Texas. I’ve covered Celltex on this blog in the past and you can see archived posts here. Over the years of blogging occasionally about Celltex I’ve been verbally attacked and even threatened by some of their supporters so there are clearly strong feelings out there.
Since federal law trumps state law it’s unclear what would happen if these bills pass. However, with Donald Trump and Rick Perry, who is now DOE Secretary, both in power at the federal level, and uncertainty about the views of future FDA leadership on stem cells, maybe the feds would back down on stem cells if Texas pass these laws? That’s probably what the folks backing these bills are daydreaming about as they imagine the future. Their wish is likely that Trump & Perry will lean heavily on the FDA to back off. Such political pressure on the FDA is possible and in theory could work, but it would be a really bad thing for both patients and the FDA itself in terms of its reputation if it backed down.
“Now, hold on, Paul,” you might say, “these laws are only about making promising stem cell therapies available to needy patients!” As much as that sounds good, I believe that’s not true. No one is more bullish on stem cells than me, but despite their great longer-term potential both for healing patients and boosting the economy, mostly they are not ready.
The stem cell field has good momentum now and I believe new game-changing therapies are coming via several types of stem cells including adult stem cells, but unfortunately it takes time so if you take shortcuts you can royally mess things up and harm many people. Today most of what is offered for sale on the stem cell front directly marketed to patients by clinics is more hype than hope. These Texas bills would end up just helping the clinics and risk harming patients with new health risks and big hits to their wallets. The US stem cell field, including physicians and scientists working hard every day especially in Texas labs, but also all across America, also stands to be harmed by these bills.
If you are a Texan and find this situation concerning please call your representatives and tell them to oppose these bills. There is a reasonable chance that these bills will never become laws, with them particularly likely facing opposition in the Texas Senate, but you never know. Make a difference by helping to make sure this ends right.
Comments:
Daniel on May 8, 2017 at 2:38 pm said:
Patients are doing stem cell therapy anyway and having to fly overseas just to get their cells introveniously back in them. I’ve not heard of any negative experiences from the patients themselves about CellTex. We the patients should have the right to try. If it’s left up to the FDA and big pharma, there’s no hope for us until they decide to develop a drug that they can sell which is just not starting for regenerative therapy.
After reading several of your articles, it’s clear to me that you actually have no clue what you’re reporting on especially when it comes to these house bills. It seems your goal is to place fear in patients and steer them clear of the future of stem cell and the potential that it has for patients today. You just make subtle remarks making jabs at clinics that are actually doing cleared trials such as CellTex. With that being said, your reporting only angers me to the point of feeling the absolute need to comment, which I rarely ever do and so far, have done twice on your fake news reports. So, this is the last report of yours I will ever read and hope people actually research some of these clinics for themselves before drawing a conclusion based on your fake reports.
Reply ↓
admin
on May 8, 2017 at 3:23 pm said:
@Daniel,
As I write this blog, I have to call it like I see it (on opinions I write) and I’m careful about researching what I write about on the more factual/news side.
When it comes to this “news” element of any particular piece, I aim to be completely factual in a way that is independently verifiable. If you have questions about the factual nature of specific things that I write about, let me know. Of course I can be mistaken at times.
By instead saying inflammatory things like “you have no clue” and “your fake news”, what does that achieve?
As to opinions, I don’t think we are going to see eye-to-eye and I understand that you disagree with my views.
Paul
Jeanne A. Pawitan on May 8, 2017 at 11:08 pm said:
Dear Paul,
In my opinion, to prevent desperate patients becoming prey is to educate them how to sue when bad things happen, and be careful when they are signing the informed consent.
Be careful, not to sign that they will not sue. Be aware, what is their right, what are the promises, and what if the promises are not fulfilled.
I think that it will be very valuable if you can make a blog about this, to educate the patients to be.
I do not think that there were clinics that wanted to be sued. This will make them to take more care about the safety and efficacy.