August 23, 2018 Richard Jaffe
http://rickjaffeesq.com/2018/08/23/king-canute-and-why-the-fda-will-never-stop-the-private-stem-cell-clinics/
But first, two predictions:
Prediction 1
The FDA will win its injunction cases against US Stem Cell, and the California Stem Cell Treatment Centers, and obviously these injunction decisions will be bad precedent for the private stem cell industry.
Prediction 2 (and the big one)
The injunction decisions, even after the Court of Appeals affirms both injunctions -which will happen – will not stop or even slow down the explosive growth of the private clinic stem cell industry.
And the lesson of King Canute tells us why
Seeing the FDA’s relatively timid efforts to date reminds me of King Canute putting his throne at the sea’s edge and commanding the incoming tide to stop. (It didn’t.)
The FDA will have about as much success as King Canute had. (Of course, if the king sat by the beach for 24 hours, tides being what they are, it might have appeared that the sea was listening to him for some portion of the day. Maybe that’s taking the analogy too far, or maybe not.)
For sure, the FDA is going to win its current injunction actions in a relatively short period of time, (a year or eighteen months ish) in part because these cases are being defended by the same big firm, and big firms are masters of linear defense thinking. In cases like this, linear thinking will lead to permanent injunctions.
But these two cases aside, the FDA’s problem is that even now there are just too many clinics for too few FDA resources. It is estimated that there are around six to seven hundred clinics providing some kind of stem cell treatment. I think there are more, because some are flying under the radar screen, and the counting methodology is based on Internet searches.
To understand why the FDA’s task is impossible, consider what’s involved in getting to the place the FDA is in these two injunction cases.
Each FDA case starts with a site visit by multiple (usually three) FDA inspectors (usually called “consumer safety officers”). They spend anywhere from one to three weeks at the clinic. At the end of the visit, the facility receives a 483 inspectional observations report. Then there is a lengthy administrative process: a response by the clinic, consideration of the response by the FDA. If the response is inadequate, (and it always is), a warning letter is sent, but that will be many, many months after the site visit, because a warning letter involves much internal review from a couple different levels of employees and divisions.
Then the clinic has an opportunity to respond to the warning letter. Then there is a further administrative/bureaucratic process for reviewing the clinic’s response to the warning letter. Assuming, (as is always the case), the clinic’s response is inadequate, the FDA has to decide what to do about it, and that’s a further administrative review process.
If the FDA decides to proceed with litigation, it involves its counsel’s office and then the civil division of the US Attorney’s Office in the district in which the stem cell clinic operates.
The US Attorneys’ Office acts as the lawyer for the FDA which is the client. This involves another layer of bureaucracy. US Attorneys’ Offices are usually very busy places, and the lawyers in the civil division usually have big case dockets involving a wide variety of federal matters. They are a very smart and experienced bunch of people, but they are overworked, have to deal with many demanding federal judges and demanding clients who think their agency’s business and the agent’s case is the most important thing in the world.
The FDA’s practical problem here is that most US Attorneys’ Offices throughout the country have not dealt with stem cell cases, so there is some learning curve, which eats up more time. For sure, the US Attorneys’ Offices are aided by the FDA’s counsel’s office, and the FDA investigators, but still, it’s more inefficient than say federal administrative agency cases which are filed in the District of Columbia District Court, which handles many federal administrative cases and the DC US Attorneys’ Office which works on many cases in the same fields involving the same legal issues.
Consider that the two clinics/networks facing injunctions are notorious and have been known by the FDA for years. And yes, the FDA has also sent a few other warning letters to stem cell clinics over the past few years, but it’s not a big number relative to the number of clinics out there. Even if the feds up their game, and file more cases which are in the pipeline, what’s that number going to be? Five, seven? It’s not going to be 50 or even 20, given all of the above and the fact that CBER only has around 1100 total employees. (By comparison CDER (the drug division) has over 4,000 employees.)
Of course, the FDA has graciously said that it’s going to give these clinics three years to come in compliance, and is only now going after the most egregious violators who pose the greatest risk to patients.
That’s a very laudable position, but it reminds me of Siddhartha’s statement “when you have nothing to eat, the best thing to do is to fast.”
Apart from the sheer number of clinics, here are some other reasons why the FDA won’t be able to stop the tide of stem cell clinics:
2. The stuff works, and too many people are being helped
Not in all conditions or in all people, but basically I think the market has spoken and continues to speak by virtue of the fact that there are so many clinics out there and so many more coming online. You can’t fool all the people all the time.
The alternative is that everyone who gets stem cells is a moron, especially those who keep going back for retreatment, like MS patients. The MS stem cell patients are obviously delusional because they don’t understand that the clinical benefit they supposedly achieved every time they do their stem cell treatments is happenstantial/just a temporal correlation with their treatments and not caused by it, or is a placebo effect.
But here’s the thing, most of the MS stem cell patients have tried and failed multiple prior conventional therapies. So obviously these stem cell clinics have just happened to discover a better acting placebo. Ultimately, the bed rock mantra from the stem cell scientific community is, wait for it, “It’s just anecdotal evidence and not science.”
But I digress.
I think stem cells treatment is like medical marijuana. Regardless of all the studies showing that drug abusers suffer side effects and brain damage, there are so many people who have benefited from medical marijuana that the feds have been unable to stop the explosive growth of the use of medical marijuana, and many states have passed laws allowing it, despite its continued illegality under federal law.
I think we are seeing the same thing in stem cells, but to a lesser degree and we’re earlier in the cycle because 1. It’s a much more recently developed therapy than cannabis, 2. You have to go to a medical clinic to get stem cells, where it’s possible to get cannabis without a physician’s recommendation. 3. Stem cells are of course a quantum level more expensive than medical marijuana.
But it is the same societal forces at work. Ultimately, over time people know when something can benefit them. I think that’s one of the benefits of the internet; it’s all out there, the good and the bad. Obviously, this is a heresy for scientists but, respectfully, the scientist and the scientist policymakers on this issue are like King Canute thinking that they can affect the stem cell tide with all their unproven and harm talk. And speaking of harm:
3. There’s not enough harm from stem cell treatments
In all the years that stem cells have been given outside of clinical trials, there just isn’t enough harm to create the necessary groundswell of support to stop it.
In my last post, I discussed the publicly reported serious adverse events around the world from stem cell treatments.
Here is that post:
http://rickjaffeesq.com/2018/08/09/some-perspective-on-private-stem-cell-clinics-and-the-fdas-response/
Here are the numbers: one US death, 10 or 11 other deaths throughout the world, and a total of less than 40 serious adverse events, in the world from the presumed tens of thousands of people who have received stem cell treatments. Those are extremely low numbers for a medical intervention.
Contrast that to over 42,000 deaths from opioid abuse in 2016. After I did that post, the 2017 numbers came out and they are even worse, over 70,000 deaths, the large majority of which were from FDA opioids.
Yes, the institutional stem cell industry and its spokesmen are decrying the venality, villainy and danger of these stem cells clinics, but their own numbers show that it’s not all that dangerous, at least compared to real societal drug problems like the opioid crises.
4. There’s too much money to be made in the field, and it’s quite easy for physicians (and others) to get into the field
Stem cell establishment folk will argue that money/greed is the primary reason why the FDA might have trouble eliminating the private stem cell clinics. No doubt there is a great deal of money to be made in the field. And greed often is a factor in big bucks enterprises. The treatments are expensive ($6,000 to $18,000). It’s a high margin business. Best of all, it’s a strictly cash business, meaning no insurance, and that’s as good as it gets for a health care practitioner, just ask the cosmetic surgeons. So for sure, the money is an important reason why many clinics won’t be scared off by two injunction cases, even when they result in permanent injunction orders.
In addition, there are models out there which are not physician driven, witness the new chiropractor based stem cell model. That is only one of several models which has opened the field up to non-physicians. Good luck trying to stop it King Canute. I’m not making a judgment here, just an observation and a prediction.
Reason Number 5: The FDA does wholesale well, but this is retail and that’s a whole different ballgame
The FDA primarily regulates pharmaceutical companies making drugs and vaccines, device manufacturers, and it also regulates the nation’s blood supply. It does a reasonable job of that given its limited resources. (And by the way, regulating the nation’s blood supply is a really, really important job for CBER, which is the FDA division which also regulates tissue based products and entities like stem cell clinics. Does anyone think it would be a good idea to transfer a bunch of FDA personal from protecting our blood supply, which affects everyone in the country going under the knife or who gets a transfusion, to shut down a few more stem cell clinics?)
The thing about trying to regulate retail clinics as drug manufactures is that the drug source is different; it walks in with the patients. The technology necessary to process the “drug” is relatively simple and cheap. Moreover, the training necessary to administer the drug/biologic is easily obtained, relatively cheap and quick (many would say much too quick, but that’s another topic and another one of my stories).
In market and economic terms, this is a low barriers to entry business model, and especially, to reiterate, because the patient comes in with his/her own drug supply and the clinic just processes it. This is just another part of the tidal forces facing the FDA.
And the last reason why the FDA will never stop the private stem cell clinics:
They are a moving target, and the target is starting to move on from fat
Readers of my book will know that I was involved in the original iteration of private stem cells business model, namely umbilical cord blood from blood banks. (See chapter 9 of Galileo’s Lawyer about the first stem cell criminal investigation https://www.amazon.com/Galileos-Lawyer-Alternative-Complementary-Experimental/dp/0980118301/ )
Autologous from fat is the second, much more popular model, and as readers of my posts know, I was involved in the beginning of that too.
But the field has been reading the tea leaves, meaning the warning letters and the guidance documents administrative process, and it is starting to move on. The new iteration is autologous bone marrow based products, which are claimed to be exempt under 21 CFR 1271.15. (I haven’t looked hard at the issue yet, but I expect to in the future, for one reason or another.)
It took the FDA 12 years to publish final autologous fat guidance documents. It will likely take the FDA less time to work through the bone marrow model, but some of these clinics are going to slip through the cracks, either because of limited FDA resources, low risk of harm, or because they actually do meet the 1271.15 exemption criteria (essentially, homologous use, not more than minimally manipulated, and provided in the same surgical procedure).
My prediction is that the better, smarter, more informed clinics will end up being in compliance, others will not.
But one way or the other, we’re going to go through the same process as what happened with autologous fat derived stem cells, and that’s going to take a significant amount of time.
And so we start again.
Rick Jaffe, Esq.
www.rickjaffe.com
rickjaffeesquire@gmail.com
Post Script
In case some of you never heard of King Canute, he was King of Denmark, England and Norway in the early 11th century. There is an apocryphal story about him putting his throne at the edge of the sea, ordering the incoming tide to stop before the water got to the throne. A common misunderstanding was that his hubris led him to think that he was so powerful that he could stop the tide from coming in. Admittedly, I was one of those so misinformed until I did some deep research (ok, Wikipedia).
Turns out the actual version of the apocryphal story (assuming that such a thing matters in apocryphal stories) is that he knew he couldn’t affect the tides, and that only God could, but he did it to shut-up his retinue who thought he was all powerful.
If so, then maybe the whole FDA analogy/metaphor to King Canute doesn’t even apply (or maybe it still does).
http://rickjaffeesq.com/2018/08/23/king-canute-and-why-the-fda-will-never-stop-the-private-stem-cell-clinics/
But first, two predictions:
Prediction 1
The FDA will win its injunction cases against US Stem Cell, and the California Stem Cell Treatment Centers, and obviously these injunction decisions will be bad precedent for the private stem cell industry.
Prediction 2 (and the big one)
The injunction decisions, even after the Court of Appeals affirms both injunctions -which will happen – will not stop or even slow down the explosive growth of the private clinic stem cell industry.
And the lesson of King Canute tells us why
Seeing the FDA’s relatively timid efforts to date reminds me of King Canute putting his throne at the sea’s edge and commanding the incoming tide to stop. (It didn’t.)
The FDA will have about as much success as King Canute had. (Of course, if the king sat by the beach for 24 hours, tides being what they are, it might have appeared that the sea was listening to him for some portion of the day. Maybe that’s taking the analogy too far, or maybe not.)
For sure, the FDA is going to win its current injunction actions in a relatively short period of time, (a year or eighteen months ish) in part because these cases are being defended by the same big firm, and big firms are masters of linear defense thinking. In cases like this, linear thinking will lead to permanent injunctions.
But these two cases aside, the FDA’s problem is that even now there are just too many clinics for too few FDA resources. It is estimated that there are around six to seven hundred clinics providing some kind of stem cell treatment. I think there are more, because some are flying under the radar screen, and the counting methodology is based on Internet searches.
To understand why the FDA’s task is impossible, consider what’s involved in getting to the place the FDA is in these two injunction cases.
Each FDA case starts with a site visit by multiple (usually three) FDA inspectors (usually called “consumer safety officers”). They spend anywhere from one to three weeks at the clinic. At the end of the visit, the facility receives a 483 inspectional observations report. Then there is a lengthy administrative process: a response by the clinic, consideration of the response by the FDA. If the response is inadequate, (and it always is), a warning letter is sent, but that will be many, many months after the site visit, because a warning letter involves much internal review from a couple different levels of employees and divisions.
Then the clinic has an opportunity to respond to the warning letter. Then there is a further administrative/bureaucratic process for reviewing the clinic’s response to the warning letter. Assuming, (as is always the case), the clinic’s response is inadequate, the FDA has to decide what to do about it, and that’s a further administrative review process.
If the FDA decides to proceed with litigation, it involves its counsel’s office and then the civil division of the US Attorney’s Office in the district in which the stem cell clinic operates.
The US Attorneys’ Office acts as the lawyer for the FDA which is the client. This involves another layer of bureaucracy. US Attorneys’ Offices are usually very busy places, and the lawyers in the civil division usually have big case dockets involving a wide variety of federal matters. They are a very smart and experienced bunch of people, but they are overworked, have to deal with many demanding federal judges and demanding clients who think their agency’s business and the agent’s case is the most important thing in the world.
The FDA’s practical problem here is that most US Attorneys’ Offices throughout the country have not dealt with stem cell cases, so there is some learning curve, which eats up more time. For sure, the US Attorneys’ Offices are aided by the FDA’s counsel’s office, and the FDA investigators, but still, it’s more inefficient than say federal administrative agency cases which are filed in the District of Columbia District Court, which handles many federal administrative cases and the DC US Attorneys’ Office which works on many cases in the same fields involving the same legal issues.
Consider that the two clinics/networks facing injunctions are notorious and have been known by the FDA for years. And yes, the FDA has also sent a few other warning letters to stem cell clinics over the past few years, but it’s not a big number relative to the number of clinics out there. Even if the feds up their game, and file more cases which are in the pipeline, what’s that number going to be? Five, seven? It’s not going to be 50 or even 20, given all of the above and the fact that CBER only has around 1100 total employees. (By comparison CDER (the drug division) has over 4,000 employees.)
Of course, the FDA has graciously said that it’s going to give these clinics three years to come in compliance, and is only now going after the most egregious violators who pose the greatest risk to patients.
That’s a very laudable position, but it reminds me of Siddhartha’s statement “when you have nothing to eat, the best thing to do is to fast.”
Apart from the sheer number of clinics, here are some other reasons why the FDA won’t be able to stop the tide of stem cell clinics:
2. The stuff works, and too many people are being helped
Not in all conditions or in all people, but basically I think the market has spoken and continues to speak by virtue of the fact that there are so many clinics out there and so many more coming online. You can’t fool all the people all the time.
The alternative is that everyone who gets stem cells is a moron, especially those who keep going back for retreatment, like MS patients. The MS stem cell patients are obviously delusional because they don’t understand that the clinical benefit they supposedly achieved every time they do their stem cell treatments is happenstantial/just a temporal correlation with their treatments and not caused by it, or is a placebo effect.
But here’s the thing, most of the MS stem cell patients have tried and failed multiple prior conventional therapies. So obviously these stem cell clinics have just happened to discover a better acting placebo. Ultimately, the bed rock mantra from the stem cell scientific community is, wait for it, “It’s just anecdotal evidence and not science.”
But I digress.
I think stem cells treatment is like medical marijuana. Regardless of all the studies showing that drug abusers suffer side effects and brain damage, there are so many people who have benefited from medical marijuana that the feds have been unable to stop the explosive growth of the use of medical marijuana, and many states have passed laws allowing it, despite its continued illegality under federal law.
I think we are seeing the same thing in stem cells, but to a lesser degree and we’re earlier in the cycle because 1. It’s a much more recently developed therapy than cannabis, 2. You have to go to a medical clinic to get stem cells, where it’s possible to get cannabis without a physician’s recommendation. 3. Stem cells are of course a quantum level more expensive than medical marijuana.
But it is the same societal forces at work. Ultimately, over time people know when something can benefit them. I think that’s one of the benefits of the internet; it’s all out there, the good and the bad. Obviously, this is a heresy for scientists but, respectfully, the scientist and the scientist policymakers on this issue are like King Canute thinking that they can affect the stem cell tide with all their unproven and harm talk. And speaking of harm:
3. There’s not enough harm from stem cell treatments
In all the years that stem cells have been given outside of clinical trials, there just isn’t enough harm to create the necessary groundswell of support to stop it.
In my last post, I discussed the publicly reported serious adverse events around the world from stem cell treatments.
Here is that post:
http://rickjaffeesq.com/2018/08/09/some-perspective-on-private-stem-cell-clinics-and-the-fdas-response/
Here are the numbers: one US death, 10 or 11 other deaths throughout the world, and a total of less than 40 serious adverse events, in the world from the presumed tens of thousands of people who have received stem cell treatments. Those are extremely low numbers for a medical intervention.
Contrast that to over 42,000 deaths from opioid abuse in 2016. After I did that post, the 2017 numbers came out and they are even worse, over 70,000 deaths, the large majority of which were from FDA opioids.
Yes, the institutional stem cell industry and its spokesmen are decrying the venality, villainy and danger of these stem cells clinics, but their own numbers show that it’s not all that dangerous, at least compared to real societal drug problems like the opioid crises.
4. There’s too much money to be made in the field, and it’s quite easy for physicians (and others) to get into the field
Stem cell establishment folk will argue that money/greed is the primary reason why the FDA might have trouble eliminating the private stem cell clinics. No doubt there is a great deal of money to be made in the field. And greed often is a factor in big bucks enterprises. The treatments are expensive ($6,000 to $18,000). It’s a high margin business. Best of all, it’s a strictly cash business, meaning no insurance, and that’s as good as it gets for a health care practitioner, just ask the cosmetic surgeons. So for sure, the money is an important reason why many clinics won’t be scared off by two injunction cases, even when they result in permanent injunction orders.
In addition, there are models out there which are not physician driven, witness the new chiropractor based stem cell model. That is only one of several models which has opened the field up to non-physicians. Good luck trying to stop it King Canute. I’m not making a judgment here, just an observation and a prediction.
Reason Number 5: The FDA does wholesale well, but this is retail and that’s a whole different ballgame
The FDA primarily regulates pharmaceutical companies making drugs and vaccines, device manufacturers, and it also regulates the nation’s blood supply. It does a reasonable job of that given its limited resources. (And by the way, regulating the nation’s blood supply is a really, really important job for CBER, which is the FDA division which also regulates tissue based products and entities like stem cell clinics. Does anyone think it would be a good idea to transfer a bunch of FDA personal from protecting our blood supply, which affects everyone in the country going under the knife or who gets a transfusion, to shut down a few more stem cell clinics?)
The thing about trying to regulate retail clinics as drug manufactures is that the drug source is different; it walks in with the patients. The technology necessary to process the “drug” is relatively simple and cheap. Moreover, the training necessary to administer the drug/biologic is easily obtained, relatively cheap and quick (many would say much too quick, but that’s another topic and another one of my stories).
In market and economic terms, this is a low barriers to entry business model, and especially, to reiterate, because the patient comes in with his/her own drug supply and the clinic just processes it. This is just another part of the tidal forces facing the FDA.
And the last reason why the FDA will never stop the private stem cell clinics:
They are a moving target, and the target is starting to move on from fat
Readers of my book will know that I was involved in the original iteration of private stem cells business model, namely umbilical cord blood from blood banks. (See chapter 9 of Galileo’s Lawyer about the first stem cell criminal investigation https://www.amazon.com/Galileos-Lawyer-Alternative-Complementary-Experimental/dp/0980118301/ )
Autologous from fat is the second, much more popular model, and as readers of my posts know, I was involved in the beginning of that too.
But the field has been reading the tea leaves, meaning the warning letters and the guidance documents administrative process, and it is starting to move on. The new iteration is autologous bone marrow based products, which are claimed to be exempt under 21 CFR 1271.15. (I haven’t looked hard at the issue yet, but I expect to in the future, for one reason or another.)
It took the FDA 12 years to publish final autologous fat guidance documents. It will likely take the FDA less time to work through the bone marrow model, but some of these clinics are going to slip through the cracks, either because of limited FDA resources, low risk of harm, or because they actually do meet the 1271.15 exemption criteria (essentially, homologous use, not more than minimally manipulated, and provided in the same surgical procedure).
My prediction is that the better, smarter, more informed clinics will end up being in compliance, others will not.
But one way or the other, we’re going to go through the same process as what happened with autologous fat derived stem cells, and that’s going to take a significant amount of time.
And so we start again.
Rick Jaffe, Esq.
www.rickjaffe.com
rickjaffeesquire@gmail.com
Post Script
In case some of you never heard of King Canute, he was King of Denmark, England and Norway in the early 11th century. There is an apocryphal story about him putting his throne at the edge of the sea, ordering the incoming tide to stop before the water got to the throne. A common misunderstanding was that his hubris led him to think that he was so powerful that he could stop the tide from coming in. Admittedly, I was one of those so misinformed until I did some deep research (ok, Wikipedia).
Turns out the actual version of the apocryphal story (assuming that such a thing matters in apocryphal stories) is that he knew he couldn’t affect the tides, and that only God could, but he did it to shut-up his retinue who thought he was all powerful.
If so, then maybe the whole FDA analogy/metaphor to King Canute doesn’t even apply (or maybe it still does).