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ALL’S MOSTLY QUIET ON THE FDA FRONT, but don’t expect that to last now that there’s a New FDA Commissioner

ALL’S MOSTLY QUIET ON THE FDA FRONT, but don’t expect that to last now that there’s a New FDA Commissioner

It seems like forever ago since the FDA’s 2015-2016 attempt to increase its regulatory powers, or more pointedly, since the FDA regulatory thugs have tried to dramatically restrict the personal freedom of US citizens.

The good news is that most of the major proposed changes are still up in the air. The not-so-good news is that now that the FDA has a new commissioner (Scott Gottleib was confirmed by the Senate on April, 27, 2017), I’m expecting things to happen, not all of them good.

Let’s review what’s up in the air/awaiting decision/finalization, but first let me remind you about the FDA’s two main mechanisms by which it increases its power over consumers and companies that provide health care goods:FDA guidance documents and warning letters.

Guidance documents are industry-wide statements of the FDA “current thinking” on a subject. They have a one way force-of-law. The FDA can sue you for doing something in violation of a guidance document, but you can’t sue the FDA about the guidance document because it’s just the “agency’s current thinking on a subject” and so there’s nothing you the consumer or the business person can do about it, at least until you get sued.

A “warning letters” tell a specific company that they’re violating the law and should stop or else. But you can’t sue the FDA to challenge the warning letter because it takes the position that it’s not sure, they might change their mind, it’s not a “final determination” or maybe they’re just kidding. You have to wait until the FDA goes after you.

The first takeaway is that so far, things are still mostly quiet on the FDA front, but as stated, I’d expect that to change with a new FDA commissioner on board.

The Big things up in the air in FDA Land

To recap the FDA’s broad efforts to expand its powers and jurisdiction and where the draft guidelines are awaiting final approval:

1. Stem Cells: The FDA proposed four guidance documents back in the 2015-2016 which would have basically destroyed the U.S. autologous stem cell business for everything from diseases to breast reconstruction after mastectomies. See my post on these guidance documents at: http://rickjaffeesq.com/category/stemcells/

2. Dietary Supplements: The FDA proposed changed via a revised definition of a new dietary ingredient which would have turned many dietary supplements into drugs or would require drug like testing. See my post at: http://rickjaffeesq.com/category/supplements/

3. Compounding pharmacies: new regulations would severely hamper the ability of compounding pharmacists to continue to operate.

If you’re an anti or concerned vaxxer, you already know, Scott’s public comments have been in line with Pharma’s and the rest of the vaccine establishment’s position. Better luck with the CDC.

Now might be an excellent time for the supplement industry and the autologous stem cell industry and its patient supporters to reengage in a federal campaign.

Still it’s not like the FDA has been asleep

So what has the FDA been up to since this year so far?

Probably the best way to get a beat on what the FDA is up to is to review the warning letters it has issued. I’ve done that and here’s what I’ve come up with:
(If you want to look over the FDA recent warning letters yourself, here’s the place:
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/default.htm?Page=1)

Supplements have been given scrutiny in the following areas:

Supplements converted into unapproved cancer treatments:

Sometimes the FDA focuses on an issue or problem after receiving a complaint about a violation, then it goes after a bunch of folks violating the law usually on the same day. That happened in on April, 17th when the FDA sent almost a dozen warning letters to supplement makers who were marketing their products as cures or treatments of cancer. That’s a definite no-no in FDA controlled land.

Putting drugs into supplements

Some supplement manufactures have decided that the best way to increase the potency of their products to remedy some condition is by putting in a touch of a drug, or what the FDA calls an “active pharmaceutical ingredient” or “API”). It really kicks-up the product a notch, but of course, it’s illegal. I’ve worked on the issue, and the FDA’s remedies are quite draconian; for starters they make you write to all the customers and refund the money they paid, and do a product recall. And that’s it if you’re lucky. If you’re not or the feds think you did it intentionally, think an indictment on multiple FDA felony counts.

Are you a Good Manufacturer? (And that includes you distributors and resellers)

Supplement manufacturers have to manufacture their products in accordance with current good manufacturing practices (CGMP). It’s onerous but it’s the cost of doing business. Lately the FDA has sent a bunch of warning letters to supplement manufacturers complaining of lack of compliance with a lot of the technical and paperwork requirements. The surprising part of this area of regulatory law is that the downstream distributors and resellers also have quite significant regulatory obligations to ensure CGMP compliance and/or quality control. I’ve seen supplement distributors hung out to dry for very specific and somewhat onerous regulations.

Compounders Get unwanted attention

Even though the draft compounding guidelines are still pending, that hasn’t stopped the FDA from issuing warning letters to a few compounders. Things should really pick up for the FDA once the guidance documents are finalized.

So in short,
the FDA has been continuing to do what it is always does, which is some combination of protecting the public and interfering with the rights of consumers. How much of one versus the other depends on what your core beliefs or main issues are. But still, with these three big areas with pending draft guidelines (stem cells, dietary supplements and compounding), now that there is a new FDA commissioner, I’d look for some resolution of these big open issues in the next few months.

From all accounts, the new Commissioner is very friendly with Pharma and wants to see the drug approval process streamlined and shortened which will be good for Pharma. Don’t look for any help from him on the vaccine safety issue. The jury is still out on him on stem cells and supplements, but I don’t see much reason for optimism, unless there is a continued public outcry for access to more information about supplements and more access to our own body parts.

Here’s to hoping, (and maybe some doing).

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Texas stem cell legislative battle goes down to the wire, but alas, it’s less the meets the eye

Texas stem cell legislative battle goes down to the wire, but alas, it’s less the meets the eye

Under current law, it is illegal for patients to have their own stems cells removed, cultured/expanded and reinjected. That’s too bad because there are plenty of instances where this treatment seems to be helping patients with incurable chronic diseases such as MS. Patients who want this type of treatment have to go abroad, usually either Mexico or Panama. That’s quite burdensome for some, given their medical problems.

Texas MS Patients to the Rescue, (maybe)

During the current Texas legislative session, a group of deeply committed Texas stem cell patients have been leading the charge to change the law in Texas, to allow patients access to their own cultured/expanded cells and even allogeneic stem cells.

The bill they have championed, HB 810, passed the Texas House easily and just a few days ago passed the Senate, and Governor Abbott has promised to sign it. So all good right? Well, actually no.

There’s a hitch and it’s a big one.

In Texas it’s easy to kill a bill, and very hard to pass a bill if there is any opposition whatsoever. And there is a lot of opposition to this bill, some visible and some, I believe, behind the scenes.

How to cut the heart out of a bill

One of the nastiest ways to kill a bill is to gut it with an amendment; by making it meaningless via a seemingly innocuous and reasonable addition. That’s exactly what the Senate did to HB 810. My guess is that there were one or two Senators who were told by the powers-that-be,(and that would probably be the Texas Medical Association and the Texas Medical Board) to kill the bill, and this Senator or two, convinced the other Senators to go along with the changes, with the other Senators not realizing that they were actually killing the bill.

HB 810

HB 810 gives people the right to use their own cultured stem cells and even other adult stem cells (meaning from umbilical cords and from humans, but not fetal stem cells) as long as the use was part of a “clinical trial.” However, HB 810 did not say that it had to be an FDA approved clinical trial, and that is important. So HB 810 would allow doctors to do their own non-FDA approved clinical trials. That’s critical because getting the FDA to approve a clinical trial, via filing an IND (Investigational New Drug application) is a very, very expensive and time consuming process and well beyond the abilities and financial wherewithal of doctors and clinics.

Under the bill, a physician had to agree and certify that the treatment was necessary, and of course there had to be informed consent. But that’s basically it. HB 810 would have dramatically opened the doors for patients with all kinds of diseases to receive their own expanded cells and someone else’s stem cells in Texas.

HB 810 is good news for patients, but bad news for the establishment types

That would be very good news for patients with chronic, incurable diseases who are willing to accept the risk of undergoing treatments which haven’t been approved by the FDA. But it would be very bad news for the stem cell research Mafioso, the guardians of the Holy Grail who are trying to corral everyone they can into FDA approved clinical trials. It would be worse news for the medical establishment types who have the heartfelt belief that patients need to be protected from their own foolishness, and the false hope that their own stem cells might be able to help cure or mitigate their condition, or that these foolish people have the right to try this kind of treatment in the U.S. These folks have decided that they decide when patients can use their own body parts.

I surmise that some of these establishment types had some quiet conversations with one or two state senators and were told to kill HB 810.

Here’s what they did, and regrettably, it’s good.

The HB 810 Bill-Killer’s Amendments

1. The Senate bill added a provision that the use of stem cells sanctioned by HB 810 has to be in accordance with 21 CFR 1271, which is the section of the federal code of regulation which states that autologous, expanded stem cells (your own stem cells which are cultured) and someone else’s stem cells are drugs and cannot be used until they are approved for marketing by the FDA (or under an FDA approved clinical trial). This completely eviscerates HB 810. The whole point of the bill was to allow patients to get stem cell treatment which did not comply with 21 CFR 1271. It’s already legal to use stem cells which are 1271 compliant, so… well you get the idea.

2. Another Senate amendment requires that the stem cells can only be administered in a hospital or ambulatory surgical center. That’s a very expensive proposition and basically puts stem cell treatment beyond the reach of most physicians. By the way, this was the same tactic used in the Texas abortion law to effectively outlaw abortion clinics, (which provision was, I believe, struck down.)

3. Finally, the Senate amendment proposed that stem cells can only be given if their use is approved by a university or big hospital IRB (Institutional Review Board). I can tell you that no university is going to approve non-FDA approved stem cell treatment unless the clinical trial is approved by the FDA, via the full IND process. Further, stand-alone big hospitals don’t have a full IRB, and those which do research and have IRB’s are not going to jeopardize their on-going research by using or allowing their IRB’s to sanction non-FDA approved drugs to be administered outside of FDA approved clinical trials. For these folks, there is no such thing as a non-FDA approved clinical trial of a non-FDA approved drug. Practically speaking, this makes it very difficult to impossible for a physician to deliver these unapproved stem cell treatments under this Seanate amendment.

There are only a couple days left in the current legislative session. While there is still time to negotiate, my guess is that the Senator(s) who introduced these amendments, who did so to kill HB 810 is (are) not going to back down, barring some almost miraculous level of public pressure put on him (them).

Here’s hoping……

Rick Jaffe, Esq.

rickjaffeesquire@gmail.com

Landmark Texas Stem Cell Legislation Gets through the Texas Legislature!

Landmark Texas Stem Cell Legislation Gets through the Texas Legislature!

Over the Memorial Day weekend, the Texas Legislature passed amended HB 810, which allows access to autologous (yours) and allogenic (not your) stem cells. It is landmark legislation in that it is the first state law allowing access to stem cell treatments which are not FDA approved, and which do not fit within the narrow types of autologous stem cell treatments permissible under federal law.

Here is the amended bill awaiting the Governor’s signature. (The Governor has previously tweeted that he’s going to sign it)
ftp://ftp.legis.state.tx.us/bills/85R/billtext/html/house_bills/HB00800_HB00899/HB00810F.htm\

Bluntly speaking, the passage of HB 810 means that treatments which are illegal under federal law will be permitted, if given in Texas, at least under Texas state law.

That makes the Texas stem cell law analogous to the medical and recreational marijuana state laws, in that those state laws are in direct conflict with federal law. Another example of state laws in conflict with federal FDA law are the “right to try” laws which allow access to post phase 1 clinical trial drugs outside of FDA approved clinical trials, which is illegal under federal law.

Will the feds try to stop people from getting stem cells in Texas under the Texas law?

My guess is no for a variety of reasons. I don’t think the bill will open-up the floodgates to the kind of single doc small clinics based on the very severe limitations which the amended bill places of facilities and physicians seeking to do these treatments. For reasons which I’ll explain, you’re going to have to be big, well financed and well-connected to open-up a stem cell clinic in Texas which takes full advantage of the Texas law, meaning using cultured/expanded stem cells or umbilical or other allogenic (other people’s) stem cells.

The easy part of complying with the bill

To be eligible to receive stem cells under the bill, you’re going to need a certification from a physician that you have a terminal or chronic, incurable disease. That’s easy, since there are, regrettably, an overabundance of these types of conditions, anything from cancer, to MS, ALS and dozens more incurable diseases.

The patient is going to have to receive “informed consent” and maybe the Texas Medical Board will have a say in that, but that’s easy too. It’s experimental treatment, meaning that it hasn’t been proven by controlled clinical trials to be safe and effective. But these treatments are only going to be available for people with no other hope of cure, so informed consent won’t be much of an issue.

The Hard Part

The amended bill which came from the senate contained three onerous conditions. The first, which basically killed the whole bill, required that the treatments be in compliance with federal law. The whole point of the bill is to allow stem cell treatments not currently permissible under federal law, namely cultured/expanded autologous stems cells and umbilical cord and other types of allogenic stem cells. Fortunately, based on negotiations between the House and Senate, this provision was dropped, and that made the bill at least meaningful and possibly helpful to patients.

However, the House had to accept the other two Senate requirements to get the job done, and these limitations will mean that these type of stem cell treatments will probably only be available at a handful of places in Texas, at least for the foreseeable future. Here are the limitations on access to these treatments under the passed legislation:

1. Where you can get treated

The treatment will only be available at a hospital, medical school or ambulatory surgical center (“ASC”). In other words, you can’t get it at a regular physician’s office. Further, you can forget about getting these treatments at any medical school hospital because none of them (all of which do FDA approved research) are going allow the administration of non FDA approved drugs without FDA approval via the IND approval process (Investigational New Drug application). They get mega bucks from Pharma to do FDA clinical trials, and they’re not going to jeopardize that on so-called “unregulated human experimentation.”

The ASC (ambulatory surgical center) requirement was previously used by the Texas Legislature to eliminate or severely restrict abortions because individual physicians couldn’t afford to turn their offices into ASC level facilities. That might not be as much of a financial barrier in the stem cell arena since stem cell treatments are orders of magnitude more lucrative than abortions (hundreds of dollars versus 20k a pop for stem cells). Still, if a doc wants to provide these services, he/she will have to shell-out a few large, (as in millions) for up-front costs to create an ASC. That won’t be a problem for some of the popular off-shore stem cell clinics which had years to amass war chests awaiting their entry/reentry into the US market. Because of all the money in the field, ultimately, there will be players who will be able to either create ASC’s or partner-up with cash needy hospitals.

2. University or Big Hospital IRB Approval, Oversight and Paperwork Submission

The biggest impediment to unfettered access to unapproved stem cell treatments is that all stem cells under this bill must be given with IRB (Institutional Review Board) approval and oversight from a university/teaching hospital or large hospital IRB. As indicated, I don’t see any University IRBs granting IRB approval for the administration of non FDA approved drugs outside of clinical trials. But per previous, the lure of huge amounts of cash (and all these non FDA approved stem cell treatments are cash treatments) will induce at least some large but cash poor hospitals to try to set up an IRB and partner with or start their own HB 810 stem cell clinics.

The IRB requirement will stop every Tom, Doc and Harry from opening-up strip mall, doc-in-a-box facilities, and that’s probably not a bad thing. But it probably won’t stop the big off-shore or U.S, stem cell players.

Treatment will be expensive because the IRBs are going to have to maintain information about all patients treated and make annual submissions to the Texas Medical Board which takes time and money. The stem cell providers are going to have to give the hospitals and their IRBs their cut, while maintaining their substantial profit margins.

3. Texas Medical Board Approval of IRBs?

The bill allows the Texas Medical Board (TMB) to regulate the IRBs overseeing HB 810 stem cell clinics. I have a crystal ball and I’m getting a very clear picture that the TMB will decide to do so. Wait… I’m also seeing some language. Yes, I see the actual text of the TMB’s regulations of these IRBs. Here is what the TMB’s IRB regulations will look like:
In addition to being affiliated with a university or hospital per the bill, the IRB will also have to be accredited by the Association for the Accreditation Of Human Research Protection Programs, Inc. (AAHRPP) and be registered and qualified under the federal IRB statute (21 CFR part 56) dealing with human experimentation, or some other national accreditation organization recognized by the TMB.

Ok, my crystal ball isn’t that accurate, but I do know how to read the TMB’s current rules. The TMB already regulates IRBs overseeing the use of investigational agents, (Board Rule 198). What I’ve related above is what the TMB currently requires for IRBs supervising investigational agents. There is no reason to think that the Board will do anything other than apply this already existing board rule to stem cells.

4. Physician Compliance with Board Rules
The bill also states that a physician administering stem cell treatments must comply with all applicable medical board rules. That’s alittle vague for my taste. As an experienced Texas Board lawyer, it opens up all kinds of stumbling blocks and pitfalls. But we’ll leave that discussion for another day.

So here it is: Texas is poised to become the first state to allow the use of cultured/expanded stem cells, as well as umbilical and other allogenic tissue products outside of FDA approved clinical trials.

That is very good news for patients with terminal and incurable chronic diseases who chose to assume the risk of “unproven” treatment, (and I personally think this is a basic but heretofore unrecognized right). It’s bad news for the stem cell institutional Mafioso who wants to limit access to these treatment to FDA approved clinical trials.

The patient advocates (and the legislators) deserve a great deal of credit. They did an amazing and almost unbelievable job which will benefit many patients.

But my message to them is that it’s not over yet, even when the Governor signs the bill. The ball will go to the TMB’s court and there are many ways in which this can all go sideways.

So continued vigilance is the watchword.

Still, congrats on a job well done. Patients with incurable diseases owe you big-time.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

The Sleeping Giant Awakens: The FDA starts its final push to eliminate practice of medicine stem cell clinics

The Sleeping Giant Awakens: The FDA starts its final push to eliminate practice of medicine stem cell clinics

In late August, the FDA issued a trilogy of pubic actions and announcements advancing its goal of shutting down what I’ll call the practice of medicine stem cell clinics (“POM”). These clinics provide autologous stem cells and other autologous tissue or tissue based products which have not been approved by the FDA. These clinics have exploded in popularity over the past dozen years, which has caused the FDA and the stem cell institutional players much angst. The FDA’s efforts to close these clinics started a couple years ago when it sent warning letters and issued four draft stem cell guidance documents which, if followed, would all but eliminate the ability of patients to use their own stem cells for therapeutic purposes. I’ve discussed these guidance documents often and at length. Here are a few:

http://wp.me/p7pwQD-2ohttp://wp.me/p7pwQD-4yhttp://wp.me/p7pwQD-4B
http://wp.me/p7pwQD-4Xhttp://wp.me/p7pwQD-5g
http://wp.me/p7pwQD-5zhttp://wp.me/p7pwQD-64

The guidance documents propose dramatic changes to critical terms, such as what constitutes homologous vs non-homologous use of a stem cell (or other tissue) and the definition of “more than minimal manipulation.” The purpose of these proposed definitional changes is to render illegal most same day autologous therapeutic transplant procedures.

Last September, the FDA held a two-day public comment hearing on the draft guidance documents. Many of the stakeholders on both sides of the issue testified.

Then there was nothing

Since September 2016, there’s been nary a peep out of the FDA. Of course there was the little matter of the election, and the resulting interesting times. In due course, a new FDA commissioner was appointed.

And then the sleeping giant awoke

In late August, the FDA made three dramatic pronouncements, which have the same underlying message: the FDA is going after the POM clinics. Here they are:

1. Warning Letter to Kristina Comella and the US Stem Cell Clinic in Sunrise, Florida
On August 24, 2017, the FDA issued a warning letter to US Stem Cell Clinic in Sunrise, Florida and its head, Kristina Comella.
Here it is:
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573187.htm

Ms. Comella and her clinic had become infamous after an anti-POM clinic New York Times story reported that several patients had gone partially or totally blind as a result of the clinic’s nurse practitioner (NP) injecting the patients’ eyeballs with stem cells (actually a stromal vascular fraction derived from adipose tissue) for therapeutic purposes (macular degeneration). Given these seemingly egregious facts, it was just a matter of time until the feds went after the clinic.

The warning letter had several parts. First, in line with the draft guidance documents, the FDA said that the clinic’s SVF (stromal vascular fraction) was a drug and not exempt from regulation under 21 CFR 1271.15 (see my prior discussions on this regulation listed above).

The FDA’s drug determination had two bases: First, the SVF product was more than minimally manipulated because it altered the relevant characteristics of the adipose tissue (i.e. fat). Second, the use of the fat derived product was “non-homologous” since it was used to treat an eye condition, which is not a homologous use of fat. Thus, the FDA’s conclusion that the product was an unapproved new drug, and not something which is exempt from the FDA’s new drug laws.

The FDA’s other disconcerting finding was that that the clinic was deficient in terms of its CGMP (Current Good Manufacturing Practices) and CGTP (Current Good Tissue Practices) standards, compliance of which is presumably required under federal law. The FDA cited fourteen areas of CGMP and/or CGTP deficiencies.

Based on my experience, it is going to be very hard for a regular medical clinic to be fully CGMP and CGTP compliant. Further, I can’t think of any other examples of types of clinics in which such rigorous standards are applied by the FDA to medical clinics. Also, I have firsthand experience that early on, the FDA took the position that if the 21 CFR 1271.15 exemption criteria are met, the FDA did not have jurisdiction over the procedure or the clinic because it was the practice of medicine. Obviously, the FDA has changed its view.

The warning letter documented the clinic’s impeding the FDA’s inspection, which is never a good idea, since as the FDA pointed out in the warning letter, such actions can administratively transform approved drugs into adulterated ones.

The warning letter acknowledged the clinic’s prior response to these violations (presumably noted in the 483 (i.e. the inspection report issued by FDA inspectors at the conclusion of the inspection)). The clinic argued that it was engaged in the practice of medicine and hence exempt from all FDA drug and inspection requirements. The warning letter rejected the clinic’s contention.

This was the same argument used by the Regenerative Science clinic in Colorado a few years back when it tried to argue that the culturing/expansion of autologous stem cells was the practice of medicine and exempt from federal regulation. Regrettably, the federal court rejected the argument which surely emboldened the FDA in its current mission.

And that brings up an annoying point: Bad Cases Make Bad Law

The Regenerative Science case was a bad case in the sense that under current regulations culturing stem cells seems like more than minimal manipulation. The decision fed the beast, which from my perspective was a bad thing.

The problem with the FDA’s choice of using this particular Florida stem cell clinic is that the case involves nasty, and almost inexplicable facts. A nurse practitioner injecting tissue products into people’s eyeballs! What genius thought that was a good idea, legal though it may be under the Florida scope of practice laws. So when patients were harmed by the NP, the FDA could not have found a better poster child to show the dangers of these unregulated and “illegal” clinics.

My guess is the Florida clinic is not going to roll-over, and will either sue the FDA first (and that case will be dismissed) or wait for the FDA to sue the clinic. It’s going to be a tough job defending the clinic on those facts. If the clinic loses (and there’s a very excellent chance it will), that will be another nail in the coffin in the POM stem cell clinics.

2. FDA Raids California Stem Cell Clinics

Here is the headline from the FDA’s August 28th Press Release involving two California POM clinics:

“FDA acts to remove unproven, potentially harmful treatment used in “stem cell” centers targeting vulnerable patients”

Gulp (or hurray for the FDA, depending on your perspective).

Here is the press release:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573427.htm

According the press release, the clinics were using a live virus vaccine (Vaccinaia Virus Vaccine (Live) on patients, presumably as part of the stem cell or other autologous tissue treatment. The FDA contends that the vaccine is not commercially available and poses a danger to patients. I haven’t heard about the use of this kind of product in processing autologous stem cells, but I’m hoping the clinic has a good explanation, because it will need it.

My guess is that after investigation, the FDA will issue a warning letter/cease and desist, on the grounds that the autologous product which either contains the vaccine or is used to process the material constitutes the FDA trifecta of illegality (introducing into interstate commerce an unapproved new drug, adulteration, and misbranding). I think the FDA may seek to extract a formal cease and desist, then it’s entirely possible that a criminal case will be started, after the civil side is resolved. So watch out you guys!

3. The FDA Commissioner’s public statement

Here is the title of the Commissioner’s August 28th press release:
“Statement From FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine”
Here is the press release:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573443.htm

Here are some of my favorite parts of his statement:

“There are small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive and sometimes corrupt assurances to patients based on unproven and, in some cases, dangerously dubious products. These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products as a way of deceiving patients and preying on the optimism of patients facing bed illnesses. . . A select few often motivated by greed without regard to responsible patient care, are able to promote unproven, clearly illegal, and often expensive treatments that offer little hope, and, even worse, may pose significant risks to the health and safety of vulnerable patients.”

* * *

Commissioner Gottlieb further stated that while the FDA has taken action recent action against a few of these clinics, “but unfortunately, these are examples of a larger pool of actors who claim that there unproven and unsafe products will address a serious disease, but instead put patients at significant risk. We will seek to take additional actions in the coming months as we address this field, and target those who are clearly stepping over the line, at the same time that they created potential danger to patients.” (Emphasis added by me)

* * *

“I have directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever and legally enforceable means are necessary to protect the public health.”
Double Gulp. The FDA has painted a target on all of the POM stem cell clinics and the Good Dr. Commissioner Gottlieb is not shy about saying so.

What’s next?

1. Expect the Final Guidance Documents soon

It’s been a year since the close of the public comment period on the draft guidance documents, and it’s been almost a month since the FDA issued its trilogy of announcements of its new campaign against the POM stem cell clinics. So I would expect in the next few weeks the FDA to issue the final guidance documents. We already see the big picture: the therapeutic use of stem cells and other tissue or tissue derived products will be regulated as drugs, meaning they will not be exempt under 21 CFR 1271.15. I hope and expect to see some small carve-outs, like for fat for breast reconstruction purposes. I also expect the FDA to clarify and/or reinforce its position that even for exempt uses under 21 CFR 1271.15, CGMP and CGTP regulations apply. That’s bad news for the POM clinics.

2. More FDA Inspections of POM clinics

I suspect that the FDA has obtained a list of the POM stem cell clinics from the authors of the study published on these clinics.

I would expect the FDA to conduct inspections of some of these clinics, to get the message out that the FDA means business. The initial targets will likely be the big, high visibility clinics whose only business is providing stem cells or such products to patients.

It might be a good idea for POM clinics to have an inspection plan in place before the FDA appears at the front door. FDA inspectors don’t have to make an appointment in advance. They just show up and demand entrance.

A relationship with knowledgeable counsel would be a good idea also. If the clinic is using materials imported from outside the U.S., FDA criminal experience would be good and useful in said counsel, because once the importation becomes known to the inspectors, OCI (Office of Criminal Investigations) is likely to get involved.

So what should the POM Clinics and its supporters do?

As stated, preparing for an inspection would be a good start. Warning letters and guidance documents are tricky regulator creatures. I suspect the founding fathers would have been very perplexed that the system they created could conceive such creatures. But alas, they have to be dealt with, and there’s only two ways to deal with them head on: the courts and Congress. Both avenues need to be explored, but more about that another time.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com
www.rickjaffe.com

California enacts a new stem cell law, but it won’t do or change anything

California enacts a new stem cell law, but it won’t do or change anything

On Monday, October 2, 2017, Gov. Jerry Brown signed into law SB 512, which requires what I call the practice of medicine stem cell clinics to notify their patients that the use of stem cells by the clinic is not FDA approved. And that’s it!

Here is the link to the law:
http://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201720180SB512

The law should be a welcome relief to the hundred plus California clinics that provide stem cell treatments to patients, because it does not affect their businesses at all. Any prospective patient who knows enough about his/her condition or disease to consider stem cells, knows that the therapeutic use stem cells is not FDA approved, and has probably failed conventional treatment, so lack of FDA approval is not a concern.

But even beyond that, most clinics (and all of the clinics I represent) already inform patients about the non-FDA’s approval status of their treatments, and provide much more information to secure and document informed consent. Thus my conclusion that SB 512 won’t have any meaningful effect on these clinics. Nor will the law provide most stem cell patients with information that has heretofore been lacking.

The law also gets the California Medical Board into the picture, sort of. The board will have to separately identify complaints received and disciplinary/administrative actions taken against licensees who administer stem cell therapies. I suppose that may provide some useful information down the road, but I don’t think any of the California stem cell clinics will give this provision a second thought.

So in my view, the California stem cell clinics have nothing to worry about, so long as they post the required notice and give the patient the required form.

The institutional stem cell mafia (which is against the practice of medicine stem cell clinics) is likely to be wholly unsatisfied by the law because it does not restrict these clinics, and because the Mafioso doesn’t believe that non FDA stem cell treatment should be available outside of clinical trials, even with complete informed consent.

The real problem the practice of medicine stem cell clinics have is, of course, the recent spate of activity by the FDA and the likely content of the FDA’s four final guidance documents on autologous stem cell therapies. See my prior post at:
http://rickjaffeesq.com/2017/09/22/sleeping-giant-awakens-fda-starts-final-push-eliminate-practice-medicine-stem-cell-clinics/

I’m still expecting the issuance of these documents soon, but we’ll see.

Richard Jaffe, Esq.
rickjaffeesquire@gmail.com
www.rickjaffe.com

Big Surprise: FDA’s Final Stem Cell Guidelines Threaten the Existence of Stem Cell Clinics

Big Surprise: FDA’s Final Stem Cell Guidelines Threaten the Existence of Stem Cell Clinics

As widely reported yesterday, the FDA finalized the draft guidance documents concerning stem cells, or as the FDA refers to the category broadly, HCT/P’s.

The draft guidance documents proposed a couple years ago made it very hard for what I call unregulated stem cell clinics to operate. Based on recent FDA action against a couple of these clinics (see my prior post at http://rickjaffeesq.com/2017/09/22/sleeping-giant-awakens-fda-starts-final-push-eliminate-practice-medicine-stem-cell-clinics/),the tea leaves weren’t looking good for the FDA loosening-up the rules in the final version. Well, the final documents are out and the feds didn’t (lossen them up). The final guidance documents are at least as bad as the drafts, and in one important respect, worse.

Here is the main guidance document on minimal manipulation and homologous use.
https://pactgroup.net/system/files/GD_HCTs_20171116_UCM585403.pdf

The FDA also issued a final guidance document on same day surgical procedures, but practically speaking, that one is irrelevant, based on the main guidance document. And that’s because, per many of my previous posts, the two critical concepts which determine the legality/illegality of the delivery of HCT/P’s to patients outside of clinical trials are: homologous vs. non homologous use, and more than minimally manipulation (“MMM”).

What’s a Non Homologous Use? Answer: It’s what you’re all doing!

If there is one sentence in the FDA guidance document which sums up the FDA’s position on the use of HCT/P’s by the heretofore unregulated clinics, this is it:

“If an HCT/P is intended for use as an unproven treatment for a myriad of diseases or conditions, the HCT/P is likely not intended for homologous use only.” (Page 15 of “Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use”, here is the link again: https://pactgroup.net/system/files/GD_HCTs_20171116_UCM585403.pdf )

To remind you, if the use is non-homologous, (meaning not the same function as from where the HCT/P derived), it’s a drug, requiring the IND/NDA path, and the non-homologous use of which is a violation of the regulation, the law which leads to bad things.

Every unregulated stem cell clinic that I am aware of falls within this FDA statement, and I wouldn’t get my hopes up based on the FDA’s “likely” qualification. If you’re using an HCT/P to cure a disease and it’s not something like hematopoietic cells or bone marrow for blood conditions, blood related cancers, or immune system issues, your use is non-homologous according the guidance documents (draft and final).

When is an HCT/P More than Minimally Manipulated? Answer: Every process used on an HCT/P unless there is scientific proof to the contrary

The nastiest thing in the final guidance document is that the FDA has created in effect an irrebuttable presumption that anytime you do anything to an HCT/P, it’s MMM unless there is information that that the process is minimal manipulation, or as the FDA puts it:

“Please note that if information does not exist to show that the processing meets the definition of minimal manipulation, FDA considers the processing of an HCT/P to be “more than minimal manipulation”, (which basically makes the HCT/P a drug)

For structural tissue like fat, MM is defined by the FDA as “processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement.”

For sure, when you separate the mesenchymal stem cell (“MSC”) from the adipose substrate, that’s MMM, let alone when the MSC is further processed into something like SVF or some other derivative product.

Prior to the draft guidance documents and even under the draft guidances, you were more or less free to argue that what you were doing to the HCT/P was not changing its relevant characteristics or MMM (more than minimally manipulating it), and then presumably force the FDA to prove that you were. Under the final guidance document, if there’s no “information” that what you’re doing is MM, then it’s not.

What Kind of Information is Needed Exactly?

Frankly, I’m not sure. Part of my uncertainty is there is some fuzziness, in my mind at least, about what are the relevant characteristics, etc. It’s an FDA created concept or administrative conclusion, rather than a biological fact or physical thing like a stem cell or HCT/P. Or it’s a question of where you draws the line. So is there a new business in creating “information” that some process doesn’t alter relevant characteristics?

How broad is the Guidance Document? Answer: Broad enough to cover basically any human tissue used by the unregulated clinics.

The guidance document covers almost every conceivable human tissue except some specific things like vascularized human organs, blood and blood components as listed in the regs, secretions or extracts like milk or other bodily fluids, bone marrow not MMM and a couple other things which are not of interest to the unregulated stem cell clinics. All other human tissue is subject to the guideline and the resulting restrictions. (See footnote 3 of page 2 of the guidance document for the list of excluded products).

So is there any Good News in the Final Guidance Document? Maybe, if you’re a Super Optimist

Perhaps to lessen the sting to the unregulated stem cell clinics, (or more cynically, to give them a false sense of hope), right in the beginning of the guidance document, the FDA says that in some cases it will use its enforcement discretion, and not enforce its interpretation of the regulations for three years to give stakeholders time to decide whether they are in compliance with the law or need to go the IND/NDA route. Later in the document, the FDA lists some factors which it will use to decide who it will not go after during these three years. (See pages 21-22).

The good of it is that autologous use lowers the risk.

The really bad of it is that high on the FDA hit list is non-homologous uses for serious and life threatening diseases and where the HCT/P’s are delivered by “high risk” methods like IV, infusion and some other methods. (See page 21 paragraph V B). The FDA considers the unapproved use of HCT’s for such life threatening conditions particularly nefarious since it might delay patients receiving “safe and effective medical treatment.” That’s an unfunny joke because the main, if not the only reason people seek out HCT/P treatment is because there are no safe and effective treatment for such conditions.

So basically, if you’re using HCT/P’s for curing or mitigating diseases other than blood or immune conditions, I’d say you’re not going to be the beneficiary of the FDA’s enforcement discretion largess.

Does that mean you should expect to receive a visit or letter from the FDA in the next year or three?

Not necessarily. There are hundreds of you clinics out there. It takes a lot of man-hours (sorry, person-hours) by many line investigators and back office federales to do each investigation. The FDA’s resources are insufficient to open up investigations and engage in the process of finding violations for anywhere near the number of clinics out there.

So what’s going to happen?

The FDA will continue with the administrative process of the high profile clinics which it has recently targeted. I think it will start the investigatory process with a few other high visibility clinics, as time and person-power permits. This will reinforce the message that the FDA is out there and remind the clinics that what they are doing is illegal (according to the FDA).

It will probably take almost a year or two before there is a judicial decision on the validity or enforceability of the guidance document. A safe bet is that the FDA will bring an injunction action against one of these clinics for not, in effect, closing. Injunction cases are tried to the judge, not a jury.

If the first case involves the Florida clinic where a nurse practitioner injected eyeballs with HCT/P’s and caused blindness, well you don’t have to have a crystal ball to know the result. Like I say, bad cases make bad law.

It’s going to interesting times for the unregulated stem cell folks.

More to follow.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com
www.rickjaffe.com

I’m flattered but this is what the stem cell clinics are up against; To me it’s all about personal freedom

I’m flattered but this is what the stem cell clinics are up against; To me it’s all about personal freedom

I’ve just had the distinct but perhaps questionable honor of being quoted extensively by the Grand Inquisitor of all things unconventional (medicine wise). here is his post:

https://respectfulinsolence.com/2017/11/21/fda-cracks-quack-stem-cell-clinics/

Like M.C. Escher so brilliantly explains in his pictures, it all depends on your perspective, whether you think the the FDA final guidance documents are a good or bad thing.

But, one thing I’ve never been able to figure out about the other side is why the obsession with the stem cell clinics with how much money they are making. 580,000 people a year pay a ton of money in cancer treatment and die in spite of what they spent. Where’s the outrage from the other side for all the money which patients spend on approved but unsuccessful treatments? And that’s just cancer. And what about all the approved treatments which have caused or hastened death, disability or morbidity?

To me it all comes down personal freedom. Why should the FDA, Paul Knoeffler or David Gorsky be able to tell me that I can’t pay someone to remove part of my body which may have some healing power and reimplant it, especially if there is no other treatment available, or the options carry lifestyle or serious morbidity risks. We all get that it hasn’t been blessed by the FDA or the stem cell mafiaoso, but it’s my body. That seems to me to be the core issue. We get that people like you think we’re making a foolish decision. But society lets people do many worse things, like smoking. Maybe it’s time for Congress to get involved, if it can pull itself away from the reality show and start doing the people’s business.

rick jaffe, Esq.
rickjaffeesquire@gmail.com
www.rickjaffe.com

The year in review and some predictions about next year/ Part One: Stem Cells

The year in review and some predictions about next year/ Part One: Stem Cells

It’s time to look back at what happened this year, and make some predictions about next year. Part One will focus on stem cells.

We started 2017 awaiting the FDA’s final guidance documents on HCT/P’s (“stem cells”). In late August, the FDA foreshadowed the guidance documents by issuing warning letters to two of most high profile (or infamous) stem cell clinics in the country. Both clinics were warned that their use of HCT/P’s were in violation of the FDA trifecta (unapproved new drug, misbranding and adulteration), and that their facilities were not in compliance with applicable good tissue and manufacturing practices.
Here is my post about it:

http://rickjaffeesq.com/2017/09/22/sleeping-giant-awakens-fda-starts-final-push-eliminate-practice-medicine-stem-cell-clinics/

Within two months of the warning letters, the FDA published the final guidance documents. They were at least as bad (from the perspective of these clinics and the patients which seek out non-FDA approved stem cell treatments) as the draft guidance documents.

See my prior post analyzing the final guidance document:

http://rickjaffeesq.com/2017/11/17/big-surprise-fdas-final-stem-cell-guidelines-threaten-existence-stem-cell-clinics/

On the other hand, two states passed stem cell legislation. California passed a meaningless law aimed at providing informed consent to patients.

See my post at:

http://rickjaffeesq.com/2017/10/05/california-enacts-new-stem-cell-law-wont-change-anything/

Texas passed a stem cell law which could allow patients to use both autologous and allogenic stems cells therapeutically (or in FDA parlance, “non-homologously”).

The law won’t open-up the floodgates because of the relatively high barriers to entry (i.e., the cost of an ambulatory surgical center, and the big-time IRB requirements), but as I’ve said, as long as the Texas Medical Board doesn’t mess it up, Texas could become the Mecca for the therapeutic use of stem cells.

here is my post about it:

http://rickjaffeesq.com/2017/05/31/landmark-texas-stem-cell-legislation-gets-through-the-texas-legislature/

And yes, Congress did pass some legislation involving stem cells, but it just deals with supposedly faster approval. It won’t cause a single patient to receive stem cell treatments in 2018, or so is my prediction. The bill was just a tactic to get stem cell advocates off of Congress folks’ back.

Finally, last week, a civil lawsuit was filed against the Florida clinic which has become the poster child of the “greedy and evil” for-profit, heretofore unregulated stem cell industry. These are the folks that had a nurse practitioner inject HCT P’s in the eyeballs of patients and allegedly caused blindness or reduced vision. That’s bad news for them and all of the stem cell clinics in the intermediate term. It’s going to take a while for the case to reach any meaningful result. But the institutional stem cell Mafioso will surely keep banging the drums about this case to keep the pressure on the FDA to do more.

What’s going to happen in 2018 in the stem cell field?

For sure, the FDA will try to pick-off a few more clinics by starting the process of inspections, issuing 486 field reports, and then following-up with warning letters. I expect to see one or more of the recipients of these warning letters to be involved in litigation with the FDA. However I don’t expect any court rulings until at least mid to late 2018. As I said before, if the first case decided involves the Florida clinic involved in eyeball injections, the stem cell field won’t like the result.

Are private stem cell clinics going to disappear from the US in 2018?

Absolutely not! If anything I think 2018 will bring more options to patients in terms of use of their own stem cells and even umbilical cord stem cells and other HCT/P’s.

You might ask how I can possibly think this in light of the final guidance documents and the FDA’s recent warning letters?

I think the delivery of these new therapies is going underground. My read is that more and more physicians are quietly using HCT/P’s in their practice. Therefore, I think that in 2018 and beyond, more people will have access to these treatments, but not necessarily through the large, high profile stem cell only clinics, because some of them will be mired in legal battles with the FDA.

Won’t the FDA shut all of these stem cell docs down?

I don’t think so because the FDA doesn’t have the resources or infrastructure to eliminate the clinical use of stem cells.

More in the weeds: more doctors are using stem cells in their clinical practice. The FDA isn’t equipped to go after all of these practitioners, because its structure, resources and operations are geared towards drugs, not the practice of medicine. (And the practice of medicine just happens to be the best defense these docs have, albeit, not recognized by the one case in which it was raised, but more about that another time).

Equally important, patient demand is too great, and more and more physicians are seeing the dramatic benefits of these treatments.

I predict that many more docs will start using stem cells because of these two factors, and FDA be dammed. Ultimately, I predict that the popularity and the anecdotal evidence of success will prevail over the FDA and the stem cell Mafioso. So while the FDA may pick-off a few of the large, high profile or infamous clinics, I think there will be as good, if not better access to these innovative treatments in 2018. That is my prediction and hope.

Richard Jaffe, Esq.
Rickjaffeesquire@gmail.com
www.rickjaffeesquire.com

FDA sends a Happy New Year greeting to another stem cell operation!

FDA sends a Happy New Year greeting to another stem cell operation!

As a prelude to more of what may be coming this year, the FDA has issued its first warning letter to a for-profit stem cell entity, on the third working day of the New Year. As per previous posts, expect more to follow in the coming weeks and months, targeting the most visible stem cell only entities.

Here is the warning letter:

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm591225.htm

Same ol, same ol, but with a twist

The letter is largely the FDA’s standard form warning letters to stem cell operations, but not quite. This entity, based in New Jersey, produces SVF (stromal vascular fractions) from adipose tissue, which is what most of these places do. That product is considered “more than minimally manipulated” under the FDA’s final guidance document. The business also apparently claims that its product may treat a wide variety of diseases, which makes the use “non-homologous,” under the aforesaid guidance document.

The letter also makes noises about a “biologics license.” Places like this New Jersey entity have more of a chance of seeing a unicorn than they do in obtaining a biological license.

And like two prior warning letters, this warning letter finds cGMP noncompliance, including not having a (very expensive) clean room, and well as numerous other facility, hardware, systems and documentation deficiencies involved in commercially producing drugs.

The rub/twist in this case

Based on the warning letter, it appears that this entity doesn’t actually treat patients, but rather just manufactures the product for resale/injection by health care providers.

The other rubs is that there is an IRB (Institutional Review Board) involved and, according to the warning letter, the product is listed “for research use only.” The FDA didn’t think either of these things helped the company’s case and made the product legal.

Just to recap the regulatory process

First, the FDA shows up for an inspections, usually unannounced and with at least three FDA inspectors. They stay for at least a week demanding to see documents. The last day of the inspection, the company is handed a 483 inspection report, which is the agency’s preliminary and non-binding and non-exhaustive findings/”observations.” (In these FDA stem cell inspections, I have to believe the agents have a standard form or template, since all of these entities have the same basic operation and operational deficiencies).

The company is given a short time to respond in writing to the noted 483 deficiencies. The FDA then reviews the response. The FDA is never satisfied with the response (at least in for- profit stem cell entities), so 3-6 months later, a warning letter arrives in the mail, usually after it is posted on the FDA warning letter web page
The company has another short period (15 working days) to respond to the warning letter. Most of the time, and especially if the entities respond without counsel, they just repeat their response to the 483 observations. The FDA then considers the response, and then . . . .?

What’s next?

This is the third warning letter issued against stem cell entities since late summer. (See my earlier post on the prior two warning letters:

http://rickjaffeesq.com/2017/09/22/sleeping-giant-awakens-fda-starts-final-push-eliminate-practice-medicine-stem-cell-clinics/

So far, the FDA hasn’t taken the next step which would be a civil injunction action to stop the stem cell providers for administering and manufacturing their products. But dollars to donuts, the civil actions are coming. I suspect they will be (or the two summer warning letter at least) will be filed about the same time, so as to maximize the PR/threat impact.

The FDA’s choice of the three initial targets is interesting and possibly informative

The Florida stem cell clinic involves the most egregious facts. A nurse practitioner injected stem cell products into patients’ eyeballs and caused permanent vision damage, and the operation is run by someone without any actual health care background or training. This should be an easy case for the FDA, on the merits and more importantly, it and won’t cause public outrage even from the pro stem cell clinic field because of the bad facts. As I’ve said before, this is the best initial target, from the FDA and stem cell Mafioso’s point to view.

The California clinic supposedly uses some illegal or non FDA approved toxin either in or in the processing of its HCT/P’s. That’s about as good as you can get from the FDA’s point of view in terms of trying to solidify the FDA’s position on “more than minimal manipulation.” It’s going to be very hard for a federal judge to go for the stem cell advocate’s view if a clinic is using dangerous toxins in its product.

The New Jersey case is interesting and useful to the FDA because it targets an HCT/P manufacturer. This an important part of the FDA strategy because there are many, many docs out there using HCT/P’s who are buying the product from manufacturers like this New Jersey company. With this warning letter, the FDA is telling all these manufacturers that it hasn’t forgotten about them.

We’ll have to see how it all shakes out, but I’m still predicting that multiple injunction actions will be filed by the FDA in 2018, and I’ll bet sooner rather than later.

I still feel that the defense is going to be part legal and part public/legislative, and there’s probably still some arguments to be made which might be more receptive to the courts than to the FDA, but we’ll see.

Rick Jaffe, Esq.
Rickjaffeesquire@gmail.com
www.rickjaffe.com

First 2018 Stem Cell Update

First 2018 Stem Cell Update

We’re now beginning the second month of 2018, and we are a few months past the FDA’s issuance of the final stem cell guidance documents which are intended to dramatically limit the availability of stem cell treatments outside of FDA approved clinical trials.

See my prior post at: http://wp.me/p7pwQD-bB

So what’s going on so far in 2018?

FDA Inspections?

Rumor has it that there already have been several facility inspections this year. What I can say is that it’s more than a rumor. I can also say that the FDA is looking hard at cGMP and GTP compliance issues, and my informed guess is that not many of the private stem cell clinics are so compliant. I think the FDA’s reaction to these non-compliance issues as these entities go through the administrative process will vary and depend on some key factors. But we’ll have to wait and see how this shakes out.

The new Texas Stem Cell Law: Are we there yet?

The short answer is no because the law isn’t fully implemented yet.

For the details of the Texas law, see my post at: http://wp.me/p7pwQD-ab

The Texas law (HB 810) called on the Texas Medical Board (TMB) to issue a rule flushing out the law. Presumably, it’s not going to be legal to treat patients under HB 810 until the board creates an implementing rule.

Does that mean that stem cell treatments are not available in Texas now? Of course not. There are many docs and clinics administering stem cells right now in Texas. But they are operating very arguably in violation of federal FDA law. HB 810 creates, in effect, a Texas safe harbor for stem cell clinics to operate, but not until the TMB passes a rule about it. (The TMB already has a rule on investigational treatments, but that rule excludes stem cells.)

There was an initial stakeholder meeting in December about the rule, and there is a second meeting set for next week. The stakeholder group is composed of approximately 25 various interest groups, legislators, and state agencies. No doubt the key players are the stem cell clinics which plan to open up under the new law and some of the patient groups, which groups did the heavy lifting for the passage of the new law. They are a formidable group of people.

The Medical Board has already set up an ad-hoc committee to consider the rules once they are drafted. Expect the draft rule to be published in the Texas Register.

But that’s not the end of the process. Even if the TMB passes a rule, the statute requires that Health and Human Services Commission (HHSC) define terminal illness and severe chronic disease which are the statutory requirement to be eligible for treatment with stem cells. HHSC has delegated those duties to the Department of State Health Services, which has not yet started its rulemaking process.

The bottom line for patients: Don’t expect to get the treatment from these statutory clinics in the near future.

And for potential clinics: same, but further: It’s not a slam dunk that these statutorily approved clinics will ever see the light of day in Texas. After all, the Texas stem cell law bumps-up hard against federal law. Texas is a very conservative state, medically speaking. I have been dealing with the TMB and the AG’s office for 30 years, and I can tell you they are deeply committed to protecting the public against what they feel are unsafe or questionable medical practices. I think the HB 810 conflict with federal law is likely to cause some serious reflection on their part, and I think they will be very, very cautious in light of all the negative PR about the private stem cell clinics. But we’ll see.

And speaking of the drone of negative information about private stem cell clinics:

Of course there continues to be the hand-wringing and fear mongering about the private medical clinics and how the FDA is not doing enough to regulate them (read, put them all out of business). Expect the drum beat to continue, with citation to the same three eyeball injection/blindness cases brought to you by those idiots in Florida, along with the dangers of the deadly viruses used by the California stem cell physician group, that is, until there is a new stem cell horror/ fear inspiring story.

But there’s also a new PR tactic: mock those who say there is a conspiracy between Pharma, government, the stem cell academic institutions and stem cell trade groups to pressure the FDA to shut down the private stem cell clinics. I don’t know about Pharma’s role, but I suppose my constant use of the phrase “Stem Cell Mafioso” makes me a member of the conspiracy mongers. I’ve been called worse.

I’m going to be an adjunct professor! (for two hours anyway)

I’ve been asked to speak about stem cell regulation at a major university health law center graduate seminar on healthcare controversies. I was flattered to be asked, especially when I heard that the other speaker (pro-regulation) was Professor Leigh Turner, who is half of the Knoepfler-Turner team which published the seminal article about the 500 plus unregulated, wild west stem cell clinics, which article has been one of the key justifications of the aforementioned Stem Cell Mafioso’s efforts.

For sure, we’ll talk about the recent California and Texas stem cell laws, but I hope to broaden the discussion out to the role of medical innovation and restrictions on innovation. I think I’m also going to talk about the myth and limitations of evidence based medicine. I haven’t stepped foot in a law school lecture hall since law school, and that was when most of the original Saturday Night Live cast was still on the show. Yikes!

Any ideas of what I should talk about or what I should ask Professor Turner?

Should be interesting for a guy who lives in the trenches to have a brief visit to lofty academia.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com
www.rickjaffeesquire.com