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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

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

Happy New Year! Last year review, and what’s coming this year/ ACCME/Cali. Vaccine /Homeopathy/Supplements/Antitrust/Obamacare

Happy New Year! Last year review, and what’s coming this year/ ACCME/Cali. Vaccine /Homeopathy/Supplements/Antitrust/Obamacare

As we start the New Year, let’s look back and forward:

CAM’s ACCME problem

The biggest challenge facing the CAM community in the coming years is that CAM organizations are under direct attack by ACCME, the main CME accrediting agency. In the last year or two, the ACCME have initiated a process to revoke several CAM organization’s CME credit provider status.

See my post:

http://rickjaffeesq.com/2017/04/04/bad-day-cam-patients-first-cam-group-caves-accmes-extortionre-education/

If ACCME succeeds, the result would be devastating to these groups because they are financially dependent on their annual conferences. CAM physicians travel to these conferences in no small part to satisfy their annual CME requirements. Removing CME accreditations would likely dramatically reduce attendance, which would put these organizations in deep financial jeopardy. The conferences are where the CAM docs learn about the latest CAM therapies, so it’s all bad, if the CAM groups lose their course accreditation status.

There are now a handful of CAM organization that are in the process of having their CME accreditation status “reviewed.” I think revocation of ACCME CME status is the intended and likely result of ACCME’s review process of these organizations. Most of these groups are keeping this problem quiet, because they understandably fear that disclosure might jeopardize membership and future conference attendance.

What there hasn’t been yet or even seriously discussed is an all-CAM response and mobilization to deal with the problem. And I think that’s a shame and short-sighted.

Reminds me of a joke: A guy jumps off a hundred story building. As he passes the 50th floor, someone asks him “How you doing.” He responds “So far, so good.”

I have to believe there is a smoking gun out there. The ACCME has seven members, one of which is CAM’s biggest institutional adversary/detractor, the Federation of State Medical Boards.

Because there are so many CAM groups that have come under review/attack in such a short period of time, I have to believe that it’s not chance; its a concerted effort, or a conspiracy if you will, to eliminate CAM organizations which will make the dissemination of CAM information much more difficult.

Hey Santa Claus, I know I’m alittle late (or early), but what I want for Christmas is that smoking gun from the Federation to the other ACCME members laying out the illegal conspiracy to revoke the ACCME certification of all CAM groups. That would be a gift that would keep on giving and I think could result in the end of the attack.

Are you listening Santa?

The California vaccine concerned folks

For better and worse, not a lot happened in California vaccine concerned world.
You didn’t need a crystal ball to predict that every lawsuits challenging SB 277 would be dismissed, and that’s exactly what happened. And the same result awaits any new lawsuits which are direct attacks on the law (which removed the personal belief exemption).

The law’s primary legislative sponsor, Dr. Richard Pan, tried some other legislative tricks to eventually force all parents to vaccinate their kids, but nothing has gotten close so far. The vaccine concerned have to remain vigilant because there’s surely more coming from this guy and his vaccine happy posse.

There’s some talk about a SB 277 repeal bill. Obviously that won’t happen next year, but there are benefits to keeping the issue alive in the California legislature. So go for it, I say.

The Biggest surprise

I had thought that 2017 would bring a spate of new board actions against Cali docs who have written medical exemptions, since according to conventional medical authorities, there’s no such thing as a valid exemption from all vaccines throughout childhood. But apart from the Bob Sears case, (and maybe one other), I haven’t seen the California Medical Board go after the many docs who are writing these exemptions. It might because the board requires a complaint from someone to initiate an investigation, and there just aren’t any complaints yet.

What’s going to happen in 2018 for the vaccine concerned?

This year we should get a ruling in Bob Sears’s case and that ruling will tell the community and its docs who are writing the exemptions whether it’s safe to continue to do so. So keep your fingers crossed and stay tuned!

The Green Pharmaceutical homeopathy case

Homeopathy is under attack in California.

See my most recent post on it:

http://rickjaffeesq.com/2017/12/12/update-green-pharmaceuticals-homeopathy-caseyou-can/

The plaintiffs did file a response to Green’s request to the California Supreme Court to review the appellate court’s decision which overturned the bench trial judge’s defense verdict. Green’s lawyers have submitted a reply, and several groups and at least one private attorney (me) filed amicus letters. We should know this month whether the Cali. Supremes will take the case. I hope they do.

Can physicians sell supplements?

Last year, I handled a case in New Mexico involving a physician’s sale of supplements. The AMA considers it unethical for physicians to sell supplements.

Who Cares? The eight or so states that incorporate the AMA ethical precepts into their standard of care laws.

New Mexico went after a physician for selling a therapeutic herbal remedy (Byron White formulas) to a patient, a practice violation based on the AMA precepts. We said it wasn’t.

I didn’t change or clarify the law, but I did get the case against the doc dismissed, (which was my job), and I had some help from star and energy powerhouse Shirley MacLaine.

See my post:

http://rickjaffeesq.com/2017/07/05/new-mexico-integ…danger-work-done/

Thanks again Shirley!

Can a CAM physician sue a medical board for antitrust violation for bringing a board case?

My view is that it’s almost impossible to win such a case.
See my post at:
http://rickjaffeesq.com/2017/04/14/want-sue-medical-board-antitrust-violations-restraining-trade-prosecuting-practicing-kind-medicine/

Nothing has happened since the post to change my mind. Every doc who has tried has had his/her case dismissed. I don’t see anything changing in the next year on that score. Are there possible benefits to bringing this kind of case and getting thrown out of court? It depends on who you ask.

Obamacare

I end with Obamacare because its demise continues to be predicted, but from the CAM business perspective, Obamacare is basically irrelevant. Let’s face it, CAM by definition is unaccepted by the mainstream which in insurance-speak means it is experimental and makes it not insurance reimbursable (at least if the therapies and procedures are properly coded). CAM practice is a cash-based business model. So I don’t see the recent or future efforts to cripple Obamacare as having a direct adverse impact on CAM practitioners. In addition, the large majority of Americans receive their health insurance through their employers or various associations, and those folks will not be directly impacted by whatever the Republicans do to further cripple Obamacare.

Indirectly however, as more people are forced out of insurance, they will either not get the care, or get the care and not pay for it. This will raise the cost of healthcare and health insurance for others. Higher costs for healthcare and healthcare insurance which will result in people having less income for discretionary, non-insurance reimbursable CAM healthcare. So as Obamacare becomes increasingly crippled, in the mid-term, there could be some financial downside experienced by CAM businesses. (I’m not going to go into the morality or efficiency of what’s going on as I’ve already addressed those issues in prior posts dealing with what’s wrong with the American healthcare system.
See my post at:
http://rickjaffeesq.com/2016/09/24/whats-wrong-u-s-healthcare-system-take-fix/

That’s about all for now. Looking forward to the New Year’s challenges.
To paraphrase George C. Scott in Patton as he overlooks the aftermath of a brutal battle: God help me, I love this stuff.

Happy New Year!

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

Update on the Green Pharmaceuticals Homeopathy Case/You Do What You Can

Update on the Green Pharmaceuticals Homeopathy Case/You Do What You Can

To recap and expand on my prior post on the case:

(http://rickjaffeesq.com/2017/11/05/big-trouble-ahead-companies-selling-homeopathic-remedies-california-revised/)

Green Pharmaceuticals which makes SnoreStop was sued by a bottom feeding (IMO) plaintiffs class action law firm for false advertising and unfair business practices in California. The theory of the case was that homeopathy is unscientific nonsense and none of the product’s ingredients have any possible effect on snoring.

What made the case harder for the plaintiffs’ lawyers was that unlike most homeopathic products, the claims supporting SnoreStop were based on a gold standard clinical trial, i.e., a double blind, placebo controlled clinical trial, the results of which were published in a reputable international scientific journal. At the bench trial, the plaintiffs’ expert, a retired pharmacologist, disputed the validity of the study.

The defense called a well-regarded homeopath, but he had no conventional medical or scientific credentials. The judge rejected his testimony in toto as unhelpful and biased. (I’ve talked to both the homeopath and the trial attorney about the reasons for disqualification. It’s complicated and, not having access to the trial transcript, I can’t evaluate the disqualification).

Apparently a company employee (maybe the wife of the owner) also testified and discussed the study. It’s unclear to me (and to the Green Pharma people as well) whether the study was offered and admitted into evidence. I think it should have been if it wasn’t because the study is the scientific justification for the claims, and it was a bench trial so there was no issue of jury confusion.

The trial judge gave judgement to Green, finding that the plaintiffs didn’t prove their case on either count. The decision on its face was odd because after the plaintiffs rested, the defendant moved for judgement arguing that the plaintiffs hadn’t made their case (made a prima facie showing in legalese), but the judge denied the motion, finding that the plaintiffs put on enough evidence such that they could win unless Green rebutted the plaintiffs’ case. But since the judge rejected the defendant’s expert testimony, and he didn’t say he thought that the clinical study rebutted the plaintiffs’ expert testimony, his judgement for the Green was a real head-scratcher in that it seemed inconsistent with his earlier finding.

The plaintiffs took the case up on appeal. The appellate court also had a problem with what the judge did, and not only reversed, but ordered the trial court to enter judgment for the plaintiff class members and figure out how much each should get back from Green. This was an absolutely stunning and shocking result. The appellate court did this by disregarding some pretty important and hard-fought legal precedent protecting homeopathy. The appellate court also, in effect, rewrote the false advertising statute to make it easier to sue any manufacturer. Rewriting statutes is not something the courts are supposed to do.

My friends at the National Heath Freedom Coalition asked me to look at the case and give my opinion. The more I looked at it, the more pissed-off I got. I called some of the people involved to see if I could figure out how this all happened. I haven’t figured it all out yet, but I know enough to know that the appellate court’s decision is dead wrong, sort of outrageous and the result, ordering judgement for the plaintiffs rather than sending the case back for retrial or reconsideration, is either incompressible under clear existing law or idiotic (or both). I also know that the decision will hurt the CAM field and consumers who use products like this.

Green’s lawyers timely filed a petition for review with the California Supreme Court. They did a good job, especially on the technical points about why the appellate court was wrong. Interestingly, the plaintiffs didn’t file any opposition papers. There is no automatic appeal to the Supreme Court in California; it’s discretionary, and it’s very hard to get the Supreme Court to take a case. So the plaintiffs played the odds and didn’t file a response.

I hate legal bullying and I really hate opportunistic class action lawsuits which only benefit lawyers. This case had both. Despite Green’s good papers, I was concerned that more, more concise and focused, and something broader was needed to show the Supreme Court the bad things that would result from this horrible decision.

Well if not me, who?

Here is my amicus letter to California Supreme Court. For some reason, the published clinical study which supported Green’s claim wasn’t made part of the record that the Supreme Court was going to review, so I decided to remedy that problem as well and attached it to my letter.

greenamicusletter1

Hope it helps. Stay tuned!

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

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

Saturday Night Gala for Brain Tune-ups for TBI Vets

Saturday Night Gala for Brain Tune-ups for TBI Vets

This Saturday night, I’m going to the Brain Wellness Gala at the Army/Navy Club in DC. The organization raises money for funding veterans with TBI (traumatic brain injury) to get treatment with an effective but completely non-invasive treatment involving micro current stimulation. It’s a form of Neurofeedback.

Here is info about the event.
http://www.brainwellnessfund.org/

Neurofeedback for therapeutic or lifestyle purposes isn’t new. But these folks have are using the technique on TBI’ed vets with some dramatic results. Sounds a little out there maybe, but, I actually have experience with the technique.

One of the best parts of my job is seeing all the cutting edge therapies and new health related technologies. Every case I work on I learn something new, and every health conference I go to I pick up something to incorporate into my health/wellness/fitness regime.

A dozen years ago, I had a case in Maryland involving therapeutic brain biofeedback or Neurofeedback. The practitioner was a highly regarded neuro feedback specialist. The case was straightforward. The practitioner had a PhD in psychology, but she was licensed as a clinical social worker. The Maryland Medical Board thought that Neurofeedback should only be done by a medical doctor, and certainly not by a social worker even one with the highest level of state social work credentials and a PhD in psychology. After enlisting the support of some heavy duty professional organizations, I got the medical board to drop the case. Later, the psychology board tried the same thing, and fortunately, we achieved the same result.

When I flew up for the initial interview for the practitioner with the board, I asked if I could try her treatment to see what it could do for me. Like I said, I’m into this stuff. She said no. She was afraid that it might interfere with my representation of her at the interview.

Several years later, when I was back in DC on another case, I asked again. This time she agreed. The first thing that happened was that she did a brain map of my electrical wave activity. When she looked at my brain map, she was shocked. She told me that my brain waves were all jumbled up. (Maybe she used a more technical term). She couldn’t believe the high level of functioning I had achieved, and she surmised that it had to take more energy for me to focus and stay on task than most other people. Something about all the noise and cacophony inside my head.

Next came the treatment. She hooked up some electrodes to my head, based on the results of the brain mapping. I didn’t feel anything as it was just micro currents. The treatment only lasted five minutes, so she told me. I couldn’t tell because I fell asleep. But maybe I wasn’t completely asleep. I felt my body, but it felt much lighter. After I woke up and the treatment ended, I felt refreshed. I don’t ever recall having as restful or peaceful sleep or whatever state I was in.

I thanked her and went on to my next appointment which was lunch with the Executive Director of a prominent health advocacy group. I’ve known her for some time and during the course of the lunch she commented that I seemed different, more animated and had better energy. I reflected on that, and in fact I did feel an unusual sense of calm, focus, and a level of positiveness, that a crotchety guy like me doesn’t get to very often.

The clarity and well-being lasted for days. Eventually, it wore off and I returned to my regular self, for some better but mostly worse.

Over the next couple years I didn’t have occasion to get back to the DC area, but I wanted to get back to that place, so I tried a few other brain biofeedback practitioners in Texas. They all used different techniques and devices. Your eyes tracked or try to control a rocket ship or race car. None of the other stuff got me back to my happy space. Some actually gave me severe and persistent headaches.

Last year I got back to DC area and had another couple treatments. It was great. The only other time I felt almost as good, brain and mood wise was when I was following a strict Paleo diet and became mildly ketogenic, but that was hard work and ultimately I couldn’t sustain the strict Paleo diet, and I lost most of the benefit. I’m hoping one of these days she can sell a portable unit so I can permanently reside in my happy place.

But back to the TBI vets. The practitioner has results from a study she did on the TBI vets, and they seem dramatic if not amazing. She’s continuing to treat TBI vets, but on a very small scale. I hope she and her team can take it to the next level. It’s been slower progress than she and her support group, Brainwellness.org had hoped. But maybe someone big will step forward and make it happen.

If you’re in the DC, come to the Gala this Saturday night November 11th. It should be fun and rewarding to hear some of the stories and meet some of the vets being helped by this treatment.

Info again about the Gala:

http://www.brainwellnessfund.org/

And if you’ve got jumbled brain waves and/or too much internal chatter, have Mary Lee Esty, PhD quiet things down and tell her Galileo’s Lawyer sent you.

http://www.brainwellnessandbiofeedback.com/

See you Saturday night!

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

Dr. Bob Sears Medical Board Case Update: LA Times tries to squeeze, shame and goad the California Medical Board to go after Bob Sears and other vaccine exemption writing Docs harder and faster

Dr. Bob Sears Medical Board Case Update: LA Times tries to squeeze, shame and goad the California Medical Board to go after Bob Sears and other vaccine exemption writing Docs harder and faster

We recently received hearing dates in late May, 2018 for Dr. Bob’s hearing before an administrative law judge. The case is primarily about his writing a note excusing the child from vaccination due to two prior severe vaccine reactions.

But May, 2018 apparently is not soon or severe enough for the LA Times which today published a story complaining that Dr. Bob and many other doctors are still writing medical exemptions that don’t meet the standards of medical exemptions by conventional pediatrics and the CDC (under which standards there are no medical conditions which justify a blanket exemption from all vaccines throughout childhood). The Times seems to want all these docs rounded out or put out of business today.

The title of the article says it all:

“Why hasn’t California cracked down on anti-vaccination doctors? A loophole in state law”

Here is the article:

http://www.latimes.com/local/lanow/la-me-ln-vaccine-doctors-20171106-htmlstory.html

The article has some interesting quotes from Senator Ben Allen, one of SB 277’s authors about the intent of the bill and how he doesn’t support the medical board trying to intimidate doctors who write exemptions. The article also quotes Jay Gordon, another prominent vaccine concerned doc opining that it’s up to the doctor to decide whether to give an exemption or not.

Maybe the board is moving slowly because it’s starting to realize that the issue is more complicated and nuanced than the rabid pro-vaxxers make it out to be.

In working on Bob’s case for the past year, a couple things have come out that surprised me, and having been in the cutting-edge medicine field for more than 30 years, not much surprises me these days.

First, in looking for academic experts for the case, I keep hearing the same thing over and over again. The academic expert is concerned about vaccine safety but can’t go public because of fear of reprisals from the vaccine Mafioso. I find this understandable but disheartening.

Second, I keep hearing about doctors, beyond those in the vaccine concerned movement, who aren’t fully vaccinating their kids, but they are doing it quietly.

Third, there is a black hole out there when it comes to any information other than full-on negative against the vaccine concerned. Scientists not being able to get their work published. Hell, I wrote a simple update on Bob’s case and raised some issues about aluminum, and got banned from Huffington Post for doing so.

This is one of the few areas in medical science and policy where a point of view is considered too dangerous to have openly expressed in the general media apparently. I suppose I understand the reasoning behind it: fear of creating fear which could/would reduce vaccination rates. Seems wrong to me.

If there are any brave academic pediatricians willing to take a stand, get in touch.

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

Big trouble ahead for companies selling homeopathic remedies in California (revised)

Big trouble ahead for companies selling homeopathic remedies in California (revised)

Last month, the California Court of Appeals came out with a decision which should scare the bejesus out of companies selling homeopathic remedies in California. The case is Rosendez vs. Green Pharmaceuticals. Here is the decision:
https://www.leagle.com/decision/incaco20171004089

First horrible thing: It was a class action

You want to get a company’s attention: file a class action. It’s more time consuming and expensive for plaintiff’s counsel to obtain “class certification” as opposed to filing a case for just one or two plaintiffs, but obviously a class action ups the stakes for the defendant. In my view, many class actions are about the lawyers making money, since except in wrongful death or serious injury cases, each class member gets a small amount of money and/or the damage or injury is relatively insignificant. All the real money goes to the attorneys.

This was surely the case here. The plaintiffs’ firm, Newport Trial Group, files a lot of class actions, especially labeling claims against product manufacturers. These guys get a lot of bad press for many reasons, but the legal system allows for these semi extortionistic lawsuits, so these lawyers are just taking advantage of an imperfect system. I’d like to see the class action system changed to make it much more difficult to obtain class certification, but so long as the plaintiffs’ bar continues with its generous and public spirited support of legislators, change is not coming.

So what were the terrible wrongs that this big bad class action lawsuit tried to rectify?

Green Pharmaceuticals makes a homeopathic remedy called “SnoreStop” which claims to eliminate or reduces snoring. It’s a homeopathic product meaning that there are very, very small amounts of the active ingredients or no chemical traces of the active ingredients, (which makes it more potent under the homeopathic principle of infinitesimals/dilution). The company cited one scientific study as support for its claim.

The plaintiffs’ allegation was that the product is just a sugar pill which has no proven benefit, thus making the company’s efficacy claims a violation of California’s false advertising and unfair business practices laws. California like most states, has a false advertising and unfair business practices causes of action. Until recently, these types of statutes were not used a whole lot against CAM health products.

The trial court rules for the defendant, but sometimes winning isn’t enough

The case was tried to a judge. Because of the way the case unfolded, the judge’s decision granting judgment to the defendant was perplexing.

The plaintiffs had a well credentialed expert pharmacologist who testified that 1. None of the ingredients listed on the label have any proven effect on snoring, 2. The homeopathic law of infinitesimals/dilution as well as the other tenant of homeopathy – the law of similars – are unsupported and contradicted by legitimate science, 3. The study supposedly supporting the claims is worthless because of fatal methodological flaws, 4. Whatever benefit the study might have found was due to the placebo effect, or at least the study wasn’t properly placebo controlled.

After the plaintiff rested, the defendant moved for judgment on the grounds that the plaintiff hadn’t made its case (in legal parlance, failure to make a prima facia showing). The judge denied the motion, finding that the plaintiffs expert’s testimony, established a prima facia case for both the false advertising and unfair business practices claims.

By denying the motion for judgment at the end of the plaintiffs’ case, the judge was saying that you Mr. Defendant have to produce evidence to rebut the plaintiffs’ case and if you don’t, you lose.

So the defendant put on its case primarily in the person of Dana Ullman, a very knowledgeable and well-regarded homeopathic practitioner and author. Dana however has no mainstream recognized scientific or health care credentials. Knowledgeable as Dana might be, bringing only a “Mr.” to rebut a “Dr.” on a technical scientific matter is like bringing a knife to a tank battle. Don’t get me wrong, a knife could come in handy in a tank battle, but what you really need is a tank.

The trial court was turned off by the fact that Dana believes in or made some positive comments about radionics, which for those who don’t know, involves healing through mental energy and can use pictures of a person to direct the energy or test the potency of a proposed remedy. Even in the integrative medical community, radionics is way, way out there.

The plaintiffs moved to disqualify Dana as an expert witness. The trial judge granted the motion, finding him biased and unqualified. That should have been a death blow to the defense, but strangely it wasn’t. Despite rejecting the defendant’s expert and plaintiffs’ expert’s withering attack on the one study supporting the snore relief claims, the judge granted judgement for the defense, ruling that the plaintiffs failed to meet their burden of proof. The judge made some noises about the plaintiffs’ expert not having tested the product. But still, the defense had no rebuttal evidence to the Plaintiffs’ case that there was no valid scientific support for the product or its ingredients and the expert’s testimony that the principles of homeopathy were scientific nonsense was unrebutted.

You don’t have to be a legal scholar to realize that the judge’s final decision for the defendant was technically and legally inconsistent with his previous decision requiring the defendant to put on a case to rebut the plaintiffs’ case. Moreover, while judges have some latitude in rejecting expert testimony, in this case, the plaintiffs’ expert testimony was at least allowed into evidence by the judge which meant it met the basic evidentiary test of reliability (the Daubert standard). Because the plaintiffs had some evidence and the defense had no evidence in rebuttal, it’s hard to see what was going through the judge’s mind.

The plaintiffs appealed. Not surprisingly, the appellate court reversed. The decision pointed out the inconsistency of the lower court’s decision, and stated that the plaintiffs produced evidence showing that the product was worthless and hence the claims of benefit or cure were false, and the defendant produced no evidence since its expert testimony was rejected by the lower court and the one study supporting the product was eviscerated by the plaintiffs’ expert.

The appellate court ordered the lower court to enter judgment for the plaintiffs and figure out how much money the company should pay the class members (and their lawyers). Very bad for the defendant obviously.

I hear Green is looking to raise money for a cert petition to the California Supreme Court (There’s no automatic right to appeal to the California Supreme Court).

What the case means, Part 1

Of course the appellate court decision is bad for the company but also bad for all homeopathic manufacturers who sell in California. All homeopathic remedies have some claims that they help some medical or lifestyle problem, and none of these claims are supported by the level of scientific evidence required for drug or even health claims approval. So if it is false advertising and unfair business practices to make a claim which doesn’t have a drug level of proof, then any company that makes such claims could be as liable as the company in this case, and that’s obviously a bad thing.

And of course, Dana Ullman one of the luminaries in the field has taken a professional hit, which hurts the homeopathic community.

The case and its legal context is actually more complicated than it appears, and raises some conundrums and Hobson’s choices for manufacturers of homeopathic remedies, but that requires getting into the weeds of FDA statutes, prior legal cases and some heavy legal analysis, which I’ll save for Part 2.

Stay tuned.

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