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As widely reported yesterday, the FDA finalized the draft guidance documents concerning stem cells, or as the FDA refers to the category broadly, HCT/P’s.

The draft guidance documents proposed a couple years ago made it very hard for what I call unregulated stem cell clinics to operate.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

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

Insurance and healthcare for dummies, (and I mean you, members of Congress)

Insurance and healthcare for dummies, (and I mean you, members of Congress)

I just can’t stand it anymore, listening to these idiots in Congress talk about insurance and healthcare costs. The more you listen to these people, the more you realize that most of the people representing us don’t have a clue about what insurance is and what’s required to make health insurance and health care more affordable. Either that or they don’t want to or don’t have the political will to do what is necessary to make sure that everyone has decent medical care.

Every time one of them starts talking about “competition in the marketplace” or that people should have the right not to purchase health insurance, or just get catastrophic insurance and pay dramatically less than people who are bigger users of healthcare, I just want to throw something at the TV, because these guys are missing what is obvious to anyone who has given any thought to the issue.

So in order to make this simple enough so that even a congressperson can understand, let me explain it as a parable (that’s a made-up story to make a point).

Someplace far, far away in a distant time in the past, a bunch of people lived in a town. They noticed that every so often, something bad would happen to a few of them. (It doesn’t matter what happened or whether it happened to their person or property.) This bad thing had a devastating effect on the family and ruined their lives. The problem was there was no way to tell for sure to whom this bad thing was going to happen. The only thing people knew was that periodically something bad would happen and when it happened, the family would lose everything they had.

At one of the town meetings, Joe Aetna suggested that each family put two days of wages each month into a common pot, and that the proceeds would be distributed to the one or two families that this bad thing happened to. All the townsfolk thought that was a pretty nifty idea, and because it was his idea, it was decided that Joe Aetna would collect the money, and when necessary, distribute it to the one or two families to whom this bad thing befell.

The system worked pretty well, and the afflicted families no longer became destitute. Eventually Joe had his daughter do the bookkeeping, and as the town expanded, he brought in his son and son-in-law to help with the collection and the processing of the payments to the unfortunate few. The town agreed that that Joe and his family would be given wages for their service which was deducted from the collections.

No one seemed to mind paying two days of wages per month, even though almost none of the townsfolk received any direct benefit in return. But then two things happened: First, instead of one or two families experiencing this bad thing, for several years in a row, it happened to more than a dozen families. Also, because there were so many more people having this bad thing, the cost of fixing the damage resulting from this bad thing doubled.

The first year Joe Aetna didn’t complain, even though he had to go in his own pocket to pay his family members who were working for him because the money he received from the townspeople (what Joe called “premiums”) didn’t cover the money he had to give over to the dozen families who had this bad thing. (For some reason, Joe called the payouts “losses.”)

Indeed, not only did Joe have to pay his family out of his own pocket, there was a shortfall in what was needed to pay the dozen families. As a result, he was forced to do two things which made him and the recipients of the money very unhappy. First, he had to give a big chunk of the wages he received for operating the fund to the unfortunate (he called them “loss payees”). Second, he only gave the current loss payees half of what the prior loss payee families had received. So while the unfortunate didn’t become destitute, they had to pay a painful amount of their own wages which left them with a lot less wages than the other townsfolk. (Joe called the payments the unfortunate had to make to the tradesmen a “deductible”)

At the next town meeting, Joe said he couldn’t do this anymore and told everyone that based on past recent events, everyone was now going to have to pay eight days of wages a month as a premium to ensure against this bad event, because 1. The bad thing was happening to more people, and 2. The tradesman fixing the bad thing were charging a lot more.

To justify the increase, he pulled out a ledger listing all the events for the past years, and how much he paid out, and he did some magic with numbers which sort of predicted what the future might look like. To give his ledger containing his experience more gravitas, he made up a new official sounding term, an “actuarial table.”

Despite the actuarial table, the townsfolk were outraged by the proposed increase. Another thing they started to realize was that there was a certain pattern or characteristics that were sort of associated with this bad thing. It wasn’t a hundred percent correlation, but if a family had these factors or did these things in the past, the bad event was more likely to happen, and hence they were more likely to need the payouts. Joe admitted this to be the case, and because he really liked making-up new terms, he called these things “risk factors” and “preexisting conditions.”

Some of the townsfolk started making noises that they weren’t going to pay into the fund anymore and they would just take their chances that the bad thing wouldn’t happen to them, especially the ones who realized that they didn’t have the risk factors or the pre-existing conditions.

One townsperson contacted his cousin in a neighboring village. In that village, Sammy Cigna was doing the same thing Joe Aetna was doing. So the townsperson in Joe’s village invited Sammy to offer a fund which would compete with Joe Aetna’s fund, to try to force Joe to lower the premiums.

The problem was that Sammy was having the same kind of problems as Joe. More of his townsfolk were needing payouts, even more than in Joe’s village, and the cost of fixing the problem had tripled!

In fact, because Sammy had recently told his townsfolk that he was going to have to raise the premiums to 10 days of wages a month, some of the townsfolk in Sammy’s town had contacted Joe Aetna about setting up a competing fund in Sammy’s town.

Both Sammy and Joe gave the same response to each other’s townsfolk. “No way am I going to double my losses.”

The situation in the towns was intolerable. The funds were about to collapse between the townsfolk who were threatening to stop paying and the unfortunate who felt they should be made whole, and Joe and Sammy spending their own wages. So it was decided to consult with the regional wise man. Joe and Sammy and a townsperson from both villages took the journey and laid it all out for the wise man.

The wise man pondered the problem a bit, and said he could tell them what needed to be done, and that it was really quite simple, but that it was going to be their job to get the townsfolk to do it, and that might be the hard part.

So Joe says, “Ok Mr. Wise Man, what do we have to do?

The wise man raises his thumb and says: “First, everyone has to pay into the fund.” “This fund which I’ll call “insurance” works by taking money from many people who won’t use the money, and giving it to the few who need it. If only the people who need it buy “insurance,” it doesn’t work. That’s not insurance. That’s paying for it out of your own pocket.

The wise man then raised his pinky finger and says “Second, the people in the land surrounding villages need to pay into the fund. They are less likely to have the loss, so it will lower the number of days of wages people need to pay in, and there’s always a chance the bad thing will happen to them, so they’ll get some comfort. You need the greatest possible number of people in the fund to lower what you’re calling the premiums.

Joe then asks, “Great, anything else?”

The wise man then raised his index finger and says, “Next, you have to talk to the tradesmen fixing the bad thing, and they’re going to have to reduce their cost by 3 days of wages. Since all their work is coming from the townsfolk, they’ll have to do it.

Sammy then asks, “Are we done?”

“No we’re not grasshopper” says the wise man, as he raises his ring finger and says “Joe and Sammy, you’re going to have to cut back one day of wages per month from what you’re charging; the townsfolk are going to have to pay an extra day’s wage, which is a lot better than the six extra days Joe wanted. And, finally, now that we see what some of the risk factors are, it’s going to be in everyone’s interest to cut back or stop some of that behavior, and if that happens, maybe you’ll be able to move back to the two days of wages premium you had before.”

Joe rubs his chin in skeptical contemplation and says: “I see what you’re saying, but some of the townsfolk insist they have the right not to pay into the fund, and a few of the tradesman say they have the right to charge what they want to fix the bad thing. What do I tell them?”

The wise man raises his middle finger and says, “that’s what you tell them.”

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

New Mexico Integrative Practitioners Dodge a Bullet (with Shirley MacLaine’s help) but there’s still danger and work to be done

New Mexico Integrative Practitioners Dodge a Bullet (with Shirley MacLaine’s help) but there’s still danger and work to be done

(Dinner with Shirley MacLaine, Pamela Costello, M.D., and Bill Wolfe, D.D.S.)

Awhile back I reported that the New Mexico Medical Board was going after a prominent integrative medical practitioner because she was prescribing and selling herbal protocols as primary therapy for the treatment of various environmentally caused neurological conditions, supposedly in violation of the AMA ethical guidelines.

See http://rickjaffeesq.com/2017/03/22/can-cam-docs-legally-prescribe-and-sell-herbals-and-nutritional-supplements-as-therapy-without-bad-things-happening-prescribe-yes-sell-well-see/

New Mexico is one of a handful of states that incorporates the AMA’s ethical guidelines as rules of practice, the violation of which are disciplinable offenses. Ironically, the AMA never intended its ethical precepts to be used as practice guidelines to discipline doctors. How do I know this? Easy, after each general ethical precept, the AMA places the following cautionary language: “The Opinions in this chapter are offered as ethics guidance for physicians and are not intended to establish standards of clinical practice or rules of law.” So why have some states like New Mexico decided to disregard the very limitations placed on these precepts by the AMA? Good question.

Ethical precept 9.6.4 puts severe restrictions on the sale and even the use of nutritional supplements. (I won’t repeat my detailed discussion of this section in my prior post http://rickjaffeesq.com/2017/03/22/can-cam-docs-legally-prescribe-and-sell-herbals-and-nutritional-supplements-as-therapy-without-bad-things-happening-prescribe-yes-sell-well-see/.)

The effect of the rule is to make it basically AMA unethical and New Mexico disciplinable for a physician to sell supplements out of his/her office or via a web site. Previously, when the New Mexico Medical Board found out about a physician’s sale of supplements via a Board complaint, the doc has been forced to stop, which apparently prompted a few to quit the state.

I got involved after the case was presented to a panel of the Board to see if there was a violation. Based on the AMA “guideline,” the panel gave the doctor the same ultimatum as it had to other docs: stop selling supplements or face formal charges. That didn’t make sense to me for a few reasons, not the least of which was that she wasn’t just selling supplements for general health or immune purposes. Rather, she was using natural remedies as primary therapy, which because of training requirement set by the manufacturer, the products were only sold to company trained practitioners for dispensing to their patients.

The AMA seems to cover this type of practice in precept 9.6.6 which allows the sale of drugs, devices and “other treatments.” That seemed like a better fit and it didn’t have all the anti-supplement nonsense contained in 9.6.4. So after I came into the case, we asked the prosecutor to re-present the case to the board panel. Because the Board’s statute of limitation to file the case was fast approaching we suggested we would be agreeable to waive the limitation period in the hopes he would ask the panel to change its mind based on this new information.

And then a funny thing happened…. Actually, nothing happened. We didn’t hear back from the prosecutor for over a month. We had expected to receive a formal waiver of the statute of limitations, to be signed by the doctor, and we would have advised her to sign it. The proposed settlement had contained such a waiver, and we expected to get a proposed written waiver. But we never got it. Instead, over a month later, we got basically the same settlement agreement with the same prohibition against the sale of supplements, and the same waiver of the statute of limitations as in the original settlement proposal, but this second settlement proposal was over a month after the statute of limitations had expired. Hmmm.

I decided to take another run at the prosecutor to change his mind about the case. I gave him case studies showing the miraculous results achieved by the doctor on non-functioning patients who tried and failed many conventional modalities. We also showed him that almost all New Mexico integrative practitioners were selling supplements for general health, in direct violation of the AMA rules. I even showed him that the University of New Mexico’s Integrative Medicine Clinic was selling supplements to patients, and the University was teaching medical students about the use of herbal remedies.

This case against the doctor arose because her office staff did not timely respond to the patient’s request for medical records. So I had the doctor take a medical records keeping course (which the board requested in the two settlement proposals) and offered that she would accept responsibility for the oversight, as a full settlement of the case.

But the prosecutor was a tough guy and insisted that she comply with the AMA supplement guideline, the way the other doctors faced with board action had done. As incentive (read threat), after he sent the first settlement proposal, he said that if she didn’t take the deal, he’d go after her license. When he finally filed the case, he made good on his threat by throwing in a charge of incompetence for using herbal remedies, which could result in license revocation.

Despite all my efforts at persuasion, I couldn’t get him to back-off. I started to think about an appropriate time to file a motion to dismiss based on his failure to timely file the case. Filing the motion wouldn’t make dealing with him or the Board any easier. But frankly, I was tired of all his crap about supplements and how he was going to take out my client for being a supplement distributor.

Maybe I was waiting for a sign, and I got it. On a routine email exchange on a Monday, he announced that he was leaving the board on Friday and going into private practice. That was good enough for me. The following Monday I filed a short motion to dismiss based on the fact that the complaint (called a “Notice of Contemplated Action” in New Mexico) was filed more than two years after the Board had notice of the patient complaint, which makes the case dismissible under New Mexico law. I’d let the new prosecutor figure out how to deal with the fact that his predecessor never presented us with a written waiver of the statute of limitations even though we offered to enter into such an agreement.
Turns out the Board didn’t have a replacement for him, so he ended up responding to our motion. Awkward! I didn’t think much of his responding papers.

The motion was to be heard by the full Board. I figured they wouldn’t be too fond of me or my client for trying to dismiss a case on a technicality, based on its mission to protect the public and considering the fact I did offer to enter into a waiver of the statute of limitations. I also didn’t think I had much of a chance to have the Board make a public finding that its own prosecutor screwed the pooch. Hmm. What to do?

I have a saying or rule which I try to follow. You have to give a board/judge the will and the way to rule for you. But even though my motion was legally correct, I had given the Board neither. After more thought, I figured it out. I filed another motion to dismiss in the interests of justice, and argued that the supplement issue was a matter of great public interest that was better addressed in a rule-making rather than a disciplinary process, in part because all integrative practitioners, including the University of New Mexico’s own clinic were already selling supplements. I also showed the Board the doctor’s truly impressive case studies. My goal was to go to the hearing and immediately pivot to the interest of justice motion, so as not to have to deal with the unpleasantness of the Board’s own prosecutor’s screw-up. It was a good plan, but it was not to be.

Things got really interesting right before the hearing. The prosecutor recused himself from the case because he was going to have to be a witness explaining why he didn’t obtain a written wavier of the statute of limitations from the doctor. (The irony was that Mr. Tough prosecutor charged the doctor with incompetence, and yet he was the one going before the Board testifying about his conduct and competence. Who says the universe doesn’t have a sense of humor and karma.)

The other super interesting thing was that one of the patients whom the doctor was dramatically helping is Shirley MacLaine. She lives part-time in New Mexico. As luck would have it, she was going to be in town on the day of the hearing. I insisted that the doctor contact her and try to have Shirley come to the hearing. It was going to be a very tough day with personal attacks directed my way, so some star power wouldn’t hurt. More metaphysically, based on her life and books, she seemed to be a very powerful force, (as in “the force is strong with that one”), and I really needed all the help on that front/dimension I could get.

We all showed-up at the hearing. My plan to pivot to the interest of justice motion failed. The Board insisted of focusing on the statute of limitations motion, despite my repeated efforts to talk about how the public would be better served by the Board considering the supplement issue in a rulemaking capacity and to dismiss the case to allow that process to take place.

As expected, as I argued that the prosecutor missed the deadline under the law, he as a witness and some of the Board members went after me, questioning my professionalism honesty and integrity. But zealous advocacy is the job, and taking some incoming is sometimes a part of it.

We went at it for over an hour and a half. The former prosecutor testified in effect that I was a sleaze ball, and me arguing that he didn’t do the one thing he had to do, get a written waiver, while imploring the Board we should really be talking about creating a public forum for input on the supplement issue.

For over an hour I got nowhere, or so it seemed, but then one Board member asked me a question which suggested that the former prosecutor should have gotten a written waiver, and I ran with it. Then the chairman of the Board asked me how important a right it was for someone to have statute of limitation protection, and how would that right best be protected. Terrific question! From then it was all downhill. Some of the other members starting asking similar questions, then the Board said they heard enough and excused us to go into executive session.

We waited almost half an hour. In the lobby, some board employees came out from their offices to meet Shirley. She was gracious and engaging. We both chatted-up the new prosecutor, whom I’d be dealing with if the Board denied our motion. Shirley was apparently fascinated by the proceeding. She had never been to a board hearing or seen the kind of legal back and forth. She told the prosecutor she was going to do a feature film about the case, and asked the prosecutor – a fit and attractive woman of Hispanic decent, who she wanted to play her in the movie. They prosecutor loved it. They had a lengthy discussion about different actresses and they decided that Jennifer Lopez would be offered the part. We had a great time waiting, laughing so loud at times that the Board members inside must have wondered what was going on.

Finally, we were called back into the room. The chairman announced that they were going to vote on two motions. Ok, I had only argued one, but I had put in strong papers on my interest of justice motion. The first motion was the limitations motion. One-by-one they voted. We lost that vote by a wide margin.

Then the chairman called a vote on a motion to terminate the proceedings against the doctor. No interests of justice, no nothing, just a motion to end the case. We won that motion by a wide margin. And so the case against the doctor ended. It took a while for it to sink in. We thanked the board profusely.

You know the saying “when you make the sale, sit down.” Well I don’t subscribe to it. I wasn’t done. I told the Board members that I hoped they would consider the physician sale of supplements issue because integrative physicians and the people of New Mexico deserved to have input. In response, the Board chairman told us that the Board had decided to address the issue at an upcoming meeting, and, he invited me to return and make a presentation to the Board. I immediately accepted.

Finally, I told the Board members that I was giving them all homework. They had to decide who they wanted to play them in the movie. Everyone got a good laugh, and I’m sure they left the meeting amused and had a good story to tell their families.

I’m hoping to enlist some of the American College of Nutrition luminaries and other of my high-profile integrative physician friends to take a trip to Santa Fe and help make the case for rescinding that idiotic AMA “guideline.”
Any takers?

And finally, the one burning question which I’m sure is on everyone’s mind:
Who’s going to play me? George, Brad or Ben.

Happy Independence Day to you Dr. Pamela Costello, holistic neurologist extraordinaire, and thank you Shirley MacLaine.

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

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

I want to sue the Medical Board for Antitrust violations, because it’s restraining trade by prosecuting me for practicing my kind of medicine.

I want to sue the Medical Board for Antitrust violations, because it’s restraining trade by prosecuting me for practicing my kind of medicine.

I hear that a lot from CAM docs. There is nothing more emotionally satisfying for a doc being prosecuted/persecuted by a medical board than to turn the tables and sue the board, its ignorant and venal board members and its executive director. Aside from the pure joy for the doc, isn’t the best defense a good offense?

Good sentiment for sure, but regrettably, two problems

First, board members are typically immune from damage awards regarding their decisions. That brings up a related but often forgotten point. Usually, docs want to sue the board after the informal settlement conference has failed to dismiss the investigation, or right after the board staff files the administrative case. But at this juncture, most of the board members haven’t even heard of the doc and only will learn about the case after an administrative judge issues a proposed decision.

But we’re suing in part to stop the bastards from ruling against me in the future and interfering with my right to practice, right?

That leads to the second problem, and here’s the short of it: No court has ever or will ever stop an on-going medical board proceeding.

But what if the board hasn’t followed its own rules in filing the administrative complaint against me?

Doesn’t matter. The reason, in legal parlance is ripeness (maybe also failure to exhaust administrative remedies).

Until the board makes an actual and enforceable decision on your case, there is nothing for the Court to do, because the board hasn’t taken final action, and courts only review final actions of administrative agencies, (unless specifically granted the authority to do so, and that’s almost never the case). Maybe the administrative judge and the board will agree with you after a hearing. That’s the way the courts look at it, so they wait until the board makes its decision.

But filing the case against me is public and hurts my reputation and I’m being injured now even without a final board decision.

Sorry, but that doesn’t matter. Having an administrative case or even a criminal case filed against you is not something which can be stopped by another court just because you think the board or prosecutor is wrong, out to get you, or even if you think you will suffer harm because there is a pending case against you. Very sorry, but the law just doesn’t stop cases against people because the case might injure a person’s reputation or business.

So whatever tactical reasons there might be for suing the board which has or is about to file a case against a doc, expecting that a court will actually stop the board from proceeding with its case is not realistic; it’s just not going to happen.

There might be other reasons to sue the board: Maybe you think you can wear a government agency down. Maybe you want to show that you’re a tough guy. Or maybe (and this is my personal favorite) you have such a deep respect for the legal profession, and such gratitude for the noble attorneys who defend CAM docs that you want to make a substantial contribution to their well-being.

Well, if that’s your motivation, then I say go for it!

But know that the trial court is going to deny your request to stop the board from proceeding against you, the appellate court will affirm the dismissal, and neither the state supreme court nor the U.S. Supreme court will hear your case (in case you want to make a really, really big contribution to your attorney’s financial well-being).

>Antitrust to the Rescue?

Well what about this new antitrust deal?

A new or developing thing is trying to sue boards for antitrust violations. Every CAM doc has heard that a couple years back the Supreme Court upheld the FTC’s suit against the North Carolina Dental Board’s because it tried to stop non dentists from offering teeth whitening at shopping malls. Here is the Supreme Court’s decision:

http://www.scotusblog.com/case-files/cases/north-carolina-board-of-dental-examiners-v-federal-trade-commission/

So why can’t I sue the board for antitrust restraint of trade for trying to put me out business; the board is restraining my trade?

It’s a fair question. I could tell you the answer in a one word sentence, but better to give some background and analytical tools, so you can understand what’s required to present a viable antitrust claim.

You can’t sue the state government for antitrust (and neither can the federal government)

States cannot be sued for antitrust violations. Congress understood that it couldn’t prohibit all state regulation which displaced or affected competition. This limitation of federal antitrust law was laid out by the Supreme Court in Parker v. Brown in 1943.

But what about state agencies like the medical boards which are usually controlled by professionals who are competing with the people the board is targeting?

Very good grasshopper! That was exactly the question raised and answered in the North Carolina Dental Board case.

The Federal Trade Commission sued the North Carolina Dental Board for restraint of trade because it had sent warning letters to shopping mall dental whitening stores which services were not performed by dentists. North Carolina law didn’t specifically say that teeth whitening was the practice of dentistry.

The Board tried to wrap itself in the Parker v Brown state immunity from antitrust liability mantle. But the Supreme Court said no. It held that because the dental board was controlled by “active participants” (meaning competitors of the mall dental whitening places) and because the board’s decisions were not “actively supervised” by some higher authority, the dental board was not entitled to state immunity from antitrust liability.

Not only did the Supreme Court hold that the dental board could be sued for antitrust, the FTC found that the dental board did illegally interfere with competition and ordered it to stop. So it was a complete loss for the North Carolina Dental Board.

Two questions: First, what does it mean for a board to be actively supervised? The FTC has published some guidelines. Here they are.

https://www.ftc.gov/system/files/attachments/competition-policy-guidance/active_supervision_of_state_boards.pdf

But I can tell you that in a state like California, where the Medical Board’s decisions are final, and can only be reversed by a superior court judge, that’s not active supervision.

The second and big point is just because a board is not immune from antitrust liability doesn’t mean that any tom, dick or doc can assert a viable antitrust claim; you still have to plausibly assert all the requisite elements of an antitrust violation. And that my friends is where an antitrust case filed in response to an administrative complaint against a doc runs into trouble.

Restraints of trade as would be asserted by a doc against a medical board would be evaluated under a “rule of reason” analysis, meaning the court considers the net effect of the restraint on “competition.” The oft-repeated mantra in antitrust jurisprudence is that “the antitrust laws protect competition, not competitors.”

An antitrust plaintiff cannot assert a valid antitrust claim, let alone win, by alleging that the restrictive action by the board harmed the doc. The doc would have to show how the board’s action harmed competition or the type of services generally.

In a board administrative case, especially one that hasn’t yet resulted in an adverse order, it’s going to be hard-to-impossible to show injury to anyone but the suing doc, (and that assumes a court would find injury to the doc, which is doubtful since the board hasn’t done anything, if the antitrust action is filed before the board makes a final decision).

To see if your case involves harm to competition, do a thought experiment: Forget about your case. What’s left? If your case is the main part of the claim, and there aren’t many other practitioners who are being subjected to the same thing, then the case doesn’t impact competition.

Well what about the chilling effect the case will have on other CAM docs, or the fact that this case will be a “springboard” to other cases?

Sorry, the courts have rejected that argument, because it’s too speculative. Here are two cases where the doc sued the board for antitrust, and got thrown out of court for lack of antitrust injury, despite their springboard or chilling effect argument.

http://www.leagle.com/decision/In%20FCO%2020160516084/PETRIE%20v.%20VIRGINIA%20BOARD%20OF%20MEDICINE
http://www.leagle.com/decision/In%20FDCO%2020170222F17/JEMSEK%20v.%20NORTH%20CAROLINA%20MEDICAL%20BOARD

There has to be hard and specific evidence of that the board’s actions will have a negative effect on competition, like there was in the North Carolina Dental Board case where the stated purpose of the warning letters was to put the non-dentist teeth whitening clinics out of business.

North Carolina provides another example of what it takes to successfully allege an antitrust case against a professional board. The North Carolina Acupuncture Board, at the behest of the acupuncture trade association sent out letters to physical therapists to cease and desist doing “dry needling” because the acupuncturists thought that the technique belonged to them exclusively. The PTs sued for antitrust violations. The acupuncture board tried to dismiss the case, but the judge allowed the antitrust part of the case to go forward, because the PTs alleged antitrust injury, i.e. the board’s action alleged a specific negative effect on competition, not just an individual PT. Here is the case:

http://www.leagle.com/decision/In%20FDCO%2020170131D06/HENRY%20v.%20NORTH%20CAROLINA%20ACUPUNCTURE%20LICENSING%20BOARD

The lessons I take from these cases are:

1. If a board tries to stop a group of providers not licensed by the board but which offers the same services of the board’s active participants, that states antitrust injury and a viable antitrust claim (assuming the other requirements are met, but

2. It is impossible, or close to it, for a doc to successfully sue a medical board for antitrust violations if the basis of the antitrust suit is that the board has started or is about to start a disciplinary action against him/her.

So if you’re going to sue a board for antitrust because the board has started a disciplinary action against you, have a realistic idea of what you can get out of it, and what you won’t.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com