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Author: Richard Jaffe

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

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

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

Here is the link to the law:

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

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

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

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

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

The real problem the practice of medicine stem cell clinics have is, of course, the recent spate of activity by the FDA and the likely content of the FDA’s four final guidance documents on autologous stem cell therapies. See my prior post at:

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

Richard Jaffe, Esq.

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.

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:

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:

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:

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:

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.

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.


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

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.

Landmark Texas Stem Cell Legislation Gets through the Texas Legislature!

Landmark Texas Stem Cell Legislation Gets through the Texas Legislature!

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

Here is the amended bill awaiting the Governor’s signature. (The Governor has previously tweeted that he’s going to sign it)\

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

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

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

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

The easy part of complying with the bill

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

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

The Hard Part

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

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

1. Where you can get treated

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

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

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

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

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

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

3. Texas Medical Board Approval of IRBs?

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

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

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

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

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

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

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

So continued vigilance is the watchword.

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

Rick Jaffe, Esq.

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.

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:

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:

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:

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.

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:

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.

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.

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:

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.

A Bad Day for CAM and patients: First CAM Group Caves-in to ACCME’s Extortion/Re-education

A Bad Day for CAM and patients: First CAM Group Caves-in to ACCME’s Extortion/Re-education

Regrettably, members of a heretofore prominent CAM (Complementary and Alternative Medicine) physician group who attended its 2016 conference will soon be advised that they received “invalid information” from several of the lecturers, and that the incorrect information should not be used to make clinical recommendations. The “incorrect” information comes from some of the most respected, best credentialed and most published practicing physicians and educators in the CAM field.

Because I was given this information in confidence, I cannot reveal the name of the group, but once the group’s members receive the letter, the cat will be out of the bag.

The members will also be provided with materials constituting the “best practices” based on “national guideline clearinghouse (, recent review articles from high-impact journals from organizations such as the national Institutes of Health, the Agency for Healthcare Research and Quality, and the Centers for Disease Control and Prevention.”

In other words, standard failed treatment recommendations for chronic and intractable conditions.

You will also informed:
“Important: In the absence of established resources, inform your learners that appropriate evidence-based resources are not available.”

I guess that means practitioners should decline to offer to treat patients unless there are the abovementioned evidence based medicine sources or treatment recommendations.

You also will be provided a survey to identify whether you have used this “incorrect” information in clinical decision making and asking a few other questions.

Needless to say, this is bad on so many levels. What’s the point of going to future seminars for a CAM group which is only going to teach the so called “best practices,” “high impact journal” and national guidelines based information? You might as well just go to AMA or your specialty board conferences to get the same recycled guidelines.

Surely, there is a place for protocol medicine, as it is curative or at least beneficial for many. It would be crazy to give unconventional care to a CML cancer patient because the disease is virtually 100 % curable with Gleevac, or giving CAM care for simple infections which are easily resolvable by common drugs.

The problem of course is that most CAM physicians work with patients with chronic diseases, where the “best practices” didn’t work, meaning you basically work in the realm of protocol medicine failures. And that’s obviously where the treatment options from high impact journals and national guidelines don’t help. It’s well and good for a non-clinical practice organization like ACCME to recommend that physicians advise patients that there is no evidence based solution, but what is the doc supposed to do?

It’s like the dental monitor ad I discussed in the last post. “You’ve got a terrible problem. Yes I’m a licensed health care practitioner who deals with this type of problem, but I can’t treat it because there is no accepted national consensus on a curative treatment, so we’re done here.” These ACCME idiots have to know that medicine and medical innovation doesn’t work that way. But CAM gets special treatment. Thanks!

But I’m preaching to the choir.

So what to do?

1. For the docs who gave the lectures which the ACCME calls incorrect?

That’s easy: If the group asks you to retract your presentation, my advice: Don’t. Further: tell the group that you stand by your presentation that it is cutting edge and literature based (because you wouldn’t have presented it if it wasn’t literature supported which you considered valid and sufficient to rely on).

There’s no good that will come to you if you agree to retract your presentation. If you do accede to the group’s request, your credibility is shot in the field in general, and certainly as a future expert witness, if that matters to you.

Much more importantly, go explain to your medical board, your insurance carriers (both health insurance plans in which you participate, as well as your malpractice carrier) or your patients why you are using treatment methods which you presented and retracted because they are too dangerous to teach and to be used. This is not something you want out there. Consenting to the group’s request that you retract is possibly the beginning of the end of your clinical career.

Obviously, you won’t be presenting at any future conferences for that group, but so what. Any group that asks its lecturers to retract because the material is not supported by the so called best practices (and all the rest of that crap), and agrees to only provide the best practice stuff in the future, probably doesn’t have much of a future.

2. Advice to the members of the Group(s) who retract presentations because they are not “evidence based”

Object: Tell your group that you think they should stand by their speakers, against the ACCME’s position that the presentations are not sufficiently evidence based. Find out if all future conferences with be in accordance with the ACCME new views, and if so, plan on finding another source for clinical practice information for 2017, and communicate your intentions to the group. They need the feedback.

3. For the Other CAM groups not yet the target of ACCME Action

Alert your members of what’s happening and what may be coming. Recommit to providing the most up-to-date literature supported information. Look for information amongst your members about who is really behind this new attack and identify allies or people or organizations who can help beat this back.
Prepare for the ACCME to come after you. How? No substantive changes to the content, but maybe have your lectures identify what the community standards are (or that none exist) and the problems with the standards. Maybe make clear that the recommendations are based on new literature, or individual practices which haven’t been adopted by mainstream), which is basically everything you teach anyway, and be prepared to fight for what you folks believe in.

I’d also like to see a massive increase in published case reports by the community. There is a whole new on-line open medical literature. I believe we are in a transition period which will end the stranglehold of the so called “high impact” journals. They are way too slow in the age of instant information. Medical issues which have been resolved by non-standard approaches need to be quickly disseminated. As more physician try these novel treatments, the high impact journals will eventually be relegated to something between review article journals and textbooks. Eventually, there will be new forms of publications based on big data analyses, which will further debase these 20th Century means of communicating new treatment information.

4. For the CAM groups who have knuckled-under or about to

I feel your pain. You don’t have any good choices. It is understandable that you want to protect your organization and make sure that all prior CME credits are not rescinded. But keep in mind that you exist and serve at the pleasure of your members. Their primary interest is that they receive the best and newest information possible to make clinical decisions. If you’re not going to do it, what’s the point?

Now that you are sending the retraction notice, your biggest, and indeed existential problem is convincing your members that despite the retraction of lectures from the best and brightest lights, your future conferences will continue to present cutting-edge, innovative research which should be implemented in clinical practice. I wish you good luck.

I’m still hoping that there are some politically connected CAM docs or supporters out there to get to the medical boards or the legislatures’ health committees involved and force the ACCME to back off. At some point, a direct response may be necessary.

You know the homeopaths were a major force in the national health care in the nineteenth century, and then they weren’t.

Rick Jaffe, Esq.

Maybe it’s time for the health concerned multitudes to come together, throw their weight around and change things up

Maybe it’s time for the health concerned multitudes to come together, throw their weight around and change things up

Per my two last posts, the CAM (Complementary and Alternative Medicine) community is under attack on at least two fronts. First, several CAM professional or issue related organizations have recently been subjected to corrective action regarding their CME accreditation for their annual conferences. Some of their last year’s conference CME’s have been retroactively rescinded, they have had their future conference CME accreditation withdrawn, and/or the groups have been warned to conform to “evidence based medicine,” code for conventional medical practice. See my post:

This is significant because these organizations depend on physician seminar income to sustain them, and practitioners depend on these seminars to learn the latest research and best practices involving CAM therapies. My prediction is that more CAM related organizations will be subjected to the same kind of scrutiny and corrective action by the ACCME. My hunch is that some entity other than the ACCME is calling the shots on this.

The second shot across-the-bow comes from a medical board in a state law that has incorporated the AMA’s “ethical standards.” These standards render unethical the sale of health related products. This board has initially determined that this ethical prohibition applies to a physician prescribing and selling active CAM therapy, which can only be obtained from the physician, after the physician receives training. See my post:

This has been a mostly dormant issue despite the AMA ethical rule, since countless CAM physicians sell supplements or prescribe food, herbals or dietary supplements as primary or secondary therapy without incident. I’m thinking this new case may be a foreshadowing of more to come.

These two fronts are interrelated because a part of the ACCME’s stated concerns is the financial connection between the lecturers and their sponsoring companies. However, I think the ACCME’s concerns are pretextual because this issue has been successfully dealt with for decades by CAM and mainstream groups, through disclosure of conflicts and prohibitions from mentioning specific products. Do you think Paul Offit and folks like him never lecture about their vaccine research and products which they’ve patented or in which they have a financial stake?

But there are other assaults on people who hold beliefs skeptical of some mainstream medical or public health modalities and who have a preference for more natural or less invasive modalities. For example, if you are concerned about the safety or number of vaccines which your children are getting, well you’ve had some tough times lately.

More states are eliminating the personal belief exemption (PBE), and in California, which is perhaps the epicenter of the vaccine concerned movement, the last year was really bad: SB 277 which eliminated the PBE kicked-in. The people who brought you SB 277 are upping their game with SB 18, which over time will likely force home-schoolers and other exempt children to be fully vaccinated, on pain of having the state sue their parents for violating their constitutional rights to “proper medical care.” See my post on SB 18:

Plus, the California Medical Board has brought a case against one of the most high profile vaccine concerned docs, Bob Sears. See my post:

Tough times indeed

So a couple weeks ago I participated in PIC’s (Physicians for Informed Consent) initial meeting for vaccine concerned docs and interested laymen. For me, the most emotionally moving and enlightening speaker was Candace Lightner, the founder of MADD (Mothers Against Drunk Drivers). Like many movement founders, a horrendous personal tragedy transformed an apolitical stay-at-home mom named Candy into the political and organizational super human, Candace Lightner. In the 30 plus years since she founded MADD, her group has passed something like 1500 laws against drunk drivers. It has been estimated that her organization has saved over 400,000 lives. Now that my friends is a huge positive societal impact.

Meeting and listening to Candace got me thinking about other people and groups who have had a transformational political or societal/health impact with whom I have worked with over the years.

Remember Act-Up, the 1980’s and 90’s AIDs activist group? This group had major impact in forcing the federal government to focus on AIDS research. I recall one of its early techniques. There was this new high-tech communications tool which had taken the business world and the government by storm. You could actually send documents over the telephone lines. It was like magic and was called a facsimile machine, later shortened to fax. Act-Up was the first group to make an effective use of the fax blast. It inundated the FDA with something like 300,000 faxes in support of faster drug approval and allowing the personal use exemption for imported foreign drugs. These folks tied up the FDA’s fax lines for days. And it worked!

In the 90’s I did a lot of work for chiropractor groups. The Chiros don’t take any crap from anyone, not even the AMA, as proven by their successful antitrust lawsuit against the AMA in the 1970’s. I got into the mix with my federal racketeering lawsuit against the New Jersey Department of Insurance Fraud for trying to illegally extort fines from New Jersey Chiropractors. See chapter 6 in Galileo’s Lawyer

In the ensuring years, I’ve had some interesting battles for other groups fighting the mainstream and specialty practitioners in fields like environmental medicine, cancer, chelation, bioidentical hormone therapy, herbal treatments, homeopathy and many, many other CAM treatments.

I’ve also encountered some of the high profile medical gurus and thought-leaders. Back in the late 1980’s, my New York law firm represented Bob Atkins, who started or foreshadowed the entire paleo and low carb movement. He was a character and a strong voice in the nascent CAM community. He would have really enjoyed seeing how much his ideas have been embraced of late.

More recently, I’ve encountered best-selling doctor-authors like David Permutter and Steve Sinatra. I even helped edit Suzanne Somer’s cancer book, Knockout. Her books about bioidentical hormones have been transformational for women around the world (and their husbands or partners are pretty happy about that too, I suspect). I think she’s sold over 25 million books, (and many thigh masters too). She is surely one of the most influential voices in the CAM health field in the modern era.

I have also encountered some of the important health media types like Jonathan Colin of the Townsend Letter and Don Peterson, the Publisher of Dynamic Chiropractor, and more recently Del Big Tree, a Vaxxed producer (whom I’ve joked about in public that when I come back, I want to come back as him).

And then there are the health freedom fighters and groups who fight against all manner of attacks on health freedom; people like Diane Miller who runs the National Health Freedom Coalition which is connected to dozens of groups on all kinds of issues from organic farming, to GMO labeling, to access to unlicensed health practitioners.
And then there are all the schools which teach all this stuff. Places like University of Bridgeport and Bastyr.

After meeting Candace at the PIC conference, I started thinking about how many people around the country these medical media gurus, the CAM medical groups, disease groups, and the activists have influenced. It strikes me that it’s a very, very big number, surely in the millions, if not in the tens of millions.

Think not? Consider the size of just the nutritional supplement industry. I’ve heard estimates of almost 20 billion dollars a year. Add to that other products and visits to CAM practitioners, the millions of books sold by the health media gurus, the zillions of clicks on the mega popular health web sites. I’m telling you, it’s a really big number.

So I got to thinking …

There are all kinds of established groups representing specific constituencies, like AARP. Many are not tied to one political party, but exercise influence on the political process. There are many, many disease groups which organize and lobby, some CAM oriented, most not and some are just shills for Pharma’s interest.

What there doesn’t seem to be is a highly visible and effective group/coalition that looks after the interests of all the health concerned, CAM oriented, CAM practitioners, CAM oriented chronic disease patient groups, and the health freedom groups. And yes, I know that there are some groups which are trying to do this, but I don’t think any of them has been effective. As far as I’ve seen, none has been able to bring together all the CAM professional, disease and grass roots organizations.

What could a congress/coalition of such groups expect to achieve? For starters, information exchange amongst the groups would be a good thing and would be easy to accomplish. A resulting coalition might even have some influence in the current national debate about health care.

Apart from the ACCME accreditation problem and the AMA ethics prohibition on the sale of supplements, there are many other big and little things which a congress and coalition could address. Making real progress on these issues would take the action of the entire CAM community. Here are a couple of my biggies, which I think are the key to changing the health world view:

1. Pharma advertising

Did you know that the US and New Zealand are the only two industrialized countries which allow direct-to-consumer TV advertising about drugs? Pharma’s advertising money buys too much influence on the media, most of it unhelpful from a societal point of view. I think we could make some real progress in public health if Pharma was banned from the TV media, the way cigarettes were banned a few decades ago. It might also help with the black hole and extreme negative outlook the media has towards all things CAM. I think the entire CAM community/industry needs to take this on as one of the top two action items.

2. Helping to Bury The Evidence Based Medicine Medico/Religious Paradigm

I think we are at the very beginning of the end of the dominance of the “evidence based medicine” thing. (I’ve discussed how that paradigm arose in Chapter 7 of my book.)

In cancer, because of tumor testing and targeted agents, the whole protocol/cookbook/prior clinical trials/regional clinical study group approach is starting to die out, at least for tough multiple gene cancers. Although I had been involved in this battle for a dozen years, mostly via Dr. Burzynski, my realization that we’re at the beginning of the end of the evidence-based medicine era hit me after reading Siddhartha Mukherjee (the author of the stunning book on cancer called The Emperor of All Maladies), New York Times article last year. The title says it all (or a lot of it anyway): “The Improvisational Oncologist: In an era of rapidly proliferating, precisely targeted treatments, every cancer case has to be played by ear.”

In the article, he says that all oncologists are or will become empiricists, meaning they will create individualized treatment plans based on the specific markers and tumor testing results, and that the days of cookbook/protocol driven cancer treatments are numbered. I suspect that the same thing is going to happen in various other medical specialties involving heretofore incurable chronic conditions. (An aside, the medical establishment came down hard on this guy for his article, big surprise.)

The above two issues seem core, and a solution to both would go a long way to undoing the stranglehold which conventional medicine has over policy makers and the body politic.

Here are a couple more issues:

3. Limiting the Government’s role in medical decision-making by eliminating the federal government’s jurisdiction over a person’s own body parts

It drives me nuts that the federal government interferes with my ability to use my own stem cells and other body parts. I mean it’s my body. If I want to hire a doctor to remove, my body parts, grow them and put them back inside me, why the hell should the federal government be involved? If the doc is screwing up, or has an unsanitary facility, let the state medical board or the state department health go after the doc. But the notion that the federal government gets involved in this kind of treatment just galls me. I’m hoping that the new FDA commission might help out on this one, and he’s more apt to do so if a few million people give him a piece of their mind. This will be necessary to counter the stem cell institutional-based Mafiosi who want to control my body parts until they are satisfied that my body parts are safe and effective for me to use for an intractable and incurable disease. Just stating the problem shows how overreaching the FDA’s current position is.

Of course, every disease and interest group thinks that their issue is the most important, and it absolutely is to them and those affected by their issue or disease.

But in the end, I’m thinking we have to go big and broad, at first, at least, and let the powers-that-be know that we’re here and a force to be reckoned with. But there is one more issue which should be addressed.

4. Vaccination

Vaccine issues have an element of complexity different from other health issues for the simple reason that the so-called “established science” has concluded that the lack of community vaccination adversely affects other people and public health. (Yes, the vaccine-concerned vehemently disagree with the established view). This is unlike other CAM or health freedom issues which only affect the individual, like the right to take an unproven treatment, the right to be informed if a product is GMO, or the ability of a physician to receive CMEs for learning new CAM methods.

One result of this difference is that many reasonable people, and even some CAM inclined people think the vaccine-concerned, (or at least the hard-core anti-vaxers) are unreasonable and dangerous. I’m sorry, but that’s just a fact. So care is needed, at least on an all-CAM level. As a litigator, I focus on the weakest part of an adversary’s position. Here are two of the weakest pasts of the mainstream’s vaccination argument:

a. Vaccine testing, (or the lack thereof) especially in pregnant women

Pregnant women appear to be Pharma’s next big vaccine marketing push. I think that is going to scare the bejesus out of many reasonable people, and open up the issue of the lack of adequate testing in general. I’d like to see some serious national public advocacy on this issue.

b. Finally, Get William Thompson on the Record!

This might be the most immediately impactful and most feasible action item. If reports are true, that a key CDC study which supposedly proved no connection between vaccines and autism was intentionally manipulated by the authors, that would be huge, and impactful well beyond vaccination and autism.
The most important thing I’ve learned in all the years doing what I do is that science isn’t nearly as neat, clean and objective as the high priests of the church of medical orthodoxy would have us believe. Showing that the government manipulated data and findings to achieve a predetermined result, if that’s in fact what Thompson’s testimony would show, would be… Well let’s just try to get him on the record and see what develops.

The bottom line (finally!)

I’m no Candace Lightner, but I do know how to raise a call-to-arms, and start the ball rolling. I’d like to see as many CAM professional groups, disease groups, issue groups, freedom groups, and even a few media and thought leaders sitting down in one place at a congress of groups. The purpose would be to establish some core common principles, concerns and action items, and identify resources and funding sources for continued efforts on areas of mutual concern.
I’m thinking end of May might be the time for the first congressional pan CAM conference.
Any thought leaders, media luminaries or future Candace Lightners interested?

Rick Jaffe, Esq.