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The United States vs Your Own Stem Cells: Trial days Three and Four

The United States vs Your Own Stem Cells: Trial days Three and Four

The FDA’s case against the California Stem Cell network went forward last Thursday and Friday for the third and fourth days. Yesterday, Monday was an off day. The trial resumes today at 8:30 PDT.

Very briefly, (I hope because I have a lot on my plate today) here are my main observations:

1. The judge has already made up his mind about the case. In a sense that is an obvious implication of his decision denying the government summary judgment. He said the factual issue to be tried is whether what was removed was the same thing that was put back in. Framed in that fashion, it seemed clear that the defendants were going to win the case, and nothing about the judge’s actions or demeanor during the trial suggests otherwise. He does not seem super engaged by either side, and while he is listening politely, my sense is that he’s done, and just wants it over as quickly as possible so he can get about his business of writing the decision. Viewed another way, I don’t get the sense that the judge feels anything he is hearing on either side is particularly helpful.

2. It is obvious that the government doesn’t try many of these cases. The two FDA female doctors (one M.D. and one Ph.D.) were extremely knowledgable but between the defense counsel’s objections and cross-examination, the judge’s rulings, on what would be admissible testimony and their obvious and admitted lack of experience testifying (the MD at least), they were kept on a very tight leash and didn’t get to testify about everything they had to say. The FDA doesn’t have to try many of these cases, as the defendants usually cave in or the courts rule against the defendants on summary judgment. Doing trials on these complicated regulatory issues is a lot different from having an FDA attorney prepare a declaration for an FDA expert employee.

3. On the third day, there was much testimony on what is the same surgical procedure, as there should have been. The MD FDA witness tried to explain the difference between a surgical procedure and what the defendants were doing which was using a surgical procedure to harvest a product/material as a treatment. She also talked about the purpose of the surgical procedure, but I don’t think the explanation was clear as testified or as received by the judge. My sense was that he felt surgery is surgery.

4. The Ph.D. witness barely got to testify since apparently, the bulk of her testimony was about the ultimate legal issue in the case, namely whether SVF is a new drug because it is more than minimally manipulated and whether what was taken out was what was put back in. The judge ruled that expert testimony on the ultimate issue was not permitted under the rules of evidence. The Government lawyer cited some case law to the contrary. The judge pivoted to saying that since these were stated elements of the government’s case, it was his decision to resolve and didn’t need factual testimony about it. I’m not sure about that, but as a general matter, there is only one expert on the law in a trial, and that would be the judge. So to the extent an FDA regulatory expert tries to testify about the application of FDA law to the facts of a case, I think he’s on solid ground. And even on general legal principles of FDA law, let’s remember that the courts no longer give judicial deference to agency interpretations of its own regulations absent a finding of ambiguity.

5. I admit that I am not a big fan of FDA regulators and especially their actions in the stem cell field, but I have to say, between defense counsel’s overaggressive badgering and the somewhat unskillful redirect (and direct) by the government lawyer, even a guy with my predilection (bias), felt bad for the two FDA witnesses. Let me just repeat that the judge kept a very tight leash on what these witnesses were allowed to say. I think that caused some major problems for the government in presenting its case through these two witnesses. Still, even a biased guy like me gives credit where credit is due. Both witnesses were quite knowledgeable, straightforward, sincere, and came off well (to me). I think they handled themselves very well especially because of the above challenges (as painful as it is for me to admit it, though actually, it isn’t, since they both seemed like decent, dedicated, and hard-working professionals doing their jobs on sort of a grey area where they did not have any direct experience, and that wouldn’t a bad impression for the defense if the judge also thinks that).

6. The defenses: The cross-examination of these two witnesses clearly revealed the defenses main arguments or defense tactics: Make the point that the FDA doesn’t usually get involved/inspect surgical facilities and has no expertise in that area and that goes for these two witnesses (though they both watched the same video about a cornea operation, which is sort of pathetic). Make the point over and over again that the FDA doesn’t regulate the practice of medicine. Make the point over and over again that patients get opened up and that is surgery. Make the point that SVF has a bunch of different things in it, and what is taken out is the same thing that is put back in.

7. What about the vaccine stuff (ACAM something or other)? The defense is that the government confiscated the product from some other entity so the defendants no longer have it, and I suppose they will argue that what’s the point of enjoining something that the defendants no longer have and can’t get anymore.

8. What about the defense to the use of expanded stell cell products which prior persuasive authority has held to be more than minimally manipulated? I’m not sure about that, maybe just argue that the change in the deference standard makes the Regenerative Science decision bad law now. That might be persuasive to this judge.

9. The one thing that might have bothered the judge: There was evidence on direct from the Ph.D. that the enzymes used just don’t stop working; that they keep on breaking down tissue even after the product is reinjected back into the patient in the absence of chemical neutralizing process (I am a little unclear on the process required). The implication being that the defendants’ inadequate processes are going to limit or eliminate any beneficial effect the material/treatment might have. In response, the defense took her through the defendants’ article which claimed that the three washings removed over 99 percent of the enzyme. The witness was skeptical. I didn’t get a read on the judge’s reaction. So this is just my reaction that if there is anything that might have caught the judge’s attention and could impact him against his prior inclination that the defendants’ activities are not FDA regulatable, this was it.

10. The Ph.D. witness made the point that irrespective of the 1271.15 same-day surgical inspection issue, the defendants still had to comply with the FDA’s cGMP requirements. I think the defense’s counter was general about how the FDA doesn’t regulate surgical practices or procedures. The FDA’s response was yea but we regulate products. The judge: Hey let’s use the word treatment and I’ll decide if it is a regulatable product, and there were many variations of that basic point-counterpoint and counter-counterpoint.

11. “Did I read this correctly?” Really?

The craziest thing I saw technically was the defense counsel’s repeated question “Did I read this correctly” after reading a cherry-picked supportive statement contained in a defense article supporting the safety or efficacy of stem cells. Obviously, the defense was just using the witness to read to the judge these positive statements about stem cells. But what he didn’t do was ask any follow-up questions. Rather, he just moved to the next positive statement from the article and then to the next article and so on for each of quite a few articles.

I don’t get the government’s failure to object after the first time defense counsel pulled that nonsense. He should have made a speaking objection pointing out that without a follow-up question to the witness about whether she agreed or disagreed with the statement, the question posed was irrelevant. There is no issue in the case about whether defense counsel can accurately read a statement from a written text. The government attorney could have offered to stipulate that defense counsel has that reading capability (ok, maybe too sarcastic). I just didn’t get the govenment’s nonreaction other than these guys don’t have to try many of these kinds of cases. Defense counsel got away with it. I wish I could get away with stuff like that. The government did do some redirect on the point, but I don’t think it was sufficient in light of the hammering the witness took and the reading of all those cherry-picked statements. Tactically, some hard pushback including more extensive redirect on why the FDA expert thought those statements were incorrect or misleading.

My bottom line from these two trial days is that I think the defendants should be feeling pretty good about the case. The government, not so much. And the defense hasn’t even put on its full defense yet, though it is pretty clear what the defense is via the cross. I think that speaks well for the defense counsel’s preparation and execution. Good on them.

Rick Jaffe.

Stem Cell Breaking News: Cali Stem Cell Trial Adjourned until Sometime After November

Stem Cell Breaking News: Cali Stem Cell Trial Adjourned until Sometime After November

Yesterday, California federal district court judge Jesus G. Bernal on his own adjourned the the FDA’s trial against Cell Surgical Network (“CSN”) and their owners Mark Berman and Elliot Lander. The parties were ordered to meet and confer about a new trial date to take place after November, 2020. The trial had been scheduled to commence on July 28th. Because of my deep interest in the case, I have been checking the Riverside Ca. Covid-19 numbers and once the numbers started to rise, and based on what has been happening in California in general (which is another area of interest and which I write about), I was pretty sure the the judge would have to knock the case off the docket. This is too big and too important to do via Zoom, and the judge really had no choice. Too bad, as this is for sure the most important stem cell case in the country right now, and in general, and for reasons having to do with my stem cell work, I was really hoping to get some clarity, or more specifically, another ruling similiar to the judge’s seminal summary judgement decision.

For my own needs, I have recently reviewed some of the pre-trial filings in the case, and in particular the proposed findings of facts and conclusions of law filed by the parties. (Findings of fact and conclusions of law are the main documents filed in a bench trial. In a jury trial, the parties would file proposed jury instructions. But in a bench trial, the findings of fact and conclusions of law are what the parties expect to show fact wise, and what they argue how the law applies to the facts, and of course, present the proposed outcome. In case you were wondering, there is no federal (7th Amendment) right to a jury trial in cases in which the relief is equitable, like injunctions and declaratory judgments).

CSN’s findings and conclusions, prepared by Venerable’s LA office’s team headed by Celeste Brecht are about the best I have ever seen in an FDA case (or maybe in any case). They clearly lay out CSN’s position in the case. If you want to understand exactly what the defendants did and why they think all of it is legal, and how the FDA improperly used industry guidance procedures to substantively change the law without going through the proper and required procedure, then read this document. (I know I am being alittle redundant, but I just love saying how the government acted improperly; it’s a defense lawyer’s thing, and spoiler alert, I’m not done yet!) Here it is.

csnproposedfindings

This document also cogently and succinctly lays out the evolution of the same day surgical procedure exception, from whence MSC/SVF procedures were considered 21 CFR 1271.15 EXEMPT, to the FDA’s illegal transformation of the procedure and a person’s body part into an illegal, unapproved, adulterated and misbranded drug.

In all my years doing this law thing, this one action, (and did I mention that it was illegal and improper?) is the single stupidest thing I’ve ever seen. Your body part removed and reimplanted during the same surgical procedure is a drug! In my opinion, this is perhaps the most extreme case of over regulation and lack of common sense that I have ever seen in the field.

For a long time, I thought the FDA would get away with its improper transformation, and that this case would reach a similiar result as the US Stem Cell case in Florida, because of the deference federal courts are required to give federal agencies like the FDA when it interprets its own regulations. However, in 2019, (after a few Justices gave some heart warming hints), the Supreme Court came out with a couple decisions which limit deference to laws and regulations which were ambiguous. This might well prove to be the death-knell of the FDA’s decade plus effort to (improperly) rewrite the the same day surgical exception.

So getting back to Venerable’s findings of fact and their succinct history of the FDA’s regulation of this issue, here it is:

“Regulatory History of the SSP Exception
6. Until 1997, the FDA exerted little to no control over human cellular and tissue-based products.
7. In 1997, the FDA introduced Guidance providing that:
the agency would not assert any regulatory control over cells or tissues that are removed from a patient and transplanted back into that patient during a single surgical procedure. The communicable disease risks, as well as the safety and effectiveness risks, would generally be no different than those typically associated with surgery.
(Ex. 88 (emphasis added).)
8. In 2001, the FDA then promulgated the Same Surgical Procedure Exception (“SSP Exception”) based on the 1997 Guidance.
9. The SSP Exception exempts from any FDA regulation:
[A]n establishment that removes HCT/P’s from an individual and implants such HCT/P’s into the same individual during the same surgical procedure.
21 C.F.R. § 1271.15(b).
10. The FDA has not amended the SSP Exception since its promulgation.
11. HCT/Ps are defined as “articles containing or consisting of human cells or tissue that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” 21 C.F.R. § 1271.15(b).
12. In 2014, the FDA released a draft guidance that sought to create ambiguity in the SSP Exception. (Ex. 89.)
13. The draft guidance proposed substantive changes that interpret the SSP Exception to exclude surgical procedures that would otherwise qualify for exemption by requiring that the patient’s transplanted HCT/P be implanted in its
“original form,” which is very narrowly defined and otherwise limits the types of surgical procedures that would fall within the SSP Exception. (Id.)
14. The “original form” language is not included anywhere in the regulation, see 21 C.F.R. § 1271.15(b). Instead, the SSP Exception unambiguously states that a tissue or human cell is not a drug if it is removed from an individual and then re-implanted in the same individual.
15. The FDA adopted the draft guidance, which was improperly signed by Ana Abrams, in December 2017. (Ex. 87.)”

Ahh, this is music to my ears and will be to many in the stem cell field (on this side of the fence anyway). Only thing that’s needed is the judge’s signature. But alas, that can’t/won’t happen until sometime after November. We’ll all have to stay tuned until then.

Rick Jaffe, Esq.

Stem Cell Shocker: Cali. Federal Judge Denies the FDA Summary Judgement and Orders a Trial in the Cell Surgical Network Case

Stem Cell Shocker: Cali. Federal Judge Denies the FDA Summary Judgement and Orders a Trial in the Cell Surgical Network Case

Ok, let me get this out of the way up front. I predicted publicly and privately that the California federal court judge would follow the reasoning and result of the Florida federal judge who granted summary judgement to the FDA and issued a permanent injunction barring the Florida stem cell operation from using its SVF (stromal vascular fraction) product in humans.

I am very happy to report that I was wrong, (at least for now and until there is a trial).

Here is the judge’s opinion

stemcelldecision

The bottom line is that the California federal judge found a disputed issue of fact which requires a full trial. The issue of fact and how the judge got there is important and could foreshadow a result which the FDA and the stem cell institutional mafioso won’t like.

So, what is the issue of fact?

Here is the judge’s words and they are short and simple:

“The parties dispute whether the SVF Procedure alters the SVF cells (citation to brief omitted). Because both parties have submitted competing evidence on this point, there is a triable issue of fact and summary judgement is not appropriate.”
(Order at last page).

Why is it important/critical/dispositive whether or not the SVF Procedure alters the SVF cells?

The FDA argued that the procedure creates an unapproved, adulterated and mislabeled new drug.
The Defendants argued that they are doing a surgical procedure which falls under the single surgical procedure (“SSP) exception to full drug regulation of HCT/P’s under 21 CFR 1271

If the SSP exception applies then the FDA loses. If it does not, the FDA wins.

Here is how the judge phrases it:

“While the SSP exception could apply to a procedure that removes SVF cells by removing adipose tissue from a patient and implants only extracted SVF cells back into the same patient, it only applies if those cells remains unaltered.”
The count then concludes with the language first quoted.

There are prior steps to the judge’s reasoning/conclusion, relating to whether you compare the total product removed (adipose tissue which includes fat and other stuff) versus what is reimplanted (SVF), or do you look at the target of what is sought to be removed (the SVF) and compare that to what is reimplanted (the same SVF, according to the defendants).

The judge choose the latter, which required him to dig deeper into whether the cells were altered, i.e. whether they were the same as what was taken out.

He determined that the parties had different views about that. In other words, there was a factual dispute about a critical element of the case, and factual disputes are resolved by trials, not by summary judgment. Hence the denial of the government’s summary judgment motion. This is a big loss, (albeit interim) for the FDA.

Something else that the feds won’t like is that the judge did not show the almost universal deference given to an administrative agency’s interpretation of its own statutes and regulations. The judge thought that the agency’s view of “what is taken out of the body” was overly broad and didn’t make any sense. Basically, the judge accepted the defense view on this, and then held that there is no deference to an agency’s opinion which is not realistic and doesn’t make sense. Ouch!

Something else the judge didn’t like, and something which I found really offensive about the government’s efforts, was its attempt to bar defendants Berman and Lander from testifying either as an expert or any way else. I think the judge was offended by that whole argument and called out the government on it, at one point castigating the government for wasting the his time. Really Big Ouch on that one.

So, what’s next?

Per a court approved December 2019 joint stipulation, the parties have 14 days to submit a proposed schedule for the trial and whatever else has to be scheduled, but perhaps the government might try something else. We’ll see.

What is the effect of this order?
As a lawyer on the side of the private stem cell clinics, this is very good news for these clinics. I happen to think that the SVF taken out is the same SVF put back in, because ultimately all the process does is strip out the fat and the structure from the remaining SVF. If the judge thinks so too, then the government is going to lose the injunction case, at least based on the judge’s analysis in his order today.

This could set up an appeal by the government, and could result in conflicting decisions between the Ninth and Eleventh Circuits (home of appeals from Florida).

This is also good news for the Florida clinic because a federal judge has accepted the argument it had made, but unfortunately, it was not the federal judge on its case. Still that’s why they have appellate courts.

This is also welcome news to the customers who have banked their SVF with the Florida operation, to the extent the material had not been destroyed (and last I checked a few months ago, it hadn’t been).

Finally, it is very, very good news for the physician affiliates of the Cell Surgical Network, as well as other physicians using SVF, (at least outside the Southern District of Florida.) The judge’s opinion is a clear indication that the only legal hurdle left is whether the SVF coming out is the same SVF going back in. If it is, and the judge so finds, then there’s going to be a substantial uptick of SVF procedures being offered in this country (outside of the Southern District of Florida). But then again, I’ve been wrong before, so we will just have to see what happens.

A shout out to federal Judge Jesus G. Bernal for this important decision standing up to the government, and to the very excellent work of defense counsel, the very venerable Venerable law firm.

Rick Jaffe, Esq.

Breaking News: Manhattan Doc in NY AG Case Files Answer Targeting the FDA and Says New Yorkers have a Privacy Right to the Treatment and a First Amendment Right to Info About it

Breaking News: Manhattan Doc in NY AG Case Files Answer Targeting the FDA and Says New Yorkers have a Privacy Right to the Treatment and a First Amendment Right to Info About it

Earlier this month, the New York Attorney General’s Office filed a false advertising case against a Manhattan Stem Cell clinic owned by Joel Singer, M.D. The clinic offers autologous stem cell transplant procedures for a wide variety of medical conditions. The clinic used to be affilated with the California Cell Surgical Network run by Mark Berman and Elliot Lander, who as you know, are defendants in one of the two FDA’s civil injunction lawsuits.

Here is the Washington Post article about the case.

https://www.washingtonpost.com/national/health-science/fda-sends-letters-to-20-companies-in-attempt-to-rein-in-stem-cell-industry/2019/04/03/7e01556e-564e-11e9-8ef3-fbd41a2ce4d5_story.html?utm_term=.e6c968d5d4c1

It was also reported in the New York Times

https://www.nytimes.com/2019/04/04/health/stem-cells-lawsuit-new-york.html

and the New York Post.

The articles reported that they couldn’t reach the clinic or its attorneys for comment.

The clinic’s attorney just filed the answer to the complaint. It’s not half bad, but you can judge for yourself.

Here it is.
singerfiledanswer

STAY TUNED!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

The grass is still growing ever so slowly in the FDA’s injunction cases against U.S. and California Stem Cell Clinics

The grass is still growing ever so slowly in the FDA’s injunction cases against U.S. and California Stem Cell Clinics

Since my last update about these cases in early August, not much has happened, which is to be expected in federal civil litigation. Nonetheless, here is an update.

Let’s start with what hasn’t happened

1. There has been no announced agreement in either case that the defendants have stopped treating patients with their SVF, stem cell therapy which the FDA claims are unapproved new drugs, adulterated and misbranded, pending the final decision by the judges in these injunction actions.

2 The FDA hasn’t filed a motion for a preliminary injunction against either company to stop them from treating patients until the judges’ final rulings.

The FDA sure isn’t litigating these cases like these clinics are a big public threat. There are a few well-publicized cases of harm from U.S. Stem Cells patients, and there is much made of the fact that California group was using a dangerous toxic substance in processing their “drug” product. But as I’ve said in some previous posts, the FDA has bigger fish to fry.

See my post at:

http://www.rickjaffeesq.com/2018/08/01/update-on-the-fdas-stem-cell-injunction-cases”>http://www.rickjaffeesq.com/2018/08/01/update-on-the-fdas-stem-cell-injunction-cases”>http://www.rickjaffeesq.com/2018/08/01/update-on-the-fdas-stem-cell-injunction-cases

Of course, it’s a complicated subject for a federal judge, and maybe the FDA is worried about losing in the abbreviated hearing process of a preliminary injunction motion. Maybe the thinking is “do it right and take your time.” If so, I can’t argue with it.

Here is what has happened

U.S. Stem Cell

The defendants filed an answer in August. It largely parallel’s the answer in the California case, which isn’t surprising since the same big firm is lead counsel in both cases. Here is the Answer:

09261800

There is one big difference: U.S. Stem Cell’s answer contains a demand for “a jury trial as permitted by law.”

No such request was contained in the California Stem Cell Treatment answer. Getting the case away from a judge and into a jury’s hands would be a good thing for a defendant in this type of case, so did the California lawyers miss an opportunity?

I don’t think so. Injunction cases aren’t decided by juries; they are decided by judges. I think the Florida lawyers just tossed out a jury request and the docket just mechanically picked it up and the mechanical/automated software spit out the jury trial forms deadline. My guess and prediction is that down the road the jury trial issue will be addressed and rejected by the judge, even if the case gets that far.

The case is set for trial during a two week period starting June 10, 2019.

The more relevant deadline is March 11, 2019, which is the summary judgment motion deadline. Seems a safe bet that the FDA will file a summary judgement motion for a final judgment. (FYI: That’s how the Regenerative Sciences case was resolved). The feds will do some discovery, nail down via admissions and depositions what the company does and doesn’t do – most notably, being cGMP compliant – which establishes adulteration. The feds will get in admissible form the label instructions for use, which establishes misbranding, and obtain admissions and deposition testimony of the facts of how the product is processed, and how/for what indications it’s being used, which should establish non-compliance with the main regulatory requirements for drug status, i.e., more than minimal manipulation and non-homologous use, (at least under the FDA guidance documents.)

With those facts established in admissible form in discovery, there probably won’t be any factual issues to be tried by the judge (or jury). That makes the case amenable to resolution via summary judgement.

The defenses challenge is to find a disputed issue of fact on which the judge has to hear factual testimony from the parties at a trial. In this case, it will be a challenge, but there are some possibilities. The defense has smart lawyers and will figure it out, if there’s something to be figured out. And who knows, they might even come up with a legal basis to move the case sideways.

I’d look to have the defense seek a delay to filing papers in opposition to the summary judgment motion, figure a month. (Anything beyond that would probably interfere with the early June trial setting.) That would make a decision on the summary judgement motion in May. That’s how and when I’d see this case wrapping-up unless defense counsel figures out a way to derail or slow down the proceedings. Speaking as a defense lawyer, sometimes delay is the best you can hope for, because who knows what the future will bring. This point is aptly made in a fable I related at the beginning of my chapter on cancer doctor Stanislaw Burzynski’s several decades war with the FDA and the Texas medical board in Galileo’s Lawyer. It’s a good story. Here it is for those who have an immediate need for a smile.

mendal

Sometimes horses learn to fly, and a year or two could present an entirely new regulatory reality.

California Stem Cell

The parties filed a joint preliminary statement, which sets forth the claims and defenses, lists the witnesses, and the documents (and of course it can be amended as more information becomes available through discovery), and sets forth a proposed case schedule. The parties are looking at a trial in late July to early August, subject to the Court’s availability. They are proposing a motion deadline of late May. Here is the joint statement. castemcelljtdiscovery

There is a scheduling conference with the judge on Tuesday, October 1, 2018, at which point proposed deadlines will be adopted or changed.

The legal issues related in the joint statement are as expected and as discussed in prior posts, namely whether the defendants’ procedure is an unapproved new drug or not regulated by the FDA because it’s a same day surgical procedure, with not more than minimally manipulated autologous cells, given for a homologous use and all the practice of medicine and lack of jurisdiction stuff thrown in. The relevant trial documents are the 483 inspectional observations, communications between the parties and the final guidance documents pertaining to these issues, as well as patient complaints. Predictably, the defense seems to want to have some patients testify, and I’m always in favor of that. Look to the government to seek to stop that, because hey, that’s how they roll.

Yawn. I warned you it’s like watching grass grow.

Since the discovery process does not normally result in the publishing or making public, documents or other information revealed in discovery, I think nothing exciting is going to happen in these two cases (or nothing we will hear about) until summary judgement papers are filed (unless the lawyers come up with an interesting delay strategy). The Florida judge did refer the case out to mediation, but that’s a non-starter. U.S. Stem Cell isn’t stopping, and the FDA isn’t going away until it stops the Florida operation.

So any more news from the FDA in the stem cell field will be about other lawsuits or collateral things, like its cracking down on private stem cell clinics using clinicaltrials.gov to promote their clinics via patient funded clinical trials, per a recent post by the big dawg. https://ipscell.com/2018/09/fda-outlines-potential-crackdown-on-clinicaltrials-gov-offenders/

(And for the record, I don’t have a problem with the feds restricting clinicaltrials.gov to IND clinical trials, or at the very least, requiring disclosure that the trials are not FDA approved and that the “participants” pay for the treatment. That seems fair and reasonable.

I’m also very much in favor of the private stem cell clinics providing accurate and complete information about their operations, including that their treatments are not FDA approved, are not considered to be safe and effective by institutional authority, and that anecdotal evidence is not considered scientifically reliable, or even disclosing that there is no government review or verification that the statements made by the clinics on their web sites are true (like what the supplement manufacturers have to state). And I also don’t have a problem with the FDA or the FTC going after any health care facility which puts out materially false information to fraudulently induce patients to undergo the treatment. I’m all about providing the patients with accurate and complete information and let them make an informed choice, because it’s their bodies and their body parts we’re talking about).

So in sum about the status of the FDA’s two pending injunction cases: the millstones (wheels) of justice grind exceeding slow . . . . (you know the rest).

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

For those who don’t: “The wheels of justice grind exceeding slow, but they grind exceedingly fine.” The odds favor the millstone over Mendal in these cases, so per Damon Runyon, “The fight isn’t always to the strong, or the race to the swift, but that’s the way to bet.”

RAJ

Some things in the private stem cell clinic debate are complicated, but some aren’t

Some things in the private stem cell clinic debate are complicated, but some aren’t

I am a believer and advocate that patients should have the freedom to use their own processed and expanded stem cells. That should mean that I support US Stem Cell Clinic’s fight against the FDA’s injunction action.

But I don’t.

I just can’t get past the fact that this Florida stem cell operation allowed a nurse practitioner to inject stem cells into several patients’ eyeballs which resulted in total or partial blindness. A nurse practitioner! Legal though it may have been under Florida law, it is an inexcusable lapse of judgement. Plus, the clinic had already settled several malpractice lawsuits and is facing at least one more lawsuit involving a patient.

I am an advocate for a patient’s right to use his/her own stem cells, but that doesn’t mean that a clinic which continues to cause serious harm to patients has the right to keep injuring them.

In my opinion, US Stem Cells has done serious and irreparable harm to patients, and it needs to be stopped now, not in next few years, which seems like the FDA’s current time table. I don’t often agree with the big dog (aka Paul Knoepfler) but on this issue, I do. See his post at https://twitter.com/pknoepfler.

How the Florida clinic can be stopped sooner rather than later

One of the stem cell luminary thought leaders, Bernie Siegel mentioned to me his hope that the latest big malpractice case against US Stem Cells might shut the place down. I told him I didn’t think so. Here’s why:

Malpractice claims are typically covered by malpractice insurance, and I have to believe given the clinic’s past experience, the first bill it pays after rent is its malpractice policy premium. It’s surely tough being sued, but when you’re not paying to defend and not paying the settlement amount, it’s not quite as tough, and is not a business ending event. So I don’t think any single or even a small number of malpractice lawsuits will do the job.

More effective would be fraud or deceptive practices lawsuits. These most likely won’t be insurance covered, at least not by malpractice insurance. I think there has been at least one such case filed against the clinic by a Miami law firm. I’m rooting for the plaintiff in that case. But these cases take time, and often times, the cases are settled. And insurance or not, I assume these Florida clinic folks have made a ton of money from their stem cell patient business, and they also have a training and franchise operation of sorts, so I wouldn’t expect even a fraud lawsuit or two to put them out of business, not in the short term at least.

So where does that leave those that want to see this clinic gone now?

We have to circle back to the FDA and think about what the agency would need to do to stop this clinic now(ish). And while some parts of the proposed plan may seem harsh, shocking and almost unbelievable, all these tactics have been used against me and my physician/clinic clients in the past by the FDA and other federal agencies.

1. Get the FDA’s OCI (Office of Criminal Investigations) involved

The FDA site inspection which resulted in a form 483 inspectional observations last year establishes what the clinic is doing. The statutes as interpreted by the final guidance documents establish probable cause that the FDA criminal trifecta has been violated (introducing into interstate commerce an unapproved new drug, misbranding and adulteration). The prior warning letter and the injunction complaint establish sufficient knowledge and intent to support a probable cause finding that the crimes are felonies. That should be enough for a federal magistrate to sign-off on a search warrant.

2. Execute the search warrant and take all the clinic’s patient records. If the clinic wants to see the medical records, it will have to come down the local FDA’s office and copy them.

3. Have the warrant search for non-FDA cleared medical devices or any other devices used in connection with the alleged criminal activity. (The latter is not a slam dunk.) That might/would stop the clinic from processing the fat into the stem cell SVF (stromal vascular fraction) product.

4. Invite the Florida medical board to participate in the raid. I don’t know whether the board has taken any action against the nurse practitioner and the supervising doctor yet, but if it hasn’t, there’s probably a decent case for an interim suspension proceeding against both. These proceedings are done ex parte, meaning it’s like a star chamber, done without telling the doctor in advance of the suspension.

5. Start interviewing the clinic’s patients. Many will be supportive of the clinic, including some who have received no benefit, but some won’t be.

6. Interview all the clinic’s employees and vendors/suppliers. OCI has some interesting interviewing techniques which in effect threaten criminal prosecution to people doing business with the target without technically threatening them, but the vendors get the message.

As I said, some or all of this might seem like legal thuggery, but me and my clients have been on the receiving end of all of them (Many of these tactics are discussed in chapters 2 and 9 in my book, Galileo’s Lawyer.). Combined, these tactics will get the clinic’s attention in a way which hasn’t heretofore happened. The other purpose of my discussing this is to show the FDA’s investigative tool box in cases where it really wants someone gone.

Other Government and private actors

US Stem Cells is a public company and that opens up another line of attack. The continued publicity already has and will continue to generate some interest by the SEC (Securities and Exchange Commission) which is looking into the company’s reporting documents (10K’s and 10Q’s). It’s probably a safe bet that the company’s disclosures were inadequate. With all the federal attention, some class action firm might file a shareholder’s suit, and that kind of suit burns a lot of cash for the public company.

The private lawyers who have filed civil malpractice or fraud lawsuits or are contemplating filing will be circling in the air waiting for any government action and especially any agency or judicial decision, which will make the civil fraud or SEC claims easier and faster to resolve favorably. To that end:

FINALLY

The FDA and the US Attorney’s Office should do what they should have done in the beginning, file a preliminary injunction motion, and request a hearing as soon as practical.

That’s going to present some interesting conundrums for the clinic’s principals. Do they testify? If they do, they can’t lie, or they’ll be charged with perjury. Can they say they didn’t know what they were doing is illegal? They can say it, but the judge doesn’t have to believe it. I doubt they’ve been told by an FDA attorney that what they’re doing is legal, so there won’t be an “advice of counsel” defense. Ultimately, they will either be forced to testify and most likely further incriminate themselves, or they’ll fold their tent and go away. (I’d bet on the former.)

If they don’t close down, then the final step is a criminal indictment, and that will put a whole new complexion on things. There’s a saying in criminal law. “You can beat the rap, but you can’t beat the ride.”

But in this case, once the blinded patients and the other injured patients testify, a preliminary injunction case, the permanent injunction case and a criminal trial are effectively over. No reasonable judge or jury is going to let these people continue.

And that’s why this is such a horrible case for stem cell advocates like myself. The idea that these people are the poster children for patients’ unfettered access to their own stem cells is disconcerting. That this case might set precedent for all same-day surgical procedure clinics should be distressing to all such clinic operators.

Therefore, best case scenario for both sides of the debate would be for the Florida clinic to voluntarily shut its doors now. Since that’s not going to happen, next best case scenario for everyone (including and especially patients) is that the clinic be shut down by the government as soon as possible.

And after that happens, the plaintiffs attorneys circling above will swoop down pick the clinic and its operators clean. If the clinic operators have an asset protection plan involving family members or family trusts, there will be fraudulent conveyance lawsuits.

Government and private action could trigger a voluntary bankruptcy proceeding by the corporate clinic/franchise entity. If so, the bankruptcy trustee will hire an attorney whose main job will be to claw-back all the money paid to the insiders, at least in the year prior to the filing, and probably longer. Ultimately, the lawyers (on both sides) will get it all.

That’s how I see it playing out if the FDA decides to take the case more seriously.

Of course, this is just my opinion and speculation based soley on publicly available information viewed through the lens of my 35 years working my side of the street.

What effect would all of the above have on the other private stem cell clinics?
Probably make them much more careful in what they do, say, and who they do it to. And even for a guy on my side of the street, that’s a good thing.

Post Script: I’ve recently read that these people have a new marketing idea and targeted audience: They’re doing penis stem cell injections.
Here we go again!

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

Texas Medical Board to patients needing stem cells (and the Texas legislature): Drop Dead!

Texas Medical Board to patients needing stem cells (and the Texas legislature): Drop Dead!

Last year, the Texas legislature passed landmark stem cell legislation (HB 810). The law didn’t open the floodgates for every physician who wanted to inject patients with stem cells. However, it did allow patients to access their own stem cells (as well as other people’s stem cells), under controlled circumstances, namely the procedure had to be performed in a high level facility (an ambulatory surgical center or hospital), and it required university type IRB (institutional Review Board) approval.

Here is the Texas law:

https://capitol.texas.gov/tlodocs/85R/billtext/pdf/HB00810F.pdf#navpanes=0

As the bill was winding its way through the Texas legislature, a few Texas senators (probably doing the bidding of the Texas Medical Association and/or the Texas Medical Board (“TMB”) tried to kill the bill by adding requirement that the procedure had to be FDA approved, i.e., part of a clinical trial.
(I pointed this and other flaws in the bill in a post. See: http://wp.me/p7pwQD-a )
Let’s just say that my comments were not appreciated.

The whole point of the law was to allow people to receive stem cells even if they were not part of clinical trials or under FDA approved special exception. Obviously, by re-imposing the clinical trial/FDA approval requirement, the law would be meaningless. Fortunately, the clinical trial requirement was dropped from the final bill.

But………..

There was one other provision in the bill that was particularly worrisome to me: that the TMB was given carte blanc to promulgate rules implementing the stem cell statute.

I’ve been litigating cases before the TMB for 30 years and have interacted with dozens of board members. They are very conservative medically, and most don’t believe in physicians practicing beyond established clinical guidelines. So I was very concerned when the Texas legislature gave the TMB unfettered discretion to set-up rules for stem cells. I said so publicly, subtly in my past posts(see the end of this post, http://wp.me/p7pwQD-ab) and much more bluntly in private conversations with the patient advocates shepherding the bill through the legislature. Let’s just say my concerns were not well-received.

But my long (and hard-fought) experience with the board members and the Board’s legal staff was telling me that the Board was going to be very reluctant to implement the statute as the legislature intended. In fact, the relative ease in which the opposing Senators gave up the FDA clinical trial requirement made me suspect that they simply decided to pass the bill knowing that the Board would kill it, or at least never let it be implemented as the rest of the legislature intended.

So what’s in the Board rule?

On March 26, 2018, the TMB published its proposed rule on HB 810, the stem cell law as well as regulations implementing the Texas “right to try” law (I’ll deal with the right to try regulations in a separate post).

Here is a link to the entire revised rule on investigational treatments:
http://www.sos.state.tx.us/texreg/archive/April62018/Proposed%20Rules/22.EXAMINING%20BOARDS.html#30

Here is a pdf of just the stem cell part of the proposed rule.
SUBCHAPTER B

But it’s a statute and thus pretty boring, so I’ll just relate the part which kills the stem cell law:

“(d) Stem cell treatments which are under investigation in a clinical trial and being administered to human participants:
(1) may be administered or provided to eligible patients with qualifying terminal illnesses or severe chronic diseases as defined by the executive commissioner of the Health and Human Services Commission; and
(2) must be done in compliance with applicable law.
(e) In order for a patient to be eligible to receive treatment with investigational stem cells, the eligible patient must:
(1) be enrolled in a clinical trial investigating the use of adult stem cells in humans;”

As previously stated, the whole point of HB 810 was to make stem cells available to patients outside of clinical trials. There is no need for a law that says patients can enroll in clinical trials, because that’s already the law. The point is to allow clinicians not doing clinical trials to administer stem cells outside of clinical trials.

Well why can’t a clinician just start a clinic trial and administer stem cells to his/her patients?

The answer: because it’s illegal (or so says the FDA). Physicians can’t give non-FDA approved drugs (which the board rule calls “investigational drugs”) to patients except in an FDA approved clinical trial. If they do, they are violating the FDA’s trifecta of introducing an unapproved drug into interstate commerce, and providing a misbranded and adulterated drug to patients. That’s the thrust of the recent injunction actions that I wrote about in my last two posts. (And it’s a nonstarter for the average clinician to do a clinical trial; it’s a quantum level more work and money than any clinician or clinic can do (unless your name is Burzynski).

And remember, the TMB’s proposed rule states that the stem cells being administered to patients in clinical trials must be done so “in compliance with applicable law.” There’s no more applicable law than the FDA law and regulations on clinical trials.

I think there are other problems with the TMB rule regarding IRBs which will make compliance practically impossible for university level IRBs, but that’s secondary to the fact that the proposed TMB rule limits stem cell access to patients on clinical trials performed “in compliance with applicable law,” which was exactly the law before Texas legislature passed SB 810!

Way to go TMB! The stem cell Mafioso is breathing a sigh of relief.

The good news, if there’s any, is that that this is just the TMB’s proposed rule. Public comments are allowed. Here is the number for more information:
(512) 305-7016.

There might be a public hearing sometime in the future. To state the obvious, there’s more work to be done by the folks who are advocating for access to stem cells outside of clinical trials.

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

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

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

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

Here is the warning letter:

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

Same ol, same ol, but with a twist

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

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

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

The rub/twist in this case

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

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

Just to recap the regulatory process

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

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

What’s next?

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

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

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

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

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

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

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

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

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

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

Landmark Texas Stem Cell Legislation Gets through the Texas Legislature!

Landmark Texas Stem Cell Legislation Gets through the Texas Legislature!

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

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

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

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

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

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

The easy part of complying with the bill

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

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

The Hard Part

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

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

1. Where you can get treated

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

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

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

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

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

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

3. Texas Medical Board Approval of IRBs?

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

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

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

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

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

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

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

So continued vigilance is the watchword.

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

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Hey Mr. President: how about some quickie executive orders on prescription drug importing, stem cells, and vaccination

Hey Mr. President: how about some quickie executive orders on prescription drug importing, stem cells, and vaccination

Mr. President: looks like you’ve kept your word so far on Obamacare by signing a vague executive order allowing federal government agencies to do what they can to lower the costs or make more efficient whatever the agencies can figure out they can do without congressional approval. Hopefully that will work out.

I have a couple of ideas for some quickie executive orders, consistent with your campaign speeches or your thinking. As always, I’ll keep it short:

1. Consumers importing cheaper prescription drugs

Congress took up the issue, and since both parties are in the Pharma’s pocket, it once again declined the chance to help people by allowing them to import prescription drugs from Canada and other places where Pharma sells its products for a lot less money. You recently took Pharma to the woodshed in a recent tweet. On behalf of the people, thanks. In your inauguration speech, you railed against Congress for not watching out for us. Here’s my suggestions:

First: we need a standard Trumpian tweet excoriating Congress for protecting Pharma by its recent action in continuing the prohibition of patients from importing drugs manufactured by major drug companies which are sold for a lot less money abroad.

Second: how about an executive order ordering the FDA, DOJ and Customs not to enforce the existing drug importation restrictions. That would send a message to Pharma and Congress, as well as immediately save patients money.

Yes, you and the rest of the Republicans hassled Obama for using executive orders to circumvent enforcement of existing federal laws like immigration.

But let’s get real. That’s just an argument used by the party that doesn’t control the presidency. Further, I don’t think we should worry about little things like consistency. I’m guessing you’re okay with that, especially if some minor inconsistency can benefit the people who supported you, and trust me, your working class supporters will really appreciate having the option of cutting their out-of-pocket drug costs by half or more. You do this, and I guaranty your approval rating will jump-up a few points.

2. Stem Cells

Don, first thing I’d like you to do is call Rick Perry, and ask him about his experience in getting a stem cell transplant for his back problems. FYI, his stem cell procedure was flat-out illegal under federal law. But he was the Governor, so who was going to stop him? I’ve heard it helped him alot. If so, why shouldn’t the tens of thousands of patients who could similarly benefit from stem cell treatments get them? Do you really have to be a Governor to get the state-of-the-art treatment?

I’ve covered the FDA’s regulations and the technicalities in numerous prior posts,
http://rickjaffeesq.com/category/stemcells/

But the bottom line is that your FDA severely limits access to stem cell treatments, and you should do something about it immediately, even before the FDA Commissioner is identified or sworn-in. So here’s what I suggest:

First: A quickie executive order that whatever draft guidance documents concerning stem cells (and there are currently four, explained in prior posts, see above) are on hold, and no final guidance documents will be issued except on the approval of your FDA Commissioner.

Second: Another executive order that as matter of enforcement policy, neither the FDA nor the Department of Justice will take any action against a clinic which removes stem cells or any other human tissue from a person, and reinjects or reimplants that tissue into that person. And the enforcement policy should make clear that it applies even when the stem cells are other materials are expanded or cultured, which is the procedure which was so successful on Rick Perry. If Rick Perry could do it, let the rest of us have access to this stuff. (And BTW, there is less of or no consistency problem here since the regulations actually allow many stem cell treatments; it’s just the FDA has decided in its infinite unwisdom to try to stop almost all of these procedures.). The institutional stem cell players and the aforedescribed media cheerleaders won’t like it, but your supporters and many, many others will love you for it.

3. Vaccination

First: Let’s get moving on the Bobby Kennedy Jr. Vaccine/Autism thing. Maybe this could be done by executive order as well. Hell, it’s just a commission. I know you received some pushback from the institutional vaccine pushers and their cheerleaders in the media, but there is a groundswell of support for Bobby and the Commission from the people, and per your speech yesterday, that’s what important to you.

Second: as you probably know, federal agencies have some kind of internal oversight, referred to as the “OIG” (Office of Inspector General). In light of some of the recent stories about cover-ups and scientific fraud at the CDC concerning the autism issue, you need to give some serious consideration to the CDC OIG position. Your pick needs to be willing to take on the powers that be in the agency. So choose wisely.

Enjoy the job, and hope you really shake things up in the health care field. It’s long overdue!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com