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Author: Richard Jaffe

Medical Board 1, Ron Kennedy 0

Medical Board 1, Ron Kennedy 0

A few months ago, Dr. Ron Kennedy made a big splash in the Cali vaccine concerned community by announcing that he was suing the California Medical Board and its individual members, because the board was obtaining copies of his medical exemptions from the schools.

I understand how a doctor can assert the privacy rights for his patients’ medical records which the doctor posseses. But I never understood how a doc could assert the patients’ rights over a school record (which is what a vaccine exemption letter becomes once it gets to the school). Sure, the doc may have signed the exemption, but it’s obviously not HIPAA protected once it’s filed in the school. School records are not covered by HIPAA, but are privacy protected under another law, FERPA, but that doesn’t have anything to do with a doc or his right to protect patient medical records in his possession. But who knows, maybe those folks know something I don’t.

The case was originally filed Sonoma County, but had to be removed to San Francisco County because that’s one of the only four counties the board can be sued in. (I don’t rule out a clever tactical decision to file in the wrong county.)

From what I can tell, that case is in some kind of administrative twilight zone like limbo. I can’t access the records on the superior court’s web site and it seems like the case might stay in limbo for some time. (I can’t rule out the possibility that it’s part of a clever tactic.)

But that administratively mislplaced lawsuit is not really what this post is about.

After receiving the exemptions, the board subpoenaed the records of the patients from Kennedy. He refused to comply, asserting his patients’ privacy rights. And that I understand (though for reasons discussed later, seems like a futile jesture).

In early February, the board filed a motion to compel compliance with the subpoena. Kennedy responded, and evntaully sought to delay the motion because of the pendency of his lawsuit against the board. (And therein lies the possibly clever tactic in filing the lawsuit, filing it in the wrong place and or allowing the case to be in administrative limbo, but I’m just speculating).

The judge didn’t buy it, and on April 15, 2019, granted the board’s request for the medical records.

I think every physician who writes medical exemptions should read the opinion because it shows how the judiciary is going to approach vaccine related issues. I’ll let you folks figure out what those lessons are.

Here it is. It speaks for itself and it speaks loudly.
ordercompelingcompliance

And in terms of resisting board subpoenas, I think the last time a California court refused the board’s request for medical records was in 2004, the Bearman case. Bob Sears tried it and lost last year. I’ve tried it in two cases in 2016 and 2017 and lost both times, and all the savvy Cali. lawyers have also tried and lost every time. (psychiatric records are still protectable).

The thing about losing a motion like that is that you have to comply because if you don’t, you can be held in contempt, and the conduct is board sanctionable. Of course, you can appeal, but if you don’t get a immediate stay from the appellate court, you get sanctioned for non-compliance without a stay.

So, my guess is that Kennedy’s patient records will be given to the board and the investigation will follow the usual path, interview in a few months, and an accusation by the end of the year. But by that time, the whole doctor medical exemption thing might be ancient history, and the moving vans taking the vaccine concerned out of state to greener PBE pastures will be long gone. But one way or the other, I’m going to predict that Dr. Kennedy won’t be in the vaccine exemption writing business this time next year, based on the brief description in the judge’s opinion.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Can I sue Senator Richard Pan for doing his job as a California Legislator? THAT WOULD BE A HARD NO!

Can I sue Senator Richard Pan for doing his job as a California Legislator? THAT WOULD BE A HARD NO!

I’ve been asked this question a couple times recently as the frustration of the Vaccine Concerned grow as SB 276 winds its way through the California Legislature, so a public answer might be in order.

The job of legislators is to propose and pass legislation. It doesn’t matter if a small minority or even a large majority of citizens don’t like a particular bill or law, or think its unfair, horrible or even murderous. The process is the process, regardless of how corrupt you might think it is. The remedy is to stop a bill you don’t like and/or vote the people proposing the bills you don’t like out of office.

Legislators have absolute immunity from suit with respect to their legislative activities, which is in essence proposing bills and passing them so they become law.

You can’t sue Richard Pan for proposing SB 276. It’s just a bill and it won’t become law unless a majority of both houses of the California legislature passes it. So, you would have to sue every legislator who voted for the bill, and there is no such thing in law, based on the aforementioned absolute immunity.

So, sorry, there’s no possible judicial action against Dr. Pan or any other legislator for doing his/her job, regardless of how much you don’t like what he or they are doing.

Also, and this has been asked, neither he nor any other legislator can be sued if a parent vaccinates a child and the child suffers a serious adverse event even if the parents were forced to vaccinate if SB 276 becomes law. And for same reason; absolute immunity.

Respectfully, move on and focus on stopping the bill.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

The Mother of All Anti-SB 276 Letters

The Mother of All Anti-SB 276 Letters

If you want to read the mother of all anti-276 letters, here it is from my friend and colleague Greg Glaser, Esq. When I have a question about vaccines, he’s the guy I call.

Glaser Letter Opposing SB 276

It’s long but really worth it. nuf said.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

The Other Part of How to Win the Cali SB 276 battle (and what’s not going to work)

The Other Part of How to Win the Cali SB 276 battle (and what’s not going to work)

My last post “Go Big and Go Smart or Move Out of State”
generated some sharp disagreements (at least on my Facebook page), but that’s not a bad thing. These issues need to be discussed, but quickly, so that action isn’t delayed.
here is that post:
http://rickjaffeesq.com/2019/04/11/to-the-cali-sb-276-opponents-go-big-and-go-smart-or-move-out-of-state/

One criticism I got is don’t piss-off the legislators; they won’t like you. My guess is that most of the legislators already think you’re a bunch of anti vax wackos, so I wouldn’t worry too much about trying to win any popularity contests. And there’s a difference between trying to pass and kill a bill.

One comment I received raised something I haven’t mentioned in public, but which I have talked about with movement leaders, and it is another part of how to increase the chances of defeating SB 276, and that of course is:

Go small, quiet and personal

The California Legislature has 80 Assembly members and 40 Senators. Per the previous post, they matter, big time. But there are other people who matter. Each legislator has a chief of staff, at least one policy person, they all have a secretary/personal assistant, and there’s someone in charge of the legislators’ home office. That’s another roughly 500 people who also matter. If any legislator is going to agree to vote down 276, he/she will need some internal support/cajoling from the staff. So, think about reaching out to these folks also.

Let’s think numbers and connections

Let’s define the VC universe as roughly the three to four hundred thousand people who signed the SB 277 recall petition.

Let’s analogize from the 6 degrees of separation between any two random people. I have to believe that there have to be at least a couple hundred people in the vaccine concerned universe who know personally, or know someone who knows personally, one of the 120 legislators, or their 500 closest aides. Obviously, if your one of those people who knows one of these folks, for sure make the call and do what you can, and see if you can arrange a meeting with someone from the VC groups. Maybe you don’t know one of them, but maybe someone you know (outside of the vaccine concerned world) does. Personal contact with close staff surely matters.

And it’s a two-way street.
Information in, and information/intelligence back about what’s happening in the inside. You never know, there might be a smoking gun/game changer fact or memo/letter somewhere. I can’t tell you what it is, but like they say, you’ll know it when you see it.

What’s not going to work

You can forget about having doctors coming out in mass against SB 276. The CMA and the AAP are in favor of the bill, probably because most of their members who are involved in vaccination are afflicted with PCDS.

You all know what that is, but are probably not familiar with this soon-to-be proposed technical name for this disorder: Practitioner Cognitive Dissonance Syndrome. It affects pediatricians because their lifestyle income (as opposed to their professional wage) comes from vaccines, either directly or through insurance incentives. Take vaccines out of a pediatricians’ practice, and they’d be leasing Subaru’s rather than Mercedes and BMW’s, and they’d be saying good-bye to the other accoutrements of wealthy professionals. Besides, most of them are probably tired of explaining to you that they’re not going to write exemptions for your kids because they are convinced that vaccines are safe and that there is no credible evidence that it causes autism or even heartburn.

Circling back: reach out and find people who know these 500 and get to work, but do it quickly!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

To the Cali SB 276 Opponents: Go Big and Go Smart, or Move out of State

To the Cali SB 276 Opponents: Go Big and Go Smart, or Move out of State

I saw some Facebook video clips from the Sacramento anti-SB 276 rally which took place yesterday, April 10, 2019. The hundreds of participants seemed highly motivated. The speakers which included Rock Star Del Big Tree and RFKJr, (who I consider the brightest and most cogent star in the Vaccine Concerned firmament) was also there I’ve heard.

Del is broadcasting today, and has some other heavyweight movement leaders. It is certainly democracy at work.

I have a question for the anti-276 leaders, and some observations.

How different is what you’re doing now from what you did against SB 277? The obvious reason I ask is that if it’s not that different, and you lost on 277, maybe you need to think about what more it would take to have a different outcome.

Some Observations

I have some observations based on things I’ve seen in political heath freedom activism from the 1980’s. IMO, the most effective health political movement I’ve ever seen were the AIDS activist group Act-Up. (Actually, now Goldwater Institute which has brought you right-to-try might be as or more effective, but I have a feeling these folks have some serious cha-ching behind them, unlike ACT-Up which was grass roots.)

I’ll get back to ACT-UP in a minute, but first a couple things you won’t like to hear.

Liking, emojiing and sharing things on Facebook and other social platforms with your circle of friends is not political activism. It might feel good and it might feel like you’re doing something meaningful, but unless all this social media chatter is going to lead to some tangible political action, in my (perhaps, not so) humble opinion, it’s just a bunch of digital hot air shot out into the infinite internet space.

The problem is that you all have closed social circles and you don’t reach anyone who matters. Another way of putting it, you’re just preaching liking/sharing to the converted/committed/choir.

Unless all this hot air is focused on a specific practical plan, directed at who matters, your feel good button clicking, and small-time protests, is no more than small-time collective self-pleasuring.

So, who matters?

That’s easy. If there are Senate health committee members still in play, they matter the most.
Next, the rest of the Senate and the other house matter.
That’s sort of obvious, but, every single thing you folks do should be aimed at influencing those dozens of people who are the only people who matter.

A corollary is that if you’re not trying to repeatedly and directly influence these select group of people, you’re not in the game, as good as you might feel about what you’re doing.

And ultimately that means one of two things: Boots on the ground in Sacramento AND at their local legislative offices, or massive, and I mean stupid massive communications efforts directed at these folks.

Some history

Back in the mid 80’s, when I first started working the health freedom legal beat, I saw up close and was peripherally involved consulting with the ACT-UP folks. They were smart, and very committed. It was easy for them to be so since some were dying of AIDS, some were HIV positive and the rest knew or feared they would get it.

President Reagan wouldn’t even acknowledge the problem and the FDA was stopping people at the border from bringing in potentially life saving medications. So, these dying gays decided to do something about it. They picked a day and they effectively shut down the FDA via a phone barrage, and a lot of protests. They became too big of a problem to avoid. Reagan acknowledged the problem and started throwing money at it. The FDA relented and loosened up its rules on personal importation of unapproved drugs, and in my view, it was all because of the dying and HIV gay activists They didn’t have time to do whatever was the equivalent of Facebook liking and emojing. They acted in a big way.

I’m not suggesting that you close the Sacramento Legislature down by a massive protest. What I am suggesting is that you don’t confuse social media work with actual political work. I would venture a guess that few if any of the people you need to influence are your Facebook friends. So sure, rile yourselves up, but have an actual political plan, and that means boots on the ground and calls and emails and stupid big numbers.

And let’s talk numbers

My view, which you won’t like, is that having hundreds of people protesting yesterday might have felt good for the participants, but from my office two blocks away from the Capital I used to see protests all the time there, busloads full of people. So regrettably and respectfully, I think you folks are deluding yourselves if you think that 500 or 800 people protesting on an issue is going to have a meaning impact in a state like California. Furthermore, I think having legislators receiving dozens or even a hundred calls is equally meaningless in the grand scheme of California politics, especially on a super-hot button polarizing issue like this, where frankly you are a very, very small minority.

I recall hearing that there were three to four hundred thousand signatures on the SB 277 recall referendum. Somewhere between yesterday’s few hundred protestors and the recall number is what I would call the threshold of effectiveness, but it’s not in the order of magnitude of the yesterday’s feel good effort.

Some of you might be thinking, “Ok big talker about the good-old-days, smarty pants, so what should we do?
Fair question (if somewhat harsh).

I do have a small suggestion, but first another critical observation.

Another thing which feels good, but I question the efficacy of are legislative hearings.
It’s really fun and rewarding to assemble like-minded folk and testify, but on a hot button issue like that, I sort of doubt that experts, or even the brightest star have much of an impact on most legislators under normal circumstances. These legislative folks are all about keeping their jobs, and that just means numbers.

I think that clear and cogent arguments, like those made by RFKJr and the Janis Joplin like super VC rock star Toni Bark will be better received with the right attitude adjustment inputs before the hearing.

For example, they might be more focused, if on the afternoon before the hearing, April 23, 2019, say from 2-5 PM, every recall petition signer called and visited their legislators to let them know their views. Email is ok too, but only in addition to calls and visits.

And here’s the thing, why should the calls only come from the California VC? If the California legislators get away with taking away physician medical exemptions here, you think other states won’t try the same thing? Maybe this should be a national effort, April 23, 2019 being the California day kick-off.

I’m not a VC organizer activist, but if I were, I’d give some hard thought to having every vaccine concerned person in the country give the California legislators a piece of their minds on April 23, 2019 in the afternoon, and maybe, just maybe, that might help the VC rock stars do their job.

To adapt a common phrase: Go Big and Go Smart, or Move out of State.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Where is the California Medical Board’s Outrage over SB 276?

Where is the California Medical Board’s Outrage over SB 276?

Unless you follow general health care issues, you might have missed the outrage expressed by the head of the California Insurance Commission, when it came out that nurses rather than doctors were making insurance coverage decisions about expensive medical procedures, and for high cost procedures, denial of coverage means denial of care.

Here is an article explaining it.

https://www.newsmax.com/thewire/aetna-medical-director-nurses-decide/2018/02/12/id/842821/

At least Aetna had nurses reviewing the medical records before they denied coverage (FYI: I hate health insurance companies. See Chapter 2 my book for why)

SB 276 is even worse.

First, the bill doesn’t require that the public health official rejecting or revoking the exemption has to be a doctor, a nurse or even a witch doctor. Second, medical records aren’t reviewed, just an application.

As I’ve previously stated, there is a reason they’re called medical exemptions. See http://rickjaffeesq.com/2019/03/26/cali-sb-276-moves-to-eliminate-physician-medical-exemptions-but-hey-numb-nuts-theres-a-reason-theyre-called-medical-exemptions/

Could it possibly be because the decision involves making a medical judgement about whether, for example, a close relative’s family history of an autoimmune disease suggests that the risks of continued vaccination might outweigh the benefits?

Isn’t it a shame that we don’t have experts to study these issues on individual cases?

But of course, we do; they’re called medical doctors, and to reiterate, SB 276 doesn’t require these medical decisions to be made by physicians or even nurses.

Based on the Insurance Commissioner’s outrage when it came out that medical doctors were not making coverage decisions, I’m not understanding why the medical board sits silently. How can it accept a law which doesn’t require its licensees to make decisions which could severely injure children.
I exaggerate you think?

A few posts ago, I quoted from a recent appellate court judge’s dissent in the affirmance of the denial of compensation by the vaccine court The case is Oliver v HHS and Judge Newman’s words and his quote from the legislative history should be repeated to the medical board and legislators who consider SB 276.

“The National Childhood Vaccine Injury Act of 1986
It had long been known that a small percentage of childhood vaccinations have led to grave injury and permanent disability, as discussed in the legislative record:
‘Childhood vaccines are essential to maintain the health of our society. They have been invaluable weapons against the dread diseases that used to kill or injure hundreds of thousands of children every year: polio, measles, pertussis, diphtheria, tetanus, rubella, mumps, and smallpox. But while these vaccines have brought the gift of life and health to millions, there are a very small number of children every year who are injured by unpredictable side effects of the vaccines through no fault of their own or the vaccine manufacturers.
132 Cong. Rec. S17,343–02 (1986) (statement of Sen. Kennedy).’ The House Report reiterated the concern for unforeseeable injury flowing from compulsory vaccinations:
‘While most of the Nation’s children enjoy greater benefit from immunization programs, a small but significant number have been gravely injured. . .
. . ..
But it is not always possible to predict who they will be or what reactions they will have. And since State law requires that all children be immunized before entering school, most parents have no choice but to risk the chance—small as that may be—that their child may be injured from a vaccine.
H.R. Rep. No. 99-908, at 4–6 (1986), as reprinted in 1986 U.S.C.C.A.N. 6344, 6345–46.’

The legislative record states that about one half of one percent of children each year experience vaccine-related injury;1 and with four million births each year in the United States, this is about 20,000 vaccine injuries per year.2″
(emphasis added; footnotes omitted).
Here is the decision again. If you haven’t read it, you should.

Decision – 2019 – oliver – scn1a – dissent in fed cir – 17-2540.Order.1-9-2019.1

So back in 1983 Congress acknowledged that 20,000 kids would suffer grave injury and permanent disability from vaccines. And that was when kids got seven vaccines in 20 shots, now the number is between 69 and 74 shots.

And this is big: We know a little (or actually a lot) more about predicting who might become vaccine injured than we did in 1983.

And who might these people be who might have that knowledge?

It’s not a trick question.

It’s the physicians. It’s not public health officials.

Let’s go sideways to consider something else:

What about all these fake SB277 medical exemptions?

Unless I’ve been in a catatonic trance these last three years and missed basically everything, as of today, April 9, 2019,
there has not been a single board adjudication that any SB 277 exemption has been unjustified, false or fraudulent and I repeat, not one. (The one board case which did involve vaccines was a consent order for Bob Sears, but that was a custody, litigation-related letter he wrote for a non-school age child prior to the enactment of SB 277.)

So, there is no evidence that there have been even a single fraudulent or incorrect SB 277 medical exemption written by a California physician.

What is the purported evidence that is the basis of SB 276?

The fact that the medical exemption rate has gone up three or four times, from under a thousand prior to SB 277 to around 4,000 in 2018. The assumption is that the difference is parents switching from PBE’s (personal belief exemptions) to medical exemptions.

What’s the evidence for that? Maybe I’m still catatonic, but I haven’t heard any. There’s no data, just the raw numbers.

Let’s assume for the sake of argument that the unsupported assumption is true, namely that every child who had a PBE is now under a medical exemption and that’s why the numbers went up by a few thousand (and that’s not a big number relative to the size of the state. I’ve heard it went from 0.2 to 0.7 percent of school age kids.) That still doesn’t prove anything to anyone who understands what the word proof or evidence means.

How do the SB 276 authors know that all these kids didn’t have family history issues exemptable under SB 277, but the families didn’t need to get the medical exemption before SB 277, and only sought it out as a result of 277? How do the legislators know that’s not the case? There’s no data. It’s just a second level assumption.

So, let’s tie these two threads together:

We know to a congressional certainty that vaccines will seriously harm and permanently injury tens of thousands of children nationally. But we have some information that we didn’t have thirty-five years ago, about which kids might be most likely to be gravely injured and permanently disabled.
The professionals who have that information and make similar medical decisions all day, every day are …. Hey, it’s not a hard question ….

Right, it’s the doctors.

But doctors won’t be able to make that decisions because the number of medical exemptions went up by one half of one percentage point. And that in spite of the fact that there’s not a single confirmed case of a fraudulent 277 medical exemption.
And from all that you get what? Doctors can’t be trusted to decide on medical exemptions?

Maybe it’s just me, but I’m not seeing how that makes any sense. (common or even regulatory sense, the half-witted, “special” brother of common sense) I’m also not understanding why the California Medical Board isn’t jumping up and down, or at least quietly telling the legislators, that they are going too far on this one.

Here’s hoping for some well-deserved outrage from the regulators. But maybe I’m being overly optimistic.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Good News for the Vaccine Concerned: NY Judge TRO’s Rockland County Executive’s Ban

Good News for the Vaccine Concerned: NY Judge TRO’s Rockland County Executive’s Ban

A New York judge in Rockland County has just issued a TRO stopping Rockland County Executive Edwin Day’s March 26, 2019 ban on unvaccinated orthodox jewish children from being in public places for one month because of the measles outbreak in Rockland County.

This might be the first ever something like this has happened, maybe both ways, the County executive’s action and a judge stopping it.

In addition to issuing the TRO, the judge signed an order to show cause setting a hearing date of April 19th for the preliminary injunction motion (to see if the TRO will be continued).

The hearing might be moot since the executive order is set to expire on April 25, 2019, but from the country’s point of view, the TRO is probably pretty important negative precedent, so the County will fight it, is my guess.

The other thing I’m watching for is whether the County seeks an immediate stay of the Judge’s order at the Appellate Division. I would guess the county is already on the phone to line up a judge to hear a stay application, but we’ll see.

A very big congrats to the legal team on this. Civil Rights attorney Michael Sussman was the lead (and I think he was probably quietly helped by Professor and all round deep thinker Mary Holland, Esq.).

With the last week or two the way it’s been, some good news is much needed for the Vaccine concerned.

Here is the decision and the order to show cause. Enjoy!

rocklandtro452019

osc

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

EXTRA, EXTRA: US Stem Cell Litigation Goes to the Court for Decision

EXTRA, EXTRA: US Stem Cell Litigation Goes to the Court for Decision

Per Pacer, on April fools day (with whatever significance that has to you), both sides submitted their replies on their respective summary judgement motions. The case is now as lawyers say, sub judice, (submitted for and pending decision).

No big surprises in these last papers. The government says the defendants are violating FDA laws and regulations, based on the FDA’s interpretation of the FDA statutes, and that the defendants admit the violations. The defendants argue that they are not subject to FDA drug requirements because the law doesn’t apply to them because it’s the practice of medicine and it’s a same day exempt surgicial procedure under 21 CFR. 1271.15.

The papers filed on both sides are excellent. The arguments were clearly made, and professionally and forcefully highlight the differences between the parties’ position.
I don’t think there was any more to be said on behalf of the defendants.

High quality papers like these help the judge make a decision, and I’m sure are appreciated by the court. So, congrats to both sides for a job well-done.

Look to a decision by late April.

Still, I don’t think that a Government win will have the effect the FDA or the anti-private stem cell clinic folks are hoping for. The industry has already, or is in the final process of moving on to the next HCT/P’s, and some of these puppies are likely to be harder for the FDA to stop under the current regulations and guidance documents. And, even if not, the whole process is going to have to start over again, the outcry from the stem cell establishment, inspections, delays, warnings letters, lawsuits. My prediction is that we will be well into the mid-2020’s before we’re at the same point with the next batch of products, at least if the FDA follows its current game plan. That’s going to make some folks happy, and others, not so much.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

The Feds Send Some Love Letters to CBD Companies

The Feds Send Some Love Letters to CBD Companies

CBD is the new gold rush in complementary and integrative health. It’s everywhere. But while CBD based products may be legal federally, they are obviously not approved drugs, and are at best regarded as dietary supplements. As such, no medical claims can be made. But legal technicalities have not stopped the CBD companies from marketing their products as miracle cures for all things pain related and more.

And therein lies the problem according to the feds.

Two days ago there was a joint FDA and FTC announcement of warning letters being issued to four CBD manufacturers who made disease or cure claims. Here is the press release.
https://www.ftc.gov/news-events/press-releases/2019/04/ftc-joins-fda-sending-warning-letters-companies-advertising

One of the companies was selling a CBD based product for dogs. Lucky them.

Here is the warning letter to that company which lays out the standard FDA/FTC litany of violations for false and unsubstantiated advertising and the unapproved new drug mantra.
https://www.ftc.gov/system/files/attachments/press-releases/ftc-joins-fda-sending-warning-letters-companies-advertising-selling-products-containing-cannabidiol/advancedspine_relievus_wl.pdf

The warning letter is instructive for companies to see what’s not allowed to be claimed (and not much is allowed).

CBD is now on the fed’s radar screen for medical and disease claims, so CBD manufacturers should be careful.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Revised and Updated Breaking FDA News: Finally Some Action Against a Cord Blood Manufacturer & MORE TO COME SOON!

Revised and Updated Breaking FDA News: Finally Some Action Against a Cord Blood Manufacturer & MORE TO COME SOON!

For some reason, and for the life of me I can’t figure out what it is, up until now, the FDA has been extremely shy about confronting cord blood manufacturer/resellers. I can’t think of a single warning issued against these folks, even though they claim to their physician customers that their products are FDA exempt, which I have publicly doubted is the case. (See my post: http://rickjaffeesq.com/2019/02/08/is-cord-blood-um…-treatment-legal/

Per the NY Times today, that changed last Friday, and for those living under a rock, but with access to the internet, here is the NY Times article.
https://www.nytimes.com/2019/04/03/health/stem-cells-fda.html

Here is the actual warning letter sent to the company on Friday, March 29, 2019.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635078.htm

Big surprise, the FDA takes the position the company’s umbilical cord stem cell product is an unapproved new drug, not an exempt or solely regulated under a Section 361 type HCT/P product, under 21 CFR 1271.10. Also, and again no surprise here, the manufacturing facility is not up to cGMP snuff.

If you read my stuff, you know what’s coming next procedurally: a response by the company in which they’ll claim they are exempt and a promise to endeavor to look into fixing some of the cGMP issues, dead time, FDA response that the compnay’s response to the warning letter is unsatisfactory. Maybe another response, then more dead time and thereafter, if the company still has the same name and location, an FDA injunction lawsuit.

If the FDA has performed inspections at other umbilical cord facilities, and there are a number of them out west, expect another warning letter or two.

What effect is that going to have on the doctors buying and using this and other company’s product?

In the short term, none, whatsoever.

Why? Think whack-a-mole, and some economic and market realities. The econmic realities are that cord blood products are typically cheaper or alot cheaper than the autologous fat/MSC/SVF surgical proceedures, and cheaper is more popluar obviously, since the entire market is cash/non insurance reimbursable. Second, less training and equirement outlays for the docs for injecting products manufactured by others. Even chiros and naturopaths are getting into the non-autologous market. Third, skyrocketing demand based on the ineffectiveness of current treatment for many othopedic and other conditions. When you combine all three, you’re going to need a whole lot of hammers to whack all these moles.

But at least I give the FDA credit for going after the manufacturers, or the discredit for interfering with people’s rights to get the treatment they want without government interference. It all depends on your perspective.

AND NOW FOR THE MORE TO COME!

In a statement released eariler today, April 3, 2019, the outgoing FDA Commissioner issued a public statement about this warning letter and 20 others that have recently been filed. These are not on the FDA’s web site, but I suspect they soon will be. We’ll see if it includes the usual cord blood suspects in the western part of the country or if it includes folks other than manufacturers.

Here is the commish’s public statement:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635165.htm

Stay Tuned!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com