Browsed by
Category: Uncategorized

EVERYONE NEEDS TO TAKE A BREATH!

EVERYONE NEEDS TO TAKE A BREATH!

The new California vaccine exemption law only has an obvious immediate effect on physicians contemplating writing new exemptions. Families with vaccine medical exemptions have some time to figure things out, especially families with all their kids currently in school.

There will be legal challenges which will take months to resolve, if not longer. Analysis, planning and strategic thinking are what’s needed. Not emotion or panic.

Because of what I think are some technical defects in the law, there are not definitive answers to some of your questions, and some facets of the new law are going to depend on how the schools and public health department interpret defects and poor drafting of a law which was substantially changed at the very last minute.

If your kids are in school now, you don’t need an answer right this minute to every question about what’s going to happen to your medical exemption next year or the year. As indicated, some of those answer will only be known once the authorities start interpreting and applying the law.

So take a breath, exchange ideas with community members and see what ideas/workarounds are out there, and don’t panic!

Rick Jaffe, Esq.

To All California Physicians: Watch out for Scammers Claiming to Be DEA Agents and Demanding $25k

To All California Physicians: Watch out for Scammers Claiming to Be DEA Agents and Demanding $25k

As if physicians didn’t have enough to worry about, apparently there is a scam being being run on California physicians. They are getting a call from someone claiming to be a DEA agent stating that the physician is under investigation. The caller requests a $25,000 bond, maybe to make the investigation go away.

Here is what the Medical Board of California says about it:

“Fake DEA Agents Extortion Scam
The Medical Board of California (Board) has learned that scam artists posing as U.S. Drug Enforcement Administration (DEA) agents or Board staff are calling California physicians as part of an extortion scheme. The scammers identify themselves as DEA agents or Board staff calling about ongoing investigations regarding their license issued by the Medical Board of California (Board). The scammers tell victims their license may be suspended for illegal drug trafficking and the suspension means they will not be able to practice. The scammers may provide an “Agreement for the Bond and Protocols” that includes statements that licensees are not to share or disclose the investigation to any third party and agree to a bond fee payment of $25,000.00. The scammers’ phone number may show up as the Board’s toll-free number (800) 633-2322.

No DEA agent or Board staff will ever contact physicians by telephone to demand money or any other form of payment. If you receive a call such as the one described, refuse the demand for payment. Please also conisder the following:

If the caller is stating they are from the DEA, immediately report the threat using the DEA’s Extortion Scam Online Reporting form.
If the individual identifies themselves as a Board employee, please contact the Board at 1-800-633-2322 or send an email to webmaster@mbc.ca.gov.
If the phone number of the caller appears to be the Board’s toll-free number, it is recommended that you submit an online complaint with the Federal Communications Commission (FCC) using the FCC’s Consumer Complaint form or contact the Board so it can provide this information to the FCC.”

http://www.mbc.ca.gov/News/Fake_DEA_Agents.aspx

Don’t be fooled!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Major Update on the Stoller Case: New Defendants Added and New Claims Made

Major Update on the Stoller Case: New Defendants Added and New Claims Made

Here is the update on the gogetfunding website:

https://gogetfunding.com/blog-single-update/?blogpre=6112639&single=39663

Here is a pdf of the amended complaint. (The beginning is mostly the same as the original)

Amended Complaintfiled

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

So, You Just Received a Certified Letter from the Cali. Medical Board Asking you to Sign a Release for your Child’s Medical Records. What are your Options?

So, You Just Received a Certified Letter from the Cali. Medical Board Asking you to Sign a Release for your Child’s Medical Records. What are your Options?

Social Media is abuzz with posts from parents who have received a certified letter from the Medical Board of California demanding that they sign an enclosed release which authorizes their child’s physician to release his/her medical records to the Board.

What should you do?

Actually, for a variety of reasons, I am not going to tell you what to do or give you legal advice of any kind. What I am going to do is lay out a decision tree providing you with some information which may help you decide.

FYI: As I’ve explained in a recent post, California may be the only state in which its medical board cannot automatically obtain patient medical records from a physician. Here is that post: http://rickjaffeesq.com/2019/07/05/can-the-cali-medical-board-obtain-your-childs-medical-records-without-your-consent/

That means the California Medical Board has to first ask the patient’s permission to obtain the records. Most of the time, that isn’t an issue, since many Board investigations are started by a patient complaint, so the patient is obviously willing to have the Board review his/her medical records. But if someone other than the patient complains, well then it becomes an issue. In vaccine exemption Board investigations, the complaints almost never come from the patients, but rather from school nurses or the child’s PCP, most often an HMO.

So, in these cases, the Board is obligated ask the family for a waiver/permission to obtain your child’s medical records. The letter mentions subpoenas and legal process. These letters are meant to intimate you but are vague enough so as not to make a direct threat against you. All with an eye to maximize the chance that the family will comply and send back the release/waiver.

Here is how you should analyze the letter.

You have two options:

Option 1: sign the release and send it back to the Board.
The Board will send the release to the physician, and the physician will be obligated to send the medical records to the Board. The records will be reviewed by a medical consultant. If the care involves, let’s say, a medical vaccine exemption beyond the CDC contraindications, (or to make it even more simple, if it is a permanent exemption from all childhood vaccines), the medical consultant will conclude that the exemption was not within the standard of care. Eventually, the doctor will be charged with a Board violation.

Option 2: Do nothing.
If you do nothing, for sure in a few weeks to a month or two, you will receive the same letter again. If you continue to do nothing, then either 1. That will be the end of it, or 2. It’s possible, that you might get a visit from a board investigator who will you ask you in person to sign the form. (I suppose another option would be to write back and say you don’t agree to release the records, which may or may not avoid an Board investigator’s visit)

You have two choices:

Choice 1: Sign the form

Choice 2: Tell the investigator that you’re not going to sign and politely ask him to leave. If you do, he/she will indicate in the most authoritative/mildly intimidating tone that he/she is going to have to subpoena the records from your child’s physician.

You have two possible responses:

Response 1: Sign the release

Response 2: Tell him you’re still not going to sign, and again politely tell him to leave.

What happens to you if you chose Response 2?

NOTHING. You do not have the medical records he/she seeks, so there is nothing the Board can do to you or your family.

In short, you are NOT legally obligated to sign the waiver to release your child’s medical records, and there will be no consequences to you if you refuse to do so.

What happens to my child’s physician if I do not sign the waiver?

The board will serve your child’s physician with a subpoena for the records. The physician may or may not comply. If you do not want your physician to comply, after you receive the letter from the Board, inform your doctor about the request and tell him that you do not agree to have your child’s medical records released to the Board.

At some point, the Board will go to court to compel the physician to turn over the records. Candidly, there is a very good chance that the court will side with the Board.

But that’s not your problem and is not necessarily directly relevant to your options and decision as to what you should do if you receive that Board letter.

So, there you have it. Hope it helps.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

San Francisco City Attorney Event Starts Soon; Here is the Updated Contact Information

San Francisco City Attorney Event Starts Soon; Here is the Updated Contact Information

The event starts soon:

Call the City Attorney’s main number

415-554-4700

or TTY 415-554-6770

or fax: 415-554-4715

or email him at cityattorney@SFcityatty.org

Corrected Stoller Complaint

Corrected Stoller Complaint

Per my previous post, the complaint had a couple misplaced decimal points and the wrong antonym in a sentence. I fixed it and some folks wanted the corrected version to drop-off to their Assembly person, which I’ve said is a very excellent idea.

Here is the corrected version, and it even the official case number.

correctedcomplaint

Go and spread the word to the Assembly folk that unvaccinated kids are not the primary vectors of the measles problem in, at the very least, the San Francisco Bay area, and that when it is all laid out like it is in the Stoller complaint, it’s clear that Senator Pan et al are just trying to pull another fast one, and finish what they couldn’t get done with SB 277.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Rally Day for Cali SB 276: Keep your eye on the ball!

Rally Day for Cali SB 276: Keep your eye on the ball!

Today, April 24th is hearing day on SB 276, which bill seeks to remove the medical exemption decision making from the physician, and places it in the hands of public health officials, and there’s no requirement in the bill that it be a physician. That seems like a bad idea to me.

On the other hand, I wouldn’t mind seeing some guidelines issued by the Medical Board, similar to the medical marijuana guidelines the board issued after California allowed physicians to recommend medical marijuana. A number of docs got into trouble prior to the issuance of those guidelines, because they had no guidance as to what was permissible until the guidelines or at least until the board issued what it called a “precedential decision.”

The same thing is happening with the doctors who are currently writing vaccine exemptions. I was involved in what is so far the only filed case on a vaccine exlusion, and had a chance to get a look at what the board via its experts think about these cases. They take a very strict view of exemptions under the statutes, basically, there are none, at least there are no complete medical exemptions from all childhood vaccination throughout the duration of childhood for otherwise healthy kids.

I’m also working on some active board investigations involving exemption writing physicians. My sense is that some physicians and their supporters have a completely different view of what is permissible exemption-wise, than all conventional medical authorities. The result of these differences is the reason you’ll be in Sacramento today. But keep in mind a couple things:

First: keep your eye on the ball and focus on the actual issue:

Here’s what today is NOT about, at least from the legislators’ point of view:

It’s not about your personal freedom, your right to refuse vaccines for your children because you think vaccines don’t work or are dangerous, or because of any other personal beliefs you or your vaccine concerned friends might have.
Folks, you lost that battle with the enactment of SB 277, and all the failed lawsuits challenging the law.

It might feel good to try to beat a dead horse, but it won’t revive it.

Today is about convincing the legislators that only physicians who have a doctor/patient relationship should be permitted to make a decision as important as which if any vaccines from which a specific child should be exempted.
THAT’S IT!

If the board has concerns about doctors not following what it might call the standard of care, it has two obvious options; Investigate the physicians, and they are doing that now, and promulgate some guidelines, hopefully with the input of the vaccine concerned community (admittedly perhaps naïve),

However, California law does recognize the right of physicians to adhere to a minority view in medicine, because the California legislature wisely understood that it could take a long time for new thinking to change the medical paradigm. I think that’s a lesson which the legislators should remember.

Here’s what could set you free:

“Universal Citation: CA Bus & Prof Code § 2234.1 (through 2012 Leg Sess)

(a) A physician and surgeon shall not be subject to discipline pursuant to subdivision (b), (c), or (d) of Section 2234 solely on the basis that the treatment or advice he or she rendered to a patient is alternative or complementary medicine, including the treatment of persistent Lyme Disease, if that treatment or advice meets all of the following requirements:
(1) It is provided after informed consent and a good-faith prior examination of the patient, and medical indication exists for the treatment or advice, or it is provided for health or well-being.
(2) It is provided after the physician and surgeon has given the patient information concerning conventional treatment and describing the education, experience, and credentials of the physician and surgeon related to the alternative or complementary medicine that he or she practices.
(3) In the case of alternative or complementary medicine, it does not cause a delay in, or discourage traditional diagnosis of, a condition of the patient.
(4) It does not cause death or serious bodily injury to the patient.
(b) For purposes of this section, alternative or complementary medicine, means those health care methods of diagnosis, treatment, or healing that are not generally used but that provide a reasonable potential for therapeutic gain in a patient s medical condition that is not outweighed by the risk of the health care method.
(c) Since the National Institute of Medicine has reported that it can take up to 17 years for a new best practice to reach the average physician and surgeon, it is prudent to give attention to new developments not only in general medical care but in the actual treatment of specific diseases, particularly those that are not yet broadly recognized in California.
(Amended by Stats. 2005, Ch. 621, Sec. 28.5. Effective January 1, 2006.)”
(emphasis added).

It’s worth a shot!

Good Luck!

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

The Smartest Thing the Vaccine Concerned Have Done Recently (or maybe ever)

The Smartest Thing the Vaccine Concerned Have Done Recently (or maybe ever)

But first, the dumbest thing the VC do, IMO. I have been very critical of both the tactics and strategic decisions made by the Vaccine Concerned powers-that-be. For example, although I understand the emotions behind them, I think all the lawsuits challenging SB 277 were a waste of time and money.

No court is going to create a constitutional right to a personal belief exemption, or stop mandatory vaccination under the current medical vaccine paradigm.  (You all know and hate the paradigm/mantra: vaccines are safe and effective, serious side effects are rare, herd immunity is a thing and vital, and vaccines have saved zillions of lives.)

I think the VC community has it backwards by looking to the judiciary for protection. The judiciary basically enforces medical norms/paradigms, at least when it comes to public health and safety. Judges do not create rights that jeopardize public health according to the accepted state of medical knowledge.

In explaining why every single vaccine rights case has upheld mandatory vaccination and denied a right to a PBE, one of the most prominent thought leaders candidly stated at the recent Physicians for Informed Consent workshop that judges don’t want to make a decision which could cause an infectious disease outbreak. That sums up the futility of attempting to obtain any kind of vaccine relief from judges on direct challenges.

In my view, there are only two viable ways to move things in the VC’s direction. The first is legislation, but even that’s hard in light of the vaccine paradigm.

The good news for the VC is that most states still have either a PBE or a religious exemption. In Arizona, expanding vaccine concerned rights is on the legislative table.  The bad news is that there is a renewed effort afoot to eliminate the PBE (recently failed in Washington, still pending in Oregon) and a new concerted effort to eliminate negative vaccine information from the Internet is underway.

Obviously, the best way to change things wholesale is to change the vaccine paradigm.

Beginning last week something surfaced which I think is the smartest and most exciting development in the VC area, maybe ever. I think if played right, it could be the game-changer the community has been searching for.

Here is is:

Rock Star physician Paul Thomas announced on Rock Media Star Del Big Tree’s podcast last week that in response to an Oregon medical board investigation about his public vaccine position, he commissioned an outcome study on his patients.  So far, he’s focused on the rates of autism in his pediatric practice. He’s a popular guy and reports seeing 3345 pediatric patients.

Here are the numbers:

CDC published autism rates:    1 in 45

Autism rate in his signature “Vaccine Friendly Schedule               1 in  440

Autism rate in his complete unvaccinated patients

(actual numbers, not rate)             1 in 715

Here is the link to a U tube where Thomas discusses this.

That’s a dramatic difference, but of course, it’s only one pediatric practice.

I’m wondering what the autoimmune disease picture would show with the same stratification? I would speculate that if you take a historical graph of the explosive acceleration of autoimmune disease over the past few decades and plotted it against the graph showing the dramatic increase in the number of vaccines given in the last few decades, there would be a strong correlation. (Or maybe that’s already out there in the VC world.)

Of course, that proves nothing. But then if you take what we have learned over the past decade or so about SNPs/genetic polymorphisms and adjuvants, a causation hypothesis/mechanism of action starts to appear. But that’s just the speculations of a lawyer.

So, what’s needed to help change or challenge the current paradigm?

More data for sure.

Here is my suggestion to the VC thought leaders. Think by example or for strategic guidance, medical and recreational marijuana, and right to try, and for goal purposes, think cancer registries.

Look, it’s clear that the feds aren’t part of the initial solution. Indeed, based on all the conflict, collusion and outright fraud at these agencies, the feds seem to be at the heart of the problem. Same with the main professional organizations. So, they have to be bypassed.

Impossible you say?

Look at the marijuana situation. It’s still federally illegal, but the pot movement bypassed the feds and went right to the states. They are winning the legalization battle, state by state. The feds have largely been marginalized in the medical marijuana field.

Same thing with the right to try. I worked on federal right to try legislation back in the 90’s and got nowhere. (In fairness, we had no money and some were some other problems). In the last few years, the right-wing Goldwater Institute has engaged in a fabulously successful campaign to make right to try the law in most states. The feds came around with its own right to try law last year, but that was only after dozens of states already had the law on their books.

The point is bypassing the federal vaccine mafia in favor of individual states is a plausible and probably better strategy to start to change the vaccine paradigm.

How?

What if what the data Paul Thomas collated was required to be reported under state law? Suppose every pediatrician was required to register autism cases, severe autoimmune conditions and say vaccine status, and maybe even when each condition appeared in relation to vaccination. This is like what happens in state cancer registries, part of the reason for which is to identify cancer clusters. I think within a year or two, things might become much clearer on many fronts.

What if all the data was made public and you could look up a pediatrician’s autism and autoimmune disease rate? We are a society of consumers and consumers are entitled to as much information as possible to make an informed decision about their health care professionals. Why shouldn’t such information become a standard part of shopping for a pediatrician?

In addition, what I’ll call the “Thomas Gambit” should be employed by every pediatrician who comes under attack by a state board for vaccine beliefs or exemption activities. Also, I’m thinking it might be an interesting talking point, to demand that this information be collected and made public from the pro-vax pediatrician talking heads. Sort of a head-to-head comparision. Think there will be any takers?

Anyway, slick move Paul. Keep it up!

Rick Jaffe, Esq.

rickjaffeesquire@gmail.com