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Category: Vaccination Issues

The San Diego School District’s Attack on Medical Exempitons

The San Diego School District’s Attack on Medical Exempitons

Since the passage of SB 276/714 there have been reports that random schools have been rejecting medical exemptions (“ME’s”). Before the pandemic, the San Diego School district hit the radar screen on the issue because of Medical Board subpoenas issued to obtain the student records of the vaccine medically exempt. That wasn’t completely successful based on a lawsuit filed (but I lost track of that case, so I do not know for sure).

Then I started hearing crazy stuff like exemptions were being rejected because the issuing doctor had died. I don’t recall seeing that in the law, but I suppose there is some convoluted argument that could be made if it was challenged in court.

Then there is the issue of transfer within the same grade span. The way I had read the statute was that students with otherwise valid grandfathered ME’s maintained their ME status upon transfer within the same grade span.

Recently, a new official interpretation of the law has been promulgated with a contrary interpretation, namely that a transfer requires and new ME.

Because of the press of other cases and something else, I haven’t looked at the new interpretation. But the other thing is that generally speaking, courts defer to the interpretation of a statute or rule handed down by the issuing government agency or the agency which has to apply it. This general concept is known as judicial deference to administrative agency interpretations.

If this new published interpretation was challenged in court, the first thing the court would look at is whether the issuing agency has the authority to issue what it issued. The second thing is whether the issuing agency followed the required process to issue it. If the issuing agency is not enforcing it, then the court would look to see that the agency following it is required or allowed to follow it, I suppose (but that seems like a given in this kind of case).

If the answer to one or two is no, (and I suppose no to three as well which is unlikely) then a court should overturn it.

If the answer is yes to both (or all three), then it’s somewhere between an steep uphill battle and next-to-impossible to overturn a regulation, order, a formal interpretation unless it contradicts the underlying statute or is arbitrary and capricious (and a bunch of unhappy people disagreeing with the interpretation does not meet that test).

Apart from a court challenge, the only and probably best way to challenge this is on a case by case basis with the school or district. I don’t know that it has or will work on the transfer issue, but Warrior Grandma Linda Jauregui (see my previous post:  https://rickjaffeesq.com/2020/06/11/how-its-done/  ) has something to say about the dead doctor thing.

Here is the recent email I received from her:

“Hey Rick,

I just had to follow up to share with you a victory. First I fought against the dead doctor issue, talked many times with the San Diego county immunization manager who took the time to contact the nurse and tell her she couldn’t invalidate those exemptions.

Then I went over the nurse’s head to the superintendent on the new parking lot metric. She was going to kick out my grandson going into 3rd, as well as another child going into 3rd, plus a k student who was there as a tk (and my twins next year). I sent the law and the code of law plus letters from a voice for choice and PERK. I reminded him he is the governing authority and must follow the law as written. I also found a lawyer to write a demand letter if needed and another legal team ready to investigate the case this next week. Well, he called me yesterday to tell me the district lawyers told him to follow the checkpoints as they are written in the law or it could be a mess for them. Kids get to stay in school unless they are new tk/k, 7 or without grandfathered medical
Exemption. I am now encouraging other parents to individually fight their districts and who to talk to for formal advocacy and legal help.

Will be following the UC case and Doctor Stoller case and praying for your victory. Thanks for being in the fight.

Sincerely,

Linda Jauregui”

I’m guessing one or two of you might want to know who helped her out, so I asked her and here is the info:

“Her name is Lorraine from the Real League of Justice and then the attorney group is one PERK is working with, Tyler and Bursch.”

Hope this helps.

Rick Jaffe, Esq.

 

 

 

 

 

 

Digging into the Moderna Vaccine Clinical Trials Protocols and Results

Digging into the Moderna Vaccine Clinical Trials Protocols and Results

Moderna has just announced that its RNA based vaccine is starting a phase 3 clinical trial with 30,000 subjects, so I thought it might be useful to take a look at the publicly available information about the trial, and how they got there. Let’s go logically and chronologically and start with the phase 1 safety study.

The Phase 1 study

A phase 1 study is a safety study. They usually have relatively few subjects, and different doses are given because dosing in terms of side effects is usually an important endpoint in a safety study.

Here is the “Brief Summary” of the Phase 1 study published by Moderna
“Brief Summary:

This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. One hundred and fifty-five subjects will be enrolled into one of thirteen cohorts (10 micrograms [mcg], 25 mcg, 50 mcg, 100 mcg, and 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters [mL]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post-second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post-second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults.”

Here is the study information from clinicaltrials.gov

https://pubmed.ncbi.nlm.nih.gov/32663912/

I will be referring to other parts of it later on

The important parts of this summary are (IMO):

1. 155 subjects
2. All subjects have to be in good health, over 18 and not pregnant females
3. 2 shots of the vaccine, the second on day 29 (so 28 days from the first to the second shot)
4. There will be 13 different subgroups stratified by age group and vaccine dose.
5. Periodic follow up to assess response and report side effects for 13 months following the initial vaccine shot.

From the Study Design section, we learn the following:

Actual Enrollment: 120 participants
Actual Study Start Date: March 16, 2020
Estimated Primary Completion Date: November 22, 2021
Estimated Study Completion Date: November 22, 2021

(And by the way, phase 1 studies are not blinded, double-blinded, masked in any way, nor are they placebo-controlled, because the endpoint is just safety and lab values of the study vaccine. All that blinding and comparative stuff comes in later in phase 3 studies.)

The first big take away from this phase 1 study is that it is not over, meaning, that although it is no longer accruing new subjects, the data collection and subsequent evaluation will not be completed until sometime after November 22, 2021, roughly sixteen months hence.

That is pretty interesting in light of all the optimism about an FDA approved vaccine by late 2020 or early 2021 because if it’s Moderna’s vaccine that is approved/licensed, it will have been approved before even the phase 1 study had been completed. Yes, that’s a little disconcerting, but we’re in a pandemic, but not cutting any safety corners, so they say.

More on the sub groups/stratification

It looks to me that there was a three age-group stratification: 18-55, 56-70, and 71 and older. A second stratification was by dosage, 10, 25, 50, 100, and 250 mcgs. Each of the 13 sub-groups had between 10 and 15 participants.

The preliminary results of the study were reported in a NEJM article published on July 14, 2020, and linked to the bottom of the clinicaltrials.gov entry referenced above, but here is a direct link to the journal article.

https://pubmed.ncbi.nlm.nih.gov/32663912/

So, what were the results?

The vaccine had some immunogenicity benefit (i.e. antibodies, titers which are surrogate endpoints to vaccine efficacy/protection). In terms of side effects, here what was said:

“Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events.”

Actually, unless I am misreading the chart, I think the authors are understating the results. The way I read the chart, 100% percent of the study participants who took either 100 or 250 ug’s of the vaccine had a systematic symptom, the overwhelming majority of which were characterized as “moderate” (After the second injection). And 100% of the same groups had a local symptom, the majority of which were “moderate” with about 5% being considered severe, (also after the second injection.) The first injection also produced substantial local and systemic symptoms, but less than after the second shot.

(Hint: Remember these doses and their side effects during my discussion of the phase 3 study protocol, as I will be circling back to them)

And of course, the study just started four-plus months ago, and who knows what new or continuing symptoms/adverse effects might show up.

So, what was the authors’ conclusions?

“Conclusions: The mRNA-1273 vaccine-induced anti-SARS-CoV-2 immune responses in all participants and no trial-limiting safety concerns were identified. These findings support further development of this vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461).”

My translation: no one died yet, so let’s keep moving forward on this.

The Phase 2 studies

Actually, I could not find any information about the phase 2 studies. Given the fact that (a) the phase 1 study started in mid-March 2020 and is scheduled to continue until November 2021, (b) the results of the phase 1 study were just published two weeks ago, and (c) the announcement that the phase 3 study started yesterday, July 27, 2020, I am going to go out on a limb and say there weren’t any phase 2 studies.
But this is a pandemic, but no safety corners were cut.

The Phase 3 study

Here is the basic information about the study:

“Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 30000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older
Actual Study Start Date: July 27, 2020
Estimated Primary Completion Date: October 27, 2022
Estimated Study Completion Date: October 27, 2022”

here is the link to the study information on clinicaltrials.gov:

https://clinicaltrials.gov/ct2/show/NCT04470427

The important points: It started July 27, 2020, and is supposedly going to run until October 27, 2022, and accrue up to 30,000 subjects. It will be randomized and fully blinded.

The study will have three categories of outcomes they are looking at (my interpretation/restatement of what they are looking to find out):

1. Will the drug prevent people from getting the virus by comparing the post-injection infection rates between the vaccine group and the control group?
2. What kinds of adverse events the subjects have (and AE’s will be stratified in many different ways, which I will discuss later)
3. Lab value results in terms of antibodies and titers, i.e., the surrogate endpoints for the vaccine doing what it’s supposed to do, prevent people from contracting the virus (or as recently restated, you still catch it but won’t be as likely to kill you.)

Who can be in the study?

Well, it’s not quite as limited as the Phase 1 study which was just for healthy people. The phase 3 study is open to “Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.”

Who is excluded?

All kinds of immunocompromised patients of course, and interestingly, people who have had a significant reaction to a prior vaccine (“History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine”). But since these kinds of reactions are so exceedingly rare, I wouldn’t expect that many people would be excluded on that basis (cough). But it is a voluntary study, so what kind of idiot would you have to be to volunteer to get an entirely new kind of vaccine if you had a significant reaction to a prior vaccine which had already been proven to be safe and effective (cough, sorry I must have a scratchy throat, but since I’m basically quasi isolating, I’m pretty sure it’s not the virus).

Of course, the big exclusions are kids and actively sick old people. Regrettably, those are the two groups which are most likely to be forced to get it (kids via an amendment to the ACIP vaccine schedule used by every state, and sick older adults because of their increased risk of death from the virus and their resulting fear).

And that is probably the biggest problem with the study if it is used as the sole basis for approval. It would not have been tested on the people most likely to get it. Granted, there are legitimate ethical reasons to do initial studies and even phase 3 studies with healthy or not actively sick adults. But usually, there would be further studies pre-approval/license. My guess is that this one study is going to be it for this vaccine before an application for approval/license is filed. Further, I am also guessing that the approval license application will be submitted before the conclusion of this phase 3 study, and even before the conclusion of the phase 1 study in November 2021. As has been oft said, what can possibly go wrong with giving a vaccine (or as here, a new type of vaccine) to very old people many of whom have multiple co-morbidities where the vaccine has not been tested in actively sick old people?

And speaking (again) of side effects, what’s the dose given in the vaccine arm?

“Participants will receive 1 intramuscular (IM) injection of 100 micrograms (ug) mRNA-1273 on Day 1 and on Day 29.”

That is the same 100 ug dose that produced mostly moderate local and systemic symptoms in 100% of the completely healthy 120 phase 1 subjects. Again, what could possibly go wrong with giving it to those who are not completely healthy?

I confess to being unclear about what exactly was meant by the phase 1 study’s use of a “moderate symptom” as opposed to a severe or mild one. Thankfully, the AE/symptom stratification is much more refined in the phase 3 study. Here is the breakdown of AE’s: “Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal [ Time Frame: Up to Day 759 (2 years after the second dose) ]; Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 8 (7 days after the first dose) and up to Day 36 (7 days after the second dose) ] Number of Participants with Unsolicited AEs [ Time Frame: Up to Day 57 (28 days after each dose)]”.
(Ok, so maybe it is just a smidgen better.)

Note that AE reporting as a stated “outcome measure” is limited to 28 days after each dose or 57 days after the first injection. I guess they think that any problem, local or systemic which happens on the 58th day or after is presumptively not a result of the vaccine so is not reported as an AE. (I know how much my vaccine concerned doc clients will be outraged by that.)

BUT HERE IS THE REALLY, REALLY BIG GOOD NEWS (really!):

The study will be true placebo controlled!

Here is the language:
“Placebo Comparator: Placebo
Participants will receive 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29. Biological: Placebo
0.9% sodium chloride (normal saline) injection”

This is huge. The biggest problem with vaccines according to the vaccine concerned is that they are not safety tested against a true placebo, but rather against another vaccine, or the test vaccine less the antigen. Therefore, it is impossible to know the actual safety profile of the study vaccine. The only safety conclusion that can be reached is a relative safety profile compared to some other vaccine. And since none of the ACIP required vaccines were safety tested against a placebo, there is nothing but relative safety data comparing one vaccine’s safety (or lack thereof) to another, from which you cannot make a safety analysis, according to the vaccine concerned medical and scientific professionals. Thus, the protocol which requires an actual real, inert placebo is, as I said, huge.

Alas, I have to point out that the Oxford trial protocol originally had a real placebo as well, (I learned that from Bobby Kennedy’s debate with Alan Dershowitz. If you haven’t seen it, here is a link to the post which has a link to the debate.https://rickjaffeesq.com/2020/07/27/the-kennedy-dershowitz-debate-must-see-tv/) but was changed to the meningitis vaccine as the control, which I am told is particularly noxious and harmful.

So, we will have to see if they stick to the actual inert placebo in the trials. If they don’t, it will have to be disclosed, I would think, but it will likely be buried in some footnote and further obscured in gobbledygook faux scientific language and justifications.

That is about all I can tease out of these documents, at least at a first pass, given my time constraints. The big problem I fear will be transparency. How much will the public really get to see the data? Not much I expect. It will be critical to follow this and the other studies very closely, and let’s see what happens.

The big tell/sign that the fix is in is if the protocol is amended to eliminate the saline placebo. If that happens, that means that the side effects are too severe and widespread to make the vaccine palatable to the public, so that’s when they would make the change to compare it to a more toxic vaccine and proclaim its (relative) safety. If they stick with the saline placebo, then let the chips fall where they may. But to my mind, the phase 1 study results do not bode well, and my bet is on them dumping the true placebo, no later than halfway through the study, with some scientific-sounding justification, but I hope I am proven wrong.

Rick Jaffe, Esq.

The Kennedy-Dershowitz Debate: Must See TV!

The Kennedy-Dershowitz Debate: Must See TV!

A few days ago, the Bobby Kennedy/Alan Dershowitz debate was released. As a lawyer involved in the vaccine issue, it was very heartening to see such a high quality debate on the subject. It was very enjoyable to watch these two extremely smart, deep thinkers talk about these issues with open mindedness, clarity and mutual respect for each other, and for the opinions of the other with which they did not agree. I can’t personally recall anything like this ever happening in the vaccine area. I hope that there will be more of them.

If you haven’t seen or shared it on social media, please do. If you have seen and shared it, share it again! Here is a link:

https://childrenshealthdefense.org/news/vaccine-debate-is-on-robert-f-kennedy-jr-vs-alan-dershowitz/

I made some notes and have some thoughts about what I particularly liked about the debate, and I thought I’d share them.

First, it wasn’t so much of a debate as a discussion among two people with very different areas of expertise. AD is a long-time legal scholar and extremely well versed on constitutional law. Bobby Kennedy is a health and environmental advocate, and knows a zillion times more about the science and policy than AD. Bobby himself acknowledged the differences in their areas and expertise and jokingly said he would try to keep the discussion on the science and policy rather than constitutional law. And he succeeded in doing so, providing AD with a much-needed education of the many of the mainstream-suppressed scientific facts concerning vaccines.

AD’s basic initial and general point was that based on Jacobson and other cases, the government had the right under its police powers to forcibly inject everyone with vaccines.

BK thanked AD for participating in this debate and lamented the difficulty he has had getting people on the other side (like Offit and Hotez) to debate him.

BK correctly pointed out that Jacobson didn’t force anyone to get a vaccine. It only upheld a law that mandated a small pox vaccine or pay a $5.00 fine. AD came back that there were other cases which upheld compulsory medical procedures. The debate didn’t get into the specifics, but AD was talking about Buck v Bell, a case from the late 1920’s in which Oliver Wendall Holmes upheld a Virginia law for forced sterilization for a woman (incorrectly) claimed to be mentally defective. The most significant eugenics-like quote from the opinion was that “three generations of imbiciles are enough.” AD didn’t talk about that case, which is probably a good thing, since it is viewed as one of the worst Supreme Court decisions ever (along with the Dred Scott and the Korematsu decisions). (Here is an article about OWH which discusses the opinion, for anyone interested. https://education.blogs.archives.gov/2017/05/02/buck-v-bell/

My comment: I think BK is correct that forcibly injecting people with vaccines is fundamentally different from the issue in Jacobson. In addition, it has been over a hundred years since our government has had mandatory universal adult vaccines. That, plus the likely shortages of a COVID-19 once it is released could mean that the issue of a mandate for the vaccine will not come up. The caveat is that, despite the shortages and priorities of vaccine delivery, some states try to pass mandatory vaccine laws, either for adults or for children. That is something we’ll have to watch out for.

BK made the important point that unlike almost every other medical procedure, vaccines are given to healthy people, so there should be a higher standard for safety.

My comment: that argument should resonate with open-minded people.

BK made the point that vaccines are for others, not the individual. AD pushed back a little. However, I think most vaccine experts believe that most vaccines are for the protection of the recipient as well as the public. Even the HPV vaccine is thought to protect others (and specifically, the sexual partner of the HPV vaccinated). So not the strongest point, in my view, at least based on the accepted view of vaccine experts.

AD asked BK to agree that vaccines have been spectacularly effective in the past like with polio and small pox. BK said it was a complicated issue and cited literature about how it was sanitation and other public health measures, rather than the vaccines. Since this isn’t AD’s wheelhouse, he didn’t have much to say in response. BK would have had a much harder time with a vaccine expert, and I would think that this would be where the debate would have broken down, with the vaccine expert calling BK a crazy anti science anti vaxxer.

What about Masks? Twice (at least) AD asked BK to agree with him that ordering masks was constitutional. BK ducked the issue. It’s complicated

BK’s most important point was about the lack of true placebo testing in vaccines in general, and in one of the leading COVID-19 drug trials underway now. He pointed out that the protocol originally called for an actual placebo as the control, but during the trial, the protocol was changed to a meningitis vaccine as the control (a fauxcebo according to vaccine policy thinker Mary Holland, Esq.) BK pointed out that this vaccine had one of the worst safety profiles of any vaccine. Therefore this trial will grossly overstate the safety of the COVID-19 vaccine candidate, and there will be no way to actually assess the safety profile of this vaccine candidate, just like there is no way to assess the safety profile of any current mandated vaccine because in none of the testing was a true, actual, real placebo used as the control. This is the heart of the vaccine-concerned argument against vaccines (and you can expect to see this pointed argued in all of the cases I am working on for the California doctors fighting the medical board).

What Bobby is pointing out about the switcheroo in the control group is catching vaccine manufacturer in the act of scientific fraud, or at least showing why vaccine trials are flawed, unscientific, intellectually dishonest, but regrettably how all these medical products are actually approved. This is an extremely powerful point. I hope it will be repeated and be reshared in social media.

While the lack of placebo testing was the most important point substantively in the discussion (in my opinion anyway), I think the most important takeaway by AD was that his annual flu and pneumonia vaccines given by his long-time and trusted physician might be doing him more harm than good. BK made the point, supported by a high-quality study, about the overall deterioration of the immune system with the use of these vaccines in older people. I think that really shook-up AD, and I expect he has already sent his physician the study BK cited. I don’t think AD will be too excited in the future about getting these annual sticks.

And BTW: one of the things I really liked about the debate, format-wise, was the showing the first page of the studies and articles which they were talking about. Hey Bobby, if all the references you cited are not already up on your web site, please put them up, so we all can easily access them.

All in all, I think Bobby Kennedy did an excellent job presenting the case against mandatory vaccination and how vaccines are much less safe than most people think and most vaccine experts are willing to acknowledge. It was a pleasure to see such a high-level and cordial discussion amongst very smart and highly accomplished professionals, which regrettably is all too rare in the days we live in.

One further thing:

Bobby’s organization, the Children’s Health Defense, is being partially suppressed by FB and some of the other social media entities. So, keep visiting their web site directly and if possible, donate to the group. Here is the link to donate:
https://childrenshealthdefense.org/about-us/donate/

They are doing excellent advocacy work, and they also financially support some key lawsuits around the country on vaccine and freedom issues. (That would include yours truly’s defense of Ken Stoller against the Medical Board of California. Thx for that Bobby. Keep up the fight and keep debating!

Rick Jaffe, Esq.

Will my child’s California permanent medical exemption be valid next year if she changes schools?

Will my child’s California permanent medical exemption be valid next year if she changes schools?

I answered that question a few times in other posts dealing with medical exemptions and their future viability in general. However, I figure it is time to do a post specifically on this question, so here goes:

The Law (and the good news)

There is nothing in current California law (and that would be SB 276/714) which states or implies that switching schools within a grade span causes an otherwise valid SB 277 grandfathered medical exemption to become invalid. The only listed reason an otherwise valid ME could be revoked or would not be good is if the physician who wrote it is under a California medical board order (roughly speaking). Otherwise, under the law, a ME should be good for an entire grade span, regardless of a change in school (within the grade span).

The Sometimes Reality (which is the bad news)

After SB 276/714 was signed into law last September, and even before that time, it had been reported to me that some schools were not honoring otherwise perfectly valid permanent medical exemptions. I believe this was largely a collateral effect of the media campaign orchestrated by Senator Pan and his associates in their quest to pass SB 276. As you recall, the narrative was that there were a handful of doctors who were writing fake and/or fraudulent medical exemptions for vaccine hesitant families. I think some school nurses and administrators picked up on that narrative and decided, without any legal basis, to simply reject some of these medical exemptions.

Under SB 277, there was absolutely no legal mechanism by which a technically compliant medical exemption could be revoked by the California Department of Public Health or not accepted by a school. With the passage of SB 276/714, a mechanism/process came into existence by which form medical exemptions submitted electronically starting in 2021 could be reviewed and eventually rescinded by the CDPH. The new law also stated that ME’s written by physicians under board order could be (or possibly automatically were) revoked.

I think what started happening is after SB 276/714 were signed into law, some schools just decided not to accept these permanent medical exemptions for otherwise healthy children. However, it would not shock me if there were communications encouraging schools to do so from the usual public and private sector suspects, but I have seen no evidence of that.

We are now three months into the pandemic, things are starting to open-up, but California is now trending upwards for new COVIF-19 cases. Recently, a letter has been circulated stressing the importance of childhood immunization in these pandemic times. The reason for this communication is in large part because childhood immunization has fallen off because of the shelter in place orders.

This is the context and the times we live in. Per a previous post, I could not even say with certainty that all permanent medical exemptions would be honored in the same school because of all that is going on.
Here is that post.
https://wp.me/p7pwQD-F6

It seems obvious to me that switching schools means that fresh eyes are going to be looking at your child’s records, including immunization records. In my mind, that puts every child switching schools within a grade span on the radar screen. What a particular school nurse or school administrator does with that might be an individual decision, but again, it would not shock me if some of the usual suspects were encouraging schools to reject ME’s which are technically valid/grandfathered under the current law.

Look, families have to do what they have to do for whatever reasons they have, like moving for a new job. However, I think it is fair to say that if you are going to move your child to a new school within a grade span, that will increase the risk that his or her current and ME will not be accepted at the new school. There is no way to know how much of an increased risk because we do not have enough data points. My guess is that by the first month of the fall session (if there is one), we will know whether this is an isolated problem in just a few schools or something more widespread.

What are my remedies if my child’s school illegally refuses to honor his or her ME.

Since there is no legal basis to reject an otherwise valid grandfathered SB 277 ME, theoretically an injunction lawsuit could be filed. But candidly, lawsuits are very expensive to file and beyond the means of most people. Think many thousands of dollars. I suppose if there are a few students in one school (or school district) whose exemptions have been rejected, costs could be allocated and might be more financially feasible.

I have two caveats: First, if things get bad California, I think judges might be quite hesitant to order an unvaccinated child back into school, in the times we live in. But that just decreases the likelihood of success and is not a risk per se. But second and more importantly, my experience is that most families who have medical exemptions for their children do not publicize that fact, and want that fact protected, as is their right under federal and state school privacy laws. For sure, these lawsuits would be filed with a fictitious named plaintiff(s), but you have to believe that the information would (or at least could) make its way back into the school system and in the school community. In other words, I do not think anonymity can be completely or practically guaranteed. That might be a negative consideration for some families.

With those caveats, yes, a lawsuit by one or a number of families whose children’s ME’s were improperly rejected would be at least viable. Further, there is some preliminary analogous New York State precedent to support such an action.

So, do what you have to do, moving school wise, keep your ear to the ground for others in the same situation, and we will see how it shakes-out in the fall.

Good Luck and stay healthy and safe!

Rick Jaffe, Esq.

Will Your Child’s Cali. Medical Exemption Be Good When Schools Reopen in the Fall?

Will Your Child’s Cali. Medical Exemption Be Good When Schools Reopen in the Fall?

I have been getting that question a lot lately. It is understandable with all that is going on.
The answer is that I don’t know and I don’t think anyone can know for three reasons.

First, Senator Pan had to give-up some important ground at the end of the last session, via SB 714 which watered down some of SB 276’s more onerous provisions. The biggest problem (from the regulators’ point of view) with the current SB276/714 law is that there is no filing/reporting requirement for grandfathered ME’s. Under the law, ME’s written by a physician who has been disciplined by the Medical Board are revocable by the CDPH, but there is no specific administrative procedure by which grandfathered ME’s of these physicians are submitted to the CDPH. For sure, in an ad hoc manner, schools can forward these exemptions, but some might, some might not. Right now, only one high profile ME writing physician is currently under a disciplinary order which precipitates ME revocation, but by early to mid-next year, there will probably be other physicians whose exemptions are revocable. Will the CDPH find out about these docs and their revocable ME’s? My guess is it will, if Senator Pan has anything to say about it (as discussed below).

But for now, we simply cannot say for sure whether or how many of this one physician’s ME’s will be revoked and by when, or whether there are other exemptions which will be affected during the upcoming school year.

The second reason I can’t tell you whether your child’s permanent medical exemption from all vaccines will be valid for the entirety of next year is because the California Legislature is back in session and it is a good bet that Senator Pan will try to clean-up and get back what he was forced to give up to the Governor who caused the last minute inclusion of SB 714. Alas, we live in a different world now, and it is possible that there is now less daylight between Senator Pan and the Governor. Time will tell.

But I have to believe that Senator Pan is thinking hard about completely eliminating the problem of the 10-12k permanent medical exemptions, because some of these ME’s could be good for years. To the consternation of some, I have speculated about the probable and drastic/worst case scenarios of what he could do this session. Here is that post.

https://rickjaffeesq.com/2020/04/17/what-could-be-next-in-the-california-legislative-vaccine-front/

We will know more once he drops the initial version of his new bill, unless he decides to sit this session out because of the pandemic, (which to me seems unlikely).

The third reason I can’t tell you if your child’s permanent exemption will be valid and accepted next school year is because who knows how some schools will react to the pandemic.

What I can tell you is that last year, after SB 276/714 was passed, but before it went into effect, (and even before it was passed), some schools were rejecting permanent, complete vaccine exemptions for seemingly healthy but medically fragile students. It seems a reasonable guess that some, and probably more schools will, on their own, and without a direct legal basis, question or reject these ME’s regardless of whether the issuing physician is under a Board order.

Could there be a legal redress, i.e., a basis to sue? Sure, and a few such cases might be filed. Maybe some families will get legal relief, but the worse the pandemic becomes, and the closer to home it hits, the less likely a California judge is going to force an unvaccinated healthy but medically fragile kid back into school over the its objection. But this is just speculation and is based on my feeling that the school nurses are going to be even more skeptical and fearful of the unvaccinated, regardless of how irrational you all think that might be. And while none of you think this is right or fair, many of you probably also fear or think that is how it is going to play out.

What about if your child has an IEP?
Right now, legally, nothing should change, but let’s see what the new bill says, and how the schools react to current events.

So, what should you do about it, right now?
Sorry, I just don’t have any good ideas right now in advance of knowing the contents of new legislation. If there is a new bill introduced, and if it eliminates or jeopardizes your child’s ME, then there will be the lobbying and protests for sure. Also, an as yet unanswered question is whether most of California will continue to avoid the dire effects of the pandemic which other places in the Country are facing.

For now, I think the only thing to do is sit tight and wait to see what happens, but I don’t think you’ll have long to wait to at least get a sense of what is coming.

Rick Jaffe, Esq.

What Could Be Next in the California Legislative Vaccine Front

What Could Be Next in the California Legislative Vaccine Front

Supposedly, the legislative session is going to restart on May 4th. But whenever it continues, I would expect Senator Pan and his allies to clean-up and fix the slippage which resulted from SB 714’s amendment of SB 276, and to take advantage of the COVID-19 pandemic.

Although there is not a vaccine for the disease right now, there surely will be, in a year to eighteen months as is the general (possibly) optimistic estimate, or maybe even sooner. Because it might be sooner than a year and because public policy and the law takes time to plan and implement, I expect a 2020 bill to address the new vaccine, if not explicitly, then implicitly to facilitate the quick implementation of the new vaccine’s mandate. (New York has already initiated some steps along the same lines.) I have no special access, but here is my guess as to what the first cut of the new bill will look like:

1. Mandatory reporting of grandfathered exemptions. In SB 276, there was a mandatory reporting/filing requirement for all medical exemptions as a prerequisite of their continued validity. That requirement was eliminated in SB 714 because of the Governor’s push back against SB 276. Seems easy to predict that a new bill will reinstate the mandatory reporting/filing requirement of all ME’s with the public health department.

2. But the filing of medical exemptions is meaningless unless there is some mechanism by which these broad ME’s can be revoked. So, look to the new bill to include the grandfathered ME’s in the review and revocation process which now exists for ME’s written after December 31, 2019. In short, grandfathered exemptions will no longer be immune from review and revocation.

3. Removal of the requirement limiting the addition of vaccines to the schedule. Right now, technically at least, the law appears to prevent the addition of vaccines to the California mandatory vaccine schedule set out in Health and Safety Code Section 120325 (b) unless there is both a medical exemption and a personal belief exemption. (Health and Safety Code Section 120338 provides “Notwithstanding Sections 120325 and 120335, any immunizations deemed appropriate by the department pursuant to paragraph (11) of subdivision (a) of Section 120325 or paragraph (11) of subdivision (b) of Section 120335, may be mandated before a pupil’s first admission to any private or public elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center, only if exemptions are allowed for both medical reasons and personal beliefs.” (emphasis added).

Since there is no longer a PBE, look to the new bill to rescind or modify Section 120338. This provision seems to have been part of the give to the vaccine concerned in SB 277, along with the “robust” medical exemption. SB 276/714 put the kybosh on the robust part of the ME, so look to the new bill to finish the SB 277 take back, due to the pandemic.

That would be the minimum of what I would expect the new bill to address, but I think the pandemic presents too big of an opportunity for Senator Pan and his allies to go big and get what they really want. And what they really want is the revocation of all these medical exemptions; by that I mean all medical exemptions from all vaccines throughout childhood/while attending public school.

I would remind you all that under conventional standards, these total and permanent exemptions do not exist except in the minds of the vaccine concerned, and under a minority standard of care which has not yet been confirmed by the courts, (plus the argument that such exemptions were permitted under SB 277). Right now, the law allows for the revocation of total and permanent ME’s written by physicians who have been disciplined by the Medical Board. But hey, we are living through a pandemic, and extreme times call for extreme measures, or so it will be argued.

I think it is a reasonable guess to think that Senator Pan and his confreres are going to try to require COVID-19 vaccination (once it is available), and I don’t see them letting kids who are seemingly healthy, but “medical fragile” back into school without it. Hey, it’s a pandemic! The easiest way to do that would be to rescind all ME’s that do not comply with SB 287/714 2021 guidelines. That would certainly be harsh, but now would be the ideal time to try this because there is more fear than knowledge about how this pandemic will shake-out. Meaning, will it come and go quickly, and not reoccur like all the recent epidemics, or will it come back in waves like the Spanish Flu (where the majority of the 50-100 million deaths occurred during the second wave in the fall of 1918). Look what these folks did with under 200 measles cases (38% of which were from the vaccine) and no deaths.

I hope I am wrong about this, and that Senator Pan and his group will sit this legislation session out on the vaccine issue and not try to take back what they were very begrudgingly forced to give up in 2015 and 2019, but maybe I am being too hopeful. Regardless, it is worth thinking about a plan, and I suspect some are already doing so.

Rick Jaffe, Esq.

Latest Stoller update: judge knocks out 2 witnesses, doesn’t throw out exhibits, yet

Latest Stoller update: judge knocks out 2 witnesses, doesn’t throw out exhibits, yet

here is the latest update

https://gogetfunding.com/blog-single-update/?blogpre=6408571&single=47062

Medical Board Claims that “Evidence of Vaccine Safety and Vaccine Safety Data is Irrelevant” to the Stoller Case

Medical Board Claims that “Evidence of Vaccine Safety and Vaccine Safety Data is Irrelevant” to the Stoller Case

from the gogetfund me update, which I couldn’t post from my web site due to something suspicious.

Under SB 277, a physician is permitted to issue a medical exemption if she determines that immunization “is not considered safe” for the patient. I confess to perhaps naively thinking that we could defend the Board’s case against Dr. Stoller by showing why he did not consider immunization safe in the 10 patients involved in the Medical Board’s accusation against him. To that end, we are offering a great deal of evidence in the form of medical literature, transcripts (like the Simpsonwood transcript originally publicized by Bobby Kennedy) and also recent things like the WHO conference excerpts.

In response to all this evidence, the Board is making an almost unbelievable argument to stop any of this information into evidence:

The board is literally arguing that vaccine safety evidence and data is irrelevant to any legitimate issue in the case.

Really!

The board’s view is that the only issue in the case is whether the medical exemptions issued by Ken complied with ACIP Guidelines. If they didn’t, then the Board claims the case is over, because actual evidence of vaccine safety should not even be admissible since it is not relevant, even though SB 277 specifically states that a physician’s decision for exemption should be based on a determination of immunization safety for the patient. That’s really what the board is saying!

The board doesn’t think there is any medical judgement to make. All a physician has to do is look at the contraindication and precaution list in the ACIP guidelines and act accordingly. But of course, that’s not what SB 277 said, and around and around we go.

Our view is that the language of SB 277 and the integrative medical standard for vaccine exemptions (allowable under Bus.& Prof. Code Section 2234.1) permits the kind of exemptions written by Ken in this case, and also protects other California integrative physicians who have written broader than ACIP guideline based exemptions. If we ultimately win, all such physicians will be protected. If we don’t, I would expect all these other physicians to suffer the same fate as Ken will in this case. So, this is important for the doctors and the entire community.

We will know by Thursday afternoon whether the administrative law judge will disregard the words of SB 277 and agree with the Board. If she does, it will probably be a much shorter hearing that we had hoped, and with a foregone conclusion, at least until we get to the appellate courts.

(Note, administrative law judges in medical board cases only issue a “proposal for decision” with a recommended sanction. The Board has the power to accept, reject or change the ALJ’s proposal. I predict, this case will be ultimately decided by the California Appellate Courts sometime in 2021 (or 2022 if it gets to the Cali. Supreme Court), so buckle-up, and prepare for a long ride!)

The hearing begins on Monday, March 16th.

Stay Tuned for an Update by Friday on whether the judge agrees with the Board and finds that vaccine safety is irrelevant to writing medical exemptions under SB 277. I have no prediction on what she will do, because I am not sure we’re not not living in the Twilight Zone.

We’re still accepting donations! Thanks to all who have given so far.

https://gogetfunding.com/dr-ken-stoller-and-his-medically-vaccine-exempt-patients-need-your-help-again/

Rick Jaffe, Esq.

Stoller Case Share

Stoller Case Share

Tommorow, the ALJ will tell us whether we get to present evidence justifying ten SB 277 medical exemptions that Ken Stoller issued which stated that immunization was not safe for these children. Yes, it is surprising that we might not be able to present evidence on vaccine safety since vaccine safety (or lack thereof) is the actual statutory basis for writing medical exemptions under SB 277. But maybe special rules apply to cases involving vaccines, or maybe it is the times we live in.

The Board’s view is that there is no medical judgement to be made. Physicians just consult the ACIP chart of contraindications and precautions. If the basis isn’t on the chart, there’s no exemption for that shot. Of course, that’s not what the law says (or not what the passed version of the law says), but again, maybe it’s the times we live in.

Part of our case is based on the testimony of the highly regarded physician, James Neuenschwander who gave a moving and very elegant presentation at a recent ACIP meeting. In administrative cases (and civil trials) the parties have to exchange expert reports. The community might be interested in reading Neu’s (as he’s referred to) report. So here it is. It is very, very good.

neureport

Another part of our case which is also being attacked by the board is testimony from Greg Glaser, the general counsel of Physicians for Informed Consent and the most knowledgeable person on California vaccine law in the state. He worked with the group of integrative doctors to assess the impact of SB 277. We feel his information is critical to understand why integrative physicians believe they had the right to write medical exemptions under SB 277 much broader than ACIP guidelines.

Greg’s testimony is about his analysis of the law which he conveyed to Ken and others, which we think is a relevant consideration in this case. If nothing else, it shows the state of confusion of a significant number of California physicians who had the impression from the statute and statements from Senator Pan that exemptions could be written based on family history of even cousins. Apparently, their bad for actually reading the law and taking Senator Pan seriously and literally, and worst of all, for actually using the space in between their ears to decide what’s best for their patients, even if it conflicts with the ACIP chart.

Tomorrow, we will find out whether he will be permitted to testify. There is a legitimate legal issue involved here. Typically, lawyers cannot testify about what U.S. law is or means because the only legal expert in a case is the judge. This is mostly due to possible jury confusion, and to make sure the jury follows the judge’s instructions about the law. But, of course that is not a problem when there is no jury, like in administrative law cases. I am completely confident that the judge will understand that she decides the legal issues in the case, and that she is able to accept Greg’s testimony for the limited purposes for which it is offered, but we’ll see.

Here is Greg’s witness statement. Like Neu’s, it’s quite brilliant and compelling.

https://physiciansforinformedconsent.org/wp-content/uploads/2020/03/Glaser-Letter-for-Dr-Stoller-re-Medical-Board-Proceeding-web.pdf

here is the gogetfunding page for donations:

https://gogetfunding.com/dr-ken-stoller-and-his-medically-vaccine-exempt-patients-need-your-help-again/?single=46997#

More by Friday.

Rick Jaffe, Esq.