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Major Update in Ken Stoller’s Medical Board Appeal, and it’s not half bad

Major Update in Ken Stoller’s Medical Board Appeal, and it’s not half bad

The judge did not issue a tentative decision in the case today because he wants an oral argument to discuss some issues. Here is what is on the judge’s mind in his own words:

“Oral argument will be conducted remotely through the Zoom Application. The court clerk will provide counsel with the Zoom ID via email. ****

At the time of hearing, counsel may address any issue raised in the legal briefs. In addition, counsel shall be prepared to address the following issues:
(1) With Senate Bill 277 (2015), the Legislature excised the phrase “medical condition or circumstances that contraindicate immunization” from Health and Safety Code Section 120370(a) and replaced it with the phrase “medical condition or circumstances, including, but not limited to, family medical history, for which the physician does not recommend immunization.” The ACIP Guidelines, which are virtually identical to the AAP Red Book, contain a single reference to family history in its table of contraindications and precautions. Given this, and given that SB 277 substituted the term “contraindicate” with “not recommend,” how can the subject amendments in SB 277 be construed as anything other than an enlargement of physicians’ discretion? (See State Comp. Ins. Fund v. Workers’ Comp. Appeals Bd. (2008) 44 Cal.4th 230, 244 [“ ‘We presume the Legislature intends to change the meaning of a law when it alters the statutory language [citation], as for example when it deletes express provisions of the prior version…’ ”].)

(2) In Section 120370(a) as it existed before SB 277 was enacted into law, did the term “contraindicate” possess any special meaning? Specifically, is there any reason to believe that the term included or excluded “precautions” like those listed in the ACIP Guidelines?

(3) Petitioner argues that SB 277 created a stand-alone standard of care. Does Section 120370(a), as it then existed, read like other statutory standards of care? (See, e.g., Galvez v. Frields (2001) 88 Cal.App.4th 1410.) Which part of the statutory language for example, informed the physician’s determination that immunization was not considered “safe?”

(4) Assuming that SB 277 did not create a stand-alone standard of care, but that it did authorize exemptions based on conditions or circumstances beyond those supporting the contraindications and precautions in the ACIP Guidelines or the AAP Red Book, what standard governed the physician’s determination that a vaccine was unsafe for the patient?

(5) Respondent’s Accusation against Petitioner did not refer to Section 2234.1, but Petitioner’s First Amended Notice of Defense did refer to that section. At the administrative hearing, who bore the burden in connection with Section 2234.1?

(6) Assuming that the court grants the petition on the ground that the Board applied the wrong standard of care, should the court reach any other ground for relief raised in the petition?”

Let me just say that I discussed the issues which the judge identified above in very great detail, and my basic point is that the Board used the wrong standard of care which means it didn’t make its case because the board has the burden of proof. For sure, it’s a technical argument, but my experience is that judges have a thing about technicalities, even if (or especially when) the government is involved.

That’s about all I want to say now. Miles to go before I sleep, preparation wise for tomorrow, but I will say that I am both hopeful and encouraged that he is approaching this in a methodical and logical manner, which is all a litigant can ask for, and in my view, means it works out.

Anyone who wants to watch or listen should be able to follow it on zoom I believe.

Fingers crossed, positive energy, send a message to the field or whatever.

Rick Jaffe, Esq.

Update on the California Medical Board cases against physicians for writing SB 277 medical exemptions.

Update on the California Medical Board cases against physicians for writing SB 277 medical exemptions.

A lot is going on in this space and I will have some answers and timelines for a few of these cases, so let’s get to it.

Ron Kennedy (not my client or case)

As you know, Ron Kennedy’s license was put on probation with severe conditions a few months ago. I think many, most or all of the medical exemptions he wrote have been revoked because of the sanction order. Initially, he started to appeal the Board’s decision, but last week, the Board disclosed that Ron agreed to a voluntary surrender order, whereby he surrendered his medical license. In the order, he also agreed to terminate all of it in litigation against the Board. Since he no longer has a medical license, the other investigations disappear, which I assumed was the point of the Board continuing to investigate him. I believe he wrote a lot of the state’s medical exemptions, maybe more than anyone else in the state. Therefore, the revocation of all his medical exemptions will stand. Not good news for those families.

Moving on to Ken Stoller’s case

All the paperwork in our appeal (called a writ of administrative mandate) has been filed. The hearing on the writ is set for this Friday, July 23rd. Per previous posts, we should get what is called the “tentative decision” on the afternoon of the 22nd. Judges rarely change their minds once they issue a tentative decision, so that is pretty much it, or will be it. You will recall that the judge initially denied our request for a stay of the Board’s sanction order because the judge didn’t think we would win on the appeal based on the papers we filed. So, we filed stronger papers and now the judge has the entire record of the proceeding below.

I would say the main point of the writ is that SB 277 allowed Ken and the other doctors to do exactly what they did, which is to write medical exemptions broader than the ACIP guidelines. The Board’s position was that every doctor has to follow the guidelines. The judge’s initial position was to try to find a middle ground by saying that what Ken did wrong was that he didn’t even “consult” the guidelines. In our new papers, we pointed out that there is no such thing as “consulting” with the guidelines. They are either followed or they are not followed, and that was the board’s position.

We pointed out to the judge that the strongest and irrefutable proof that doctors did not have to follow the guidelines comes from the testimony of the cosponsors of the bill at the June 9, 2015 assembly health committee. If there is any more clear way to say what Sen. Ben Allen says, then I surely do not know what that is. Here is the setup and the argument we made to the judge in the new set of papers:

” Now that this Court has reviewed the ACIP guidelines and their application under the prior law, it is in a better position to understand the concerns expressed to then Assembly Health Committee Chairman Bonta that under the then-current law people thought it was hard to get a medical exemption. We now know that was because a medical exemption was only available for anaphylaxis or the one or a few other medical conditions listed in the 4.1 table.

1. Co-sponsor Ben Allen’s statement that SB 277 is beyond the ACIP (and Red Book) guidelines and that under the bill physicians did not have to follow them

As indicated above, the members of the Assembly committee were concerned about how hard it was to get a medical exemption under the CDC’s guidelines and they were concerned that California physicians would be forced to follow them and not use their discretion to write exemptions that were not consistent with the guidelines. Member Waldon asked Senator Pan “would you say that SB 277 would still conform to the CDC guidelines regarding a medical exemption? Senator Pan assured the committee that a physician could exercise his professional judgment despite the limitations in the CDC guidelines.” (R 10-page B 647 to page 649 ln. 2).

But after hearing Senator Pan’s answer, member Waldron apparently was still unclear or unconvinced and asked the opposition witness, Barbara Loe Fisher, to respond and she said that “99.99% of children under federal guidelines do not qualify for a medical exemption.” Senator Allen then jumped in and made the following statement: “and I believe you deserve a short answer to your question. No, we would not be in CDC – in compliance with the CDC. The CDC – the committee on immunization practices, the American Academy of Pediatrics would be apoplectic about the loosening of all these guidelines and yet I do like the amendment because if the bill passes at least [there would] still be some discretion. But no, we are way out of compliance with the CDC.” Id. at page B 653 ln. 15 to page B 654 ln. (Emphasis added).”

Ok, so you tell me. Did physicians have to slavishly follow the ACIP guidelines as the Board argued in Ken’s case, or could Ken and other physicians write exemptions based on what the statute expressly refers to as “family history”?

And just to remind you what co-sponsor and pediatrician/family practitioner Senator Richard Pan represented to the same committee, in terms of examples of the kinds of medical exemptions which were authorized under SB 277,

“If the physician feels that there’s a genetic association in a sibling, a cousin, some other relative, it’s not safe for a vaccine, they can provide a medical exemption for that vaccine. There is no limitation on a physician from doing that other than their own professional judgment, their own knowledge, and expertise about what they believe is safe for the patient.”

So, what did the sponsors intend with SB 277? to constrain physicians to write only medical exemptions which comply with ACIP guidelines? I think not, but then, what I think doesn’t matter.

If the judge does change his mind and he could either send the case back for another hearing or throw the case out entirely. Probably under either scenario, the revocations of Ken’s medical exemptions should be reversed. On the other hand, if the court stays with its earlier view, essentially that it cannot interfere or does not want to substitute its own judgment for the Board’s, then obviously the revocations of Ken’s medical exemptions will continue.

The current plan is to appeal if the judge denies the writ, funding permitting. It should take between eight months and 14 or 15 months for an appellate court decision on this case.

Kelly Sutton’s case

Last week, we received the Board’s written closing argument. We have until midish August to put in our responsive closing. Essentially, like above, our case is that the language of SB 277 and the clear statements of the bill’s authors, prove that physicians in California did not have to follow the ASIP guidelines. The board only offered testimony indicating that none of the exemptions complied with these guidelines. They offered no evidence about any other standard of care. Therefore, if we are right, then the Board’s case fails as a matter of proof i.e., the board does not have any. We also had three amazing expert witnesses testify in our case who explained Kelly’s concerns about continuing the vaccine program with these kids could cause them further problems.

The judge will get the case for a decision in early October and has 30 days to send her proposed decision to the board. The Board then reviews the decision most likely at the next Board hearing which is mid to late November. I would expect that a decision in the board would come by the end of November. However, we will get a pretty good indication of where we are in the case, for better or for worse, with the decision in Ken’s writ proceeding, because the issues are essentially the same.

We are still short of funds to cover the legal expenses in Kelly’s case, so if you haven’t contributed and the issue is important to you, please contribute. Here is the link to the funding site.

https://gogetfunding.com/kelly-sutton-mds-legal-defense-fund-to-save-her-medical-exemptions/

Other cases/investigations

I have two other cases involving Northern California doctors. In one case, there is an accusation, but there has not been much movement lately. The other case is before the Superior Court but is still in the investigation stage. The board has requested medical records from a physician for two patients who received medical exemptions. However, the families refused to release their childrens’ records which precipitated the Board filing a special proceeding to force the doctor to turn over the records The hearing, in that case, is at the end of July. We are making essentially the same arguments about SB 277 as we are making in Ken’s and Kelly’s cases. For better or worse, we are going to have two Superior Court judges taking a look at SB 277 and what it means. Alas, we’re in pandemic times, and in pandemics people are afraid, and judges are people. And in these times, judges are going to be fearful of overturning decisions of the public health establishment for what one judge has recently called the “vaccine preferences” of some people. If these cases were before a computer judge program, I would say we have a slam dunk winner. However, with human institutional players like judges, who might not be completely receptive to physicians who advise people that vaccines are unsafe or that their children should not be vaccinated, well, let’s just say that there are contextual/current events challenges.

So there you have it. Fingers crossed.

Rick Jaffe, Esq.

A Detailed Summary of Kelly Sutton’s First Hearing Day (6/14/2021)

A Detailed Summary of Kelly Sutton’s First Hearing Day (6/14/2021)

For those of you who want a blow-by-blow of what happened at Kelly’s Sutton’s hearing, you’re in luck because Kelly took very detailed notes of the first two days of the hearing. (She testified on the third and final day and so didn’t take notes). I think we made some excellent and needed points, but judge for yourself. Tomorrow I will post her notes from the second day of the hearing which contains the testimony of our other two experts, Drs. Jim Nerenschwander and Le Trinh Hoang.

If you haven’t contributed to her legal defense fund and want to, here is the link:

https://gogetfunding.com/campaigns

Kelly Sutton’s Notes of The First Day of her Medical Board hearing, 6/14/21

Openings:

Greg Chambers: This is a simple case. Medical exemptions were written of indefinite duration for all vaccines, not targeted for certain vaccines.
I expect arguments based on 2234.1.
There is no expectation of therapeutic gain from withholding normal treatment.
Minority view is not defensible because science referred to has been debunked.
Dr. Sutton does not have the training or experience to make decisions regarding medical exemptions. She lacks basic medical knowledge. Her license should be revoked because she is cannot be rehabilitated.

Rick Jaffe: I will give some context– how we got here. And explain what we hope to prove.

The statute in question has two important parts.
Vaccine exemption is not a medical diagnosis, but is a legal construct. It exists because the law says it exists, originally in the narrow context of contraindications when Personal Belief Exemptions existed.
After measles outbreak, it was determined that 37% of measles cases were of vaccine origin.
SB 277 removed Personal Belief Exemptions. Due to the public outcry, there was a trade-off in making the law because of complaints against the lack of real availability of medical exemptions.
Assembly Health Committee, please see Exhibit A, there are two points of note. Senator Allen spoke in response to the complaints that no one could qualify for a medical exemption, and said ‘we’re making this broader, and the ACIP / AAP would be apoplectic if they knew.’ Senator Pan said ‘a doctor can give a medical exemption for a problem with a cousin.’
Physicians for Informed Consent PIC made guidelines for writing medical exemptions under the statute, using a standard of care based on the words of the statute.
The statute as written appears to give physicians the authority to go beyond ACIP guidelines. Effectively, SB 277 created another standard
These cases. Case 4,7, and 8, were written based on the medical condition or vaccine reaction of the patient, not on family history.
Dr. Lehmann is a Pediatric Infectious Diseases specialist. She deals with common and rare infectious diseases, diagnosis and treatment of individuals, and protection of the public.
Effectively there are 6 pages that constitute the ACIP guidelines in toto, and some of those pages are half-blank.

Our first witness is a Pediatric Neurologist, who will address mitochondrial dysfunction in two patients who in his view need medical exemptions in spite of ACIP, and he will discuss the supporting literature some of which he has written.
Our second witness is a primary care physician with a specialty of treating the vaccine injured. He brings the concept of immune activation, and shows its relationship to mitochondrial dysfunction. This is a different perspective than the infectious disease specialist’s point of view
Then we have a primary care physician who is in the trenches treating patients. And Dr. Sutton will testify.
Dr. Lehman raised the issue of vaccine safety ?
How does someone go 40+ years of medical practice without a problem and now be called incompetent?
This group of physicians looked at the new law, consulted an attorney, and came up with different view. It looked like there was another standard of care. There is lots of case law to support this action.
The Medical Board of California never put out guidelines instructing doctors. That is an important mitigating factor. We are not really dealing with incompetent doctor. We wouldn’t be here today if SB 277 were clear.
There is in fact now no way anybody could know who could have a serious adverse event and be vaccine-injured. This approach is broader, different, and keeps children safer than the narrow ACIP guidelines.
GC calls Deborah Lehman
GC: Are you licensed?
DL: yes, in 1989, I’ve been practicing 31 years. I worked in Kaiser Permanente Infectious Disease in 1994¬1995; I did not do any studies. I published in peer-reviewed A65-66 journals and in the textbook by Ku and in Rudolf’s Pediatric Infectious Diseases book. I am an editor for Journal Watch for New England Journal of Medicine. I write for Knowledge Plus to help doctors prepare for boards. I educate medical students about pediatrics including vaccines’ impact on public health. I lecture on the vaccine schedule once a month. I explain its importance and why it is the way it is, how it is arrived at. I have conversations with people regarding questions about vaccines and with people who are experiencing vaccine hesitancy.
GC: I would like to admit exhibit 4, CV for Dr. Lehman.
DL: The vaccine schedule is developed by the Advisory Committee on immunization Practices and the Center for Disease Control. It is put out yearly. Other professional societies endorse it, for example, the American Academy of Pediatrics, the Academy of Obstetrics and Gynecology. (NB: they don’t discuss they endorse! MKS)
Doctors refer to ACIP guidelines to know what to give and when to give it, and how close together, and what can be given at the same time. The schedule is developed to keep children and communities safe.
GC: 2015 legislation was regarding guidelines.
DL: Guidelines change all the time. Physicians are notified. (NB How? Did I overlook regular notices from ACIP??? I am obviously tracked scrupulously, but the same tracking mechanism is not informing me scrupulously. MKS) CDC notifies physicians. The Morbidity and Mortality Weekly Report for example announces the new flu vaccine yearly, along with precautions and contraindications.
CDC and ACIP guidelines allow physicians to make a risk/benefit analysis and consider contraindications and precautions for medications and for vaccines. Anaphylaxis is a contraindication to penicillin or to a vaccine. (NB: Docs give pcn to sick people worthwhile risk of anaph; vacc are given to healthy MKS)
For HIV patients, most vaccines are OK. CDC gives guidelines for the degree of immunodeficiency-¬according to the number of T cells, etc. It is not a blanket yes or no. Patients with Crohn’s can receive vaccines if they are on immunomodulators. Not all vaccines are the same. They are very different including the covid vaccine. There are live viral vaccines, live attenuated, such as Varicella Zoster, MMR. The decision must be made on the individual vaccine. (NB This dramatically increases the burden of proof on the exemptor, to find evidence from a system that is designed to limit the existence of adverse evidence. MKS) An exemption must NEVER BE PERMANENT FROM ALL VACCINES because it doesn’t make any biological sense. (NB This sets up the wrong default. This default is the vaccines are de facto perfect. The fact is the human physiology is de facto proven successful by test of time and is the default. Intervening must be proven. The ‘biological sense’ is the final common pathway of inflammation, which all vaccines do or they cannot be called vaccines. The real ‘biological sense’ for permanent exemption from all vaccines is when the PATIENT’S HEALTH cannot endure more inflammation, the chronic immune activation. The patient’s health is individual, the vaccinations are cut of one cloth, the cloth that produces intentional inflammation. MKS)
RJ questioning DL
DL: CISA I am not familiar. I work with standards of care for pediatrics practice, and for vaccinating children.
RJ: Exhibit 3
(I missed some here MKS)
DL: A simple departure is one that leads to no harm, for example, incomplete notes.
Extreme departure is one that leads to adverse outcomes, one which a doctor knowingly could recognize harm could come from an action or inaction. A reasonable physician in a similar situation would make decision differently. Reasonable decision making by a physician with respect to patient’s presentation. It is an extreme departure if a similar physician would take different action. If it departs from traditional expected understood treatment.
GC: The term ‘neurologic vulnerability’– is it a contraindication or precaution?
DL: It’s not a medical term. (NB: It’s a medical term if a doctor uses it to identify coherently a pattern of findings. There is reason behind my using it. Dr. AZ’s science explains what is happening with many children with ‘neurologic vulnerability,’ tendencies to sensitive nervous system that manifests tics, stuttering, enuresis, sensory issues. This child may have a metabolic abnormality. There are ‘soft signs’ on neurological exam, a similar use of language to indicate a group of abnormalities that may or may not be enough to make a diagnosis. MKS) The term ‘immune activation syndrome’ — vaccines do this (NB: she considers all vaccines as a whole right here, and provides the biological sense to exempt from all vaccine: viz, their action MKS), a pathogen does this. Immune activation syndrome is not a real medical term.
Is this a contraindication or precaution defined by ACIP?
DL: No
Mitochondrial dysfunction—is this a medical term?
DL: Yes there are mitochondrial defects.
Is this a contraindication or a precaution for vaccinating?
DL: Mitochondrial defects are not listed. They are very rare disorders.
DL: AB is there any record of physical exam? p. 121 is the chart notes. Meningitis occurred at 11 months. Meningitis is preventable by 3 vaccines. Pneumococcal is the most common type of meningitis. Also Hib and another. We rarely see meningitis today. It is a vaccine success story.
DL: Family history of a vaccine reaction is not a contraindication to vaccination in a patient. 3rd cousin has a movement disorder. There is no definable contraindication. Covid vaccine has brought the pandemic under control. Yet Dr. Sutton exempted this child from lifesaving vaccines in the future. We need the record to see what type of meningitis this was, because the patient may be at risk of further meningitis and would need additional vaccines.
Patients with recurrent ear infections have increased susceptibility to Strep. Pneumoniae. Therefore, give extra vaccines to these children, the polysaccharide pneumococcal vaccine. This child is likely eligible for more vaccines. Father having had meningitis; it would be interesting to know what kind because important to know for the child. (NB Fam hx /heredity /genetics given relevance by this statement– MKS)
There is no record of physical exam on this patient. There is no contraindication to give reason for a medical exemption.
GC: Is it important to receive records from the primary care provider?
DL: If I am a consultant, making decisions, I always review past history and communicate with the referring doctor. The PCP needs to know what happened.
DL I don’t do primary care pediatrics so I always relates to the primary care provider.
GC: Was there a good faith exam of patient prior to the medical exemption me being written?
DL: I didn’t see that.
GC: Did Dr. Sutton provide reasonable potential of therapeutic gain by exempting patient from vaccines?
DL: Patient was placed at greater or less risk. Exempting from all vaccines increases risk of the child developing additional infections. It is a departure from the standard of care, extreme because the medical exemption was permanent and without any real indication.
CASE 2 MB No physical exam is evident. There is a question if the visit was in-person or by phone. There is no indication of physical exam prior to the second permanent medical exemption, or of having met with the physician.
Is there a vaccine reaction that would exempt a child from all future vaccines?
Not that I’m aware of. We give several on one day. If anaphylaxis occurs, it is hard to determine which one caused it. We have to sort that out. That certainly does not exempt the person from future vaccines.
There were no defined contraindications or precautions prior to providing ME. No medical records appear to have been sought.
Genetic testing was discussed at the time of 2nd ME. Were any other records sought from pcp?
I didn’t see any.
With regard to family history – was there any significant chronic underlying disease?
Sensory processing disorder tendencies require follow up.
There is lots of family history but it is not relevant.
Aluminum is intentionally added to vaccines. Aluminum is not a reason not to vaccinate. The CDC explains why it is used and why it is not a concern.
Does the CDC accept autoimmune disease within the family as a reason to not vaccinate the child?
We vaccinate patients with systemic lupus and dermatomyositis. The American Study for Rheumatic Diseases has guidelines for vaccinating patients with autoimmune disease.
SNPs are small genetic variations We are not all the same. They indicate an amino acid substitution. (NB actually a NUCLEIC ACID substitution—MKS) We all have those. I see a medical exemption based on SNP variation, but these are common, are normal. They are not relevant to vaccine reactions. (NB we don’t understand them fully, but definitely the difference in vaccine reactions between one person and another has some kind of genetic or other identifiable base. Do we ignore emerging information that is not yet complete? Or do we use it to try to protect patients? MKS)
GC: Did the patient seek Dr. Sutton for the purpose of getting a medical exemption?
DL: — looking for intake
Based on records, there was no good faith exam before either ME.
GC: Did writing first ME provide reasonable potential for therapeutic gain?
DL: ME for 1 year placed the child at risk for that 12-month period. Risk is greater than any possible benefit.
GC: Did permanent exemption provide reasonable potential for therapeutic gain?
DL: No– it created further risk for life or for the next few years.
GC: Did you see any contraindications or precautions that the CDC would have accepted?
DL: No
GC: Was this departure from the standard of care?
DL: Yes, Extreme departure. (NB But it is not extreme enough departure from standard of care to misdiagnose sepsis resulting in loss of hand and foot, or to have obstetric issue with death of baby/mother? These doctors received no disciplinary action. — MKS)
Patient 3 I can’t tell if visit was by phone or in person. There is no physical exam. Does the chart give evidence of the current state of health? It is hard to interpret what is about the patient and what’s about family members.
Was raw milk recommended?
Yes.
What is the medical necessity for the child to consume raw milk?
We recommend against raw milk because of outbreaks of infections which are not vaccine-preventable. Raw milk can be quite dangerous.
There is no sign of physical examination. The parent came for the appointment in order to get ME. There is no evidence of reaching out to the PCP. I see no request for medical records.
This patient had chickenpox. A child can get the chickenpox vaccine from age 12 months onward. What is the damage to the child if the child is not vaccinated?
Uncomfortable rash, but also 110 people die every year, some of them are immune compromised. You can get toxic shock with bacterial superinfection of chickenpox, severe pneumonia, meningitis, post-infection encephalitis. (NB: IOM found consistently supportive evidence that chickenpox vaccine can activate disease, and I believe there is pneumonia, encephalitis from vaccine also—MKS) Reactivation chickenpox occurs with shingles. We encourage shingles vaccine for age 50 +. Usually benign.
Certain children cannot receive the vaccine for chickenpox—for the immune compromised, this vaccine was developed — for children with leukemia who died because of chickenpox. For leukemia patients with maintenance therapy. We count on the community to be vaccinated, so chickenpox is not circulating in kindergarten classrooms.
GC: Did ME provide potential for therapeutic gain ?

DL: No, it placed the child at continued risk for further infections. And permanently.
GC: Was there a good faith exam?
DL: There is no documentation of that.
GC: Was there any contraindication and precaution based on ACIP guidelines for this patient?
DL: No
GC: Was the treatment of the patient a departure from the standard of care?
DL: Yes.
GC: Was it simple or extreme?
DL: Severe. Extreme. A permanent exemption from all vaccines is extreme.
Patient 4
DL: There is no in-person visit documented. I see no physical exam. I am referring to the audio interview regarding no physical exam. There were no records requested of the PCP. There were no vaccine contraindications or precautions identified according to ACIP guidelines.
GC: When do you ask for the medical record?
DL: If assuming care or if consulting for example, a developmental pediatrician or neurologist. But if you want to assess the safety of vaccines, autism is not relevant.
GC: Are there any records other than the vaccination record? There is a paternal uncle and paternal
cousins with learning disability and ADD, so would you consider those contraindications or precautions by CDC guidelines?
GC: Was there a good faith exam prior to issuing the ME? Was there reasonable potential for therapeutic gain that outweighed risk of the healthcare method?
DL: No. There is not any contraindication or precaution with regard to family history in relation to ACIP guidelines. No.
GC: Was respondent’s treatment of Patient 4 a departure from the standard of care? Simple or extreme?
DL: Yes. Extreme because the ME was permanent and from all vaccines.
PT 5
DL: I can’t tell if the patient was present when ME was written. There is no evidence of a physical exam. There is no evidence of respondent reaching out to the prior pediatrician.
GC: Is genetic testing of importance to a doctor working within the standard of care?
DL: No, genetics shouldn’t be used to exempt anybody. It is misrepresented to use genetics to predict vaccine reaction. That is outside the scope of the scientific medical community’s understanding. This is not science. (Medical caste system – MKS)
GC: Any contraindications or precautions seen?
DL: The child screamed after initial vaccinations. I would counsel the family and provide anticipatory guidance. I would not recommend leaving the child unprotected.
GC: There is a lack of physical exam prior to 4/17 and failure to request prior med records, do you believe there was a good faith exam prior to me being written?
GC: Was there a therapeutic gain in patient’s medical condition that outweighed the risk?
DL: We have a vaccine that prevents against cervical cancer. And this child is exempted from protection going forward, not allowing her to have protection from that virus.
This is a departure from the standard of care, extreme because it is missing the opportunity to prevent this child from infections and cancer in the future.
Patient 6
DL: No physical exam, no in-office visit. (OVERLOOKED NOTE LATER SEEN UNCLEAR WHETHER IN PERSON)
Patient’s family was requesting ME. The father’s request to avoid his experience of adverse reaction is not a reason for a ME>
GC is there any contraindication or precaution pursuant to CDC guidelines?
DL: The family mentions a lot of infections, but that is reason to be sure you’re vaccinated. Father’s reaction is to flu vaccine. Pneumonia, ear infections, sinus infections—we have vaccines that can prevent these. (NB Many are viral for which there are no vacc, chlamydial, fungal—MKS) Headaches are irrelevant to the administration of vaccines.
There are no contraindications or precautions present. There was no request for records or discussion. No physical exam recorded, therefore no good faith exam prior to issuance.
GC: Was there reasonable potential for therapeutic gain outweighed by risk of not having the medical treatment?
DL: No. The risk of not vaccinating is greater. This is a departure from the standard of care, extreme because it was permanent for all vaccines.
Patient 7
DL: There are some records. I see no vital signs of physical exam. There is a Well child visit by prior provider, p A479, with physical exam.

You need to vaccinate more if child has asthma, immunize every year.
Based on the shot record, asks if good faith exam occurred prior to ME being written
GC: Any precautions or contraindications? Did ME provide reasonable potential for therapeutic gain in patient’s medical condition compared with risk to health of avoiding medical treatment?
DL: This is a departure from the standard of care, extreme.
Patient 8
GC: Were there any vital signs in the records? Was the respondent in the room with the patient?
DL: Can’t tell from the record. There was a febrile seizure and an ER visit. The high rate of rise of fever in febrile seizure is common in toddlers. There is no long-lasting effect. They aren’t associated with further neurologic injury or increased seizures in the future.
GC: Are febrile seizures a complication of MMR?
DL: Febrile seizures can happen from several vaccines. They can occur from MMR. But they are scary of course but benign because of no long-lasting effects. (NB since these are benign, let’s make no effort to avoid seizures. Let children have lots of febrile seizures. They don’t matter. No wonder the 5x higher rate of seizures after MMR than after measles is not a concern (1/250). And in families with a sib with febrile seizures, the risk of seizure after MMR is 1 in 50. It’s benign. Just have the seizure. It’s okay. MKS)
GC: Are there any other records beyond ER record?
DL: I don’t see any.
GC: Are there any notes of reaching out to consult prior to issuing ME?
DL: No.
GC: Is it common for febrile seizures to occur 1 yr after MMR?
DL: Febrile seizures can run in families. If they occur once, they can recur. Use aggressive Tylenol and ibuprofen. They are benign. There are no lasting neurological outcomes. I talk with families. If the child receives MMR at an age older than 12-15 months, there is slightly great likelihood of febrile seizure after MMR.
I want to know more information about the seizures at age 5 years. Did they occur with fever? Also wants more info about timing of —?vacc
I see no effort to get records I would get records if basing a permanent vaccine exemption on seizures.
GC: Is there any good faith exam evidence?
DL: No.
GC: Are there any contraindications or precautions pursuant to CDC ACIP guidelines?
DL: No. One wants more information and conversation with the family about the febrile seizures. The patient is well out of range of febrile seizures now. They are no longer relevant at time of evaluation.
GC: Is there a reasonable potential for therapeutic gain that was not outweighed by risk of exemption itself?
DL: The risk of not vaccinating is much greater. This is a departure from the standard of care. Extreme because it is a permanent exemption from all vaccines.
GC: Do you still agree with your written statement against the importance of aluminum in vaccine medical exemptions? page ?76
DL: I still agree page 83-84. Page 92 I still agree.
GC: 11-14 ‘come in within 12 months’ for office visit. Would any physician in CA issue ME for up to 12
months before seeing a patient? Do you know of any?
DL: Yes, but I don’t think it’s within the standard of care.
RJ: most of your patients are referrals and you do two things basically, figure out if a patient has an infectious disease that a referring physician couldn’t determine and second, see patients with ID diagnoses who have not responded to treatment as expected?

DL: Most patient are referrals yes. Mostly I receive referrals from PCP — I answer question whether the patient has an infectious disease, and if diagnosed infectious disease is not responding to treatment. That work is separate from teaching, academics. What kind of cases? In-patient, out-patient, I provide second opinions. I see vaccine hesitant families to help them to understand the risks of not vaccinating their child. I do provide primary care for HIV patients. I personally have not written MEs. I haven’t treated patients with suspected vaccine injury. Infectious disease whether exotic or common, and I fill a public health role to prevent the spread of disease at large. In 2014 I had patients exposed to the measles outbreak but who were unable to be vaccinated— I applied some public health help for them. (NB What does this mean? What public health help? Did she give vit A? If so, why only to those ‘unable’ to be vaccinated? MKS)
RJ: What is the difference between a contraindication and a precaution?
DL: Contraindication is a term widely used in medicine for example if a person is allergic to penicillin, there is a contraindication to giving that patient penicillin. No exemption is required because we have other antibiotics, and the child can attend school without penicillin. In the case of vaccines, a contraindication allows attending school without a vaccine.
RJ: Is the word ‘vaccine exemption’ in the ACIP document?
DL: No. The job of ACIP to recommend FOR vaccines and say how they are to be given. It is not their job to mention vaccine exemptions. ACIP compiles studies. (NB Are these studies listed somewhere? Have they been carefully reviewed by US? MKS) ACIP reviews the recommendation of other bodies. Medical professionals then provide exemptions, for example if a patient is on an immunomodulating agent then precaution is needed.
There are different kinds of exemptions that excuse the individual from treatment, for example religious exemption, medical exemption, personal belief exemption.
RJ: You would find out about a medical exemption by consulting the law.
GC: She can’t offer a legal opinion
JUDGE: Objection sustained.
RJ: Where does ME come from in CA? There were senate bills that were introduced. There were state bills about MEs. SB 277 eliminated personal belief exemption. Are you familiar generally with what happened? what role if any does SB277 in any of your opinions expressed today? Is consideration of 277 forming a basis of your opinion?
DL: I do know the law but I didn’t refer to it to make my opinion. It increased the number of MEs. But irrespective of law, physicians writing permanent MEs for all vaccines is outside the standard of care. The law is about school attendance. I’m talking about care of children. The law benefits the care of children. If they don’t have vaccines, they can’t go to school. It is based on the real importance of protecting children against these diseases. The law doesn’t impact my decision-making in that sense. (NB Nor does the standard of care impact my decision-making if I follow the higher standard of First do no harm— MKS)
RJ: MEs increased because personal belief exemptions and religious exemptions no longer allowed for school attendance. About 928 MEs pre-277 were written by oncologists and immunologists, correct?
DL: I don’t know what majority were for.
RJ: Are your opinions based on community std of care?
DL: Yes, the scientific medical community. I am not familiar with statutory standard of care. I am not aware of two sources of standards of care. (NB Yet she has implied there are two communities, the scientific and the other—MKS)
DL: If a patient is allergic to a vaccine component, that is a contraindication to that vaccine. Egg, neomycin – these are contraindications to that individual vaccine not to all vaccines. (NB How many vaccines contain egg? How many contain neomycin? Blumberg didn’t know in reviewing Ken’s cases. Would you exempt a child allergic to neomycin from all vaccines containing neomycin? Egg? If they reacted to one vaccine which contained egg? Neomycin? In the vaccines which contain egg, is there any other ingredient that could cause anaphylaxis? How do you know egg caused anaphylaxis? In the vaccines containing neomycin, are there any other ingredients that could cause anaphylaxis? How do you know neomycin caused the anaphylaxis? So, there are multiple ingredients in each vaccine which could cause anaphylaxis. How do you narrow that down? Does each case of anaphylaxis to a vaccine get cross-referenced to fully understand the ingredient causing the anaphylaxis? If not why not? What is the risk of death in anaphylaxis [up to 20%] How carefully is the allergy history of a child taken before administering a vaccine? In the pharmacy where vaccines are given? Is it true that the system for screening for allergies is less important than getting the largest possible number of patients vaccinated?)
RJ: What is an allergic reaction?
DL: It is an abnormal immunologic response that would not ordinarily happen in other people. It is from a specific part of the immune system. Signs of allergy–difficulty breathing, hives, rash, anaphylaxis– are mediated by a certain part of the immune system. The body is creating response. Most people don’t have it, For example, to shellfish.
RJ: What is primary vaccine failure?
DL: The vaccine doesn’t work, does not result in not enough antibodies. In the case of the covid vaccine, there is no recommendation to test antibodies because we don’t know that absence of antibodies means you have no protection. Not all ___ produce antibody response. We think we know what produces immune protection but we don’t know. (NB So we mandate it…MKS) Primary vaccine failure is very unusual. But it is possible that their cellular immune system would mount a response if exposed to the pathogen.
Individuals whether vaccinated or infected (NB vaccinated are treated as a group – they have a common characteristic – they are like the infected MKS) can have a significant immunologic reaction — it is very rare, Drevet syndrome. After a febrile illness or a vaccine, it leads to encephalopathy. These patients are thought to have vaccine reactions, but they are not vaccine reactions because the same thing would have happened with infection. It is very vaccine, rare. (NB Is this screened for? How are these people protected from encephalopathy from vaccine? MKS)
Our job is to investigate reactions, but not to exempt from future vaccines. (NB How do you investigate a vaccine reaction? Tests you do? What are some examples of the information gained from the investigations? What do you do with the information you learn? How do you protect the sibs/relatives of the person whom you have investigated? How do you protect other children? MKS)
We use aluminum to boost the immune response. It is not in live viral vaccines.
Family history is not a reason on which to base a medical exemption. (NB Have you so testified at the time SB 277 was passed? MKS) CDC has not recognized it playing a role. (NB CDC not recognizing does not mean it does not exist. It means the authority structure does not currently include that information. MKS)
Neurologic vulnerability is not a term physicians use (NB A physician used it, so I guess it is a term physicians use. MKS)
RJ: You don’t like ME letters being form letters
DL: They are not individualized for the patient.
RJ: Are you familiar with what the school requires for MEs? the checklist?
DL: I have communicated with other physicians and indicated if a child should not be vaccinated, for example if the child received gamma globulin, then I would advise giving no varicella or measles vaccine for 11 months in my note. If this was needed for the school, then I would communicate to the school. I have seen the forms for school. I haven’t completed one. The school wants form. I don’t know if they require specific forms.
Dr. Sutton made laundry lists of why children shouldn’t receive vaccines. That is my objection.
RJ: What is the risk of vaccinating versus the risk of not vaccinating?
DL: I have no answers but it’s a great question. The risk of not vaccinating is greater than the risk of vaccinating for each patient. Polio is not one of higher risk diseases except if you travel. Meningitis risks of developing _____ Measles has a mortality rate of 1/1000. This is in the Redbook page ___. Measles is not a mild disease. Late encephalitis can occur subacute sclerosing panencephalitis SSPE, pneumonia, encephalitis —you are not out of the woods if you get past measles.
I can’t tell a patient a number of risk. I move the discussion to seatbelts which are the same thing. I don’t need a number. If you get a vaccine you will not get measles. The risk is infinitesimal from the vaccine. I will not argue about hypothetical risk. It has been adjudicated. Risk is real. If my child, I wouldn’t take that risk. If you get measles, this is the risk of you doing very poorly.
This is settled science. This is not the forum to go into this.
RJ: I direct you to an article by Peter Aaby, Exhibit 21.
DL: I have not heard of him.
DJ: He describes research in an urban African setting related to the introduction of diphtheria vaccine in 1981.
DL: These are not vaccines we use in the US. conclusion:_____ Object because this is from 1981.
RJ: Peter Aaby found DPT was associated with 5-fold increased mortality. He stated DPT is an indicator of national vaccine programs, and the effect of routine vaccination on all-cause mortality is not included in randomized trials. Dr. Lehman, has there ever been such a study?
DL: DPT is not in the current schedule. I’ve never heard of this journal. Come on. Ten children died of pertussis in 2010 because they couldn’t be immunized. Then we began stopping pertussis by immunizing pregnant mothers and reducing the age of pert vaccination to 6 weeks. This is not an article I would ever read.
RJ: How do you know the vacc are not killing people?
DL: That’s not how studies are done. I’m not here for that. I was doing LPs every night in 1980s when I trained Today’s residents don’t even know what meningitis is. Look at covid 19 – where we had 300 patients in the hospital and now there are 3 patients in the hospital. I can argue vaccine efficacy all day and I’ll come out ahead. It’s been decided. Vaccination is one of the top ten interventions ever I hope all physicians who are passionate about care of children also are passionate to vaccinate. I do not accept blatant disrespect, disregard for science. We take an oath as physicians, to treat disease. I see someone who for financial gain is not doing that. I do have a problem with that. I’ve seen children die of preventable diseases. Irrespective of any prior adverse event, unless that event constitutes a contraindication or a precaution, no medical exemption is indicated.
RJ: Would you give your testimony any differently if state legislation had said ME can be written on family history alone irrespective of ACIP guidelines?
DL: My opinion is not based on law, so the answer is no.
RJ: Thank you.
DL: I have no training as a neurologist. Febrile seizures are not grounds for ME — I counsel families that there is a slight increase in seizures with MMR vaccine and even slightly higher with MMRV.. They are scary but not dangerous. That’s medical fact.
RJ: “F” is indication of father on the meningitis question.
DL: Predisposition to meningitis can be genetic. That’s the kind of family history. I would want to know what kind of meningitis, how old, to see if this child is at increased risk. Children with asplenia or a defect in type of immune system need earlier immunizations and additional vaccines, for example pneumococcal conjugate in infancy/childhood. But if predisposed to meningitis they should also get Pneumovax which old people get. This protects against more of the pneumococcal types
DL: Aluminum is ever present –in brst milk, foods.
RJ: Is there a difference in ingestion and injection?
DL: Yes, but this is resolved. There is no correlation between blood levels and hair levels. I won’t debate the flat earth society. I follow the science and read the science and the amount of aluminum is not an issue. Take it on faith. I am an expert.
RJ: What is the absorption rate of aluminum by injection over that by ingestion?
DL: I don’t need to cite because this has been decided. Children’s Hospital of Philadelphia has wonderful resources on aluminum, mercury, and also CDC.
RJ: Please see E 623. Because Dr Sutton’s MEs are not within guideline contraindications — every contraindication is anaphylaxis — severe allergic reaction — but also encephalopathy. What is encephalopathy?
DL: Encephalopathy is brain inflammation or brain abnormality. It is a catch all term. It can be due to infection, genetic conditions, a lot of things.
RJ: On ACIP charts all vaccines have anaphylaxis as contraindication, and some have encephalopathy. Some have a precaution, for example during pregnancy or with prior Guillain Barre Syndrome after LAIV flu vaccine. This six pages are the recognized contraindications.
DL: We need to review medical records, examine patients. We do this every time we give a medication, review previous reactions, as part of medical care.
RJ: After 4.1 is 4.2 chart — conditions incorrectly perceived as contraindications and precautions to vaccines.
DL: These are misunderstood. Family history of SIDS, family history of DTP or DTaP followed by seizure-
– none merit ME under these guidelines. We never want to deny protection against these 3 diseases. SIDS are investigated cases.
Autoimmune disease is not grounds not to vaccinate– we want to be sure to vaccinate because they are frequently on immunosuppressants.
With asthma the patient SHOULD get vaccines — we recommend for all children 6 months age on, asthma is a top tier indication for covid vaccine. Patients with asthma are more likely to be hospitalized, be on a ventilator, and die, and we know flu vaccine prevents that.
Prolonged crying seen with DPT, not DTaP. There are fewer side effects with DTaP. Treat with tylenol. I would not want a child to be susceptible to pertussis going forward.
RJ: Another page– references to support recommendations. Would this indicate how the science is settled?
DL: This is a very small fraction of what has been done.
RJ: What’s the fear of pertussis?
DL: If the child who is too young to vaccinated gets whooping cough, the child can have encephalopathy, or dies. In 2010, 9 full term infant died of pertussis. Older patients get a cough– the 100-day cough. They cough for months, break ribs. They don’t die. Infanats get pertussis from older children, adults, family. The pertussis vaccine is not as good as measles vaccine. It protects 85% from pertussis being transmitted to a newborn. That child can die. Pertussis is transmitted within the household.
RJ: Do you understand the standard of care to be medicine as practiced by doctors in the community? RJ: How do CDC and ACIP get their guidelines?
DL: Committees review data — their meetings are publicly available and researchers present data. They review all studies for efficacy, immunogenicity, safety, side effects, and what place the vaccine should be given in the schedule. They discuss risk of disease vs side effects of the vaccine. All these things are discussed. Meetings are open. They develop recommendations based on this. Studies are usually worldwide. ACIP takes a vote up or down. Discussion is thorough.
DL: I don’t think any have died from pertussis vaccine. Death would be reported in couple ways VAERS. You would know. In the last 10 years, I am not aware of any pertussis vaccine deaths.
DR Andrew W. ZIMMERMAN
AZ: Specialist in Pediatric Neurology CV 2 years at NIH doing clinical and lab research in metabolism and neurology. National Inst for Neurological Disorders and Stroke NINDS. Then Johns Hopkins. Then in Connecticut for 8 years in private practice of neurology adult and pediatric In Knoxville TN for 11 years. Then Johns Hopkins Kennedy Krieger Institute for 16 years. 2010 Massachusetts General Hospital Murray Center for Autism for 3 years. University of Massachusetts medical school Worcester faculty. I see patients at Mass General Hospital for pediatric neurology evaluation at Cape Cod. These are young adults with pediatric neurological problems. I have written and published 86 peer-reviewed articles. My areas of interest autism spectrum disorder, from the mid-80s after in private practice, until the present.
AZ: Pediatric neurology addresses any problem that relates to the nervous system. Headache, seizures, ADHD, autism spectrum, neurodevelopment disorders, epilepsy, absolutely febrile seizures. I consult with pediatricians. I have published on epilepsy. I am familiar with the literature on febrile seizures.
Work with the immune system and autism spectrum disorder. Very interested. There is an increased risk of autism in families of children who have autoimmune disorders. 1999. Result of observations in my practice in Tennessee. Frequency of rheumatoid arthritis and other autoimmune diseases is found in the families of children with autism. I have written subsequent other publications on autoimmune disease and autism. It may not be causation but there is frequent association. This stimulated my interest in the immune system as it pertains to autism spectrum.
AZ: Neurological injuries associated with vaccines—yes. I treat these patients. There are quite a few. I am comfortable talking about vaccine injured patients and what kinds of treatment they should have and what kind of things they should and shouldn’t do.
RJ: Case 4 and Case 8 May 3, 2021, one page opinion expert report you provided is in front of me in Case lines E,5
AZ: Pertinent medical info Case 4, DH vaccine reactions with subsequent development of ASD and ADHD. Family history of a relative who had autism with regression, lost developmental skills following vaccine. This raised Dr Sutton’s concern leading to exemption from immunizations. Regression after an immunization many parents report. 30% of autism patients start normally developing then regress between 1st and 2nd year of life and often this is temporally associated with immunization. This is a difficult subject because I am pro-vaccine and I take care of these patients day in and day out. Parents go to great lengths to avoid vaccination for their child. I sent you a copy of my publication regarding regression. Mitochondrial dysfunction is a distinct finding in children who regress. Mitochondria energy elements. Brain, nervous system and the immune system are especially vulnerable if mitochondria can’t provide energy for these two systems. Those systems suffer. It is my long-held goal to understand the clear association between regression in autism and mitochondrial dysfunction. So the majority of children who regressed have had mitochondrial dysfunction. And the majority have history of regression following immunizations.
AZ: What to do? No easy answer. We have gone to great lengths to elucidate mitochondrial dysfunction biochemically. That was done with this child, correct? There is a distinct abnormality showing mitochondrial dysfunction on the Mitoswab test. Dr Sutton was correct in giving this child an exemption from immunizations based on the belief and her thinking that the child could have a problem with mitochondrial function quoted in the article by Poling et al. Reading from summary W
RJ:What should reasonable practitioner be concerned about with these set of medical conditions? Why would you deny all the benefits vaccines provide?
AZ: Because if a child has autism and mitochondrial dysfunction, further immunizations could
exacerbate the problem, until you understand and treat the metabolic problem and make sure the child is in optimal health before immunizations are given. The risk outweighs the benefit until you understand the problem. The problem is only now beginning to be understood. Dr. Sutton has pretty good understanding based on what she wrote and the references she chose.
RJ: Is this in line with thinking as pediatric neurologist?
AZ: Yes.
RJ: In the event there are reviewing judges, why not vaccinate just because mitochondrial capability on the cellular level is impaired? Why would it lead to a worse problem?
AZ: One, immunizations stimulate the immune system. That’s how they work. If the immune system is abnormal for variety of reasons that we find in autism, or if there is mitochondrial insufficiency, that will exacerbate the problems of the child reacting adversely to vaccines. This was first brought to our attention by the patient described in Poling et al, 2006. It was astute of her along with her reasoning to make this association, which with recent testing has been borne out.
RJ: Immune stimulation is good–why do you say it is bad?
AZ: In this case the immune system can’t function properly because of mitochondrial dysfunction. At least until it’s proven that the immune system is not the problem.
RJ: You agree with Dr. Sutton’s decision to provide ME to this patient. What does this have to do with ACIP guidelines — the committee from CDC that sets up guidelines for immunization and exemption?
AZ: Each child presented risks Dr. Sutton considered appropriately in making her recommendations. still stand by it
RJ: What role — what is the physicians’ job— in talking to family of Case 4– what should the job of the physician be?
AZ: First and foremost is concern for the child, the patient. She would want to follow ACIP guidelines if possible. But they are very constrained, very restrictive and aren’t necessarily up to date for all children who are affected and can’t possibly take all factors into consideration. Dr. Sutton is rightfully concerned about this patient’s history.
RJ: What about protecting the public? That’s important too.
AZ: But everything in medicine is a decision of risk and benefit. Doctors have to concern ourselves primarily with the patient we are dealing with.
RJ: Any other considerations? citation 1-4 references bottom of 1st page and top of 2nd page. Why do these references support your opinion? why did you cite them?
AZ: First 3 ___ Goldenthal Edmonston Solid on immune system and autism. Well written, well researched. Points up different aspects of what I’ve been speaking about, how the immune syst is involved in autism spectrum disorder. Goldenthal goes into how mitochondrial dysfunction interacts and are active in this disorder. 4th Stein et al I spoke to previously. Our publication last year regarding developmental regression and autism. Mitochondrial dysfunction correlates directly with a history of developmental regression in autism. This child has a family history of that very phenomenon. We don’t know genetics but we know it occurs in families. We don’t have the answers yet. There are a lot of people working very hard on the problem. That family history is important for you or any physician to make the decision of medical exemption. Patients may also have family history of autoimmune disorders which raise my concern as well.
RJ: What is the relation between autoimmune conditions and why a patient might be more at risk for an untoward medical problem associated with vaccines? What Is it about that that would raise your concern with continued vaccination?
AZ: There are many diff types of autoimmunity, quite a few different kinds, in autism. Distortion in normal immune responses–that is a risk factor for a child not having an appropriate immune response. We don’t know the connection yet. We don’t know where it comes from. But children with autism have a problem with neuroinflammation. Their microglia are overactivated. We don’t know why. But it’s an important finding that will eventually lead us to solve this problem. We don’t want them to be overactivated. Increased stimulation of the immune system can lead to autism especially with family history of autoimmunity and autism.
AZ: Case 8 is concerning because of recurring seizures starting right after receiving vaccines. Also, he had frequent seizures associated with ear infections from 2 – 6 years of age.
RJ: Deep dive on febrile seizures. Are they benign?
AZ: Mostly. The majority are very benign if they last less than 5 min and are uncomplicated, that is, the child recovers quickly and resumes normal function. Repeated febrile seizures, especially if prolonged, raise the possibility of developing epilepsy. 5% of children have febrile seizures. There is a genetic predisposition. Of those 5%, 15% will develop epilepsy. It is not clear that febrile seizures cause epilepsy, but they are more likely to develop epilepsy. The last reference I provided speaks to the adverse effects of febrile seizures. Melosing 2020, an association reported in people who develop psychiatric disorders later in life were more likely to have had febrile seizures. Also sudden unexplained death syndrome SUDS is associated with febrile seizures. They are not entirely benign. Most of the time they are. Fever is common after immunizations. If febrile seizure occurs repeatedly and if seizures are prolonged, that is concerning. There is a family history of vaccine reactions. Mother had miscarriage after vaccine and required D&C, had complications. Maternal grandmother swelling at vaccination sites. Mother had autoimmune disease as did Father. Paternal grandmother, and so on, several had major autoimmune disorders.
RJ: Why? Who cares? Why is this relevant to concerns about continued vaccination in this child?
AZ: The problem may be the child had immune deficiency himself. If I were faced with this, I’d step back and exempt and find out how the immune system is functioning. That is done with lab tests, immune system evaluation. Also evaluate the nervous system in more detail, an EEG to evaluate for signs of epilepsy, even if there is no family history of epilepsy. Prolonged seizures are not mentioned here. The index of suspicion is the recurrence of the febrile seizures.
RJ: You would have ordered all these tests, correct? Provide therapy, right?
AZ: Otitis media, recurrent ear infections, are common. Every ear infection the patient had a seizure. Possible immune deficiency which may have fit into ACIP guidelines.
RJ: What role do allergies play, in the analysis to determine if a ME is reasonable?
AZ: Allergies are different. It implies an immune system component. I am not sure it would change my thinking, but he should have an immune system evaluation.
RJ: If a person has allergies – is it more important to vaccinate?
AZ: I’m not expert but there are some who have allergies to components of vaccines called adjuvants, and that would be a concern especially if there are one or two components the child might react to.
RJ: Citations 5-7 How do these support opinions you rendered?
AZ: Frye. Different possible ways seizure activity in children with autism spectrum may be part of the disorder. Refer to immune system. Campfield very good discussion of febrile seizures being benign except for Febrile Seizures Plus, which are longer in duration and more numerous. Melosing et al discusses complciations of febrile seizures, including ___. I am struck by how sensitive Dr. Sutton was to these patients’ histories, when people disagree with her action and thinking, but I would have done same thing in her position. But as a specialist, I would dive deeper.
AZ: Aluminum is an adjuvant in some vaccines. I am not familiar enough to comment. I am not an expert.
DAG Oserly
AZ: Presently board certified in pediatrics. Never licensed to practice in CA. Also board certified in neurology with special competence in child neurology. I have taken or taught no classes in infectious disease. My immunology experience is from working with immunologists but not special training. No specific training in genetics. I have published 86 articles, one last week, so 87, but not in immunology. Quite a few involve immunology of autism. I have done no independent research on vaccine safety.
O: is there a common component to all vaccines?
AZ: There is no common component to all vaccines.
O: CDC ACIP allows contraindications and precautions, but doesn’t use the wording medical exemption, according to the last witness. What is a contraindication?
AZ: A contraindication is an absolute no, something should not be given.
O: And with regard to vaccines, what would be example of immune deficiency in which a patient couldn’t handle it?
AZ: Hypogammaglobulinemia, congenital abnormality of immune function.
O: Both patient 4 and patient 8 neither meet ACIP guidelines for contraindications.
AZ: Correct.
O: Patient 4 was 4 yo at time of ME, exempting him from all vaccines.
AZ: Yes.
O: Is there any evidence Dr. Sutton consulted with pcp prior to me?
AZ: My understanding was Dr. Sutton was pcp. I don’t know if she did or not.
O: Would you take issue with non pcp issuing ME?
AZ: if I were involved I would suggest the child have further evaluation.
O: You suggested genetic mitochondrial and metabolic testing. Vaccines change year to year. And components change.
AZ: Yes.
O: And so, exemption from vaccines not yet developed is overly broad?
AZ: It is broad but not overly broad, understanding that further testing is recommended.
O: Should there be a basis for an exemption before exemption I given? how can exempt from something that doesn’t exist?
AZ: On the basis of many different factors, historical factors, because of the possibility of underlying medical problem that needs to be evaluated. Vaccines could be appropriate if testing is done.
O: This is a blanket exemption?
AZ: Yes. The logical thing is to do further testing.
O: Is there any indication that MEs are tied to CDC contraindications?
AZ: No.
O: Case 8 Febrile Seizures.
AZ: Caused by fever ostensibly. But in a few references, there is considerable concern there is actually an underlying difference in brain function that makes them susceptible to more seizures, development of epilepsy, and psychiatric disorders, and sudden unexplained death syndrome. We don’t understand it yet.
O: Seizures stopped, ceased age 5 yrs. Age 12 yo at the time a blanket exemption for vaccines was given. Do you recall testifying about neuroinflamation? AZ: In the case of autism, and in reference to autoimmune disorders and possible connection to neuroinflammation. I am not making a connection with autism in case 8 and neuroinflammation. There is a strong family history of autoimmune disorders and concern for immune deficiency because of recurrent infections. Concerned with suscept to epilepsy and cognitive impairment.
O: Case 4 was there an issue of inflammation exacerbating autism?
AZ: Yes. That may be one of the connections to the immune system that is abnormal.
O: Can inflammation lead to regression?
AZ: Yes when combined with mitochondrial dysfunction.
O: Can’t inflammation also be caused by infection? So deciding to vaccinate, is it a balancing act between potential reaction to vaccine and catching infection?
AZ: Yes. But once you understand the mitochondrial problem you have an option to treat it, which would hopefully allow vaccination. There was recent testing, but not at time of blanket exemption.
O: Case 8
AZ: There was no family history of seizures. There is a strong family history of vaccine reactions as well as autoimmune disorders.
O: You would have done additional testing—were any of those a condition of the blanket exemption Dr. Sutton gave case 8?
___
O: Records for case 4 and case 8 stated the purpose of the visit was to obtain ME. AZ: I believe so but would have to double check.
RJ: Your approach is as a specialist you would test, try treatment, over the course of years.
AZ: Pediatricians usually refer patients to me. I write the MEs and do the testing. Pediatricians will also say ‘should this patient be exempt b/c of___ ?’ and I write the MEs
RJ: When you write MEs, do you write MEs for all vaccines, including those not yet created?
AZ: Yes, until we sort out what is going on. Then we can clarify. (I wonder if there are patients whom he thinks should NEVER be vaccinated? MKS)

END OF DAY 1

Stay tuned for day 2 of the hearing and I promise, you will LOVE it!!

Rick Jaffe, Esq.

What’s still going to happen if Cali SB 276 becomes law

What’s still going to happen if Cali SB 276 becomes law

I’m getting some requests for information/advice about what happens if SB 276 becomes law. I did a post about it based on the original version of the bill.

The only things that have changed regarding current exemptions is 1. the date parents have to submit their child’s medical exemptions has been pushed back from mid 2020 until end of December 2020, and 2. Now, there is no requirement that the department of health look at past exemptions.

This meaningless change was made to lessen the financial impact of the bill (I and others speculate), but you can bet that every local and state official involved will look at the old ones post 277 and pre 276, and revoke them all, per my prior post.

Here it is. it’s still the way I see it and should answer your questions:

http://rickjaffeesq.com/…/memo-to-cali-parents-of-currentl…/

good luck in the Assembly!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

It’s Surprisingly Quiet on the California Vaccine Front

It’s Surprisingly Quiet on the California Vaccine Front

It has now been two years since California rescinded the PBE (Personal Belief Exemption) for vaccinating school kids (SB 277). Let’s take a quick look back and see what can be learned from what has and hasn’t happened.

1. The Legal Challenges to the law were a complete bust
From the get-go, I was extremely critical of the lawsuits challenging the law. (See my earliest posts in the SB 277 section of this web site). The bottom line was/is that so long as it continues to be “accepted science” that 1. Vaccines are safe and effective and serious side effects are rare, and 2. Herd immunity is a thing, no California court will overturn the people’s will (expressed through their duly elected state legislators) to limit PBEs. No U.S.court has ever done so, and for the above two reasons, no U.S. court will ever do so, until the scientific consensus changes PERIOD

Thankfully, the vaccine-concerned have moved on from that folly, after all the challenges were rejected.

2. Here’s some good news: There haven’t been a slew of disciplinary actions against vaccine exemption writing docs (yet)

So far as I am aware, the only physician who has been disciplined for writing a vaccine exemption type letter is Dr. Bob Sears, but that was based on a case before the new vaccine law came into effect. People were afraid that all the docs writing these exemptions would be “targeted” by the board, but that hasn’t happened yet.

A perhaps interesting and important digression about how medical board cases start

Despite how it may seem to those being prosecuted, the medical board doesn’t go out and look for doctors to sanction. Medical board investigations are complaint generated and driven. The board receives information from patients, co-treating physicians, insurance companies and state agencies which either are complaints or contains information that the board determines is a violation of some law or regulation that the board enforces. (In some relatively rare cases, the board itself is the source of the information, like when a physician is on probation and thinks the doc violated a term of probation.)

Even in the vaccine context, someone has to complain to the board about a doctor writing a vaccine exemption.

Advice to California exemption writing docs: Never write an exemption for a child unless both parents request it/are on-board with it, especially if the parents are divorced.

It doesn’t matter if the sole custody parent requests it. Well, actually it does sort of matter, but if the non-custodial parent is not on-board, it is possible to very likely that the non-custodial parent will file a complaint against you, especially if there are on-going disputes between the parents. In these situations, fighting parents lash-out against a third-party like a doc. So don’t put yourself in the middle of family problems.

So who else can complain? Here’s the bad news:

County public health officials have been quietly going around the state and seeking information about which doctors are writing exemption letters and providing that information to the board. Somehow, probably illegally, they are convincing the school officials to turn over privacy protected information about students who have vaccine exemptions. It’s not a HIPAA violation once the school has the information, but it is a FERPA violation (Family Education Rights and Privacy Act). There may or may not be a private right or action for a FERPA violation, but so far, no one has taken a state or county agency to court on a FERPA privacy violation claim. (Too bad, since the case needs to be litigated.)

Based on the reporting on Dr. Bob Sears’ settlement, it appears that the board has received about 50 complaints, half of which have been dismissed or terminated, presumably without a formal board proceeding. (I haven’t heard of any exemption vaccine case having gone to a hearing yet).

Of course that means that half of the 50 board complaints are still pending. My guess is that those case involve only a handful of doctors, at most.

So what’s next on those cases?

My guess is that in the next six to nine months, the board will file accusations against a few other physicians for writing exemptions based on things like family history of autoimmune dysfunction, which I think is a popular basis for vaccine exemption.

More advice to physicians: If you’re going to use family history as a basis for an exemption, there better be very good documentation/details supporting the family history. Same, if not more so for a child’s history of prior adverse reactions. I can categorically state that it’s not enough just to record what the exemption-wanting parent says about a prior adverse reaction. Problem of course is that most adverse reactions are not worked-up because a regular pediatrician tells the parent that it will pass and advises not to come in or go to the ER.

Nonetheless, writing an exemption without at least the prior medical records which record the prior adverse event will be viewed by the board as a violation of the standard of care.

3. Indirect anti-vaccine legislation

There have been a few attempts by the pro-vaxer legislator-in-chief to pass legislation under the guise of children’s rights and other Orwellian Newspeak to abrogate the parents’ power not to vaccinate their children, but it seems like the vaccine concerned community has done a good job stopping that. But expect the attempts to continue in ever increasingly creative and indirect approaches.

The 900 Pound Gorilla

Since even before Robert Kennedy Jr. announced that he was on some to be created vaccine commission, the community has been hoping that Pres. Trump would do something about the vaccine problem, since in the past he has expressed support for the vaccine/autism connection.

Well, there’s no commission yet, and there’s not much going on in terms of presidental initiatives. But with him, you never know, and he could certainly take some game-changing action. Just don’t hold your breath.

The big unknown

I think it’s fair to say that so far, the medical board has acted deliberately, and even cautiously in dealing with the medical vaccine exemption issue. One settlement in two years, and that wasn’t even a case under the new law. Of course these cases take time, and two years from complaint to hearing is not a long time, especially if the parents don’t give permission for the release of the child’s medical records, which requires the board to go to court to get them.

So for whatever reason, we still don’t have any law or guidance about whether doctors who write exemptions for other than the labeled contraindications for each vaccine will be sanctioned by the board. What I can tell you is what you already know, namely, the standard of care for the majority of pediatricians is that there is basically never a reason to fully exempt a child from all childhood vaccination, and that following the labeled contraindications for each vaccine is the standard of care for exemption of specific vaccines, according to the speciality groups (AAP, AAFP, etc.) and the governmental agencies (CDC).

There is an argument to be made that there is another standard of care and if a doctor follows it, he/she shouldn’t be sanctioned, but my guess is that it’s going to take at least another year or two to get some board and court opinions on it.

And this just in

China is also having problems with vaccine manufacturing.

Here is a post about it which just broke today

https://www.cfr.org/blog/chinese-parents-pharma-industry-worried-sick-after-latest-vaccine-scandal

My prediction

In the next two years we’ll get some governmental legal clarification about the contours of writing exemptions, but until then, frankly, we’re all just winging it.

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

Dr. Bob Sears Medical Board Case Update: LA Times tries to squeeze, shame and goad the California Medical Board to go after Bob Sears and other vaccine exemption writing Docs harder and faster

Dr. Bob Sears Medical Board Case Update: LA Times tries to squeeze, shame and goad the California Medical Board to go after Bob Sears and other vaccine exemption writing Docs harder and faster

We recently received hearing dates in late May, 2018 for Dr. Bob’s hearing before an administrative law judge. The case is primarily about his writing a note excusing the child from vaccination due to two prior severe vaccine reactions.

But May, 2018 apparently is not soon or severe enough for the LA Times which today published a story complaining that Dr. Bob and many other doctors are still writing medical exemptions that don’t meet the standards of medical exemptions by conventional pediatrics and the CDC (under which standards there are no medical conditions which justify a blanket exemption from all vaccines throughout childhood). The Times seems to want all these docs rounded out or put out of business today.

The title of the article says it all:

“Why hasn’t California cracked down on anti-vaccination doctors? A loophole in state law”

Here is the article:

http://www.latimes.com/local/lanow/la-me-ln-vaccine-doctors-20171106-htmlstory.html

The article has some interesting quotes from Senator Ben Allen, one of SB 277’s authors about the intent of the bill and how he doesn’t support the medical board trying to intimidate doctors who write exemptions. The article also quotes Jay Gordon, another prominent vaccine concerned doc opining that it’s up to the doctor to decide whether to give an exemption or not.

Maybe the board is moving slowly because it’s starting to realize that the issue is more complicated and nuanced than the rabid pro-vaxxers make it out to be.

In working on Bob’s case for the past year, a couple things have come out that surprised me, and having been in the cutting-edge medicine field for more than 30 years, not much surprises me these days.

First, in looking for academic experts for the case, I keep hearing the same thing over and over again. The academic expert is concerned about vaccine safety but can’t go public because of fear of reprisals from the vaccine Mafioso. I find this understandable but disheartening.

Second, I keep hearing about doctors, beyond those in the vaccine concerned movement, who aren’t fully vaccinating their kids, but they are doing it quietly.

Third, there is a black hole out there when it comes to any information other than full-on negative against the vaccine concerned. Scientists not being able to get their work published. Hell, I wrote a simple update on Bob’s case and raised some issues about aluminum, and got banned from Huffington Post for doing so.

This is one of the few areas in medical science and policy where a point of view is considered too dangerous to have openly expressed in the general media apparently. I suppose I understand the reasoning behind it: fear of creating fear which could/would reduce vaccination rates. Seems wrong to me.

If there are any brave academic pediatricians willing to take a stand, get in touch.

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

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

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


Per my two last posts, the CAM (Complementary and Alternative Medicine) community is under attack on at least two fronts. First, several CAM professional or issue related organizations have recently been subjected to corrective action regarding their CME accreditation for their annual conferences. Some of their last year’s conference CME’s have been retroactively rescinded, they have had their future conference CME accreditation withdrawn, and/or the groups have been warned to conform to “evidence based medicine,” code for conventional medical practice. See my post:
http://rickjaffeesq.com/2017/03/16/the-next-big-cam-battle-is-here-and-its-ugly/

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

The second shot across-the-bow comes from a medical board in a state law that has incorporated the AMA’s “ethical standards.” These standards render unethical the sale of health related products. This board has initially determined that this ethical prohibition applies to a physician prescribing and selling active CAM therapy, which can only be obtained from the physician, after the physician receives training. See my post:
http://rickjaffeesq.com/2017/03/22/can-cam-docs-legally-prescribe-and-sell-herbals-and-nutritional-supplements-as-therapy-without-bad-things-happening-prescribe-yes-sell-well-see/

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

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

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

More states are eliminating the personal belief exemption (PBE), and in California, which is perhaps the epicenter of the vaccine concerned movement, the last year was really bad: SB 277 which eliminated the PBE kicked-in. The people who brought you SB 277 are upping their game with SB 18, which over time will likely force home-schoolers and other exempt children to be fully vaccinated, on pain of having the state sue their parents for violating their constitutional rights to “proper medical care.” See my post on SB 18:
http://rickjaffeesq.com/2016/12/21/no-cali-mandatory-childhood-vaccination-yet-may-coming/

Plus, the California Medical Board has brought a case against one of the most high profile vaccine concerned docs, Bob Sears. See my post:
http://rickjaffeesq.com/2016/09/13/press-release-re-dr-bob-sears-case-ca-medical-board/

Tough times indeed

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

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

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

In the 90’s I did a lot of work for chiropractor groups. The Chiros don’t take any crap from anyone, not even the AMA, as proven by their successful antitrust lawsuit against the AMA in the 1970’s. I got into the mix with my federal racketeering lawsuit against the New Jersey Department of Insurance Fraud for trying to illegally extort fines from New Jersey Chiropractors. See chapter 6 in Galileo’s Lawyer
https://www.amazon.com/Galileos-Lawyer-Alternative-Complementary-Experimental/dp/0980118301/

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

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

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

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

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

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

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

So I got to thinking …

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

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

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

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

1. Pharma advertising

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

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

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

In cancer, because of tumor testing and targeted agents, the whole protocol/cookbook/prior clinical trials/regional clinical study group approach is starting to die out, at least for tough multiple gene cancers. Although I had been involved in this battle for a dozen years, mostly via Dr. Burzynski, my realization that we’re at the beginning of the end of the evidence-based medicine era hit me after reading Siddhartha Mukherjee (the author of the stunning book on cancer called The Emperor of All Maladies), New York Times article last year. The title says it all (or a lot of it anyway): “The Improvisational Oncologist: In an era of rapidly proliferating, precisely targeted treatments, every cancer case has to be played by ear.”
https://www.nytimes.com/2016/05/15/magazine/oncologist-improvisation.html?_r=0

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

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

Here are a couple more issues:

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

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

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

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

4. Vaccination

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

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

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

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

b. Finally, Get William Thompson on the Record!

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

The bottom line (finally!)

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

Rick Jaffe, Esq.
Rickjaffeesquire@gmail.com

Finally, Some Intelligent Action by the Cali Anti SB 277 Community!

Finally, Some Intelligent Action by the Cali Anti SB 277 Community!

I’ve been a vocal opponent of all of the anti-SB 277 constitutional lawsuits. The most recent one was a federal lawsuit filed in mid-November, 2016, in Los Angeles, and dismissed by the federal district court in January 2017. I think all of these lawsuit were (and will be if more are filed) a terrific waste of time and money. As I have repeatedly said, as long as the medical consensus is that 1. Vaccines are safe and 2. Herd immunity (from vaccines) is a thing, no court will ever overturn a mandatory vaccination law or a law eliminating a PBE (personal belief exemption) or a religious exemption.

(For my reasoning, see my posts in the SB 277 section of my web site. Here is the link.
http://rickjaffeesq.com/category/sb-277/ )

Whatever satisfactory resolution the VC (vaccine concerned) community is going to achieve, I am certain it won’t come from the judiciary, at least so long as 1. and 2 above are the “accepted” scientific facts. The constitution isn’t a suicide pact, and the few do not have the right to infect the many, and that’s what judges are thinking when you file these lawsuits because of the “accepted” science. The vaccine concerned have to figure out a more productive use of their limited time and resources.

(Hint: change the accepted science or change-out the folks who decide what’s accepted, and that’s not as far-fetched as it would have seemed prior to November 8, 2016.)

While I doubt my message got through to anyone of authority in the movement, I am happy to report that I’ve seen some signs of intelligence in the VC community, post SB 277. No answers yet, but at least there is a promising gathering of some of the folks who could possibly come-up with solutions, both on the medical/research level and on the political action level.

I’m talking about the upcoming vaccine safety conference organized by a new group called Physicians for Informed Consent (PIC). As suggested by the name, this is a group of physicians who at the very least are skeptical of the current vaccine schedule and have some safety concerns. Many of the group’s members are pediatricians who have to deal with vaccine issues every day. The conference is this Sunday, May 12, 2017 at the Costa Mesa Hilton.

Here is the Facebook link to the event. Registration technically closes Friday.
https://www.facebook.com/events/1834537363451194/

The conference has two parts. The morning session is only open to physicians and will consist of a panel discussion with some of the leading vaccine concerned physicians explaining their views on when medical exemptions are appropriately given. That will be followed by a legal panel discussing the legal issues in giving medical exemptions in California. I will be speaking at that panel, and I can tell you that some discussions might be controversial, because at least one of the speakers is blunt and has been highly critical of past VC actions, (but he shall remain nameless).

If you are a California physician and write exemptions or thinking about doing so, you should be at the meeting, period.

Starting at 11:00, the meeting is open to the public. There will be various topics about vaccine safety from some well-known vaccine researchers. A couple of the docs from the morning panel will give their insights to the public about the general requirements California physicians will or should employ in evaluating when a school vaccine exemption should be given. The group’s general counsel will also give his insights about the legal challenges facing the docs and the VC community.

My guess is that this information will help the vaccine concerned public understand what’s required of them to obtain an exemption.

One of the most interesting presentations is likely to be from the founder of MADD (mothers against Drunk Drivers). That’s a pretty impressive grass-roots movement which has had a tremendous positive influence in the country and legislation. My view is that it’s going to take a MADD-like movement to effectuate any real change in the medical, public policy and legislative landscape regarding the safety of vaccines, and to take on Pharma and the medical/public health establishment. So I hope the thought and movement leaders listen carefully to what she has to say. It was a pretty nifty, out-of-the-box idea to invite her. Kudos to Shira Miller and her crew for bringing her to the VC community.

On the merits, I have a strong feeling that there’s going to be presented some new information, at least to the docs, about a powerful new explanation of the connection between vaccines and neurological related conditions, including autism, based on some doctors’ (Diane Powell) and thought leaders (JD Handley) connecting the international research dots. Think microglia/pruning and the brain’s immune system. Who knows, maybe even an attorney might talk about the implication of these concepts as a game changer which cuts across the scientific/policy/legislative and even the medical administrative landscape.

Stay tuned and more after the conference!

Rick Jaffe, Esq.
www.rickjaffe.com

Cali. Medical Board makes it official: Docs who write non- standard-of-care medical exemptions will be prosecuted, (but maybe not)

Cali. Medical Board makes it official: Docs who write non- standard-of-care medical exemptions will be prosecuted, (but maybe not)

vaccineimage
The elimination of the PBE (personal belief exemption) via SB 277 has put a lot of pressure on vaccine concerned California pediatricians to write medical exemptions for the children of vaccine concerned parents. The recently dismissed San Diego federal anti-SB 277 lawsuit showed that at least one school board is collecting information about the docs who write these medical exemptions and will forward the information to the medical board for prosecution.

Based on some non-binding legislative history, and some personal discussions with legislators, the vaccine concerned community was hoping that the medical board could not or would not assert jurisdiction over docs who write these exemptions. That seemed completely unrealistic to me based on my experience dealing with medical boards. These guys just don’t give up jurisdiction on their licensees’ conduct.

In case you had any doubts, the board has made it official in its recent executive summary. Here is its position which couldn’t be clearer:
“The passage of two legislative bills increased the Board’s authority to investigate allegations of misconduct. * * *
In addition, SB 277 (Pan and Allen, Chapter 35) effective January 1, 2016, deleted the personal belief exemption from the existing immunization requirements. The Board will investigate any complaints in which a physician may not be following the standard of care in these two new areas.”
(From page 6: http://www.mbc.ca.gov/Publications/Annual_Reports/annual_report_2015-2016.pdf)

So there you have it. It’s basically open season on docs who write full vaccine exemptions, because according the pediatrician groups and the CDC, there are almost no medically justifiable reasons to excuse a child from all childhood vaccinations.

So what can be done about it? In the very short term, nothing really. Many pediatricians will probably be wary of writing medical exemptions.

Still, here are a couple hints. If your child had some prior vaccinations and had a serious adverse event associated with (not necessarily provably caused by) a prior vaccine, you may be able to obtain an exemption from the right doc, which decision would be literature supported. Make sure you bring documentary proof of the prior adverse event(s). The doc will need it for his records. Prior auto immune problems in the child or family members? That might help as well. Again, bring documentation. Help your pediatrician make the case and help him document the exemption. That’s the best protection for you and your doc. Admittedly, right now there is no medical board authority indicating that this would justify or exculpate a doc who writes an exemption on this basis, but I hope to change that within the next six months, in connection with my work on the current medical board case I’m working on, so stay tuned.

Next, an obvious mid-term solution is to amend SB 277 by making medical exemption decisions unreviewable by the medical board. As stated, there is some legislative history indicating that SB 277 was not intended to have the medical board second-guess the decisions of docs who write these medical exemptions. Realistically, passing such an amendment is a long-shot, but it’s time, energy and money better spent that filing another frivolous SB 277 constitutional challenge. (By the way, whatever happened to the dismissed San Diego federal lawsuit which was supposed to be refiled October 1st?) My suggestion: start working your legislators to get some feedback on whether it’s a possibility. If it is, that’s where the community should put its efforts and money.

Finally, there’s a soon-to-be publicly announced group of vaccine concerned docs, which is open to the public. It’s called Physicians for Informed Consent.

Check out their Facebook page at https://www.facebook.com/search/top/?q=physicians%20for%20informed%20consent.

Here is their web site. www.physiciansforinformedconsent.org

These folks have done more good for the vaccine concerned community even before they’ve officially started than all the lawsuits combined, but I can’t talk about that now. Go to their Facebook page, sign up and support them. They have and will continue to make a difference.

Rick Jaffe, Esq.
Rickjaffeesquire@gmail.com

Self-Dismissal of SB 277 Lawsuit: Smartest thing they’ve done so far: Is it a one-of or are they on a roll?

Self-Dismissal of SB 277 Lawsuit: Smartest thing they’ve done so far: Is it a one-of or are they on a roll?

 

I’ve been very skeptical of the federal SB 277 lawsuit and preliminary injunction motion, for technical legal and substantive reasons. (See my prior posts:

http://rickjaffeesq.com/2016/06/10/cali-anti-vaxer-friends-heres-probably-unwanted-possibly-useful-advice/

http://rickjaffeesq.com/2016/06/14/190/

http://rickjaffeesq.com/2016/08/21/time-get-real-sb-277-real-battle-will/

http://rickjaffeesq.com/2016/08/26/shocker-sb-277-preliminary-injunction-motion-denied/)

Well the powers-that-be finally did something smart; they voluntarily dismissed the case before the state had a chance to file a dismissal motion and before the judge terminated the case for good, or in legal parlance, “with prejudice.”

So what’s next? Based on Tim Bolen’s recent post, http://bolenreport.com/sb-277-lawsuit-case-dismissed/#more-4880, it looks like the case will be refiled with factual allegations on the two points which I (and any other experienced federal civil litigator) would deem necessary to try to allege a valid claim, namely, challenging herd immunity, and the alleged severe harm and danger of vaccines to significant numbers of recipients. (Which is not to say there is any realistic chance of success, but whatever chance there is has to involve these two factual contentions.)

Looking into my crystal ball, here is what’s going to happen, (or what’s not going to happen.)

  1. Think you’re getting rid of Judge Sabraw by refiling, think again.

Now that the federal lawsuit has been dismissed, it’s over, meaning, someone has to file a new lawsuit, pay another filing fee, serve the defendants again, and the rest. Normally, judges are assigned on a random basis, and there are a number of federal judges in the southern district, so one might think the odds favor getting another judge on the new case.

However, if the new case is filed on behalf of some of the same plaintiffs, and the defendants will be the same, and the same lawyers, then it’s a related case, and probably should be so designated in the initial filing, but even if not, the state will probably point that out right quick. Related cases go to the judge hearing or who heard the other case. Call it judicial efficiency or not allowing judge shopping.

So, prediction number 1 is that if the case is filed again in the southern district, it will end up with the same judge, and we already know what he thinks about whether there is any set of circumstances in which the beliefs or rights of the few can supersede the rights and health of the many.

Hint: The only way to make sure the same judge won’t hear the new case is to file in another California district court. There are three others, and Santa Barbara isn’t in the Southern District. Sure, you might be accused of forum shopping, and all the judges read the same law books, so it probably won’t matter, but if the goal is to get a different judge, a different district is the way to go.

  1. Preliminary Injunction? fugetaboutit! That ship has sailed.

The dismissed lawsuit was filed before the school year started in the first year SB 277 effected kids. So there was at least an arguable urgency, which is a prerequisite for the extraordinary remedy of a preliminary injunction. However, by the time the new case is filed (supposedly by October 1st) vaccination decisions for this school year have already been made, thereby eliminating the urgency of an expedited decision.  Any other arguable urgency would just be a pretext and won’t fly.  And even the impending school year didn’t work because the urgency was self-inflicted or a tactical decision (which is what the judge said).

Further, the whole “preserve the status quo ante” crap in the prior injunction is a joke and a non-starter in a public health case. Why? Justified or not, SB 277 was a legislative response to one very well publicized disease outbreak (and there were supposedly others).  No judge in his right mind is going to “preserve the status quo ante” by stopping a law specifically designed to prevent future disease outbreaks, not even if Jesus Christ shows up and argues for it.

Anyone who doesn’t understand this is either too close to the vaccine issue or has spent too much time doing field research on the medical marijuana issue.

And let’s not forget that a judge has already denied a preliminary injunction motion involving all or some of the same plaintiffs, defendants and lawyers. The idea that the same or even a different judge is going to reach a different outcome because of some new alleged facts in a complaint is, let’s just say, naïve.

  1. How about a Jury Trial? Not a Chance

Bypassing all the abstruse jurisprudence, there is no 7th Amendment jury trial right when you’re trying to overturn a statute. Those decisions are made by a federal district judge.

  1. So what’s Going to Happen in the New Lawsuit(s)

I get that the vaccine concerned community has a strongly held belief against vaccines, that they are toxic, hurt thousands of people and that vaccines haven’t been proven effective by scientific standards of controlled clinical trials. I also get that they think that the herd immunity concept is unproven superstition.  I am neither an anti vaxer nor pro all vaccines. Also,  I’m not a vaccine lawyer,  and there is no point for a guy like me wading into the scientific dispute or pseudo dispute since I’m just an outsider looking into this controversy. But I have spent my entire professional career litigating cutting-edge and novel legal/medical issues. In that (depressingly long) time, I’ve been thrown out of some of the finest federal courts, and have even prevailed once in a while. So on the litigation part, I’ve very confident about my ability to understand and predict litigation outcomes.

My crystal ball tells me that no federal (or state) judge is going to stop SB 277 because of any complaint or declaration (sworn statement)  supporting the complaint that may be filed. To think otherwise, in my opinion, is based on a non-objective/uncritical view of the case law, and/or a misunderstanding of the limited role of judges in matters of public health, even in the face of an alleged scientific controversy and a minority view of the overall danger of vaccination, even if that minority view eventually turns out to be true and accepted.

Further, none of these cases will ever see a bench trial and all will be dismissed under Federal Rule 12 b.

Bottom line, I do not believe that there is any viable direct legal challenge to SB 277. Indirect, maybe, where the two concepts are successfully challenged in a court case, but relief in such a suit won’t be the judicial overturning of the law. That will only come when there is some recognition/validation of the vaccine concerned’s position on the two key issues of herd immunity and vaccine harm/schedule.

In law, there are just some alleged wrongs or government actions which don’t have a judicial remedy. For the last hundred years, unfettered freedom from vaccination has not been recognized by the judiciary and will not be so recognized given the current view of vaccine science/safety, however wrong the VC community thinks the mainstream consensus view is.

So guys, file away. It’s sometimes important to empower a community even if the boost/feeling is short-lived. The vaccine concerned will certainly feel good about the new filings, and will feel that their heartfelt beliefs are being considered, and that could be a good thing and the lawyers filing these cases will be viewed as heros, (for awhile anyway).

But at the end of the day, the result will be the same as in all of the other cases. And there will be more of the same kind of explanations/excuses or different explanations/excuses, or fulminations about how we live in a police state and there will be more fragmentation of the VC community as they point fingers at eachother assessing blame for failed strategy. But none of those explanations or heartfelt beliefs or fingerpointing is going to change the “established” scientific facts or the law, until there is a change in the worldview, but I’ve said that before.

Rick Jaffe