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:
Kelly Sutton’s Notes of The First Day of her Medical Board hearing, 6/14/21
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?
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?
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?
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?
GC: Was the treatment of the patient a departure from the standard of care?
GC: Was it simple or extreme?
DL: Severe. Extreme. A permanent exemption from all vaccines is extreme.
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.
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.
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.
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.
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?
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?
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?
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.
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.
O: Patient 4 was 4 yo at time of ME, exempting him from all vaccines.
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.
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?
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.