“Dr. Bob” Sears, MD, the controversial California physician known for his Godwin-esque advocacy against vaccination requirements and a vaccine book filled with misinformation, is facing another accusation from the Medical Board of California, less than a year after he was placed on probation for medically negligent practices. Ironically, the complaint was filed just two days before Sears testified at a California legislative committee hearing against SB 276, a bill that aims to prevent exactly the behavior that led to his previous censure and this complaint.
“I find it astonishing that a person who is on probation with the medical board is going to be the main spokesperson to say the bill is bad, the person the bill is designed to protect against,” California State Senator Richard Pan, MD, FAAP, (D – Sacramento) told me after the bill he’s sponsoring passed out of the Assembly Health Committee 9-2 yesterday.
The complaint, brought by Kimberly Kirchmeyer, executive director of the Medical Board of California, alleges that Sears filed medical vaccination exemptions for a pair of siblings who did not have medically recognized contraindications for any vaccines, based on what he recorded in their medical records.
Medical exemptions allow children to attend California schools without having received immunizations required by the state for school attendance. Following SB 277 in 2015, California became the third state to only allow medical exemptions. Similar bills have since become law in Maine this May and in New York last week.
The patients are a 7-year-old unvaccinated boy with psoriasis and his sister, whose only medical history is a bee sting allergy. Both saw Sears on May 4, 2016 for a complaint of “vaccine exemption appt.”
Sears recorded the children’s family medical history as “autoimmune disorders, lupus, psoriasis (in Dad), inflammatory bowel disease, irritable bowel disease, irritable bowel syndrome (in Dad), gluten sensitivity severe in Mom and Aunt, suspect CD [celiac disease] in aunt, neurodevelopmental disorders, ADD/ADHD (in Dad), psychiatric disorders, schizophrenia (Dad), bipolar, and depression.”
The boy’s exam included “psoriatic plaques on scalp, back of neck and ears,” and the girl’s exam was normal, though Sears documented no vital signs for her (blood pressure and temperature). Both children were diagnosed with “viral infection, unspecified” and “feeding difficulties” despite the purpose of the appointments being solely recorded as “vaccine exemption” visits.
Sears determined that the boy “qualified for medical exemption from vaccines for family history of autoimmune disorders (Dad and others), inflammatory bowel disease (Dad), neurodevelopmental disorders (Dad), psychiatric disorders (Dad), and the child’s own autoimmune disorder.” Sears determined the girl qualified “based on review of her past medical history, family history, and current state of health.” He filed letters for both children “exempting [them] from all vaccines for the rest of [their] childhood.”
None of the conditions or family history, as noted in the children’s records, meet the criteria for contraindications to any CDC-recommended childhood vaccines, according to the CDC. The complaint notes for the boy that a “childhood long medical vaccine exemption… based on diagnosis of psoriasis, without immunosuppressive medication, is a simple departure from standard of care.”
Immunosuppressive medication, including that used to treat autoimmune disease such as psoriasis, is a contraindication for live vaccines, such as the MMR and chickenpox vaccines, explained Jaime Friedman, MD, FAAP from Children’s Primary Care Medical Group in San Diego. The complaint goes on to say the boy’s diagnosis and both children’s family history “are not a known contraindication or precaution to routine childhood vaccination.”
The father of the children appeared to agree. Seven months later, on January 25, 2017, the children’s mother called to tell Sears’ office that the children’s father “retract his consent regarding the medical exemption letter.” Since exemptions require consent from both custodial parents, Sears told her the exemption letter was no longer valid. To get another letter, both parents would need to come in and bring the children’s past medical records, he said. Both children’s records “contain an amended copy of the medical exemption letter dated May 4, 2017, stating the original exemption letter is no longer valid and should be disregarded due to a change in family circumstances and consent.”
The Medical Board accusation includes “failure to maintain adequate records” as a second cause for discipline because Sears “failed to obtain and document an appropriate and accurate past medical history, physical exam and family/social history” for the children. This charge was also in the previous accusation that led to Sears’ 35-month probation in July 2018. Sears did not return my emailed request for comment.
UPDATE: Sears has addressed the complaint on Facebook here. He defends his decision to issue a medical exemption for the child with psoriasis on the basis of eight studies he links:
- One study involves 43 patients who received the 2009-2010 flu vaccine; patients’ ages are not noted. Patients with psoriasis are actually at higher risk for some infectious diseases since psoriasis is an autoimmune disorder. Interestingly, another study Sears linked reports “recent infectious disease” as a risk factor “for a first episode of acute guttate psoriasis.”
- Two are single case studies—a 26-year-old woman in Korea after the H1N1 vaccine and a 50-year-old in Portugal after the tetanus-diphtheria (Td) vaccine—which cannot be used as evidence of causation.
- Another uses a national survey to identify 10 adult patients with psoriasis onset or flares after the 2009-2010 H1N1 vaccine in France—a different vaccine than that given in the US. The authors conclude “the likely very low incidence of psoriasis following vaccination emphasizes the safe profile and the relevance of vaccination strategies in psoriasis patients.”
- He mentions two studies, here and here, related to the BCG (tuberculosis) vaccine, which is not a routine childhood immunization in the US. BCG vaccinations in the US are rare, particularly for children.
- And finally, Sears lists a case study of two patients after the BCG vaccine and one for the flu vaccine — published in 1955.
Medical Exemptions Appear Inappropriate
“Without being able to review the child’s medical chart and assuming the child was not on immunosuppressive medication, I don’t see a reason for the child to have a vaccine exemption,” Friedman told me. With the “viral infection, unspecified” in the chart, Friedman said that “could be a contraindication to giving the vaccine that day but not to giving it in the future.”
Friedman, who has written three medical exemptions for her patients, said contraindications certainly exist for certain vaccines but are rare. “These are the patients you want to protect, so these are the kids you want to surround with vaccinated people, like their classmates and their siblings,” she said. If she had a patient on immunosuppressive medication for an autoimmune disease, she said she would work with the child’s specialist, such as a dermatologist or rheumatologist, to determine if and when it was safe for the child to receive vaccines.
Pan agreed that if children “had a skin rash so severe that they would need immunosuppression significantly enough that they can’t be vaccinated, probably a specialist is involved, especially for something like psoriasis.” He also noted the unusual decision to provide an exemption until “the end of childhood.” “Unless you have proof that this condition suddenly terminates at the end of childhood,” Pan said, a doctor would issue either a permanent exemption for a chronic, permanent contraindicated condition or a temporary exemption until the contraindicated condition or medication resolves.
The complaint contains other “much more fundamental issues,” said Sonia Khan, MD, FAAP, director of Pediatric Crisis Solutions, a consulting firm, and medical director of the Team Substance Use Disorder Program at City of Fremont in California. Khan testified for SB 276 at the California Assembly.
“He didn’t even do vital signs on these kids. If you don’t do vital signs on the kids, right off the bat, the medical exam isn’t complete,” Khan told me. “If these do prove to be valid accusations, then there are some pretty flagrant violations.”
She said this complaint reveals the need for the California Department of Public Health (CDPH) to be able to track down medical exemptions and determine the exams and exemptions were done properly.
What SB 276 Would Do
SB 276 bill requires guardians whose children receive a medical vaccine exemption to sign a form that releases the medical records to CDPH and the Medical Board of California for review. The current incarnation of the bill includes two potential triggers for review: if the child attends a school with an immunization rate below 95% or if the physician who wrote the exemption has issued more than five medical exemptions in the previous year.
The second requirement is not a cap, Pan said. A pediatric oncologist, for example, may need to write many more than five exemptions in a year. It simply means the CDPH can review the exemptions. If multiple exemptions appear invalid, the CDPH can refer the case to the medical board, the disciplinary agency. Currently, both the CDPH and medical board have difficulty reviewing exemptions because they lack access to the medical records of children with exemptions.
“The difficulty up until now in chasing down potentially fraudulent exemptions is that the families are complicit,” Khan said. “When a doctor gets reported, the family or someone else is triggering an investigation. In a fraudulent exemptions, the families aren’t going to cooperate.”
“HIPAA [Health Insurance Portability and Accountability Act of 1996] has a specific exception for public health agencies engaged in ‘public health surveillance, public health investigations, and public health investigations,’ that covers SB276 and board investigations,” said Dorit Reiss, a professor of law at the University of California Hastings College of Law who specializes in vaccine policy. Reiss, who formally entered her name in support of SB 276, wrote a backgrounder about the bill here.
But that doesn’t mean the records are easy to get. Another ongoing case illustrates this problem: The Medical Board of California sued Bay Area pediatrician Ron Kennedy, MD, to compel him to produce patient records “of three minors for whom Dr. Kennedy provided vaccination exemptions.” Kennedy refused, and the San Francisco city and count court compelled him to provide the records. Kennedy filed an appeal, and this most recent filing denied his request to stay the court’s demand that he turn over the medical records.
Sears’ complaint does not note who reported him or provided the medical records. His previous accusation arose from a parent who provided the records, according to an unnamed, verified source.
Parents are typically not the ones who trigger medical exemptions, Pan explained. In fact, pediatricians do not have “medical exemption appts” at all. Appointments are typically well visits, acute care visits, chronic care visits or follow-ups.
“A medical exemption should usually result from the pediatrician or a specialist seeing them saying ‘given the condition or situation you have, I would recommend we either don’t vaccinate or hold off on these vaccines,’” Pan said. “It’s odd for parents to ask for a medical exemption.”
Increased Medical Exemptions Triggered SB 276
Yet that appears to have become a trend after SB 277 eliminated personal belief exemptions. In late 2018, a study in Pediatrics found problems that had emerged from implementation of the law, including confusion and frustration over which medical exemptions were valid, how schools and health departments should track them, high fees doctors were charging for them and concerns that medical exemptions were increasing.
Indeed, just this month, some of the same researchers found California medical exemptions had increased despite an overall decline in unvaccinated children entering school in California. A year after the bill took effect, 4.4% of kindergartens entered school without all required vaccinations, down from 7.2% the previous year. But medical exemptions quadrupled from 0.6% to 2.4%. The following year, non-up-to-date kindergartners ticked up slightly, by 0.5%. In a state of nearly 40 million people, that’s a couple hundred thousand additional children not fully vaccinated in a year with the most measles cases since the disease was eliminated from the US.
Another study in the American Journal of Public Health found that SB 277 was interpreted and implemented unevenly in school districts and local health departments throughout California due to “vague legislative and regulatory language.” The researchers also found “lack of centralized review of medical exemptions allowed medical exemptions that are not consistent with valid contraindications for immunizations to be accepted.” Among the uncertainties were what kinds of physicians can write vaccine medical exemptions, which health conditions qualify for one and how to report dubious or suspicious ones.
Those are precisely the issues that SB 276 aims to address.
“The major purpose of SB276 is to prevent unscrupulous doctors from selling unnecessary exemptions so we can restore community immunity,” said Leah Russin, executive director of Vaccinate California, who is co-sponsoring SB 276 with the California Medical Association and the California chapter of the American Academy of Pediatrics.
She noted that 835 schools in California—with nearly 400,000 students—have kindergarten MMR immunization rates under 95%, according to CDPH data.
“If true, the new complaint against Dr. Bob Sears demonstrates exactly why SB276 is needed. Currently no entity in state or local government, including the schools, have the authority to reject an exemption letter signed by a doctor,” she said. “The exemptions described in the complaint do not follow the standard of care, and if issued after implementation of SB276 and subject to the triggers specified in it, they would likely be flagged as unjustified.”
Sears’ History May Prevent Leniency
Some observers believe the medical board’s previous ruling on Sears’ misconduct was forgiving but hope that won’t be the case again, especially since his case could be an example to other physicians writing spurious medical exemptions.
“I certainly hope that as the medical board is looking at these issues and investigating and evaluating them, they recognize his previous history, that he’s already on probation, that he hasn’t expressed remorse for what happened and acknowledged the error of his ways,” Pan said. “He has continued to proclaim he did nothing wrong, which I find very disturbing. You’re put on probation for acts of negligence, and you go on Facebook and say you’re not in the wrong.”
Even if the board does not fully revoke Sears’ medical license—which is one potential outcome of the complaint—Pan hopes the consequences will ensure he cannot continue to issue medical exemptions.
“If that’s the issue he’s being cited for, then certainly whatever sanction he receives needs to stop him from continuing that behavior,” Pan said. “Otherwise, one could argue that’s sending the signal to other people that the consequences aren’t very serious.”