Protecting the Future of Medicine: Why AB 2098 is Bad Medicine

What is the biggest threat to the future of medicine?

The biggest threat to the future of medicine is not what you think.

It’s not the impending likelihood that antibiotic resistance may be the leading cause of death by 2050.^[1]
It’s not the burdening of our healthcare system with lifestyle-related noncommunicable diseases that kill over 7 in 10 people around the world each year.^[2]
It’s not the mental health crisis that has caused 1 in 5 high school students to think about suicide, and 1 in 10 to actually go through with it.^[3]

So what IS the biggest threat to the future of medicine?

The biggest threat is when doctors are no longer allowed to ask questions.
The biggest threat is when doctors are no longer allowed to personalize healthcare recommendations to best meet the unique needs of their individual patient sitting in front of them.

And that is exactly the slippery slope that could happen if AB 2098^[4], California’s Covid-19 Vaccine Misinformation bill, becomes law.

AB 2098 states that:

“It shall constitute unprofessional conduct for a physician and surgeon to disseminate misinformation or disinformation related to COVID-19, including false or misleading information regarding the nature and risks of the virus, its prevention and treatment; and the development, safety, and effectiveness of COVID-19 vaccines.”

Sounds reasonable – false information should not be disseminated. But AB 2098 then goes on to define “misinformation” as:

“false information that is contradicted by contemporary scientific consensus contrary to the standard of care.”

And that’s where the threat to the future of medicine lies.

Let’s break this down a little further …

“Contemporary scientific consensus”

How many times has the contemporary scientific consensus changed during the pandemic?

The Pfizer COVID-19 vaccine was authorized for 12-17 year olds as a 2-dose regimen spaced 3 weeks apart. In June of 2021, Canada reported^[5] that extending the time between doses to over 8 weeks significantly reduced the risk of post-mRNA, COVID-vaccine myocarditis by OVER 5 times, than if the standard dosage of ≤30 days was followed.

Later research^[6] ^[7] ^[8] found that extending the interval between dose 1 and dose 2 for both Pfizer and Moderna COVID-19 vaccines by 6-16 weeks actually IMPROVED immune response and induced higher neutralizing antibody response compared to a 3-4 week interval regimen. And the longer the interval, the higher the neutralizing antibodies. Remember, the 3-4 week interval was what was recommended by the contemporary scientific consensus at the time, and still is.

So in June of 2021, as a pediatrician, I started discussions with my young patients and their parents to consider waiting longer than 3 weeks between dose 1 and dose 2 of their Pfizer vaccine, to reduce their risk of myocarditis and improve their immune response.

If AB 2098 had been passed in June 2021, I could have lost my license for not following the contemporary scientific consensus – even though I was making personalized recommendations based on the latest evidence and individual needs of my teenage patients. My teenage patients who I know better than any legislator on capitol hill, or any physician on the Medical Board.

In February 2022, the CDC eventually did change its contemporary scientific consensus to state that 8 weeks “might be optimal for some people,” especially teenage males, because it could reduce their risk of myocarditis.

A preprint study^[9] posted December 25, 2021 showed that while for most people, the risk of myocarditis was greater after COVID-19 infection than after vaccination, this was NOT the case for males under 40 years of age. In fact, for young males, the risk of myocarditis was about 4X higher after dose 2 of Moderna than after COVID-19 infection. This same article was peer-reviewed and published^[10] in the Journal, Circulation, on August 22, 2022 – 8 months later.

What made the headlines in August 2022? Breaking news: “Risk for Myocarditis Rises Significantly After COVID-19 Infection, Not Vaccination.” This article was published by the Infectious Disease Special Edition^[11] – a self-designated “one stop” resource for clinicians – without a single mention of the increased risk of myocarditis after vaccination relative to infection in males <40 years of age.

When will this knowledge become contemporary scientific consensus?

As a pediatrician, ALL of my patients are < 40 years of age. My patients can’t wait for the contemporary scientific consensus to catch up.

If AB2098 passes, sharing this information to help boys and parents make informed decisions could be grounds for discipline by the Medical Board.

“Standard of Care”

Is there such a thing as standard of care for COVID-19?

And how common is it for physicians to stray from a “standard of care” that is already well-established for other conditions? More common than you think.

Let’s take a look at the case of ear infections, or acute otitis media – one of the most common reasons for a visit to the pediatrician’s office^[12] and the most common reason for antibiotic prescriptions for children in the US. ^{[13] [14]}

In 2009, the American Academy of Pediatrics (AAP) convened a committee to develop new standards of care for the diagnosis and management of acute otitis media, based on evidence that had emerged since 2000.

There was growing recognition that many ear infections are viral for which antibiotics won’t have any effect, in addition to increasing concern for the development of antibiotic-resistant bacteria. A large Cochrane review of studies published in 2009 (since updated in 2015), confirmed that most cases of acute otitis media resolve spontaneously on their own without short- or long-term complications – whether or not the child takes antibiotics. Giving antibiotics right away versus taking a “wait-and-see” approach did not make a significant difference in time to pain reduction or longterm outcomes – virtually all kids do well. On the other hand, compared with placebo or a wait-and-see approach, antibiotic use was associated with a significantly increased risk of vomiting, diarrhea and rash.^[15]

Updated AAP guidelines were officially published in 2013.^[16]The most significant change in practice guidelines included a “wait-and-see” approach for most healthy children with nonsevere, uncomplicated acute otitis media:

“The clinician should either prescribe antibiotic therapy or offer observation with close follow-up based on joint decision-making with the parent(s)/caregiver,” and begin antibiotic therapy if the child worsens or doesn’t improve within 48-72 hours.”

So back to the initial question – how common is it for physicians to stray from a “standard of care” that is already well-established for other conditions? Very common.

A study^[17] released in May 2022 of 2,804,245 children found that up to 70% of children received inappropriate antibiotics for viral infections, and up to 36% of children received inappropriate antibiotics for bacterial infections. And inappropriate antibiotics were associated with increased risk of several adverse drug events, including Clostridioides difficile infection and severe allergic reaction.

Antibiotic stewardship and reduction of the inappropriate use of antibiotics is critical not just to reduce the growing threat of antibiotic resistance, but also to potentially reduce the worsening epidemic of chronic childhood disease:

Antibiotic use during toddlerhood may increase the risk of later child and teenage psychiatric disorders by up to 50% – including sleep disorders, ADHD, mood and anxiety disorders, and other behavioral concerns.^[18]
Antibiotic use during the first 6 months of life significantly increases the risk of every single allergic disease by 4 years of age – including asthma, eczema, anaphylactic food allergies, hayfever, hives, and more.^{[19] [20]}

So should every physician who inappropriately prescribes antibiotics be subject to discipline by their medical board? And should every physician who makes a clinical decision that is not consistent with the current “standard of care” be subject to discipline? The answer isn’t so clearcut.

AB 2098 Undermines Evidence-Based Medicine and the Physician-Patient Relationship

I would guess that every single physician reading this article has at one point in their career inappropriately prescribed antibiotics – often through no fault of their own, and in their best clinical judgment with an understanding of their patient’s unique circumstances. In the updated AAP guidelines on acute otitis media, the AAP notes that clinicians should devise their treatment plan “based on joint decision-making with the parent(s)/caregiver.”

Joint decision-making must take into account the best “Evidence-Based Medicine” available at the time.

The phrase “Evidence-Based Medicine” has been thrown around as dogma during the pandemic. Most people don’t realize that the original definition of “evidence-based medicine,” coined in the 1990s when I was in medical school, is intended to encompass both the art and the science of medicine.

As defined by Sackett in 1996^[21]:

“Evidence-Based Medicine (EBM) is the conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients. EBM integrates CLINICAL EXPERIENCE and PATIENT VALUES with the best available research information.”

Evidence-Based Medicine is a TRIAD between research, clinical experience and patient values – and one is not more important than the other.

A further exploration of Evidence-Based Medicine in 2008^[22] notes that:

“The practice of evidence-based medicine is a process of lifelong, self-directed, problem-based learning in which caring for one’s own patients creates the need for clinically important information about diagnosis, prognosis, therapy and other clinical and health care issues. It is not “cookbook” with recipes …”

Physicians are no longer needed if all that is required is a bureaucrat who can follow the treatment recipe provided. By only allowing for a cookbook practice of medicine that follows a single standard of care and the current contemporary scientific consensus, AB 2098 undermines both the advancement of Evidence-Based Medicine and the physician-patient relationship. If physicians are not allowed to make evidence-based, personalized recommendations for their patients that they know best, we lose both the art and the science of medicine.

The current standard of care means that as a pediatrician, I should:

Put kids with asthma on steroids before trying evidence-based omega-3 fatty acids, probiotics and dietary changes ^{[23] [24] [25]} – when steroids can suppress the immune system, weaken the bones, cause adrenal suppression, and may cause brain changes.
Put kids with constipation on MiraLAX before addressing their gut dysbiosis, magnesium insufficiency and dairy sensitivity – when MiralAX may cause neuropsychiatric symptoms. A concern that the FDA has asked the Children’s Hospital of Philadelphia to investigate.^[26]Most parents (and possibly most physicians) have no idea that MiraLAX is not FDA-approved for children under 17 years of age, and has never been studied for long-term use in children, even though many children are on MiraLAX for years.
Put babies with reflux on antacid medicines before trying evidence-based herbal medicines and probiotics – when antacids in the first 6 months of life can increase the risk of every single allergic disease by 4 years of age. ^{[27] [28]}
Put toddlers on antibiotics for ear infections before trying evidence-based herbal ear drops – when antibiotics in infancy may increase the risk of later child and teenage mental health disorders by up to 50%.^[29]

Would you want your doctor, or your child’s doctor, to make personalized evidence-based recommendations that are best for YOU or YOUR CHILD, based on the latest research … even if they’re different from the current “standard of care”?

AB 2098 is a Threat to the Future of Medicine

AB 2098 is about COVID-19. But if AB 2098 becomes law, it’s a slippery slope to not allowing physicians to ask any questions, or make any recommendations against the standard of care for any condition, even if in their patient’s best interest – without fear of discipline.

California’s AB 2098 squashes scientific inquiry and advancement by making any deviation from “contemporary scientific consensus” and the “standard of care” punishable.

We benefit most when we acknowledge that we simply don’t have all the answers, and continually seek the truth – without fear of disciplinary action.

If “contemporary scientific consensus” and the “standard of care” are never questioned, we will stop advancing medical care for the benefit of our children, ourselves and our world.

Conventional medicine asks, “Is this treatment safe and effective?”

The future of medicine asks, “Is this treatment safe and effective, and for whom?”

The questions we must ask now:

Who decides what is contemporary scientific consensus?
Who decides what is misinformation?
Who decides which questions can be asked?

What is misinformation today, may be truth tomorrow.

It’s Not Too Late to Stop AB 2098

AB 2098 is waiting on Governor Newsom’s desk to be signed into law. Without his veto by September 30, 2022, AB 2098 will become law. It’s not too late for Governor Newsom to veto AB 2098 – which if passed, could have negative, unintended consequences far beyond COVID-19 vaccine misinformation. Please Contact Governor Newsom’s office TODAY and ask him to veto AB 2098:

By phone: (916) 445-2841

By Governor Newsom’s Official Email Form: https://govapps.gov.ca.gov/gov40mail/

Thank you,

Elisa Song, MD

^[1] https://amr-review.org/sites/default/files/160518_Final%20paper_with%20cover.pdf

^[2] https://www.who.int/news-room/fact-sheets/detail/noncommunicable-diseases

^[3] https://www.nami.org/Your-Journey/Kids-Teens-and-Young-Adults/What-You-Need-to-Know-About-Youth-Suicide

^[4]https://leginfo.legislature.ca.gov/faces/billCompareClient.xhtml?bill_id=202120220AB2098&showamends=false

^[5] https://www.medrxiv.org/content/10.1101/2021.12.02.21267156v1

^[6] https://www.cell.com/cell/fulltext/S0092-8674(21)01221-6

^[7] https://jamanetwork.com/journals/jama/fullarticle/2786992

^[8] https://www.nature.com/articles/s41467-021-27410-5