[Editor's Note: This opinion essay is in response to our current Big Question, which we posed to experts with different viewpoints: "Where should society draw the line between requiring vaccinations for children and allowing parental freedom of choice?"]
Our children are the future. The survival of humanity is advanced by the biological imperative that mothers and fathers want and need to protect their children and other children from being harmed for any reason.
Science is not perfect, doctors are not infallible, and medical interventions come with risks.
In the 21st century, consensus science considers vaccination to be one of the greatest inventions in the history of medicine and the greatest achievement of public health programs. The national vaccination rate for U.S. kindergarten children is 94 percent and most children today receive 69 doses of 16 federally recommended vaccines. However, public health is not simply measured by high vaccination rates and absence of infectious disease, which is evidenced by the chronic inflammatory disease and disability epidemic threatening to bankrupt the U.S. health care system.
Science is not perfect, doctors are not infallible, and medical interventions come with risks, which is why parents have the power to exercise informed consent to medical risk taking on behalf of their minor children.
As a young mother, I learned that vaccine risks are 100 percent for some children because, while we are all born equal under the law, we are not born all the same. Each one of us enters this world with different genes, a unique microbiome and epigenetic influences that affect how we respond to the environments in which we live. We do not all respond the same way to infectious diseases or to pharmaceutical products like vaccines.
Few parents were aware of vaccine side effects in 1980, when my bright, healthy two-and-a-half year-old son, Chris, suffered a convulsion, collapse, and state of unconsciousness (encephalopathy) within hours of his fourth DPT shot, and then regressed physically, mentally and emotionally and became a totally different child. Chris was eventually diagnosed with multiple learning disabilities and confined to a special education classroom throughout his public school education, but he and I both know his vaccine reaction could have been much worse. Today, Chris is an independent adult but many survivors of brain injury are not.
Barbara Loe Fisher and her son, Chris, in December 1981 after his fourth DPT shot.
The public conversation about several hundred cases of measles reported in the U.S. this year is focused on whether every parent has a social obligation to vaccinate every child to maintain "community immunity," but vaccine failures are rarely discussed. Emerging science reveals that there are differences in naturally and vaccine acquired immunity, and both vaccinated and unvaccinated children and adults transmit infections, sometimes with few or no symptoms.
Nearly 40 percent of cases reported in the 2015 U.S. measles outbreak occurred in recently vaccinated individuals who developed vaccine reactions that appeared indistinguishable from measles. Outbreaks of pertussis (whooping cough) in highly vaccinated child populations have been traced to waning immunity and evolution of the B. pertussis microbe to evade the vaccines. Influenza vaccine effectiveness was less than 50 percent in 11 of the past 15 flu seasons.
Vaccine policymakers recognize that children with severe combined immune deficiency or those undergoing chemotherapy or organ transplants are at increased risk for complications of infectious diseases and vaccines. However, there is no recognition of the risks to healthy infants and children with unidentified susceptibility to vaccine reactions, including children whose health suddenly deteriorates without explanation after vaccination. Medical care is being denied to children and adults in the U.S. if even one government recommended vaccination is declined, regardless of health or vaccine reaction history.
When parents question the risks and failures of a commercial pharmaceutical product being mandated for every child, the answer is not more force but better science and respect for the informed consent ethic.
The social contract we have with each other when we live in communities, whether we belong to the majority or a minority, is to care about and protect every individual living in the community. One-size-fits-all vaccine policies and laws, which fail to respect biodiversity and force everyone to be treated the same, place an unequal risk burden on a minority of unidentified individuals unable to survive vaccination without being harmed.
A law that requires certain minorities to bear a greater risk of injury or sacrifice their lives in service to the majority is not just or moral.
Between 1991 and 2013, the Institute of Medicine (IOM) published reports documenting that vaccines can cause brain inflammation and other serious reactions, injuries and death. A 2012 IOM report acknowledged that there are genetic, biological, and environmental risk factors that make some individuals more susceptible to adverse responses to vaccines but often doctors cannot identify who they are because of gaps in vaccine science. Congress acknowledged this fact a quarter century earlier in the 1986 National Childhood Vaccine Injury Act, which created a federal vaccine injury compensation program alternative to a lawsuit that has awarded more than $4 billion to vaccine-injured children and adults.
We give up the human right to autonomy and informed consent at our peril, no matter where or in what century we live.
Vaccine manufacturers and administrators have liability protection, yet today almost no health condition qualifies for a medical vaccine exemption under government guidelines. Now, there is a global call by consensus science advocates for elimination of all personal belief vaccine exemptions and censorship of books and public conversations that criticize vaccine safety or government vaccine policy. Some are calling for quarantine of all who refuse vaccinations and criminal prosecution, fines and imprisonment of parents with unvaccinated children, as well as punishment of doctors who depart from government policy.
There is no civil liberty more fundamentally a natural, inalienable right than exercising freedom of thought and conscience when deciding when and for what reason we are willing to risk our life or our child's life. That is why voluntary, informed consent to medical risk-taking has been defined as a human right governing the ethical practice of modern medicine.
In his first Presidential inaugural address, Thomas Jefferson warned:
"All, too, will bear in mind this sacred principle, that though the will of the majority is in all cases to prevail, that will to be rightful must be reasonable; that the minority posses their equal rights, which equal law must protect, and to violate would be oppression."
The seminal 1905 U.S. Supreme Court decision, Jacobson v. Massachusetts, affirmed the constitutional authority of states to enact mandatory smallpox vaccination laws. However, the justices made it clear that implementation of a vaccination law should not become "cruel and inhuman to the last degree." They warned, "All laws, this court has said, should receive a sensible construction. General terms should be so limited in their application as not to lead to injustice, oppression, or an absurd consequence. It will always, therefore, be presumed that the legislature intended exceptions to its language, which would avoid results of this character."
Mothers and fathers, who know and love their children better than anyone else, depend upon sound science and compassionate public health policies to help them protect their own and other children from harm. If individuals susceptible to vaccine injury cannot be reliably identified, the accuracy of vaccine benefit and risk calculations must be reexamined. Yet, consensus science and medicine around vaccination discourages research into the biological mechanisms of vaccine injury and death and identification of individual risk factors to better inform public health policy.
A critic of consensus science, physician and author Michael Crichton said, "Let's be clear: the work of science has nothing whatever to do with consensus. Consensus is the business of politics. Period."
Condoning elimination of civil liberties, including freedom of speech and the right to dissent guaranteed under the First Amendment of the U.S. Constitution, to enforce vaccination creates a slippery slope. Coercion, punishment and censorship will destroy, not instill, public trust in the integrity of medical practice and public health laws.
There are more than a dozen new vaccines being fast tracked to market by industry and governments. Who in society should be given the power to force all children to use every one of them without parental consent regardless of how small or great the risk?
We give up the human right to autonomy and informed consent at our peril, no matter where or in what century we live. Just and compassionate public health laws that protect parental and human rights will include flexible medical, religious and conscientious belief vaccine exemptions to affirm the informed consent ethic and prevent discrimination against vulnerable minorities.
[Editor's Note: Read the opposite viewpoint here.]
In late March, just as the COVID-19 pandemic was ramping up in the United States, David Fajgenbaum, a physician-scientist at the University of Pennsylvania, devised a 10-day challenge for his lab: they would sift through 1,000 recently published scientific papers documenting cases of the deadly virus from around the world, pluck out the names of any drugs used in an attempt to cure patients, and track the treatments and their outcomes in a database.
Before late 2019, no one had ever had to treat this exact disease before, which meant all treatments would be trial and error. Fajgenbaum, a pioneering researcher in the field of drug repurposing—which prioritizes finding novel uses for existing drugs, rather than arduously and expensively developing new ones for each new disease—knew that physicians around the world would be embarking on an experimental journey, the scale of which would be unprecedented. His intention was to briefly document the early days of this potentially illuminating free-for-all, as a sidebar to his primary field of research on a group of lymph node disorders called Castleman disease. But now, 11 months and 29,000 scientific papers later, he and his team of 22 are still going strong.
On a Personal Mission<p>In the science and medical world, Fajgenbaum lives a dual existence: he is both researcher and subject, physician and patient. In July 2010, when he was a healthy and physically fit 25-year-old finishing medical school, he began living through what would become a recurring, unprovoked, and overzealous immune response that repeatedly almost killed him.</p><p>His lymph nodes were inflamed; his liver, kidneys, and bone marrow were faltering; and he was dead tired all the time. At first his doctors mistook his mysterious illness for lymphoma, but his inflamed lymph nodes were merely a red herring. A month after his initial hospitalization, pathologists at Mayo Clinic finally diagnosed him with idiopathic multicentric Castleman disease—a particularly ruthless form of a class of lymph node disorders that doesn't just attack one part of the body, but many, and has no known cause. It's a rare diagnosis within an already rare set of disorders. Only about 1,500 Americans a year receive the same diagnosis. </p><p>Without many options for treatment, Fajgenbaum underwent recurring rounds of chemotherapy. Each time, the treatment would offer temporary respite from Castleman symptoms, but bring the full spate of chemotherapy side effects. And it wasn't a sustainable treatment for the long haul. Regularly dousing a person's cells in unmitigated toxicity was about as elegant a solution to Fajgenbaum's disease as bulldozing a house in response to a toaster fire. The fire might go out (though not necessarily), but the house would be destroyed.</p><p>A swirl of exasperation and doggedness finally propelled Fajgenbaum to take on a crucial question himself: Among all of the already FDA-approved drugs on the market, was there something out there, labeled for another use, that could beat back Castleman disease and that he could tolerate long-term? After months of research, he discovered the answer: sirolimus, a drug normally prescribed to patients receiving a kidney transplant, could be used to suppress his overactive immune system with few known side effects to boot.</p><p>Fajgenbaum became hellbent on devoting his practice and research to making similar breakthroughs for others. He founded the Castleman Disease Collaborative Network, to coordinate the research of others studying this bewildering disease, and directs a laboratory consumed with studying cytokine storms—out-of-control immune responses characterized by the body's release of cytokines, proteins that the immune system secretes and uses to communicate with and direct other cells. </p><p>In the spring of 2020, when cytokine storms emerged as a hallmark of the most severe and deadly cases of COVID-19, Fajgenbaum's ears perked up. Although SARS-CoV-2 itself was novel, Fajgenbaum already had almost a decade of experience battling the most severe biological forces it brought. Only this time, he thought, it might actually be easier to pinpoint a treatment—unlike Castleman disease, which has no known cause, at least here a virus was clearly the instigator. </p>
Thinking Beyond COVID<p>The week of March 13, when the World Health Organization declared COVID-19 a pandemic, Fajgenbaum found himself hoping that someone would make the same connection and apply the research to COVID. "Then like a minute later I was like, 'Why am I hoping that someone, somewhere, either follows our footsteps, or has a similar background to us? Maybe we just need to do it," he says. And the CORONA Project was born—first as a 10-day exercise, and later as the robust, interactive tool it now is. </p><p>All of the 400 treatments in the CORONA database are examples of repurposed drugs, or off-label uses: physicians are prescribing drugs to treat COVID that have been approved for a different disease. There are no bonafide COVID treatments, only inferences. The goal for people like Fajgenbaum and Stone is to identify potential treatments for further study and eventual official approval, so that physicians can treat the disease with a playbook in hand. When it works, drug repurposing opens up a way to move quickly: A range of treatments could be available to patients within just a few years of a totally new virus entering our reality compared with the 12 - 19 years new drug development takes.</p><p>"Companies for many decades have explored the use of their products for not just a single indication but often for many indications," says Stone. "'Supplemental approvals' are all essentially examples of drug repurposing, we just didn't call it that. The challenge, I think, is to explore those opportunities more comprehensively and systematically to really try to understand the full breadth of potential activity of any drug or molecule."</p>
The left column shows the path of a repurposed drug, and on the right is the path of a newly discovered and developed drug.
Cures Within Reach
A Confounding Virus<p>The FDA declined to comment on what drugs it was fast-tracking for trials, but Fajgenbaum says that based on the CORONA Project's data, which includes data from smaller trials that have already taken place, he feels there are three drugs that seem the most clearly and broadly promising for large-scale studies. Among them are <a href="https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30503-8/fulltext" target="_blank" rel="noopener noreferrer"><u>dexamethasone</u></a>, which is a steroid with anti-inflammatory effects, and <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-combination-treatment-covid-19" target="_blank" rel="noopener noreferrer"><u>baricitinib</u></a>, a rheumatoid arthritis drug, both of which have enabled the sickest COVID-19 patients to bounce back by suppressing their immune systems. The third most clearly promising drug is <a href="https://www.nih.gov/news-events/news-releases/full-dose-blood-thinners-decreased-need-life-support-improved-outcome-hospitalized-covid-19-patients" target="_blank" rel="noopener noreferrer"><u>heparin</u></a>, a blood thinner, which a recent trial showed to be most helpful when administered at a full dose, more so than at a small, preventative dose. (On the flipside, Fajgenbaum says "it's a little sad" that in the database you can see hydroxychloroquine is still the most-prescribed drug being tried as a COVID treatment around the world, despite over the summer being <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2021801" target="_blank" rel="noopener noreferrer"><u>debunked</u></a> widely as an effective treatment, and continuously since then.)</p><p>One of the confounding attributes of SARS-CoV-2 is its ability to cause such a huge spectrum of outcomes. It's unlikely a silver bullet treatment will emerge under that reality, so the database also helps surface drugs that seem most promising for a specific population. <a href="https://jamanetwork.com/journals/jama/fullarticle/2773108" target="_blank" rel="noopener noreferrer"><u>Fluvoxamine</u></a>, a selective serotonin reuptake inhibitor used to treat obsessive compulsive disorder, showed promise in the recovery of outpatients—those who were sick, but not severely enough to be hospitalized. <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2772185" target="_blank" rel="noopener noreferrer"><u>Tocilizumab</u></a>, which was actually developed for Castleman disease, the disease Fajgenbaum is managing, was initially written off as a COVID treatment because it failed to benefit large portions of hospitalized patients, but now seems to be effective if used on intensive care unit patients within 24 hours of admission—these are some of the sickest patients with the highest risk of dying. </p><p>Other than fluvoxamine, most of the drugs labeled as promising do skew toward targeting hospitalized patients, more than outpatients. One reason, Fajgenbaum says, is that "if you're in a hospital it's very easy to give you a drug and to track you, and there are very objective measurements as to whether you die, you progress to a ventilator, etc." Tracking outpatients is far more difficult, especially when folks have been routinely asked to stay home, quarantine, and free up hospital resources if they're experiencing only mild symptoms. </p><p>But the other reason for the skew is because COVID is very unlike most other diseases in terms of the human immune response the virus triggers. For example, if oncology treatments show some benefit to people with the highest risk of dying, then they usually work extremely well if administered in the earlier stages of a cancer diagnosis. Across many diseases, this dialing backward is a standard approach to identifying promising treatments. With COVID, all of that reasoning has proven moot. </p><p>As we've seen over the last year, COVID cases often start as asymptomatic, and remain that way for days, indicating the body is mounting an incredibly weak immune response initially. Then, between days five and 14, as if trying to make up for lost time, the immune system overcompensates by launching a major inflammatory response, which in the sickest patient can lead to the type of cytokine storms that helped Fajgenbaum realize his years of Castleman research might be useful during this public health crisis. Because of this phased response, you can't apply the same treatment logic to all cases.</p><p>"In COVID, drugs that work late tend to not work if given early, and drugs that work early tend to not work if given late," says Fajgenbaum. "Generally this … is not a commonplace thing for a virus." </p>
Thursday, March 11th, 2021 at 12:30pm - 1:45pm EST
On the one-year anniversary of the global declaration of the pandemic, this virtual event will convene leading scientific and medical experts to discuss the most pressing questions around the COVID-19 vaccines. Planned topics include the effect of the new circulating variants on the vaccines, what we know so far about transmission dynamics post-vaccination, how individuals can behave post-vaccination, the myths of "good" and "bad" vaccines as more alternatives come on board, and more. A public Q&A will follow the expert discussion.
SPEAKERS:<img lazy-loadable="true" data-runner-src="https://leaps.org/media-library/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNTY3Mzc4NS9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY0NjYwNjU4NX0.Tdrh5pze5P4XxgiJK3J4JFrsrijfabIzNJz-AATghDE/image.jpg?width=534&coordinates=365%2C3%2C299%2C559&height=462" id="87554" class="rm-shortcode" data-rm-shortcode-id="b6c7311be7aec25807f9af19b683bf1d" data-rm-shortcode-name="rebelmouse-image" data-width="534" data-height="462" />
Dr. Paul Offit speaking at Communicating Vaccine Science.commons.wikimedia.org<p><strong><a href="https://www.research.chop.edu/people/paul-a-offit" target="_blank" rel="noopener noreferrer">Dr. Paul Offit, M.D.</a>, is the director of the Vaccine Education Center and an attending physician in infectious diseases at the Children's Hospital of Philadelphia. He is a co-inventor of the rotavirus vaccine for infants, and he has lent his expertise to the advisory committees that review data on new vaccines for the CDC and FDA.</strong></p>
Dr. Monica Gandhi
UCSF Health<p><a href="https://profiles.ucsf.edu/monica.gandhi"></a><strong><a href="https://profiles.ucsf.edu/monica.gandhi" target="_blank">Dr. Monica Gandhi, M.D., MPH,</a> is Professor of Medicine and Associate Division Chief (Clinical Operations/ Education) of the Division of HIV, Infectious Diseases, and Global Medicine at UCSF/ San Francisco General Hospital.</strong></p>
Dr. Onyema Ogbuagu, MBBCh, FACP, FIDSA
Yale Medicine<p><strong><a href="https://medicine.yale.edu/profile/onyema_ogbuagu/" target="_blank" rel="noopener noreferrer">Dr. Onyema Ogbuagu, MBBCh</a>, is an infectious disease physician at Yale Medicine who treats COVID-19 patients and leads Yale's clinical studies around COVID-19. He ran Yale's trial of the Pfizer/BioNTech vaccine.</strong></p>
Dr. Eric Topol
Dr. Topol's Twitter<p><strong><a href="https://www.scripps.edu/faculty/topol/" target="_blank" rel="noopener noreferrer">Dr. Eric Topol, M.D.</a>, is a cardiologist, scientist, professor of molecular medicine, and the director and founder of Scripps Research Translational Institute. He has led clinical trials in over 40 countries with over 200,000 patients and pioneered the development of many routinely used medications.</strong></p>