The Harm Coming First

by Ambassador Thomas Graham (Retired) and David Bernell

The Hippocratic Oath from ancient Greece, which embodies a code of ethics that all doctors in modern times swear to observe, is encapsulated by the phrase, “First do no harm.” This was also the title of an article we published a few months ago about Health and Human Services Secretary Robert F. Kennedy, Jr. and the harm he had begun inflicting on the American public health system.

Prior to becoming Secretary, Kennedy was best known for his incendiary, unsubstantiated anti-vaccine statements, claiming that vaccines are unsafe, cause autism, and worsen public health. His apparent ignorance of medicine and public health, and particularly the science that has improved health, seems beyond measure. He has said that “there is no vaccine that is safe and effective,” that “the polio vaccine killed many, many, many more people than polio did,” and that, “the COVID vaccine is the deadliest vaccine ever made.” His most outlandish claim – rejecting not merely vaccines, but science itself – is that diseases are not caused by germs (viruses, bacteria). He has said that this view is “simply untrue,” and has instead falsely claimed that the massive decline in infectious diseases over the past several decades is not due to vaccines, but to improvements in sanitation and nutrition. (No one would argue with the health benefits of good sanitation and nutrition, but trying to argue, or even imply, that these can stop the spread of infectious diseases or make people immune to them is senseless.) Still, in the unpredictable world of American politics under Donald Trump, Kennedy was rewarded for his views with a position in the cabinet, where he has begun to dismantle the nation’s very successful system for vaccinating people against infectious diseases.

The Secretary’s animus toward vaccines is now becoming official policy and practice in the United States government, which has great impact on the health and the health care system of the country. The federal government spends $1.9 trillion a year on health programs, research, and services. It regulates hospitals, the practice of medicine, insurance companies and the medical coverage plans they provide to people. And of course, as part of its engagement in every part of the U.S. health care system, it approves vaccines and makes recommendations on their usage (which population should get them, when, at what dose, etc.). With Kennedy at the helm of this system, the threats to public health are immense, particularly as he is able to turn the machinery of the United States government into implementing his ignorance and misrepresentations.

Kennedy’s strategy for achieving his aims begins from a general statement that is true: he correctly points out that the United States spends more on health than any country in the world, and yet it does not have the best health outcomes in the world. It is well-known that the U.S. has higher mortality for young babies and for women during childbirth, more gun violence, more opioid deaths, and more obesity, which leads to many other medical afflictions. These points have merit, though Kennedy also often falsely asserts that the United States is “the sickest country in the world,” which is not true at all. From his premise, Kennedy then engages what can be described as a massive “bait and switch.” He argues that the American health system needs changing, but instead of addressing the deficiencies that actually contribute to high costs and poor health outcomes (such as lack of equal access to reliable and affordable insurance, and lack of access to preventive care), Kennedy and the administration instead use these “as excuses to demolish what is best about America’s health and science infrastructure.” While one part of the administration (along with the Republican controlled Congress) reduces funding for science and research, and cuts healthcare by $1 trillion, Kennedy focuses largely on attacking vaccines, which represent some of the great success stories of the American health care system.

Defending the Indefensible

The latest burst of activity over the past few weeks culminated in President Trump at a press briefing riffing on the causes of autism, vaccines, and even Tylenol and pregnancy, in what was described as “arguably the most irresponsible public health press conference in history.” But the president’s comments were only the latest occurrence over a four week period filled with numerous assaults on American health care. In the middle of all this, Kennedy appeared at a hearing of the Senate Finance Committee to report on aspects of his tenure. The Senators wanted to hear Kennedy’s explanation of the chaos he is creating in the American health care system, particularly surrounding vaccines, and the many damaging actions for which he was responsible. Kennedy said in his opening statement that under his leadership, HHS was the busiest it has ever been. However, this was the problem, as Kennedy had been creating one calamity after another.

In May, he changed the CDC guidance on COVID vaccinations, without involvement by the usual committees and processes, saying the vaccine was no longer recommended for healthy children and pregnant women. And in August he canceled $500 million in funding for the development of mRNA vaccines. These were the types of new vaccines that had been instrumental in protecting people from COVID-19, and had been developed, tested, and given to millions of people in record time, to great effect in reducing the severe impacts of COVID. Kennedy has also presided over the largest outbreak of measles in the U.S., which spiked in March. Kennedy’s repeated comments sowing doubt about vaccine effectiveness, even before serving as Secretary of HHS, has been a driver in reduced vaccination rates in the country. In the midst of the outbreak, Kennedy suggested that measles was attributable to poor nutrition and exercise (as opposed to avoiding the vaccine), and recommended ineffective treatments like taking vitamin A and cod liver oil, while also suggesting that the risks of the measles vaccine (which is given alongside a mumps and rubella shot in a combined MMR vaccine) were underestimated.

Kennedy has also been busy firing people who do not fall in line with his views on vaccines. A key issue at the time of the hearing was his dismissal of Susan Monarez, the Director of the Center for Disease Control and Prevention (CDC), America’s distinguished institution for promoting the public health and known throughout the world. She had been appointed by Trump and had been in her position only one month, but the direction Kennedy wanted to go with vaccines was too much even for her. She refused to approve Kennedy’s proposed changes without appropriate scientific evidence and review, so he fired her. After her dismissal, Monarez said that she had been pressured to fire senior staff and to “preapprove the recommendations of the vaccine advisory panel newly filled with people who have publicly expressed antivaccine rhetoric.” Shortly after her firing, three other senior CDC leaders resigned from their positions, saying they could no longer serve in their positions due to the politicization of public health, along with the budget cuts and agency reorganization that were detrimental to protecting public health. One stated that the CDC had become a place where “undue influence and ideology would drive the science.” Since Kennedy arrived, the agency has lost more than a quarter of its staff due to firing, resignations, and reductions in the workforce, which are occurring amidst what has been described as an open revolt against Kennedy and administration policy.

Also at issue has been Kennedy’s abrupt dismissal in June of all the members of the CDC Advisory Committee on Immunization Practices (ACIP), some 17 in all, and replacement of them with own handpicked team of largely anti-vaccine ideologues. ACIP provides guidance and recommendations on the use, target populations, and scheduling of vaccinations. This guidance has long determined who gets what vaccines, and whether or not health insurance will pay for them. Kennedy had actually promised to Senator Bill Cassidy (a Republican and a physician) during his confirmation hearings in February that he would not change ACIP or try to work around it. But after breaking his promise, Kennedy touted his changes to ACIP when he met with the Senate Finance Committee, saying that his “changes were absolutely necessary” because the CDC had not been the world’s gold standard public health agency it was supposed to be, but had instead “failed miserably.”

The Senate committee was not convinced, as both Democrats and Republicans grilled Kennedy and strongly criticized him and the harm and chaos he is causing in the American healthcare system. (The GOP critics on the committee were far more guarded in their negative comments than the Democrats, reflecting yet another example of the fear exhibited by Republican policymakers in contradicting or questioning President Trump and his team).

Going Backward with Vaccines

In mid-September, Kennedy’s newly-picked ACIP panel met and began to take the actions its critics expected. Some members, including the chair of the panel, protested during the meeting that “we are not, as a committee, anti-vaxxers,” and that they did not have “pre-determined opinions,” but it is also the case that both the public and the experts who know the committee’s business knew why these members were selected. It was for the holding views that were in sync with the man who appointed them.

The ACIP panel in their meeting changed and weakened recommendations for COVID vaccines, saying that people should get them in consultation with their doctor. The panel did consider requiring a prescription for the vaccine, but chose not to recommend this. While this change may seem benign, it amounts to placing another potential barrier in the way of vaccinations by couching this in the language of informed consent. HHS had to later clarify that doctors, nurses, and pharmacists all count as providers due to the confusion caused by the recommendation. In addition, this decision will end up deferring some decisions to states, which have differing rules, including the possibility of requiring prescriptions, so the new guidance may result in doctors getting large numbers of requests for in-person or virtual consultations and prescriptions. The committee also voted that the combined vaccine for measles, mumps, rubella and chickenpox no longer be recommended, nor will it be paid for by government insurance programs. They instead recommended that the chickenpox vaccine be administered separately – one for MMR, and the other for chickenpox – which is how most children get these vaccines. The committee brought up the topic of changing recommendations for the hepatitis-B vaccine, but decided to postpone the matter.

The meeting didn’t result in a sweeping set of changes feared by their biggest critics, but the meeting did not inspire confidence. The two-day meeting was described as “chaotic,” and filled with cherry picked data and anecdotes by panel members that were decidedly anti-vaccine, and confusion among members about the subjects they were considering and the role of their panel. The committee chair, trying to excuse what was clearly a meeting of people who didn’t know what they were doing, said that the reasons for the chaos was that the panelists were “rookies.”

Perhaps more important than the decisions taken was what they suggest as the new playbook moving forward. One observer, Leana Wen, a doctor and former health commissioner of Baltimore, noted several concerning developments. One is that the process for reviewing vaccines is now being deliberately subverted by the ACIP. The process of transparent scientific review that had been standard in the past was largely discarded. In fact, ACIP limited the scope of what vaccine experts at CDC could present, while “individuals with fringe views were given a platform to promote conspiracy theories.” Another is that what counts as evidence is selected by certain members to “fit a predetermined narrative,” such that “randomized controlled trials showing no link between vaccines and alleged harms were brushed aside, while anything that reinforced the opposite view was amplified.” Prior to the meeting, Wen had written that she expected childhood vaccines to be “on the chopping block”, and it may be that the decisions and conversations ACIP held on MMR and hepatitis-B are only a start. What we are seeing now, she argues, “is merely the opening salvo of Health and Human Services Secretary Robert F. Kennedy Jr.’s calculated strategy to unravel the nation’s vaccine infrastructure.” The question, Wen says, “isn’t whether vaccines will be removed from the childhood immunization schedule, but which ones, how quickly and how many people will pay the price.”

Preserving the Gains We’ve Made

One response to the changes being wrought is that some states and professional organizations have taken matters into their own hands, and are now offering their own guidance and taking action to provide a more reliable and trustworthy alternative to the federal government. California, Washington, Oregon and Hawaii have formed the West Coast Health Alliance, which will base its vaccine recommendations on well-established national medical organizations such as the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Obstetricians and Gynecologists. For decades doctors have turned to the CDC for evidence-based recommendations. If the CDC is seen as no longer providing evidence-based advice, but instead ideology-based advice, state health organizations are increasingly likely to step in and fill the gap. With the support of national health organizations, states may be less intimidated by political pressure or even possible threats of legal action from Kennedy and HHS. There is a risk that some states may cease support for their citizens in helping to provide for the vaccines that they need, as the Florida state government has already done. But it can also be argued that “a fractured system is better than watching Kennedy systematically tear apart the current one.”

In addition, professional associations are taking action. In one instance, the American Public Health Association and several other medical societies have filed suit against Kennedy for “acting arbitrarily and capriciously when he unilaterally changed Covid-19 vaccine recommendations for children and pregnant people,” which they charged have been in violation of federal procedural rules. The suit also says that “a coordinated set of actions by HHS and Secretary Kennedy were designed to mislead, confuse, and gradually desensitize the public to anti-vaccine and anti-science rhetoric.”

Actions being taken by independent authorities will be necessary to maintain the benefits long provided by vaccines, which are considerable, lest people forget. Aaron Carroll, the president and CEO of Academy Health (a non-partisan group that advances evidence-based health policy), has noted that Secretary Kennedy often suggests that children were healthier in the 1950s and 60’s, but this is erroneous. He notes that, “A child with acute lymphoblastic leukemia had almost no chance of survival in 1960; today the vast majority can expect to be cured. We no longer need to worry about smallpox and polio. Infections caused by Hib (Haemophilus influenzae type b) once hospitalized tens of thousands of children each year, killing or disabling many. I’ve never seen a case as a pediatrician because vaccines have effectively eliminated such infections.” Overall, he says, because of vaccines, “death rates for American children between the ages of 1 and 15 fell more than 75 percent from 1950 to 2018.” Now, he notes, chronic diseases are more common in children. That is because the biggest killers used to be infectious diseases prevented by vaccinations, which have almost entirely been eliminated for millions of children.

The progress made on vaccines over the decades has occurred alongside other advances in health research. As Carroll argues, “Advances in healthcare over the last few decades are staggering. People with HIV now live long lives. Many cancers that were death sentences in the 1970s are now curable. Hepatitis C, once incurable, can now be eradicated with a 12 week course of pills.” Moreover, it is the National Institutes of Health, which is by far the largest funder of biomedical research in the world, that has led the effort in the development of these new medicines. It is no accident that the United States leads the world in scientific discovery and Nobel laureates for medicine. It is a direct result of the federal funding in science and health research, which is being significantly cut by Kennedy and the Trump administration.

The United States most certainly needs to improve how it pays for and delivers health care, but the Trump administration is looking to cut some of the very institutions and programs that will continue to maintain and improve the health care system. Moreover, the administration’s push to cut Medicaid and allow Affordable Care Act subsidies to expire could leave millions without access to care.

There are two courses of action: further develop what works well on a national basis, which is the job of institutions like the CDC and the FDA and others, with an insurance arrangement to make sure all have access to good healthcare. The other is the path of placing people who are not well qualified in positions of leadership, and advancing ideology over good science, which will weaken the nation’s health system and take healthcare in the wrong direction. The ongoing attack against vaccines that have proven effective for decades is but one part of the risky path that RFK Jr. is pursuing.

What is at stake might be best described by a quote from the book So Very Small: How Humans Discovered the Microcosmos, Defeated Germs—and May Still Lose the War Against Infectious Disease. In referring to vaccines and medical advances, the author Thomas Levenson asks “What have we won?” He answers his own question by saying that, “From the 1930s forward, a growing tally of viral pathogens were…tamed. Yellow fever, the terrifying ‘yellow jack’ of colonialist nightmares, got its jab in 1937. The vaccine for pertussis (whooping cough) followed in 1939. More shots brought more diseases under control with each succeeding decade—perhaps most famously polio in the 1950s; and then measles, mumps and rubella at the end of the 1960s. Anyone who reads these pages lives in a unique moment in history, one that began in the last half of the twentieth century, which is to say living memory. These last seventy or eighty years form the only time in history in which humans—at least those in reach of adequate healthcare systems—have not had to fear either the most prolific childhood killers or the worst pandemic assassins.”

This is what Robert F. Kennedy Jr. and the Trump administration want us to give up.