CDC distorts shared decision-making for kids' vaccines

"Sowing confusion and fear...misleading...erroneous...not based on evidence."

The concept of shared decision-making in health care was described at least as far back as the 1980s. It is a process in which both the physician and patient discuss the tradeoffs between potential benefits and harms involved in a decisionwhen there is no clear choice of which among several options is best. The participants explore the patient’s values and preferences in agreeing on a treatment or testing decision.

Now new confusion and controversy is attached to the term after the Centers for Disease Control and Prevention recommended the approach be used between physicians and parents in childhood vaccination decisions.

In announcing the new childhood immunization schedule and recommending this process, the CDC introduces another cloud of doubt into vaccine decision-making that did not exist before. What does this mean to parents who have not heard this process used in vaccination decision-making in the past?

The Annenberg Public Policy Center at the University of Pennsylvania found that many don’t know what the term means - on paper, much less in practice.

In a pair of nationally representative panel surveys of U.S. adults conducted in August and December, the Annenberg Public Policy Center (APPC) asked Americans about their understanding of this new policy from federal health authorities. … The surveys find significant gaps in Americans’ understanding of shared decision-making when it comes to getting vaccinated and having their babies and children vaccinated against potentially deadly illnesses.

“Expecting parents to engage in shared decision-making with health care providers about routine, thoroughly studied childhood vaccinations suggests that the public health community has doubts about the safety and efficacy of these vaccines when it does not,” said Patrick E. Jamieson, director of APPC’s Annenberg Health and Risk Communication Institute. “These vaccines have been part of the recommended childhood schedule because the benefits of taking them substantially outweigh the risks.”

STAT News quoted Daniel Jernigan, MD, an infectious disease specialist and former CDC official:

“This is just one more example of the decisions coming out of HHS that are sowing confusion and making it harder for people to know what to do.”

STAT also reported that Jernigan said that:

… pediatricians will be hard pressed to meet the demand for extra visits the shared decision-making policy will require. “By making these vaccines a shared clinical decision-making, it introduces one more barrier that prevents a child from getting a lifesaving vaccine,” he said.

Imagine the reaction from pediatricians all over America who are now told they need to add even more time to each visit to have a discussion about vaccinate-or-not with multiple vaccines - when the evidence tells them there is no doubt about what the best approach is.

Dr. Sean O’Leary, a pediatric infectious disease specialist at the University of Colorado, gave his reaction on the PBS NewsHour:

I really don’t understand this move. It’s really based not on any kind of science or evidence, but simply a political ideology. …What this is doing is really just creating a lot of confusion, creating different tiers for vaccine recommendations that are going to be confusing not only for parents but for clinicians. …It’s really a disturbing irony that they are making these claims that they’re doing this to restore trust when these are exactly the same people who have been working for decades to sow fear and sow distrust in vaccines.

This article on TheConversation.com, by a George Washington University health policy researcher, offers a perspective on how this would play out in the real world of pediatric clinical practice. Excerpt:

Shared decision-making sounds straightforward: a patient and their doctor putting their heads together to make an informed choice. But when applied to routine childhood vaccines, the concept shifts the burden of deliberation onto already-stretched clinicians and parents. …

According to the American Academy of Pediatrics, more than half of pediatricians report spending from 10 to 19 minutes counseling parents about vaccines, and nearly 1 in 10 spend more than 20 minutes – often several times per day.

Shared decision-making takes even longer. When vaccines …require shared decision-making, that work lands on the doctor and parent in an already-packed appointment. The doctor must walk through the disease and the vaccine’s benefits and risks, ask what concerns the parent has, make sure they understand, and then document the whole conversation.

That’s one more barrier to vaccination, and one that won’t fall evenly. Getting medical care can take more time for families with fewer resources. When a policy change adds steps, those families feel it most.

The data might end up showing that some parents “chose” not to vaccinate. But for many families, it won’t really be a choice – it will be a reflection of who had time to come back, and who didn’t.

Dr. Kenny Lin, a professor of clinical family medicine at Georgetown and deputy editor of the American Family Physician, wrote on his Common Sense Family Doctor site that the CDC move fits into a troubling “do-it-yourself medicine” picture.

RFK Jr.’s DIY approach to childhood vaccinations (which HHS misleadingly and unethically calls “shared clinical decision making”) is likely to increase the incidence of certain cancers.

Parents who follow the new, expertise-free HHS guidance and disregard their pediatrician or family physician’s advice to give their children hepatitis B vaccine at birth, or at all, will expose them to the risk of acquiring chronic viral hepatitis, which will put them on a path to developing liver cancer. (Hepatitis B is treatable with antivirals, but not curable.) And dropping the second dose of the human papillomavirus (HPV) vaccine based on promising but incomplete evidence from other countries who have done so mainly for cost reasons could put more people at risk for not only cervical, but oropharyngeal and anorectal cancers caused by HPV.

You should click on that first link in his quote about the ethics involved in the CDC’s distortion of shared decision-making. It takes you to this paper in JAMA Pediatrics. Excerpts follow:

What has yet to receive much scrutiny is HHS’s use of medical ethics, through terms like informed consent and the doctor-patient relationship, to defend this policy change. This appeal to medical ethics is likely intended to lend credibility to their decision. On further scrutiny, however, this tactic is not only misleading and erroneous—the vaccine decision, ie, has always required informed consent—but also risks undermining the foundational role of medical ethics in the pediatric vaccine encounter.

The Associated Press quoted a California pediatrician who “likened the latest federal move to pouring gasoline on a fire of mistrust that was already burning.”

“We’re worried the fire’s out of control,” he said. “Already we’ve seen that with measles and pertussis, there are increased hospitalizations and even increasing deaths. So the way that I look at it — and my colleagues look at it — we’re basically regressing decades.”

In short, just when you think that you’ve seen the worst in the communication of, the impact of, and the reasoning for new policy decisions by current federal health agencies, there’s always a new surprise awaiting.

This one feels especially shameful. The CDC is wrapping itself in supposed medical ethics but it feels more like forcing pediatricians to act as if there are two reasonable options to discuss with parents when in fact the evidence doesn’t support that. And then telling those pediatricians, “You figure it out, and find time to squeeze it into your day.”

A footnote to all of this. Throughout the 1990s I worked alongside shared decision-making pioneers on the Dartmouth Medical School campus producing shared decision-making programs on a variety of topics. Although it was not traditional journalism, it felt like the most important patient-centered work of my career. The Informed Medical Decisions Foundation named me one of 25 champions of shared decision-making in 2014. It is upsetting to see the concept politically pirated and perverted in the manner outlined above.

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