First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others.
To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters to the Editor received in response to them. You can submit a Letter to the Editor here, or find the submission form at the end of any First Opinion essay.
The story
“Shared decision-making on vaccines is not the enemy,” by Peter M. Sandman
The response
Peter Sandman’s recent STAT First Opinion is deeply misleading in its framing of “shared clinical decision-making,” or SCDM, as synonymous with informed consent. Its false implication is that critics of policy changes somehow misunderstand patient autonomy.
SCDM is neither a medical-legal synonym for informed consent nor a safeguard for vaccine access. Suggesting otherwise is gaslighting: It suggests prior clinical practice lacked informed consent, which is untrue, while obscuring the real consequences: reduced vaccine uptake.
It is useful to distinguish among four different concepts.
First, in clinical practice, “informed consent” is a well-defined ethical and legal obligation: A clinician must disclose the material risks, benefits, and alternatives of a recommended intervention and obtain the patient’s voluntary agreement to proceed. The doctrine emerged from early 20th-century tort law grounded in bodily autonomy and it protects patient agency in every medical encounter — vaccination included — regardless of whether a recommendation carries an SCDM label.
Second are routine vaccine “recommendations”: evidence-based determinations that a person should receive a vaccine because experts have concluded the benefits clearly outweigh the risks, communicating that vaccination is the medically preferred course of action. Informed consent still applies — risks and benefits are discussed, questions answered, and patients may decline.
Third, recommendations are not “mandates.” Recommendations do not compel vaccination. States may independently require certain vaccines for school attendance or health care employment to protect population health. This is a distinct policy choice that balances individual liberty with collective risk. In 1905, as the concept of informed consent was taking shape, the Supreme Court upheld vaccine mandates in Jacobson v. Massachusetts, recognizing an acceptable coexistence.
Finally, SCDM is an unclear, amorphous and frequently misconstrued policy label. SCDM is not a legal standard for patient consent and it is not a clear recommendation.
I criticized SCDM long before it was misappropriated by anti-vaccine activists because it fails to convey clear and actionable guidance to providers and patients. The current administration has worsened this problem by taking evidence out of the equation and providing even less guidance to health care providers. Robert F. Kennedy Jr., his advisers, and compatriots in the anti-vaccine movement are not serious about protecting patient autonomy or access to care. They do not share an objective to reliably facilitate meaningful patient-provider conversations about vaccines or to preserve vaccine access. Rather, their goal is to raise public doubt and to guide Americans to dangerous and unsupported conclusions about vaccines.
— Richard Hughes IV, Epstein Becker Green/George Washington University Law School
The response
Peter Sandman is right about one important thing: Vaccine conversations can and should be better. I also agree that shared decision-making (SCDM) is not inherently wrong as a framework for discussing vaccines, nor is patient agency something clinicians should fear.
Where I diverge is in the assumption that presumptive recommendations undermine agency or ethical informed consent. In daily pediatric practice, shared decision-making is already happening, often more than is acknowledged. A presumptive recommendation does not remove choice. It establishes a starting point grounded in evidence and professional responsibility, then opens space for discussion.
What erodes trust is not presumption, but the failure to listen, to acknowledge fear and identity, and to recognize that vaccine hesitancy is rarely about data alone. Too often, the real breakdown occurs when the conversation becomes narrowly focused on “getting the vaccine given” rather than on building understanding and trust.
In practice, we routinely share the vaccine information statement, review benefits and risks, and answer questions. That process is informed consent. That process is shared decision-making. Families are not passive recipients of care in these encounters, even when clinicians begin with a strong recommendation.
Prevention adds a unique challenge. When children are healthy, the absence of harm is easily misinterpreted as absence of risk. The threat is abstract, the benefit invisible. These are emotionally charged conversations, shaped by identity, past experiences, and broader system frictions, not simply by evidence quality.
Much of the resistance to SCDM among clinicians stems from uncertainty about documentation, variability in who can engage in it across states, and fear of added administrative burden, not from disregard for patient agency. Labeling certain vaccines as SCDM risks reinforcing the false signal that evidence is weaker, even when clinical conversations have not meaningfully changed. If a clinician makes a presumptive recommendation, shares the VIS, listens carefully, and addresses concerns honestly, shared decision-making has already occurred.
The solution is not abandoning presumption, but restoring empathy, curiosity, and trust as the central goals of vaccine conversations.
— Diego Hijano, St. Jude Children’s Research Hospital
The story
“Did my prostate cancer screening do more harm than good?” by Howard Wolinsky
The response
As a recently retired family physician, I appreciated your article. I would just like to make two points regarding informed consent and liability. Throughout my entire career dating back to the 1980s, I never ordered a screening PSA without discussing the pros and cons. Specifically, while it might lead to needed early treatment, it might also lead to unnecessary further testing, biopsies, and treatment. Also, their first PSA can be the most difficult to interpret as they have no baseline PSA for comparison. Finally, the liability risk may be greater in the U.S., making more conservative approaches to this problem more difficult. Nobody with metastatic prostate cancer is going to appreciate their physician’s past attempts to minimize intervention.
— Thomas Peterson
The story
“What I got wrong 33 years ago as a new pediatrician talking to parents about vaccines,” by Richard Besser
The response
Dr. Besser nailed it, in my opinion. When parents interview a pediatrician in the prenatal period and issues about one’s practice are delineated, immunization schedules will likely be a point of discussion. Dr. Besser encourages listening to the parents’ point of view about vaccines and importantly where they obtain this information (e.g., the internet, current policies from HHS). Hearing that, the pediatrician can then provide information about the practice’s evidence-based approach to immunizing infants, children, and adolescents. If the parents are not in sync with those guidelines, the pediatrician can acknowledge this disparity and agree to work with the them over time to win their trust and ultimately fully immunize their child. If the parents decide to choose this practice to care for their baby, they recognize the practice’s guidelines regarding immunizations so they potentially could be amenable to changing their views.
If that doesn’t happen, it is possible this is not the best practice for this family regarding the well-being of the child and parting ways might be the best choice.
— Larrie Greenberg, George Washington University School of Medicine and Health Sciences/Children’s National Hospital
The story
“The 30-year itch: Hormone promotion is back with a vengeance,” by Patricia Bencivenga and Adriane Fugh-Berman
The response
While I agree with the overall sentiment in this op-ed, I am more than a little frustrated that the authors did not include very, very important caveats regarding the Women’s Health Initiative (WHI) trial they seem to be referencing throughout. Some of the biggest caveats in my opinion include:
The study evaluated only one form of estrogen (oral conjugated equine estrogen) and one progestin (medroxyprogesterone acetate). These forms are quite outdated by today’s standards.
Hormones were given orally. (This is not true across the board anymore.)
The average participant was 63 years old, which is about 10+ years past menopause. The authors also state “one third of the participants were in their 50s.” That’s still much older than most women when they start hormone therapy.
To extrapolate on side effects found in the WHI without giving important context weakens the argument for this op-ed, which is a shame, because I also believe that the benefits and the side effects are being manipulated by those wishing to make money in this arena. To make a truly qualified argument, we must be sure that we are not doing the same thing as those we are arguing against.
— Jessica DiGiacinto, MedShadow Foundation
The story
“The complicated truth about urinary tract infections in the elderly,” by Neil Gaffin
The response
You are damned if you do and damned if you don’t. These infectious disease doctors have been shouting this mantra for 40 years and yet there is no new solution. No doctor wants to contribute to antibiotic resistance. But if one of those aforementioned patients gets septic and dies (and some invariably do), and they did not get antibiotics for the possible UTI, the doctors are completely liable and did not follow essentially the standard of care. This plays out daily at every hospital. And the demented patient is almost by definition asymptomatic. It’s frustrating for everyone.
— David Wiebe
The story
“U.S. scientists must compete internationally, just like auto and steel workers do,” by Mikko Packalen
The response
While this essay is an interesting thought exercise, implementation would cause both short- and long-term damage to U.S. science. It is dangerous to advocate in favor of global competition for NIH grants when internal U.S. competition is already so fierce.
The National Cancer Institute (NCI) payline in 2025 for RO1 grants, the major funding mechanism for long-term individual projects, was 4%. In broad terms, this means that only four out of every 100 applications submitted were funded. This is not the only NIH institute which funds such a low percentage of the overall grants submitted.
Many young scientists are already moving into positions outside of academia, citing the inherent difficulties of life as an academic researcher, which includes the incredible difficulty in winning funding. Inviting international competition would increase the number of applications, further drive down success rates, and in turn disincentivize U.S. trained scientists from staying in research.
I agree that the U.S. does not have the best of every kind of research, and that the U.S. does not need to have the best of every form of research. Supporting this, NIH has traditionally (although recent policy moves are changing this) provided funding to international researchers as part of subawards to U.S. researchers. These direct collaborations spur U.S. science while also allowing research that is best done outside of the U.S. due to external expertise to happen outside of the U.S. Steel and auto companies are selling a product and are competing for buyers. Disruption and pain resultant from competition could lead to growth in order to weather the competition.
However, what I think we see more frequently in the current economic markets is cutting corners to undercut rivals and sell a cheaper, often worse, product. International science is not inherently better or worse than U.S. science, but inviting competition now, at a time where U.S. academic researchers relying on NIH funding are already stretched so thin, would be catastrophic.
— Brad Davidson
The story
“I’m a CVS pharmacist. My retail pharmacy colleagues and I face a crisis,” by Chris Eggeman
The response
I am one of the millions of frustrated CVS customers. Unfortunately our anger gets directed to the pharmacist and technicians. What can we individuals do? How can we help? Should we take our business elsewhere? Please give us some ideas how we can be part of the solution.
— Bruce McGarvey
