Understanding New Risks for Clinicians Under Utah’s Health Law

Posted on February 20, 2025 by gutsandgrowth

K Underhill, KM Nelson. NEJM 2025; 392: 523-525. Legal Threats to Clinicians and Patients

An excerpt:

In January 2023, Utah added a section to its Health Care Malpractice Act (see box). The change was part of Senate Bill 16, a larger package of laws targeting gender-affirming care. The new Malpractice Act language specifies that for “hormonal transgender treatment” and surgery on “sex characteristics,” patients treated when they are minors have the option to disaffirm — revoke — their consent before 25 years of age...

Although patients consent at the time of treatment, Utah’s new law enables them to withdraw their informed consent retroactively, even years later, and pursue legal claims based on being treated without consent...

Utah’s new law places a tremendous burden on clinicians…

It is unrealistic and unreasonable to expect clinicians to predict which patients may later reverse their consent to treatment. Clinicians who undertake these predictions will make mistakes in both directions — either failing to predict regrets (which are rare²) or, more likely, erroneously denying medically necessary care to minors who would benefit from it…

Allowing minors to recant their consent undermines the efforts that many states have made to strengthen minors’ independent access to care for sexual health, mental health, and substance use. Laws that have a chilling effect on medical services can also interfere with the pipeline of clinicians who have the training and experience to deliver care, reducing access for all patients…

Utah’s law is more worrisome, however, as a potential harbinger of things to come…As legislators develop and test state laws interfering with gender-affirming care, the same strategies become available for other politically contested forms of health care.

My take: Allowing individuals to recant consent for treatment years later will undermine access to all types of health care.

Related article: DG Aaron, C Konnoth. NEJM 2025; 392: 526-528. This article explains the flawed “Cass Review” which was a a 388-page report commissioned by England’s National Health Service (NHS) concluded that “there is not a reliable evidence base upon which to make clinical decisions” regarding gender-affirming care (GAC).

“Our concern here is that the Review transgresses medical law, policy, and practice, which puts it at odds with all mainstream U.S. expert guidelines. The report deviates from pharmaceutical regulatory standards in the United Kingdom. And if it had been published in the United States, where it has been invoked frequently, it would have violated federal law because the authors failed to adhere to legal requirements protecting the integrity of the scientific process..³ The Review calls for evidentiary standards for GAC that are not applied elsewhere in pediatric medicine.“

Critique of the 21st Century Cures Act

Posted on July 5, 2015 by gutsandgrowth

The most compelling article (Avorn J, Kesselheim AS. NEJM 2015; 372: 2473-5) in a recent edition of the NEJM delved into the 21st Century Cures Act which was recently introduced in the U.S. House of Representatives; it was approved 51 to 0 in committee but continues to be debated.

One of the underlying premises of the bill is accelerate approval for new products. Key features:

Increase in National Institutes of Health (NIH) of about 3% per year for 3 years. And, additional $2 billion per year for 5 years to create an “NIH Innovation Fund”
Instructs FDA to consider nontraditional study designs for clinical trials. This is aimed at shorter, smaller and less expensive studies. This could allow FDA to rely on “observational studies” and “clinical experience.”
The bill encourages the FDA to rely more on surrogate end points
The bill would allow informed consent to be bypassed if the “proposed testing poses no more than minimal risk.”

Critiques for each point, point by point:

1. The funding increases largely counterbalance stagnating funds at the NIH secondary to sequestration and budget cuts.

2. The premise that the FDA is inefficient is not accurate.

“A third of new drugs are currently approved on the basis of a single pivotal trial” with a median of 760 patients.
Most drugs are approved based on studies with a duration of 6 months or less, even medications taken for a lifetime.
Evaluation of nearly all new drug applications is completed within 6 to 10 months.

3. Surrogate markers often overestimate the potential benefit of medications. The FDA “already uses surrogate end points in about half of new drug approvals.” Specific examples:

Bevacizumab has been shown to delay tumor progression in breast cancer “but was shown not to benefit patients.
Rosiglitazone “lowered glycated hemoglobin levels in patients with diabetes even as it increased their risk of myocardial infarction.”
One new tuberculosis drug improved bacterial counts in the sputum but “the treatment group had a death rate four times that in the comparison group.”

4. Informed consent has been “sacrosanct, with exceptions made only when consent is impossible or contrary to a patient’s best interests.” With this new proposal, “it is not clear who gets to determine whether a given trial of a new drug poses “minimal risk.”

Bottomline (from authors): The 21st Century Cures Act’s call for increased NIH funding may prove to be its most useful component. But political forces…could lead to the approval of drugs and devices that are less safe or effective than existing criteria would permit.”

Audio interview with Jerry Avorn: nej.md/1TPy6Ta

Some pictures from yesterday’s Peachtree Road Race:

Coveted T-shirt -2015 Edition

Rainy Day for a 10K

Largest 10K in the World

Complex Medicine and Informed Consent

Posted on April 17, 2015 by gutsandgrowth

A recent review (Grady, C. NEJM 2015; 372: 855-62) stresses some of the emerging challenges of informed consent, particularly in the research setting.

Key points:

“Research participants have deficits in their understanding of study information, particularly of research methods such as randomization.”
“Reasonable people disagree about the adequacy of the information presented on the consent forms.”

Trends Which Challenge Current Informed Consent Process:

Learning Health Systems. “Should informed consent for these activities be more similar to research informed consent or clinical informed consent?” “Is it ethically acceptable for a patient or research participant to provide consent for an unspecified or broad range of activities?”
Adoption of Complex Technologies, like genetic sequencing. “How should information be presented [with]..complex information, substantial uncertainty…incidental findings, and implications for blood relatives?”
Consent for Future Use of Clinical Data or Biologic Specimens. “How specific does the information provided in the consent process need to be regarding future uses of data or specimens?”
Demographic Changes/Diminished Capacity in Elderly. “Older age, diminished mental capacity, and dementia per se do not indicate that a person is incapable of consenting…there is a need for respectful and efficient tools and processes for assessing capacity.”

Bottomline: In order to treat patients in a respectful manner, continued efforts at addressing these questions are needed to promote informed choices of patients while advancing medical science and clinical care.