Tuesday, October 19, 2021

On the primacy of the physician-patient relationship, from an unlikely source - the Attorney General of Nebraska

I have not written much at this site, or any site, in recent years due to being kept busy supporting litigation regarding bad healthcare information technology as an expert witness.

A recent letter, however, so caught my eye regarding both current events and my past writing about bad health IT, that I decided to write about it.

It is perhaps a poignant reminder of the craziness of the times in which we physicians find ourselves that a well researched letter on the primacy of the doctor-patient relationship, and the non-interference with that relationship by outside forces based on opinions of non-clinicians, half-baked ideas, overzealous government, media hysteria to garner audience share, etc. comes not from the hallowed halls of academia or a prestigious medical journal - but from a state Attorney General, namely, of Nebraska.

The letter, dated Oct. 14, 2021 and entitled "Prescription of Ivermectin or Hydroxychloroquine as Off-Label Medicines for the Prevention or Treatment of Covid-19", is located at this link: https://ago.nebraska.gov/sites/ago.nebraska.gov/files/docs/opinions/21-017_0.pdf

It was requested by Dannette R. Smith, the Chief Executive Officer of the Nebraska Department of Health and Human Services.

I recommend reading it in its entirety.

In this 48-page letter, arguments regarding sanctioning of Nebraska physicians for their decisions on how to treat their patients with FDA-approved drugs for off-label purposes are discussed in significant detail and with significant literature references.  The letter reaches the conclusion that:

...  Based on the available data, we do not find clear and convincing evidence that a physician who first obtains informed consent and then utilizes ivermectin or hydroxychloroquine for COVID-19 violates the UCA (Nebraska Uniform Credentialing Act). This conclusion is subject to the limits noted throughout this opinion. Foremost among them are that if physicians who prescribe ivermectin or hydroxychloroquine neglect to obtain informed consent, deceive their patients, prescribe excessively high doses, fail to check for contraindications, or engage in other misconduct, they might be subject to discipline, no less than they would be in any other context ... Allowing physicians to consider these early treatments will free them to evaluate additional tools that could save lives, keep patients out of the hospital, and provide relief for our already strained healthcare system.

No matter one's opinion on the specifics of this particular controversy, the primacy of the physician-patient relationship - absent extreme circumstances of malfeasance/malpractice - is a principle that should not now, and should never need a 48 page letter for its justification

I find the following passage on pg. 36 particularly intriguing relative to my many essays in the past on observations by many parties that healthcare information technology (e.g., EMRs) are unhelpful and even harmful to provision of medical care, and the response from the Medical Informatics "establishment" and HIT industry that those observations are "anecdotal" and meaningless (e.g., see my 2010-2011 posts "Health IT: On Anecdotalism and Totalitarianism" at https://hcrenewal.blogspot.com/2010/09/health-it-on-anecdotalism-and.html and its linked posts, also "The Dangers of Critical Thinking in A Politicized, Irrational Culture" at https://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html and "Australian ED EHR Study: An End to the Line 'Your Evidence Is Anecdotal, Thus Worthless?'" at https://hcrenewal.blogspot.com/2011/03/australian-ed-ehr-study-putting-lie-to.html).

... To be sure, these data derive from large-scale observational studies rather than RCTs, and we understand that RCTs are considered the gold standard in medicine. But for at least two reasons, we find these observational studies sufficient for our purposes.  

First, our role is not to set a standard for the practice of medicine. Rather, we must simply confirm whether reasonable medical evidence supports the use of hydroxychloroquine as an early COVID-19 treatment, and we determine that a collection of large-scale observational studies suffices for that purpose. Second, a seminal review of the scientific literature has revealed that “on average, there is little evidence for significant effect estimate differences between observational studies and RCTs, regardless of specific observational study design, heterogeneity, or inclusion of studies of pharmacological interventions.” 235 There is thus no basis to cast aside the observational studies demonstrating hydroxychloroquine’s efficacy as an early COVID-19 treatment.  

235 Andrew Anglemyer et al., Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials, Cochrane Database of Systematic Reviews, at 1 (2014), available at https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.MR000034.pub2/epdf/full (last visited Oct. 14, 2021)

I find the second observation in that paragraph about outcomes of observational studies vs. RCTs truly fascinating.

The arguments by the HIT hyper-enthusiasts that observational data from a wide variety of qualified personnel is "anecdotal" and thus invalid (e.g., from physicians such as at my Jan. 2010 post "An Honest Physician Survey on EHR's" at https://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html as just a small example of the observational data accumulated over many years) and demands that only RCT's (which are, in fact, nearly impossible to conduct) could validate efficacy and safety risks of EHRs fail under the above.

Observational data by qualified observers needs be taken more seriously in all of biomedicine, and not dismissed with the refrain that "it's not a RCT."

If that had happened in the domain of HIT, perhaps I would not now be spending so much time assisting litigation regarding HIT evidentiary obfuscation, HIT-related patient harms, and other litigation issues.

-- SS