Goat Glands versus Polio Vaccine: Finding the sweet spot in occupational regulation
Robert Graboyes
Senior Research Affiliate
Downloadable PDF of Article for Offline Reading
How do you craft occupational regulations that allow Jonas Salk to test his polio vaccine but prohibit John Romulus Brinkley from implanting goat testicles into gullible members of his radio audience? This, in brief, is the fundamental question that one faces in crafting occupational regulations for medical professionals.
Occupational regulations are supposed to protect the public from unscrupulous or incompetent practitioners, but almost any regulations devised will exhibit one or both of the following: (1) allowing some harmful practices to proceed apace, and (2) prohibiting some beneficial practices. The only way to eradicate the first failing is to prohibit everything. The only way to eradicate the second failing is to prohibit nothing. Therefore, crafting regulations requires policymakers to consider the tradeoffs between these two failings and to plant their flag at some sweet spot that is, at least in part, subjectively determined.
For example, requiring practitioners to meet standardized education requirements in board- or state-approved schools ensures with a high degree of certainty that all practitioners will share a certain set of mandated competencies. But such standardization discourages risk-taking and heterodox thinking. This can limit the types of care available and stanch the development of technological innovations.
In science, the equivalent tradeoff problem is known as the “Type I/Type II error” problem. In hypothesis testing, a Type I error is a false positive, and a Type II error is a false negative. A webpage at the National Institutes of Health (NIH) portrays hypothesis testing as analogous to a judge’s decision in a criminal trial.[1]
Judges and Scientists, Verdicts and Proofs
In American jurisprudence, convicting an innocent person is considered a far worse travesty than acquitting a guilty person. Hence, the default assumption is that the defendant is “innocent until proven guilty” and should not be found guilty unless the evidence suggests guilt “beyond a reasonable doubt.” In the hypothesis testing example shown in the table, the researcher is asking whether the vaccine (antiviral drug) Tamiflu is guilty of provoking psychotic manifestations. The default assumption (“null hypothesis”) is that the Tamiflu vaccine should be considered innocent until proven guilty, beyond a reasonable doubt. In the case of drug testing, “beyond a reasonable doubt” means that there is a very low probability (say, 5 percent or 1 percent) that the data would suggest an association between Tamiflu and psychosis if no such association exists in reality. The fact that “Tamiflu is innocent” is the null hypothesis might suggest that the researchers think that wrongly tarnishing the drug’s reputation poses a greater danger than missing an actual Tamiflu/psychosis association.
| Table 1: The analogy between judge’s decisions and statistical tests | |
| Judge’s decision | Statistical test |
| Innocence: The defendant did not commit crime | Null hypothesis: No association between Tamiflu and psychotic manifestations |
| Guilt: The defendant did commit the crime | Alternative hypothesis: There is association between Tamiflu and psychosis |
| Standard for rejecting innocence: Beyond a reasonable doubt | Standard for rejecting null hypothesis: Level of statistical significance (%) |
| Correct judgment: Convict a criminal | Correct inference: Conclude that there is an association when one does exist in the population |
| Correct judgment: Acquit an innocent person | Correct inference: Conclude that there is no association between Tamiflu and psychosis when one does not exist |
| Incorrect judgment: Convict an innocent person. | Incorrect inference (Type I error): Conclude that there is an association when there actually is none |
| Incorrect judgment: Acquit a criminal | Incorrect inference (Type II error): Conclude that there is no association when there actually is one |
We can borrow the NIH’s schema and view occupational licensure as equivalent to a judge’s decision in a criminal trial. More narrowly, we could apply this reasoning to scope of practice, which is, in effect, a license to perform a specific task. In Tables 2 and 3, we’ll explore how these fit the Type I/Type II schema.
How one formulates the null hypothesis is in part subjective, reflecting complex philosophical angles. American jurisprudence favors “innocent until proven guilty,” whereas some countries effectively mandate “guilty until proven innocent.” The NIH table implies that incorrectly associating Tamiflu with psychosis is worse than correctly failing to correctly associate Tamiflu with psychosis. One could also formulate an hypothesis in the opposite manner.
Judges and Licensers, Verdicts and Licenses
We can apply the same equivalence to judges and those charged with granting and denying healthcare licenses. Table 2 implies that barring a scrupulous, competent practitioner from practicing healthcare is worse than allowing an unscrupulous incompetent to slip through at times. Table 3, on the other hand, assumes that allowing an unworthy practitioner to treat patients is worse than barring a worthy practitioner. It’s sort of a glass-half-full/glass-half-empty choice.
In Table 2, perhaps the licensure hurdles are set high enough to allow 10 unworthy practitioners to slip through in order to allow 1 worthy practitioner to operate. Or, maybe we’re more risk-averse and tighten the regulations to make the ratio 5-to-1. Doing so will likely mean fewer unworthy practitioners, but also fewer worthy ones.
| Table 2: Competent Until Proven Incompetent | |
| Judge’s decision | Professional licensure procedure |
| Innocence: The defendant did not commit crime | Licensure granted: This health practitioner is scrupulous and competent and should be allowed to practice. |
| Guilt: The defendant did commit the crime | Licensure rejected: This health practitioner is unscrupulous and/or incompetent and should not be allowed to practice. |
| Standard for rejecting innocence: Beyond a reasonable doubt | Standard for rejecting licensure: Failure to meet an exhaustive set of predetermined criteria. |
| Correct judgment: Convict a criminal | Correct inference: Deny the license when the practitioner is unscrupulous or incompetent. |
| Correct judgment: Acquit an innocent person | Correct inference: Grant the license when the practitioner is scrupulous and competent. |
| Incorrect judgment: Convict an innocent person. | Incorrect inference (Type I error): Deny the license when the practitioner is scrupulous and competent. |
| Incorrect judgment: Acquit a criminal | Incorrect inference (Type II error): Grant the license when the practitioner is unscrupulous and incompetent. |
Table 3 implies the opposite mode of thinking. Perhaps we’re willing to bar 10 worthy practitioners from treating patients if doing so prohibits a single unworthy one from doing so. Or, perhaps we loosen the regulations to make the ratio 5-to-1.
| Table 3: Incompetent Until Proven Competent | ||
| Judge’s decision | Professional licensure procedure | |
| Innocence: The defendant did not commit crime | Licensure rejected: This health practitioner is unscrupulous and/or incompetent and should not be allowed to practice. | |
| Guilt: The defendant did commit the crime | Licensure granted: This health practitioner is scrupulous and competent and should be allowed to practice. | |
| Standard for rejecting innocence: Beyond a reasonable doubt | Standard for accepting licensure: Success in meeting an exhaustive set of predetermined criteria. | |
| Correct judgment: Convict a criminal | Correct inference: Grant the license when the practitioner is scrupulous and competent. | |
| Correct judgment: Acquit an innocent person | Correct inference: Deny the license when the practitioner is unscrupulous or incompetent. | |
| Incorrect judgment: Convict an innocent person. | Incorrect inference (Type I error): Grant the license when the practitioner is unscrupulous and incompetent. | |
| Incorrect judgment: Acquit a criminal | Incorrect inference (Type II error): Deny the license when the practitioner is scrupulous and competent. | |
Visible and Invisible Graveyards
This question of the default situation is one of the core debates in occupational regulation and other forms of regulation—perhaps particularly in the case of healthcare, which occupies a particularly sensitive emotional space. Economist Alex Tabarrok, for example, addressed the issue in his 2015 essay, “Is the FDA Too Conservative or Too Aggressive?”[2]
“I have long argued that the FDA has an incentive to delay the introduction of new drugs because approving a bad drug (Type I error) has more severe consequences for the FDA than does failing to approve a good drug (Type II error). In the former case at least some victims are identifiable and the New York Times writes stories about them and how they died because the FDA failed. In the latter case, when the FDA fails to approve a good drug, people die but the bodies are buried in an invisible graveyard.”
Tabarrok explored this tendency in more detail in “Why the FDA Has an Incentive to Delay the Introduction of New Drugs.”[3] Technology expert Adam Thierer has made a career of arguing for “permissionless innovation” (let people offer technological innovations unless you have really persuasive evidence that you shouldn’t) versus the “precautionary principle” (don’t let people innovate unless you have really persuasive evidence that you should).[4] In a 2023 article, Thierer discusses the debate raging over how tightly artificial intelligence (AI) should be regulated.[5] In my own writing, I’ve explored both the promise[6] and the perils[7] of AI in healthcare.
The Debate at Ground Level
In a classic 2013 New York Times column, the late Princeton professor Uwe Reinhardt considered this tradeoff between safety and expanded supply of and variation in healthcare.[8] The proximate issue motivating Reinhardt’s column was a California legislative initiative that would have allowed nurse practitioners to offer a state-limited menu of services to patients without supervision by a physician.
Reinhardt noted that, at the time, 17 states already allowed NPs to operate in such a manner. In the California battle, AARP supported the legislation, while the California Medical Association vehemently opposed what Reinhardt termed, “the proposed intrusion on the medical profession’s economic turf.” Many of Reinhardt’s writings appear to be the work of someone a bit left-of-center, albeit eclectic; in this article, however, he appears to tilt toward the view of the late conservative/libertarian economist Milton Friedman. Reinhardt extensively quotes the “Occupational Licensure” chapter in Friedman’s Capitalism and Freedom (1962)[9]. In that chapter, Friedman decried the “medieval guild kind of regulation in which the state assigns power to members of the profession,” allowing the profession to exert monopoly power over the public. Such regulators can override patient preferences either because of self-interest (e.g., higher profitability) or by paternalism (e.g., imposition of higher risk-aversion than a patient desires).
Friedman focuses heavily on the cynical aspect of medical licensure—doctors establishing a guild to stave off competition. But it can be difficult to separate that selfish motive from the more altruistic goal of protecting patients from substandard care. In an oft-cited passage, Friedman noted the confluence of these two goals—one antithetical to patients and the other aimed at helping those same patients[10]:
“In the United States the American Medical Association has for decades been one of the strongest labor unions in the country, keeping down the number of physicians, keeping up the costs of medical care, preventing competition by people from outside the profession with those in it. All, of course, in the name of helping the patient.”
To Pump, or Not to Pump?
Are occupational regulations designed to protect inside providers, or are they designed to protect patients from undue risks. The answer, one might say, is, “Yes.” Looking outside the medical field, I recently wrote of a laughable regulatory hysteria that swept across Oregon in 2017.[11] Oregon was one of only two states (along with New Jersey) that did not allow self-service pumps at gasoline stations. The reasons were both protectionist (preserving the jobs of gas station attendees) and risk-averse (saving drivers from a host of supposed terrors associated with allowing non-professionals to pump gas). The state itself compiled a list of 17 reasons to prohibit drivers from pumping their own gas[12]. Some were protectionist:
- “Self-service dispensing at retail contributes to unemployment, particularly among young people;”
And some were based on fears that could easily be dismissed by observing the 48 states that then allowed self-service pumps:
- “Appropriate safety standards often are unenforceable at retail self-service stations in other states because cashiers are often unable to maintain a clear view of and give undivided attention to the dispensing of Class 1 flammable liquids by customers;”
- “The dangers of crime and slick surfaces … are enhanced because Oregon’s weather is uniquely adverse, causing wet pavement and reduced visibility;”
- “The dangers … are heightened when the customer is a senior citizen or has a disability, especially if the customer uses a mobility aid, such as a wheelchair, walker, cane or crutches;”
- “Self-service dispensing at retail presents a health hazard and unreasonable discomfort to persons with disabilities, elderly persons, small children and those susceptible to respiratory diseases;”
- “Small children left unattended when customers leave to make payment at retail self-service stations creates a dangerous situation.”
Oregonians took to social media to express their own menus of fears. Of course, none of this says that there are no dangers involved in pumping gas. Clearly there are. In my youth, a friend’s uncle was killed in an explosion as he delivered a shipment of gasoline to a service station. But in the many decades since that time, the gasoline industry has introduced sufficient safety features that a large majority of Americans find self-service pumps acceptable—and desirable.
Returning to healthcare, the question is not, “Occupational regulation: yes or no?” Rather, it is a complex menu of questions: How do we measure the tradeoffs between probabilistic benefits and probabilistic harms? Should public officials (elites) limit those probabilistic benefits in the interest of limiting probabilistic harms? Or should individuals be allowed to make such determinations for themselves? Should we promote harm reduction prospectively (e.g., by ex ante occupational regulation) or retrospectively (e.g., by ex post litigation)?
All of this may seem a bit abstract, so here are two quite concrete examples to think about.
Brinkley and his Kids (Goats)
John Romulus Brinkley was a controversial Kansas doctor (later Texas) who pioneered the useless and dangerous practice of implanting goat testicles in men who believed they were impotent or sterile. (Brinkley called them “goat glands.”) He had more or less purchased a medical degree from a shoddy diploma mill. He attracted his voluminous clientele by, for all practical purposes, inventing talk radio. He would give folksy, dire medical sermons about the supposed prevalence in male reproductive problems and promote his bizarre surgical procedure as a cure-all.
To attract a larger audience, he constructed what was likely the most powerful radio station in American history, with a range stretching from Canada to Mexico—powerful enough to be audible on bedsprings, barbed-wire fences, and dental hardware. His sermons were interspersed between offerings of cutting-edge country-and-western music—helping to launch the careers of Red Foley, Patsy Montana, Jimmie Rodgers, Gene Autry, the Carter Family, and a host of others.
Some recipients of his implant patients became sick and disabled. Others died. Brinkley issued 42 death certificates for patients who, it is said, were not ill when they came to his clinic.
Brinkley found himself under regulatory and professional assault on multiple fronts. Kansas stripped him of his medical license in 1930, so he decided that he would have to become governor and appoint a new medical board that would give him his license back. He very nearly won as a write-in candidate. (He likely received more votes than his successful opponent, but a controversial election-rule change invalidated a large number of his votes.) He ran again in 1932 against Alf Landon, who would become the 1936 Republican presidential nominee. The Federal Radio Commission took his broadcast license away. Eventually, Brinkley packed up and moved to Del Rio, Texas, so he could re-establish his radio station across the border in Mexico. Morris Fishbein of the American Medical Association pursued Brinkley relentlessly. Eventually, the State Department became involved and persuaded Mexico to shut him down. Late in life, he became something of an enthusiast for Nazi Germany.
From then on, Brinkley’s life and career spiraled downward, consumed by bouts with regulators and litigation in courts. The above description has barely scratched the surface of Brinkley’s weird, colorful, and sometimes terrifying story. For a much fuller account, his biography is Charlatan: The Fraudulent Life of John Brinkley[13]. For those with less time to spare, his Wikipedia biography offers a fairly deep introduction.[14] Suffice it to say that nearly a century later, Brinkley is still an icon for those urging stronger regulation of healthcare professionals.
Salk and His Kids (Human)
Jonas was also a colorful and controversial doctor, though the nature of his controversies were far more elevated than those surrounding Brinkley. After the release of his polio vaccine, Salk was evermore a celebrity in the public eye. While Brinkley had his country music artists, Salk eventually married Françoise Gilot, an accomplished ceramics and watercolor artist who had been Pablo Picasso’s lover.[15]
Like Brinkley, Salk pioneered an utterly unconventional medical treatment, to the consternation of many in the medical establishment. He pushed the boundaries of medical practice to apply his treatment to millions of patients (as opposed to Brinkley’s thousands). As with Brinkley, there were deaths along the way. But unlike Brinkley, Salk developed a pathbreaking preventative that helped end a nationwide scourge of death, compared with Brinkley’s useless, dangerous treatments. And, unlike Brinkley, there were no questions about Salk’s credentials or institutional base.
Before Salk’s vaccine, the American populace was gripped by terror of waves of the disease sweeping across the population. For a visual look into the disease, one can watch this brief video of Paul Alexander, who fell victim to polio in 1952 at the age of 6. As of this writing (6/12/23), Alexander has spent 71 years in an iron lung with constant care. Through efforts unimaginable to most of us, he was able to attend K-12 schools, go to college and law school, and practice as a trial lawyer. As of today, he is the last polio victim who remains in an iron lung—the maintenance of which has become a challenge, as parts and experienced mechanics have disappeared from the scene.[16]
For some numbers, “In 1952 alone, nearly 60,000 children were infected with the virus; thousands were paralyzed, and more than 3,000 died.”[17] We who have lived through the COVID-19 pandemic have an inkling of what the fear was like, but only an inkling. Because, while COVID mostly affected the elderly and those who had already suffered other infirmities, polio struck down tens of thousands of otherwise healthy, happy children. A website at the University of Pittsburgh, where Salk developed his vaccine between 1947 and 1955, said that “at its peak in the 1940s and 1950s, polio was killing or paralyzing more than a half-million people worldwide each year, especially children and young adults”[18].
Salk was forever something of an outsider in his profession. His vaccine used dead viruses, as opposed to the live-virus vaccine developed by his rival, Albert Sabin, and licensed for use in the United States in 1961. In a 2014 NPR interview, historian David Oshinsky described the medical community’s antipathy toward Salk[19]:
“Jonas Salk was always seen in the vaccine community as the people’s scientist, and Albert Sabin was seen as the scientist’s scientist. And Jonas Salk therefore was the white knight in the lab coat who would come out and tell us that the vaccine was almost ready and it was going to be successful and nobody should be worried about it. And he was a great spokesperson for it. What I think is interesting though is that once the vaccine comes out there are many people in the virology community who believed, incorrectly, that it was an inferior vaccine because it didn’t create a natural infection in the body. And Jonas Salk was kind of blackballed by the virology community. If you can believe it, it’s scandalous. He is the only major polio researcher never to have been inducted into the National Academy of Sciences. It’s a scandal, but he was. Indeed, I think he paid a price for his celebrity.
Oshinsky concludes that the sort of work that Salk did would likely be impossible today. In Salk’s environment, unlike our own:
“there were very few government restrictions. It basically was parental consent, meaning a parent would just sign a consent form. And I think that the interesting thing you mentioned, there were close to two million children taken place. That would never happen today. I think parents at that time had a much greater sense of risk versus reward.”
Conclusion
Returning to the opening sentence of this article, “How do you craft occupational regulations that allow Jonas Salk to test his polio vaccine but prohibit John Romulus Brinkley from implanting goat testicles into gullible members of his radio audience?” Set the hurdles too low, and you let charlatans like Brinkley engage in useless, dangerous, unscientific practices like implanting goat testicles in those lured in by music and folksy radio chats. Set the hurdles too high—as they perhaps are today—and you stop those like Jonas Salk from developing lifesaving procedures. What array of education, licensure, practice standards, oversight, and litigation will say “yes” to Salk and “no” to Brinkley?
Milton Friedman’s and Uwe Reinhardt’s comments from long ago suggest that the current system of healthcare licensure may not be the optimal regulatory tool in this regard. The same can be said for other contemporary regulatory arrangements—scope of practice, mandatory collaborative practice agreements, certificate of need laws, and so forth. A 2021 book, Don’t Wait for Washington: How States Can Reform Health Care Today, reviews these arrangements and possibilities for reform.[20]
In asking how one determines optimal regulations, part of the answer lies in knowing that there will always be Type I and Type II errors. So, policymakers must ask two sides of the same question: How many Brinkleys am I willing to tolerate to empower one Salk? And how many Salks am I willing to forgo to sideline one Brinkley? Type I versus Type II. (Or, if you’ve formulated your default assumptions/null hypothesis differently, Type II versus Type I.)
Regulation versus deregulation is a spectrum, not a binary.
Downloadable PDF of Article for Offline Reading
Dr. Robert Graboyes is a Senior Research Affiliate with the Knee Center. Separate from his work with the Knee Center, Robert describes himself as an Economist, Journalist, and Musician.
[1] Banerjee, A., Chitnis, U. B., Jadhav, S. L., Bhawalkar, J. S., & Chaudhury, S. (2009). Hypothesis testing, type I and type II errors. Industrial psychiatry journal, 18(2), 127–131. https://doi.org/10.4103/0972-6748.62274
[2] Tabarrok, A. (2021, September 27). Is the FDA Too Conservative or Too Aggressive? Marginal REVOLUTION. https://marginalrevolution.com/marginalrevolution/2015/08/is-the-fda-too-conservative-or-too-aggressive.html
[3] Why the FDA Has an Incentive to Delay the Introduction of New Drugs | FDAReview.org. (n.d.). https://www.fdareview.org/issues/why-the-fda-has-an-incentive-to-delay-the-introduction-of-new-drugs/
[4] Permissionless Innovation: The Continuing Case for Comprehensive Technological Freedom. (2016, March 15). Mercatus Center. https://www.mercatus.org/research/books/permissionless-innovation-continuing-case-comprehensive-technological-freedom
[5] A balanced AI governance vision for America, Contributor, A. T. O. (2023, April 16). The Hill. https://thehill.com/opinion/congress-blog/3953916-a-balanced-ai-governance-vision-for-america/
[6] Graboyes, R. F. (2021, November 10). How AI Can Make Medicine Fleet as a Fox – InsideSources. InsideSources. https://insidesources.com/how-ai-can-make-medicine-fleet-as-a-fox/
[7] Graboyes, R. F. (2023, April 4). The Talented Doctor Ripley (GPT). By Robert F. Graboyes. https://graboyes.substack.com/p/the-talented-doctor-ripley-gpt
[8] Reinhardt, U. E. (2013, October 11). The Dubious Case for Professional Licensing. Economix Blog. https://archive.nytimes.com/economix.blogs.nytimes.com/2013/10/11/the-dubious-case-for-professional-licensing/
[9] Friedman, M. (1962). Capitalism and freedom. Chicago: University of Chicago Press.
[10] investbligurucom. (2010, June 14). Ep. 8 – Who Protects the Worker [1/7]. Milton Friedman’s Free to Choose (1980) [Video]. YouTube. https://www.youtube.com/watch?v=UYBLYg9IFbI
[11] Graboyes, R. F. (2023b, May 19). Chickens and Neutrons and Long-leggedy Horsies and Things that Go Pump In the Night. Bastiat’s Window. https://graboyes.substack.com/p/chickens-and-neutrons-and-long-leggedy
[12] ORS 480.315 – Policy. (n.d.). https://oregon.public.law/statutes/ors_480.315
[13] Brock, Pope. Charlatan: The Fraudulent Life of John Brinkley: Crown/Archetype, 2008.
[14] Wikipedia contributors. (2023). John R. Brinkley. Wikipedia. https://en.wikipedia.org/wiki/John_R._Brinkley
[15] As a personal aside, I can never mention Salk without noting a cherished memory of my wife, Alanna Siegfried Graboyes. She grew up in the Atlantic beach community of Far Rockaway, New York. In 1955, her parents escorted her to a block party celebrating their summer neighbor, Jonas Salk, to celebrate his success in producing his vaccine. She recalls him sitting like royalty in a large wicker chair where neighbors would receive a handshake or, in her case, a hug from the good doctor.
[16] Gizmodo. (2017, November 20). The Last Few Polio Survivors – Last of the Iron Lungs | Gizmodo [Video]. YouTube. https://www.youtube.com/watch?v=gplA6pq9cOs
[17] Beaubien, J. (2012, October 15). Wiping Out Polio: How The U.S. Snuffed Out A Killer. NPR. https://www.npr.org/sections/health-shots/2012/10/16/162670836/wiping-out-polio-how-the-u-s-snuffed-out-a-killer
[18] University of Pittsburgh University Marketing Communications Webteam. (n.d.). Ending Polio’s Reign of Terror | 225 Years | University of Pittsburgh. Copyright 2010 University of Pittsburgh. https://www.225.pitt.edu/story/ending-polio%27s-reign-terror
[19] Npr. (2014, October 28). Jonas Salk’s Polio Vaccine Trials Would Be Hard To Repeat Today. NPR. https://www.npr.org/2014/10/28/359632703/jonas-salks-polio-vaccine-trials-would-be-hard-to-repeat-today
[20] Blase, B., Ingram, J., Miller, C., Mitchell, M., Graboyes, R., Bryan, D. N., Lopez, N., Singer, J., & Overton, H. (2021). Don’t Wait for Washington: How States Can Reform Health Care Today. I’ll suggestion two of the books chapters, in particular: “Welcome Competition: Scale Back Certificate of Need Laws,” by Matthew Mitchell, and “Unshackle Providers: Don’t Waste Their Training,” by Robert Graboyes and Darcy Nikol Bryan.