Virus shining a light on regulatory frustrations

In the 1950s, medical researcher Chester Southam devised an experiment to test the immune system’s response to cancer. He would inject live cancer cells into three groups of human subjects: people already sick with cancer; people dying of other causes; and healthy people.

“His plan,” as explained by Cathy Gere in her thought-provoking book “Pain, Pleasure, and the Greater Good,” “was to inject these cells into the patients’ arms or legs and see how long it took for a ‘subcutaneous nodule’ to form and then to disappear.”

His healthy controls were prisoners at the Ohio State Penitentiary, to whom he fully explained his experiment. Cancer patients were in ample supply at his home institution, Sloan-Kettering. He told them their new treatment involved the injection of cells without revealing that the cells in question were malignant. He found his dying subjects at the Jewish Chronic Diseases Hospital in Brooklyn. He specifically instructed his staff not to inform the terminally ill patients what the “skin test” actually involved.

When word of the experiment leaked out, the public was scandalized by the echoes of Nazi medical experiments on concentration camp inmates. Southam, unimpressed by the outrage, airily asserted that the risk of any subject developing cancer was quite low. But when Science magazine asked him why he didn’t try the experiment on himself, he replied, “Let’s face it, there are relatively few skilled cancer researchers and it seemed stupid to take even the little risk.”

His life was worth more than theirs.

At the time, almost unbelievably, medical opinion was divided on the ethics of Southam’s experiments. Today, when the principle of informed consent is enshrined as a fundamental tenant of all medical experiments on human beings, condemnation would be universal.

This past winter, the Seattle Flu Study carefully obtained informed consent from hundreds who agreed to have their sinuses swabbed as part of its influenza monitoring project. In January, as researchers learned about the rapid global spread of the novel coronavirus, one of the researchers, Dr. Helen Y. Chu, realized that by re-testing the project’s samples, she and her colleagues could determine whether COVID-19 was spreading in the Seattle area, information of utmost significance to the nation’s response to the pandemic.

But her proposal to repurpose already-collected nasal swabs ran into a series of bureaucratic obstacles, as detailed in a March newspaper account by Sheri Fink and Mike Baker. First of all, the subjects had consented to have their mucus tested for flu, not SARS-Cov-2. They hadn’t agreed to have the results shared with the local health department. Moreover, Dr. Chu’s lab was accredited only for research, not clinical work, and so was prohibited from providing test results to anyone outside her research group.

When Dr. Chu re-tested some samples anyway, discovering the nation’s earliest outbreak of COVID, she informed the local health department – which ordered her to cease and desist immediately.

The principle of informed consent is monumentally important. It protects a human subject’s autonomy and dignity. It repudiates Southam’s arrogant ranking of people’s worth.

But it’s hard to see how the dignity and autonomy of the Seattle subjects was impaired by subjecting their previously-collected mucus samples to a second diagnostic test. And the principle of fully informing patients is a reason to tell them their COVID-positive status rather than the opposite.

Similarly, it’s entirely reasonable that a clinical lab, whose results directly influence patient care, is held to different standards than a research institution. But enforcing that distinction in this instance frustrated the very purpose for which the public health agencies charged with its enforcement were created.

Just as the virus exposes many social divisions in our society, it also shines a harsh light on the inbuilt frustrations of the regulatory state. In ordinary times, bureaucratic obstacles might be dismissed as the annoying cost of doing business. But in a crisis, they can become, literally, matters of life and death.

And yet it’s essential that government workers charged with enforcing regulations are incentivized to enforce them strictly, as happened in each of these examples. Rigidity on the front line is necessary to discourage bribery, political pressure, favor-swapping and all other forms of improper influence. If a regulation is worth having, it’s worth enforcing fairly and impartially.

Sometimes people complaining about regulations believe the purpose isn’t worthwhile. That’s a political issue.

But often, I think, the core of the complaint is that enforcement has become disconnected from purpose.

The incentives given to the enforcers, while entirely appropriate on their own terms, nonetheless conflict with the overall goals of the organization.

The next column will return to the subject.

Joel Jacobsen is an author who in 2015 retired from a 29-year legal career. If there are topics you would like to see covered in future columns, please write him at”>href=”http://legal.column.tip”>


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