U.S. agencies’ unethical virus error
The name of the Centers for Disease Control and Prevention (CDC), America’s federal public-health agency, has always struck the ear of the ordinary English speaker a little oddly. Before Google and Wikipedia, it used to be difficult to have reporters get the plural right unless they were on the health beat full time. Indeed, the agency was the Communicable Disease Center before an acronym-saving name change in 1970.
Centralization is the CDC’s raison d’être; it is designed to send experts armed with quasi-military powers and materials to hot zones of infectious disease while accumulating and organizing important clinical data from all across the U.S. Infectious disease is the paradigmatic “local problem that can become universal in a hurry if you screw it up,” so there is obvious value in making the funds and manpower of an entire nation available to fight local outbreaks.
That’s the theory, and as far as it goes it has been vindicated a thousand times over. But the CDC is (are?) now facing unprecedented scrutiny because of its (their) mystifying central mismanagement of the coronavirus threat. Centralization, like any other virtue, turns out to be good only up to a point.
The United States now understands that it was let down in the early weeks of the coronavirus problem by CDC ineptitude, and by problems with the CDC’s Big Alphabet sibling, the Food and Drug Administration
(FDA). While other countries closer to China were already testing hundreds of thousands of citizens, the CDC was preparing for the impact of the virus in America by shipping a small quantity of faulty test kits to regional labs and state public-health agencies.
The technical issue, frustratingly, was with the neutral reagent that is supposed to serve as a sort of experimental control in the testing process. If you watch auto racing on television, you will often hear the commentators rhapsodize about a $1-million car crashing because a 50-cent part failed. Same deal here, but with human lives instead of dollars.
The failure of a single agency on which American health care had come to depend delayed the rollout of tests that could have identified virus carriers before they could spread it in the U.S. Now the prevalence of the virus in some parts of the U.S. is completely unknown, and probably critical. But on Monday The New York Times offered a concrete depiction of a different aspect of the same problem. The story of Dr. Helen Chu wasn’t a tale of failure in an industrial process — it was an argument over ethics that Big Alphabet, with its dependence on hard written rules, got wrong and still won.
Chu is involved with the Seattle Flu Study, an ongoing multi-centre inquiry into how specific strains of ordinary seasonal influenza spread. When a Washington man who had visited Wuhan tested positive for coronavirus in January, she realized that she was sitting on a large number of mucosal samples from her study’s participants — samples that could be checked for coronavirus. The problem, which Chu and other flu-study doctors saw, was that the flu patients in the study had not consented to tests for anything other than flu.
The CDC, having thousands of the world’s best infectious disease specialists under its umbrella, understood that this was a crucial moment in the population life cycle of the disease. But the CDC isn’t an ethics regulator. It told the Seattle Flu Study team to talk to the FDA. Which said no. Rather understandably, since the FDA’s main job is to say no to the adventurous use of things like patient data and medical samples.
When the flu-study doctors decided it might be all right to test the samples for their own private edification, they immediately found coronavirus in a Washington teenager who had no hot-zone travel history. The enemy had been spotted in the wild. The teen was tracked down just as he turned up in the morning at school; he was sent home, and the school later closed outright. But when Chu arranged a conference call with representatives of the CDC and FDA, she wasn’t told “Wow, congratulations;” she was told very clearly, in the words of a colleague, to “cease and desist” the unauthorized testing.
History will not view this error benignly. The Seattle Flu Study’s ethics review board has concluded that it would have been unethical for Chu and her colleagues not to test the existing samples in the face of an emergency. The participants in the study, along with their loved ones and their neighbours, were endangered by the contextually inappropriate exercise of a good rule — a rule of explicit consent intended to protect their privacy.
No human being or group of human beings has any business sitting on the throne of God and handing down universal, unconditional ethical fiat. But that is the position in which a strongly centralized system placed the CDC and the FDA. Chu had to pass her notions of right and wrong under the nose of someone else, someone very far from the consequences of any decision. Was this part of the bargain when the American states allowed powerful federal agencies to be created to fight disease and protect the public? Or, to put it another way: did they provide informed consent?