Evidence, Openness, and

Medical Accountability

Theodore M. Porter

Department of History

University of California, Los Angeles

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Sources of evidence-based medicine.

1. State efforts, in support of elite physicians, to raise the standard of medical practice.

2. An explosion of medical research (including dubious or compromised research), attended by an explosion of costs.

3** New efforts to regulate medicine, as much to control costs as to raise quality.

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Practitioners using therapies that we have rejected thought they had evidence, too.

In Europe, it usually reflected Galenic humoral theories as well as clinical experience.

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Donizetti’s Doctor Dulcamara, from The Elixir of Love, personifies evidence-based medicine. (After Nemorino drinks his Isolde-potion and promptly becomes the object of rapt female attention, Dulcamar knows it was effective.)

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What sort of evidence does EBM endorse?It gives little credence to expert opinion or even

to non-clinical science.It prefers what is rigorously standardized.It aims to use all the available data.

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When A. B. Hill lectured to doctors about statistical trials, he emphasized that they could never substitute for medical expertise. But he needed the support of doctors. He preferred instrument measures over medical judgment in assessing outcomes.

Modern champions of EBM tend also to concede the special skill of doctors. But they have strong support already from researchers and regulators.

Austin Bradford Hill (1897-1991, son of a physiologist,trained in economics and statistics.

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EBM is now incorporated into medical education. But medical statistics has also been part of an effort to regulate medicine.

EBM defines worthy medical interventions, for cost control.

State and private insurance alike have taken this up. (And they need to able to defend their decisions)

Insurers also decide who receives approved treatments.

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Physicians in the US must seek advance approval for many procedures, which are screened in data-processing centers by people with no formal medical training.

This requires the reduction of medical justification to something simple and formulaic.

In principle, that is. There are always ways of appealing and negotiating.

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EBM is in part a system of standardization

Doctors defend their expertise against the (idealized) transparency and inflexibility of rules.

Yet the expertise can never be discarded. A computerized diagnosis and treatment would depend on skilled observers to recognize and categorize symptoms.

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The American excitement about “death panels” has this much truth, that a system of insurance must somehow set limits on treatment.

(Are individual health accounts an alternative?)

This is a powerful force for EBM (of some sort).

That dynamic is not limited to welfare states, but is worked out in a still more cunning way in private (neoliberal?) insurance systems.

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Is EBM sufficiently explained as a social technology of medical regulation?

No, it has, of course, scientific sources as well.

Medical science has long aimed to articulate the basis for a proper medical practice. “Medical tact” was invoked as a defense against science long before clinical judgment faced off against bureaucracy.

But medical evidence near the top of the pyramid is not strictly allied to the ethos of university research.

Clinical trials now are done by research factories, which are cheaper and more reliable.

As for data manipulation (I mean processing) … !

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As EBM has become powerful, it has (inevitably) come to be subverted.

The expense of therapeutic trials helped create “Big Pharma.” The companies are very skilled at getting results they want.

They hire obliging companies to do the clinical trials, suppress negative results, write up the positive ones in house, conduct meta-analyses, and sign on university psychiatrists as authors of record (ghostwriters).

Now medical schools and journals are trying to down to salvage their reputations (but they also advertise for pharmaceutical research funds).

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EBM tends to restructure medicine by ruling certain kinds of knowledge out of court.

This is especially evident in psychiatry.

The celebrated third edition of the DSM (Diagnostic and Statistical Manual), issued in 1980, was a victory of Kraepelin over Freud, of symptom-based diagnostic categories over deep etiologies.

A drug could be tested for its effect on one of these 265 categories of mental disturbance. Any new diagnosis creates new classes of patients and new opportunities for clinical trials.

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This kind of evidence seemed important to make psychiatry a respectable field of medicine, worthy of inclusion in medical insurance. (The US FDA has required clinical trials of drugs since 1962).

Since the consequences were so great, the DSM has given rise to famous struggles over diagnoses such as the celebrated ADHD (attention deficit hyperactivity disorder).

Which of course, may require medication, followed by clinical study of its symptomatic effects, issuance of treatment guidelines, ….

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Andrew Lakoff’s study of clinical testing in Argentina reveals some unexpected implications.

Argentina, a somewhat poor country with many psychiatrists, seemed a promising site for clinical trials.

The French Company GENSET wanted to use these trials to study the genetic basis of psychiatric disorders.

But Freudians did not accept (at first) many of the disease classifications, so it was difficult to recruit suitable experimental subjects. Argentine psychiatry had to be transformed!

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Is this the subordination of the medical profession? Was medicine so weak?

We have a process of contradictions and ironies, medicine a victim of its own economic success.

Physicians no longer rule the roost, but share power and authority with insurers, pharmaceutical companies, etc.

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In state and “private” medical systems alike, the autonomous medical professional is now subject to an economic logic, and above all an administrative one, with corporate managers and government officials playing somewhat similar roles.

Is this neoliberalism? Hard to say. Is it states seeking to harness individualized incentives, or insurance organizations deploying bureaucratic power?