Medicine must allow for customization: A lesson for policymakers - and regulators

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  • Policymakers need to abandon the notion that experts always know best @DShaywitz

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  • Policymakers must recognize that customized solutions work better than one-size-fits-all fixes @DShaywitz

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  • Give physicians and patients the opportunity to decide whether a risk/benefit is worth it, rather than impose high hurdles

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As appealing as it is – as useful as it is – to imagine that there exists a gold-standard way to practice medicine, and a single-best way to approach most human ailments, the reality is considerably more complex and messy, as Hartzband and Groopman’s (continued) critique of so-called “best practices” makes clear.

The heart of their argument is this: “For patients and experts alike, there is a subjective core to every medical decision. The truth is that, despite many advances, much of medicine still exists in a gray zone where there is not one right answer. No one can say with certainty who will benefit by taking a certain drug and who will not. Nor can we say with certainty what impact a medical condition will have on someone’s life or how they might experience a treatment’s side effects. The path to maintaining or regaining health is not the same for everyone; our preferences really do matter.”

This resonates (see here and here), although I’ve also heard distinguished health policy proponents argue convincingly that even if experts can’t agree what is definitely “right,” there can definitely be agreement about a number of ways of practicing medicine that are clearly “wrong,” yet very common – so that while it may be harmful, and disingenuous, to insist upon a single algorithm or best approach, it could be helpful to at least provide clear guidance so that physicians would know to avoid certain therapeutic approaches.

"The challenge... is to advance a regulatory policy with the wisdom and humility to enable and support this sort of shared decision-making, rather than effectively circumventing it." -- David Shaywitz

Not only does Hartzband and Groopman’s argument have implications for the current healthcare debate, it also would seem to have significant implications for the way we view medical product regulation. 

Currently, in deciding whether the benefits of a particular medical product are worth the cost, regulators, as I’ve discussed, often deliberately adopt the most restrictive view possible, taking it upon themselves to decide that this decision is in the best interest of patients.

Yet, as Hartzband and Groopman write, “Policy makers need to abandon the idea that experts know what is best. In medical care, the ‘right’ clinical decisions turn out to be those that are based on a patient’s goals and values.” 

If regulators took this admonition to heart, they would recognize the utility in offering more physicians and patients the opportunity to decide whether a particular risk/benefit is worth it, rather than impose excessively high hurdles and in many cases, take the decisions out of the hands of patients and physicians – and into their own hands instead.

Policymakers, like technologists and pharma companies, clearly struggle with the complexity of medicine and the nuance of medical decision making, and more generally, with the concept that as convenient, and efficient, as one-size-fits-all solutions might appear (whether a policy, a decision tree, or a new drug), it’s far better to provide meaningful opportunities to individualize and customize solutions for each patient. 

The challenge, and urgent need, right now is to advance a regulatory policy with the wisdom and humility to enable and support this sort of shared decision-making, rather than effectively circumventing it.

David Shaywitz is an adjunct scholar at AEI.

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