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

Article Highlights

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

    Tweet This

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

    Tweet This

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

    Tweet This

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.

Also Visit
AEIdeas Blog The American Magazine
About the Author

 

David
Shaywitz
  • Dr. Shaywitz trained in internal medicine and endocrinology at MGH, and conducted his post-doctoral research in the Melton lab at Harvard. He gained experience in early clinical drug development in the Department of Experimental Medicine at Merck, then joined the Boston Consulting Group’s Healthcare and Corporate Development practices, where he focused on strategy and organizational design. He is currently Director of Strategic and Commercial Planning at Theravance, a publicly-held drug development company in South San Francisco. He recently wrote Tech Tonics: Can Passionate Entreprenuers Heal Healthcare With Technology? 

  • Email: davidshaywitz.aei@gmail.com

What's new on AEI

image The Census Bureau and Obamacare: Dumb decision? Yes. Conspiracy? No.
image A 'three-state solution' for Middle East peace
image Give the CBO long-range tools
image The coming collapse of India's communists
AEI on Facebook
Events Calendar
  • 21
    MON
  • 22
    TUE
  • 23
    WED
  • 24
    THU
  • 25
    FRI
Wednesday, April 23, 2014 | 12:00 p.m. – 1:30 p.m.
Graduation day: How dads’ involvement impacts higher education success

Join a diverse group of panelists — including sociologists, education experts, and students — for a discussion of how public policy and culture can help families lay a firmer foundation for their children’s educational success, and of how the effects of paternal involvement vary by socioeconomic background.

Thursday, April 24, 2014 | 12:00 p.m. – 1:30 p.m.
Getting it right: A better strategy to defeat al Qaeda

This event will coincide with the release of a new report by AEI’s Mary Habeck, which analyzes why current national security policy is failing to stop the advancement of al Qaeda and its affiliates and what the US can do to develop a successful strategy to defeat this enemy.

Friday, April 25, 2014 | 9:15 a.m. – 1:15 p.m.
Obamacare’s rocky start and uncertain future

During this event, experts with many different views on the ACA will offer their predictions for the future.   

No events scheduled this day.
No events scheduled today.
No events scheduled this day.
No events scheduled this day.
No events scheduled this day.