Healthcare’s Bad Business with FDA Changes

Guest post by Edgar Wilson.

Edgar Wilson

President Trump’s promises to reform and deregulate the FDA seem doomed to do the opposite of what they were intended to do.

His track record on other issues notwithstanding, Trump might be excused for not knowing that American medicine is a bizarro-world where the good intentions of outsiders and insiders alike transmogrify into destruction, disruption, and bureaucratic chaos.

Big Business That Depends on Regulation

In a world where insurance wasn’t a prerequisite for accessing almost any care, and the free market actually was the primary force in driving patient and provider behaviors, broad strokes deregulation might work.

But in America’s healthcare system, “access” isn’t access. Rather, having a payer on board who will cover drugs, treatment, and providers is “access.” Simply knowing that a new wonder-drug exists doesn’t help people who need it. Steamrolling the FDA so that drugmakers can offer the drug on the open market, it should come as no surprise, also helps no one in particular. Because payers–insurers–look to the FDA for evidence of a drug’s value and clinical efficacy (rather than, say, patients desperate for a cure or drugmakers looking to cash in), disrupting the approval process serves also to disrupt payer confidence.

In other words, without the FDA’s lengthy, cumbersome, and expensive approval process, payers will be shy to cover new drugs–and thereby enable patients to access them. Drugmakers, by extension, would rather not face the uncertainty of what payers, providers, and patients might decide to do with new drugs absent the structured system of insurers taking their cues from the FDA, and thereby driving the behavior of the rest of the system.

To be fair, the FDA and its system for testing and approving new medications and devices has flaws. An overreliance on drugmakers’ own data, rather than independent research, sometimes leads to a lack of rigor and poor follow-up allowing unsafe drugs and devices to slip through to market only to be proven faulty by consumers, rather than regulators. A lack of clarity in its labeling requirements creates onerous demands on manufacturers and retailers, yet provides little to no benefit to the very consumers it is supposed to help protect and inform. There is no shortage of ways in which the FDA and its operations could be improved.

But Trump’s approach to the FDA treats the organization like a Gordian knot — something more easily cut through than carefully managed — with predictably mixed and messy results. He isn’t entirely wrong that there are problems to be solved, but his approach also isn’t graceful or nuanced. More than that, though, it makes the mistake so ubiquitous in business and leadership today, of relying too much on generously vague terms like “innovation” and the amorphous power of “science” at large to provide cures not just for injury and illness, but all of society’s woes.

When Will Science Save Us

In a tech-obsessed period of American life, the instinct–apparently shared from the Trump White House on down through to developers and plenty of consumers and patients–is to rely more on automation and digital systems like EHRs to facilitate the spread of knowledge, best practices, and to capture performance and quality metrics. But overcoming both the imperfections of the FDA as well as the habits of practicing clinicians may still fall to the humans of the medical profession, rather than to their tools and tech.

An explosive piece from David Epstein and Propublica in The Atlantic explained at great length how practicing clinicians routinely ignore or neglect to follow changes in best practices as they relate to everything from surgery and procedure to prescribing drugs and devices. Any scientist worth his or her salt knows that science is not about reaching conclusions, but about testing theories, repeatedly. Given the influence of Silicon Valley over so much of American (and frankly, global) life, the mantra of “Iterate, iterate, iterate” shouldn’t be so foreign, yet much of what passes for cutting-edge medicine is really just the ingrained and the familiar.

Despite continuing education and maintenance of certification rules, it is not uncommon for clinicians to stick to whatever they learned in school, and leave the transformative change to someone else. Overworked and faced with their own set of existential burdens beyond keeping up with the back and forth of conventional medical wisdom, more expectations, regulations, and systems controlling their behavior are as much part of the problem as they are efforts to help. As with the FDA, this isn’t a problem endemic to the whole body of caregivers or medical schools, nor is the solution as simple as telling practiced professionals, “You’re fired!” and replacing them overnight.

Nurses have an expanding role in both determining care plans, and helping doctors follow new and evolving best practices. Their push into higher levels of certification is driving growth of Clinical Nurse Leaders in hospitals, charged with educating patients as well as their provider peers, bringing the notion of peer review to the bedside as well as the administration of clinics, rather than letting it languish in the journals.

Nurses and doctors alike are also walking away from the burn and grind of clinical roles, in a growing number cases even returning to school to acquire an MBA and the associated managerial bona fides, to do as Gandhi suggested and becoming the change they wish to see in their world of healthcare.

The current president is not the first to rush headlong and earnestly into the upside-down hornet’s nest of healthcare reform, only to find both the problem, and the array of possible solutions, were all more complicated than the casual observer might reasonably expect. The continuing aftershocks of Meaningful Use, and the persistent challenge of interoperability, show that even switching from paper files to digital records is easier said than done.

We can’t revolutionize our way out of the modern medical quagmire that is America’s healthcare system with more gizmos, easier pathways to market for innovators, or by simply calling it quits with efforts to control standards, training, and management. Technology and creativity have important roles to play, but so do the human–including bureaucracy. Getting it right is harder, but more important, than getting rid of it.

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