By Nick van Terheyden aka Dr Nick, Principal, ECG Management Consulting
Twitter: @drnic1
Host of Healthcare Upside Down – #HCupsidedown
Do you know whether the drugs you’re prescribed are actually delivering value? Are you confident that your best interests are being considered in the clinical decision-making process?
If you’ve traditionally deferred to the Food and Drug Administration (FDA), the main regulatory body responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, the recent controversy about Aduhelm might give you pause.
Aduhelm is a Biogen-made drug designed to treat Alzheimer’s disease. Two large studies of Aduhelm were submitted to the FDA: one found that the drug could delay the loss of memory and thinking, while the other found no clear benefit. The advisory panel to the FDA recommended against allowing the drug, but the FDA rejected the advice and gave it conditional approval.
That ruling has confused patients and divided physicians and medical institutions. Despite the uncertainty, the rate for Medicare premiums was recently raised by the largest amount in history, in part because of the expected impact of prescribing Aduhelm—a drug that may not work but nonetheless costs more than $28,000 per year—for patients covered by Medicare.
All of this is happening against a backdrop of clinical data that’s available but not being applied to decisions about our healthcare. “We live in a world of assumption,” says Pramod John, CEO of Vivio Health. “We live in a world that says, ‘If the FDA approves a drug, of course it must work. Why else would the FDA approve it?’ We make assumptions there. We make assumptions around the fact that physicians understand all the data behind this.”
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On this episode Pramod explains why we need to ask the right questions about our healthcare system, rethink many of our assumptions, and examine the ways that economic incentives influence care decisions. Here are three takeaways from our conversation.
Fewer assumptions, more data.
The controversy surrounding Aduhelm raises a question that some might consider naïve, but is fair to ask: why would the FDA approve a medication or therapy that isn’t certain to help patients? And why would physicians prescribe it?
“It starts with the assumptions we make about what everyone else does.” Pramod says. “We make assumptions that politicians don’t take money from pharma and other places, and that those things don’t influence the way they create public policy. We make assumptions that the FDA [exists] fundamentally to help the American people. We make assumptions that physicians understand this data, and that they’re experts in the data.”
That’s a lot of assumptions, and relying on them precludes us from taking a more critical view of our healthcare system. “Stop making assumptions and find the data for yourself,” Pramod says, “because the data and the facts speak for themselves.”
But that’s easier said than done, Pramod acknowledges, because we’ve effectively allowed the sellers of products to hold all the data. “Today, the only parties who have information are the people who sell things,” he says. The solution, he says, is to “invert the asymmetry of information.”
“We’re not skeptical anymore,” Pramod laments. “We don’t ask the questions ourselves.”
Demanding more as consumers.
Part of the problem is that, as consumers, we don’t bring the same set of standards to healthcare that we do to so many other areas of our lives. “Do we all believe that we should be able to find things that work and that don’t work?” Pramod asks, noting how frequently we turn to sources such as Consumer Reports to guide our purchasing decisions. “We’re always looking for information about ‘well, does it do what it says it’s going to do, or not?’ Why should drugs be any different?”
While he admits that the criteria for consumer evaluation of a drug might differ from that of a household product, he insists that quality is still the central question. “What is quality fundamentally based on?” he asks. “It’s based on the assumption that it must improve your quality of life or your life expectancy. Otherwise, why would one take it? It’d be the equivalent of buying a car that doesn’t run. We would never buy that.”
Misaligned incentives.
No one wants to pay for a medication that isn’t effective—or worse, that could have harmful side effects. But the Aduhelm situation should prompt us to question the safeguards that ostensibly protect us from buying drugs that aren’t effective. Is the FDA immune from economic influence? Are our physicians?
The problem, according to Pramod, is a system warped by misaligned incentives. “Every PBM and health plan in this country pretty much benefits when more healthcare—and more expensive healthcare—occurs, right?” he asks. “So now you have a problem. All the people who were supposed to sit in the middle to protect the people…now have economic incentives every time someone gets more healthcare, or the cost of healthcare goes up.
“So you’ve got a problem out of the gate—your economic incentives are misaligned. They’re not aligned around answering the question of ‘is this a great therapy’—they’re aligned around the question of whether we can make more money.”
About the Show
The US spends more on healthcare per capita than any other country on the planet. So why don’t we have superior outcomes? Why haven’t the principles of capitalism prevailed? And why do American consumers have so much trouble accessing and paying for healthcare? Dive into these and other issues on Healthcare Upside/Down with ECG principal Dr. Nick van Terheyden and guest panelists as they discuss the upsides and downsides of healthcare in the US, and how to make the system work for everyone.
This article was originally published on the ECG Management Consulting blog and is republished here with permission.