On January 26, 2016, Editor-in-Chief Patrick Reilly spoke with Adam Cifu, a practicing physician and Professor at the University of Chicago Medical School, to discuss his new book Ending Medical Reversal: Improving Outcomes, Saving Lives. This book, which Cifu co-authored with Vinayak K. Prasad, discusses the problem of “medical reversal,” in which doctors prescribe medical treatments that are later found to be ineffective or even harmful. Noting that about 40 percent of medical procedures are eventually reversed, Cifu and Prasad propose reforms throughout the medical system that will encourage doctors to rely more on proven, evidence-based treatments and less on experimental ones.
This interview was made possible through the Gate’s partnership with International House’s Global Voices Interview Series and can also be found on their website.
The Gate: In your new book, Ending Medical Reversal, you predict that 40 percent of treatments that doctors currently prescribe are unhelpful or otherwise harmful. In your field, are there any treatments currently in use that you think might soon be reversed?
Adam Cifu: It's a difficult question, right? It's seeing into the future. I think there are certainly medications that I use that I think work, but I also recognize that the evidence behind them is not terrific. And so at least I know that there's the potential that in the coming years some of those will fail.
Gate: A frequent criticism of the FDA is that it takes too long to approve new medications. What differentiates the reversed treatments that you write about in your book from the ones that get bogged down in the approval process?
Cifu: That's one of the great difficulties. The people who work at the FDA, in a way, are heroes and saints, right? On the one side they have people telling them, "You're not approving drugs fast enough! We need to get this stuff out to treat cancer and HIV disease!" And any time they try to regulate things, they're blamed for slowing down research and stifling medical progress. On the other hand, there are people like me who say, "God, you know, you need to be absolutely sure of these things before you approve them!" Because sometimes we get these things out there, a million people receive a drug or a therapy, and then we find out, “Ah! This wasn't really the right thing.”
So, the FDA needs to figure out—and I'll put all the responsibility on them—the proper in-between course to run. What they do now frequently, which I think is fine, is approve therapies based on intermediate measures. Things where they might say, "That's not solid but it's pretty good," with the expectation that the drug company or the device maker will test it further once it's out. The problem is—and there's pretty good data on this—that further testing is almost never done, because once something's approved and being used, there's really no incentive to test it further. My hope is that, in coming years, the FDA will be better in terms of following up, and that they’ll say, "Look, if we don't have data in two years, we're taking away our approval."
Gate: How have people, either at the FDA or the patient advocacy groups who want a faster approval process, responded to your book?
Cifu: It's funny. I think because our book is an academic press book, and not a huge seller, those people don't feel threatened by it. The people who I've heard the most from have already bought into the "less-is-more" philosophy that we're pushing in the book. We've heard a lot of those people say, "This is wonderful! Every physician should read this! All the people at the FDA should read it!" I think if it's read more, we'll [also] start hearing from people who think, "This is not the direction we want to go."
Gate: What role, if any, do insurance companies play in the problem of medical reversal?
Cifu: I think a lot about the makers of drugs and devices being a stimulus for reversal. They're the ones who are pushing new, expensive treatments a little bit too quickly. The insurance companies, in a way, could play a really positive role by saying, "Listen, we're the gatekeepers, we're the ones who have to pay for this, and we want to make sure things work before we pay for them." And the insurance companies who often get berated for being a horrible force could, in this way, actually be a source for good.
They have not stepped up in that way, and I think that is partly because of fear, because they think, "Let the FDA get blamed for slowing things down. We don't want to be seen as stopping access to drugs that work." In fact, you could almost blame them because there are certainly things, both medications and, probably more importantly, procedures, that insurance companies will cover just because it's becoming common care even though it's not really based on any data.
Gate: Are there any of those treatments in particular that come to mind, or that you talk about in your book?
Cifu: The things which have been overturned most recently are some orthopedic procedures for the knee, arthroscopic surgery for osteoarthritis of the knee . . . and steroid injections for a certain kind of back pain, for spinal stenosis. Those are examples of things that I've referred people for in the past [that have since been overturned]. I have never heard an insurance company get on the phone and say "Wait! You can't do this!"
Gate: It seems that our whole system of insurance companies and healthcare providers is very unique to the United States, to use the most neutral term possible—
Cifu: Yes. [Laughs]
Gate: —so is medical reversal an American problem? Or does this occur in other countries?
Cifu: It certainly goes on in other countries. And in fact, although America’s healthcare —and a lot of people put "system" in quotation marks, because it's really something which has just grown up in some strange way over the last fifty years—system is quite unique, and to some extent strange, our regulatory environment is actually more stringent than much of the world’s. Other than direct-to-consumer advertising, the FDA is probably slower to approve things than in many other places, so the problem of reversal is just as much of a problem in other countries. Interestingly, the research that's been done on it, other than here in the United States, has mostly been in the United Kingdom and Australia . . . where the government paying for things that may not work or may actually harm people is more of a concern.
Gate: Do you see a need for any kind of a solution that would need to be legislated?
Cifu: It's difficult. As a doctor, I'm always so concerned about other people entering the room with me and the patient. When we think about solutions to medical reversal, much of what we've talked about is training physicians better, so that physicians really expect a high bar before they adopt new therapies, and that medicine in general says, "We have to really think about our 'do no harm' oath and think about everything we prescribe. Do I know this is gonna work, and if I'm not sure it works, let me at least inform the patients."
The image featured in this article was taken from Davenin's Flickr page. The original image can be found here.