Despite the political mudslinging that continues to erupt at mere mention of the Affordable Care Act, it’s clear that the law has opened up the healthcare system to millions of Americans. A Gallup poll recently found that the adult uninsured rate fell from 17.1 percent in the fourth quarter of 2013 to 13.4 percent in the second quarter of 2014, the lowest level in six years. But while this expansion of coverage is a boon to the many who lacked sufficient access to medical treatments and services, it draws attention to questions that cut to the heart of healthcare reform: To what extent is our consumption of healthcare extraneous, and to what extent is it harmful?
Though the US economy is still struggling to recover from the recession, spending on healthcare is on the rise. In fact, the US spends more on healthcare than any other country. According to the California HealthCare Foundation, total healthcare spending is projected to hit $3.1 trillion this year, an amount that the Centers for Medicare & Medicaid Services expect will climb approximately 6 percent per year from 2015 through 2023.
While the largest segment of those expenditures—about 32 percent—goes to hospitals, it’s pharmaceutical corporations, as well as their distributors and benefit management services, whose earnings are the most concentrated. McKesson, the largest drug distributor in the US, earned revenues of over $120 billion in 2013. The country’s biggest pharmacy benefit management service, Express Scripts, landed over $100 billion, and pharmaceutical company Pfizer collected over $50 billion. For some perspective, in the last fiscal year, the revenues of McKesson and Express Scripts were each greater than those of Citigroup, Amazon, or PepsiCo.
Such dramatic figures are the result of an inefficient and economically unsound healthcare system, one fueled by overtreatment, argue Shannon Brownlee and Dr. Vikas Saini of the Lown Institute, a Boston-based nonprofit committed to “building a compassionate and sustainable health care system based on people receiving the care they need and eliminating unnecessary care that can cause harm.”
Brownlee, a former medical reporter for U.S. News & World Report and current senior vice president of the Lown Institute, investigated the overblown nature of the healthcare system in her book Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer. Saini, a clinical cardiologist, lecturer in the Department of Medicine at Harvard Medical School, and president of the Lown Institute, helped convene the Avoiding Avoidable Care Conference in April 2012. Through the Lown Institute’s initiatives, including the RightCare Alliance network of practitioners, patients, and advocates, Brownlee and Saini are deeply engaged in the intersection of patients’ rights, clinicians’ needs, appropriate care, and the road to a more functional healthcare system.
I spoke with Brownlee and Saini by phone while they were at their offices near Boston. Our conversation traversed matters medical, political, and personal; of an unnecessary medication that Brownlee’s father had received, she said, “It just about killed him.” In the interview that follows, Brownlee and Saini articulate the structural and cultural issues in the American healthcare system that enable the drug and device empire to do such harm.
—Grace Bello for Guernica
Guernica: Shannon, you started your career as a medical reporter and eventually honed in on the issue of overtreatment. How did that come about?
Shannon Brownlee: It was a slow evolution. When I was the lead reporter covering the medical and biomedical beat for U.S. News & World Report, I started to realize that something was amiss in medicine. I came upon this story about prostate-specific antigen (PSA) testing. At the time, everyone thought that the PSA test was a great thing; it was going to save men’s lives the way mammography was saving women’s lives.
But the more I researched, the more I found that, in fact, there were lots of doctors who were worried about PSA testing. The test was discovering pseudo-diseases—things that looked like cancers but in fact probably wouldn’t hurt you. The part that resonated with me the most was that men were getting treatment for this pseudo-disease. The subsequent surgery that many men sought left them impotent or incontinent or both. That was a wake-up call. I started to realize that, everywhere I looked, I saw examples of unnecessary care, hospitalization, or treatments that weren’t backed by good science.
Guernica: Dr. Saini, as a physician, what led you to focus on overtreatment?
Vikas Saini: I suppose it’s a combination of my background, my training, and my worldview. I went to medical school in Canada. When I came to the States, I noticed a significant difference in the culture, specifically around innovative technologies that were not yet proven. I found a much greater willingness in the US to employ those technologies and to justify that use. This tendency toward new technologies was much less prominent in med school. But I could never tell whether that was just the difference between being a student versus being a practitioner or whether that was a difference between Canada versus the US.
The second factor was, in the course of my clinical training, I increasingly found myself managing patients with a less-is-more approach. This was merely based on what I was seeing right in front of me. For example, we had a very high volume of heart attacks in the hospital where I trained. I had elected to take a lot more training in cardiology than I needed. By the end of that period, I found myself managing patients with less technology and finding that other doctors were using more. I sometimes got criticized for my approach. But as I learned more about the evidence, I learned that the quantity of care doesn’t matter as much as the quality of care.
I certainly wasn’t convinced that when patients were getting a lot more done to them they were getting better care.
The other way that I came across overtreatment was, after I trained here in Boston with Dr. Bernard Lown—who has championed a much less invasive approach to managing heart disease—I went out into practice. I saw how differently most of the world addressed their patients’ needs. I certainly wasn’t convinced that when patients were getting a lot more done to them they were getting better care. And then the more I read and reviewed the evidence, the more I saw that the data was incomplete, contained a lot of bias, and quite often entailed aspects of habit that have nothing to do with science.
Shannon Brownlee: I wanted to ask Vikas—was there a patient whom you saw who was harmed by care that wasn’t necessary or that was more invasive than necessary? I’ve never asked you that before.
Vikas Saini: Well, when I was a trainee, it was harder for me to judge my betters. My second month as an intern, I had somebody with end-stage lung disease whom we had on a ventilator. I took care of him for maybe a month and a half in the ICU. And he died there.
In retrospect, that month and a half that we kept him in the ICU was like torturing him. But at the time, I didn’t know any better; I thought that this was our way of providing good, high intensity medical care. I wasn’t yet in a position to judge whether or not this patient was going to make it.
Now, twenty years later, who knows? I can’t transport myself back to that time. But I have to believe that now—more often than I did back then—I might meet with a patient or their family members and say, “The odds of actually pulling out of this are vanishingly small. It probably won’t do you any good to undergo such invasive treatment.”
Guernica: Shannon, what about you? Did you have a similar personal experience?
Shannon Brownlee: I did, but I didn’t recognize it as such until later. My dad had an unusual reaction to a statin drug—a cholesterol-lowering drug. At the time, the cutoff point for what was considered healthy cholesterol had just been lowered. So one day he had so-called normal cholesterol—according to the guidelines—and the next day he had slightly elevated cholesterol—according to the guidelines. So he was put on this statin.
It caused his muscles to break down. It started to destroy his kidneys. He was getting weaker and weaker. We didn’t know what it was. He was experiencing chest pains, and everyone thought he had angina.
It turned out that he was having this reaction to the statin. It did kill one of his kidneys. It just about killed him. Later, I started to see that it really affected the next decade of his life in a serious way. I started to understand that this kind of unnecessary treatment happens over and over again. And it hurts people.
Guernica: How do pharmaceutical companies promote these drugs?
Shannon Brownlee: Well, there are two kinds of advertising for the drug industry: one is to patients, and the other is to physicians. Drug companies put a lot of money, effort, and time into both of these markets because the patient can demand the product, and the physician can prescribe it. In addition, the pharmaceutical companies are also marketing more and more heavily to nurses, nurse practitioners, and pharmacists.
You know, when we advertise detergent, we don’t think there’s anything wrong with that. And the fact is, your average consumer can tell that one brand isn’t that much different from another. But for a patient, it’s very difficult to know the true value of a medication. So they employ an awful lot of smoke and mirrors to persuade people that, first of all, they have a condition, and that, second of all, the condition should be treated with whichever drug the company is advertising.
There’s a slightly different kind of advertising that happens on the physician side. Physicians are more likely to listen to someone in the medical community, someone who’s an authority in that particular area. For instance, practitioners might see an academic physician as having more knowledge and more authority, and an academic physician might see an expert in a particular specialty as having more knowledge and authority.
The pharmaceutical industry has been very adept at using physicians themselves—and weak science—to market these drugs.
Vikas Saini: The other thing is that the pricing is completely divorced from rationality or efficacy.
Shannon Brownlee: [laughs] That’s putting it nicely!
Guernica: So how does the pricing work?
Vikas Saini: There are many, many examples, but I’ll give you a simple one.
I believe that statins, the same class of drug that affected Shannon’s father, are not a panacea, but they are typically good agents. My point is that the first statin out of the box really deserves some value. The pharmaceutical company has a patent, they get to set a price, etc.
But there is a lot of money spent on me-too drug products that are not really breakthroughs in science. Study after study has shown that they’re just adding a few atoms. That way, they are able to patent it. The drug companies hope for fewer side effects, but it has the same effect.
I think a lot of the researchers in the drug industry are honest, hardworking people, so that’s not where the fault lies. But the fact is, the issue of pricing is all theoretical. The second and third and fourth me-too statin should be cheaper and cheaper. But there’s a divorce between what people end up paying and the actual benefit. And much of that is due to many, many factors that are completely independent of science.
Shannon Brownlee: Just to clarify, my dad did not have heart disease at the time that he was prescribed the statin.
Guernica: Wow.
Vikas Saini: Primary prevention?
Shannon Brownlee: Supposedly.
Guernica: Why is the cost of the drug so separate from how effective it is?
Vikas Saini: We apply lots of economic principles that contain assumptions about how markets should work and how they actually work. Especially in something as life-important and personal as your health.
The famous example is that the federal government—though it pays a ton of money for healthcare, including prescription drugs—is not allowed to negotiate on price. By law. But I think there are many other ways in which the pricing is divorced from the clinical benefit.
I think some of it has to do with the fact that insurance companies have only a little bit of skin in the game. They often will pass on those costs to the patient. Although insurance companies like to portray themselves as part of the cost solution rather than the problem, the reality is that many of them are just flow-through vehicles.
I don’t think insurers are doing the kind of job they could do. There are many ways in which pharmaceutical marketing—both to consumers and to doctors—creates these undercurrents of persuasion that allow market share to shift without any reference to what kind of care might work best.
Shannon Brownlee: It’s not just drugs, by the way. With just about anything you can name in American healthcare, the price doesn’t have a lot of relation to the value.
Vikas Saini: Right. This is true pretty much everywhere in the system. From the cost of procedures like appendectomies to basic blood tests—you name it, it’s just the Wild West.
Guernica: Do you know of any legislature that’s being put in place to limit the scope of the pharmaceutical industry?
Vikas Saini: I’m not aware of any discussion around regulating. I mean, given the recent ruling of the Supreme Court and others, no one is really contemplating regulating free speech of corporations; I’m sure that’s how any proposed legislature would be framed.
It’s just like with any drug dealer; the first nickel bag is free.
Guernica: In terms of direct-to-consumer marketing, pharmaceutical companies often offer free samples to doctors who then disperse them to their patients.
Shannon Brownlee: It’s just like with any drug dealer; the first nickel bag is free. Free samples are a marketing ploy to get physicians and patients hooked on a particular brand. A lot of physicians say, “I like getting free samples because I get to give them to my poorest patients.” But the reality is that a huge number of free samples go to patients who are not poor or to the physician’s friends and family.
The practice of handing out free drug samples has been recognized by many people as purely a marketing strategy—and a very effective one. It results in brand loyalty from physicians and patients. The thing about the drug industry is—you’ve got to hand it to them—they’re geniuses at marketing.
Guernica: I want to take a look at one of the anecdotes in Shannon’s book, the case of Justin Cheslek, who took the antidepressant Effexor, which his family didn’t realize could possibly lead to suicidality.
Shannon Brownlee: Yeah, that’s a tragic story. He was a student in college. He was having a little bit of trouble sleeping, he was smoking, he was staying out late, he was probably drinking too much, he was having trouble with his classes. The school physician prescribed an antidepressant. Antidepressants at that time were really not recognized for the possible side effect of increase in suicide risk.
Part of why this side effect wasn’t recognized was that there was a pretty active effort by the industry to dismiss those side effects. Those risks were there in the drug companies’ data, but the side effects had been buried pretty effectively.
Justin was prescribed a drug, and he had a reaction called akathisia, which patients describe as “wanting to jump out of your skin.” You feel so agitated and so uncomfortable that you can’t stand being yourself. Ultimately, he hanged himself.
The terrible irony was that his mother was a nurse. A short time after he died, she got a Dear Provider notice from the manufacturer saying that there was some concern that this drug may increase suicidality.
Guernica: In terms of marketing and advertising, Shannon, you mention in your book that, for Lunesta, one firm spent $60 million on TV advertising to get their commercial on prime time during Desperate Housewives.
Shannon Brownlee: And there are two pieces to that. One is called disease branding. This is a really smart marketing tool. The pharmaceutical company persuaded people that they had a problem. With the sleep drugs in particular, they effectively bought the patient advocacy organization—which I’m sure began with the best intentions—to promote better sleep. As a society, yes, we are fairly underslept. But they pushed this organization to exaggerate the problem. The pharmaceutical company branded the disease and then followed with, “We have the solution, and it’s this drug.”
Vikas Saini: While we’re talking about pharma, I’d like to go back to my point about the divorce of cost of care and quality of care. Part of the defense is that it’s about innovation. The high profits, the extension of patents—they defend it by saying it’s the price of progress.
A decade ago the total amount of drugs that the FDA approved that year was 314. The number that were new molecular entities—which is a class of innovation—was only eight-nine. And the amount of new entities that were significant improvements over older drugs was thirty-two. And of those, the number that actually originated from a US drug firm was seven. Out of 314 drugs, real innovation occurred in seven of them.
If you look at the amount of money drug companies spend on research and development versus marketing, marketing wins, hands down. So the price is really divorced from the value and the science and all the other pieces of the puzzle. As we said earlier, that’s true for devices and other parts of the system, too.
Shannon Brownlee: You know, it’s very easy to demonize the drug industry and the device industry. Goodness knows they’ve done many, many things that are not in the best interest of patients. However, in some ways, I don’t blame them, because that’s the way the rules work. That’s the way the system is set up.
We should also remember that this focus on the money side versus the social-good side is really a symptom of our entire system. Even if a hospital calls itself nonprofit, it’s still fundamentally a profit-seeking organization. That’s in part due to the way we pay for services and in part due to the general culture of American society—this belief that markets solve all problems.
This has become an enormous issue in medicine for doctors, nurses, and other healthcare providers; they entered medicine in large part because they really wanted to help people. They’re smart, and they want to use their knowledge and their compassion in ways that do good. The drug industry’s behavior and the device industry’s behavior are symptomatic of what ails medicine in general and the American medical system in particular. It has started not only to harm patients but also robs healthcare practitioners of their sense of connection and their sense of meaning in what they do. It just starts to be all about the money.
Guernica: You mentioned the profit-seeking nature of hospitals. Specifically, some treatments such as chemotherapy are more lucrative than others. So how does that influence the kinds of treatments that physicians recommend?
Vikas Saini: It doesn’t occur on an individual patient level for a given test or procedure, I don’t think. It tends to occur on the group level where the system begins to manifest its cultural center of gravity.
Remember, it’s about how the funds flow. So that particular profit-seeking behavior pattern tends to be exaggerated when payments are volume-based. If a particular procedure is more profitable—if you’re paid piecework for a particular test and you make more money on it and aggregate it across five or ten or fifteen doctors—those tests and procedures end up becoming more attractive.
Hospitals spend more time, more effort to make sure the patient doesn’t miss any opportunity to use the treatment. The criteria for recommending the treatment become looser because it can be portrayed as a win-win. With these kinds of tests and procedures, the moral hazard of “someone else is paying for this” really emerges.
On the other hand, other aspects of care lack high margins. For example, just speaking with the patient as their physician—that’s really hard to do. You don’t get paid for that, so there’s less incentive to have a conversation with them about their care, and therefore it happens less often than it should. So, culturally, how money gets allocated does influence behavior, but it doesn’t correspond in a one-to-one manner.
Overtreatment can afflict Medicaid patients as well as patients with gold-plated insurance.
Shannon Brownlee: Ask a physician who owns—and happens to profit from—an MRI machine whether they are more likely to use that imaging. They would say, “Absolutely not! I only recommend this when it’s right for my patient!” But according to several studies, if you own that machine, you’re much more likely to recommend MRIs. So part of this is possibly unconscious. This attitude of more is better infuses the system. It infuses the culture. It infuses the patient’s expectations as well.
Vikas Saini: We’ve been talking about overtreatment, but it’s important to remember that there’s a huge imbalance in the system. A lot of overtreatment is selectively happening with patients who are a greater source of income. However, many patients haven’t had care and often remain undertreated. Both of these issues impact people’s quality of life, people’s health, and, ultimately, how much it costs patients to get treated.
Shannon Brownlee: Well, sometimes it happens in the same person. Overtreatment can afflict Medicaid patients as well as patients with gold-plated insurance.
Guernica: To what extent do patients themselves request more medical services and treatments than they need?
Vikas Saini: This goes beyond the US, but as a society, we seem to believe that the brighter, shinier, newer technological object is better, which means that everyone starts to want it—including people who haven’t had access to health insurance. So that becomes the norm and the definition of so-called good care.
This is the challenge for all of us—from citizens to policymakers—to begin to recognize that that just ain’t so. And it’s not a sustainable model of healthcare.
Guernica: Has the Affordable Care Act addressed any of the problems that we’ve been talking about?
Shannon Brownlee: Certainly, more people are insured, and that will help address undertreatment. But it has also inserted a lot of chaos and turmoil into the system.
Vikas Saini: In one study, people modeled the effects of RomneyCare in Massachusetts. There are estimates that many thousands of lives have been saved. It’s imperfect data, and we don’t have nationwide statistics yet, but I think it would be fair to say that there will be many people whose health will improve. Many lives will be saved by this modest extension of medical coverage, the Affordable Care Act.
However, saying that improved healthcare has led to improved appropriateness of care is a long, long leap. I doubt there’s any evidence of that, and I’d be surprised if the Affordable Care Act made that sort of impact.
Guernica: Dr. Saini, you were talking about how physicians are persuaded by the authority of certain other physicians. Can you talk more about this?
Vikas Saini: I would say that there are two classes. There are key opinion leaders who are participating in the design, the clinical trials, and perhaps the funding of the trials. They make a career out of it, they publish papers, they become authorities. And with these folks, some of that conflict of interest may be money, but a lot of it is more about professional advancement. So in their case, they suffer from a professional bias.
Then there’s another class. Through an alliance with a marketing program, physicians who aren’t experts in a particular area become local experts. These companies host dinners at fancy restaurants and the practitioners give talks, and oftentimes the slides for the presentation have been skewed in favor of the product being marketed.
Part of that bias is, by the way, not venal. It’s that a certain drug or treatment is the cool new thing, right? No practitioner wants to be out of date. Everybody thinks, “Oh god, I have to keep up.” So the fact is that wanting to be on the cutting edge drives people to want to learn more, and it’s what allows individuals who aren’t particular experts to become local experts.
In other parts of the world, the level of corruption around this is extremely high. A lot of money changes hands under the table. There are free trips involved. It’s a practice that’s no longer happening in the US, although it did occur about twenty or thirty years ago. But there are other forms of influence. It’s happening, and sometimes it’s caught, but sometimes it isn’t.
Shannon Brownlee: I think there are two kinds of those covert marketers: the witting and the unwitting. When I was writing Overtreated, I think that most practitioners who went to one of these sponsored dinners about knee surgery and the use of Celebrex—they thought they were getting important scientific information. They did not understand that the person standing up there was, in effect, marketing to them. They didn’t know that every slide the person showed had been put together by the marketing department of the drug company. And some of those people doing the presenting didn’t realize that they had essentially been bought to do just that. Whereas others are quite aware of the role that they’re playing in marketing and are doing it quite willingly.
Right now, the drug industry is investing in patient-marketers. If you look at some of these platforms such as PatientsLikeMe and similar services, these sites supposedly help patients share information about their success or failure with a particular treatment. But some of these people are being paid by the industry to push their products. It’s a new form of covert marketing, and it uses the patients themselves.
The spine surgeons did not call out spinal fusion, one of the fastest rising procedures among Medicare patients; the interventional cardiologists left the overuse of cardiac stents off their list.
Guernica: What can patients do, and also what can clinicians and community leaders do, to curb overuse of medical services?
Shannon Brownlee: There are multiple efforts underway to curb overuse, all of them entirely reasonable approaches. For example, there’s Choosing Wisely, an initiative of the American Board of Internal Medicine Foundation, which asked each of the physician specialty societies to come up with a list of five procedures, tests, or treatments that their members should curtail or stop doing entirely. Hospitals around the country are now trying to get their doctors to pay attention to these lists and comply with them.
You can probably predict two of the main problems with such an approach. First, the specialty societies generally did not go after the most egregious—and lucrative—overused practices. The spine surgeons did not call out spinal fusion, one of the fastest rising procedures among Medicare patients; the interventional cardiologists left the overuse of cardiac stents off their list. Second, hospitals make money on a lot of the things that are overused and thus are disincentivized to get their doctors to relinquish them.
The hospital’s disincentive to reduce overuse would be ameliorated if, instead of being paid on a fee-for-service basis, they were paid a set amount monthly or annually to take care of a given population of people. It’s called global budgeting. This method of payment is part of the longterm plan for Massachusetts and is built into health systems like Kaiser Permanente and Group Health Cooperative of Puget Sound. Basically, it compels hospitals to stop delivering stuff that patients don’t need and that costs the hospital money.
You can probably see the downside of global budgeting—unethical hospitals will go from delivering what patients don’t need but is profitable to withholding services that are beneficial but are costly.
Guernica: And what about reforming the US healthcare system more broadly?
Shannon Brownlee: American healthcare isn’t in need of reform, it needs a radical transformation. It is dominated by hospitals and specialists, despite the volumes of evidence that the path to better health requires major changes: a much stronger primary-care infrastructure, and the labor and infrastructure to care for people in their communities and their homes as much as possible.
American healthcare, far from being the best in the world, is outrageously expensive, wasteful, and dangerous. That isn’t a system in need of a few minor tweaks; it needs a serious overhaul. Community leaders need to understand that. They have advocated long and hard to get coverage for the uninsured and the poor. Now they must turn their efforts toward making sure that the care to which we have access is effective, safe, local, timely, and affordable. To do that, they’ll need to join forces with the many good doctors and nurses out there who are advocating for real change.