Barack Obama’s health reform proposal includes creating a center for comparative effectiveness research.
John McCain also has expressed support for this research.
And the American College of Physicians would like patients and doctors to use comparative effectiveness information when making health decisions.
What the heck are they talking about?
Policymakers, pundits and journalists have begun throwing around the term “comparative effectiveness” as if people know what it means.
I haven’t seen a formal survey, but I’m confident that the general public does not understand the concept behind this jargon nor the reasons why a national center might be needed to compare different medical treatments and procedures to find out what is most effective for different patients.
The first step to helping people understand these issues is to stop using the term comparative effectiveness. Using insider terms like this will ensure the public never engages in the issue and never buys into it. And public buy-in is important — crucial actually — says Gail Wilensky, the term’s mother of sorts.
Wilensky, former head of Medicare and Medicaid and former chair of the Medicare Payment Advisory Commission, published a paper in the November, 2006 issue of Health Affairs laying out an argument for why a center for comparative effectiveness was necessary and how it might be organized in the U.S.
The concept of assessing the benefits of health technologies, however, is not new. Many nations have such agencies, including the United Kingdom whose National Institute for Clinical Health and Excellence (NICE) recently made headlines when it advised against using GlaxoSmithKline’s oral cancer drug Tyverb in the National Health Service because, essentially, the clinical benefits were not worth the price.
Here Shannon Brownlee, author of “Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer,” discusses the U.S. government’s first dabble in comparing health technologies during the first Bush Administration. Then like now, health costs were rising, and one congressional response, was to create the Agency for Health Care Policy and Research (AHCPR). It was a group of experts appointed to produce clinical guidelines based on science and research to help doctors sort through conflicting data.
But a few years later, Congress eliminated the agency’s funding. Brownlee attributes the shift in opinion to the aggressive lobbying from the back surgeons after the agency found little evidence to support surgery as a first-line treatment for low-back pain, and recommended that doctors and patients first try nonsurgical interventions. “Back surgeons went wild,” she wrote.
In this essay, journalist and author Maggie Mahar also discusses the financial reasons that make following a comparative-effectiveness model such a tough political sell.
Allowing the federal government or regulators to decide the best medical treatments for the entire population is not only a tough political sell — it’s a tough sell to individuals.
“A characteristically American reverence for new technology and abhorrence at putting a price on life conflict with the premise of value-based decisions,” Marjorie Ginsburg wrote in a 2004 essay published in Health Affairs.
One could argue, and both Republicans and Democrats are doing so, if Americans want continue access to high quality care, we must learn to spend our money more wisely. Or in other words, stop wasting money on expensive technologies and treatments that don’t work or don’t work any better than the lesser expensive options.Selling that point won’t be easy, though, and unless the talking heads come up with a different way to explain it than asking for more “comparative effectiveness” research, no one’s going to buy it.
When I asked Wilensky recently to describe the concept in a simpler way, she said comparative effectiveness research is finding out “what treatments work best for whom under what circumstances.”
That’s pretty easy to understand.
I posed the same question to Brownlee. Her lay description: “It’s being able to compare different kinds of treatments to find out which one works best for which patient.”
Again, simple. While I realize the concept is incredibly complex, and the average person will never learn the nuances of the policy debate, if framed in an understandable way, some people might learn about the relationship between their doctors’ decisions and their monthly insurance premiums.
Starting the conversation
So how do we start a conversation that engages people in this debate and helps them understand? Brownlee said the first step is “getting people to understand that the vast majority of what their doctor does isn’t based on science.”
In other words, inform people that doctors recommend many medical procedures and treatments that haven’t been rigorously tested and proven beneficial or worth their price.
Is a patient really going to ask her doctor if he understands statistics and can tell the difference between good and bad medical evidence? Probably not. Journalists, however, can and should do a better job of asking those questions, Brownlee said.
“Medical reporters have been reporting any rubbish that comes down the pipe,” she said. “If we can get reporters to write and think more critically, we can convince the public of the importance of having more evidence.”
Some journalists, though, might not be keen on Brownlee’s ideas. LA Times reporter Ricardo Alonso-Zaldivar wrote a largely negative article in June about comparative effectiveness research.
Zaldivar’s lead paragraph: “Medical researchers and politicians are tiptoeing into an area of health care that makes some Americans uncomfortable, even angry, and it has nothing to do with such hot-button issues as cloning and stem cell research. This time, the controversial idea is to press doctors and patients to use particular drugs and treatments in order to save money.”
“They call it ‘comparative effectiveness’ research, sidestepping a direct reference to costs,” he wrote.
The NY Times’ ongoing series, “The Evidence Gap,” is also aimed directly at the core issues driving the push for more medical evidence. These questions sum up the dilemma:
“How much evidence must there be before billions of dollars are spent on a drug? Who decides? When, if ever, should cost come into the equation?”
Wilensky said doctors have to be involved in this discussion. Her general pitch to them was that rising health care costs are unsustainable, and figuring out which treatments work best and using them is a much less draconian way to restrain costs than most alternatives, such as introducing spending caps.
Slowing spending means someone will lose out on profits, and whoever that someone is won’t be happy. That’s why changing the system will be “so difficult short of some crisis environment” unless there is substantial research and data to support the changes, Wilensky said. “If there is good clinical evidence you have a chance of getting people to change behavior.”
But clinical evidence is only one step. Communicating the meaning and implications of the evidence is equally important.
In their book, “The System,” journalists Haynes Johnson and David Broder recount the Clintons’ infamously failed attempt at national health reform in the 1990s. Among the many factors that contributed to the great flop, the authors said, was that policymakers and the press failed to help the public understand the proposal and how it would affect individuals.
If another major health reform debate occurs, the public needs to join the conversation. Using eight-syllable terms like “comparative effectiveness” will ensure that doesn’t happen.
Willensky said a debate on adopting a national center for comparative effectiveness research is on the near horizon — like within the next 12 months. If she’s right, it will be interesting to see how the idea is communicated to the public, and if the messengers learn to put the issue in context for real people using understandable language.
Editor’s note: Brownlee and Wilensky are discussing comparative effectiveness today at the Center for Science in the Public Interest – Integrity in Science Fourth National Conference in Washington D.C.
Perhaps in spite of its clumsy sobriquet, Comparative Effectiveness Research could well be a major part of the next generation of American health care. The pace may be slow but public awareness that much of health care is not strongly evidence-based is growing. An increasing volume of more highly targeted and more expensive treatments will raise the pressure to base coverage decisions on sound evidence.
As this happens it will become more and more important to foresee how CER will impact highly valuable innovation in health care — the kind of innovation that doesn’t simply create something new, but creates better outcomes for patients and more sustainable results for society, the health care system, or both.
Much of the debate on CER has centered on issues of implementation and impact on patients, providers, payers and manufacturers; there has been little discussion to date about how CER might more broadly affect valuable innovation across the health care system.
To fill this void, my colleagues at the New England Healthcare Institute (NEHI) are examining the impact that CER will have on sector-by-sector decision making throughout the health care system. Among the issues to be explored:
• When is an innovation (a drug, a device, a procedure) truly ready for review? Should innovations be given a period of time to prove themselves — albeit a period of time when payers and patients might have to pay for it?
• What will happen to clinical experimentation with novel or unanticipated uses of existing technologies, including the contentious area of off-label use? Can we have a vigorous CER program and still allow potentially valuable experimentation by practitioners in the field?
• How will ongoing scientific breakthroughs affect CER and, in turn, innovation?
• If we made a stronger national commitment to research in biomarkers, healthcare IT and advanced analytical methods, could we make CER cheaper, faster and more authoritative? If personalized medicine advances, will it make CER easier to conduct, or make it irrelevant?
Whether it targets drugs, devices, processes, procedures, treatments or costs, CER has the potential to become a major factor in all sectors of health care. It is therefore critical to understand the potential impact of CER, not just what’s behind the funny name.
I like how the Institute of Medicine has approached the issue, which is to separate it from cost-related decisions about coverage and focus on “clinical effectiveness” (see their Jan 2008 report “Knowing What Works in Health Care”). The IOM recommended a national program for comparing the effectiveness of various treatment options for specific conditions, but not specifically as a vehicle to shape coverage policy. We need to dump a lot of money into comparing treatments, not to a placebo, but to each other. I have faith that if the federal government adequately funds such research and operates a user-friendly clearinghouse for it, then physicians would eat it up based on their professional obligation to practice effective medicine. Given observations in other posts regarding Americans’ negative attitudes about limiting medical options, I think we should keep the focus on clinical effectiveness, at least in the near term.
How best to describe what evidence-based healthcare is, how it works, and why it matters? This is something we – Bazian – grapple with everyday.
Unfortunately, like a lot in the world of IT, much of EBHC is inherently complicated and can’t easily be reduced. But we agree with the author that it must be.
Indeed, for many years we’ve been arguing that even in the medical world (universities, hospitals, doctors practices) that ‘evidence-based medicine’ is a sub-optimal term. Indeed some of the comments here show why: It implies what went before has no evidence behind, which is rarely the case, and it gets working doctors backs up. (FWIW ‘comparative effectiveness’ is even more opaque.)
We’ve been pushing for the term ‘evidology’ in professional circles. We recognise it’s not a consumer-friendly term, but we believe you have to get the professional side sorted out first before you try to sort out your customer/consumer message.
A new medical specialty that enables medical research to be incorporated systematically into clinical practice
[Latin videre to discern, comprehend; evideri to appear plainly]
There’s a PPT presentation about it here: http://www.bazian.com/about_us/publications/ressources/Bazian_PuttingEvidenceIntoPractice.pdf
We see Evidology as new clinical specialty – one in which doctors lead the development and implementation of evidence-based policy and decision-making, forming a bridge between management and procurement on one hand, and management and commercial concerns on the other. For EBHC to work it must be clinically led, and these ‘evidologists’ would work at Obama/McCain’s new centre, would work at NICE, would work at Bazian. But it’s going to require new funding (anyone have a hook-up with Bloomberg? We know he’s interested in public health) and new departments and curriculums.
We hope to see the Royal College of Evidology in our lifetimes. It took Radiology 60 some-odd years, so we’re trying to beat that.
Comments like “getting people to understand that the vast majority of what their doctor does isn’t based on science.” are not a good way to sell this to doctors. Although I agree that evidence based clinical medicine has a long way to go, the VAST majority of treatments do have some scientific evidence behind them. Its determining who needs surgery versus conservative therapy versus medication that is the nuance. Cost/Risk/Benefit each need to be weighed. As opposed to unregulated herbs or alternative medicine markets which in the VAST majority of cases have no trials.
The comment in the post about educating the public is the crucial one. When a new drug or procedure surfaces, after the lengthy FDA ordeal, physicians face twin pressures: from often desperate patients to whom the drug or procedure has been oversold by the vendor and from the vendor directly through monetary incentives and indirectly through carefully orchestrated peer pressure from colleagues. The skids for overuse or inappropriate use are thoroughly greased.
The political pressure on a comparative effectiveness agency will be a direct function of whether CMS or major payors require its signoff before approving the drug or procedure for coverage. If the agency is designed as a fiscal gateway for new drugs, it will be incinerated by the first serious dispute over its findings. In a surprising number of instances, the “evidence” supporting a clinical innovation is pretty thin because the underlying scientific knowledge is thin. Having said all this, such an agency is critically needed, and Congress needs to take steps to protect its political independence.
It sounds great until the disease that you or your family member has is subject to the comarative effectiveness axe.
Case in point is the Alzheimers drugs issue in the UK. NICE looked at the data, felt the drug didn’t do much and “wasn’t worth it,” and took steps to stop covering it. Advocates were livid. (as were the drug companies) “how could you not help granny from delving futher into dementia. How heartless, etc, etc.” The fact that the drugs are expensive and provide little benefit (according to many studies), didn’t mean a thing. Benefit, however small, was being revoked, which is heartless and mean and unacceptable and penny pinching and…….
That’s in a country that’s used to centralized decisionmaking for medical issues. How do you think it’s going to go over here?
Once again, a good idea is being distorted by politics. Most docs do NOT see comparative effectiveness research as rationing – but as a way to truly find out what treatment works best for what patient. Right now treatment is often determined by where the doc trained and what his mentors at that institution learned – largely from THEIR mentors. Bad and outdated information gets passed down this way. Comparative effectiveness research is sadly lacking in U.S. medicine today due to lack of funding. None of the big private players want to fund it since the results might hurt them. Hence, the idea for a government-funded center which would oversee this greatly needed research.
I realize you all are cynics with good reason – but this is an idea which should be implemented. Scream all you want for proper safeguards preventing its use for cost control only, but realize this research will help you, not hurt you.
comparative effectiveness = rational rationing
what we have today is irrational rationing
“Comparitve effectiveness” = Rationing. Yes America if you want cost controls and affordable healthcare then neither the private sector NOR government can give you all you want when you want it. Looking more like single-pay isn’t it.
AHCPR didn’t get eliminated entirely. Its budget was cut and it was changed to the Agency for Healthcare Research and Quality (AHRQ). And Brownlee is right, it was back surgeons who caused that. Here’s an article from Health Affairs on AHCPR’s history:
Let’s not ignore the fact that the back surgery controversy took place just as the GOP took over Congress. The GOP Congress eliminated the Office of Technology Assessment entirely and, at the behest of the surgeons, took an ax to the AHCPR budget. Basic biomedical research that can be used by big pharma however is a good thing, so they increased NIH’s budget. Independent research on whether an expensive surgical intervention is worthwhile, however, is a bad thing.
“comparative effectiveness” – It is what it isn’t.
Doctors go to school many years to be able to understand health care options. Why do policy makers think that the rest of us will be able to understand them without that education, or have the cognitive ability to understand the options?
Health care is complicated, variable, and scary to the patient. Asking them to figure out everything for themselves is just too much. That is why we go to doctors, to have THEM figure it out. What part of that don’t the politicians and other policy makers get?