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Comparative Effectiveness Research

Conservatives love to apply “cost-benefit analysis” to government programs—except in health care. In fact, working with drug companies and warning of “death panels,” they slipped language into Obamacare banning cost-effectiveness research. Here’s how that happened, and why it can’t stand.

Why are you reading this when you could be doing jumping jacks?

And how come you’ve gone on to read this sentence when you could be having a colonoscopy?

You and I could be doing all sorts of things right now that we have reason to believe would improve our health and life expectancy. We could be working out at the gym, or waiting in a doctor’s office to have our bodies scanned and probed for tumors and polyps. We could be using this time to eat a steaming plate of broccoli, or attending a support group to help us overcome some unhealthy habit.

Yet you are not doing those things right now, and the chances are very strong that I am not either. Why not?

Continue reading “The Republican Case For Waste In Health Care”

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The new Patient-Centered Outcomes Research Institute (PCORI) has been asking different stakeholders about the most important issues to address with the hundreds of millions of dollars the quasi-governmental group will shortly be doling out in grants. Not surprisingly, the stakeholders have been more than happy to respond.

PCORI’s most recent day of dialogue, which I attended as a representative of the Society for Participatory Medicine (SPM), was characterized by genteel civility and a big question mark: “Is PCORI serious about transforming health care?” When I asked directly, I didn’t get much of an answer. The reason, I suspect, goes to PCORI’s origins. It is the offspring of a shotgun marriage between goo-goos and pinky-ringers, and no one is quite sure yet what this child will be once it grows up.

Let me pause here a moment to parse the political shorthand. “Goo-goos” are “good government” types, the kind of folks who trumpet the need for transparency in government or better public transit. Goo-goos, seeing the half trillion dollars or so of waste in U.S. health care system, called for a new national organization to carry out comparative effectiveness research in order to help Americans get the most value for our money.

The goo-goos pointed out that our current regulatory structure is designed to ensure that treatments are safe and effective, not compare them. Nor does the private sector have much incentive to pay for comparative studies that may undermine products currently selling quite nicely, thank you.

Continue reading “Patient Politics: the PCORI Puzzle”

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The Food and Drug Administration’s Prescription Drug User Fee Act is up for reauthorization next year, and so is the consumer and drug industry face-off over the contentious issue of comparative effectiveness research (CER). Consumers, patients and some physicians are demanding that CER be required of all new drugs coming to market when there are already FDA-approved therapies for the same condition. They say it will give payers and patients immediate feedback on the relative worth of the latest drugs, which are always more pricey than what preceded them, especially if the older drugs are coming off patent.

Industry opposes including CER arms in final efficacy trials. The companies claim it will place additional costs on the already expensive new drug development process; provide inadequate information for actually divining the relative worth of two competing therapies; and dissuade companies from investing in follow-on drug research, which can turn up drugs that are significantly better than older drugs.

The American Enterprise Institute’s Scott Gottlieb, who served in the FDA during the Bush administration, this week offered a lengthy brief in support of the industry position. Unfortunately, he sets up a straw man in order to knock down what could be a very effective tool for lowering the cost of medicine. It behooves industry leaders to ignore his advice, and to ignore the bleating of their marketing departments’ incessant demand for follow-on drugs.

 

Continue reading “FDA Should Add a Comparative Effectiveness Arm to Final Trials”

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Today’s New England Journal of Medicine reports the results of a government-funded study of two potential approaches to giving emergency diuretics to congestive heart failure patients who show up on emergency room doorsteps gasping for breath. Should it be through a continuous drip or periodic injections? Should physicians prescribe high doses or low doses of these fluid dispersal drugs? Cost isn’t an issue since diuretics are generics. The pressing question was whether high doses caused a greater incidence of renal failure, which had been suggested by a number of smaller trials.

This comparative effectiveness study is the kind of research that never receives attention in the press. No new drugs are involved, nor does it involve a high-profile disease. But it merits closer scrutiny because of the patient population. There are more than a million patients who enter hospitals every year with acute episodes of congestive heart failure. The average age in this study was 66, i.e., Medicare was paying the tab. Three quarters had been admitted to the hospital within the past year. More than half had diabetes, and around 40 percent had implanted defibrillators. Most were on two or more drugs for high blood pressure. I searched for data on the average weight of this population, but, alas, that wasn’t included. I think you can guess.

The results were mildly interesting. It didn’t matter what approach physicians took, the outcomes were about the same. Fears of exacerbating renal failure in this vulnerable patient population from high dose diuretics appear to be overblown.

I’m afraid this is going to be the conclusion of much comparative effectiveness research, which received a major shot in the arm through the 2009 stimulus bill and will receive a continuous injection of funds from the Affordable Care Act, presuming the Republicans in Congress aren’t successful in de-funding the bill. Physician and hospital practice will have better evidence about what to do in certain situations, but radical changes in procedures that have a dramatic impact on cost will be elusive. Continue reading “Heart Failure or System Failure?”

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Media coverage of the government’s new investment in comparative effectiveness research leans heavily toward the effects of such research on new drugs and technologies: Will such evaluations lead to restricted access to the latest innovations?  Will insurance no longer cover a drug that might give my aunt another year to live? Will such research hinder the development of a drug that could cure my nephew of type I diabetes?

The focus on how results from comparative effectiveness research might affect new approaches  obscures for the public and for policymakers the vital role of such research in evaluating current approaches to diagnosis and treatment that may not only be ineffective but in fact harmful to us.

I am now slogging through chemotherapy for stomach cancer almost certainly caused by receiving high doses of radiation for Hodgkin lymphoma, which was the standard treatment until long-term side effects (heart problems, additional cancers) emerged in the late 1980s.  So I am especially attuned to the need for registries and trials to track the short- and long-term effectiveness of treatments.

So choosing a surgeon in September to remove my tumor shone a bright light for me on the importance of research to evaluate current practices. Two of the three surgeons I consulted wanted to follow “standard treatment procedures” and leave a six-centimeter cancer-free margin around my tumor. This meant taking my whole stomach out, because of the anatomy of my stomach and its arterial supply.

Continue reading “More Can Also Be Less: We need a more complete public discussion about comparative effectiveness research”

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This is a summary of the HIT Trends Report for October 2010.  You can get the current issue or subscribe here.

The evolving health information exchange market. The HIE segment was center-stage this month with a game-changing announcement by Surescripts. It will combine its national physician directory and EMR connectivity with apps from its strategic investment in Kryptiq to offer physician-to-physician clinical messaging beginning in December, extending its dominant market position.  As first to market with these functions, it will likely cement its standing as the country’s premiere neutral national network.  It also enables a platform for additional web services from collaborating partners in the future.  We are also reminded this month in Healthcare IT News of the relative dominance of Epic in the IDN and large practice market with the startling statistic that 75% of Wisconsin residents are in the databases of its state user group.  Using Epic tools and with patient consent physicians in the state can see patient information across institutions.  And there’s a story this month that Verizon is expanding its vision as an HIE by adding clinical lab and imaging results to its networking services with leading transcription companies.  These three lenses:  (1) Surescripts as the leading national network; (2) Epic as the leading national EMR; and (3) Verizon as the leading national telecom, exemplify the rapidly changing dynamics in this segment.

EHRs and HIT have become central to transformation of clinical practice. One large driver is the announcement by the insurance commission of the inclusion of HIT as well as wellness and care management as medical expenses for insurers under PPACA.  In the past these areas were generally allocated to the administrative budget of health plans which limited participation.  This will increase payer investment.  A CMS exec, Anthony Rogers, reported to Healthcare IT News on early results of CMS accountable care organization (ACO) pilots.  He noted that practices with EMRs were getting most of the $36M in incentives and said, “If that’s not a business case [for EHRs], I don’t know what is.”   The Patient-Centered Primary Care Collaborative, the organization driving medical homes released two reports this month also highlighting HIT’s role in transformation.  One report looks at best practices to engage patients in a medical home project using HIT.  It’s a compendium of 15 essays by a diverse set of experts on different perspectives about using health IT to engage patients, plus snapshots of two dozen case examples.  The other report focuses on five ways to implement HIT effectively to enable clinical decision support.  And CSC released a roadmap for HIT in ACOs with an elegant six factor model:  member engagement; medical management; clinical information exchange; quality reporting; business intelligence; and  risk and revenue management.

Continue reading “HIT Trends Summary for October 2010″

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Comparative Effectiveness Research (CER) is suddenly a hot topic at all the health care conferences. How come? Everybody agrees that we have to decrease per-capita cost and increase quality. Why? Government programs like Medicare and Medicaid foot more than 50% of our nation’s health bill, and if everything stays the same these programs will go belly up (bankrupt) in 8 years. Big problem.

Health and Human Services (HHS) has defined comparative effectiveness research as conducting and synthesizing research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor health conditions in “real world” settings. In other words, CER is figuring out what treatments, tests, and drugs work and which ones don’t work.

John E. Wennberg spent a whole career at Dartmouth studying American medicine, and he comes to the startling conclusion that 60% of Medicare is spent on supply sensitive care (physician visits, consultations, imaging exams, and hospital and ICU admissions) and 25% on preference sensitive care (PSA tests, mammography, and elective surgery). Although we assume that this care is based on solid scientific evidence, Wennberg states that “medical science is virtually silent on such matters” as how often to see a patient, what test to order, and whether to admit a patient to the hospital or ICU. Some evidence based medicine experts state that only about 20% of what physicians do is based on sound science.

Continue reading “How Come Comparative Effectiveness Research is All the Rage?”

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The Government Accountability Office last week appointed two “faster cures” patient advocates and a former insurance company executive now on the AARP board to the three slots reserved for patient and consumer representatives on the Patient-Centered Outcomes Research Institute board, which will oversee comparative effectiveness research under health care reform.

The reform legislation passed last March gave GAO the job of appointing the 17 public members, which also includes five representatives of private payers, five physicians, and three industry representatives (one each for drugs, devices and diagnostic manufacturers). A full list can be found here.

The three “patient and consumer” representatives are:

  • Ellen Sigal, chair, Friends of Cancer Research.

Sigal is an outspoken advocate for more money for cancer research. Her board is comprised largely of fellow executives in the research community, including staff from the American Cancer Society, Research America!, and the American Society of Clinical Oncology, which represents cancer docs. She serves on numerous non-profit boards, including the Reagan-Udall Foundation set up by the Food and Drug Administration to expedite drug development; and has served on numerous Institute of Medicine panels investigating new ways of conducting cancer research that can lead to faster access to new medicines.

Continue reading “Consumer Groups Shut Out of Comparative Effectiveness Board”

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Not long ago I was lucky to be invited to a New England Healthcare Institute discussion entitled “From Evidence to Practice:  Making Comparative Effectiveness Research Findings Work for Providers and Patients “ in Washington, DC.

How to disseminate and implement Comparative Effectiveness Research (CER) so that patient care is really improved was the first topic tackled by the expert panel and the moderator, Clifford Goodman of The Lewin Group.

The target audiences for CER findings include: patients, disabled patients, providers, policy makers, health plans, medical device companies, pharmaceutical companies, hospital administrators, academic researchers, community physicians, professional societies, and regulators.

Michael McGinnis, MD, of the Institute of Medicine, offered clusters as a way to organize these different targets:  Cluster 1 (patients, providers, policy makers), Cluster 2 (control levers like payers, purchasers, system managers, professional societies, regulators) and Cluster 3 (researchers and those concerned with methodology).

Seth Frazier, Vice President of Transformation at Geisinger, was the first of many to point out the gap between the academic literature of CER and what patients and providers need at the point of care.  He noted that providers need actionable recommendations that can be integrated into the flow of the clinic and hospital and that much of the evidence-based medicine product is not usable in this practical way.   This observation reminded me of the gap between the public and the health care experts that Drew Altman of the Kaiser Family Foundation documented so effectively and the Kristen Carmen Health Affairs survey that said patients regard evidence-based medicine as a barrier to what they want.

Continue reading “Will Comparative Effectiveness Research Really Make a Difference If the Public Doesn’t Want It?”

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Writing in the New England Journal of Medicine (Identifying and Eliminating the Roadblocks to Comparative-Effectiveness Research) three authors share their experience in running a head-to-head trial of Avastin (bevacizumab) versus Lucentis (ranibizumab) for wet age-related macular degeneration (AMD). They describe the barriers they faced and suggest that they will need to be removed for comparative effectiveness research –as envisioned under ARRA– to succeed. They make good points and may well be correct in their policy recommendations.

However the case of Avastin and Lucentis is unusual. The products are made by the same manufacturer and are essentially identical. Avastin and Lucentis are marketed separately by Genentech mainly to allow the company to capture a return on investment from its R&D. The issue is that a regular dose of Avastin (e.g., for lung cancer) can be divided up into many doses for the eye. Since the products are sold by volume it turns out that Avastin is cheap when used for wet AMD, even though it’s pricey when used for cancer. As I’ve suggested previously, Genentech should be able to charge Lucentis prices for Avastin when it’s used in the eye. So there are quite a lot of people –starting with the manufacturer itself– who didn’t really want this study to go forward. That’s less likely to be the case with other studies. Continue reading “A Tale of Two Diseases: Repairing Comparative Effectiveness Research”

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