Friday, February 11, 2011

Why conservatives, of all people, should support effectiveness research

After voting to repeal the health reform law, the House of Representatives passed a resolution to provide direction on the “replace” part of “repeal and replace.” The resolution instructed the health committees to develop legislation to replace the health care law with “incentives to encourage personal responsibility for health care coverage and costs” among other GOP ideas, like selling insurance across state lines.

Why in heaven’s name, then, are some influential House Republicans trying to end support for research to help people “to take more personal responsibility” for their own medical care?

Rep. Thaddeus McCotter (R-MI) has introduced H.R. 556, which describes itself as the “Preserving Patients Choice Act” even though in my mind the bill actually would reduce the ability of patients to choose wisely among different treatments. The bill would repeal funding for comparative effectiveness research (CER) conducted by the new Patient-Centered Outcomes Research Institute (PCORI) and by the Agency for Health Care Research and Quality. Rep. McCotter, the immediate past-chairman of the House Republican Policy Committee, says that “H.R. 556 would repeal . . . the Patient-Centered Outcomes Research Institute, an entity with the potential to inject the federal government into the doctor-patient relationship.”

But the PCORI was set up to help patients and their doctors make their own choices, not to impose decisions on them. This is how ACP described the PCORI in a statement submitted yesterday to a House Ways and Means committee hearing:

“Each day, in the privacy of the examination room, patients are treated for conditions for which there are numerous treatment options. . . The limited availability of valid data to supplement the physician’s clinical experience and professional knowledge – data that compare the clinical effectiveness of different treatments for the same condition – makes it difficult to ensure that an effective treatment choice is made, one that meets the unique needs and preferences of the patient. The ACA helps to address this issue by establishing an independent, non-profit, tax exempt corporation, known as the “Patient-Centered Outcomes Research Institute” to provide comparative effectiveness information to clinicians and patients. The law also funds the development of shared decision making tools to translate the results of the research into information that is understandable by patients . . . In this way, Medicare patients and their physicians will be empowered to make informed, and therefore improved, health decisions based on the best and most recent evidence of clinical effectiveness.”

Dr. Fred Ralston, ACP’s president, in remarks made at ACP’s State of the Nation’s Health Care briefing, put the value of such research in words that any physician or patient would understand:

“I look at rational use of resources on a personal level as obtaining and using the proper information on diagnostic and treatment options that I would want used on my family. If a test or treatment is shown to be superior to other options on the basis of safety, outcomes, and/or cost it is what I would want my mother, my wife or my sons to receive. We need unbiased research to make sure that physicians and patients have access to the best treatment options.”

The logic of comparative effectiveness research is simple: if patients and physicians have more information about the effectiveness of different treatments, they will be more likely to choose the ones that will work best them. An article in the current issue of the Annals of Internal Medicine notes that people often know more about consumer products than their own health care:

“The purpose of CER is to help patients, providers, and policymakers make more informed decisions about health care. As some observers have commented, consumers often know more about the pros, cons, and costs of televisions, cars, and appliances than they do about health care interventions. If CER also assesses utilization and costs, it can further help provide a foundation for cost-effectiveness analysis.”

This is not to say that the science of doing comparative effectiveness research is simple – it’s not – but the challenges involved in conducting such research speaks to the need to ensure stable and sufficient funding.

Fiscal conservatives, of all people, should embrace giving doctors and patients the information needed to “encourage personal responsibility for health care coverage and costs.” Providing patients with the results of CER could help drive down costs, by reducing some of the estimated $700 billion that the United States spends each year on ineffective care, while resulting in better outcomes for individual patients and the U.S. population.

In the absence of providing patients with information on comparative effectiveness, it is more likely that someone else – the government, the insurance company, or even a well-meaning but misinformed family member – will make treatment decisions for them.

In the absence of information on comparative effectiveness from trusted and independent scientists, it is more likely that patients will be influenced by slick industry-fund, direct-to-consumer ads for prescription drugs or motorized wheelchairs to seek treatments that they really don’t need and won’t help them, adding billions to the cost of health care.

And in the absence of information on comparative effectiveness, it is more likely that patients will be subjected to harmful and unnecessary tests and treatments.

Patients and physicians alike should urge Congress to preserve the funding for research to help people make more informed choices about their own health care, and remind conservative legislators in particular that such research will “encourage personal responsibility for health care coverage and costs”—an idea the GOP has said it intends to champion.

Today’s question: What is your reaction to the effort by some legislators to eliminate funding for comparative effectiveness research, which is intended to help people take personal responsibility for their care?


ryanjo said...

Clever premise of this post -- trying to equate comparative effectiveness research with incentives to encourage personal responsibility for health care coverage and costs. But most of us outside the Beltway can recognize double-talk. Now we need an institute to tell patients to exercise, lose weight, check their blood pressure and keep taking their meds?

The multitude of new agencies and institutes set up by the ACA is one of its most objectionable components. It is hardly surprising that the new Congressional majority, elected to reduce government involvement in the voters lives, seeks to eliminate these new bureaucracies. The AHRQ itself, despite its mandate to improve patient safety in the aftermath of the 1999 Institute of Medicine report (with a new "Center for Patient Safety" and double the budget), according to recent studies cannot demonstrate any measurable reduction in medical errors. So a new agency with the politically correct name of "Patient-Centered Outcomes Research Institute" leaves me cold.

Why not try the radical approach of paying physicians fairly to spend time with patients discussing their own responsibilities and their options, instead of tying payments to volume of visits and procedures? Again, the ACP leadership misses the chance to promote its members interests, instead endorsing new government intrusions into medicine.

Robert J. Sobel, M.D. said...

We seem to get off track when we have to redefine another term. Clinical effectiveness research as a novel concept is misleading. The history of clinical medicine has incorporated experience, bench research, and clinical research for years. It is more complex today and many of the most important questions are yet to have answers. When research is not there to help me at the bedside, it is often because there are skewed financial incentives that determine what gets funded and what does not. I'm not sure a central arbiter of what is clinical excellence is such a great idea.

Look at the UK. NICE just published CER on oral agents for type 2. Meaningless jibberish, if you ask me. The costs of the drugs bear no resemblence to our market. One new study on the new drugs and relative risks could dramatically change. Let's not forget that frontline physicians are making these judgements every day. We cannot be accountable for costs we don't control.

Bob, your ACP paper looking at the strengths and weaknesses of other nation's systems is important. If you look closely, I'm sure you'll see an argument for primary care autonomy on the basics. A structure rewarding frontliners while prorating the cost of the new is the only way. Why don't we just keep clinical care a simple, small practice phenomenon and regulate the costs of the commdities?

I listened to Dr. Berwick at Ways and Means and was more impressed with Illinois Congressman Schock speaking about his father retiring at 62. The quality comments struck me as tone deaf and offensive to those of us who feel we are providing such now. Re the Democrats and Republicans, neither side has hit the mark at this point. Keep it simple and fix the basics. If the FDA has to make do with millions less, just streamline the whole pharmacopeia and we'll all be fine.

Arvind said...

Agree with ryanjo and Robert. I am not sure when the ACP leadership and you (Bob) will get the message that more government intrusion into the sphere of clinical medicine is bad for quality of care as well as cost of care.

CER is a contradiction in itself. A government agency cannot identify what works and what doesn't without knowing each individual's clinical needs. This is another avenue to lead us into cookbook medicine, which can be used to force us to practice like the government wants us to.

Every item on the ACA will need to be identified and eliminated, if possible if practicing physicians have any hope of salvaging the physician-patient autonomy (if it still exists).

carol Vassar said...

We do need the help of independent research and the federal govenment seems to be the only available source. We don't need another agency. We badly need to have research to answer our questions, which are our patients questions. By how much would simvastatin BE LIKELY to reduce my risk of a heart attack or stroke? How much would walking 2 miles an hour, 30 minutes a day 2 days a week vs. 3 miles an hour 30 minutes a day 6-7 days a week be likely to reduce my risk? What if I both exercise and take simvastatin? The public, legislators and physicians themselves, perhaps, need to recognize that physicians do not have the answers to most medical questions, we just play the odds. Sometimes the odds are pretty clear, many times they are not. Thalidomide, estrogen, tight control of diabetes, PSA, axillary dissection in breast cancer are few examples that should be familiar to all doctors and many of the public where we did not have adequate evidence but went ahead with what seemed like a good idea at the time.
We know better, we need to demand better evidence before we adopt new tests and new therapies. Where is the final end point data for these new diabetes drugs? Don't we know well enough by now that intermediate end points aren't adequate?
Yes we need better research, and we need access to it, not a $35/article fee to Elsevier. Creating a new agency may just give us medication comparisons and delude the public into thinking that we will then be able to give them the "right" treatment meaning medications.
We need good evidence before we can practice evidence based medicine. Being an RCT is recognized as a prerequisite for providing reliable information but that alone does not ensure that the study is either reliable or useful. Comparative research is no sure route to being useful either. The right comparisons have to be made. Yes we need the help, but that help could come from the agencies we already have. We have no reason to think that the job will be better done by a new agency.