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Recent Articles
From Comparative Effectiveness to Clinical Practice Guidelines: Independence Is Key
The House-backed economic stimulus plan contains $1.1 billion for health-related comparative effectiveness research, which would evaluate competing medical technologies to determine what works best and in what circumstances. Proponents, including the Obama administration, believe it is key to moving the bloated health care sector toward using more clinically effective care, which ought to save money in the long run.
Now that the government is on the cusp of making a major investment in comparative effectiveness research, a coalition of patient advocacy groups, most of which accept pharmaceutical industry donations, is lobbying Congress to give industry a major say over how it will be run. A letter soon to go to Capitol hill demands that any agencies conducting comparative effectiveness reviews be run through an open and transparent process that allows for patients, providers and other stakeholders to participate equally in governance and input, starting from the research planning stage.
The groups letter also calls for limiting the governments right to conduct cost-effectiveness analyses, which it says will lead to one size fits all, not personalized medicine and discourage innovation. Initial signers include groups like the Friends of Cancer Research, Mens Health Network, and the Plasma Protein Therapeutics Association.
The letters program is nothing less than an effort to strangle comparative effectiveness research in its cradle by giving industry the right to veto controversial inquiries and limit the scope of research. Do publicly traded companies have a seat on the governing board of the Securities and Exchange Commission? Should we give Boeing and Airbus the right to determine the scope of the National Transportation Safety Boards inquiry into airplane crashes?
Its simply bad governance to give industry a seat at the table when government officials decide what comparative effectiveness studies will get done.
A timely commentary in this mornings Journal of the American Medical Association addresses a similar topic: who should be allowed to write clinical practice guidelines, which, while voluntary, have a major influence over the way most physicians ply their trade. Alas, the call for reform by Allan D. Sniderman of McGill University and Curt D. Furberg of Wake Forest creeps up on creating a rigorous, independent process for writing practice guidelines, but falls short of its goal.
As the authors point out, the 2,373 guidelines already registered in the National Guidelines Clearinghouse are produced by 285 self-appointed organizations, which often reach very different conclusions. How is this possible? they wonder. After all, replication is the distinguishing characteristic of scientific knowledge and an essential test of the validity of any scientific statement.
In part, its the process, they claim. Few associations submit the final products of the guideline process for external review before they are accepted and, therefore, in a limited but real sense, the committee, which is a creation of the organization, becomes the final arbiter of its process. Moreover, Because gaps in the evidence are inevitable, they must be filled in with judgments, and judgments tend to preserve previous positions. Thus, what is to be decided is often already decided with the selection of the deciders.
The publication process rarely provides a check on those subjective judgments because most guidelines are produced by organizations that also run journals, and those journal editors are required to publish the guidelines as is and without peer review.
Finally, the authors point out that guideline-writing committees often contain physicians with ties to manufacturers whose products are discussed in the guidelines. Disciplines like epidemiology and biostatistics are often excluded, as are independent health care economists.
Their call for reform includes establishing more balanced committees; rotating committee leadership; allowing dissenting opinions; posting interim guidelines and allowing public comment; and independent peer review prior to publication. All well and good.
Then they call for full disclosure of conflicts of interest for anyone serving on the guideline-writing panels, including publication of the dollar amounts of the financial relationships. Disclosure isn't enough to make the process truly independent.
Why not emulate the U.S. Preventive Services Task Force, which excludes anyone with conflicts of interest from its evaluative panels? If USPSTF believes certain clinicians have crucial insights into a particular field, they are invited to submit testimony to the guideline-writing panel. But they are excluded from voting when it comes time to actually evaluate the evidence.
Writing clinical practice guidelines has a lot in common with comparative effectiveness research. Both look at the existing research, evaluate its quality and draw conclusions. A well-funded comparative effectiveness agency will also be able to commission new research to fill knowledge gaps.
But to earn the trust of physicians, patients, consumers and providers, it must be rigorously independent. Otherwise, its pronouncements will only add to the cacophony of competing claims that are already contained in the governments guidelines database.
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Comments
Your point about conflicts of interests on guidelines, conflicting guidelines, and gaps in evidence leading to reliance on the judgment of the expert panel is important. Today, with the rise of managed care and treatment guidelines, medicine has evolved to the point that expert panel opinions can dictate and limit treatment options for patients and replace clinical judgment and individualized care. When guidelines recognize that an area of medicine is not yet settled or depends upon patient preferences, they typically provide for treatment options and let the physician and patient choose the most appropriate approach. The AAP has a model template for this decision making process (see figure 1, Classifying Recommendations for Clinical Practice Guidelines, http://pediatrics.aappublications.org/cgi/content/full/114/3/874 ), which essentially requires that when a recommendation is based on the expert opinion of the panel, the recommendation can only provide for treatment options or no recommendation. When expert guidelines panels take it upon themselves to substitute their expert opinion for that of the treating physician, there is centralized medicine without accountability. (Authors of guidelines have not been held liable for malpractice, but physicians are.) This is particularly egregious when a medical society has monopoly power and excludes other points of view and forecloses treatment options.
When the Infectious Diseases Society of America began to update its Lyme disease guidelines in 2006, patient groups, other medical societies, and even IDSA doctors who disagreed with the guidelines sought to have a voice in the process. The IDSA denied these requests for participation out of hand in what appears to be a professional turf war over protecting its role as the experts on all matters infectious. For patients, it meant that the fundamental right to choose among treatment options was foreclosed in a set of guidelines that did not acknowledge or permit treatment options, like long term antibiotic care. For physicians, it meant that to practice medicine using their best clinical judgment could cost them their professional medical license. (Malpractice is based on the standard of care determined by a consensus of physicians, but powerful guidelines can displace the standard of care or drive the community practice distorting the standard of care.) The worst part was that because the guidelines did not even acknowledge the controversy or different treatment approaches used, physicians and patients who did not know about the controversy would assume that none existedthat there were in fact no treatment options, no controversy, and no choices to be made or alternate opinions to seek. Innovation, which often springs forth from clinical judgment, is suppressed as well.
Lorraine Johnson, CEO, California Lyme Disease Association
I appreciate this analysis and commentary very much.
Until I contracted Lyme Disease, I never thought about the politics of research much. As the numbers of bacteriological and viral illnesses increase with climate change, it's clear that the research on how to best treat these illnesses must be conducted independent of bias. Thanks, Merrill.
Sometimes clinical practice guidelines are questioned on the basis of profit conflicts. Specialty medical societies work to insure their specialist members get reimbursement for common procedures/treatments, the drug industry works to produce evidence statements that promote use of their drugs, so some questions arise that do not seem comfortable that many trials are unobjective and balanced. How long would a drug company pay researchers who would continue to disappoint with poor efficacy trial results, since we all know that poor outcomes in drug trials are often not reported the the FDA or the public.
The entire premise upon which these societies base their evidence-based guidelines may be biased towards maintaining flow of their life blood-industry funded clinical trial dollars. Could it be that they focus on guidelines to both justify and feed the proposition that because cancer patients are probably going to die, then the FDA, CMS and taxpayers are supposed to pay for any combination of these wanna-be cancer drugs for any type of terminal cancer?
Evidence-based medicine has morphed into pharma-based medicine and HMO-based medicine. Evidence is based on data from medical journal articles, epidemiology and economics, which relies on randomized clinical trials, which doesn't even require a medical education. Nonphysicians trained in social science, science or even public policy analysis, have judgement over medicine. Where doctors defined the "standard of care," now payers and purchasers of medical services redefine the standards for appropriate medical care, encouraging doctors to act in ways to promote their financial interest when they make medical decisions.
The use of clinical trials to establish prescribing guidelines for evidence-based medicine is highly criticized because such trials have little relevance for the individual patient in the real world, the individuality and uniqueness of each patient. The problem is not lousy doctors, it's a lousy system. In cancer medicine, the best reform to the system is to totally remove the profit incentive from chemotherapy administration. Take physicians out of the retail pharmacy business and force them to be doctors again.