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Two recent “Commentaries” in the same issue of JAMA address different challenges to the implementation of evidence-based practice guidelines. One, “Direct-to-consumer cardiac screening and suspect risk evaluation,” addresses the challenges posed by the potential for profit that occurs when companies market screening tests directly to the consumer (DTC) that may not be indicated, may not be indicated for the people who it is marketing to, or may even be harmful to the recipients of such screening. This harm can be physical, as in untoward events, or in risks inherent in the further procedures for those who “screen positive” but turn out to have been “false positives.” The harm is also financial, for there is a cost to doing these tests – to the individual (sometimes) or to their insurer; in the latter case, whether that insurance is public (e.g., Medicare, Medicaid) or private, the cost is to all of us. And, of course, that cost is the reason for such marketing, as it is what translates into profit for the company selling the test.
In the case of cardiac screening, Lovett and Liang, using the recommendations of the US Preventive Services Task Force (USPSTF), the American Heart Association/American College of Cardiology Foundation (ACCF/AHA), describe heavily-marketed tests that can cause more harm than benefit to the many people who are not in the narrowly-targeted group for whom the tests are indicated; other tests which have valid indications although, again, in the appropriate populations; and finally tests for which there is little or no evidence. The marketing of these tests can incur anxiety or fear in people who have no reason to be worried about these conditions and may occur outside the physician-patient relationship, thereby not allowing people to get the physician’s analysis of the results even when the test is indicated, and cost a great deal of money. This is particularly true when a possibly-positive test needs to be followed up with a number of other tests to rule it out, this time covered by insurance. They make several suggestions for how DTC companies should be regulated. They conclude that, “DTC cardiac testing may pose more harm than benefit to many consumers. Oversight efforts are needed to protect the public from inappropriate testing and to ensure that the health care dollar is spent on care promoting health in an evidence-based fashion.” I would say that is a mild suggestion!
The issue raised by the other article is probably more insidious; because it lacks the obvious profit motive present in DTC marketing, we may be less wary. In "Health advocacy organizations and evidence-based medicine," Sheila Rothman examines the tendency for groups created around a single disease (e.g., breast cancer, epilepsy, autism, etc.) to push for screening tests, diagnostic tests, and treatments for “their” disease whether or not there is evidence to support their use. In response to an Institute of Medicine (IOM) survey that sought to identify what tests and treatments should be included in a basic benefits package, “They contended that EBM [evidence-based medicine] should serve merely as an aid in medical decision making, not as the basis for it. Outcome data, they insist, should not limit patient choice or restrict available services.”
This is truly remarkable. These groups are basically saying “our disease is so important we should screen everyone, everyone who screens positive should have diagnostic tests, and everyone who has it should be able to get any treatment that they want, even if there is weak or no evidence for its efficacy. And, of course, someone else should pay for it.” This would probably be unreasonable if there was only one such disease, but there are hundreds and each is the “most important” for its advocacy organization. The reason that this is more insidious is that these groups are not seeking to make a profit on these tests and treatments (usually); they are (usually) functioning as advocates for people who are truly suffering. However, the fact that people are suffering does not mean that society should screen large numbers of low-risk people for all of these conditions.
Sometimes, advocacy groups may have a financial interest in a test or treatment, but even when they do not, they may push for policies that allow physicians to prescribe expensive brand-name drugs even when generic drugs have not been tried. Or they may demand the availability of expensive but unproven treatments: “’Autism Speaks’ criticized insurance companies that refused to pay $300,000 for 4 years of applied behavior analysis therapy for toddlers, despite a lack of evidence of effectiveness.” That is a lot of money even if we know a treatment is effective, but it is an awful lot when we do not. The issue is that this organization is focused only on people with “its” disease, and has no concern for what the money could otherwise be used for to treat other people with proven therapies. Maybe this is their role, but there is no reason that the rest of society must buy into this logic.
Cancer, of course, has the strongest set of advocacy organizations. In this context, the Food and Drug Administration recently approved several new drugs for metastatic prostate cancer. The cost can be over $90,000 for each treatment cycle and might exceed $500,000. In the June 28, 2011 NY Times article, “New prostate cancer drugs extend lives but raise costs”, Andrew Pollack notes that Medicare is going to look into whether to pay for these drugs, but that “…some patient advocates and politicians portrayed the review as a step toward rationing.” Excuse me? Don’t we already have rationing based on whether or not one has money or insurance? It is not okay for “patient advocates” to advocate for some people to get any kind of treatment paid for by someone else (e.g., Medicare) when everyone who has that medical need is not able to get care. And since there will be more things to spend money on than there is money, there needs to be a more rational system than “Me first!” This system is the use of evidence-based guidelines.
Rothman concludes her commentary: “However valuable independent advocacy organizations are for a democratic society and however important their services provided to targeted populations, their advocacy positions and the related underlying assumptions must be scrutinized with the same diligence as those of other stakeholders. There should be no automatic assumption that all health advocacy organizations deserve special standing or represent the common good.”
And for good reason - because they probably do not.
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