“Evidence-Based Care”: Hazardous to Your Health?

Remember the words evidence-based care. They are likely to be very much a part of your future. To its advocates, evidence-based care follows medical treatment guidelines and protocols developed by experts, based on the scientific literature—as reported in medical journals and scholarly reports. If all doctors follow the same protocols, they argue, patients with similar conditions will be treated the same way. Wide variations in the practice of medicine would be replaced by uniform, standardized treatments.

Don’t you want your doctors to base their advice on scientific evidence? Don’t you want them to follow guidelines that have been written by reputable scholars who have surveyed all the relevant literature? So what’s not to like? A lot, it turns out. Think about the calendar you keep on your laptop or your cell phone. It’s probably an invaluable aide to help you organize your life. Now suppose that instead of being your servant, the calendar becomes your master. What if there were a rule that says you can’t do anything during the week unless it is on the calendar by Sunday. Call this “calendar-based scheduling.” Instead of being an aide, the calendar would quickly become an oppressive barrier to your freedom of action.

The same principle applies in medicine. Protocols and guidelines can be helpful or harmful, depending on how they are used. And there are six reasons why such guidelines—in the wrong hands—can reduce the quality of care you receive.

First, in most areas of medicine, there are no treatment guidelines, and where there are, they are often unreliable, conflicting, and incomplete. Even for something as seemingly straightforward as deciding when women should get mammograms, the advice is conflicting.[1] If insurers have to choose among conflicting and inconsistent guidelines, which ones do you think they will choose? The ones that cost them less money, of course.

Second, even well-established guidelines are inevitably written for the average patient. But suppose you are not average. Are doctors free to step outside the protocols and give you care based on their training, knowledge and experience? Or will they be pressured to stick to the cookbook, regardless of how the patient fares? Health plans always say that doctors are free to step outside the guidelines if they have good reason for doing so. But if they have to fill out multiple forms and jump through many hoops to make this possible, they will be tempted to conform to the guidelines even if that’s not the best choice for you.

Third, guidelines are often written by people who are not disinterested. One study found that 56 percent of the doctors who helped write guidelines for treatment of heart ailments had potential conflicts of interest.[2] These conflicts are more common than is generally realized. Writing in the­ New ­York ­Times, University of Texas law professor Ronen Avraham made the following observation:

Guidelines produced by insurance companies sometimes put their interests first. Malpractice insurers, for example, may recommend yearly mammograms, even if they are not necessary, because they bear the costs of lawsuits for late diagnoses of breast cancer—and not the costs or health risks of the extra mammograms. Moreover, the nonprofit groups behind many other guidelines have traditionally depended on pharmaceutical and medical device companies to finance their work. Last year, the Council of Medical Specialty Societies issued a new code of conduct seeking to stop these industries from sponsoring the development of guidelines, but there are still too many loopholes, and thousands of guidelines produced before the reform[s] are still in circulation.[3]

In one particularly egregious case, Eli Lilly and Co. funded medical guidelines for the treatment of a deadly infection in an effort to boost sales of a drug with questionable benefits.[4]

Fourth, evidence-based guidelines are based on studies, and these studies often exclude entire segments of the population. For example, a large number of studies on patients with heart failure excluded elderly patients, even though most of the people who have this problem are elderly.[5] If you are an elderly patient, do you want your doctor to follow procedures that were based on studies of patients thirty or forty years younger than you are? According to Don Taylor, a health policy analyst at Duke University, it is not at all unusual to exclude patients with certain characteristics and conditions from clinical trials, while the patients who are excluded are still subjected to the guidelines after the trial is over.[6]

Fifth, the “gold standard” of medical research is the randomized controlled trial. But Steven Goldberg has catalogued all kinds of reasons why even these experiments are often poor guides for practitioners dealing with real patients:

In the field, where researchers are dealing with specific communities of people with virtually unlimited and sometimes indeterminate or hidden characteristics, creating truly random experiments is maddeningly difficult, time-consuming and expensive.[7]

Finally, the whole idea behind guidelines and protocols is that it is appropriate to treat patients with similar conditions the same way. But individuals are individuals. They don’t always respond to treatments the same way. For substance abuse, for example, there apparently is no such thing as a protocol that works for diverse groups of patients.[8]

Evidence-based guidelines could be a boon to medical practice, helping doctors do their jobs. One place where standardization seems to be working remarkably well, for example, is at Geisinger Health Systems in central Pennsylvania. Doctors there follow forty specific steps before performing elective heart bypass surgery, and the operation is cancelled if even one step is overlooked. The system is so efficient that it offers patients a ninety-day warranty—any mistakes that require readmission are taken care of gratis![9]

When these tools developed by outside entities substitute for the doctors’ judgments, however, patients are likely to be the losers.

(For more on hazardous trends in health policy, please see my book Priceless: Curing the Healthcare Crisis.)

Notes:

1. “Screening for Breast Cancer,” US Preventive Services Task Force, US Department of Health & Human Services, November 2009, http://www.uspreventiveservicestaskforce.org/uspstf/uspsbrca.htm; see also Gina Kolata, “Mammograms’ Value in Cancer Fight at Issue,” New ­York­ Times, September 22, 2010; Gina Kolata, “Study Sets Off Debate Over Mammograms’ Value,” New­ York­ Times, December 9, 2001; and Gina Kolata, “Dispute Builds Over Value of Mammography,” New­ York ­Times, February 01, 2002.

2. Thomas R. Burton, “Study Cites Cardiology Conflicts,” Wall ­Street ­Journal, March 28, 2011, http://online.wsj.com/article/SB10001424052748703739204576228850121858250.html.

3. Ronen Avraham, “A Market Solution for Malpractice,” New­ York ­Times, March 28, 2011, http://www.nytimes.com/2011/03/29/opinion/29Avraham.html.

4. Diedtra Henderson, “Article Questions Eli Lilly Marketing Push,” ­Boston ­Globe, October 19, 2006, http://www.boston.com/business/globe/articles/2006/10/19/article_questions_eli_lilly_marketing_push/.

5. Don Taylor, “More on Generalizability,” The­ Incidental­ Economist (blog), March 29, 2011, http://theincidentaleconomist.com/wordpress/more-on-generalizability/.

6. Don Taylor, “COPD and Generalizability,” The­ Incidental­ Economist­ (blog), March 28, 2011, http://theincidentaleconomist.com/wordpress/copd-and-selection-bias/.

7. Steven Goldberg, “Deciding What Works Responses,” The ­Healthcare ­Blog, March 28, 2011, http://thehealthcareblog.com/blog/2011/03/28/deciding-what-works/.

8. Anirban Basu, “Economics of Individualization in Comparative Effectiveness Research and a Basis for a Patient-Centered Healthcare,” National Bureau of Economic Research, NBER Working Paper 16900, March 2011, http://www.nber.org/papers/w16900.

9. Reed Abelson, “In Bid for Better Care, Surgery with a Warranty,” New­ York­ Times, May 17, 2007.

[Cross-posted at Psychology Today]