Sunday, June 30, 2013

Guidelines, bias, and your health

One of the challenges in educating health-care professionals is the massive – and growing -- amount of information about diseases, diagnosis, and especially treatments that are available. This is not only an issue for students and residents, but for continuing education; if a doctor or nurse or pharmacist knows only what they learned in school, it will be outdated in a very few years. Thus, the health professions have committed to the concept of “life-long learning”, but how this happens, and how effective and accurate it is, is the challenge.

With the development of the Internet, information is extraordinarily widely shared very quickly. It makes information available not only to health professionals, but to everyone; in the “old days”, perhaps someone with symptoms, or a new diagnosis, might go to the library, or find an outdated copy of Morris Fishbein’s “Handy Home Medical Encyclopedia” or a similar book. Now they go to the internet and are overwhelmed with information. The problem is that this information may be correct, partially correct, or wrong; it may be complete, incomplete, or valueless. There is a difference between information and truth, and certainly between information and wisdom. Wisdom, and truth, require information, but much  of the information is chaff or worse.

If keeping up with information and sifting through it to discover what is true, relevant, and important is hard for a person who wants to find out about their one condition, it is truly daunting for health professionals who need to keep up on many. There are so many drugs! And new ones all the time! And they are all better, improved, more effective (and certainly more expensive!) than the old ones. Until, of course, we find out that they are not. Or, worse, dangerous. Sometimes so dangerous that they have to be pulled from the market.

In his Op-Ed piece in the New York Times on June 12, 2013, “Healing the overwhelmed physician”, Dr. Jerry Avorn of Harvard Medical School calls this the “Stendhal syndrome”, after the French author who, on an 1817 visit to Florence, “…was seized by palpitations, dizziness and a feeling of being overwhelmed by the abundance of great art surrounding him”; the over-abundance of information, too much to grasp, integrate, and categorize, not to mention utilize effectively.  How can doctors and other health professionals get through this to “truth”? To be able to most effectively help, and, primum non nocere,  not hurt you?

One traditional method, adopted by our friends in the drug industry, has been “detailing”. Pharmaceutical representatives (called, regardless of gender, “detailmen”) fanned out, visiting physicians, giving out free samples of their wares as well as food and pens and sticky-note pads and clocks and calendars and little scale models of whatever organ their drug worked on, along with information about the drug. The information might have been accurate and complete, but often was skewed, and almost always was research funded by the manufacturer. The detailpersons were easily identifiable, even when not pushing a cart full of pizza for “grand rounds” because they were all good-looking and so much more well-dressed than run of the mill health care workers. What a great system! You get information about new drugs, direct from the person selling them, and little scale models of the urinary system and donuts too! Isn’t that how we all hoped our doctors were keeping up with the field of caring for our health?

Well, ethics rules have limited the ubiquity of detailpersons, and free gifts, and even samples; the “educational cruises” to the Caribbean just for being a high-utilizer of a company’s drugs are all but gone. A resident asking a drug rep to fly their whole residency class to Las Vegas for graduation is so last millennium! But an incredibly wealthy industry like the pharmaceutical industry will not give up there. This is the real thrust of Avorn’s op-ed piece. He discusses the influence that these companies have on the development of “clinical guidelines” by groups of experts in a particular medical field.

Clinical guidelines can be really good and helpful. The information glut is real, sifting through all the data is almost impossible for all the conditions that exist, especially ones that are seen rarely by a particular practitioner. It makes sense that a group of experts in the field review all the evidence in that narrow area and make recommendations that we can count on as accurate and can utilize effectively. But we may be reaching a point where there are too many guidelines, often with conflicting recommendations. Avorn focuses on recent recommendations from the American Association of Clinical Endocrinologists (AACE) on caring for patients with diabetes:
The A.A.C.E.’s latest guidelines elevate many second- or third-line drugs to more prominent positions in the prescribing hierarchy, rivaling once uncontested go-to medications like metformin, an inexpensive generic. They also emphasize the riskiness of established treatments like insulin and glipizide, which now carry yellow warning labels in the A.A.C.E. summary. Several of the now promoted drugs are expensive newcomers that lack the track records of clinical effectiveness and safety held by the older, potentially displaced treatments. The changes were made, ostensibly, to give physicians more treatment choices for their patients. But there is also concern that they could have been influenced by another factor: the manufacturers of some of these new drugs financially supported the development of the guidelines, and many of the authors are paid consultants to some of those companies.”

Avorn goes on to cite previous examples of expert-generated and industry-sponsored guidelines that have led to overuse of drugs with very bad outcomes for patients. He also cites reliable sources of clinical guidelines, which are based solely on review of the evidence, not the opinions (possibly influenced by money) of experts, “…including the Institute of Medicine, the American College of Physicians and the Cochrane Collaboration, an international network of experts that evaluates clinical research.” He also refers to the practice of “academic detailing”, which he helped to develop[1] [2], in which academic physicians and pharmacists try to counter the impact of drug-industry detailpersons by going out to practicing physicians and presenting evidence-based recommendations.

There are at least two other sources of bias in addition to any direct influence exerted by drug company funding of research, guidelines development, and individual experts. One is the fact that many treatments, particularly when they involve procedures, can increase the income of the individual physicians doing them. Unfortunately, we have seen (and continue to see) the persistence of many procedures for which there is weak evidence overall or for as broad a population as it is being used on, presumably for this reason. The other, less overtly money-driven and thus more insidious, is that many experts are, almost by definition, specialists (well described in this context by the more pejorative “partialists”) who are focused on the impact of a treatment on “their” disease and may miss the potential for negative impact on the patient. An example may be very tight control of blood sugar in people with diabetes; it may improve the outcomes from diabetes, but if it also leads to potentially dangerous episodes of low blood sugar, it may not be a good idea.

Guidelines issued by different organizations also may be in conflict. An excellent example is mammographic screening for breast cancer, discussed in two outstanding “Viewpoint” articles in a recent JAMA. Michael Marmot addresses potential benefits and harms from different guidelines, focusing on UK recommendations[3], and Kachalia and Mello look at the differing US recommendations from the US Preventive Services Task Force (USPSTF), American Cancer Society (ACS), and American College of Radiology (ACR).[4] If a radiologist reads a mammogram as normal, but, following ACR guidelines recommends another in one year, while the clinician is following USPSTF guidelines for less frequent screening, does that place the clinician at increased legal risk? They argue at least for consistent guidelines to be utilized within a single institution.

Finally, there is the potential for unintended outcomes. One of the most reliable evidence-based sources of recommendations is the USPSTF. Its recommendations are based solely on review of the science, which has generated controversy before when those recommendations were unpopular with powerful groups (see mammography guidelines). Their reliability led them to be written into the health reform law, ACA, which mandates insurers pay for preventive services with an “A” or “B” recommendation from USPSTF. However, as articulately described by USPSTF members Steven Woolf and Doug Campos-Outcalt in another recent JAMA[5], this creates the unintended consequence of turning USPSTF into a group that decides whether companies and doctors will make money; you can imagine the lobbying by a company to try to prove that its product deserves a “B” rating!

You sure can imagine it. It is not what we need. Essentially, as long as potential for big profit exists in health care, for providers, drug companies, device manufacturers, insurers, and others, there will be plenty of opportunities -- and actual occurrences – of this, not scientific evidence, guiding medical practice.

And I doubt that this is what you want for your health.

[1] Soumerai SB, Avorn J,  “Principles of educational outreach ('academic detailing') to improve clinical decision making.”, JAMA. 1990 Jan 26;263(4):549-56. PMID: 2104640
[2] Fischer MA, Avorn J, “Academic detailing can play a key role in assessing and implementing comparative effectiveness research findings,Health Aff (Millwood). 2012 Oct;31(10):2206-12. doi: 10.1377/hlthaff.2012.0817.
[3] Marmot M, “Sorting through the arguments on breast screening” JAMA. 2013;309(24):2553-2554. doi:10.1001/jama.2013.6822
[4] Kachalia A, Mello MM, “Breast cancer screening: conflicting guidelines and medio-legal risk”, JAMA. 2013;309(24):2555-2556. doi:10.1001/jama.2013.7100
[5] Woolf SH, Campos-Outcalt D, “Severing the link between coverage policy and the US Preventive Services Task Force”, JAMA. 2013 May 8;309(18):1899-900. doi: 10.1001/jama.2013.3448. 

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