Friday, September 08, 2006

Bernadine Healy Takes Some Cheap Shots at EBM

Bernadine Healy MD, cardiologist and former director of the National Institutes of Health (NIH), writes a periodic health column for the US news magazine, US News and World Report, to which I subscribe. Imagine my surprise when I read her latest column, in which she slams evidence-based medicine (EBM), based on a mish-mash of misunderstandings, innuendo, and illogic.

Misunderstandings

EBM is Based Mainly on Randomized Controlled Trials (RCTs) and Cost-Effectiveness Analysis? -

Healy wrote,

'best' evidence, gleaned mostly from randomized clinical trials and cost-benefit studies, is the basis for what docs should or shouldn't do.
A quick definition of EBM is medicine based on critical review of the best available evidence from clinical research, combined with clinical judgment, knowledge of biology, and patients' values and preferences. (See also: "Evidence-Based Medicine: What It Is and What It Isn't" from the 1996 British Medical Journal for a better explanation.) Although most EBM advocates regard evidence from clinical trials, all things being equal, as more trustworthy than evidence from observational research studies, it is a relatively common misperception that EBM disregards evidence from other kinds of studies. I have never heard of EBM placing any special emphasis on cost-benefit studies.

EBM Ignores Biology and Patient Preferences? -

Healy wrote,

EBM sees itself as a major shift away from traditional medicine that emphasizes the expertise of the medical profession. That includes knowledge of the underlying nature of disease, mechanisms of therapy, basic and clinical research, and physician experience.
As noted above, most EBM advocates see EBM as incorporating clinical expertise, knowledge of biology, and patients' values and concerns. This has been expressed in many of the seminal articles on EBM.

EBM is an Attack on Physicians? -

Healy wrote,

The autonomy and authority of the doctor, and the subsequent variability in care, are the problems that EBM wants to cure.
She also wrote,

According to Marc Rodwin, professor of law at Suffolk University Law School in Boston, EBM puts experts trained in social science, public health, epidemiology, and economic analysis on par with physicians and 'breaks the lock hold' the profession has over how medicine is practiced and compensated.
Most of the early EBM advocates were physicians. Most of us physicians who support EBM see it as a way to empower individual physicians (and other health professionals, and patients) to independently make judgments about the best way to manage particular medical problems based on best evidence and logic, rather than edicts from above. There are certainly some epidemiologists involved in the EBM movement, which makes sense. I have never seen a large number of sociologists, non-physician public health specialists, or economists involved in the movement, and have never been aware they were trying to deprofessionalize physicians.

EBM is Cook-Book Medicine? -

Healy wrote,

patients are forced into a one-size-fits-all straitjacket
EBM advocates have taken pains to show that EBM involves using the best available evidence to make decisions for individual patients, based on each patient's unique circumstances, clinical context, values and preferences.

EBM is Meant to Support a "Microfascist" Ideological Agenda? -

Healy first wrote,

EBM carries its own ideological and political agenda separate from its clinical purpose.
Later she seemingly approvingly wrote about

a scathing commentary on the EBM movement in the International Journal of Evidence-Based Healthcare by Dave Holmes, a professor of nursing at the University of Ottawa. He and his colleagues argue that EBM is 'outrageously exclusionary' and even 'microfascism' in the way it sifts knowledge. Though harsh, he makes a point....
I wrote an extensive post on the article by Holmes et al (here). I wonder if Healy has any idea that she was agreeing with an argument that based on the authority of post-modernists like Deleuze, Guttari, and Foucault (and based on little else). I also wonder if Healy had any idea that she was agreeing with an attack on the biomedical research basis of health care. (Holmes et al wrote, for example, "The philosophical work of Deleuze and Guattari proves to be useful in showing how health sciences are colonised (territorialised) by an all-encompassing scientific research paradigm – that of post-positivism – but also and foremost in showing the process by which a dominant ideology comes to exclude alternative forms of knowledge, therefore acting as a fascist structure.")

Innuendo and Illogic

By writing that EBM emphasizes the "'best' evidence," with the word best in quotes, Healy implies that EBM uses an arbitary method to assess evidence. Later she wrote that EBM was "anointing only a small sliver of research as best evidence and discarding or devaluing physician judgment and more than 90 percent of the medical literature." She seems to have no idea about how much effort EBM advocates have put into developing clear, objective, logical methods to assess clinical research. For an example, see the 600+ pages of Guyatt G, Rennie D. Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice.

Although Healy clearly acknowledges that an important element of EBM is addressing clinical research, she wrote that EBM is a "major shift" away from medical expertise, and included within the scope of that expertise, "clinical research." That's illogical.

Healy attempted to illustrate her concerns with two examples, the controversies over screening mammography and using PSA to screen for prostate cancer. Both examples had to acknowledge that some of the EBM based concerns about these screening tests were based on knowledge of the biology of the relevant diseases, contradicting her earlier assertion that EBM ignores biology. And neither controversy was resolved in a way that suggested some fault with EBM concepts. Note that Healy wrote that the mammogram controversy was resolved by political power, not necessarily by clear consideration of what was actually best for patients.

Summary

In summary, it is too bad that Dr Healy used her bully pulpit for such a cheap set of shots at EBM. As a former NIH director, she should know better.

EBM is actually a way to use logic and evidence to figure out the best way to help patients. It is the antidote to all the vested interests, ideological as well as economic, that seek to influence health care.

In that vein, could Healy's writing have been affected by her fiduciary duties to protect the interests of Invacare, obligated by her membership on its board of directors? (Invacare makes durable medical devices.) Could her writings have been affected by Dr Floyd Loop, her husband's fiduciary duties to protect the interests of Tenet Healthcare, obligated by his membership on its board of directors? I would suggest that she should have disclosed such financial interests when writing her column.

5 comments:

Anonymous said...

It's really too bad: in one swell foop, Bernardine Healey has morphed into the Katherine Harris of organized medicine. How did a former NIH chief end up writing something as misguided as this?

S Brownlee said...

Roy,

In addition to not knowing what EBM really is, Dr. Healy uses a couple of outrageously wrong-headed examples to buttress her argument: screening mammography for women under the age of 50, and the PSA test. She claims that catching cancer early is saving lives in both cases.

Show me the evidence! In fact, the evidence, which is the only thing that stands between modern medicine and blood letting, suggests pretty clearly, if not absolutely, that screening in women under 50 is not saving lives. It is, however, leading to a lot of false positives, unnecessary biopsies, and anguish for women who worry enough already about breast cancer.

The case against PSA testing is even stronger. The most recent prospective, randomized trial results suggest that there's no mortality benefit to early diagnosis and treatment with PSA screening.

What Healy fails to recognize in at least the case of PSA testing is that the decision to be screened should rest with a truly informed patient. The patient is the only one who can decide what's more frightening: dying of a cancer that might (emphasis on the word "might") have been treatable if caught earlier; or suffering the side-effects of being treated for a tumor that might never have caused symptoms.

InformaticsMD said...

"Micromanagement" or even "authoritarianism" would have at least been a more accurate term for the idea the author was trying to describe.

"Micro-fascism" (sic) is rather inappropriate and over the top. Fascism is the use of power, ooften state power (not 'evidence') to enforce an idea of religious or cultural supremacy at the expense of others (i.e., via imprisonment and murder), as well as expansionist, imperialist aims, usually also conducted by force.

The moment the word "fascism" comes into play in the EBM setting, you can likely predict the judgment of the writers on other issues is likely to be suspect.

-- SS

Anonymous said...

I was notified this weekend that US News will be publishing this response in the Oct 16th issue (though not all editions around the country; and they did not explain why)
To the Editor:

Healy castigates the practice of evidence based medicine in her polemic as if it were anathema to medical science, and, more particularly, to the individual physician's practice of medicine. Hippocrates knew that "Experience is delusory." "Experience," or anecdote, is sometimes helpful in medicine, but often harmful, because we physicians often internalize our experience into hard rules about treating patients. This often leads us down dangerous paths.

Evidence based medicine is long overdue counterweight to this kind of medical practice. EBM, when evidence is available, makes us think hard about our practices: Are we doing this because that's the way we've always done it, or because we have scientific research to back up our decisions? Sadly, it is too often the former, because the evidence is just not there or has not yet been synthesized into a useful form, or, most commonly, not yet reached the physicians "in the trenches." EBM is not "discarding or devaluing physician judgment," as Healy argues, it is rather an attempt to make our judgment more rationale.

I find it astonishing that Healy trumpets the jury awarding damages against a physician who did not order a PSA test based upon the best evidence available to him. Every physician should howl in protest at this outcome. Using this standard, we should all have monthly full body high speed CT scans and massive blood testing to search for every possible disorder that comes to the mind of the physician or the patient. But we do not practice this way because it is, yes, I'll say it, stupid!

Evidence based medicine is not a "straightjacket", but a means to an end: providing the best care based on the best scientific evidence we have.

Christopher M. Hughes, MD

Anonymous said...

Once again, Dr. Healy swims bravely upstream against a sluggish current rife with mainstream biases that are in fact an anathema to the practice of good medicine. She has far more forcefully and intelligently than most, albeit dramatically, captured the downside of EBM and brought it to the fore where at least some scientists and practitioners will be encouraged to think instead of following mediocre guidelines and average-based data culled from a biased literature. Plus, my goodness, the woman has the audacity to state her opinion in an open society! Had this been written by Eugene Braunwald, it would have have become the new manifesto. Sadly, novel ideas from a woman are perhaps the worst of all vectors to influence the intelligent practice of medicine in a male-dominated culture. Sorry, if EMB is the best evidence we have, then its supporters sadly ignore the simple facts, that negative well designed studies offer strong but neglected evidence and that individual responses to therapy that could be derived from better designed scientific studies are to be ignored in favor of an average response. Oh, and Columbus thought the world was flat too.