Thursday, April 24, 2008

What Influenced Derision of Evidence-Based Medicine as "One-Size-Fits-All?"

There he goes again. An op-ed a little while back by Peter J Pitts in the Washington Times took another whack at evidence-based medicine (EBM).

He started by saying all the current US Presidential candidates want to control health care costs using EBM.

One plan they all favor is ramping up federal funding for so-called 'evidence-based' medicine.

Pitts gave his own definition of EBM.

The theory behind evidence-based medicine is simple: If the government were to run clinical trials testing the effectiveness of drugs and medical technologies, and then use the results to determine what to cover, taxpayers would avoid paying for treatments that aren't effective enough to justify their price tag.

Sounds great, right? Too bad that in practice, evidence-based programs are largely driven by the political imperative to cut costs — not the medical imperative to give patients the best care possible.

Furthermore, Pitts derided what he asserted was evidence-based medicine's "one-size-fits-all approach."

Evidence-based programs encourage this approach. The underlying assumption is that the same care can be applied to every patient suffering from the same disease.
He concluded thus,

The theory behind and the practice of evidence-based medicine just don't match up. And until politicians can show how they'll resolve that tension, they need to look elsewhere in their quest to find politically palpable solutions to the country's health-care woes.
It is just amazing how little Mr Pitts' concept of EBM resembles that promoted by most EBM proponents. Contrast his concept of EBM with this one, written by one of the founders of the movement, Dr David Sackett, and colleagues [Sackett DL, Rosenberg WM, Muir Gray JA, Haynes RB, Richardson WS. Evidence-based medicine; what it is and what it isn't. BMJ 1996; 312: 71-72. Link here. ]

Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice. Increased expertise is reflected in many ways, but especially in more effective and efficient diagnosis and in the more thoughtful identification and compassionate use of individual patients' predicaments, rights, and preferences in making clinical decisions about their care. By best available external clinical evidence we mean clinically relevant research, often from the basic sciences of medicine, but especially from patient centred clinical research into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens.

And here is a direct refutation, written 12 years ago, for Pitts' "one-size-fits-all" criticism.

Evidence based medicine is not 'cookbook' medicine. Because it requires a bottom up approach that integrates the best external evidence with individual clinical expertise and patients' choice, it cannot result in slavish, cookbook approaches to individual patient care. External clinical evidence can inform, but can never replace, individual clinical expertise, and it is this expertise that decides whether the external evidence applies to the individual patient at all and, if so, how it should be integrated into a clinical decision.

One can find other definitions of EBM, but nearly all emphasize that the approach is designed to appropriately apply results from the best clinical research, critically reviewed, to the individual patient, taking into account that patient's clinical characteristics and personal values.

It makes no sense to call EBM a "one-size-fits-all" approach.

So Pitts' op-ed was basically one long straw man argument. He made up his own version of EBM, and then proceeded to knock it down. Why did he make the effort to give EBM a bad name?

Readers of the Washington Times op-ed were deprived of some clues to the motivation for his approach. The op-ed identified Mr Pitts as "president of the Center for Medicine in the Public Interest and a former associate commissioner of the Food and Drug Administration."

The Washington Times did not note that the Center for Medicine in the Public Interest, CMPI, received considerable industry support, as the NY Times did when it published an op-ed by Pitts lambasting comparative effectiveness research (see that article here, and our relevant post here.)

Furthermore, as we have noted before when he publicly criticized Dr Steve Nissen during the Avandia affair (see post here), and when he warned against restricting people with conflicts of interest from FDA advisory panels (see post here), Mr Pitts holds down the day-job of Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee has many big pharmaceutical accounts, as listed on the site. As Senior Vice President for Global Health Affairs, Pitts is presumably responsible for all these accounts. Thus, his livelihood seems to depend largely on his ability to convey the pharmaceutical industry's point of view. The Washington Times left all that out.

Presumably, Mr Pitts' pharmaceutical industry public relations clients may be worried about evidence-based medicine because rigorous EBM informed consideration may show that some of their products are not as good as their marketing hypes them to be. Perhaps that is the reason Mr Pitts had such an odd view of what EBM is, and felt so negative about what EBM might be able to do for health care.

At least, if Mr Pitts could be bothered to disclose where CMPI gets its financial support, and what his day job is, readers could make their own judgments about where his interests lie.

It is disappointing that a newspaper as influential as the Washington Times would publish a health policy article without disclosing all the author's relevant financial interests, particularly one so relevant and direct. Fostering more stealth health policy advocacy in ever more influential venues will just make the already confusing clamor about health care and its reform even muddier.

ADDENDUM (28 April, 2008) - See also these comments by Dr Alan Schwartz on the Making Medical Decisions blog.


Anonymous said...

It is also interesting to look at the latest lobbying list from 1998-2007, in millions:

US Chamber of Commerce 369.9
AMA 179.4
GE 163.0
American Hospital
Association 143.9

PHARMA 127.0

AARP 126.8

Per the April 22 WSJ Reports on Lobbyists Hit Snag.

It seems that on top of the above amounts some want the ability to give bundled amounts over $15,000 without listing the donors to candidates. This does not bode well for health care transparency.

Steve Lucas

Anonymous said...

The Washington Times is mostly read by conservatives. It is owned and subsidized by the Unification Church. It's circulation is much smaller than that of the Washington Post. No one I know reads it (I live in suburban Maryland and work in Washington, D.C.).


Anonymous said...

The Washington Times is generally cited by conservative luminaries such as Hannity, Limbaugh, and the like. I don't think many sane people confuse it with anything resembling a newspaper.

Nothing against conservatism per se, but the Times is less a news source than a conservative talking points launching pad.

If I were reading it in the bathroom, the Washington Times may start off in front of me, but would certainly end up underneath me.

Name the last big story broke my the Washington Times...

Anonymous said...

Unification Church, i.e. the Moonies.

A great example of why shining light on the 'whole story' is important. Although, the article is an op-ed, and so is not a reporter's piece (where there should exist a higher degree of scrutiny re: conflicts, etc.), it likely reflects the editorial board's leanings: pro-business (i.e. pharma), anti-science (i.e. conservative fundamentalist Christian ideology).

Now that 'EBM' is becoming hijacked from its original meaning we (i.e. those of us in the reality-based world of medical science) should we come up with another acronym?

Is there an equivalent Gresham's law (currency: 'bad' money drives out 'good' and not vice versa) that applies to common words and phrases?


Anonymous said...

Politicians and most (public and private) bureaucrats have no idea what real EBM is, nor do they care. "EBM" becomes an excuse to declare some rule ("guideline" or "standard") as an inviolable final dogma.

If P4P and rigid guidelines had been operational 20 years ago, who would have studied betablockers in CHF? Would our guidelines have ever changed? How long would we have continued less effective care?

It is time for physicians to openly oppose the misuse of true EBM whether by physicians or others.

The law of scientific equilibrium:

If it is settled it is not science.
If it is science it is not settled.

J Brignell (