Winners and Losers EBM on trial

Medical guidelines should insists on proof that time-honored medical practices and procedures that cost money and may harm or kill patients are actually effective. This Forum is about how to force organized veterinary medicine to issue Evidence Based Guidelines.

Winners and Losers EBM on trial

Postby malernee » Wed Apr 14, 2004 11:50 am

The original JAMA article, from January 7, 2004.

Vol. 291 No. 1, January 7, 2004

Winners and Losers
Daniel Merenstein, MD
Baltimore, Md

JAMA. 2004;291:15-16.

There are many losers in this story: the man with incurable
prostate cancer, me, my family, family practice residency
programs, national guidelines, the shared decision-making
model, and anyone who believes in evidence-based medicine
(EBM). There were also a few winners: the man with prostate
cancer's lawyer, to some extent his family, and anyone who
wants to continue to practice outdated medicine or doesn't
believe in continuing medical education.

The date was July 19, 1999, when as a third-year resident I
saw a highly educated 53-year-old patient. In June 2002, my
residency and I were served with court papers. June 2003,
the trial.

On that day in July 1999 I saw the 53-year-old man for a
physical examination. I discussed with him, and documented
in his chart, the importance of colon cancer screening,
seat belts, dental care, exercise, improved diet, and
sunscreen use. I also presented the risks and benefits of
screening for prostate cancer and documented the
discussion. I never saw the patient again, and after I
graduated, he went to another office. His new doctor
ordered prostate-specific antigen (PSA) testing without
discussing the risks and benefits of screening with him.
Unfortunately for the patient, his PSA level was very high
and he was subsequently diagnosed with incurable advanced
prostate cancer. This patient lost on many accounts. For
starters, he had a horrible cancer (Gleason 8), a cancer
that is very difficult to treat in any stage and even
harder to find early in its course. The literature does not
support that early detection would have changed his
outcome, although society and many physicians do believe
so, thus making the patient live with the false belief that
if something had been done differently, he would have
survived longer. Clearly, this patient lost the most in
this story.

When the trial started on June 23, 2003, I was nervous but
confident. I realized that the patient was going to say we
had never discussed prostate cancer screening but since I
always do and had documented it, I didn't think this would
be a very strong plaintiff argument. What I didn't
anticipate was that the plaintiff's attorney was going to
argue that I should have never discussed the risks and
benefits and should have just ordered the PSA. But he did.
In fact, a major part of his argument was that there is
little risk involved in performing a PSA and that the
standard of care is to order the test. Although we had the
recommendations from every nationally recognized group
supporting my approach and the literature is clear that
screening for prostate cancer is controversial, the
plaintiff's attorney argued otherwise.

In the medical world it is well accepted that screening for
prostate cancer is a risky proposition, in which there is
the potential for more harm than good. Nearly all of the
national guidelines—including those of the American Academy
of Family Physicians, the American Urological Association,
and the American Cancer Society—recommend nearly identical
approaches a physician should take when it comes to
prostate cancer screening. This approach is discussing with
the patient the risks and benefits, providing thorough
informed consent, and coming to a shared decision. Family
medicine has begun to stress the shared decision-making
model because of the uncertainty in the literature with
regard to such practices as hormone therapy, screening
mammography, and many other medical procedures. The shared
decision-making model and national guidelines are both
losers in this story.

As the trial progressed we presented national experts who
discussed the controversy surrounding prostate cancer
screening and explained some of the potential dangers of
PSA. We discussed such things as false positives, indolent
vs aggressive cancers, sensitivity and specificity. Our
experts explained that because of the questionable benefit
vs associated risks of PSA screening, a shared decision by
the physician and the patient was recommended by all of the
national health associations. The science was clearly in
our favor.

As a family physician I have reveled in keeping up-to-date
and providing my patients with the best possible medicine.
I have discussed with both patients and colleagues that
simply ordering more tests because we have them is not
always the best medicine. We have discussed false positives
and their implications. The active practitioners who keep
up-to-date and stay informed are the losers in this story.
During that year before the trial, my patients became
possible plaintiffs to me and I no longer discussed the
risks and benefits of prostate cancer screening. I ordered
more laboratory and radiological tests and simply referred
more. My patients and I were the losers.

A major part of the plaintiff's case was that I did not
practice the standard of care in the Commonwealth of
Virginia. Four physicians testified that when they see male
patients older than 50 years, they have no discussion with
the patient about prostate cancer screening: they simply do
the test. This was a very cogent argument, since in all
likelihood more than 50% of physicians do practice this
way. One may have argued that we were practicing above the
standard of care, but there is no legal precedent for such
an argument.

As is well documented in the literature, physicians take
quite a long time to change their patients' protocols.
Thus, we know that many practicing physicians are not using
well-proven interventions or implementing well-publicized
national guidelines. The legal definition of standard of
care protects these physicians and encourages them to
change slowly, if at all. It is often claimed that
malpractice is a mechanism for holding physicians
accountable and improving the quality of care. This case
illustrates quite the opposite: punishing the translation
of evidence into practice, impeding improvements to care,
and ensconcing practices that hurt patients. In our legal
system, the physicians who are slow to change are the

During closing arguments the plaintiff's lawyer put
evidence-based medicine on trial. He threw EBM around like
a dirty word and named the residency and me as believers in
EBM, and our experts as the founders of EBM. He defined EBM
as a cost-saving method and stated his belief that the few
lives saved were not worth the money. He urged the jury to
return a verdict to teach residencies not to send any more
residents on the street believing in EBM.

Before this case, I believed that following the current
literature and evidence-based medicine was well accepted in
medicine and throughout the country. Neither my lawyers nor
the judge ever questioned if the plaintiff's attorney could
argue against EBM or the national guidelines; the argument
was clearly admissible. Sackett and colleagues have
generally been given credit for reviving the idea of EBM,
which is generally defined as the "conscientious, explicit,
and judicious use of current best evidence in making
clinical decisions about the care of individual patients."1
Evidence-based medicine was a loser.

On June 30, 7 days after the trial started, I was
exonerated. My residency was found liable for $1 million.

The plaintiff's lawyer was convincing. The jury sent a
message to the residency that they didn't believe in
evidence-based medicine. They also sent a message that they
didn't believe in the national guidelines and they didn't
trust the shared decision-making model. The plaintiff's
lawyer won.

As I see it, the only way to practice medicine is to keep
up with the best available evidence and bring it to my
patients. As I see it, the only way to see patients is by
using the shared decision-making model. As I see it, the
only way to step into an examination room is to look at a
patient as a whole person, not as a potential plaintiff. As
I see it, I'm not sure I'll ever want to practice medicine


1. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB,
Richardson WS. Evidence based medicine: what it is and what
it isn't. BMJ. 1996;312:71-72. FULL TEXT

A Piece of My Mind Section Editor: Roxanne K. Young,
Associate Editor.

Vol. 291 No. 14, April 14, 2004 Featured Link

Evidence-Based Medicine on Trial

To the Editor: Unfortunately, the results of Dr
Merenstein's trial1 demonstrate that juries, as well as
some attorneys, misunderstand EBM, believing that its focus
is as a cost-saving method of practice. The American
Academy of Family Physicians (AAFP) stands behind its use
of EBM in the development of clinical practice guidelines,
continuing medical education, and quality improvement. We
continue to develop, on our own and with other specialty
organizations, clinical practice guidelines that are based
on critical evaluation of the current best evidence and
that incorporate shared decision making.

Some physicians may respond to high-profile cases such as
this one by ordering unnecessary tests and procedures in
the belief that if they can adhere to all
standards—evidence-based or not—they will prevent
malpractice suits. Since each diagnostic or treatment
intervention carries its own risk, attempts to practice
such "defensive medicine" will over time expose patients to
unnecessary injury. Instead, we hope that physicians and
the public will recognize that this was only one legal
case. We believe that physicians must continue to educate
their patients, the public, and the legal system about EBM
and shared decision making.

Michael Fleming, MD
President, American Academy of Family Physicians
Leawood, Kan


Vol. 291 No. 14, April 14, 2004 Featured Link
• E-mail Alerts

Evidence-Based Medicine on Trial—Reply
In Reply: I wrote my essay as catharsis for myself and with
the hope that it might bring to light some of the problems
in our current health care system. I never anticipated the
response it has generated, and I hope this initial interest
helps lead to some changes. I have heard from physicians,
lawyers, and laypeople from literally around the world and
have appreciated every call and letter. Drs Bicket, Hogan,
Morse, and Watts' letters of support are also greatly

Mr Hall and his colleagues obviously spent a lot of time
studying my case, but I am doubtful of their conclusions.
Hall states, "Merenstein's trial established no legal
principle about EBM." My essay never claimed or even
implied that a legal principle was established. Rather,
what I tried to convey was the troubling state of the
medicojudicial system in the United States, a system in
which a physician can be put on trial for following
national guidelines, the best evidence, and current
research, and for properly documenting such practices, and
then be found negligent for not following outdated and
unsupported "community" practices.

While Hall et al claim that the judge's instructions were
"entirely generic, providing nothing about EBM," they
ignore the prevalence of EBM at the heart of the
plaintiff's case. The jury was given ample evidence of my
compliance with national guidelines and the treatment
methods most supported by current research, and yet the
plaintiff's counsel was given free rein to impugn such
practices and the jury was permitted to rule against such
practices. My lawyers spoke to 2 members of the jury
directly after the trial. They expressed their belief that,
"in the end the physician should recommend to the patient
to get the PSA," and "we had a hard time accepting that
ignorance of PSA results was preferable to knowledge."
Clearly, this jury of 7 was not convinced that EBM should
be used in the physician's office despite having heard
about national guidelines and EBM for an entire week. I
fail to see how this is not a loss for EBM.

I greatly appreciate the interest of the AAFP in my case.
Dr Fleming mentions the AAFP's use of EBM in the
development of clinical practice guidelines. I applaud my
specialty organization's dedication to EBM and have always
looked toward its guidelines in my clinical use.

Daniel Merenstein, MD
Robert Wood Johnson Clinical Scholars Program
Johns Hopkins Medical School
Baltimore, Md
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