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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outdated medicine or doesn't believe in continuing medical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
winners.
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 again.
REFERENCES
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.
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