post by Paul Kelleher
Austin Frakt has an important post today about the still rocky terrain of informed consent in medicine. You should read the whole (short) post, which revolves around this case:
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.[...]
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. [...]
My residency was found liable for $1 million.
Frakt gives a little more background on the trial that led to this verdict:
[S]everal physicians testified that it was standard to conduct a PSA test without asking the patient. Hence, in the eyes of the law and despite the shared decision making process he employed, Merenstein delivered sub-standard care.
Perhaps the rationale for defining adequate care as that which would be provided by most of one's peers can be ratified by adapting that old Churchillian quip: it's the worst form of government, except for all the rest. After all, do we really want courts to be making decisions about what appropriate medical care consists in, especially when so much of the profession is united on what should be done? On the other hand, it is just as easy--and maybe easier---to raise important worries about determining the standard of care in this "prevailing practice"-based way. Perhaps Frakt's case of the resident and the PSA test is enough to convince you that we need a different standard. If not, consider this case, which comes from Rebecca Skloot's book The Immortal Life of Henrietta Lacks (pp. 129-135):
Southam injected HeLa and other living cancer cells into more than six hundred people for his research...Patients who'd unknowingly been injected with cancer cells by Southam read the articles and began contacting reporters. New York State Attorney General Louis Lefkowitz learned about Southam's research through media as well, and immediately lauched his own investigation. In a scathing five-page document filled with exclamation points, he accused Southam and Mandel of fraud and unprofessional conduct, and demanded that the Board of Regents of the University of the State of New York revoke their medical licenses. [...]
Many doctors testified before the Board of Regents and in the media on Southam's behalf, saying they'd been conducting similar research for decades. They argued that it was unnecessary to disclose all information to research subjects or get consent in all cases, and that Southam's behavior was considered ethical in the field. Southam's lawyers argued, "If the whole profession is doing it, how can you call it 'unprofessional conduct'?" [...]
The suspensions of Southam's and Mandel's licenses were stayed...[and] soon after the end of his [one year] probationary period, Southam was elected president of the American Association for Cancer Research.
Our mothers were right: just because everyone else is pushing cancer patients off the Brooklyn bridge doesn't mean it's OK for us to do it. And perhaps, just perhaps, the fact that most other doctors conduct the PSA test without first getting informed consent from the patient does not mean that this is acceptable conduct either. I won't pretend there aren't forcing pulling in different directions. But that is why we need clear examples of when informed consent is required, so we can distill generalized lessons from them.
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