In Reporting Symptoms, Don’t Patients Know Best?
The article, by Denise Graves, began with a personal account of a drug she was given to treat pain from an injury. A few days later, she woke up with a huge red blister on her tongue and immediately stopped the medication. Her doctor pooh-poohed the blister, writing it off to coincidence.
Later on the drug, Bextra, was taken off the market in the US. Amongst other things, Bextra was linked to the sometimes deadly Stevens-Johnson syndrome, which can cause mouth blisters. Ms Graves was quick to say that maybe the drug did not cause the blisters, but “I never understood why my doctor was so quick to dismiss it.”
Is this resonating with you? I thought so.
Ms Graves cites a recent article by oncologist Ethan Basch in the New England Journal of Medicine that argues that doctors need to pay more attention to patients. According to her account:
Direct reports from patients are rarely used during drug approval or in clinical trials, Dr. Basch says. If patients’ comments are sought at all, they are usually filtered through doctors and nurses, who write their own impressions of what the patients are feeling.
Typically, the clinicians downgrade the severity of the patient’s symptoms, often writing us off as whiners and complainers. Sometimes, “the downgrading may reflect wishful thinking by doctors, who may think that a certain drug will help patients and don’t want to take them off it.”
I’ve written a lot on this kind of stuff, and it’s worth quoting at length from my inaugural blog piece here at Knowledge is Necessity, from late Dec, 2008:
Early in 2008, in preparing for a grand rounds lecture I was to deliver to a psychiatric hospital in Princeton, I came across a 2006 study published in the American Journal of Psychiatry, which is put out by the American Psychiatric Association. The study concerned bipolar patients on Zyprexa, and was designed and written by Eli Lilly, which manufactures the drug.
The article listed Mauricio Tohen MD, DrPH as the lead author of the study. Dr Tohen is virtually unique in psychiatry in that he is affiliated with Harvard and Mass General Hospital AND is employed by Eli Lilly. In addition to Dr Tohen, the article listed eight other authors. Three of the names were instantly recognizable as prominent academic thought leaders.
According to the abstract of the study:
"Compared to placebo, olanzapine delays relapse into subsequent mood episodes in bipolar I disorder patients who responded to open-label acute treatment with olanzapine for a manic or mixed episode."
But the study data, not mentioned in the abstract, told a far different story. In fact, eighty percent of the patients in the study stopped taking their Zyprexa.
When I raised this to my audience of clinicians in my talk, I asked if anyone thought this was deceitful. All hands went up. I would go further, I said. I would say it's immoral.
Zyprexa is an antipsychotic with a high side effects profile, and it's not surprising that four in five bipolar patients choose not to take it, even if they are otherwise doing well on it. As Holly Swartz MD of the University of Pittsburgh told a symposium at the 2006 APA annual meeting: "If a patient doesn’t stay on it, it doesn’t do any good, even if it works.”
My audience, incidentally, entirely clinicians, stampeded to the exits as soon as I finished my talk.
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