The New York Times ticked us off again this morning.
Not as much as it did last month, but it annoyed us nonetheless.
The front page of the Week in Review section has a piece titled “Making Sense of the Great Suicide Debate.” Here’s a link.
The article quotes (and appropriately identifies as “a paid expert for plaintiffs’ lawyers”) Ronald Maris, so you quickly know where the paper’s coming from. The article notes the recent press reports that assorted drugs, including some being used to treat epilepsy, “appear to increase the remote risk of suicide.” It goes on to report certain data from clinical trials: “Doctors would have to treat about 500 patients before seeing one case of suicidal thinking or behavior that would not have occurred without the drug.”
We haven’t yet looked at the data from the epilepsy clinical trials, but we’ve seen publicly-reported data from other clinical trials, and here’s what the FDA has overlooked elsewhere:
Suppose a patient tries to commit suicide by taking an overdose of the medicine being tested in the clinical trial. If the patient takes, say, 25 anti-epilepsy pills, the patient will end up in the hospital — maybe just for a bad stomach-ache, but in the hospital. There will be contact with the health care system during which the attempted suicide will be revealed and reported.
If an identical patient was assigned to the placebo group and attempted suicide by overdose, that patient will have ingested 25 harmless sugar pills. The patient will not end up in the hospital. Unless the patient later chooses voluntarily to disclose the suicide attempt, the suicidal behavior will go unreported.
In other contexts, the FDA has overlooked that vital distinction. Patients taking active drug have more contact with health care professionals generally — and more contact in the context of attempted suicide by overdose, in particular — than patients taking placebo. You should thus expect more reports of suicidal behavior in the drug group than in the placebo group, and you must adjust for that differential reporting.
Frankly, we don’t know how the FDA has overlooked this. Lord knows, we’re not Einstein. We’re not even scientists; we just read the medical literature and talk to folks in the field. But differential reporting between drug and placebo groups just may explain the differential suicide rates seen in clinical trials of many drugs.
Until the FDA (and others) explore that hypothesis, let’s not work ourselves into a tizzy.
And, New York Times, let’s not publish articles that may discourage patients from taking much-needed medications.