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Serious adverse events

Q: During a recent radio appearance, you chided a drug company for referring to 19 deaths from a contaminated blood thinner as “adverse events.” You seem to be unaware that “adverse events” is a legitimate scientific term used in clinical trials. There’s nothing wrong with it. Check out the FDA’s website.

A: The fact that “adverse events” is a legitimate technical term in drug trials doesn’t mean that it’s legit for drug companies to use it to communicate with the public.

Scientific Protein Laboratories of Waunakee, Wis., which bought the suspect raw heparin from China and sold it to Baxter International, said publicly it’s “premature to conclude that the heparin active pharmaceutical ingredient sourced from China and provided by S.P.L. to Baxter is responsible for these adverse events.” (New York Times, March 6, 2008.)

It’s one thing to use scientific jargon in a research paper for a medical journal; it’s another to use it in a statement to the press for public dissemination.

I don’t know whether Scientific Protein’s public relations department deliberately used the expression to play down the 19 deaths or whether it was simply incapable of writing plain English. Either way, it screwed up.

By the way, I did check out the FDA website and found the term defined this way:

“A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.”

Knowing that makes me feel a lot better!

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