If I may be seemingly random here, I gotta mention this book chapter that I'm editing right now. It's for a pharmaco-epidemiology textbook; the chapter I'm editing is on the history of how pharmacoepidemiololgy developed (mostly in the US).

So basically it's a chapter full of stories like "New Drug was introduced to fight Icky Disease; soon, an outbreak of spontaneous combustion was noticed among the population. Clinicians connected the spontaneous combustion with patients who took New Drug. Dude."

And one of the stories was on thalidomide. I vaguely knew that it caused birth defects, so it was pulled from the market back in the 1970s -- what I *didn't* know (until I edited this chapter) is that, while the FDA was considering approving the drug, the manufacturer went ahead and distributed samples of thalidomide to over 1,000 doctors, because they (the manufacturer) were expecting the FDA to approve thalidomide.

You know what's coming. The 1,000 doctors who received the thalidomide samples gave them out, like you do with samples. Over 20,000 patients received the samples -- and there were never any records kept of who received them.

!!!

I didn't realize that's how it all went down. Damn skippy, that's really fucking irresponsible.

And so now, class, we have stricter legislation about the drug approval process and regulations that make sure that the only drugs that are provided as samples are drugs that are already approved by the FDA.

Consider this your history lesson for the day.

(Thanks, Professor Peabody!)

(Not interesting enough to warrant a double post, though....)

Good grief, even the doctors didn't keep notes? I mean, I"d expect the company to know which doctors they gave it to, and the doctors to be able to say "hmm, let's see...here's a note in Mrs. Smith's chart, gave some to her because she was complaining of nausea..."

Records, people! It's all about keeping records!

Records, people! It's all about keeping records!

Right? But from what I read, things like that weren't (obviously) monitored as stringently prior to the 1980s-1990s.

Ack! I knew about Thalidomide. I didn't know about the untracked samples. (Also? Ack. Suddenly have terrible We Didn't Start the Fire earworm.)

That earworm has been always burning since the world's been turning....

JZ is very, very bored, and she really likes getting phone calls, as they remind her she has not fallen off the face of the earth. I told her the board misses her.

Can someone with JZ's phone number at the hospital please send it to me? I would muchly like to speak to her, and of course have her hold the phone against her belly so I can verbally shake my wee fist at the Weenie.

My profile address is good. Thank you!

And it's not even just an old story, since female thalidomide babies are apparently at high risk of developing certain cancers later in life, from what I understand.

Insent, Jen.