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Welcome to my blog, a place to explore and learn about the experience of running a psychiatric practice. I post about things that I find useful to know or think about. So, enjoy, and let me know what you think.


Monday, June 9, 2014

New POLL Article: Clinical Trials and Legal Jeopardy

I was reading David Healy's recent post, Sense About Science: First Admit No Harm. In it, he references an article her wrote back in 1999 for the Bulletin of Medical Ethics called, Clinical Trials and Legal Jeopardy. I linked over to it and read it-it basically covers many of the points he makes in his book, Let Them Eat Prozac, which I've mentioned in the past.

Healy is very passionate in his beliefs, and I think this sometimes detracts from his arguments. His writing often sounds like he's so indignant he's just generating data for his version of the story, just as he's claiming "the opposition" does.

But he makes a lot of good points. Significantly, for me anyway, this was written in 1999, and despite his legitimate concerns, we're still not much better at getting full data from pharmaceutical companies. (See all kinds of posts from 1 Boring Old Man, David Healy, and others).

The legal jeopardy part of the article is that many medications, Prozac in the case of the article, must be prescribed by a physician (or other qualified prescriber). This principle rests on the assumption that physicians are well-informed, and that we use the information we have to make the best possible clinical recommendations for our patients. So adverse events become the physician's responsibility, not that of the pharmaceutical company. But if the pharmaceutical company in question is withholding adverse event data, then physicians can't be well-informed, even though we think we are, putting us in a legally tenuous position.

Something else I found interesting is his pointing out that there were not a lot of follow-up studies on the issue of prozac-induced akathisia/suicide attempts, despite all the data that came out about akathisia, and the use of benzodiazepines in the early trials to control agitation/akathisia. Healy reasons that if the problem was just with prozac, other companies with SSRIs in the pipeline at the time would have pounced on this fact to make their own drugs look better. But they didn't.

I'll include one quote, and corresponding references, from the article, to whet your appetite:

"As of 1986, Lilly's clinical trial base was showing rates of 12.5/1000 patients attempting suicide on fluoxetine versus 2.5/1000 patients on placebo and 3.8/1000 patients on reference antidepressants. This data remained unpublished and unreported to the FDA. There are other unpublished studies consistent with this finding, in addition to one published set of figures."

Lilly Memo re suicides and suicide attempts October 1986. Forsyth v Eli Lilly, Plaintiff's exhibit 73.
Kasper S. The place of milnacipran in the treatment of depression. Human Psychopharmacology (1997), 12 (suppl 3):s135-141.

What do you think? Is Big Pharma truly hiding adverse event and outcome data under the guise of commercial confidentiality to make unimpressive or even harmful drugs look better, or are they merely protecting patient privacy, and their investment, while providing a public service by producing useful products?

Read the article, hop on over to POLL, and comment!





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