Okay, my hiatus is over. Class is finished, and I’ve got three weeks to kill with work, blogging, and playing Lego Batman because I’m just that kind of geek.
Of course, the first blog I check when I come back is Mind Hacks, because it is one of the best psychology blogs out there, and I found the first story a bit troubling. I followed it back through all of the sources, and now I’m presenting it here. Furious Seasons has reported on this story, twice, so I also recommend you read that site for anything I may have missed.
In 2008, Robinson et al. published a piece in JAMA testing the use of the antidepressant escitalopram (Lexapro) versus Problem-Solving Therapy as a treatment for post-stroke depression. More specifically, Robinson et al. were testing whether either Lexapro or therapy would prevent depression within the first year after a stroke, stating that depression occurs in more than half of stroke patients. They studies the effects in a randomized, controlled, partially double blinded experiment. (Let me explain: it is virtually impossible to double-blind a therapy comparison, especially when one is comparing the effects of therapy with medication. What Robinson et al. did was blind the Lexapro trial with a placebo group. And when I say virtually impossible, I mean impossible, but I want to leave myself open in case I’m wrong).
Robinson et al. found that fewer people in the Lexapro group (8.5%) were diagnosed with depression after 12 months, compared with the therapy group (11.9%) and the placebo group (22%). These results were paraded through the media.
However, this is not as simple as it seems. Jeffery Lacase and Jonathan Leo published a letter in JAMA in October, stating that, while the study states that while the study finds that the Lexapro results were statistically better than placebo and the therapy results were not, the study did not assess whether the Lexapro results were statistically better than therapy. In a response in the same issue, Robinson et al. stated that “a Cox proportional hazards test did not demonstrate a significant difference between the two treatments.”
This month, Leo and Lacase published an article in the British Medical Journal (BMJ) stating that Robinson et al. did not make full financial disclosures. Specifically, Robonson did not mention that Robinson had a financial relationship with Forest Laboratories. Forest, for those who may not know, makes Lexapro. This seems like a pretty big deal. Robinson chalks it up to an “erroneous recollection” of the dates that he worked for the Forest speaker’s bureau. I don’t buy this. JAMA asks for disclosures going back five years, in this case between 2003 and 2008. Robinson states that he worked for Forest in 2004 “and perhaps 2005.” This is well within the reporting window.
If it were me, and I don’t think I’ll ever have to worry about pharmaceutical money as a lowly counselor and psychologist, I think when I filled out the disclosure form the first thing that popped in my head would be that I worked for the company that is making the drug I am supporting, not that I got money from a bunch of other drug companies.
And I’m not criticizing doctors who take money from pharmaceutical companies. From what I read, if this practice stopped it would almost halt medical research. The NIH only gets about $12 from Congress (as opposed to the billions we use to stop those pesky potheads from getting stoned and passing out while watching anime terrorizing their neighbors. What I’m criticizing here is the non-disclosure. Even if the results of the study are spot-on, it makes things look shady.
But this isn’t the end. Leo received a phone call from JAMA editor Phil Fontanarosa, who, depending on which side of the story you hear, either banned Leo from ever publishing in JAMA again, or, as a spokesperson says, ” It was something along the lines of not setting a good example for students. He didn’t say he would be banned. He didn’t think Leo was taking a very good approach by taking this confidential process within JAMA out to media and another medical journal. It’s just not the way things are handled here.”
JAMA’s Instructions for Authors state that it is best to submit a letter within four weeks of original publication. It is unlikely that Leo’s article would have been published anyway. In fact, Leo stated that he warned JAMA about the lack of disclosure 5 months ago.
The Wall Street Journal reports that Leo then received a not-so-friendly call from JAMA editor-in-chief Catherine DeAngelis. Le states that DeAngelis first called his supervisors to try to get him to retract the BMJ piece. Leo characterized DeAngelis as “very upset.”
When WSJ attempted to contact DeAngelis, she gave a remark that could have come from one of the mobsters in one of Scorsese’s best:
“This guy is a nobody and a nothing” she said of Leo. “He is trying to make a name for himself. Please call me about something important.” She added that Leo “should be spending time with his students instead of doing this.”
When asked if she called his superiors and what she said to them, DeAngelis said “it is none of your business.” She added that she did not threaten Leo or anyone at the school.
Of course, with all of the attention this is raising, I would guess that the story isn’t over.
Lacasse, J., & Leo, J. (2008). Escitalopram, Problem-Solving Therapy, and Poststroke Depression JAMA: The Journal of the American Medical Association, 300 (15), 1757-1758 DOI: 10.1001/jama.300.15.1757-c
Robinson, R., Jorge, R., Moser, D., Acion, L., Solodkin, A., Small, S., Fonzetti, P., Hegel, M., & Arndt, S. (2008). Escitalopram and Problem-Solving Therapy for Prevention of Poststroke Depression: A Randomized Controlled Trial JAMA: The Journal of the American Medical Association, 299 (20), 2391-2400 DOI: 10.1001/jama.299.20.2391
Robinson, R., Jorge, R., & Arndt, S. (2008). Escitalopram, Problem-Solving Therapy, and Poststroke Depression–Reply JAMA: The Journal of the American Medical Association, 300 (15), 1758-1759 DOI: 10.1001/jama.300.15.1758-b