Healthy Skepticism Library item: 14450

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Sharav VH.
Undisclosed Financial Ties: JAMA editor hoodwinked once again
Alliance for Human Research Protection 2008 Oct 17
http://www.ahrp.org/cms/content/view/18/87/

Full text:

In July 2008, Dr. Catherine DeAngelis, editor-in-chief of the Journal of the American Medical Association (JAM) said: “We have given away our profession and we have got to take it back. The influence does not usually amount to outright bribery. We just have to be more careful, all of us, and insist that we are not going to be hoodwinked by them, fooled by them.”

The reported findings of a study sponsored by the National Institute of Mental Health, “Escitalopram [brand, Lexapro] and Problem-Solving Therapy for Prevention of Poststroke Depression,” was published in JAMA, May 2008.
The reported findings lent the appearance of legitimacy for the use of antidepressants to prevent depression in patients who suffered a stroke.

The study authors’ conclusion in JAMA:
“the use of escitalopram or problem-solving therapy resulted in a significantly lower incidence of depression over 12 months of treatment compared with placebo, but problem-solving therapy did not achieve significant results over placebo using the intention-to-treat conservative method of analysis.”

The lead author, Dr. Robert Robinson, of the University of Iowa Medical Center, focused only on a comparison between the drug and placebo, but not on the third arm of the study, problem-solving therapy—which proved equally beneficial compared to placebo. He promoted the commercially valuable, partial findings of the study, encouraging the media to hype the use of antidepressants. He is quoted by the Associated Press stating:

“We showed you could in fact prevent the development of depression after stroke.
I hope I don’t have a stroke, but if I do, I would certainly want to be placed on an antidepressant.”

The report published in JAMA, obscures the real study findings—as identified by Dr. Jeffrey Lacasse, and Dr. Jonathan Leo, the authors who scientifically debunked the “chemical imbalance theory” of depression http://ahrp.blogspot.com/2007/12/chemical-imbalance-scientifically.html ; http://www.springerlink.com/content/u37j12152n826q60/fulltext.pdf and http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/
journal.pmed.0020392

Their letter published in JAMA (below) points out that the authors failed to make a direct statistical comparison between the two active treatments—they only compared Lexapro to placebo, not to problem-solving therapy. Their own analysis shows that the difference between psychotherapy and Lexapro does not appear to be either clinically or statistically significant.

Dr. Robinson et al, responded to several letters commenting on their report.
In their response to Drs. Lacasse and Leo, they acknowledge that “a post hoc analysis confirmed that there was no significant difference between the 2 treatments….”

First question: why did the authors fail to analyze and report the complete data findings of their study?

Second question: given that psychotherapy does not pose the serious risks that antidepressants do, why did they promote the drug and remain silent about the equally effective non-invasive therapy???

Dr. Robinson has been recommending the expanded use of antidepressants for stroke patients—“regardless of whether they have symptoms of depression”—at least since 2007. He is quoted in Clinical Psychiatry News stating at the meeting of the American Academy of Clinical Psychiatrists:
“Perhaps all patients who suffer a stroke should be evaluated by a psychiatrist and treated with antidepressants, because [these drugs] appear to improve their recovery.”
http://findarticles.com/p/articles/mi_hb4345/is_/ai_n29359239

The Financial Disclosures accompanying the JAMA report also appear to be
incomplete:
“All of the authors received salary contributions from the National Institute of Mental Health grant supporting this study. Over the past 5 years, Dr Robinson reported serving as a consultant to the former Hamilton Pharmaceutical Company and Avanir Pharmaceutical Company; Dr Jorge reported receiving 2 travel awards to participate in national meetings from the former Hamilton Pharmaceutical Company and Avanir Pharmaceutical Company. No other disclosures were reported.”

However, in 2007, Clinical Psychiatry News, reported that Dr. Robinson “serves on the speakers’ bureau for Forest Laboratories Inc. He also serves as a consultant for Hamilton Pharmaceuticals Inc. and Avanir Pharmaceuticals.”
http://findarticles.com/p/articles/mi_hb4345/is_/ai_n29359239

Forest Laboratories manufactures the antidepressant used in the NIMH study—Lexapro.

In an article in STROKE, 2005, Dr. Robinson is listed as being on the speakers bureau for Forest and Pfizer, manufacturer of another antidepressant, Zoloft:
http://www.stroke.org/site/DocServer/SCU_-_Jan-Feb_2005.pdf?docID=5161

The uncritical media was swept up by the commercial pitch with banner headlines proclaiming:

Low-Dose Antidepressant Reduces Risk of Post-Stroke Depression, Neurology Today.
http://www.aan.com/elibrary/neurologytoday/?event=home.showArticle&id=ovid.c
om:/bib/ovftdb/00132985-200807170-00003

Study: Antidepressants help stroke victims, USA TODAY http://www.usatoday.com/news/health/2008-05-27-stroke-depression_N.htm

Antidepressants could help stroke victims from the start, Associated Press, CNN http://www.cnn.com/2008/HEALTH/conditions/05/27/stroke.depression/index.html

It is clear to us that neither the vetting process by the National Institute of Mental Health nor the medical journal reviewing process succeed in filtering out biased, commercially driven-study reports.

Whether or not a particular study is funded by industry or the NIMH, the authors’ financial relationships with pharmaceutical companies undermine the objective scientific integrity of the published journal reports.

It would appear that JAMA editor-in-chief, Dr. Catherine DeAngelis, who in
2006 said. “I don’t give people lie detector tests. I am not the FBI”
has been hoodwinked once again: http://www.ahrp.org/cms/content/view/288/27/ ; http://www.ahrp.org/cms/content/view/286/27/ ; http://www.ahrp.org/cms/content/view/20/27/ ; http://www.ahrp.org/cms/content/view/296/27/ ….

Contact: Vera Hassner Sharav
veracare@ahrp.org
212-595-8974

http://jama.ama-assn.org/cgi/reprint/300/15/1757-b
To the Editor:

Dr Robinson and colleagues reported that poststroke patients randomized to either escitalopram or problem-solving therapy had a lower annual incidence of depression compared with those prescribed placebo. Although the authors discussed the finding that both treatments outperformed placebo, they did not make a direct statistical comparison between the active treatments. It would be valuable to know how psychosocial treatment compared with prescription medication.

The reported incidence data showed that the rate of depression was approximately the same in both escitalopram (8.5%) and problem-solving therapy (11.9%) groups.

This difference does not appear to be either clinically or statistically significant. The authors could enhance the value of their research by providing this additional piece of analysis.

Jeffrey Lacasse, PhD
jeffreylacasse@mac.com
College of Human Services
Arizona State University
Phoenix

Jonathan Leo, PhD
Department of Neuroanatomy
DeBusk College of Osteopathic Medicine
Lincoln Memorial University
Harrogate, Tennessee

Financial Disclosures: None reported.

1. Robinson RG, Jorge RE, Moser DJ, et al. Escitalopram and problem-solving therapy for prevention of poststroke depression: a randomized controlled trial.
JAMA. 2008;
299(20):2391-2400.

~~~~~~~~~~
http://jama.ama-assn.org/cgi/reprint/300/15/1758-a

Dr. Robinson et al acknowledge:
Excerpt:
……
“Drs Lacasse and Leo point out that a direct comparison between pharmacological and psychotherapeutic prevention strategies was not included in our study.
Our a priori hypothesis was that both escitalopram and problemsolving therapy would be superior to placebo.
We did not hypothesize that one treatment would be superior to another.

However, in a post hoc analysis, a Cox proportional hazards test did not demonstrate a significant difference between the 2 treatments (unadjusted hazard ratio, 0.88; 95% confidence interval [CI], 0.4-1.65; P=.70).”
……

Robert G. Robinson, MD
robert-robinson@uiowa.edu
Ricardo E. Jorge, MD
Stephan Arndt, PhD
Department of Psychiatry
University of Iowa Carver College of Medicine