Antidepressants' benefits may be exaggerated - vaccination honesty next?

[Guest guest]

Perhaps NEJM will publish a similar article about vaccinations and the

sweeping under the rug of adverse effects?

- - - -

*Antidepressants' benefits may be exaggerated*

* 17 January 2008

* From New Scientist

http://www.newscientist.com/article/mg19726393.300-antidepressants-benefits-may-\

be-exaggerated.html

It's called the " file-drawer problem " . A study fails to produce

interesting results, so is filed away and forgotten - a practice that

might mean antidepressants don't work as well as doctors think.

To get approval for the 12 antidepressants that went on the market

between 1987 and 2004, drug firms registered over 70 clinical trials

with the US Food and Drug Administration (FDA). But when k of

Oregon Health and Science University in Portland and his colleagues

combed through medical journals, they found that 23 of these studies

never made it into a journal. All but one of the unpublished studies

concluded that the effect of the drugs was negative or questionable (The

New England Journal of Medicine, vol 358, p 252).

Consider all 70 studies and antidepressants still emerge as helpful

drugs. Publication bias has exaggerated their effectiveness,

says, but it's impossible to know if journals refused to publish the

studies or didn't get them in the first place.

!+!+!+!

*

Selective Publication of Antidepressant Trials and Its Influence on

Apparent Efficacy*

k H. , M.D., Annette M. s, M.D., Eftihia Linardatos,

B.S., A. Tell, L.C.S.W., and Rosenthal, Ph.D.

http://content.nejm.org/cgi/content/short/358/3/252

ABSTRACT

Background Evidence-based medicine is valuable to the extent that the

evidence base is complete and unbiased. Selective publication of

clinical trials --- and the outcomes within those trials --- can lead to

unrealistic estimates of drug effectiveness and alter the apparent

risk--benefit ratio.

Methods We obtained reviews from the Food and Drug Administration (FDA)

for studies of 12 antidepressant agents involving 12,564 patients. We

conducted a systematic literature search to identify matching

publications. For trials that were reported in the literature, we

compared the published outcomes with the FDA outcomes. We also compared

the effect size derived from the published reports with the effect size

derived from the entire FDA data set.

Results Among 74 FDA-registered studies, 31%, accounting for 3449 study

participants, were not published. Whether and how the studies were

published were associated with the study outcome. A total of 37 studies

viewed by the FDA as having positive results were published; 1 study

viewed as positive was not published. Studies viewed by the FDA as

having negative or questionable results were, with 3 exceptions, either

not published (22 studies) or published in a way that, in our opinion,

conveyed a positive outcome (11 studies). According to the published

literature, it appeared that 94% of the trials conducted were positive.

By contrast, the FDA analysis showed that 51% were positive. Separate

meta-analyses of the FDA and journal data sets showed that the increase

in effect size ranged from 11 to 69% for individual drugs and was 32%

overall.

Conclusions We cannot determine whether the bias observed resulted from

a failure to submit manuscripts on the part of authors and sponsors,

from decisions by journal editors and reviewers not to publish, or both.

Selective reporting of clinical trial results may have adverse

consequences for researchers, study participants, health care

professionals, and patients.

Source Information

From the Departments of Psychiatry (E.H.T., A.M.M.) and Pharmacology

(E.H.T.), Oregon Health and Science University; and the Behavioral

Health and Neurosciences Division, Portland Veterans Affairs Medical

Center (E.H.T., A.M.M., R.A.T.) --- both in Portland, OR; the Department

of Psychology, Kent State University, Kent, OH (E.L.); the Department of

Psychology, University of California--Riverside, Riverside (R.R.); and

Harvard University, Cambridge, MA (R.R.).

Address reprint requests to Dr. at Portland VA Medical Center,

P3MHDC, 3710 SW US Veterans Hospital Rd., Portland, OR 97239, or at

turnere{at}ohsu.edu.

- **Full Text <http://content.nejm.org/cgi/content/full/358/3/252> **

- * PDF <http://content.nejm.org/cgi/reprint/358/3/252.pdf>*

- *PDA Full Text

<http://content.nejm.org/cgi/external_ref?link_type=pda_mms & doi=10.1056%2FNEJMsa\

065779>*

- *PowerPoint Slide Set <http://content.nejm.org/cgi/slideshow/358/3/252>*

- *Supplementary Material

<http://content.nejm.org/cgi/content/full/358/3/252/DC1>*

*

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