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A decade of questions over a Paxil study and military suicides

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A decade of questions over a Paxil study and military suicides

Picture of Martha Rosenberg

 Drug makers always insist they are unaware of their drugs’ true risks until a wide swath of the population uses them and safety signals emerge, but the story of the antidepressant Paxil shows that is not always the case.

Wednesday, December 23, 2015

 

In the last few years, highly promoted drugs like Vioxx, Bextra, Baycol, Trovan, Meridia, Seldane, Hismanal, Darvon, Mylotarg, Lotronex, Propulsid, Raxar and Redux have been withdrawn for safety risks after millions used them. Others like Avandia, Ketek and Xarelto are under serious safety clouds.

 

Drug makers always insist they are unaware of their drugs’ true risks until a wide swath of the population uses them and safety signals emerge, but the story of the antidepressant Paxil shows that is not always the case.

 

Paxil (paroxetine) was a top selling SSRI antidepressant drug for GSK but court proceedings brought by the New York Attorney General in 2004, soon after its approval, revealed the research published in the Journal of the American Academy of Child and Adolescent Psychiatry known as "study 329" buried the drug's suicide risks in adolescents. Nor was it even written by the 22 doctors and researchers listed as authors but by a medical communication company that GSK hired, charged researchers. "You did a superb job with this," wrote the paper's first “author,” Brown University's Martin Keller to Sally Laden, a ghostwriter working for the MCC Scientific Therapeutics Information. "It is excellent. Enclosed are rather minor changes from me."[i]

 

The Journal of the American Academy of Child and Adolescent Psychiatry where the Paxil study was published is a publication of the American Academy of Child and Adolescent Psychiatry which lists funders of its treatment guidelines for children and adolescents with bipolar disorder as Abbott, AstraZeneca, Eli Lilly, Forest, Janssen, Novartis and Pfizer.[ii]

 

In 2006, lead author Keller, former Brown Professor Emeritus of Psychiatry,  acknowledged that GSK had given him tens of thousands of dollars during and after the time the study was conducted.[iii]

 

Almost fifteen years after the research was published which increased GSK sales of Paxil to the young because of the drug’s putative safety,[iv] the furor had not died down. In 2014, two members of the American Academy of Child and Adolescent Psychiatry, Edmund Levin and George Stewart, asked the editor of the Academy’s journal why the discredited paper has not been retracted.[v]

 

In 2015, a decade after scientific questions were first raised about study 329 by leading reporters Paul Thacker, Ed Silverman and Alison Bass, author of Side Effects, and numerous psychiatrists, researchers and professors, the British Medical Journal (BMJ) published a reanalysis that amounted to a reversal of the 2001 study.[vi] It showed that Paxil indeed increases risks of suicide in young people and adolescents.

 

The reanalysis of Paxil’s safety among young people is especially alarming in light of the high suicide rates in the military. Suicides among young service people during the Iraq and Afghanistan wars and afterward exceeded combat deaths and sometimes amounted to one death a day. [vii] The Veterans Administration’s Iraq War Clinician Guide calls Paxil and other SSRIs "first line medications for PTSD pharmacotherapy in men and women with military-related PTSD." Between 2001 and 2009, 17,830 prescriptions for Paxil were dispensed according to Tricare data.[viii]

 

While it is never possible to assign absolute causality to suicide, military suicides are not highly correlated with deployment or combat--roughly a third of the military personnel who kill themselves have never deployed and 60 percent have not seen combat. They are, however, correlated with Paxil which according to a 2011 paper in Professional Psychology: Research and Practice is the preferred SSRI given out in the military.[ix]

 

The reanalysis of Paxil is a victory for safety activists, medical reporters and the public. But how many other drugs in wide use are not as safe as presented?

 

[i] Firestone C, Kelsh C. Keller's findings on Paxil disputed by doctors, FDA.

The Brown Daily Herald. Sept 23, 2008 

http://media.www.browndailyherald.com/media/storage/paper472/news/2008/09/23/CampusNews/Kellers.Findings.On.Paxil.Disputed.By.Doctors.Fda-3446422.shtml

[ii] Kowatch R et al. Treatment guidelines for children and adolescents with bipolar disorder: child psychiatric workgroup on bipolar disorder. J. Am. Acad. Child adolesc. Psychiatry, 44:3, March 2005. http://www.bpchildren.org/files/Download/TreatmentGuidelines.pdf

[iii] Heck I.  Controversial Paxil paper still under fire 13 years later. Brown Daily Herald. April 2, 2014

http://www.browndailyherald.com/2014/04/02/controversial-paxil-paper-still-fire-13-years-later/

[iv] Carey B. Antidepressant Paxil is unsafe for teenagers, new analysis says. New York Times. Sept. 16, 2015. http://www.nytimes.com/2015/09/17/health/antidepressant-paxil-is-unsafe-for-teenagers-new-analysis-says.html?_r=1

[v] Heck I.  Controversial Paxil paper still under fire 13 years later. Brown Daily Herald. April 2, 2014

[vi] Carey B. Antidepressant Paxil is unsafe for teenagers, new analysis says. New York Times. Sept. 16, 2015. 

[vii] Rosenberg M.  Suicides not caused by suicide-linked drugs say pharma consultants to the military. Opednews.Nov. 14, 2014. http://www.opednews.com/articles/Suicides-Not-Caused-By-Sui-by-Martha-Rosenberg-American-Medical-Association_Consultants_Drug-Companies-Marketing_Medical-Bankruptcy-141114-12.html

[viii] Rosenberg M. Military suicides not caused by pharma drugs say pharma-funded military consultants. Opednews. March 9, 2014.

 http://www.opednews.com/articles/Military-Suicides-Not-Caus-by-Martha-Rosenberg-Drug-Companies-Marketing_Drugs_Drugs-Prescription_Military-Exit-Strategy-Fraud-140309-83.html

[ix] A Clinician’s Guide to PTSD Treatments for Returning Veterans Sharpless BA and Barber JP,  Vol 42(1), Feb 2011, 8-15 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3070301/