News and Document archive source
copyrighted material disclaimer at bottom of page

NewsMinecabal-elitecorporatepharmaceutical — Viewing Item


Drug firms hide studies showing suicidal behavior { September 10 2004 }

Original Source Link: (May no longer be active)
   http://www.latimes.com/news/nationworld/nation/la-na-depress10sep10,1,950016.story?coll=la-headlines-nation

http://www.latimes.com/news/nationworld/nation/la-na-depress10sep10,1,950016.story?coll=la-headlines-nation

THE NATION
Drug Firms Say Secrecy Fostered Credibility 'Crisis'
In House testimony, industry officials admit failing to publish studies on antidepressants and child suicidal behavior caused a public breach.
By Elizabeth Shogren
Times Staff Writer

September 10, 2004

WASHINGTON Pharmaceutical company officials admitted Thursday that the public's confidence has been eroded by the controversy over the firms' failure to publish unfavorable results from clinical trials of the safety and effectiveness of antidepressants for children.

They said they hoped that their recent commitments, individually and collectively, to make data from clinical trials of these and other drugs available would help restore the public's trust.

"We believe there is clearly a societal crisis in terms of credibility for drug companies," Dr. John R. Hayes of Eli Lilly & Co. told the House Energy and Commerce Committee.

Pharmaceutical Research and Manufacturers of America, a trade association representing most drug companies, announced Tuesday that as of Oct. 1, it would have a website http://www.clinicalstudyresults.org with access to all study results since October 2002 for drugs marketed in the United States.

Joseph S. Camardo, a senior vice president of Wyeth Research, told reporters during a break in the hearing that the media and congressional outcry over the link between antidepressants and suicide, along with the failure of drug companies to disclose results of their drug trials, "brought the issue to everyone's attention."

During the hearing before the House Energy and Commerce subcommittee on oversight and investigations, members of Congress also assailed the drug companies and the Food and Drug Administration for failing to provide doctors and parents with the information they needed to decide whether antidepressants would help or harm children.

Fluoxetine hydrochloride, marketed as Prozac, is the only antidepressant approved by the FDA for children. But four other antidepressants were prescribed more frequently to children 17 and younger between 1998 and 2002 sertraline hydrochloride (Zoloft), paroxetine hydrochloride (Paxil), bupropion hydrochloride (Wellbutrin) and citalopram hydrobromide (Celexa), according to the FDA.

Twelve of 15 studies of popular antidepressants known as selective serotonin reuptake inhibitors failed to show that the drugs were effective in children.

When the committee began its investigation this year, only three of those studies had been published, according to the committee. Several have been made public since.

An internal FDA study and a study done by Columbia University at the FDA's request both concluded that, according to the drug companies' own trials, children were almost twice as likely to have suicidal thoughts or behavior if they took the drugs than if they took placebos.

Committee members criticized the FDA for failing to cooperate with their investigation.

Rep. Joe Barton (R-Texas) read an e-mail from an FDA official directing his colleagues not to provide Congress with "draft documents, notes, memos to self or file or incoming contacts from non-FDA individuals."

He accused the FDA of "stonewalling, slow rolling and plain incompetency."

But Dr. Janet Woodcock, FDA's deputy commissioner for operations, defended the agency, saying, "We have legal restrictions of the kind of information we can disclose."

Several committee members criticized the FDA for telling one of the companies, Wyeth, to remove information from the label of its antidepressant Effexor warning that, in clinical studies, patients 6 to 17 showed increased reports of suicidal behavior and hostility.

Instead, the FDA told the company to include a more general warning, issued in March for 10 antidepressants, stating that such drugs can cause deepening depression or even suicide.

Members of Congress said the FDA's actions had led parents to believe that these drugs could help depressed children.

"These parents are frantic," said Rep. Diana DeGette (D-Colo.) "Their children are depressed and they are under the illusion that these drugs will work."

Woodstock said the FDA had not acted more aggressively to limit the use of these drugs in children because there were so few options to treat depression in that age group. In addition, she said, the agency believes that "the jury is still out" on determining the effectiveness of these drugs in children. Suicide, the third leading cause of death in children 15 to 19, claims the lives of thousands of young people each year. Depression is a significant cause of suicide.

An FDA advisory committee plans to consider further regulatory options at a meeting next week.



40 percent of americans take prescription drugs
ADD drugs give hallucinations of bugs and snakes { March 22 2006 }
American painkiller use skyrocketing
Anti depresents linked to suicide
Antibiotic causes liver damage
Antidepressant use by adults surges { December 3 2004 }
Antidepressants addictive to some people { August 6 2006 }
Antidepressants remove obsessive focus of love
Antidepressiants increases chance of suicide { December 13 2006 }
Arthritis drugs causing cancer in childen { April 29 2008 }
Bayer sent riskier drug asia latinamerica { May 22 2003 }
Birth defects from paxil in pregnant women { December 8 2005 }
Canada makes drug deals with 2 states against fda wishes { October 5 2004 }
Cholesterol drug causes kidney damage contradicting fda { May 24 2005 }
Cholesterol meds lower test results not improving health { January 15 2008 }
Clinical trials biased by profit funding
Company hid heartattack data for painkiller { December 8 2005 }
Congressman moves retired to drug lobby
Dc council legislation blocks pharmaceutical price gounging { September 21 2005 }
Doctor gives anti depressants to 4 yr old girl
Doctors get kickbacks to promote drugs
Doctors prescribe paxil whenever asked { April 27 2005 }
Drug aleve increases stroke heart attack risk { December 21 2004 }
Drug bill well financed victory
Drug company criminal charges { May 31 2003 }
Drug firms hide studies showing suicidal behavior { September 10 2004 }
Drug firms hype up diseases to boost sales
Drug leader at NIH takes pharmaceutical money { December 22 2004 }
Fda accused too cozy with pharmaceuticals { November 18 2004 }
Fda approval surprises many doctors
Fda prevented drug expert from speaking on anti depressants { April 16 2004 }
Fda wants suicide warning on anti depressants { March 23 2004 }
Fda whistle blower seeks legal help { November 24 2004 }
Fraud studies made by drug company { March 2008 }
Man arrested if not medicating child with drugs { June 7 2004 }
Mccain knocks steroids baseball
Minnesota school shooter using prozac and others { March 26 2005 }
More anti depressant drug warnings by fda
New diabetes pill poses deadly risk
New york state sues paxil company over coverup { June 3 2004 }
Newer antipsychotic drugs more costly less effective { September 20 2005 }
Parents reverse child hyper activity without drugs { December 22 2006 }
Paxil link found with birth defects
Pharmaceutical cholesterol drugs not lowering risk
Pharmaceutical companies court doctors for sells { April 11 2008 }
Pharmaceutical companies using tax exempt charities { June 28 2006 }
Pharmaceutical secrecy on antidepressant data { January 29 2004 }
Pharmaceuticals in tap water through sewage { March 10 2008 }
Pharmaceuticals pay fda more for speedy approvals { November 22 2006 }
Return of vioxx unusual not unprecendented
Rise of european behavior controlling drug
Ritalin could be dangerous to heart { February 10 2006 }
Senators told fda too cozy with drug industry { November 18 2004 }
Sharp rise in ritalin { July 19 2003 }
Sleeping pill causes sleep driving { March 15 2007 }
Sleeping pills once a day increase death rate { March 23 2006 }
Statin drug takers suffer heart attacks anyway
Study criticizes painkiller marketing { January 25 2005 }
Study drugs for students growing { June 11 2006 }
Study shows no good effect from anti depressants { February 25 2008 }
Suicide risk increase with antidepressants { February 18 2005 }
Supreme court allows pharmaceutical to bulldoze homes { June 23 2005 }
Teens increasing pharmaceutical drug abuse { April 21 2005 }
Teens use pharmaceutical drugs to get high { December 21 2006 }
Unapproved drug tested on children in nigeria { May 7 2006 }
Unfavorable drug studies never reported
Viox risk seen with short term use { May 17 2006 }
Women participating in lilly drug trial hangs self { February 9 2004 }

Files Listed: 68



Correction/submissions

CIA FOIA Archive

National Security
Archives
Support one-state solution for Israel and Palestine Tea Party bumper stickers JFK for Dummies, The Assassination made simple