Air Date: Thursday, December 09, 2004
Time Slot: 10:00 PM-11:00 PM EST on ABC
Episode Title: "N/A"
[NOTE: The following article is a press release issued by the aforementioned network and/or company. Any errors, typos, etc. are attributed to the original author. The release is reproduced solely for the dissemination of the enclosed information.]


Drug Companies Also Took Steps to Downplay the Risk of Withdrawal Symptoms

"Primetime Live" Airs Thursday, December 9 at 10:00 p.m., ET

At least a hundred children have committed suicide, and many others attempted it, while taking antidepressants. Chris Cuomo reports that it took years for drug makers to disclose some negative information they had about antidepressants and suicidal behavior in kids. Cuomo speaks with angry parents who say that, if they'd had all of the facts about these potentially dangerous drugs, they might have been able to better protect their children. A "Primetime Live" investigation has uncovered a paper trail which reveals evidence that drug makers have also known for years about the true occurrence rate of withdrawal symptoms associated with antidepressants, but downplayed those figures. "Primetime Live" airs THURSDAY, DECEMBER 9 (10:00-11:00 p.m., ET) on the ABC Television Network.

"Primetime Live" has obtained internal Glaxo Smithkline documents that show that, as far back as 1997, some children taking Paxil demonstrated suicidal behavior. Other companies' studies had similar findings. Yet it wasn't until this year that Glaxo Smithkline and other drug makers began warning consumers about the increased risk with so-called "black box" warnings. The companies have told Congress that the number of children in their studies demonstrating suicidal behavior was statistically insignificant, and that the increased risk was not clear until the data from all studies were grouped together.

The vast majority of patients taking antidepressants do not have suicidal thoughts and the drug companies say there is no way to prove their drugs, and not underlying depression, led to the suicides and attempted suicides in question.

Other documents -- seen for the first time on "Primetime" -- show that Glaxo Smithkline studies concluded that, by FDA standards, Paxil failed to demonstrate it was effective for children and adolescents. Yet in a memo to its sales force, the drug maker touted Paxil's efficacy in treating adolescent depression. In written statements, Glaxo Smithkline told "Primetime" that they don't endorse the use of their antidepressants to treat depression in teens or younger children (no antidepressant, except Prozac, has FDA approval for use in children.)

"Primetime's" investigation reveals evidence Glaxo Smithkline also withheld information in an effort to downplay the chances that patients ending their use of Paxil would suffer from withdrawal symptoms. These symptoms range from mild headaches to debilitating electric shock sensations, and can be caused by other antidepressants as well. In a letter, the drug maker says it has provided adequate and complete warnings to physicians about these risks. They do admit to "Primetime" that, in their internal studies, as many as twenty-one percent of those taking Paxil experienced "discontinuation" symptoms. They also say most who experience discontinuation problems have mild symptoms that last no more than two weeks, and recommend tapering for patients discontinuing the drug.

"This is about money," says Congressman Henry Waxman, who is on the Congressional committee investigating the antidepressant manufacturers. "This is not about science, because what they're doing is withholding the scientific information, suppressing the studies that could have a negative impact on their sales and their profits."

Also: John QuiC1ones interviews Jodee Hogg, who survived a deadly Montana plane crash. In September, Hogg and three other Forest Service workers were being flown to work when their plane crashed in the wilderness and burst into flames. By the time rescue workers reached the crash site, they determined no one could have survived. In fact, Hogg and two others did survive, and were struggling for life on the cold, isolated mountain. Hogg details the harrowing and heroic story of how she and her badly injured co-worker, Matthew Ramige, made it out of the forest alive.

Plus: Cynthia McFadden looks at the Scott Peterson case through t eyes of two mothers -- one fighting to avenge the death of her daughter, the other pleading for the life of her son.

DIANE SAWYER, CHRIS CUOMO, CYNTHIA MCFADDEN and JOHN QUICONES are the anchors of "Primetime Live." SHELLEY ROSS is the executive producer.

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