A Suicide Side-Effect?
What parents aren't being told
about their kids' anti-depressants

For 16-year-old Angela Reich, 2002 was a year of hell. First, the Palo Alto teenager was diagnosed with a rare form of highly aggressive cancer. Then she went through months of debilitating chemotherapy that made her nauseous, caused her hair to fall out and kept her in bed for much of her last year of high school. She handled it all with unflappable poise and good humour until it seemed she was out of the woods. But the worst began when she started taking the antidepressant Paxil.

"Angela had been just pushing through and pushing through," says her mother, Sara. "She mustered all her strength and courage to face the chemo and to be sick all the time." By the end of the summer, with the most intense part of her treatment behind her, she was worn out and discouraged. "She started to feel overwhelmed and depressed."

She began seeing a therapist and talked openly about her feelings. But after a few weeks her depression had not lifted, and Angela asked about going on antidepressants.

It took six weeks for the Reich's insurance company to approve a psychiatrist, and by then Angela was in a deep funk. "She was not wanting to get out of bed in the morning," Reich recalls. "She couldn't do her homework. She said it felt terrible to live like this, but then she would say, 'I don't want to die, I don't want to hurt myself.' I remember sitting across from her at the kitchen table and tears pouring from her eyes and her saying 'This is so hard.' "
The psychiatrist prescribed Paxil, a selective serotonin reuptake inhibitor (SSRI) similar to its famous predecessor, Prozac. On a dose of 5, then 10, then 15 milligrams a day, Angela soon started feeling better. Five weeks after she began taking the medication, Angela and her mother met with the psychiatrist, who suggested another boost in dosage. "He said she's doing well now; she could be doing even better on 20 milligrams," Reich remembers. She was hesitant, but Angela wanted her old life back and thought it made sense to try. The next day, she started on the higher dose.

Restless Legs, Sleepless Nights
Within days, Reich says, her daughter was acting strangely. The first change was Angela couldn't keep her leg still. "She'd be sitting in a chair and her knee would be jerking up and down." She became irritable and had more trouble sleeping. Her parents would ask about her restless, jerking leg and she would snap at them to leave her alone.

When Reich left on a business trip, Angela called her three or four times a day and begged her to come home early. When she returned, Angela "burst in my room and hugged me," Reich says. "She kept saying, 'Mommy, I'm so glad you're home.' She was scared, like she couldn't cope. She said she dreaded going to bed because she had so much trouble sleeping. She'd lay there thinking and her thoughts got darker and became unbearable."

That night, Reich shared her daughter's bed but Angela slept little and was still wound up in the morning. When her mother tried to get her ready for a piano lesson, she said she wasn't going. "She looked funny and had a weird smile on her face," Reich remembers. "I knew something was wrong. I looked around the room and saw some pill bottles. I asked if she took any pills and she said 'Yes.' "

Under questioning, Angela told her mother she had taken four tablets of the sleeping pill Ativan. Then Angela ran to the bathroom, locked the door, and started going through pill bottles. Her father, Jim, smashed the door open and snatched a bottle of Benadryl from her hands. She ran to her purse, seized a bottle of Tylenol and began shoving pills in her mouth. Her mother grabbed her, pinned her arms, and marched her to the car, as Angela's younger brother watched.

Reich drove straight to a nearby hospital. One block from the house, Angela turned to her mother. "She said 'Mom, I don't know why I did that. It was like something took me over.' And I said 'I know, it wasn't like you. But I will keep you safe.' "

At the emergency room, the staff administered charcoal to absorb the drugs, then transferred Angela to a psychiatric hospital. The next day, the hospital psychiatrist called Reich. "He told me it was a drug-induced suicide attempt," she said, related to the increased dosage of Paxil.
Neither Angela, Sara nor her husband, Jim, an internal medicine doctor, knew Paxil might carry a risk of triggering suicidal thoughts or actions. Aside from a generic statement that depressed people are more likely to attempt suicide, there is no mention of such a risk in Paxil's prescribing information.

England Acts, United States Follows
The risk Paxil may pose to children and teenagers burst into the news this summer, when British regulators issued a warning urging doctors not to prescribe the drug to children. They were acting on new data presented to United States and British authorities showing that among 1,100 children enrolled in clinical trials of Paxil, those taking the drug were nearly three times as likely to consider or attempt suicide as children taking placebos. "There is an increase in the rate of self-harm and potentially suicidal behavior in this age group," said a statement from the British Medicines and Healthcare Products Regulatory Agency (MHRA). "It has become clear that the benefits (of Paxil) in children for the treatment of depressive illness do not outweigh these risks."

Nine days later, the FDA issued a similar warning and announced that it would conduct a detailed review of pediatric trials of Paxil, a review soon broadened to include seven other antidepressants, including top sellers Prozac, Zoloft and Effexor. In August, Wyeth Pharmaceuticals warned doctors that its drug, Effexor, triggered hostile behavior or suicidal thinking in children at twice the rate as the sugar pills taken as placebos.

Then, last month, the MHRA announced that it was urging doctors to stop prescribing a group of six antidepressants, including Paxil, Zoloft and Effexor because they caused an increase in suicidal thoughts and actions. "These products should not be prescribed as new therapy for patients under 18 years of age with depressive illness," wrote Gordon Duff, chairman of the MHRA's Committee on Safety of Medicines, in a "Dear colleague" letter to British physicians.

Prozac, the only SSRI approved for use in depressed children, was not included in the new warning. The British review did not find a significant increase in the risk of suicide-related events among children taking the drug.

The British and American warnings were a stunning turnaround that left thousands of parents whose children are using the drugs wondering whether their children were at risk. But it was also long-sought vindication for a small group of researchers, family members and lawyers who have been arguing for years that antidepressants cause some people to become violently unhinged. They say they've been frustrated in getting this word out to the public, in large part because of the FDA's unwillingness to confront and control the drugmakers.

The FDA's warning about a possible suicide risk from Paxil left Sara and Jim Reich feeling furious, betrayed, and ready to sue. "Had I known there was a threefold increased risk of suicide among kids taking Paxil, I would not have allowed my daughter to go on that drug," said Jim. In fact, Jim has prescribed the drug himself and is outraged that the Physician's Desk Reference, or PDR - the drug bible for doctors, based on FDA-approved prescribing information - says nothing about Paxil's suicide risk.

Berkeley-based writer Rob Waters' articles have appeared in Health, Parenting, and the Los Angeles Times. He is the co-author of "From Boys to Men: A Woman's Guide to the Health of Husbands, Partners, Sons, Fathers, and Brothers," which will be released in April.
*Names and identifying details have been changed

PHILLIP DAY'S COMMENT: The baleful effects of psychiatry are once again highlighted in our pages. When I compiled my award-winning book The Mind Game, I was simply appalled at the extent to which this pseudo-science has blotted and plagued so many lives. Today, from the rock-star and film icon down to the average Joe in the street, this industry has been pushing us drugs, telling us what we can and cannot think and say, and destroyed the very concepts of right and wrong in our society. Find out how these people gained so much power over us, from the school playground to the despatch box in the House of Commons, and learn what you can do to stop it.

Company 'Held Back' Data on Drug for Children
by Sarah Boseley

The British manufacturers of an antidepressant drug that was last year banned from use in children knew as long ago as 1998 that it did not work and deliberately avoided publishing the full data because of the risk to their lucrative adult market, according to a leaked internal document.

A position paper dated October 1998 shows that managers at SmithKline Beecham - now GlaxoSmithKline - were concerned at the commercial implications of two clinical trials in which their drug Seroxat was given to children and adolescents with major depression.

The results of both trials, known as protocols 329 and 377, showed that the drug was no better than a placebo - an inert pill - in alleviating the children's depression. An internal unit at the drug company called the Central Medical Affairs team prepared a strategy.

The target, says the document - leaked to the BBC's Panorama team, which has made two programmes on Seroxat - was "to effectively manage the dissemination of these data in order to minimise any potential negative commercial impact". About 500,000 adults were at the time taking the drug in the UK. Seroxat was licensed for their use, but not for use in children. Even so, some 8,000 to 10,000 children were also on it because doctors can prescribe an unlicensed drug on their own responsibility.

The paper says that following consultations within the company, SmithKline Beecham would not submit any data to the regulators to get a statement on the efficacy or the safety of the drug. It says: "It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine [Seroxat]." It adds, however, that "positive data" from the first and bigger study, protocol 329, would be published in abstract form at a psychiatric meeting the following month and that a full manuscript of the trial "will be progressed".

It was eventually published in July 2001 with the conclusion: "Paroxetine is generally well tolerated and effective for major depression in adolescents."

It was only last spring, after Glaxo submitted the full data from protocols 329 and 377, together with a third study of depressed children on Seroxat and data from trials of the drug in children with obsessive compulsive disorder and social anxiety disorder, that the UK regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), realised that not only was Seroxat ineffective in children but that a bigger proportion of those taking it in the trials thought about killing themselves than among those on placebo. The drug was then banned.

Yesterday Alastair Benbow, GSK's head of European clinical psychiatry, said the document "draws inappropriate conclusions and it is inconsistent with the facts".

He insisted that there was no sign of a suicide problem until all the trials were put together.

Richard Brook, the chief executive of Mind, the UK organisation for mental health and a member of the Seroxat review panel convened by the MHRA, said he was appalled by the revelations in the leaked document. To allow the drug to be given to children when there were known side-effects and it could not be proven to work was "morally and ethically bankrupt", he said.
Guardian, 3rd February 2004

Further Resources:
The Mind Game by Phillip Day
The ABC's of Disease by Phillip Day

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