October 26

What Parents Aren’t Being told about their Kids Antidepressants – A Suicide Side-Effect? – SF Chronicle

What Parents Aren’t Being told about their Kids Antidepressants – A Suicide Side-Effect? – SF Chronicle

Sat, 10 Jan 2004

An in-depth article in The San Francisco Chronicle reveals how the hidden hazards of SSRIs put adolescents’ lives in danger. For one 16 year old teenager, Paxil posed greater risks to her health than the chemotherapy she took to fight cancer.

The article documents FDA’s complicity–FDA officials helped the manufacturers keep the facts about these drugs’ hazardous effects hidden from physicians and the public. “One side effect of SSRIs, recognized for at least 15 years, is a sensation called akathisia, a restless agitation that ranges from jitteriness to a sensation described by some people as “jumping out of their skin.” Excerpt below

The Vancouver Sun continues its series: “When Prozac and its SSRI cousins came to market 20 years ago, depression was rarely diagnosed. Now, everybody seems to be depressed and the treatment of choice is drugs not psychotherapy.” But now the bubble has been punctured, as previously concealed documents have been brought to light showing that SSRIs are ineffective compared to placebo, and they pose very serious hazards for some for whom they are prescribed indiscriminately.

In Canada alone, nearly 31 million prescriptions for anti-depressants were written in 2002. Dr. Jane Garland, head of the mood disorders clinic at B.C. Children’s Hospital, told the Sun that tricyclics are the “gold standard” anti-depressants, and may be more effective than SSRIs for severe depression.

Despite that, she says, SSRIs have replaced them as first-line medication, with tricyclics being used in more treatment-resistant cases. Garland goes on to say that because the older drugs have much more serious and unpleasant side effects than SSRIs, “they were used more conservatively than the SSRIs.”

See: Cold water thrown on Prozac Nation by Daphne Bramham, Vancouver Sun, Saturday, January 10, 2004 at: http://www.canada.com/vancouver/vancouversun/columnists/story.asp?id=

A Suicide Side Effect?
What parents aren’t being told about their kids’ antidepressants

Rob Waters Sunday, January 4, 2004
* Names and identifying details have been changed.


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 humor 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.

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An Uncontrolled Experiment

Since 1987, when Prozac became the first SSRI on the market, America’s love affair with antidepressants has worked its way down the age ladder. Between 1987 and 1996, the use of antidepressants and other psychotropic medications by children and adolescents tripled, with most of that increase occurring after 1991, according to a recent study in the Archives of Pediatric and Adolescent Medicine. By 1996, the study found, 6 percent of American children and teenagers were taking psychotropic medications, one-third of which were antidepressants.

Biological solutions to behavioral problems were becoming increasingly acceptable, even fashionable. “I think there’s been a revolution in the way people think about behavior,” says Lawrence Diller, a behavioral pediatrician in Walnut Creek. “The idea that children’s behavior is the product primarily of their genetics and biochemistry was promoted by American psychiatry and hijacked by the drug industry. It’s simply become more acceptable to see behavior as a reflection of an imbalance in chemistry rather than an imbalance in life.”

The phenomenal growth in antidepressants prescribed to children leaves many doctors and therapists uneasy. Diller, who has written about his misgivings in two books (“Running on Ritalin” and “Should I Medicate My Child?”), cautiously prescribes antidepressants to some children, but says the new data about a possible link to suicide is making both him and some parents think twice. “It hasn’t caused me to stop using SSRIs, particularly in teenagers, but I think it’s another reminder that our information is incomplete.”

To understand how we got here, it’s important to know a bit about the drug- approval process. When a drug company applies to the FDA for approval to sell a medication, it must demonstrate that the drug is safe and effective for a particular population, such as adults, and a specific condition, such as depression. Once the drug has been cleared by the FDA and is on the market, doctors are free to prescribe it to anyone for any reason. “Off-label” prescribing, is quite common; the only real restriction is that drug companies cannot market drugs to unapproved groups. From 1987, when Prozac was first approved for adults, until early last year, when Prozac became the first SSRI approved for use in depressed children 7 and older, all antidepressants used by depressed children were prescribed off-label.

The widespread use of antidepressants by children, critics say, amounts to an uncontrolled national experiment. The prescribing physicians are often pediatricians or family doctors with little or no training in psychopharmacology. The drugs are frequently given in the absence of therapy or other interventions. The subjects of the experiment – children – are too young to give meaningful consent. There is little understanding of the long- term effect these medications have on the architecture of children’s developing brains. And the evidence that the drugs are effective is less than impressive.

When Prozac was approved for depressed children last year, it was on the strength of two controlled trials. One, published in 1997 in the Archives of General Psychiatry, found that after eight weeks, 56 percent of kids taking Prozac showed some improvement, according to the clinicians who evaluated them, compared with 33 percent of the kids in the placebo group. But 69 percent of the kids taking Prozac still had significant symptoms of depression. Clinical trials of Paxil, Zoloft and Effexor found those drugs to be no more effective than placebos in treating depressed children.

Perhaps the most notable finding from clinical trials of antidepressants is how many children respond well to placebos – as many as 59 percent in some studies. This high placebo response rate is a common finding in pediatric drug trials, in which children are generally seen once or twice a week by clinicians, says David Healy, an internationally known psychopharmacologist from the University of Wales College of Medicine who has emerged as a prominent critic of drug company practices. “This suggests that simple support can help children in many cases,” Healy says.

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SSRIs: Cleaner and Safer?

In the years since 1987, SSRIs have developed a reputation for being largely free of serious side effects, vastly improved over the older generation of so-called tricyclic antidepressants. In some respects, this is true: Distressed patients who attempt to kill themselves by overdosing are unlikely to succeed; they can usually tolerate the pills. And patients taking tricyclics are more likely to suffer from constipation, urinary retention, blurred vision and dry mouth.

But SSRIs cause sexual problems at fairly high rates, as well as insominia, nausea, dizziness and other side effects. Studies also have not found them to be more effective than the older pills at relieving symptoms of depression. “The SSRIs have sold themselves very heavily as safe and clean drugs compared to the old antidepressants,” says Healy. “Well, it’s not clear that they’re safer, and it’s not clear that they cause fewer side effects.”

One side effect of SSRIs, recognized for at least 15 years, is a sensation called akathisia, a restless agitation that ranges from jitteriness to a sensation described by some people as “jumping out of their skin.” Healy believes akathisia is the principal trigger for impulsive violence in some people taking SSRIs. “They became anxious, agitated, terrified, unable to sleep at night and restless,” he says – the symptoms that plagued Angela Reich.

There have long been signs that SSRIs sometimes cause these reactions, which drug manufacturers have tried mightily, and largely successfully, to keep out of the public eye and off the labels. This issue first arose a couple years after Prozac went on the market, amid a raft of media reports about grisly acts of murder and suicide. The most notorious event took place in 1989, when Joseph Wesbecker went on a shooting frenzy, killing nine fellow workers of a Louisville, Ky., printing plant before turning his gun on himself. Wesbecker, who had a history of mental problems, was taking Prozac. No one could prove Prozac caused his rampage, but by early 1991, some 350 suicides of Prozac patients had been reported to the FDA, according to one former FDA official. Those reports, which occurred outside the context of scientific clinical trials, were dismissed as anecdotal and sensational by company officials.

Harder to dismiss, though, was a study published by Harvard researcher Martin Teicher and two colleagues in the American Journal of Psychiatry in 1990 about six patients who developed “violent suicidal preoccupation” after taking Prozac for two to seven weeks. “It was also remarkable how violent these thoughts were,” the authors reported. “Two patients fantasized, for the first time, about killing themselves with a gun,” they wrote, while one placed a loaded gun to her head, another had to be restrained to prevent self- mutilation, and another fantasized about killing himself in a gas explosion. None of the patients was suicidal when they started taking Prozac, the researchers reported, and their fixation with violence and death abated when they stopped.

Similar symptoms were noted the next year in a paper in the American Journal of Child and Adolescent Psychiatry about six children ages 10 to 17 who developed “intense self-injurious ideation or behavior” while taking Prozac. After three weeks on the drug, one 14-year-old girl, who had been depressed but never suicidal, began cutting and otherwise injuring herself. She told hospital staff, “I’m just waiting for the opportunity to kill myself, ” and chanted, “Kill, kill, kill; die, die die; pain, pain, pain,” according to the paper. The Yale University authors noted the complexity of reaching any conclusion about the cause of these events since the children all had lengthy histories of psychiatric difficulties that put them at risk for suicide. They also noted that many children taking Prozac become agitated, restless, and disinhibited and developed insomnia to boot.

A 1998 paper by Roger Lane, a scientist at Pfizer, the maker of Zoloft, stated that “all SSRIs have the rare potential to cause akathisia.” In its most extreme form, Lane wrote, patients may feel that “death is a welcome result.”

Lane also warned that akathisia can sometimes be mistaken for worsening depression, prompting some doctors to increase the dosage – and the danger. Healy agrees. “[Doctors] have been educated to think that SSRIs take four, five, six weeks to work,” he says. “But they can cause problems long before that.” xxx cut xxx

‘Cooking the Books’

The Prozac suicide controversy, and the huge number of suicide reports that were streaming into the agency, reverberated inside the FDA, where two other SSRIs, Paxil and Zoloft, were being considered for approval. The FDA medical officer charged with reviewing Paxil’s safety and efficacy data was Martin Brecher, now an executive with the British pharmaceutical company Astra Zeneca. “The reports of successful suicide were coming in in bunches,” he said in a recent deposition. “It was extraordinary, especially in comparison to other annual reports where, you know, you had 20 reports of a cold and maybe two reports of some liver enzyme elevations and here you are with 20 deaths in a report.”

Because Paxil and Zoloft were members of the same chemical class as Prozac, the FDA asked officials at SmithKline Beecham (the predecessor to GlaxoSmithKline) and Pfizer, Zoloft’s maker, to submit reviews on the drugs’ effect on suicidal behavior of patients. Brecher called Thomas Donnelly, a SmithKline Beecham executive, and asked him to prepare such a report. In an internal company memo uncovered in a lawsuit, Donnelly described his conversation with Brecher, noting that the FDA “does not see it as a real issue but rather as a public relations problem.”

What happened next is controversial. Critics charge that the company manipulated data to diminish the apparent suicide risk among Paxil users and submitted it to the agency. One of the harshest critics is an unlikely plaintiff’s attorney in San Rafael, a self described conservative Republican and retired Navy officer named Don Farber.

Farber, who has spent the better part of the past five years suing Glaxo- SmithKline and other drug companies, is one of a handful of lawyers handling such cases. His first case involved a San Jose man, Reynaldo Lacuzong, who, in 1996, drowned his two children and himself in a bathtub three days after he began taking Paxil. After the suit was filed, GlaxoSmithKline and the surviving Lacuzong family resolved the case with an undisclosed settlement.

The same thing has happened in dozens of other cases of alleged SSRI- induced suicide or violence; few cases ever go to jury. In June 2001, however, a case did. Three years earlier, Donald Schell, a 60-year-old Wyoming man, killed his wife, daughter and granddaughter three hours after taking two tablets of Paxil given to him as samples by his internist. Surviving family members sued GlaxoSmithKline, and the jury awarded them $6.4 million for the wrongful deaths of their relatives.

“[The company] knew there was a small group at risk and Don Schell was one of those vulnerable people,” the family’s attorney, Andy Vickery told the jury. Farber makes the same argument: Drug companies have an obligation to warn doctors and patients that these drugs can pose a threat to some people.

“If there was a warning that said ‘Caution: this drug may cause suicide in some people,’ then doctors are going to know about it,” Farber says.

Instead of warning people, Farber charges, Glaxo-SmithKline tried to hide the true numbers. “They cooked the books,” says Farber during a recent interview. “They cheated on the results. And the FDA is part of this.”

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Complete article at: http://sfgate.com/cgi-bin/article.cgi?f=/c/a/2004/01/04/CM118608.DTL

©2004 San Francisco Chronicle

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