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On February 2, more than 60 families and children from all across America testified at a public FDA advisory committee hearing describing (in 2 minutes) how their children suffered drug-induced harm after being prescribed an SSRI antidepressant drug. Some parents described how their children seemed to change abruptly after starting the drugs, becoming aggressive, suicidal or violent toward others. Many were driven to suicidal attempts. Far too many parents described how their children died violent deaths at their own hand—some were as young as 8 years old.
These family testimonies were so compelling that at the end of the hearing, the committee made an unanticipated recommendation, urging the FDA to issue warnings now about the drugs’ potential risks—including drug-induced suicide, violence and hostility. See: http://fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Committees/Anti-Infective+Drugs/020204_Suicide/020204_SuicideR.htm
The Washington Post reported in a front page article (Feb 3), “FDA Links Antidepressants, Youth Suicide Risk,” reported: “Federal regulators said for the first time yesterday that clinical trials of popular antidepressants such as Prozac, Paxil and Zoloft show a greater risk of suicide among children taking the drugs compared with those taking dummy pills.”
“Although only one of these drugs has been approved for the treatment of children with depression, doctors are prescribing them to hundreds of thousands of American children every year. The new Food and Drug Administration analysis of the trials is starkly at odds with repeated assurances by the U.S. psychiatric establishment that the drugs are very safe.” See: http://www.washingtonpost.com/wp-dyn/articles/A7008-2004Feb2.html “FDA Links Antidepressants, Youth Suicide Risk” By Shankar Vedantam
The New York Times (page A-12) headline: “Stronger Warning Urged on Antidepressants for Teenagers” reported: “A scientific advisory panel urged the Food and Drug Administration on Monday to issue stronger warnings to doctors now about the possible risks to children of a newer generation of antidepressant drugs, rather than wait until the agency’s review of the drugs was completed.”
“Our sense is that we would like in the interim for the F.D.A. to go ahead and issue stronger warning indications to clinicians” about the chance that the antidepressants might be linked to suicidal thinking and behavior, hostility or other forms of violent behavior, said Dr. Matthew Rudorfer, a scientist at the National Institute of Mental Health and the chairman of the F.D.A. advisory committee. See: http://www.nytimes.com/aponline/health/AP-Antidepressants-Children.html?page wanted=print&position=
This urgent recommendation by FDA’s own advisory committee will be difficult for FDA officials to ignore. The panel was clearly not persuaded by the agency’s selective presentations and delaying rationale. Clearly, the compelling family testimonies were more persuasive.
In its January 24 briefing to the committee, FDA acknowledged for the first time that the results from company controlled clinical trials showed a “preponderance of negative studies of antidepressants in pediatric populations”—at least 12 out of 15 trials failed to show a benefit. This revelation contradicts the claimed research findings by psychiatrists whose reports were published in prestigious journals. FDA’s acknowledgement also contradicts the unsupported claims made by a task force of the American College of Neuropsychopharmacology (ACNP) on January 21. See: http://www.acnp.org/exec_summary.pdf; See critiques of the ACNP report at: http://www.ahrp.org/infomail/04/01/25.html
FDA’s efforts to prevent any independent scientist from presenting at the public hearing an analysis of the evidence that implicates SSRIs to serious harm, extended even to FDA’s own medical officers. The San Francisco Chronicle reported on Sunday (Feb 1) that Dr. Andrew Mosholder, who reviewed 20 clinical trials of antidepressants involving more than 4,000 children, had been scheduled to present his findings to the advisory committee, but was removed from the agenda. Dr. Mosholder’s review confirmed exactly what the expert British panel had found—that SSRIs pose an increased suicidal risk for children. See: Drug report barred by FDA Scientist links antidepressants to suicide in kids by Rob Waters, Special to The San Chronicle Sunday, February 1, 2004 at: http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2004/02/01 /MNGB64MJSP1.DTL&type=printable
We believe that the Chronicle news report led the FDA to reconsider, and allowed Dr. Andrew Mosholder to present some of his findings. For some committee members this was eye opening information. As The Washington Post correctly noted, it was a first time concession by the FDA that clinical trial data shows that SSRIs pose a suicidal risk for children.
The Alliance for Human Research Protection convened a press briefing during the FDA meeting lunch break to facilitate an open public debate. A panel of 6 independent experts presented their analyses of the evidence that links these drugs to life-threatening harm. The evidence is found in concealed company documents, in clinical practice, and even when carefully analyzed, in published reports. Richard Brooks, a member of the UK expert panel that had examined the pediatric SSRI data, who was not allowed to address the advisory panel, spoke at the AHRP briefing. Many from the press corps attended, and several reports quoted from the scientists’ presentations (though they failed to mention the forum at which the scientists spoke). The 6 scientists’ presentations and AHRP’s written testimony are accessible at: http://www.ahrp.org/risks/SSRIsuicide0204.html
This day of drama showed that despite FDA’s unseemly efforts to block independent presentations of scientific evidence that refutes the claims made by both industry and the psychiatric establishment, the family testimonies provided the panel with incontrovertible evidence-based on reality.
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Federal regulators said for the first time yesterday that clinical trials of popular antidepressants such as Prozac, Paxil and Zoloft show a greater risk of suicide among children taking the drugs compared with those taking dummy pills.
Although only one of these drugs has been approved for the treatment of children with depression, doctors are prescribing them to hundreds of thousands of American children every year. The new Food and Drug Administration analysis of the trials is starkly at odds with repeated assurances by the U.S. psychiatric establishment that the drugs are very safe.
Regulators said the result of their review was identical to a British analysis, which prompted Britain in December to prohibit use of most antidepressants in children. Before taking any regulatory action, however, U.S. officials have requested a second analysis of the data by Columbia University researchers. The new review, which will reevaluate the descriptions of adverse effects suffered by children in the trials, is likely to be completed by summer.
Patients and impassioned families pleaded for more urgent action at a day-long meeting of an expert advisory panel yesterday. Dozens of parents, siblings and doctors from all over the country gave lengthy and moving testimony describing family members and patients who had committed suicide or had turned violent after taking the drugs.
“We were told that Paxil and Prozac were wonder drugs,” said Glenn McIntosh of Austin, whose daughter Caitlin, 12, hanged herself with shoelaces weeks after being started on Paxil and then being switched to Zoloft. “We were lied to.”
Regulators acknowledged the demands of the grieving families but said a mistake in either direction in issuing new guidelines could have terrible consequences. Most doctors believe the drugs, collectively known as selective serotonin reuptake inhibitors, or SSRIs, save the lives of many depressed children; top researchers have warned of dire consequences if their use in children is banned.
Although only Prozac has been specifically approved for use in children, doctors are legally allowed to prescribe the drugs for any patient.
One company, Wyeth, has warned American doctors not to prescribe its drug Effexor to children. Gary Cheslek of Vicksburg, Miss., who said his son Justin hanged himself after taking Paxil, noted that the data that prompted Wyeth’s warning had been available for years. Many families questioned why neither the company nor the FDA had acted earlier.
On a day of high drama at the Holiday Inn in Bethesda, dozens of families accused the agency of turning a blind eye to the problem. Some said their children had been helped.
“My children lead full lives because of SSRI medicines,” said Suzanne Vogel-Scibilia, who said two of her children had been under psychiatric care. Vogel-Scibilia, a member of the National Alliance for the Mentally Ill, an advocacy group, said, “I shudder to think of what would happen to them if these medicines were not available.”
David Fassler, a psychiatrist who testified at the hearing on behalf of the American Psychiatric Association, said in an interview, “Hearings like this frighten parents and make it less likely they will bring their kids in for treatment.”
Fassler and other leaders in American psychiatry say large numbers of depressed children are untreated. “Medications can be lifesaving, but medications alone are not the answer,” he said.
Increasingly, however, American doctors have come to rely on drugs. Officials said yesterday that 2.1 million prescriptions for antidepressants were written for children in 2002.
A key problem, both critics and advocates said, is that the clinical trials conducted by drug companies were not designed to answer the questions that are being raised. FDA officials are trying to make comparisons among studies that used different terms to describe suicidal tendencies and different measures of what constitutes a suicidal thought or attempt.
While FDA investigators had found that “these drugs are associated with a risk of suicidal behavior in children,” said Russell Katz, director of FDA’s neuropharmacology division, “we are concerned that the categorization of events is not entirely reliable.”
Thomas Laughren, team leader of FDA’s psychiatric drug products group, wrote in a briefing paper that “there are signals of increased risk of events suggestive of suicidality for several of these drugs” but that the data were confusing. Not all trials showed such a connection, and companies used different measures to classify and count cases.
“Is there a causal link between antidepressants and suicidality?” he asked yesterday. “To err in either direction has adverse consequences.”
Researchers at Columbia will study narrative reports of adverse effects and reclassify them according to uniform criteria. The FDA asked nine drugmakers to submit details of every adverse report suffered by about 4,000 children across 25 trials. The Columbia group will not be told in advance how the companies classified the cases.
In all the trials, children with similar levels of depression were randomly chosen to receive either drugs or dummy pills. Laughren said there were 109 who were reported to have made at least one suicide attempt or had suicidal thoughts after taking a drug. The companies, however, screened out children who were suicidal to begin with, making the results of the studies less applicable to the real world, where doctors often use the medicines to treat suicidal children.
Of the 109 children, Laughren said, 66 harmed themselves. Among them, 19 cut themselves and 37 took overdoses of pills. Two children tried to hang themselves, and there was one case of self-burning — these last three suicide attempts were halted by alert caregivers. Forty-seven were hospitalized, but none committed suicide.
David Healy, a Welsh psychiatrist who has campaigned for more careful use of the medicines, estimated that about 500 American children have committed suicide as a result of antidepressants. Irving Kirsch, another critic, said the vast majority of clinical trials had failed to show that the drugs made patients any better than did dummy pills. Even when the medicines worked, he estimated that 87 percent of the benefit derived from the patients’ belief that they were effective, a phenomenon known as the placebo effect.
© 2004 The Washington Post Company
http://www.nytimes.com/aponline/health/AP-Antidepressants-Children.html?page wanted=print&position= The New York Times February 3, 2004 Stronger Warning Urged on Antidepressants for Teenagers By ERICA GOODE
EXCERPT: BETHESDA, Md., Feb. 2 — A scientific advisory panel urged the Food and Drug Administration on Monday to issue stronger warnings to doctors now about the possible risks to children of a newer generation of antidepressant drugs, rather than wait until the agency’s review of the drugs was completed.
Dr. Rudorfer said such a warning would not discourage doctors from using the antidepressants but would alert them to warning signs that a drug might be having harmful effects. The recommendation came at the end of an emotional daylong public hearing on the issue. Most of the antidepressants belong to the class known as selective serotonin reuptake inhibitors, or S.S.R.I’s.
Dr. Thomas Laughren, the team leader for the F.D.A.’s division of neuropharmacological drug products, said that the agency took the panel’s recommendation “very seriously” and that it would probably issue such a warning “sooner rather later.”
Along with experts who testified at the hearing, the panel listened to parent after parent, and children, who stepped up to the microphone to tell stories of suffering and loss. A father spoke of his 13-year-old son who hanged himself from a closet hook after starting on an antidepressant. A teenager said that after a few weeks on the drugs he took a hunting rifle to school and threatened his classmates. He had no memory of his actions, he said, and woke up afterward in a juvenile detention center.
One mother asked, “How many more people have to die before a warning gets issued?” Other parents said the antidepressants had helped their children enormously and saved many other children’s lives. “I shudder to think of their plight if these medications were not available,” said a mother whose son suffers from manic-depression.
Dr. Rudorfer said the committee was struck by the fact that in some cases described at the hearing doctors had seemingly prescribed antidepressants casually and failed to monitor the children closely while they were taking them.
“We were all concerned about the stories we heard,” Dr. Rudorfer said, noting that the drugs were “very powerful but also potentially very effective.”
Complete text at: http://www.nytimes.com/aponline/health/AP-Antidepressants-Children.html?page wanted=print&position=
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