October 26

"The scariest thing is that nobody knows" risks of depression drugs for children

“The scariest thing is that nobody knows” risks of depression drugs for children

Mon, 10 May 2004

Forest Laboratories, manufacturer of the antidepressant, Celexa / Lexapro, is the latest manufacturer to issue warnings (April 2004) about the possibility that “patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (Suicidality).” The label further warns: “Although a causal link between the emergence of [ ] symptoms and either worsening of depression and/or the emergence of suicidal impulses has not been established, consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients for whom such symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.” See: http://www.lexapro.com/pdfs/lexapro_pi.pdf

In light of recent revelations about the severe risks associated with antidepressants, the soaring prescribing of these drugs for children and adolescents is raising concern in Europe, Australia, Canada, and the US. National, international, and local media are focusing on the issue of drug safety and breach of scientific integrity in medical reports. Public awareness about evidence that these drugs have triggered violent outbursts and suicidal / homicidal acts in some individuals–is beginning to be reflected in the courts.

A California jury found that a man accused of attempted murder and assault acted under the intoxicating influence of Zoloft. See: The Santa Cruz Sentinel. Man found innocent of attempted murder By Cathy Redefern April 24, 2004 http://www.santacruzsentinel.com/archive/2004/April/24/local/stories/05local.htm

When asked by WebMD, whether it is good or bad that more and more children-even pre-schoolers–are being treated with antidepressants? Robert Findling, MD, director of child and adolescent psychiatry at University Hospital, in Cleveland and chair of the American Academy of Child & Adolescent Psychiatry’s research committee, admitted: “The scariest thing is that nobody knows.” See: WebMD Medical News. http://my.webmd.com/content/article/85/98399.htm?lastselectedguid=%7B5FE84E90-BC77-4056-A91C-9531713CA348%7D

Australian doctors wrote 250,000 antidepressant prescriptions for children and adolescents in 2003 (population of 20 million). However, Australian psychiatrists, like their British and Canadian counterparts are expressing skepticism and concern about the practice. Dr. George Halasz, a child and adolescent psychiatrist at Monash Medical Centre (Au), has no doubt that antidepressants are overprescribed for children:

“I believe there is a manufactured epidemic going on.”

The Australian newspaper, The Age reports: “Dr Halasz believes depression and attention deficit hyperactivity disorder are misdiagnosed in children. For example, grief can be misread as depression and could lead to children being medicated and tagged as “flawed products”.

In the US, more than 10 million SSRI prescriptions have been written for children and adolescents last year. Doctors and parents were misguided by reassurances from leading child psychiatrists who have substantial, ongoing financial ties to drug manufacturers. Leading academic psychiatrists and professional associations-such as, the American Academy of Pediatrics, (AAP), The American Academy of Child and Adolescent Psychiatry (AACAP). and Columbia University, the institution contracted by the FDA to examine the safety data from pediatric SSRI trials–are on record defending the prescribing of antidepressants for children, providing the industry with the legitimizing seal of professional approval to expand the SSRI market to children.

Strattera, a previously failed antidepressant–“selective norepinephrine reuptake inhibitor” similar to Effexor-is being promoted by the AACAP. AACAP’s new ADHD treatment guidelines recommend Strattera as “a first-line treatment option for ADHD” without mentioning it is a SNRI antidepressant. This endorsement is a lucrative boon for Eli Lilly. Dr Albert Allen, Lilly Research Laboratories noted: “The fact that AACAP approved a nonstimulant as a first-line therapy option has shifted the paradigm.” See: http://uk.biz.yahoo.com/040428/241/es7ls.html

Children, however, are likely to be adversely affected by the AACAP endorsement. FDA’s-approved label states: “STRATTERA was administered to 2067 children or adolescent patients with ADHD and 270 adults with ADHD in clinical studies. Yet, adverse effects analysis included only 427 children on Stattera, and reported withdrawal of only 15 of 427 children on Strattera compared to 4 out of 294 children given a placebo. See: http://www.fda.gov/cder/foi/label/2002/21411_strattera_lbl.pdf

AHRP once again asks: What happened to the other 1,640 children who were administered Strattera in clinical trials? Inexplicably, FDA officials excluded the Strattera clinical trial safety data from analysis of adverse effects and evidence of suicidal/homicidal behavior. Strattera data was not even mentioned in FDA advisory committee briefings, nor was Strattera included in FDA’s advisory warning (March 22). Dr. Andrew Mosholder, FDA’s expert medical officer was not asked to review the Strattera data either.

Academic psychiatrists have pinned their names to published reports that purport to have found these drugs “safe and effective” for children. But upon independent examination those reports in prestigious US medical journals have turned out to be scientifically invalid. The reports in JAMA, the NEJM, and the Journal of the Academy of Child and Adolescent Psychiatry, the American Journal of Child and Adolescent Psychopharmacology are based on partial (ie, favorable) data only. The data contradicting those reassuring “positive” claims remained undisclosed, hidden. Physicians and families who want facts not hype about drug effects will find more credible reports in publications not under control of the pharmaceutical industry. See: British Medical Journal. Efficacy and safety of antidepressants for children and Adolescents by Jon N Jureidini, Christopher J Doecke, Peter R Mansfield, Michelle M Haby, David B Menkes, Anne L Tonkin, free online at: http://bmj.bmjjournals.com/cgi/content/full/328/7444/879?

See: The Lancet. SSRI in childhood depression: systematic review of published versus unpublished data by Craig J Whittington, Tim Kendall, Peter Fonagy, David Cottrell, Andrew Cotgrove, Ellen Boddington http://www.thelancet.com/journal/vol363/iss9418/full/llan.363.9418.original_research.29377.1

The New York Times reported in August, that GlaxoSmithKline “acknowledged that just one of its nine studies of Paxil in children and adolescents has been published.” That study made only passing mention of suicide, concluding that the drug was effective against depression.” Dr. Graham Emslie, a leading university-affiliated child psychiatrist who was an investigator in several Paxil trials, said he suspected that the other studies went unpublished at least in part because “the results were unfavorable.” He further acknowledged in The Times:

“I know of at least a half-dozen other studies of antidepressant treatments in children and adolescents that have been completed but as yet have not been published,” he said. “More than enough time has passed for these to be published at least in abstract form.”

Dr. Emslie refused to identify the companies or the drugs involved because, The Times reported, he, like other researchers involved in similar research, has signed contracts promising secrecy. But such contracts undermine the integrity of medicine and the safety of children.

Dr. Harold Koplewicz, another leading academic-affiliated child psychiatrist, is a co-author of several published SSRI trial reports whose findings have been challenged as scientifically unsound–inasmuch as the authors relied upon partial (optimistic) data, but failed to disclose the negative findings. Dr. Koplewicz is the Editor in chief of the Journal of Child & Adolescent Psychopharmacology. In his recent editorial in that journal, “Misguided Resistance to Appropriate Treatment for Adolescent Depression” Dr. Koplewicz laments the FDA’s March 22 advisory warning because, according to him, it “may unintentionally enhance the resistance of parents to utilize the only effective available treatment for their children struggling with depression.”

Dr. Koplewicz is among many US psychiatrists who continue to deny that a problem exists despite compelling scientific evidence. These psychiatrists disregard these drugs’ failure to demonstrate scientifically evidence of a benefit for children, and they disregard evidence demonstrating drug-related hazards.

Leo Tolstoy’s observation is apt: “I know that most men, including those at ease with problems of the greatest complexity, can seldom accept even the simplest and most obvious truth if it be such as would oblige them to admit the falsity of conclusions which they have delighted in explaining to colleagues, which they have proudly taught to others, and which they have woven, thread by thread, into the fabric of their lives.”

These evidence-resistant psychiatrists may be accused of being in the same league with those who insist -despite contradictory evidence-that Iraq has WMDs. Others might argue that their continued belief may reflect substantial financial ties to these drugs’ manufacturers.

The statements contained in this Infomail are validated by major, authoritative, published reports. Most recently, a meta-analyses of the SSRI pediatric data comparing published reports of claimed findings against the unpublished data. The published reports were found to be unsubstantiated. See: SSRI in childhood depression: systematic review of published versus unpublished data. Lancet. April 24, 2004. FREE http://www.thelancet.com/journal/vol363/iss9418/full/llan.363.9418.original_research.29377.1

See: Lancet. Editorial. http://www.thelancet.com/journal/vol363/iss9418/full/llan.363.9418.editorial_and_review.29416.1

Tonight National Public Radio is scheduled to air a segment about the antidepressant controversy: Among those interviewed, FDA’s Dr. Robert Temple, Congressman Greenwood; and me.

The program will be aired at: 5:20; 7:20; 9:20 and for those interested who miss it tonight, it will be accessible online from tomorrow morning on at: www.npr.org …

Contact: Vera Hassner Sharav
Tel: 212-595-8974

THE AGE (Victoria, AU)
Unease over effects of medication
By Ewin Hannan, Amanda Dunn
April 26, 2004

George Halasz, a child and adolescent psychiatrist at Monash Medical Centre, has no doubt that antidepressants are overprescribed to Australian children. “I believe there is a manufactured epidemic going on,” he said.

Dr Halasz believes depression and attention deficit hyperactivity disorder are misdiagnosed in children. For example, grief can be misread as depression and could lead to children being medicated and tagged as “flawed products”.

Experts agree that the understanding of the effects of antidepressants in children and young people is grossly inadequate, particularly given that prescription numbers rose to 250,000 last year.

And one of the main problems is the paucity of high-quality trials of the medication in children and adolescents. This means that no one can say for sure what the effects of long-term use of the drugs by children might be, nor how good they are at treating childhood depression or anxiety.

Daryl Efron, a pediatrician at the Royal Children’s Hospital, said there was good evidence that antidepressants were effective in treating children with anxiety disorders. While more research was needed, given that most trials were sponsored by drug companies, there was no need to “throw out the baby with the bathwater”.

However, there was a strong argument that the prescribing of all psychotropic drugs, including antidepressants, should be limited to pediatricians and child psychiatrists. “To try and understand why children are dysfunctional in the way they present requires expertise and also time,” he said. “GPs have neither the expertise and certainly not the time to evaluate these kids properly.”

George Patton, VicHealth professor of adolescent health, said antidepressants worked in the short term, but there was not enough research on their long-term impact. Research funded by pharmaceutical companies was likely to look at short-term effects, Professor Patton said.

“But if you are talking about a disorder that begins in the teens and continues into adult life, it’s not the short-term outcomes that are most important. It’s what happens in the medium and long term.”

Lena Sanci, a senior lecturer in general practice at Melbourne University, said it was not practical to restrict prescription of “selective serotonin re-uptake inhibitors” (SSRIs) to specialists. “I think that’s a difficult argument, because there aren’t enough pediatricians and psychiatrists to go around,” she said. GPs were also concerned they did not have adequate support services and had to help young people in a 15-minute consultation.

Louise Newman, chairwoman of the faculty of child and adolescent psychiatry of the Royal Australian and New Zealand College of Psychiatrists, said she was concerned at the increased use of antidepressants in younger people.

“We know that depression has been increasing in the Western world,” she said. “We know we have these targeted campaigns about getting to depression early and intervening early. Maybe the price we pay for those sorts of campaigns is that actually some people are getting them who don’t need them. The other possibility is that GPs are quick to go to antidepressants because there is a lack of services.”

Child depression drugs soar
By Ewin Hannan, Amanda Dunn
April 26, 2004
Use of antidepressants in children and adolescents soared during 2003, with an increasing number of doctors prescribing drugs that Australian health authorities explicitly warn should not be given to children. New Federal Government figures reveal that 250,000 antidepressant prescriptions were issued to children and adolescents last year, a 30,000 increase on 2002.

The Government’s drug regulator, which is reviewing the use of the drugs in children, told The Age that several drugs were likely to be ruled inappropriate for use in patients under 20. The Therapeutic Goods Administration is also considering restricting access to antidepressants currently available to children and adolescents through the Pharmaceutical Benefits Scheme.

Under the proposal, discounted antidepressant prescriptions would be available only on the written recommendation of a child psychiatrist or pediatrician. The action comes amid mounting international concern about the safety of a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs) in children and adolescents. Evaluations of clinical data by British and American authorities have found evidence of increased suicidal behaviour among adolescents taking some of the SSRIs. Britain concluded that the risks outweighed the benefits for all SSRIs except Prozac.

The Australian Government has recommended two brands, Efexor and Aropax, should not be used in children and adolescents. It says data regarding the efficacy and safety of SSRIs in children is inconclusive, and doctors should prescribe them cautiously.
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