Latest / Radically Genuine / 67. Concerns over Antidepressants for Children and Adolescents
Transcript
- The story of research into SSRI use, better known as antidepressants, in children an adolescents is one of fraud, abuse and institutional failure. Utilization of antidepressant medications among children and teens since 2017 reveals a 28.0% increase in prevalence for children (aged 0 to 12) and a 41.1% increase for teens (aged 13 to 19). However, the prevalence among teens spiked from 2020 to 2021, during the first years of the pandemic, with a year-over-year jump of 12.6%, compared to an average annual increase of 7.8% from the previous years observed. Based on pharmacy claims of those who filled at least one prescription for mental health medication in 2019, nearly twice as many teenage girls take antidepressants compared to teenage boys. This statistic shows the percentage of teenagers (excluding those on government-sponsored benefits) who filled a prescription for antidepressants in the U.S. from 2015 to 2019, by gender. The number of 12-to-17 year olds prescribed antidepressants in England more than doubled between 2005 and 2017. Until the arrival of Prozac on the market in 1988, few children and adolescents were diagnosed with depression. The understanding before that time, as Harvard Medical School psychiatrist Ronald Kessler later wrote, was that “mood disorders are rare before adulthood and that mood disturbance is a normative and self-limiting aspect of child and adolescent development.” “Until about 15 years ago, no one thought children could suffer depression,” the New York Times reported in 1997. “Now experts estimate it afflicts about four million American children, or five percent.” This is a result of a worldwide marketing campaign to increase psychiatric diagnoses in children to justify use of unscientific diagnoses and toxic treatments. The benign FDA approval labels have misled physicians and the public into underestimating their hazards. a 2016 meta-analysis Comparative efficacy and tolerability of antidepressants for major depressive disorder in children and adolescents: a network meta-analysis Lancet Lead Author Andrea Cipriani of the published literature, which assesses the outcomes from 34 trials involving 5260 patients and 14 antidepressants, found little evidence that these drugs provide any benefit over placebo in children and adolescents. The “quality of the evidence was very low,” the investigators wrote, with 88% of the studies rated at high or moderate risk of bias. In this review of low-quality, biased trials, the only antidepressant that was found to provide a “statistically significant benefit” in depressed youth was fluoxetine (Prozac). However, The documents received by the BMJ reportedly went missing during the 1994 Wesbecker case that grew out of a lawsuit filed on behalf of victims of a work-place shooting in 1989. Joseph Wesbecker, armed with an AK-47, shot eight people dead and wounded another 12. He then shot and killed himself. Mr Wesbecker, who had a long history of depression, had been placed on fluoxetine one month before the shootings. One of the internal company documents,” found that in clinical trials “38% of fluoxetine-treated patients reported new activation but 19% of placebo-treated patients also reported new activation yielding a difference of 19% attributable to fluoxetine.” Dr Richard Kapit, the FDA clinical reviewer who approved fluoxetine, said he was not given the Lilly data. “These data are very important. If this report was done by Lilly or for Lilly, it was their responsibility to report it to us and to publish it.“If we have good evidence that we were misled and data were withheld then I would change my mind [about the safety of fluoxetine]. I do agree now that these stimulatory side effects, especially in regards to suicidal ideation and homicidal ideation, are worse than I thought at the time that I reviewed the drug.” Since the 1991 FDA hearings Dr Peter Breggin, who served as the medical expert in the Wesbecker case, has warned that the stimulant effects of fluoxetine can cause suicide and violence. He cautions that the 38% activation rate reported in the missing document is probably low because “it doesn't include other symptoms of activation such as panic attacks, hypomania, and mania.” How did they become approved? Based on short term 8-12 week trials referred to as discontinuiation and relapse prevention trials. In these trials, one half of the antidepressant medical clinical trial responders are randomly selected to be switched abruptly from their antidepressant to placebo immediately after entering the trial? What would happen in these cases? The placebo groups will be in withdrawal. In a 2019 review in Frontiers in Psychiatry Authors Daniel Safer and Julie Magno Zito concluded the trials used for FDA approval were characterized by high dropout rates, rapid withdrawal that occurs when you switch to placebo, and relapse rates that are not dissimilar from those in the natural course of the disorder. “There is no acceptable support for the inclusion of antidepressants in maintenance treatment for Major Depressive Disorder in youth. David Healy, Joanna Le Noury, and Jon Jureidini present their re-analysis of pediatric antidepressant trial data in a new piece published in the International Journal of Risk and Safety. In 2018, investigators who relied on FDA reviews of such trials, or found some other method for accessing trial data (and thus did not rely on reports published in the medical journal), found that all 20 pediatric studies of antidepressants conducted from 1990 to 2005 were negative on primary outcome measures (such as reduction of depressive symptoms). The drugs provided no benefit over placebo. This was true of the two trials of fluoxetine that, in the published reports, told of a drug that provided a “statistically significant benefit” in children and adolescents. Most of the 15 studies conducted since 2005 were also negative on their primary outcome measures. In spite of the negative findings from these two meta-analyses, the FDA has approved fluoxetine and Lexapro for pediatric depression. Lexapro is now widely prescribed to teenagers. How did it get approved? The March 2009 approval came less than a month after the U.S. Attorneys Office for the Massachusetts district filed a federal civil suit accusing Forest Laboratories of having illegally marketed Lexapro and Celexa for off-label use in children and adolescents from 1998 to 2005 (Psychiatric News, April 3). The suit also alleges that Forest knowingly suppressed unfavorable facts about Celexa from the medical community and the public, including the lack of efficacy in one trial and the increase in suicidality reported by pediatric patients. two other placebo-controlled trials, one of each conducted on Celexa and Lexapro, had failed to demonstrate significant benefits of either drug over placebo, the company acknowledged. One trial tested Lexapro in patients aged 7 to 17; the other tested Celexa in adolescents. So they cherry picked the studies they were able to find a statistical difference then file drawered the other two. None of these clinical trials studied the long-term efficacy and safety of Lexapro. Nevertheless, the FDA approved escitalopram for maintenance treatment because the efficacy in adolescents “can be extrapolated from adult data” and from the drug's pharmacokinetic parameters, according to Forest's announcement. In the federal lawsuit, prosecutors said that Forest aggressively promoted the positive results of the single successful trial in Celexa and concealed the negative trial from health care professionals and the public. They also alleged that the company had used kickbacks, gifts, and other illegal means to persuade or induce physicians to prescribe both drugs for child and adolescent patients. Because neither drug was approved for pediatric use at the time, the manufacturer was prohibited by law to promote off-label use. Forrest Laboratories said it would pay 10.4 million in refunds.7 On June,3 2004 the state of New York filed a fraud action against GlaxoSmithKline for repeated and consistent fraud for concealing known problems with efficacy and safety of Paxil for children and adolescents. In August GSK announced it would pay 2.5 million as part of a settlement lawsuit and agreed to publicly disclose all its clinical trials about safety on a Registry. At public hearings in 2004 the FDA presented re-evaluations of antidepressant clinical trials for children and youth under age 18 documenting that suicide risk was doubled in children taking antidepressants compared to similar individuals taking a placebo. The agency also reported that only one-fith of controlled clinical demonstrated any potential for usefulness. Antidepressants have not only proven ineffective for children and teens, they were proven to be suicidal. In summarizing the hearings, panel chairman Dr. Wayne Goodman confirmed an emerging pattern of behavioral toxicity as a result of these drugs. The agencies press release stated it is Known that antidepressants are associated with anxiety, agitation, panic attacks, insomnia, irritabililty, hostility, impulsivity, akathisia, hypomania and mania. The FDA published a new required label for all antidepressants on January 26, 2005 including a black box warnign headlined “Antidepresssants increased the risk of suicidal thinking thinking and behavior in short term studies in children and adolescents with Major Depressive Disorder and other psychiatric disorders. In a large NIMH study, known as the TADs study, 22% of adolescents treated with an SSRI had a suicide event, compared with 6.7% of those not taking the drug. Thats more than 3x the likelihood of a suicide event.Seventeen of the 18 youth who attempted suicide during the study were taking an antidepressant. From 2005 to 2012, antidepressant use among youth rose 26%. During this same period, the suicide rate for youth 10 to 19 years old increased from 4.4 per 100,000 youth to 5.0 per 100,000, a rise that might be expected, given the research showing that exposure to an antidepressant increases the likelihood that children and adolescents will “attempt and complete suicide.” Nationally, the suicide rate among persons aged 10–24 was statistically stable from 2000 to 2007 and then increased 57.4%, from 6.8 per 100,000 in 2007 to 10.7 in 2018 as antidepressants use began to increase dramatically at that time. To believe that antidepressants are tx for suicidal youth contradicts all available evidence. National trends in the outpatient diagnosis and treatment of bipolar disorder in youth Carmen Moreno 1 , Gonzalo Laje, Carlos Blanco, Huiping Jiang, Andrew B Schmidt, Mark Olfson With the prescribing of SSRIs to children and adolescents taking off in the 1990s, so too did the number of youth diagnosed with bipolar disorder. The percentage of children 0 to 19 years old so diagnosed rose forty-fold from 1994 to 2003. Pediatric -Onset Bipolar Disorder: A Neglected Clinical and Public Health Problem Gianni L. Faedda, MD, Ross J. Baldessarini, MD, Trisha Suppes, MD, PhD, Leonard0 Tondo, MD, h a Becker, MD, and Deborah S. Lipschitz, MD Those increased risks occurred during the first ten months of treatment. At the end of four years, researchers reported that 25% of depressed children treated with an antidepressant have converted to a bipolar diagnosis. At the end of 10 years, 50% of youth diagnosed with depression before they hit puberty had converted to bipolar disorder, researchers at Washington University found. How do we know fraud exists? On June,3 2004 the state of New York filed a fraud action against GlaxoSmithKline for repeated and consistent fraud for concealing known problems with efficacy and safety of Paxil for children and adolescents. In August GSK announced it would pay 2.5 million as part of a settlement lawsuit and agreed to publicly disclose all its clinical trials about safety on a Registry. Its my belief that antidepressants worsen depression in time and we have good evidence to support it. We now know that antidepressant drugs may stimulate a process that run counter to the initial acute effects of the drug. This is the loss of tx efficacy during the treatment and adverse effects that will occur only after time that include what is now diagnosed as bipolar disorder and other paradoxical reactions. I will include a paper on From 1996 to 2005, the drug industry tripled its spending on marketing, including a fivefold increase in direct-to-consumer advertising. Several studies have found that prescription drug ads don't adequately explain side effects and can adversely affect decisions by patients and doctors. In one study, American patients were more than twice as likely to request advertised drugs than patients in Canada, where most direct-to-consumer advertising is prohibited (Canadian Medical Association Journal, 2003). Patients who requested advertised drugs were nearly 17 times more likely to receive one or more new prescriptions than patients who did not request any drugs. Daniel Carlat, MD, associate clinical professor of psychiatry at Tufts University and author of the 2010 book "Unhinged: The Trouble with Psychiatry." "There is a huge financial incentive for psychiatrists to prescribe instead of doing psychotherapy," he says. "You can make two, three, four times as much money being a prescriber than a therapist.