The antidepressant Paxil has been linked to birth defects. "An Ohio federal judge on Wednesday ruled that GlaxoSmithKline must face a product liability suit brought by a woman whose child was born with heart defects after she took the antidepressant Paxil during her pregnancy, ruling that she had successfully pled fraud."
The Psychiatric Advisor reports on new research from King’s College London that suggests that antipsychotics can cause serious harm to people with Parkinson’s. According to the research: “The group that was treated with antipsychotics were four times more likely to have died following three to six months of treatment than those who did not receive any antipsychotic medication, the researchers reported in the Journal of Medical Directors Association. In addition, those on antipsychotics were also more likely to experience cognitive decline, worsening of Parkinson’s symptoms, stroke, infections, and falls.”
Writing in The Atlantic, James Hamblin reports that research continues to show that physical exercise is integral to “childhood cognition and brain health,” especially for children who exhibit symptoms associated with ADHD. These findings, Hamblin comments, have been discussed with a “phenomenal degree of reservation compared to the haste with which millions of kids have been introduced to amphetamines and other stimulants to address said ADHD.”
NPR reports on how ketamine is being used off-label to treat depression. While highlighting some of the reported benefits, the report also details some limitations. “One is that its ability to keep depression at bay can fade pretty quickly,” another limitation is the price, which can run “about $500 for each injection and $1,000 for an intravenous infusion.” There is also concern that ketamine clinics are opening up all over the country “as pure business models."
While publication bias has been known to overestimate the efficacy of antidepressant treatments, a new study suggests that research on the use of psychotherapy in depression suffers from a similar bias.
The October edition of the Journal of World Psychiatry, the 3rd ranked journal of Psychiatry, will publish a reanalysis of antidepressant efficacy versus placebo in major depression. When the researchers, Arif Khan and Walter Brown, analyzed the data from the FDA archives for antidepressants approved between 1985 and 1997, “it was evident that the conventional wisdom of 70% response with antidepressants was at best an overestimate.” In fact, “the magnitude of symptom reduction was about 40% with antidepressants,” compared to “about 30% with placebo.”
After the 2009 suicide of a seven-year-old foster kid who had been on two “black box” medications intended for adults, Florida updated its policies to protect vulnerable children from over-prescription. Unfortunately, according to a report by Orlando Weekly, “foster children are still being put on psychotropic medications without caregivers following proper procedures.”
Individuals diagnosed with psychotic disorders have an earlier onset of psychosis if they have previously been exposed to prescription stimulants, according to new research currently in press in the Journal of Psychiatric Research.
The University of Minnesota announced a change to its research ethics policies this month after coming under criticism “following the recruitment of a schizophrenia patient named Dan Markingson who died by suicide while enrolled in a drug trial,” the Star Tribune reports. Markingson, who died by suicide in 2004 during his participation in a study for three antipsychotic drugs, “was recruited, while under court commitment order, by a university psychiatrist who was running a study, treating Markingson and advising a judge on the terms of Markingson’s commitment.”
On Wednesday, JAMA Psychiatry released a meta-analysis comparing the results of cognitive-behavioral therapy and antidepressant medication in severely depressed populations. Currently, many practice guidelines suggest that antidepressants be used over psychotherapy for major depressive disorder. The analysis, however, found that “patients with more severe depression were no more likely to require medications to improve than patients with less severe depression.”
On September 18th, the one day "More Harm than Good Conference" brought together many of the leaders of the critical psychiatry movement. While the event has passed, the video and slides from the conference have been made available on the council for evidence-based psychiatry website
Let’s face it, as our kids slowly developing brains wrestle with behavioral and maturity issues while also trying to juggle expectations related to academic and social challenges, some of the behaviors they display can be quite concerning. Understandably, after trying what seems like everything in the books plus the kitchen, bathroom and laundry room sinks, caring and often exhausted parents are actively looking for help, resources and answers. But guess what? Without any need for pharmaceutical intervention or “drug therapy,” for centuries parents have been quite capable of helping challenged children overcome semi-annoying and concerning behaviors that some “experts” want to label today as symptoms of a mental disorder. Behaviors that a billion kids worldwide display every day.
Bloomberg reports that the FDA asked Pfizer in August “to modify safety warnings for its antidepressant Zoloft (sertraline) and acknowledge for the first time that some studies linked the mood-altering medication to heart defects in newborns.” According to the Bloomberg report, “Pfizer is fighting lawsuits by hundreds of women who say they weren’t adequately warned the drug could cause defects in their newborns.” “While some legal experts say the label change could help the company fend off future lawsuits, it could also help bolster claims by those who have already sued over Zoloft, once the most prescribed antidepressant in the U.S.”
On his own website, clinical psychologist Kenneth Pope has summarized 60 meta-analyses of antidepressants published between 2013-2015. The studies contain information on antidepressants “uses, effectiveness, risks, side effects, differential effects on different populations, etc.--to help clinicians, expert witnesses, researchers, and others to stay abreast of the evolving research in this area.”
Writing for the Atlantic, David Dobbs examines how much harm has been done in the 14 years since Paxil was wrongly determined to be safe and effective. “Study 329, as it became known, helped spur a huge increase in Paxil prescriptions,” Dobbs writes. “In 2002 alone, over 2 million prescriptions were written for children and teens, and many more for adults.” “Thousands of children, teens, and young adults attempted or committed suicide while on Paxil,” and the reanalysis of Study 329 in BMJ makes it seem “more likely than ever” that many did because of the drug.
New research published in the July issue of The Journal of Clinical Psychiatry found that the use of mood stabilizers, antipsychotics, antidepressants, and hypnotics during pregnancy is associated with increased health risks to the infant.
On Sunday, the front page of the UK’s Independent ran a story entitled, “Thousands of children are being medicated for ADHD – when the condition may not even exist.” Fiction novelist and author of the upcoming “Concentr8,” William Sutcliffe, writes, “The pharmaceutical/medical industry teaches us that whatever the problem, a pill is the answer.” “This notion is becoming so all-powerful, and so locked together with a pressurised, exam-centred, conformist educational system, that every parent who has a misbehaving or inattentive child may now find themselves pushed towards a diagnosis of ADHD.”
It is appropriate to hold a company or doctors who may be aiming to make money out of vulnerable people to a high standard when it comes to efficacy, but for those interested to advance the treatment of patients with any medical condition it is not appropriate to deny the likely existence of harms on the basis of a failure to reach a significance threshold that the very process of conducting an RCT will mean cannot be met, as investigators’ attention is systematically diverted elsewhere.
Individuals between the ages of 15 and 24 are more likely to commit a violent crime if they are taking an SSRI antidepressant than if they are not, according to new research out of Sweden. The study published in PLoS Medicine on Tuesday, suggests "warnings about the increased risk of violent behavior among young people taking SSRIs might be needed.”
In a major story, the New York Times presents the re-analysis by David Healy, Jon Jureidini, Mickey Nardo and others of Study 329, published in the British Medical Journal yesterday, that finds "five of six adverse events labeled 'emotional lability' in the original study involved suicidal thinking or behavior but were not presented as such." The re-analysis, according to the Times, "reverses an earlier conclusion that caused a long-running dispute, and opens the way for journals to post multiple interpretations of the same experiment."
Huffington Post and journalist Steve Brill have combined to launch a 15 part series about how Johnson & Johnson illegally violated FDA restrictions by pushing the antipsychotic drug, Risperdal, for use with adolescents and the elderly. The series, entitled “America’s Most Admired Lawbreaker,” launched yesterday and will include mixed media, videos, podcasts, source documents, as well as 15 written chapters. Click more for a synopsis of part 1.
The authors of Study 329 began recruiting adolescents for a comparative study of Paxil, imipramine and placebo in 1994 and finished their investigations in 1997. They dropped a large number of their original cohort, so the randomness element in the study must be open to question. Late in 1998, SmithKline Beecham, the marketers of Paxil, acknowledged in an internal document that the study had shown that Paxil didn’t work for adolescents in terms of the two primary and six secondary outcomes they had established at the start of the study. In a nutshell, Study 329 was negative for efficacy and positive for harm, contrary to their succinct upbeat conclusion.
In 1980, the British Medical Journal published a “Systematic Review of the Benzodiazepines” by the Committee on the Review of Medicines. The committee denied the addictive potential of Benzodiazepines and limited their suggestions to short term use. The results have been devastating.
New research published in the August issue of Psychiatric Annals evaluates the results of randomized control trials on the use of various psychotropic drugs for patients diagnosed with borderline personality disorder (BPD). Despite the “American Psychiatric Association’s practice guidelines endorsement of SSRIs as first-line therapies for BPD,” the results of the meta-analysis reveal that pharmacotherapy in BPD is “not supported by the current literature,” and “should be avoided whenever possible.”
Thirty-three percent of all inmates in New Mexico are taking at least one psychotropic drug. The rate is up from 25% in 2013, according to a report by The Santa Fe New Mexican. While the prescription rate at the federal level is 10%, 30% of male inmates and 70% of female inmates in New Mexico are prescribed psychotropic drugs.
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