Antidepressants

The Scientific American reports on a new analysis of antidepressant trials revealing that the vast majority of meta-analyses have industry links and suppress negative results.

Yesterday, the New York Times reported that schizophrenia patients in an experimental treatment program (RAISE) who experienced better outcomes had been on lower doses of antipsychotics than normal. However, the article published in the American Journal of Psychiatry on Tuesday did not divulge any data on the varying antipsychotic drug doses in the different study groups.

People diagnosed with severe depression show the same changes in brain scans when they respond to a placebo as they do when they take an actual antidepressant, according to a new study. Researchers also found that those whose symptoms were decreased by a placebo were more likely to report relief from antidepressant drugs.

Despite concerns about the drug’s necessity, effectiveness, and side-effects, Flibanserin (Addyi) has come to market as the first drug designed to increase sexual desire in women

The BMJ states that it takes on average eight weeks from submission of an article to publication. The review process for Restoring Study 329 took a year, with a three-month review process involving six reviewers to begin with, and then a further four reviews in a four-month process, leading to a provisional acceptance in March that was withdrawn.

There is accumulating evidence that taking SSRI antidepressants increases the risk of bleeding and other complications during surgery, according to a review published in the British Journal of Anaesthesia.

The BBC reports that the number of people in Scotland taking antidepressants has increased by 5% in the past year with most of the patients being women and those in the poorest parts of the country. “We are now looking at the flabbergasting statistic of more than one in seven people in Scotland being prescribed antidepressants this year,” Conservative health spokesman Jackson Carlaw said. “We urgently have to look at better alternatives than simply parking people on medication in the hope things don't get any worse, with no aspiration for complete recovery."

Statistics from the UK reveal that prescriptions for painkillers and antidepressants continue to rise despite concerns over dependence and debilitating withdrawal effects. The British Medical Association (BMA) Board of Science has released a report that acknowledges changes to medical practice, research and policy necessary for addressing the dependence and withdrawal effects of benzodiazepines, opioids, and antidepressants.

One of psychiatry's most obvious vulnerabilities is the fact that various so-called antidepressant drugs induce homicidal and suicidal feelings and actions in some people, especially late adolescents and young adults. This fact is not in dispute, but psychiatry routinely downplays the risk, and insists that the benefits of these drugs outweigh any risks of actual violence that might exist.

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."

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.”

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.”

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.”

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,...

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.

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 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.

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.”

In the September issue of The Journal of the American Medical Association (JAMA) three FDA advisory committee members describe the convergence of factors that made the committee’s recommendation to approve flibanserin especially challenging and politically charged.

In addition to hosting the Panorama programs and The Famous Grouse history of Study 329, Study329.org has a comprehensive timeline on the origins of concerns about the SSRIs and the risk of suicide, initially with Prozac and subsequently with Paxil/Seroxat. The hope is to provide a comprehensive repository for anyone who wants to study SSRIs, RCTs, and Study 329 in particular.