The drug trial that led to the death of one participant and brain damage to several others last month had three major shortcomings, according to French health minister Marisol Touraine. First, the drug continued to be tested after the first volunteer became ill. Second, volunteers were not informed of the illness and were not given a chance to withdraw their consent. And, third, no report was made to the proper authorities until the first volunteer had already been hospitalized for four days.
In a scathing editorial in this month’s Psychotherapy and Psychosomatics, Dr. Giovanni Fava takes aim at prominent medical experts who have downplayed the role of financial conflicts of interest (FCOI) in medical research and practice. Fava retraces the development of the problem, the mechanisms of "propaganda" that allow conflicts to flourish, and offers suggestions for reform, including a call to boycott commercialized medical education programs and professional societies.
“A University of Texas Southwestern study will see if giving unborn babies with Down syndrome Prozac in the womb will help improve brain functioning,” according to NBC news. “Mothers pregnant with Down syndrome babies will take Prozac about 18 to 20 weeks into their pregnancy. The child will continue to take Prozac until the age of 2.”
Richard Smith, the chair of the board of trustees at BMJ, penned an editorial yesterday bringing increased scrutiny to research misconduct and medical fraud in the UK. Smith identifies denial about the seriousness of the problem and the reluctance of universities to submit themselves to reviews as the two major reasons that Britain has failed to address these issues.
Psychologist and Professor Amber Gum has published the story of her personal journey of rethinking psychotropic medication in a special issue on "The Politics of Mental Health" in The Journal of Medicine and the Person. Influenced by Mad in America and the work of Robert Whitaker, Gum became aware of evidence that “suggests that psychotropic medications are less effective and more harmful than most believe” and now hopes to encourage other mental health professionals and researchers to engage in open-minded, critical self-assessment of standard practices.
Reporting for The Intercept, Lee Fang reveals that pharma executives "have told investors that they are working actively to influence the political debate.” After “tough talk” on the price of medications in the United States from democratic contender Bernie Sanders and others, pharmaceutical companies are stepping up their lobbying and marketing efforts in an attempt to influence policy.
Citing the work of Lisa Cosgrove and Robert Whitaker in Psychiatry Under the Influence, Giovanni A. Fava, MD, provides an analysis of some subtle and yet important consequences of financial conflicts of interest in medicine. He also strongly criticizes the recent positions expressed by the New England Journal of Medicine which called for a reexamination of the views and regulations of financial conflicts of interest in medicine.
Following a lawsuit brought by Andrew Thibault of Parents Against Pharmaceutical Abuse (PAPA), the FDA has produced adverse event and severe adverse event reports on psychotropic medications. For the first time ever, these reports have been published online. Accessing the site linked below, users can perform global searches for AERS reports by drug name (brand and generic) or case number, review reports by drug class, refine searches within each drug class, and examine individual reports.
The College of Family Physicians of Canada has now come under fire after releasing a report last month addressing conflicts of interests between pharma and medicine, STAT reports.
A recent study published in this month’s issue of Psychiatry Research attempted to examine the impact of an anti-stigma public media campaign in Germany. They focused on changes in public attitudes toward people affected by symptoms associated with depression and schizophrenia as a result of the psychenet- Hamburg Network Mental Health awareness campaign.
Yesterday, senator and presidential candidate Bernie Sanders announced that he will formally oppose Robert Califf’s nomination as FDA commissioner. “Dr. Califf’s extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans, rather than just the CEOs of pharmaceutical companies,” Sanders said in an official statement.
Only months after the American Psychological Association voted to ban psychologists from “advanced interrogation” facilities like Guantánamo Bay prison the Pentagon is asking them to reconsider, James Risen reports in the ‘Times. Steven Reisner and Stephen Soldz, who led the campaign to end the APA’s involvement in torture, say that those criticizing the ban ignore “a wealth of evidence that systemic military interrogation abuses continued long after the time when the authors claimed they were banned.”
In recent months, two teams of researchers in the UK and the US published complementary findings about the epigenetic origins of schizophrenia that have scientific communities who indulge in ‘genetic conspiracy theories’ abuzz. While these results are intriguing, and no doubt involve pathbreaking research methodologies, this line of thought represents a decontextualized understanding both of the symptoms that are typically associated with schizophrenia, and their causes.
According to new research by Joanna Moncrieff and Sebastião Viola, mental health problems have become the leading cause of disability claims in the UK. While the overall number of claims for other conditions has decreased by 35%, claims related to “mental disorders” have increased 103% since 1995.
“A quick look at drugs or drug uses that later turned out to be risky shows a disturbing trail of ‘bought’ science in major medical journals,” Martha Rosenberg writes for AlterNet. “What stands between Big Pharma's desire for blockbuster drug sales and drug safety?”
Just last week one person was declared brain dead and five more were hospitalized after taking a psychiatric drug in a clinical trial for Brial. Writing for Science, Martin Enserink provides more information about the drug as new details emerge.
The warning label for the antidepressant Cymbalta downplayed the risks of withdrawal effects, according to consumer lawsuits being filed in courts across the country. “An estimated 44% to 78% of people who stop taking Cymbalta (also known as duloxetine) will suffer from withdrawal reactions,” yet the warning label “suggests the risk is greater than or equal to 1%.”
In this month’s issue of Psychological Medicine, researchers from King’s College London found evidence for associations between different types of childhood adversity and specific symptoms associated with psychosis. As current categorical approaches to psychosis and schizophrenia diagnoses come under increasing scrutiny, this study adds support to sociological and psychological theories and treatments.
The Boston Globe reports on the discovery of a newly recognized neurological disease, anti-NMDA receptor encephalitis. The disease is believed to be caused when the body’s immune system attacks proteins in the brain associated with the communication of neurons.
A study published this week in the Annals of Family Medicine reveals that opioid painkillers, when used long-term, can lead to the onset of depression. The researchers found that the link was independent of the contribution of pain to depression.
Six men were hospitalized and one was pronounced brain dead after participating in a phase 1 clinical drug for a mood, anxiety, and motor dysfunction drug manufactured by Bial and administered by Biotrial. Carl Elliott, a bioethicist at the University of Minnesota, said investigators should look into questions like how much the men were paid and whether they properly consented to the trial. “Many Phase 1 trial volunteers are poor and unemployed, and they volunteer for trials like this because they are desperate for money,” he said. “This means they are easily exploited.”
In a review article for this month’s American Journal of Psychiatry, Daniel Weinberger and Eugenia Radulescu from John Hopkins University push back against the overreliance on MRI scans in recent psychiatric studies. While acknowledging that they both have contributed to this type of research in the past, the authors warn that “findings” from these studies “pose a serious risk of misinforming our colleagues and our patients.”
According to the CDC, January is National Birth Defects Prevention Month. New research continues to link various SSRI antidepressants with birth defects and neurological abnormalities in newborns. The latest study to examine this topic, a meta-analysis led by Dr. Anick Bérard, found a 23% increased risk for birth defects, and a 28% increased risk for heart problems, in the infants of women who took the SSRI Paxil (paroxetine) during their first trimester.
“Those who possess the data control the story.” In the wake of the reanalysis of the infamous Study 329, where scientific data claiming the antidepressant Paxil was safe and effective for teens was egregiously manipulated, researchers are pushing for open access to raw data. “The issue here, scientists argue, is that without independent confirmation, it becomes too easy to manipulate data.”
Neuroskeptic covers a short article by Susan Lederer that appeared in the American Medical Association Journal of Ethics discussing what happens when research participants die.
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