Industry

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.

Martha Rosenberg calls the reanalysis of Paxil and Study 329 “a victory for safety activists, medical reporters, the public and freedom of the press.” But, she warns, “many pro-pill doctors continue to fight evidence of Paxil’s suicide risks and similar SSRIs.”

On his website, Dr. Nardo details the hidden risks and bad science behind the growing practice of using atypical antipsychotics to augment antidepressant treatment for severe depression. The story of Atypical Antipsychotic Augmentation of Treatment Resistant Depression is a “prime example” “to illustrate how commercial interests have invaded medical practice.” “Besides the obvious dangers of the Metabolic Syndrome and Tardive Dyskinesia, these drugs don’t really do what they’re advertised to do – make the antidepressants work a lot better.”

“The Food and Drug Administration’s approval of pharmaceutical treatment for low sexual desire in women has launched a heated debate over the dangers and benefits of medicalizing sex,” Maya Dusenbery writes in the Pacific Standard. Is “female Viagra” a feminist victory or a product of clever faux-feminist marketing by Big Pharma?

Stimulant medications like Ritalin and Adderall, often prescribed to treat children diagnosed with ADHD, are known to cause hallucinations and psychotic symptoms. Until recently these adverse effects were considered to be rare. A new study to be published in the January issue of Pediatrics challenges this belief, however, and finds that many more children may be experiencing psychotic symptoms as a result of these drugs than previously acknowledged.

Researchers from the City College of New York and Columbia University published a study this month testing the hypothesis that people diagnosed with schizophrenia treated long-term with antipsychotic drugs have worse outcomes than patients with no exposure to these drugs. They concluded that there is not a sufficient evidence base for the standard practice of long-term use of antipsychotic medications.

Listen: NPR’s On Point with Tom Ashbrook discusses the new book “Moody Bitches: The Truth About the Drugs You’re Taking, The Sleep You’re Missing, the Sex You’re Not Having and What’s Really Making You Crazy,” by the psychiatrist Julie Holland.

Rob Wipond takes HealthNewsReview.org to task for its coverage of a Philadelphia Inquirer article about a medical device designed for people experiencing panic. He writes that “hyperbolic psychiatric and psychological claims frequently get free passes from otherwise thoughtful medical critics.”

Recent meta-analyses of antidepressant clinical trials have revealed that up to 82% of the effects associated with the drugs may be attributed to placebo and non-medication factors. A new study examined the attitudes of psychiatrists toward these non-pharmacologic factors and found a large discrepancy between their beliefs and the empirical evidence.

"Every year since 2006 in the U.S., the amount of new medical research in humans that’s funded by the National Institutes of Health (NIH) has gone down, while the number of industry-funded trials has gone up, a new study shows.”

An analysis of medical records in the UK reveals that the use of certain antidepressants for depression is linked to a heightened risk for mania and bipolar disorder. The research, published this week in BMJ Open, found the strongest effect for serotonin reuptake inhibitors (SSRIs) and the antidepressant venlafaxine.

In a major study, published yesterday in JAMA Pediatrics, the use of SSRI antidepressants during pregnancy was found to increase the risk of autism spectrum disorder (ASD) by 87-percent. Previous studies reveal that more than 13-percent of women currently use SSRI antidepressants during pregnancy.

“Some autistic adults have spent much of their lives with the wrong diagnosis, consigned to psychiatric institutions or drugged for disorders they never had,” Jessica Wright writes in The Atlantic.

"Terrorism researchers are trying to understand how young people in Europe become radicalized, by looking for clues in the life histories of those who have committed or planned terrorist acts in recent years, left the continent to join ISIS, or are suspected of wanting to become jihadists. A mixture of sociologists, political scientists, anthropologists and psychologists, such researchers are drawing on information generated by police, judicial inquiries and the media, and, in some cases, on interviews. They also study factors at play in prisons and socially-deprived areas. Some of their insights are summarized here.”

Citing a 43 percent jump since 2003, researchers estimate that 5.8 million school-aged children and teens in the US now have an ADHD diagnosis, a staggering 12 percent of this population. The new NIH-funded analysis also found that the percentage of girls diagnosed with ADHD was up 55% and that the percentage of Hispanic children diagnosed shot up 83% over the same timeframe.

Gepirone, a new depression drug by Fabre-Kramer Pharmaceuticals, did not meet the FDAs efficacy standards. The new drug application for gepirone has now received...

Two facts about Robert Califf are beyond question. He is an expert on clinical trials, who is already seen as a leading architect of the future of medical research. And as the New York Times put it, he has “deeper ties to the pharmaceutical industry than any FDA commissioner in recent memory”. A lot of senior figures in medicine support Califf in spite of his ties to Pharma. The guy is just so bright, and understands the nuts and bolts of drug research so well! Surely a person like this is more useful than some outsider who offers only a squeaky-clean resume, they argue.

“About 30 percent of senators and 20 percent of representatives held assets in biomedical and health-care companies, or in specialty funds set up to invest...

The authors of a large scale well-conducted systematic review of methylphenidate, also known as Ritalin, conclude that there is a lack of quality evidence for the drug’s effectiveness. Their research also revealed that Ritalin can cause sleep problems and decreased appetite in children.

In a new study, researchers found that bright light therapy was an effective treatment for nonseasonal major depressive disorder (MDD) while Prozac (Fluoxetine) alone...

For STAT, Ed Silverman reports on growing concerns about the industry ties of the new nominee for FDA commissioner.  “The nomination comes at a...

Drug makers have faced large fines for unethical and harmful practices but have simply treated these as a cost of doing business. Ed Silverman reports...

Ed Silverman reports that only 80 prescriptions for Addyi, or Flibanserin, were filled in the drugs’ first two weeks on the market. Article →