Bias, Corruption & Accountability

According to a study published in this month’s British Journal of Psychiatry, people diagnosed with depression in high-income countries are more likely to limit...

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.

In 2004, the FDA added a black-box warning to SSRI antidepressants on the increased risk of suicide among children taking these drugs. A new study suggests that this warning has increased the proportion of children who begin an antidepressant on a low dose, but the majority are still receiving higher than recommended doses.

Two patients have now died while taking the drug beloranib in an obesity drug trial. Both patients were in the active arm of the study and had received the drug rather than a placebo. Zafgen did not say whether it believed the drug had caused the blood clotting in the lungs that led to the patient’s death.

“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.

Films for Action is now hosting a video by MIA contributor Bruce Levine. In his presentation, taped at his Oct 9, 2015 National Empowerment Center talk,...

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 →

The BMJ reports that renewed concerns about the “revolving door” between government and industry have been sparked by the health minister of England’s decision to join to drug company Roche.

The abuse of ADHD drugs on college campuses has reached epidemic proportions, according to the authors of a recent review in the journal of Ethical Human Psychology and Psychiatry. ADHD drugs, like Ritalin and Adderall, have become so commonplace on college campuses that students abusing these drugs for studying, weight loss and partying have underestimated their risks. As a result, we have seen exponential increases in emergency room visits, overdoses, and suicides by students taking these drugs.

A “not otherwise specified” (NOS) diagnosis is often used when an individual may have some symptoms related to a psychiatric diagnosis but does not meet enough criteria to warrant a particular diagnosis. A new study, published online ahead of print in Psychiatric Services, reveals that the proportion of mental health visits resulting in such NOS diagnoses rose to nearly fifty percent, and that these diagnoses do not result in more conservative psychiatric drug prescriptions.

More than ten-percent of adults in the United States are currently prescribed at least one psychiatric medication but there is currently a lack of research on the prevalence of adverse drug events (ADEs) associated with these prescriptions outside of clinical trials.

Democratic Presidential nominee, Bernie Sanders, questioned the nominee for FDA commissioner, Robert Califf, during yesterday’s Senate hearing. Sanders remarked that we need a commissioner who will stand up to the pharmaceutical companies and protect American consumers. Of Califf, he added, “with regret, I think that you are not that person.”

In an open letter to all US presidential candidates published Thursday in the BMJ, a group of global health care experts assert that current research regulations allow drug companies to publish incomplete and misleading results. They ask the candidates to declare whether they support improved transparency measures that would make data on drug studies publically available and open to scrutiny.

"After making an observation and forming a hypothesis as usual, the new third step of the scientific method will now require researchers to embark upon an exhaustive search for corporate or government financing,” the satirical news site the Onion “reports.” “Next, scientists simply modify their study’s goals to align with the vision of potential funders and wait for several months to hear back. At this point—should this step be successful, of course—they can move on to the experimental stage, and then to analysis.”

In his reaction to Dr. Makari’s Opinion piece in the ‘Times, entitled Psychiatry’s Mind-Brain Problem, Dr. Nardo articulates why the legacy of NIMH director Thomas Insel is so dangerous. “He may have kept the researchers from spinning off and following some idiosyncratic path, but he did it by forcing them to follow his own idiosyncratic path.”

In the Atlantic, Ed Yong reports that despite the lack of replicability of individual studies, when you get a pool of psychologists “betting on” the reproducibility of a study their predictions are surprisingly accurate. “Which makes me wonder: What's going on with peer review? If people know which results are really not likely to be real, why are they allowing them to be published?”

For the USC Center for Health Journalism, Martha Rosenberg points out the absurdity of allowing industry funded doctors to teach classes to practitioners about psychiatric drugs. "What if the written road test drivers take were sponsored by BP or Shell and had marketing messages interspersed?"

New York Times columnist, Nicholas Kristof, relates the story of Andrew Francesco, a boy who began taking Ritalin at age five and died from complications with Seroquel when he was fifteen. His father, a former pharmaceutical industry executive, reveals the industry’s greed in his memoir “Overmedicated and Undertreated.” Now the industry is pushing for a first-amendment right to market its drugs for off-label uses.

In 2014, then National Institute of Mental Health (NIMH) director, Thomas Insel, speculated that ketamine “might be the most important breakthrough in antidepressant treatment in decades.” A recent review of the research suggests that while ketamine may produce a rapid short-term improvement in depression, the effect is short-lived and the potential for addiction and dependence warrants considerable caution.

I was a psychiatrist who participated in the Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE ETP). Although I welcomed the positive headlines that heralded the study's results, the reports left me with mixed feelings. What happened to render the notion that talking to people about their experiences and helping them find jobs or go back to school is something novel?

Marcia Angell in the New York Review of Books writes about the inherent conflict in clinical trials between “the search for scientific answers," on one hand, and “the rights and welfare of human subjects,” on the other.