Informed Consent

“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.”

A review of treatment guidelines published in Psychotherapy and Psychosomatics found that guidelines “shy away from stating clearly that SSRIs/SNRIs, like BDZs, are often (though...

“Decisions about the effectiveness of drugs are being made with incomplete information because results of almost three-quarters of clinical trials are still not published...

Psych Central covers findings published in BMJ revealing that many people in the U.K. with intellectual disabilities are being prescribed antipsychotic drugs. The study’s lead author comments: “People who show problem behaviors, along with older people with intellectual disability or those with co-existing autism or dementia, are significantly more likely to be given an antipsychotic drug, despite this being against clinical guidelines and risking possible harm.”

“Health Commissioner Leana Wen will join other health directors across the country today in asking the federal government to require a ‘black box warning’...

David Shern, from Johns Hopkins University, writes that the latest mental health “Murphy bill” in Congress is “an expansion of the approaches that got us into our current difficulties.” “Early intervention and prevention, assessable and patient-focused services with a rehabilitation orientation and increased funding for the community supports needed for successful recovery are the tickets to system improvement.”

Just last week one person was declared brain dead and five more were hospitalized after taking a psychiatric drug in a clinical trial. Writing for Science, Martin Enserink provides more information about the drug as new details emerge.

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...

According to a new STAT-Harvard poll, the majority of Americans oppose new legislation that would speed up the approval of new drugs and medical...

Dennis Embry, a clinical psychologist and government consultant on mental health, shares a letter he sent to congressman Murphy warning him about how he may have been misled concerning his mental health bill. “I am specifically writing you about erroneous, false information you’ve been given about the National Registry of Evidence Base Programs and Practices. That erroneous information is likely to cause serious problems, which have been withheld from you.”

The first systematic investigation of the adverse effects associated with prescribing drugs “off-label” found that the common practice of using drugs for conditions for which they are not approved increases the risk of adverse effects.

A woman in Texas attempted suicide while in the active group of a clinical trial for smoking-cassation drugs Chantix and Zyban, both known to...

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.

"To be sure, the FDA review process is not perfect. What is? But the agency is still considered the gold standard by which other...

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.

An investigation found that many US hospital websites were more like advertising outlets than educational portals.

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.”

The Boston Herald reports on mental health care reform bills moving through both houses of Congress. Lawmakers warn, however, “that some aspects of the legislation could create greater barriers to access mental health care for some.”

“A group of Boston doctors is proposing to join a study that would provide emergency treatment for brain-injured patients without obtaining the trauma victims’...

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...

“A new study is giving insight into how long-term care patients in the province are progressing — or, in some cases, worsening — over time. It found those living in central Newfoundland are more likely to be given antipsychotic drugs they don't need.”

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