Informed Consent

Infants exposed to SSRIs and benzodiazepines during pregnancy show impaired neurologic functioning in the first month after birth, according to a new study published in the American Journal of Psychiatry. While infants exposed SSRIs alone showed neurobehavioral effects throughout the first month, those exposed to an SSRI and a benzodiazepine had more significant problems.

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.

In the third major verdict of its kind, drug giant Johnson & Johnson was ordered to pay a Maryland man who grew female breasts while taking the antipsychotic Risperdal. The company failed to warn doctors, patients, and regulators of the risk of abnormal breast development in young males and now faces about 5,400 lawsuits involving the drug.

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.”

Oryx Cohen at TruthOut explains why the "Helping Families in Mental Health Crisis Act (HR 2646) - commonly known as the 'Murphy Bill' - appears to cater more closely to the desires of pharmaceutical companies than to the actual needs of people in psychological distress, perhaps because of Murphy's connections to key lobbyists." "If the Murphy Bill is passed, psychiatric hospitals and pharmaceutical companies will reap huge financial benefits as a result of increased hospitalization and forced treatment."

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.

Legislation is being advanced that would speed up the FDA’s approval process for new drugs and medical devices, according to a report by the Pacific Standard. Pharmaceutical and medical device companies have been lobbying heavily to reduce regulations and are winning over bipartisan support by attaching these measures to increased mental health funding.

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.”

Robert Neugeboren, who “spent most of his adult life in institutions, often subject to isolation, physical punishment and numbing medication,” was “a celebrity of sorts in the world of the mentally ill: a survivor of the horrors of mistreatment, a case history for those who point to the positive effects of kindness and talk therapy, and, perhaps most of all, the embodiment of the bottomless mystery of the human mind.”

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.

In an op-ed for the Guardian, cardiologist Aseem Malhotra writes: “Corporate greed and systematic political failure have brought healthcare to its knees. There are too many misinformed doctors and misinformed patients. It’s time for greater transparency and stronger accountability, so that doctors and nurses can provide the best quality care for the most important person in the consultation room – the patient.”

The science magazine RUBIN provides an update on patients’ rights to refuse treatment in Germany's psychiatric wards. “In psychiatric wards in Germany, patients used to be medicated indiscriminately against their will if doctors considered it necessary. It was only after a Federal Constitution Court ruling a few years ago that patient autonomy has been strengthened.”

The percentage of seniors in the United States prescribed potentially deadly antipsychotic drugs increases with age. A new study reveals that in the face of serious risks of strokes, fractures, kidney injuries, and death, over seventy-five percent of seniors given antipsychotics do not have a diagnosis for a mental disorder.

In a bellwether case, plaintiffs allege that Pfizer did not adequately warn patients that Zoloft (sertraline) would cause birth defects. The case is scheduled in Federal Court in March, and the verdict will have significant implications for future suits.

The UK Times reports that pharmaceutical companies are actively lobbying to limit the release of clinical trial data to the public. Rather than limiting results and data to medical journals, new transparency initiatives are pushing for making the information publically available. The push for transparency comes in the wake of the reanalysis of the Study 329 data on paroxetine (marketed as Seroxat and Paxil), which found that the industry study had misconstrued its results.

Results of a new study reveal that sixty-nine percent, or more than two-thirds, of patients prescribed antidepressant drugs have never, in their medical history, met the criteria for major depression. The study, published in the Journal of Clinical Psychiatry this month, also found that several demographic factors, like race and gender, were associated with the prescription of antidepressants.

A California jury ruled that Johnson & Johnson’s Janssen Pharmaceutical and a psychiatrist were responsible for the death of 25-year-old Leo Liu. During a clinical trial for Risperdal, Liu died of a heart injury that was “further complicated” by the drug and ignored by the study doctors. Janssen was found 70% responsible for Liu’s death and ordered to pay $5.6 million to the family.

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.

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

Johnson & Johnson is exposed to personal injury and product liability lawsuits over the failure to warn about Risperdal gynecomastia side effects in boys.

Writing for the Huffington Post, Caroline Beaton looks into how drugs continue to make billions in sales even after they lose lawsuits for fraud and misconduct. “The persistence of Big Pharma's fraud despite ubiquitous legal action suggests that our present efforts to hold the industry accountable are ineffective,” Beaton writes. “New polices in motion will make potentially unsafe drugs even easier to bring to market and promote.”

A former Navy pilot claims that a VA doctor misdiagnosed him with a mental disorder that prevented him from flying and ended his career. William Royster was told in 2004 that he was bipolar, that it was a permanent condition, and that he could no longer work in any capacity, according to the Navy Times. A different psychiatrist, however, later told Royster that he never met the criteria for diagnosis.

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.

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 University of Minnesota recently announced that it is ending the controversial practice of recruiting study participants from patients involuntarily being held in their psychiatric unit. In a commentary for Minnesota’s Star Tribune, bioethicist and MIA contributor Carl Elliot reports that the university has still not apologized to the patient who spoke out against this practice. Instead, “the university has done its best to discredit him.”