Industry

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.

Yesterday, the New York Times reported that schizophrenia patients in an experimental treatment program (RAISE) who experienced better outcomes had been on lower doses of antipsychotics than normal. However, the article published in the American Journal of Psychiatry on Tuesday did not divulge any data on the varying antipsychotic drug doses in the different study groups.

Results of a large government-funded study call into question current drug heavy approaches to treating people diagnosed with schizophrenia. The study, which the New York Times called “by far the most rigorous trial to date conducted in the United States,” found that patients who received smaller doses of antipsychotic drugs with individual talk therapy, family training, and support for employment and education had a greater reduction in symptoms as well as increases in quality of life, and participation in work and school than those receiving the current standard of care.

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

Bernie Sanders joins numerous public health groups and opposes Robert Califf's nomination to lead the FDA over industry ties.

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.”

Sheila Kaplan for the Boston Globe reports that Dr. Robert Califf, the Obama administration's nominee to lead the Food and Drug Administration (FDA), has removed his name from a series of scientific papers that he recently coauthored. The decision to remove his name, against publication ethics standards, has brought Califf under renewed criticism.

With the explosion of genetic testing and the emerging field of pharmacogenetics, patients can now take a DNA test and receive psychiatric drug recommendations customized to fit their genetic makeup. In an editorial for the latest issue of the Journal of Nervous and Mental Disease, Columbia University Psychiatrist Robert Klitzman warns that clinicians need to be aware of the limitations of these genetic tests being marketed to them.

NBC News reports that "Genetic tests to identify the most effective psychiatry drugs are the hot new thing in the race to create personalized treatments based on people's DNA.” An investigation by the New England Center for Investigative Reporting, however, found that these new tests are based on small studies conducted by device manufacturers, and those with financial conflicts on interest.

While publication bias has been known to overestimate the efficacy of antidepressant treatments, a new study suggests that research on the use of psychotherapy in depression suffers from a similar bias.

The October edition of the Journal of World Psychiatry, the 3rd ranked journal of Psychiatry, will publish a reanalysis of antidepressant efficacy versus placebo in major depression. When the researchers, Arif Khan and Walter Brown, analyzed the data from the FDA archives for antidepressants approved between 1985 and 1997, “it was evident that the conventional wisdom of 70% response with antidepressants was at best an overestimate.” In fact, “the magnitude of symptom reduction was about 40% with antidepressants,” compared to “about 30% with placebo.”

Psychologists for Social Responsibility (PsySR), one of the groups that led the push for changes to the American Psychological Association’s (APA) collusion in the CIA torture program (as detailed in the Hoffman report), is again calling on the APA for a change in policies.

In an Op-ed for the Times Union, Madeleine Ringwald explains how the Helping Families in Mental Health Crisis Act “would severely disable protection and advocacy organizations from protecting the civil, legal and human rights of people in mental health services.” “Whether you examine it through a scientific, civil rights or bottom-line lens, Murphy's bill should appall you,” she writes. “Any legislation that bolsters institutionalization at the cost of community-based services seeks not to help those with mental health needs, but help society find ways to hide, suppress and silence them.”

Yesterday, the Journal of the American Medical Association (JAMA) released an editorial entitled “Confluence, Not Conflict of Interest: Name Change Necessary.” The authors argue that the phrase “conflict of interest is pejorative,” and a better term “would be confluence of interest, implying an alingnment of primary and secondary interests.”

Hundreds of people have been given remote control deep brain stimulation implants for psychiatric disorders such as depression, OCD and Tourette’s. Yet DBS specialists still have no clue about its mechanisms of action and research suggests its hefty health and safety risks far outweigh benefits.

Bloomberg reports that the FDA asked Pfizer in August “to modify safety warnings for its antidepressant Zoloft (sertraline) and acknowledge for the first time that some studies linked the mood-altering medication to heart defects in newborns.”

Writing for the Atlantic, David Dobbs examines how much harm has been done in the 14 years since Paxil was wrongly determined to be safe and effective. “Study 329, as it became known, helped spur a huge increase in Paxil prescriptions,” Dobbs writes. “In 2002 alone, over 2 million prescriptions were written for children and teens, and many more for adults.” “Thousands of children, teens, and young adults attempted or committed suicide while on Paxil,” and the reanalysis of Study 329 in BMJ makes it seem “more likely than ever” that many did because of the drug.

In Saturday’s New York Times, Sabrina Tavernise describes the close industry ties of Dr. Robert Califf, a cardiologist and researcher recently tapped by the Obama administration to head the FDA. In a conflict of interest statement published last year, Califf “declared financial support from more than 20 companies,” leading some public health advocates to “question whether his background could tilt him in the direction of an industry he would be in charge of supervising.” Tavernise points to a presentation Califf gave on “Disrupting Clinical Research: Transforming a System” in 2014 where he singled out regulation as a barrier to research and innovation. “I think it illuminates his thinking,” Daniel Carpenter, a Harvard professor who studies the FDA, said of the slide. “In a sense, he’s the ultimate industry insider.”

On Tuesday, the Obama administration nominated Dr. Robert Califf to be the new commissioner of the Food and Drug Administration (FDA). In a statement, director of the Public Citizen’s Health Research Group, Dr. Michael Carome called on the Senate to reject the nomination. He contends that Califf “racked up a long history of extensive financial ties to multiple drug and medical device companies, including Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck Sharp & Dohme and Sanofi-Aventis, to name a few.”

In the September issue of The Journal of the American Medical Association (JAMA) three FDA advisory committee members describe the convergence of factors that made the committee’s recommendation to approve flibanserin especially challenging and politically charged.

MedPageToday reports that Janssen Pharmaceuticals omitted data from a 2003 study that connected Risperdal with serious side effects. Janssen was previously sued by the FDA for marketing Risperdal for off-label uses and settled for $2.2 billion in 2013. Earlier this year, a man with autism was awarded $2.5 million after growing breasts while on Risperdal. According to MedPage, documents from this latest case reveal missing data tables from a 2003 study “designed to ferret out potential adverse effects of long-term risperidone use.” The missing tables were related to elevated prolactin levels and side effects, including gynecomastia in men.

Writing for Forbes, Matthew Herper documents the FDA’s increasing drug approval rates. “In 2008, BioMedTracker says the FDA approved 20 new molecular entities (NMEs) and rejected 20, for an approval rate of 50%.” So far this year, he writes, “the FDA approval rate is more like 96%.”

The International Business Times covers a new study showing “trials for new antidepressant medications may not be applicable to the population at large.” “The finding, published in the Mayo Clinic Proceedings, shows recent trials are less generalizable than the prior studies, as researchers excluded most depressed patients from drug company-sponsored treatment studies.”

Despite updated standards requiring preregistration of clinical trials aimed at improving transparency, most studies published in the top-5 psychiatry journals from 2009 to 2013 do not meet the new guidelines, according to an analysis published in PloS one.