Bias, Corruption & Accountability

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.”

Human behavioral genetics and its allied field of psychiatric genetics are in trouble, as unfulfilled gene discovery expectations during the “euphoria of the 1980s” have continued to the present day, leading to researchers’ “nonreplication curse” dysphoria of the 2010s. In my recent book The Trouble with Twin Studies: A Reassessment of Twin Research in the Social and Behavioral Sciences, I presented a detailed argument that genetic interpretations of the common “classical twin method” finding that reared-together MZ twin pairs resemble each other more (correlate higher) for behavioral characteristics than do reared-together same-sex DZ twin pairs are invalid because, among other reasons, the twin method’s crucial MZ-DZ “equal environment assumption” (EEA) is false.

In a Science Update, the National Institute of Mental Health (NIMH) reports that Medicaid services is already taking steps to implement “coordinated specialty care” (CSC) in response to the RAISE study released last week. “The RAISE initiative has shown that coordinated specialty care for first episode psychosis is better than the standard care offered in community clinics. However, covering the cost of coordinated specialty care can be challenging. When Medicaid agrees to pay for effective treatment programs, patients in need benefit.”

Dr. Mickey Nardo adds to the ongoing discussion about the RAISE study results. He writes: “If there is ‘spin’ in the reporting of this study, we need to know about it. I personally think that it’s more important for RAISE to be reported completely and honestly than whether it comes out like they [or I] want it to come out. We don’t need some sanitized version of RAISE to tell us we need to turn our attention to a full bodied approach to the treatment of First Episode psychotic patients. We all already know that. What we do need is to have our confidence restored in our research community – that they will honestly and clearly report their findings whether they are clean as a whistle or an unholy mess.”

Despite safety concerns, a new study reveals that there has been no change in the use of benzodiazepines in the elderly from 2001 to 2010.

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.

PsychCentral presents a new study from the Center for Disease Control and Prevention (CDC) that found that foster care children are three times more likely than other children on Medicaid to receive a diagnosis of ADHD. Overall, more than one in four children in foster care receive such a diagnosis. CDC statistician Melissa Danielson interpreted these results as revealing a “substantial need” for more medical and behavioral services for kids in foster care.

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.

Last Tuesday, The New York Times and several other outlets (including Mad In America) reported on the highly-touted results of a study on psychosocial treatment for patients diagnosed with schizophrenia. Now, claims made about the study, which the ‘Times called “the most rigorous trial to date,” are coming under increased scrutiny.

Writing on his 1 Boring Old Man blog, Dr. Mickey Nardo reflects on the media frenzy around the RAISE study and asks why the prescription data has not been released. He adds skepticism about the political motives of the potentially overblown results, which he sees as a clear push for increased mental health funding.

A massive number of meta-analyses of antidepressant clinical trials have financial conflicts of interest and are unduly influenced by pharmaceutical companies, according to a review to be published in an upcoming issue of the Journal of Clinical Epidemiology. Researchers also found that meta-analyses with industry ties almost never report any negative findings in their abstracts.

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.

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.

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.”

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.”

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.