Open Data

From STAT: “Imagine that someone offers to give you a guard dog. When the wretched creature arrives, you find out that she is calf-high,...

The New England Journal of Medicine (NEJM) has come under intense scrutiny for delayed corrections and controversial editorials and articles. “The Journal and its...

John Ioannidis claims that the idea of evidence based medicine has been “hijacked to serve agendas different from what it was originally aimed for,” in a newly published critical essay in the Journal of Clinical Epidemiology. Ioannidis frames the essay as a continuation of a conversation with David Sackett, widely considered the founder of evidence based medicine.

“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...

In a scathing editorial in this month’s Psychotherapy and Psychosomatics, Dr. Giovanni Fava takes aim at prominent medical experts who have downplayed the role...

Richard Smith, the chair of the board of trustees at BMJ, penned an editorial yesterday bringing increased scrutiny to research misconduct and medical fraud in the UK. Smith identifies denial about the seriousness of the problem and the reluctance of universities to submit themselves to reviews as the two major reasons that Britain has failed to address these issues.

“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.”

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.

Researchers from the City College of New York and Columbia University published a study this month testing the hypothesis that people diagnosed with schizophrenia treated long-term with antipsychotic drugs have worse outcomes than patients with no exposure to these drugs. They concluded that there is not a sufficient evidence base for the standard practice of long-term use of antipsychotic medications.

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.

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.

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?”

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.”

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.

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.”

Today’s NY Times front page featured a story on the problem reproducibility poses for many psychology studies. The story is based on the results of a year-long study where the researchers found they were unable to reproduce 60 out of 100 studies published in three leading psychology journals. “The overall ‘effect size,’ a measure of the strength of a finding, dropped by about half across all of the studies.”

-Tom Jefferson updates on the "revolution" promised by European Medicines Agency policies on publicly releasing more detailed data from drug clinical trials.

-NIMH's Thomas Insel asks how internet-driven and crowd-sourced approaches could be applied to medical and psychiatric research.

An RCT is simply a research tool and, as a tool, it can be used in a variety of ways. Unfortunately, the idea of a hierarchy of evidence seems to be hypnotically seductive for many people and powerfully useful for the drug companies. In order to get a drug to market, regulators in the US such as the Food and Drug Administration (FDA) and also in Europe, only require the drug companies to produce two RCTs with statistically significant positive results. Perhaps this very low standard has contributed to the fact that RCTs can be much more useful as marketing tools for drug companies than for discovering new and useful ways for people to live healthy and meaningful lives.

For decades the gold standard for medical evidence was the review article - an essay looking at most or (hopefully) all of the research on a particular question and trying to divine a general trend in the data toward some conclusion ("therapy X seems to be good for condition Y," for example). More recently, the format of review articles has shifted - at least where the questions addressed have leant themselves to the new style. The idea has been to look at the original data for all of the studies available, and in effect reanalyze them as though the research participants were all taking part in one gigantic study. By increasing the number of data points and averaging across the vagaries of different studies, a clearer finding might emerge. The meta-analysis has gone on to be revered as a strategy for advancing healthcare. It has vulnerabilities.

-Experts comment on AstraZeneca's latest way of attempting to comply with pressures to provide open data.

Recently the problem of publication bias has been shaking the foundations of much of psychology and medicine. In the field of pharmacology, the problem is worse, because the majority of outcome trials (on which medication approval and physician information is based) are conducted by pharmaceutical firms that stand to benefit enormously from positive results, and run the risk of enormous financial loss from negative ones. Numerous studies have found that positive results tend to be published, while negative ones are quietly tucked under the rug.

National Institute of Mental Health Director Thomas Insel laments the lack of reproducibility in such a large majority of mental health-related research. He describes...

An editorial in the Lancet Psychiatry suggests that mental health professionals rely more on intuition and "good intentions" than "good science," and that needs...