Recent quotes:

The Influence of Industry Sponsorship on the Research Agenda: A Scoping Review

Corporate interests can drive research agendas away from questions that are the most relevant for public health. Strategies to counteract corporate influence on the research agenda are needed, including heightened disclosure of funding sources and conflicts of interest in published articles to allow an assessment of commercial biases. We also recommend policy actions beyond disclosure such as increasing funding for independent research and strict guidelines to regulate the interaction of research institutes with commercial entities.

Coca-Cola Funds Scientists Who Shift Blame for Obesity Away From Bad Diets - The New York Times

“Coca-Cola’s sales are slipping, and there’s this huge political and public backlash against soda, with every major city trying to do something to curb consumption,” said Michele Simon, a public health lawyer. “This is a direct response to the ways that the company is losing. They’re desperate to stop the bleeding.” Coke has made a substantial investment in the new nonprofit. In response to requests based on state open-records laws, two universities that employ leaders of the Global Energy Balance Network disclosed that Coke had donated $1.5 million last year to start the organization.

Pharmaceutical industry sponsorship and research outcome and quality: systematic review. - PubMed - NCBI

30 studies were included. Research funded by drug companies was less likely to be published than research funded by other sources. Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors (odds ratio 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons). None of the 13 studies that analysed methods reported that studies funded by industry was of poorer quality.

Study casts doubt on evidence for 'gold standard' psychological treatments -- ScienceDaily

"One of the things that becomes really obvious when you look at the literature is researchers are collecting and analyzing their data in ways that are extremely flexible," Sakaluk said. "If you don't follow certain rules of statistical inference, you can inadvertently trick yourself into claiming effects that aren't really there. For EST research, it may become important to define in advance what researchers are going to do -- like how they'll analyze data -- and go on record in a way that restricts what they're going to do. This would coincide with a movement to encourage researchers to propose what they'd like to do and get reviewers and journal editors to weigh in before -- not after -- scientists do research, and to publish it irrespective of what they find."

Saving the Endangered Physician-Scientist — A Plan for Accelerating Medical Breakthroughs | NEJM

In the past four decades, however, the proportion of U.S. physicians engaged in research has dwindled from a peak of 4.7% of the overall physician workforce in the 1980s to approximately 1.5% today.

The Hidden Costs of Automated Thinking | The New Yorker

Taken in isolation, oracular answers can generate consistently helpful results. But these systems won’t stay in isolation: as A.I.s gather and ingest the world’s data, they’ll produce data of their own—much of which will be taken up by still other systems. Just as drugs with unknown mechanisms of action sometimes interact, so, too, will debt-laden algorithms.

How a data detective exposed suspicious medical trials

One problem, several researchers in the field say, is that funders, journals and many in the scientific community give a relatively low priority to such checks. “It is not a very rewarding type of work to do,” Nuijten says. “It’s you trying to find flaws in other people’s work, and that is not something that will make you very popular.”

Industrial n-of-1

The N-of-1 trials propose replacing large-scale trials of whole groups with methodical study of individual patients. However, the requirement to provide specific treatment to different subgroups of patients will make clinical trials more complex, so the industry needs to redesign how it interacts with patients. CROs will need to establish expert teams to structure and run precision-medicine-oriented trials for their sponsor clients.

Why clinical trial outcomes fail to translate into benefits for patients | Trials | Full Text

We highlight problems with trial outcomes that make evidence difficult or impossible to interpret and that undermine the translation of research into practice and policy. These complex issues include the use of surrogate, composite and subjective endpoints; a failure to take account of patients’ perspectives when designing research outcomes; publication and other outcome reporting biases, including the under-reporting of adverse events; the reporting of relative measures at the expense of more informative absolute outcomes; misleading reporting; multiplicity of outcomes; and a lack of core outcome sets.

Clinical Trials of Therapy versus Medication: Even in a Tie, Medication wins | The BMJ

The medical community strives to make decisions based on evidence, but as this case illustrates we have unfortunately arrived at a point where taking the conclusions of clinical trials at face value is apparently a sign of naivette. Conflicts of interest may play an important role in the reporting of scientific findings. The problem is not limited to just a couple of isolated cases but involves the entire culture of medicine that has developed over the past ten years. Put bluntly, the scientific machinery is broken. There is no easy fix, but surely patients deserve better.

Clinical Trials of Therapy versus Medication: Even in a Tie, Medication wins | The BMJ

However, disclosure of the relationship would not have changed the troubling end result: A researcher with a history of being funded by SSRI makers completes a 'gold-standard' federally-funded study of post stroke SSRI use, which is published in one of the most prestigious medical journals in the world, and is given a forum in the national media to tell the general public that anyone who has had a stroke, whether or not they have been diagnosed with depression, should start a prophylactic regimen of Lexapro ...even though non-medical approaches perform just as well.

No evidence of added benefit for most new drugs entering German healthcare system: International drug development processes and policies are responsible and must be reformed -- ScienceDaily

And for 125 drugs (58%), the available evidence did not prove an added benefit over standard care in the approved patient population. The situation is particularly shocking in some specialties, they add. For example, in psychiatry/neurology and diabetes, added benefit was shown in just 6% (1/18) and 17% (4/24) of assessments, respectively.

Decentralizing science may lead to more reliable results in biomedical research: Analysis of data on tens of thousands of drug-gene interactions -- ScienceDaily

"The way science is often produced may inadvertently contribute to unreliable results," says senior author James Evans, Professor of Sociology at the University of Chicago, and External Professor at the Santa Fe Institute, US. "For example, a large group of scientists who frequently collaborate, use similar methods, share equipment, and frequently cite similar works are prone to producing the same, self-confirming results. Although such a group may produce repeated published experiments, our results demonstrate that their findings are not independent. Independent labs perform experiments in different ways with different expectations and are less prone to peer pressure than a densely connected networks of scientists."

Study finds psychiatric diagnosis to be 'scientifically meaningless' - Neuroscience News

“Although diagnostic labels create the illusion of an explanation they are scientifically meaningless and can create stigma and prejudice. I hope these findings will encourage mental health professionals to think beyond diagnoses and consider other explanations of mental distress, such as trauma and other adverse life experiences.”

The Pharmaceutical Industry’s Role in U.S. Medical Education » in-Training, the online peer-reviewed publication for medical students

Multiple studies report a relationship between exposure to the pharmaceutical industry and positive attitudes about industry interactions. As students’ exposure to the pharmaceutical industry increases, their ability to determine industry bias decreases. In losing their ability to detect bias and analyze pharmaceutical marketing statements objectively, medical students hinder their future ability to practice evidence-based medicine.

Use of evidence-based therapies for youth psychiatric treatment is slow to catch on: Intensive training and practices with 'proficient culture' are critical to evidence-based therapy use -- ScienceDaily

"Evidenced-based therapies are effective for treating a wide range of psychiatric conditions, but there is still a gap in widespread use," said the study's lead author Rinad S. Beidas, PhD, an associate professor of Psychiatry and Medical Ethics and Health Policy in the Perelman School of Medicine at the University of Pennsylvania, and founding director of the Penn Implementation Science Center at the Leonard Davis Institute of Health Economics (PISCE@LDI). "While findings showed a modest increase in use, the data point to a clear need for finding better ways to support clinicians and organizations in using EBP therapies. This research-to-practice gap is a historically intractable problem, which exists not only in behavioral health but all across health care specialties."

A Missed Opportunity to Address a National Shame: The Case of Sickle Cell Disease in the United States | Hematology | JAMA Pediatrics | JAMA Network

There are more than 100 000 persons in the United States with SCD, and 1:365 African American individuals are born with SCD.2 Although there have been limited, yet infrequent, local points of progress, at a national level the quality of care for children with SCD is shameful. Fundamental preventive care is not provided to most of these children despite overwhelming evidence of its effectiveness. For example, daily antibiotic prophylaxis for children younger than 5 years has been shown to markedly decrease the risk of sepsis and has been recommended by national authorities for more than 20 years.3 Yet, studies across several states have shown that less than 20% of children reliably receive such care, and rates have not improved significantly during the past decade.4 Similarly, annual transcranial Doppler screening is a proven effective mechanism to help prevent stroke in patients with SCD. However, only 22% to 44% of eligible children are screened each year,5 and no improvements have been seen in at least the past 5 years.

Or was it the "speed"?

The rates of traffic and moving violations were also significantly higher among young drivers with ADHD as compared to those without ADHD. Among these drivers, nearly 37 percent were issued a traffic violation and nearly 27 percent a moving violation within their first year of driving, compared to 25 percent and 18 percent respectively among their peers without ADHD. Drivers with ADHD had higher rates of alcohol or drug violations and moving violations (including speeding, nonuse of seat belts, and electronic equipment use). Their rate was 3.5 times that of young drivers without ADHD in the first year of driving and 1.5 times that of young drivers without ADHD in the first four years of driving.

Apixaban: Evaluation of the Inclusion of Studies Identified by the FDA as Having Falsified Data in the Results of Meta-analyses: The Example of the Apixaban Trials | Research, Methods, Statistics | JAMA Internal Medicine | JAMA Network

In our reanalysis of the 22 meta-analyses, we found that 10 (46%) yielded results that would change the initial meta-analysis findings. Each affected meta-analysis had a median of 9.5 publications (range, 2-17), and the median meta-analysis publication InCite journal impact factor was 5.830 (range, 3.154-17.202). The median weight of publications with falsified data was 55.7% (range, 13.1%-99.6%). From our reanalysis of the 22 meta-analyses, we found that 32 of 99 analyses (32%) yielded results that would change the conclusions of the initial analysis (Table). Of the 32 affected estimates, 31 (97%) no longer favored apixaban for the prevention of serious medical issues, and 1 (3%) favored the control.

The Lab Coat Is on the Hook in the Fight Against Germs - The New York Times

This change took place in part because doctors wanted to spruce up their dubious reputation. Until the advent of such medical reformers as Abraham Flexner and Sir William Osler about 100 years ago, medical training in the United States was notoriously lax. Lectures, not clinical experience, were the norm. It was the age of horse sense and the quack. So to more closely associate themselves in the public mind with sound science, physicians began donning the lab coats that were being worn by chemists and other laboratory types. These coats were generally beige. But white soon became the standard. “Our notion since the 1880s, when the germ theory of disease began to take hold, is that microbes hide in dark, dirty places, and that white stands for purity, both material and moral,” said Guenter Risse, a physician and author of “Mending Bodies, Saving Souls: A History of Hospitals” (Oxford, 1999). “Wearing white coats was a symbol that you were clean.”

ICER chastises J&J for overpricing depression drug esketamine ‘where there is such need for treatment’ – Endpoints News

Us­ing the es­ke­t­a­mine list price of $295 per 28 mg in­tranasal de­vice, the treat­ment’s use re­sults in an in­cre­men­tal cost-​effectiveness ra­tio of ap­prox­i­mately $198,000 per QALY com­pared to no ad­di­tional treat­ment, ex­ceed­ing the com­monly cited cost-​effectiveness thresh­olds of be­tween $50,000-​$150,000 per QALY. Mean­while, es­ke­t­a­mine is es­ti­mated to cost ap­prox­i­mately $2.6 mil­lion per life year gained, ICER found. Es­ke­t­a­mine’s ap­proval was also meant to en­hance ac­cess to treat­ment — since ke­t­a­mine is not cov­ered by health in­sur­ers — al­though there is a con­cern that there may still be high out-​of-pocket ex­penses through de­ductibles or non-​coverage poli­cies. In­deed, “the place for es­ke­t­a­mine may de­pend on the com­par­a­tive ben­e­fits be­tween es­ke­t­a­mine and other avail­able treat­ments, such as ke­t­a­mine. Un­for­tu­nately, such in­for­ma­tion is not avail­able at this time,” ICER said.

This Is How You Kill a Profession - The Chronicle of Higher Education

We discarded college faculty in the same way that we discarded medical general practitioners: through providing insane rewards to specialists and leaving most care in the hands of paraprofessionals. We discarded college faculty in the same way that we discarded cab drivers: by leveling the profession and allowing anyone to participate, as long as they had a minimum credential and didn’t need much money. We discarded college faculty in the same way that we discarded magazine and newspaper writers: by relabeling the work “content” and its workers “content providers.” We discarded college faculty in the same way that we discarded local auto mechanics: by making all of the systems and regulations so sophisticated that they now require an army of technicians and specialized equipment. We discarded college faculty in the same way that we discarded bookkeepers: by finally letting women do it after decades of declaring that impossible, and then immediately reducing the status of the work once it became evident that women could, in fact, do it well.

Many leading universities still failing to report clinical trial results - STAT

Specifically, findings were not posted for 31 percent — or 140 —of 450 studies that were to have been disclosed in public registries as a result of transparency requirements in the FDA Amendments Act, according to Universities Allied for Essential Medicines, a student-led organization concerned with access to medicines, and TranspariMED, a nonprofit research advocacy group. Moreover, only 15 of 40 universities previously found to have lax reporting are in full compliance. For instance, MD Anderson Cancer Center, which sponsored the largest number of applicable trials, disclosed only 77 percent of the findings. Similarly, the Mayo Clinic divulged 42 percent of studies. Columbia University had the worst track record, reporting 17 percent of trials, according to the analysis.

Time to say goodbye to “statistically significant” and embrace uncertainty, say statisticians – Retraction Watch

The bright-line thinking that is emblematic of declaring some results “statistically significant” (p<0.05) and others “not statistically significant” (p>0.05) obscures that uncertainty, and leads us to believe that our findings are on more solid ground than they actually are. We think that the time has come to fully acknowledge these facts and to adjust our statistical thinking accordingly.

Note 'average' number of treatments?!

The 16 participants in the FORSEE-II study had suffered from severe depression for 8 to 22 years and had previously undergone an average of 18 drug therapies, 20 electroconvulsive therapies, and 70 hours of psychotherapy -- without success. Prof. Dr. Volker A. Coenen, first author of the study and director of the Stereotactic and Functional Neurosurgery Unit at the Department of Neurosurgery of the Medical Center -- University of Freiburg, and his team implanted the deep brain stimulation systems in the patients medial forebrain bundle of the brain and used them to stimulate the medial forebrain bundle. This brain region is involved in the perception and regulation of pleasure and reward and is thus also significant for motivation and the perceived quality of life. Clear Relief Often within Days The doctors evaluated the success of the therapy monthly with the help of the established Montgomery-Asberg Depression Rating Scale (MADRS). The MADRS scores of ten study participants already decreased significantly within the first week and remained at a low level. All study participants reacted to the stimulation in the course of the study. Eight of the 16 patients had a MADRS score of under 10 points at the end of the study and thus were regarded as non-depressive. "Our patients had struggled with severe depression for years with no signs of improvement. Deep brain stimulation brought most of them significant relief within days, which lasted throughout the course of the therapy. Other forms of treatment like medication and psychotherapy often lose their effectiveness over the course of time. Absolutely sensational about the study data is that the effect seems to be long lasting, with the positive effects continuing for years," says Prof. Schläpfer. "We know from a pilot study that the stimulation of this brain region is very promising and we are delighted about the replication of these significant effects," says Prof. Coenen.

Fast-acting psychedelic associated with improvements in depression/anxiety -- ScienceDaily

One of the unique properties of 5-MeO-DMT is the fast action and short duration of the psychedelic effects when compared to other psychedelics. "Research has shown that psychedelics given alongside psychotherapy help people with depression and anxiety. However, psychedelic sessions usually require 7 -- 8 hours per session because psychedelics typically have a long duration of action," says Alan K. Davis, Ph.D., a postdoctoral research fellow in the Behavioral Research Unit, at the Johns Hopkins University School of Medicine. "Because 5-MeO-DMT is short-acting and lasts approximately 30-90 minutes, it could be much easier to use as an adjunct to therapy because current therapies usually involve a 60 -- 90 minute session."