Pharmalot’s Ed Silverman reports on a Senate bill aimed at loosening requirements around the reporting of financial conflicts of interest between companies and physicians. The sponsors of the legislation hope to exempt drug companies from reporting payments to doctors for medical education courses, medical journals, and textbooks.
Retraction Watch highlights a new study, “Public Attitudes Toward Data Fraud And Selective Reporting in Science,” finding that the public overwhelmingly believes that data fraud and selective reporting should be published as criminal offenses.
Earlier this year, the US Preventative Services Task Force (USPSTF) came out with the controversial recommendation that all adolescent and adult patients undergo depression screening in primary care. A new study, published in the Canadian Journal of Psychiatry, calls this recommendation into question. Researchers led by Brett Thombs from McGill University reviewed the accuracy of the existing screening instruments used for the detection of depression in children and adolescents and found insufficient evidence for their use.
From the New Scientist: “Paul Smaldino and Richard McElreath at the University of California Davis used an evolutionary theory-based computational model to analyse the problem of bad science. They found that “the most powerful incentives in contemporary science actively encourage, reward and propagate poor research methods and abuse of statistical procedures”. In short, it’s natural selection for shoddy science.”
From Ed Silverman with Pharmalot: “Drug and device makers paid nearly $6.5 billion in payments to doctors and teaching hospitals last year, according to the latest figures released on Thursday from a federal database. And physicians or their family members held $1 billion in ownership or investment interest in those companies.”
For STAT news, Pharmalot correspondent Ed Silverman reports on a new guideline being drafted by the FDA that adds new rules that could restrict someone from serving on an advisory panel. “Appearances are almost as important as actual conflicts,” said Dr. Michael Carome of Public Citizen. “If there are multiple instances where there are appearance questions, it can have negative consequences and undermine public trust in the review process.”
Recently, major researchers, including David Healy, Jon Juriedini, Mickey Nardo, and their colleagues, have brought a great deal of attention to issues of corruption in psychiatric research through their reanalysis of industry-funded trials for psychiatric drugs. This week, fellow reformer and former chair of Duke University's psychiatry department, Bernard Carroll offers a proposal for addressing these issues through the independent analysis of clinical trial data.
A new study by Lisa Cosgrove, "Under the Influence: The Interplay among Industry, Publishing, and Drug Regulation," suggests that weak drug regulation can lead doctors to prescribe more expensive, riskier, and less beneficial drugs. In his review of the article, Dr. Nardo, on his 1boringoldman blog, writes, that the "article doesn’t stop with demonstrating some of the methodology of the misreporting illustrated in the articles, but goes on to make suggestions about problems in the system and pathways to change. While you might not completely agree with all of them, they’re all valuable food for thought. That’s what academic publication is supposed to be about."
In December, MIA reported on a systematic Cochrane review on the research for the safety and effectiveness of Ritalin (methylphenidate) that found substantial bias in previous studies and a lack of quality evidence. Major medical associations, however, recommend this drug as a treatment for children and teens diagnosed with ‘ADHD.’ In a major step, the Journal of the American Medical Association (JAMA) has issued a “Clinical Evidence Synopsis” that reiterates the Cochrane findings and calls for guidelines to be reevaluated.
A new study, published in BMJ Open-Access this week, found a significant link between the level of air pollution in a community and the mental health of the children living there. After controlling for socio-economic status and other potential variables, researchers in Sweden discovered a strong association between the concentration of air pollution in a neighborhood and the amount of ‘antipsychotic’ and psychiatric drugs prescribed to children. The link remained strong even at pollution levels well below half of what is considered acceptable by the World Health Organization (WHO).
“The true balance of risk versus benefit for people taking these kinds of antidepressants will probably only emerge when independent researchers have access to all the data from clinical trials – something manufacturers of these drugs are still resisting.”
In a large review study published this week in The Lancet, researchers assessed the effectiveness and potential harms of fourteen different antidepressants for their use in children and adolescents. The negative results, familiar to MIA readers, are now making major headlines.
Our headline on an Around the Web item posted on June 8 stating that the former head of the FDA, Margaret Hamburg, had been "charged" with conspiracy and racketeering was in error. The wording "charged" implies a criminal case, which indicates that prosecutors believe there is evidence to support such allegations. A civil lawsuit in federal court was filed against Hamburg alleging such behavior; such civil actions can be filed regardless of their possible merits. MIA regrets the error.
For STAT, Meghana Kashavan reports on a new, candy-flavored, chewable, fruity, amphetamine drug on the market for children diagnosed with ADHD. “It’s a move that sanctions ‘an orally disintegrating amphetamine for kids by the morally disintegrating FDA,’ said Dr. Alexander Papp, an adult psychiatrist affiliated with University of California, San Diego. ‘What’s next?’ Papp scoffed. ‘Gummy bears?’”
While there has been a recent push to account for financial conflicts of interest in medical research, less attention has been paid to organizations that produce clinical practice guidelines (CPGs) that offer official treatment recommendations to doctors and providers. A new analysis published this week in the journal PLOS Medicine reveals that such organizations are often rife with financial conflicts of interest with biomedical companies and that these conflicts are often undisclosed. According to the study, only one-percent of the guidelines disclosed the organization’s financial relationships with companies and only half of all guidelines disclosed the financial conflicts held by individual members of the organizations.
In 2011 the American Academy of Pediatrics (AAP) issued guidelines recommending therapy over stimulant drugs as the primary treatment for children diagnosed with ‘ADHD.’ New research from the CDC reveals, however, that children between ages 2 and five are still prescribed medications before receiving the recommended therapy or psychological services. Overall, the researchers found that 75% were being prescribed “ADHD’ drugs while no more than 55% received psychological treatments. Incredibly, among those on private insurances, the percentage of children receiving psychological services for ‘ADHD’ showed no increase following the 2011 recommendations.
In a review editorial for the journal Psychotherapy and Psychosomatics, neurobiology researcher Steven Dubovsky from the University at Buffalo argues against the adoption of genetic tests in psychiatry. He calls on colleagues to resist the pressures to “appear scientific”and support industry marketing by critically examining any new genetic findings.
The Milwaukee Journal Sentinel has issued a watchdog report titled “Illness Inflation” that examines how new medical conditions are often the product of industry groups aiming to create a market for expensive new drugs. "There are powerful interests that want the numbers to be inflated," said Allan Horwitz, a professor of sociology at Rutgers University and author of "Creating Mental Illness." "All of these estimates push the numbers upward."
For CounterPunch, Martha Rosenberg and Ronnie Cummins comment on the announcement that Bayer has placed a bid to buy Monsanto. “Bayer and Monsanto both sell controversial toxic agricultural chemicals and GMO seeds,” they write. “But if Bayer’s bid to take over Monsanto goes through, it would mark Monsanto’s first entry into Big Pharma.”
Ed Silverman reports for STAT’s Pharmalot that high-ranking congressmen are accusing the Department of Health and Human Services of deliberately delaying new guidelines on the marketing of drugs off-label, or for unproven uses. In the absence of new guidelines, some worry that court rulings will end up determining policy. Meanwhile, the FDA has expressed concern that marketing claims not backed up by sufficient evidence can lead to public health problems and raise health care costs.
A study published in the journal Pediatrics reveals large differences from one pediatrician to the next when it comes to diagnosing and prescribing drugs for ‘ADHD.’ The researchers found that the percentage of children being diagnosed with ‘ADHD’ varied from as high as 16% of patients at some offices to as little as 1% of patients at others. The data also revealed significant but lower variability in the pediatric diagnosis of anxiety and depression.
According to a recent study published in the journal Psychiatric Services, black patients are almost twice as likely as their white counterparts to be diagnosed with schizophrenia, while white patients are significantly more likely to receive a diagnosis of anxiety or depression. The researchers also found that the likelihood of receiving psychotherapy for any diagnosis (34%), regardless of race or ethnicity, was much lower than the probability of receiving a psychotropic medication (73%).
In a new article for Scientific American, Diana Kwon reports on how the true risks for suicide and aggression in children and teens taking antidepressants have been suppressed by drug companies. “Taken together with other research—including studies that suggest antidepressants are only marginally better than placebos—some experts say it is time to reevaluate the widespread use of these drugs.”
According to new research, the United States spends over 200 billion annually on treatment and hospitalization for mental health issues, exceeding spending on heart conditions and cancer. Previous estimates of total healthcare spending by condition failed to account for costs associated with institutionalization but when this was factored into the latest research, the category of “mental disorders” moved to the top of the list by a substantial margin. More than 40% of spending on mental health issues are associated with institutionalization, the researchers found.
In his “Mind the Brain” blog for PLOS, well-known researcher James Coyne reviews the controversy surrounding the latest case of a fraudulently reported study on the antidepressant citalopram. “Access to the internal documents of Forest Laboratories revealed a deliberate, concerted effort to produce results consistent with the agenda of vested interests,” he writes, “even where prespecified analyses yielded contradictory findings.”
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