In a new article for the journal Social Science & Medicine, sociologist Owen Whooley investigates how the DSM-5 creators failed in their attempt to create a valid diagnostic system.
STAT’s Rob Waters profiles Vera Sharav, a holocaust survivor whose son was diagnosed with schizophrenia and died from a side effect of his antipsychotic medication. “Twenty years ago, there wasn’t much societal awareness of the corruption of academic medicine by pharma money,” said Robert Whitaker, a journalist and author who has written widely about mental health treatment. “Vera Sharav was one of the pioneers in creating awareness of this problem.”
For STAT, Sheila Kaplan reports how the pharmaceutical industry is lobbying presidential candidates and making major contributions, even to candidates who have criticized the industry. “Money is absolutely key for access, that’s the harsh reality,” said Wright H. Andrews Jr., a longtime lobbyist and former head of the American League of Lobbyists. “They are still going to make donations — directly, indirectly — or they will hire people who have.”
Today’s New York Times features a story of a drug salesman, Ashish Awasthi, who committed suicide when he felt he couldn’t keep up with his company’s goals. The company is accused of breaking ethical guidelines and even laws in the pursuit of new customers. Others have attempted to speak out against some of these practices, including mass screening camps run by sales personnel designed to pressure doctors into writing prescriptions.
In part six of a seven-part “Drugging Our Kids” series by The Mercury News, Karen de Sa and Tracy Seipel unveil California’s top foster care prescribers fueling the medication of vulnerable kids. “What I see in these numbers is: We don’t really treat, we use chemical restraints. We drug,” said Trochtenberg, who said doctors blithely prescribed multiple meds rather than help her recover from the deep pain and trauma of childhood abuse. “Medications are so overused — and so significantly — that it’s outrageous there’s such a lack of leadership in holding doctors accountable, and holding the system accountable.”
In 2004, the American Psychiatric Association published a paper supporting the use of the antidepressant citalopram (Celexa) in children and teens. After reanalyzing the data, however, researchers found no difference between the drug and placebo. It also became evident that the original study misrepresented the data and was ghostwritten, in large part, by industry insiders. Journal editors continue to refuse to retract the original study in the face of rampant criticism, and, as a result, the paper continues to be cited uncritically.
HealthNewsReview.org founder Gary Schwitzer talks to New York Magazine on the media coverage of medical research. “We in journalism have to look in the mirror and accept not all, but some significant degree, of responsibility for the fact that we spend a greater percentage of GDP on health care than anybody on the face of the earth, and we don’t have the outcomes to show for it,” Schwitzer says. “We see that every day, with this pill for every ill, whipping the worried well into a frenzy, raising unrealistic expectations about what health care can deliver — and in so doing, raising undue demand for unproven technologies that, once we do have the evidence, we might find cause more harm than good.”
Pharmaguy investigates the rise of adverse event reports filed each year and reports on a new article in the Journal of Law, Medicine and Ethics ("Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs"). The article comes out of The Harvard Edmond J. Safra Center for Ethics which also supported Robert Whitaker and Lisa Cosgrove’s latest book on institutional corruption in mental health, “Psychiatry Under The Influence.”
Pharmalot’s Ed Silverman reports that a number of generic drugs, sold by Novartis and Teva Pharmaceuticals, may be pulled off of the shelves after it was revealed that they were approved based on “flawed studies.” The flawed studies all came out of an Indian clinical research organization, Semler Research Center, that was found to have “significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples.”
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.
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