Jürgen Margraf and Silvia Schneider, both well-known psychologists at the University of Bochum in Germany, claim that psychotropic drugs are no solution to mental health issues in an editorial for the latest issue of the journal EMBO Molecular Medicine. They argue that the effects of psychiatric drugs for depression, anxiety, and ‘ADHD’ are short-lived and may have negative long-term consequences.
A new paper, published in the British Medical Journal, explains how the pharmaceutical industry has publicly denounced ghostwriting while still finding ways to engage in the practice. The author, Alastair Matheson, who worked as a consultant in pharmaceutical marketing and medical communications for 18 years, argues that the focus on ghostwriting has obscured the many other practices used to turn medical publications into marketing tools for industry, and describes medicine’s complicity in this process.
A new analysis published in the The Journal of Clinical Psychiatry investigates the public health effects of direct-to-consumer advertisements for psychiatric drugs. The researchers from Brown University systematically examined existing studies on the consequences of these ads on prescription rates and quality of treatments. They found that, although there have been limited studies addressing this issue, doctors appear more likely to prescribe when ads are referenced by patients and that this contributes to the over-prescription of psychiatric drugs.
This week an FDA advisory panel decided to remove warnings of serious psychiatric side effects from the Chantix product label. “In making its recommendation, a US Food and Drug Administration advisory panel reviewed the results of a study that was released earlier this year and found that Chantix does not appear to increase the risk of suicidal behavior,” Ed Silverman reports for STAT. “An FDA medical review team had cast doubt on the study due to problems with collecting and analyzing side effect data as well as ties some investigators had to Pfizer.”
Pfizer is petitioning the FDA to remove the black box warning for Chantix which focuses on neuropsychiatric side-effects like suicidality and depression. The regulators have pushed back, however, arguing that Pfizer’s studies are potentially biased and did not adequately capture adverse events.
Well known Stanford University researcher John Ioannidis published a new paper this week criticizing the use and production of systematic reviews and meta-analyses, often considered the highest forms of research evidence. In the paper, "The Mass Production of Redundant, Misleading, and Conflicted Systematic Reviews and Meta-analyses," Ioannidis describes meta-analyses as being taken over by industry sponsors and concludes that an estimated 3% of all of these reviews may be useful.
The New York Times’ Anahad O’Connor investigates how the sugar industry paid scientists as far back as the 1960s to downplay the link between sugar and heart disease. “Even though the influence-peddling revealed in the documents dates back nearly 50 years, more recent reports show that the food industry has continued to influence nutrition science,” they report.
A change.org petition out of the United Kingdom is addressing the extreme difficulty faced by people who attempt to taper off of antidepressants and anti-anxiety drugs. The petition calls on the Secretary of State for Health, Jeremy Hunt, to require pharmaceutical companies to produce “drug tapering kits” designed to help patients reduce their medications over time. “As it is now, many people who want to stop have no option but to reduce to the lowest possible dosage then ‘jump off’ which can be extremely challenging,” the petition reads. “Some users simply carry on taking a drug beyond the point at which it was effective and useful to avoid the challenge of stopping.”
Last week, well-known Stanford scientist John Ioannidis and his colleague Denes Szucs released a new analysis online. They examined research published in eighteen prominent psychology and cognitive neuroscience journals over the past five years and found that the studies in these fields are generally of “unacceptably low” power and suffer from inflated effect sizes and selective reporting.
STAT’s watchdogs, Ivan Oransky and Adam Marcus, explain why unpublished studies for drug makers and researchers “put young patients at risk, particularly if those data reveal dangerous side effects or other adverse events from taking medications.”
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.”
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