How Can We Address the Corruption Problem in Clinical Trials?

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.

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“You Could Be Paying More for Less Effective Medicine”

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."

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JAMA Review Questions Use of Ritalin for ‘ADHD’

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.

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Air Pollution Linked to Mental Health Problems in Children

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).

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“If Antidepressants Don’t Work Well, Why Are They So Popular?”

“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.”

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Major Review Finds Antidepressants Ineffective, Potentially Harmful for Children and Teens

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.

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Correction: No “Charges” Against Former FDA Commissioner Margaret Hamburg

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.
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“Tasty and Easy to Take, A New ADHD Drug Alarms Some Psychiatrists”

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?’”

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Undisclosed Financial Conflicts Endemic in Clinical Practice Guidelines

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.

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Despite Official Recommendations, Young Children Are Still Receiving Drugs Instead of Therapy for ‘ADHD’

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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Researcher Urges Caution When Applying Genetics to Psychiatry

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.

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Illness Inflation: Expanded Medical Definitions Create More Patients

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."

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“Bayer and Monsanto: A Marriage Made in Hell”

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.”

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“Lawmakers Accuse HHS of Delaying FDA Guidelines for Off-Label Marketing”

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.

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Does Your Child Have ‘ADHD’? It Might Depend On Your Doctor

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.

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Study Finds Racial Differences in Psychiatric Diagnosis and Treatment

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%).

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“The Hidden Harms of Antidepressants”

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.”

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Mental Health Treatments Top List of US Healthcare Spending

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.

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Coyne Covers Citalopram Controversy

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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“Why We Shouldn’t Trade a Weakened FDA for More Medical Research Funds”

Ed Silverman at STAT reports that Congress has linked increased research funding to “fast-track” approval procedures. “By linking the extra funds to speedier approvals, Congress appears ready to undermine regulatory standards. And this is a misguided notion that, unfortunately, is more likely to help companies than patients.”

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Interview: Researchers Deconstruct Ghostwritten Industry Trial for Antidepressant

Researchers, Jon Jureidini, Jay Amsterdam and Leemon McHenry, have taken a closer look at the data from a randomized control trial of citalopram (Celexa) that was ghostwritten and then used by the manufacturers to support claims of the drug’s efficacy and safety in the treatment of child and adolescent depression. Their analysis used 750 recently-released court documents from a lawsuit against Forest Labs concerning the marketing and sales practices involved in the off-label promotion of Celexa. Drs. Jon Jureidini and Jay Amsterdam were expert witnesses in the case. The article is published, open-access, in the International Journal of Risk & Safety in Medicine. 

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Report from the Parliament: Can Psychiatry At Least Be Curious?

In the past six years, I have had the opportunity to speak at several conferences or meetings that I felt had particular potential to stir some political activity that would challenge current psychiatric practices, and one of those events was the meeting convened in the U.K.’s Parliament on May 11th, which had this title for the day: Rising Prescriptions, Rising Mental Health Disability: Is There a Link?
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Antidepressants Do Not Prevent Suicides, May Increase Risk

When the CDC released data revealing an increasing suicide rate in the US, some experts, speaking to major media outlets, speculated that the increase could be tied to the FDA’s Black Box warning for teen suicides on antidepressants. It was suggested that the warnings may discourage some from taking antidepressants and that these drugs may prevent suicides. The research, however, does not appear to support these claims. A new review of studies on the role of antidepressants in suicide, published this month in the journal of Psychotherapy and Psychosomatics, concludes that there is no evidence that antidepressants prevent suicide and that the research may even suggest that the drugs  increase the risk.

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“Public Wary of Faster Approvals of New Drugs, STAT-Harvard Poll Finds”

According to a new STAT-Harvard poll, the majority of Americans oppose new legislation that would speed up the approval of new drugs and medical treatments.

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“Another Study Finds Link Between Pharma Money and Brand-name Prescribing”

New findings from Harvard Medical School reveal that Pharma industry payments to physicians in Massachusetts are associated with higher rates of prescribing brand-name drugs that treat high cholesterol. “You want your doctors to be objective rather than doing something because there is a financial gain, be it subconscious or conscious,” the lead author told ProPublica. “That’s not the way we should be doing medicine.”

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