Big Pharma's Defeat Devices

"The worse the data on the elderly got, and the worse the potential for the FDA reaction to it got, the more J&J seemed to intensify its sales effort." So writes investigative journalist Steven Brill in his chilling, meticulously researched "docuserial" America's Most Admired Lawbreaker, concerning Johnson &Johnson's efforts to market the antipsychotic Risperdal off-label -- that is, without authorization -- to seniors with dementia and children diagnosed with pediatric bipolar disorder. The series ended its fifteen-day run on The Huffington Post last week. It follows the spring publication of Brill's compelling, widely reviewed book America's Bitter Pill: Money, Politics, Backroom Deals, and the Fight to Fix Our Broken Healthcare System (Random House, 2015). What did we learn from the series? Among other things, that in September 2000 the FDA told Johnson &Johnson it would not approve the use of Risperdal for children with "conduct disorder" (a term, officials said, that "could mean anything"). J&J also should scale back the drug's accepted treatment indicators -- from management of "psychotic disorders" to the "treatment of schizophrenia" alone. Among other concerns, the agency warned that J&J had "failed to fully explore and explain what appeared to be an excess number of deaths" among the elderly treated with Risperdal -- chiefly, a sharp increase in strokes and heart-related fatalities. The FDA...
Source: Healthy Living - The Huffington Post - Category: Consumer Health News Source Type: news

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BACKGROUND: Suicide risk is high in first episode schizophrenia. Little data are available in young individuals at Ultra-High Risk (UHR) of psychosis. PURPOSEs of the study were: (1) to assess prevalence and incidence rates of suicide attempts, sui...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news
OBJECTIVES: To examine the driving variables that predict accident probability in mild dementia due to Alzheimer's disease (AD), mild cognitive impairment (MCI) and healthy older control drivers in simulated driving. To compare the three groups in mean per...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Age: Elder Adults Source Type: news
Authors: Hou Y, Liu Y, Li M, Ning B, Wen Z, Fu W Abstract Objectives: To systematically assess the efficacy of acupuncture combined with rehabilitation on unilateral neglect after stroke. Methods: The Cochrane Library, PubMed, Excerpt Medical Database (EMBASE), China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), Chinese Biomedical Literature Database (CBM), and Wan Fang databases were searched online for randomised controlled trials (RCTs) of acupuncture and its effects on unilateral neglect after stroke from their inception to September 2019. RCTs on acupuncture...
Source: Evidence-based Complementary and Alternative Medicine - Category: Complementary Medicine Tags: Evid Based Complement Alternat Med Source Type: research
D, Kiper N, Özçelik U Abstract Primary ciliary dyskinesia (PCD) is a rare, genetic disease characterized by ciliary dysfunction. Patients may present with respiratory distress during neonatal period; chronic sinopulmonary disease, bronchiectasis, recurrent otitis media, sinusitis and infertility in later periods. About 50% of PCD patients have situs inversus totalis and 6-12% have situs ambiguous known as heterotaxy syndromes. Herein, we present a case of PCD and accompanying situs inversus who had acute abdominal pain and was diagnosed with torsion of one of the multiple spleens. Evaluation of acute a...
Source: The Turkish Journal of Pediatrics - Category: Pediatrics Authors: Tags: Turk J Pediatr Source Type: research
Publication date: Available online 8 April 2020Source: Materials Today: ProceedingsAuthor(s): S. Jagadeesh, K. Narayanamoorthy, K. Ramesh, K. Gnanasekaran, S. Prathap Singh
Source: Materials Today: Proceedings - Category: Materials Science Source Type: research
Publication date: Available online 7 April 2020Source: NeuroImageAuthor(s): Jingfei Li, Godwin Ogbole, Benjamin Aribisala, Murtala Affini, Joseph Yaria, Issa Kehinde, Alade Rahman, Fakunle Adekunle, Rasaq Banjo, Moyinoluwalogo Faniyan, Mayowa Owolabi, Steffen Sammet
Source: NeuroImage - Category: Neuroscience Source Type: research
BOSTON (CBS) — TPA is a drug that is used to help stroke and heart attack victims. It works by breaking up or busting blood clots. Doctors at Beth Israel Deaconess Medical Center are now using it in a clinical trial on gravely ill coronavirus patients. “There’s a lot of very small blood clots accumulating in the lungs of these patients,” said Dr. Christopher Barrett. “And that seems to be at least contributory, if not the predominant reason, that their respiratory failure is so bad.” Dr. Barrett says TPA could help patients recover faster, free up ventilators and even prevent people from...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - Category: Consumer Health News Authors: Tags: Boston News Health Syndicated CBSN Boston Syndicated Local Cheryl Fiandaca Coronavirus Health News Source Type: news
AbstractSince the outbreak of the COVID-19 epidemic which in our region, Veneto (Italy), dates back to February, we were confronted with several challenges, but with a constant aim of keeping our Stroke Unit COVID-free. For this reason, in addition to creating a dedicated hot-spot as a pre-triage just outside the Emergency Department, together with the Neuroradiology Unit we obtained a mobile CT unit that could be used by COVID-positive or COVID-suspected patients. Furthermore, thanks to the collaboration with colleagues from different specialties (Infectious Disease, Internal Medicine, Intensive Care, Emergency Medicine),...
Source: Neurological Sciences - Category: Neurology Source Type: research
Conclusion: Risk factors, aetiology, and precipitating factors of HF in de novo and ADCHF differ. De novo HF also had lower 1-year mortality and 3-month mortality compared to ADCHF. PMID: 32252602 [PubMed - as supplied by publisher]
Source: Acta Cardiologica - Category: Cardiology Tags: Acta Cardiol Source Type: research
At the stroke of midnight, the city celebrated "liberation" from its lockdown and honored frontline workers in a light show.
Source: Health News: CBSNews.com - Category: Consumer Health News Source Type: news
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