Desperate, Vulnerable Research Subjects, Cost-Cutting Contract Research Organizations and Threats to the Integrity of Clinical Research
Introduction - Clinical Research Done by Contract Research Organizations Dr Carl Elliott seems to be one of the few people willing to investigate how modern medical research may threaten vulnerable research subjects. His book, White Coat, Black Hat, opened with a chapter on vulnerable "guinea pigs," people willing to be clinical research subjects for money. Such people may be desperate for money, and further may be homeless, and have psychiatric problems, including psychosis or drug or alcohol problems. Dr Elliott just wrote another important article on the plight of vulnerable research subjects. As Dr El...
Source: Health Care Renewal - August 13, 2014 Category: Health Management Tags: clinical research integrity clinical trials contract research organizations deception You heard it here first Source Type: blogs
Study finds students tweet about Adderall. A lot
A recent study performed at Brigham Young University in Provo, Utah, examined the tweets of college students across the USA for mentions of the pharmaceutical drug Adderall.Twitter, to most students, is a 140-character social media platform where they can freely express the stresses of college, frustrations and opinions.Yet Twitter also has become a platform for studying the abuse of pharmaceutical drugs among those students.A recent study performed at Brigham Young University in Provo, Utah, examined the tweets of college students across the USA for mentions of the pharmaceutical drug Adderall.The drug has become inc...
Source: PharmaGossip - November 25, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Shire Tries To Sell Its ADHD Pill In Europe, But Will Anyone Pay Attention?
The pharmaceutical industry may have a hard time gaining attention in Europe for one of its best-selling categories in the US – the pills that are widely prescribed to combat attention deficit hyperactivity disorder, or ADHD. Why? Many Europeans are not convinced that ADHD really exists and do not want to use medication for what is widely viewed as childhood behavior problems, Bloomberg News writes.
“There’s been a great deal of resistance to even believing there is a disease,” Mary Baker, who heads the European Brain Council, a non-profit that represents doctors, patients and drugmakers, tells the news service. ...
Source: Pharmalot - October 2, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Who is right? US or EU?
ADHD Pill Faces High Hurdle in Europe as Stigma PersistsThe European debut of a pill to treat children with attention deficit hyperactivity disorder faces a major hurdle: convincing people the condition exists.Shire Plc (SHP), the world’s biggest seller of ADHD drugs, has been rolling out the pill, Vyvanse, in eight countries while discussing the prevalence of the illness with doctors at psychiatry conferences around Europe. More than 90 percent of the Dublin-based company’s sales of ADHD drugs come from the U.S., where the illness is diagnosed about 25 times more frequently than in the U.K.While attitudes va...
Source: PharmaGossip - October 2, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Breakthroughs in Bipolar Treatment
"We should continue to repurpose treatments and to recognise the role of serendipity" (Geddes & Miklowitz, 2013).That quote was from a recent review article in The Lancet, which did not hint at any impending pharmacological breakthroughs in the treatment of bipolar disorder. In other words, the future of bipolar treatment doesn't look much different from the present (at least in the immediate term). Bipolar disorder, an illness defined by the existence of manic or hypomanic highs, alternating with depressive lows, can be especially difficult to treat. And the mood episode known as a mixed state, where irritability, ex...
Source: The Neurocritic - August 2, 2013 Category: Psychiatrists and Psychologists Authors: The Neurocritic Source Type: blogs
AZPurpleZone: A Nexium Branded YouTube Channel. "Unusual" for Pharma? Yes. "Engaging Social Media?" No!
"AstraZeneca believes that it is important to share information with patients by engaging with them online," says Ken Graham, Commercial Business Leader, GI, AstraZeneca, in a post to AZ Health Connections Blog (here). "To that end, AstraZeneca recently launched a NEXIUM YouTube channel." It's called "AZPurpleZone."According to AZ's own "white paper" on social media (see attachment to this post), social media is the "catch-all term for internet activities that engage or encourage engagement through online discussions or interactions. While static websites are often the first 'online step' for many companies (e.g., homepage...
Source: Pharma Marketing Blog - July 17, 2013 Category: Pharma Commentators Tags: YouTube AstraZeneca social media Nexium Source Type: blogs
Kerching!
Drug companies look to profit from DSM-5June 5, 2013, 8:42 a.m. EDTBinge eating and hoarding diagnoses may lead to new salesBy Jen WiecznerThe changes to the DSM-5, the updated manual of psychiatric illnesses released earlier this month, include 15 new mental disorders. Psychiatrists and consumer advocates hope that the new range of diagnoses will help more people find treatment for their suffering. But drug companies could also see a benefit: It’s likely that the changes will expand the demand for prescription medications that could treat these conditions.The DSM-5’s changes widen the treatment potential for...
Source: PharmaGossip - June 6, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Changes in How ADHD Meds are Prescribed at University & College
If you were hoping to get some medications prescribed for attention deficit hyperactivity disorder (ADHD) while in college or at university, you might be in for a rude surprise.
Colleges and university are cutting back on their involvement with ADHD, primarily due to abuse of the psychiatric medications — stimulants like Ritalin — prescribed to treat the disorder. Students — whether they are malingering the symptoms or actually have it — are prescribed a drug to treat ADHD (sometimes from different providers in different states), then sell a few (or all the) pills on the side. Profit!
Now universit...
Source: World of Psychology - May 1, 2013 Category: Psychiatrists and Psychologists Authors: John M. Grohol, Psy.D. Tags: ADHD and ADD College Disorders General Medications Policy and Advocacy Psychiatry Students Treatment Abuse Problem Adhd Meds Adhd Treatment Alan Schwarz Attention Deficit Hyperactivity Attention Deficit Hyperactivity Disorder Source Type: blogs
Strict Conflict of interest Policies at Academic Medical Centers Lead to Prescribing Older Generic Drugs
The objective of the study was to “examine the effect of attending a medical school with an active policy on restricting gifts from representatives of pharmaceutical and device industries on subsequent prescribing behavior.”
Interestingly, the study was funded by the National Institute of Mental Health (NIMH), the National Institute on Aging, the American Federation on Aging, and NIH. Which we all know means the study is completely unbiased.
Specifically, the authors looked at the probability that a physician would prescribe a newly marketed medication over existing alternatives of three psychotropic classes:...
Source: Policy and Medicine - February 28, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
Shire to Forest on Deal List for AstraZeneca: Real M&A - Bloomberg
For AstraZeneca Plc to reverse its worst profit slide, the drugmaker needs to make its biggest purchase since at least 2007. AstraZeneca reported a 37 percent drop in 2012 earnings and forecast profit this year will decline “significantly more than revenue” after the $59 billion company suffered setbacks in developing new therapies to replace best-selling drugs that are losing patent protection. While Chief Executive Officer Pascal Soriot said he will focus on internal efforts and purchases of $3 billion to $4 billion to help boost the lowest valuations in the industry, Exane BNP Paribas said only a “transformationa...
Source: PharmaGossip - February 12, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Shire to pay $57.5 million over marketing of five drugs
David Sell, Inquirer Staff Writer
Posted: Saturday, February 2, 2013, 3:01 AM
Shire P.L.C. said Friday that it would pay $57.5 million as part of a tentative agreement with the Justice Department to settle an investigation related to marketing practices of five drugs.
A spokeswoman for the U.S. Attorney's Office in Philadelphia, which handled the investigation, declined comment.
Shire has its headquarters in Ireland, but its main office is in Wayne, Delaware County. Shire said the drugs involved are Adderall XR, Vyvanse, Daytrana, Lialda, and Pentasa.
Some companies will announce such tentative agreements because the...
Source: PharmaGossip - February 2, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
FDA Center for Drug and Evaluation Research Exclusivity Board, Data Partnership and Neoadjuvant Therapies
According to a recent post from the FDA Law Blog, the Food and Drug Administration (FDA) recently announced that the Agency has established within the Center for Drug Evaluation and Research (“CDER”) an Exclusivity Board “to provide oversight and recommendations regarding exclusivity determinations made by the Center, with a primary focus on clarity and consistency of decisions.” “The CDER Exclusivity Board will oversee certain exclusivity determinations, including whether and what type of exclusivity should be granted and the appropriate scope of exclusivity grants,” according to the announcement.
The...
Source: Policy and Medicine - January 3, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
