GSK Settles for $105 Million Under State Consumer Protection Laws; Agrees to Unprecedented Compliance Provisions Through 2019
GlaxoSmithKline reached a $105 million settlement with 44 states and D.C. to resolve allegations that the company unlawfully marketed three products—asthma drug Advair, and antidepressant drugs Paxil and Wellbutrin. This settlement is newsworthy for a number of reasons. First, GSK's $3 billion settlement from 2012 involved the same allegations and conduct, brought under the False Claims Act. This $105 million settlement was brought under states' various consumer protection laws, and offers another "bite at the apple" in the sense that GSK has to pay twice for their alleged marketing practices. Second, a number of the set...
Source: Policy and Medicine - June 16, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Don't mess with Cali Attorney General Kamala D. Harris
SAN FRANCISCO – Attorney General Kamala D. Harris today announced a $105 million multistate settlement with GlaxoSmithKline, LLC (GSK) to resolve allegations that the company unlawfully promoted its asthma drug, Advair, and antidepressant drugs, Paxil and Wellbutrin. California’s portion of the settlement is the largest of any state, at $7,087,897.For the first time in a settlement with a large pharmaceutical manufacturer, GSK is prohibited from providing incentive payments to its salespeople, which serve to encourage off-label promotion of drugs, and from using paid doctors to promote its products.“Patient care is u...
Source: PharmaGossip - June 10, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Tut tut GSK
GlaxoSmithKline (GSK) has confirmed it is going to pay a massive fine after admitting it mis-promoted a range of drugs in the US.The pharmaceutical company stated that it will pay $105 million (£63 million) settlement with 44 US states and the District of Columbia following the way the firm promoted anti-depressants Paxil and Wellbutrin and asthma medication Advair.However, GSK did not admit any wrongdoing regarding the promotion of the medication and insisted that the money it is paying out is in relation to previous issues."We don't feel like this is who we are today," GSK spokeswoman Mary Anne Rhyne told the BBC. "Thes...
Source: PharmaGossip - June 5, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Deadly Medicines and Organised Crime: a review
This is a web version of a review of Peter Gotzsche’s book. It appeared in the April 2014 Healthwatch Newsletter. Read the whole newsletter. It has lots of good stuff. Their newsletters are here. Healthwatch has been exposing quackery since 1989. Their very first newsletter is still relevant.
Most new drugs and vaccines are developed by the pharmaceutical industry. The industry has produced huge benefits for mankind. But since the Thatcherite era it has come to be dominated by marketing people who appear to lack any conscience. That’s what gave rise to the Alltrials movement. It was founded in January 2...
Source: DC's goodscience - April 16, 2014 Category: Science Authors: David Colquhoun Tags: Academia badscience Big Pharma blogosphere Martin Keller Peter Gotzsche Pharmaceutical Industry Richard Eastell Source Type: blogs
Doctor Glaxo is here to teach you
GlaxoSmithKline Plc (GSK) plans to hire doctors to educate their peers about its drugs instead of paying external speakers, a further change to its marketing practices following a record fraud settlement in the U.S.The drugmaker is also investing in improving its multichannel marketing strategy through media such as online streaming of educational content, Deirdre Connelly, head of Glaxo’s U.S. pharmaceuticals business, said in an interview in Philadelphia. The changes come at a time when London-based Glaxo is introducing products recently approved to treat skin cancer, HIV and respiratory diseases.Glaxo has been re...
Source: PharmaGossip - March 17, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
When Waking Up Becomes the Nightmare: Hypnopompic Hallucinatory Pain
In conclusion, to our knowledge this is the first report of a NREM parasomnia associated with painful paroxysms, for which we postulate the following underlying pathophysiological mechanism: an internal or external stimulus triggers arousal, facilitating the activation of innate motor pattern generators in the brainstem and activating somatosensory cortical areas to produce hypnopompic hallucinatory pain.So instead of the more typical visual hallucinations, the patient experiences pain hallucinations that originate.... where?? It seems to me that the sleep EEG could be analyzed more thoroughly, beyond merely ruling out sei...
Source: The Neurocritic - December 21, 2013 Category: Psychiatrists and Psychologists Authors: The Neurocritic Source Type: blogs
When Physicians Drown in Noise
The infrequent side effects of Paxil(Click to enlarge)
I was just trying to look up the side effects of Paxil and was greeted to this incredible and quite ridiculous array of potential side effects.
I had to ask myself: how helpful is such a list? Why do we have this noise available to us?
The answer, of course, is obvious to anyone who understands our legal system in America.
But we (Source: Dr. Wes)
Source: Dr. Wes - December 18, 2013 Category: Cardiology Authors: Westby G. Fisher, MD Tags: liability Paxil pharmaceutical industry safety Source Type: blogs
PMDD is Not Just Normal Moodiness
Sitcoms, as well as movies, poke fun at PMS (Premenstrual Syndrome) and female moodiness, but PMDD is not a laughing matter.
PMDD (Premenstrual Dysphoric Disorder) is a major depressive disorder gaining more attention since its official inclusion in the latest version of the Diagnostic and Statistic Manual of Mental Disorders (it had previously been listed as a disorder needing further research).
PMDD is a mental illness that involves mood changes occurring exclusively during the two weeks prior to menses.
Over 80 percent of women experience some level of physical and emotional problems during this time, but only 3 to ...
Source: World of Psychology - November 24, 2013 Category: Psychiatrists and Psychologists Authors: YourTango Experts Tags: Depression Disorders General Women's Issues YourTango Bipolar Disorder bloating Caffeine Cognitive Behavioral Therapy Major Depressive Disorder moodiness Paroxetine Pmdd Premenstrual Dysphoric Disorder Premenstrual syndrome S Source Type: blogs
Glaxo 'Falls Short Of Open Data Disclosure:' Jureidini Explains
Over the past few months, a group of researchers has been haggling with GlaxoSmithKline over access to detailed data for an infamous 2001 study of its Paxil antidepressant called 329 that tested the pill for treating depression in adolescents. The researchers, who are led by Jon Jureidini, a clinical professor of psychiatry at the University of Adelaide in Australia, want a 1998 clinical study report that they hope to reanalyze and republish. The original results reported that Paxil was effective, but the trial actually missed its endpoints and figured in a ghostwriting controversy (here is the study). As a result, Glaxo s...
Source: Pharmalot - November 18, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
BMJ - Hidden Data Putting GlaxoSmithKline to the test over paroxetine
Cite this as: BMJ 2013;347:f6754Child and adolescent psychiatryChild and adolescent psychiatry (paedatrics)More topics ArticleRelated contentRead responses (1)Article metricsPeter Doshi, associate editorAuthor Affiliationspdoshi@bmj.comBlockbuster antidepressant paroxetine is no stranger to headlines. The drug is now back centre stage as requests for clinical data from one of its trials are testing manufacturer GlaxoSmithKline’s commitment to full transparency, Peter Doshi reportsWhen the Journal of the American Academy of Child and Adolescent Psychiatry(JAACAP) published study 329 in 2001,1...
Source: PharmaGossip - November 15, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Is Glaxo Keeping Its Commitment To Releasing Paxil Trial Data?
For the past year, GlaxoSmithKline has vowed to usher in a new era of transparency by creating a system to disclose detailed clinical trial data, a widely publicized move that has been hailed by many critics of the pharmaceutical industry who have accused drugmakers of deliberately concealing vital information that should be accessible to others in order to confirm safety and effectiveness.
Now, though, a group of researchers is putting the drugmaker to the test by requesting detailed data for an infamous study of its Paxil antidepressant, but are squabbling with the drugmaker over information being sought. In the process,...
Source: Pharmalot - October 28, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Trip Rapid Review worked example - SSRIs and the management of hot flashes
We reported 0.31 but what does that mean? I favour trying to assign various narratives based on the score, for instance:1 >> 0.5 = Intervention is highly likely to be beneficial.0.49 >> 0.25 = Intervention is likely to be beneficial.0.24 >> -0.24 = Evidence is weak or ambiguous.-0.25 >> -0.49 = Intervention is unlikely to be beneficial.-0.5 >> -1 = Intervention is highly unlikely to be beneficial.But these could be modified based on the number of trials. For instance scores based on multiple trials is likely to be more reliable than those based on a few.Trip Rapid Reviews is ...
Source: Liberating the literature - October 2, 2013 Category: Technology Consultants Source Type: blogs
Pharma Blasts EMA Draft Policy On Disclosing Clinical Trial Data
In the latest bid to thwart the European Medicines Agency from proceeding with a new policy for disclosing clinical trial data, the pharmaceutical industry has openly challenged the effort by arguing the suggested approach would weaken safeguards for protecting patient privacy, undermine trust in the regulatory system, increase the risk data would be misinterpreted and weaken incentives for research.
The European Federation of Pharmaceutical Industries and Associations “has serious concerns about the EMA draft policy, which carries negative implications for public health in its failure to adequately protect the interests...
Source: Pharmalot - September 9, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
