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
Heart Failure: The Missing 800 Pound Gorilla In Diabetes Trials
Is heart failure the missing 800 pound gorilla in diabetes trials? That’s the argument proposed by a group of prominent cardiovascular and diabetes researchers. It was long believed that by virtue of their glucose-lowering properties diabetes drugs would confer substantial cardiovascular benefits. Now, however, that belief is no longer widely held and the FDA now requires cardiovascular outcome trials for new diabetes drugs. But, write the researchers in an article published in The Lancet Diabetes & Endocrinology, these trials are failing to track and analyze one key cardiovascular endpoint, thereby dimini...
Source: CardioBrief - March 13, 2014 Category: Cardiology Authors: Larry Husten Tags: Policy & Ethics Prevention, Epidemiology & Outcomes Avandia diabetes glucose control heart failure rosigliitazone Source Type: blogs
Merry Christmas Big Pharma, from PharmaGossip and Sid Wolfe
Escalating criminal and civil violations: pharma has corporate integrity? Not reallySidney M Wolfe looks at the system that should, but does not, deter drug companies from breaking the lawAre criminal and civil penalties of hundreds of millions of dollars an important deterrent to law breaking by international drug companies?Further, would external monitoring in the form of US government mandated corporate integrity agreements (CIA)1 to prevent recurrences of such illegal activities, lasting five years after being signed, be an additional deterrent? Yes in both cases, but only if the size of the penalties outweig...
Source: PharmaGossip - December 24, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Don't Call My Liver Fat!
By Amy Campbell
Isn't there enough to contend with having diabetes? You need to take care of your eyes, feet, heart… Now you have to worry about your liver? Well, yes. Fatty liver disease may be something you're not all that familiar with, but if you have Type 2 diabetes, it's a good idea to know about this. Hence this week's posting!
Liver 101
Let's back up for a minute and talk about your liver. The liver is one of the largest organs in the body, weighing about three pounds. It's located in the right upper abdomen, below the diaphragm. It's pretty amazing what the liver does, if you stop and think about it. Here's ...
Source: Diabetes Self-Management - December 16, 2013 Category: Diabetes Authors: Amy Campbell Source Type: blogs
And while we're on the subject of the FDA . . .
Steven Nissen in BMJ has a rant that could strip paint, or strip the bark off of both the FDA and GlaxoSmithKline. After all these years, I'm still getting used to the apparently universal psychopathy of pharmaceutical executives. This one makes Charles Manson look like a sweetie pie.Specifically, in case you didn't know, in 1999 Glaxo got approval for rosiglitazone, a drug to treat diabetes. The approval was based on a so-called secondary endpoint, specifically that it lowers blood sugar. However, even before approval publicly known studies showed that people who took it appeared to have an increased risk of adverse cardi...
Source: Stayin' Alive - December 13, 2013 Category: Health Medicine and Bioethics Commentators Source Type: blogs
FDA official: “clinical trial system is broken” - BMJ
FDA investigator Thomas Marciniak has spoken out over drug companies and missing or “bad” data, most famously over rosiglitazone. He tells Deborah Cohenhow he believes the current research and development process is brokenThe clinical trial system is broken and it’s getting worse, according to longstanding Food and Drug Administration investigator, Thomas Marciniak.For seasoned observers of the drug approval process, Marciniak will be a familiar name and his comments will come as little surprise. In his 11 years at the US federal agency, Marciniak has been embroiled in high profile controversies that have pitted...
Source: PharmaGossip - December 9, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and how are you today? We apologize for our absence yesterday, but we were speaking on a panel at the Harvard University School of Public Health, which was hosting a conference on clinical trial data sharing and transparency. Yes, it seemed to go well, thank you. Now, though, there are the usual matters to occupy us. And so, we are quaffing a cup of needed stimulation before we leave the greater Boston environs to return to the blessed Pharmalot corporate campus for another long weekend. This explains the appearance of the weekly jobs column, which usually runs on Friday. Meanwhile, here are some tidbits. ...
Source: Pharmalot - December 5, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Top stories in health and medicine, December 5, 2013
From MedPage Today:
Medicare P4P to Affect More Docs in 2014. Next year will bring a number of changes to one of Medicare’s pay-for-performance programs, the physician value-based payment modifier (VPM) — changes that will show up in physicians’ paychecks a few years hence.
Ecstasy Use Doubles Over 6 Years. The number of emergency department visits involving the drug ecstasy more than doubled from 2005 to 2011, according to data from the Substance Abuse and Mental Health Services Administration.
Odd HDL Finding Seen in Diabetes Trial. Among patients with type 2 diabetes, treatment with both fenofibrate ...
Source: Kevin, M.D. - Medical Weblog - December 5, 2013 Category: Family Physicians Tags: News Heart Medicare OB/GYN Source Type: blogs
Pfizer Peels Back The Curtain On Clinical Trial Data
In response to the growing debate over disclosure of clinical trial data, Pfizer has announced an updated policy and web site that will publish large amounts of information and offer a procedure for independent researchers to obtain study data for analysis. And the drugmaker boasts that its effort exceeds the voluntary aims recently articulated by industry trade groups in the US and Europe.
“Pfizer’s expanded policy, which you can read here, is part of a larger and evolving effort by those who create and use clinical data to arrive at a transparent, harmonized process to expand access in ways that protect patient priva...
Source: Pharmalot - December 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
The Avandia hype: cooler heads prevail
(Source: Notes from Dr. RW)
Source: Notes from Dr. RW - November 29, 2013 Category: Internists and Doctors of Medicine Tags: cardiovascular endocrinology pharmacology politics and policy Source Type: blogs
Top stories in health and medicine, November 27, 2013
From MedPage Today:
Supreme Court to Consider Birth Control Mandate. The Supreme Court on Tuesday said it will hear a challenge to the Affordable Care Act’s (ACA) mandate that employer health plans provide birth control at no cost to employees — even if an employer objects to contraceptives.
FDA Clamps Down on Gene-Testing Company. The gene-testing firm 23andMe has not received approval for its product and must stop marketing its test for the time being.
Avandia Decision a Moot Point for Prescribers? It’s unlikely that the FDA’s decision to loosen some of the restrictions on the controversial type...
Source: Kevin, M.D. - Medical Weblog - November 27, 2013 Category: Family Physicians Tags: News Genetics Infectious disease OB/GYN Source Type: blogs
The FDA, The Avandia Diabetes Pill And Meta-Analyses
Following years of high-stakes drama, the FDA has loosened restrictions on the Avandia diabetes pill, which has been under the equivalent of regulatory lock and key after a protracted and heated debate over the extent to which the GlaxoSmithKline drug may cause cardiovascular risks.
The action caps a long-running episode that shined a harsh spotlight on agency decision-making and the practices of the pharmaceutical industry. The Avandia debate not only laid bare the political and scientific rifts that sometimes take place among FDA officials, but also became a prime example of how drugmakers do not always disclose unflatte...
Source: Pharmalot - November 26, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Top stories in health and medicine, November 26, 2013
From MedPage Today:
Alzheimer’s Gene Effects Show Up in Infancy. Infants and toddlers with the Alzheimer’s disease-associated APOE4 genotype already showed distinctive patterns of brain structure relative to other young children.
ADHD Prevalence Still Rising, CDC Says. Rates of parent-reported diagnoses of attention deficit-hyperactivity disorder (ADHD) continued their upward trend through 2011.
FDA Opens Door to Wider Avandia Prescribing. The FDA has loosened restrictions on the diabetes drug rosiglitazone (Avandia) — under fire since 2007 because of potential cardiovascular risks — and will allo...
Source: Kevin, M.D. - Medical Weblog - November 26, 2013 Category: Family Physicians Tags: News Diabetes Endocrinology Heart Neurology Psychiatry Source Type: blogs
FDA Removes Restrictions On Avandia
In a remarkable climax to a long-running drama, the FDA today lifted major restrictions on rosiglitazone (Avandia, GlaxoSmithKline). The drug has been the subject of intense criticism and controversy since the 2007 publication of the famous Nissen meta-analsysis that first raised the possibility that the blockbuster diabetes drug might increase the risk of heart attack and cardiovascular death. The FDA said its actions were “consistent with the recommendations of expert advisory committees.” In June of this year an FDA panel reviewed re-adjudicated data from the RECORD (Rosiglitazone Evaluated for Cardi...
Source: CardioBrief - November 25, 2013 Category: Cardiology Authors: Larry Husten Tags: MI/ACS People, Places & Events Policy & Ethics Cardiovascular disease Diabetes mellitus FDA food and drug administration GlaxoSmithKline myocardial infarction Rosiglitazone Steven Nissen Source Type: blogs
