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Does Off-Label Promotion Settlement Signal Change in FDA Policy?

Science & Medicine
PharmExec.com | Mar 3, 2016
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“The pharmaceutical industry has a responsibility to reduce its role in corruption.”

Transparency International (TI), an anti-corruption organization currently best known for its Corruption Perceptions Index, now has pharma in its sights. Pharm Exec spoke to Sophie Peresson, Director of TI’s Pharmaceuticals & Healthcare Program, about how the organization will go about understanding and combating corruption in the sector.


"Seventeen per cent of people worldwide stated they had paid a bribe when dealing with the medical sector in a global survey of 114,000 citizens in 2013, and 45 per cent believed medical and health services to be corrupt or extremely corrupt. "


Science & Medicine
STAT | Mar 2, 2016

Undisclosed Conflicts for Docs Touting Drugs on Social Media?

A STAT investigation found that doctors promote treatments on their social media accounts without disclosing they received payments from the companies developing the products.


Physicians across the United States routinely offer medical advice on social media — but often fail to mention that they have accepted tens and sometimes hundreds of thousands of dollars from the companies that make the prescription drugs they tout.


A STAT examination of hundreds of social media accounts shows that health care professionals virtually never note their conflicts of interest, some of them significant, when promoting drugs or medical devices on sites such as Facebook, Instagram, and Twitter. The practice cuts across all specialties.

Science & Medicine
The New York Times | Mar 2, 2016

NYT: ‘Document Claims Drug Makers Deceived a Top Medical Journal’

THE NEW YORK TIMES - It is a startling accusation, buried in a footnote in a legal briefing filed recently in federal court: Did two major pharmaceutical companies, in an effort to protect their blockbuster drug, mislead editors at one of the world’s most prestigious medical journals?

Science & Medicine
The New York Times | Mar 1, 2016

FDA Questions Validity of Xarelto Trial Overseen by Its Incoming Director

The Food and Drug Administration is investigating whether a faulty blood-testing device may have compromised the results of a clinical trial that led to the approval of Xarelto, a blockbuster anticlotting drug that has been prescribed to millions of Americans since it arrived on the market in 2011.


The agency has asked the drug’s manufacturer, Johnson & Johnson, detailed questions about whether there was evidence that the device was malfunctioning while the trial was underway, according to a legal brief filed in federal court on Monday by lawyers for patients and their families who say they were injured by the drug. The lawyers also cited internal company documents that they said showed doctors were complaining to the trial leadership during the course of the study.

Science & Medicine
ABA Journal | Feb 28, 2016
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Can Neuroscience Bolster Chronic Pain Claims in PI Cases?

Chronic pain is a national public health problem and an expensive one. It’s typically characterized as pain that’s persistent and lingering, as opposed to acute pain, which is sudden and sharp. Chronic pain often continues after injuries have healed, lasting for months or years, and can be debilitating. According to a 2011 report from the Institute of Medicine, about 100 million Americans suffer from chronic pain, costing society as much as $635 billion annually for everything from health care expenses to lost productivity at work. Pain is frequently cited as a factor in assessing damages in personal injury litigation and workers’ compensation cases, and can significantly boost the size of awards, depending on its severity.


That’s where things get tricky. Because there are no standardized or widely accepted diagnostic tools that can accurately or objectively measure pain, lawyers can easily challenge it. Patients are usually asked to rate their pain on a scale of 1 to 10 and sometimes are shown a poster of cartoon faces whose expressions indicate the severity of pain. The problem is that one person’s 5 might be another’s 10.


Some people do indeed exaggerate pain, which leads defense lawyers to be initially suspicious of claims for damages. It’s also the reason many physicians are cautious about how they treat pain, concerned that they might be complicit in creating or feeding addictions to painkillers for those who may not really need them.

Because of the magnitude of chronic pain’s impact, researchers have been seeking ways to better identify, understand and treat it. Neuroscientists in particular have been working to identify patterns of brain activity associated with pain that might help lead to better targeted treatments.

But personal injury lawyers see another potential value to neuroscience—as a way to document their clients’ pain if and when it might be contested. The problem, many scientists say, is that the research, while showing much promise, is still in its nascent stage.

Science & Medicine
AlterNet | Feb 26, 2016
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Opinion: The FDA Now Officially Belongs to Big Pharma

Robert Califf's ties to Big Pharma run deep and the Obama nominee just sailed through the U.S. Senate.


Califf, chancellor of clinical and translational research at Duke University until recently, received money from 23 drug companies including the giants like Johnson & Johnson, Lilly, Merck, Schering Plough and GSK according to a disclosure statement on the website of Duke Clinical Research Institute.


Not merely receiving research funds, Califf also served as a high level Pharma officer, say press reports. Medscape, the medical website, discloses that Califf “served as a director, officer, partner, employee, advisor, consultant or trustee for Genentech.” Portola Pharmaceuticals says Califf served on its board of directors until leaving for the FDA.

Science & Medicine
Fierce Pharma | Feb 26, 2016
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Health Policy Group Makes Suggestions for FDA Off-Label Marketing Rules

After a series of court decisions put its regulatory approach in question, the FDA promised new guidance on off-label drug promotions. That was more than a year ago. Now, a group of health policy wonks and legal experts has come out with some suggestions of their own.


The recommendations from the Duke-Margolis Center for Health Policy include one big change that might simplify the free-speech debate over off-label marketing. The agency could revamp its approach to official labeling to include clinical data on off-label uses, graded for evidence quality, and even post-marketing data generated through the agency's own Sentinel surveillance system.


Science & Medicine
Independent | Feb 25, 2016

Claim: Biased Information from Drug Companies Killing ‘Hundreds of Thousands’ Worldwide

INDEPENDENT - Pharmaceutical companies are causing biased information to be given to doctors about the efficacy of drugs, causing an epidemic of misinformed practitioners that is “costing hundreds of thousands of lives” across the world, it has been claimed.

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