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

Science & Medicine
Legal Newsline | Mar 19, 2016
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Outcry as FDA Inserts Significant Labeling Rule Change in Proposed Tobacco Reg

Concern still swirls around the rule change proposed by the U.S. Food and Drug Administration that would remove an existing regulation on determining intended use for drugs and devices.


The manner of its announcement caused as much outcry as the regulation itself. The FDA inserted the 245-word proposed regulation into a 10,000 word document on tobacco product regulations. This proposal would apply not just to tobacco products, but to drugs and devices in general.


“I think that it is a very poor practice for the agency to include a change to important, long-standing rules affecting drugs and devices in a rulemaking that people who focus on drugs and devices are unlikely to be following,” Allison Zieve, director of the Public Citizen Litigation Group, told Legal Newsline. “Regardless of whether the proposed change is major, it should be proposed in a notice that people will understand addresses drugs and devices.”

Science & Medicine
Forbes | Mar 17, 2016

Comprehensive TBI Study to be Launched in Minnesota

Researchers at Hennepin County Medical Center in Minneapolis, and the University of Minnesota, in collaboration with Abbott, are embarking on a groundbreaking and comprehensive study that aims to identify the spectrum of brain injuries that occur in patients on arrival to the ED, and followed through to completion for up to a year after they are discharged from the hospital.


Their goal is to develop a multimodal approach to brain injury for use in the future, similar to the way a patient with chest pain presents to the emergency department and has a battery of tests including an EKG, blood work and possibly even a coronary CT angiogram or an echocardiogram.


The researchers’ aim is to develop a new standard approach for evaluating patients with a TBI in the ED, which will include blood-based biomarkers and eye-tracking technology to assess how well the brain is working, along with specialized imaging and cognitive evaluations to better detect early signs of concussion and allow for earlier treatment and referral. Detecting abnormalities earlier will better allow physicians to improve outcomes after a TBI, according to the researchers.

Science & Medicine
Forbes | Mar 17, 2016

Study: Preventable Hospital Injuries Kill 20 People Per Hour

Researchers at Hennepin County Medical Center in Minneapolis, and the University of Minnesota, in collaboration with Abbott, are embarking on a groundbreaking and comprehensive study that aims to identify the spectrum of brain injuries that occur in patients on arrival to the ED, and followed through to completion for up to a year after they are discharged from the hospital.


Their goal is to develop a multimodal approach to brain injury for use in the future, similar to the way a patient with chest pain presents to the emergency department and has a battery of tests including an EKG, blood work and possibly even a coronary CT angiogram or an echocardiogram.


The researchers’ aim is to develop a new standard approach for evaluating patients with a TBI in the ED, which will include blood-based biomarkers and eye-tracking technology to assess how well the brain is working, along with specialized imaging and cognitive evaluations to better detect early signs of concussion and allow for earlier treatment and referral. Detecting abnormalities earlier will better allow physicians to improve outcomes after a TBI, according to the researchers.

Science & Medicine
Health News Review | Mar 15, 2016
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Xarelto, Clinical Trials and Healthcare Journal Transparency

Many media outlets, including the New York Times, reported on concerns about the validity of a huge, and hugely important, clinical trial published in the New England Journal of Medicine (NEJM) involving a drug taken by millions to decrease their risk of stroke.


What’s at issue? Whether the object of the trial–the now best-selling blood thinner Xarelto (rivaroxaban)–really does have the advantage of being safer than the traditionally used blood-thinner Coumadin (warfarin). That’s now open to question, as the BMJ reported, because of a malfunctioning blood test device used in the trial. Those in the Coumadin group may have received higher doses of Coumadin than would have been optimal, leading to an increased risk of serious bleeding. Problems with the device were reported as far back as 2002, and it was recalled by the FDA in 2014.

Science & Medicine
Forbes | Mar 15, 2016
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Pharma Trying to Figure Out How to Use Social Media

According to Dr. Kevin Campbell MD, FACC, social media is an ideal channel for pharmaceutical and device firms to educate, market, listen and connect with customers, patients and physicians.


Dr. Campbell: Pharmaceutical and device firms can use social media to educate, market, listen to and connect with customers, patients, and physicians, all while complying with industry regulations.


Science & Medicine
STAT | Mar 14, 2016
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Pharma Ad Spending Tops $5 Billion in 2015; More Than 5x Amount Spent by Lawyers

Under fire for spending so much on advertising, drug makers are doubling down.


Even as politicians and physicians press for strict limits on prescription drug ads, the pharmaceutical industry is pouring billions into new TV and print campaigns. Ad spending soared more than 60 percent in the last four years, hitting $5.2 billion last year.


And there’s no sign it’s slowing. On the contrary: Nine prescription drugs are on pace to break $100 million worth of TV ad time this year.

Science & Medicine
STAT | Mar 4, 2016

Opana Maker Fined for Downplaying Opioid Addiction Risks

Endo Pharmaceuticals has agreed to pay a $200,000 fine and revamp marketing of its Opana ER tablet as part of a settlement announced today with the New York attorney general who accused the drug maker of improperly downplaying the risk of addiction associated with its opioid medicine.


Specifically, Endo must “cease all misrepresentations” about the drug, accurately describe the risk of developing an addiction, summarize clinical studies on its web site, and create a compliance program that will prevent its sales reps from promoting Opana ER to doctors who may be involved in illegal diversion.


New York Attorney General Eric Schneiderman said his office found that Endo “improperly” marketed Opana ER as crush-resistant although the company’s own studies showed the pill could be crushed and ground, making it easier to abuse. And he said that Endo sales reps were instructed to “diminish and distort risks,” including the possibility of addiction.

Science & Medicine
Health News Review | Mar 4, 2016

Low-T Treatment: “Classic Example of the Ready, Shoot, Aim Approach to Medicine in the U.S.”

The sale of testosterone is a booming business. Some men take supplements of the hormone hoping to increase libido, energy, muscle mass, and more. But until now, there was little evidence that using testosterone would provide any of these hoped-for benefits. Enter a new study published in the New England Journal of Medicine that reports modest positive effects for men over 65 with documented low testosterone who spread a testosterone gel on their abdomens. The study was the first of its kind to establish that using a testosterone gel could deliver an effect more powerful than a placebo.


But the improvements experienced by these older men were hardly anything to write home about. The primary outcome was assessed via a questionnaire that measured participants’ sexual activity on a scale of 0 to 12. After a short-term boost of about a half a point, the difference between the testosterone group and placebo dipped to 0.3 points after a year — barely noticeable. And it’s likely that some of the 230 men receiving testosterone therapy were no better off than if they’d been using skin cream.


One of the things the Times coverage does well is emphasize the lack of long-term data about potential heart and cancer risks associated with testosterone therapy. Concerned about the huge and expanding market for testosterone treatments, Dr. Doug Campos-Outcault — one of our regular story and news release reviewers — hopes this message is one that will resonate with Times readers.


“This is a very classic example of the ready, shoot, aim approach to medicine we take in the USA,” Campos-Outcalt said, “implementing widespread use of a therapy that has not been adequately tested for benefits and harms.”

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