Reimbursement of cell-based regenerative therapy in the UK and France

Med Law Rev (2016) doi: 10.1093/medlaw/fww009
Author: Aurélie Mahalatchimy
“Cell-based regenerative therapies are presented as being able to cure the diseases of the twenty-first century, especially those coming from the degeneration of the aging human body. But their specific nature based on biological materials raises particular challenging issues on how regulation should frame biomedical innovation for society’s benefit regarding public health. The European Union (EU) supports the development of cell-based regenerative therapies that are medicinal products with a specific regulation providing their wide access to the European market for European patients.”
Find abstract here.

The 100,000 Genomes Project

BMJ 2016;353:i1757
Author: Mark Peplow
Part research project, part commercial stimulus, this enormous sequencing programme could usher genomic medicine into mainstream use, Mark Peplow reports
“Nobody could deny that Mark Caulfield, chief scientist of Genomics England, has a bold vision. “This will bring genomic medicine across the healthcare system,” he enthuses. “It is, in essence, an NHS transformation programme.” He’s talking about England’s 100?000 Genomes Project, which is now ramping up into high gear. Overseen by Genomics England, it is one of the biggest whole genome sequencing projects in the world. And it is working to a breathtaking timetable: most of these genomes will be sequenced by the end of next year.”
Find article here.

Drug makers paid fewer fines for bad behavior in recent years

STAT, 31 March 2016
Author: Ed Silverman
“After a decade in which drug makers regularly paid huge fines for various fraudulent practices, there was a noticeable drop over the past two years, according to a new analysis by Public Citizen, the consumer advocacy group. Pharmaceutical companies paid approximately $2.8 billion to settle federal and state civil and criminal charges in 2014 and 2015, compared with $9.9 billion during 2012 and 2013. The consumer group speculated that the US Department of Justice — which has regularly pursued lawbreaking by the pharmaceutical industry — may have turned its attention to pursuing different sorts of violations.”
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On the fragility of medical virtue in a neoliberal context

On the fragility of medical virtue in a neoliberal context: the case of commercial conflicts of interest in reproductive medicine
Theoretical Medicine and Bioethics, February 2016, Volume 37, Issue 1, pp 97-111
Authors: Christopher Mayes , Brette Blakely, Ian Kerridge, Paul Komesaroff, Ian Olver, Wendy Lipworth
“Social, political, and economic environments play an active role in nurturing professional virtue. Yet, these environments can also lead to the erosion of virtue. As such, professional virtue is fragile and vulnerable to environmental shifts. While physicians are often considered to be among the most virtuous of professional groups, concern has also always existed about the impact of commercial arrangements on physicians’ willingness and capacity to enact their professional virtues. This article examines the ways in which commercial arrangements have been negotiated to secure medical virtue from real or perceived threats of erosion. In particular, we focus on the concern surrounding conflicts of interest arising from commercial arrangements that have developed as a result of neoliberal economic and social policies.”
Find abstract here.

Value Pricing For Drugs: Whose Value, What Price?

Health Affairs blog, online 28 March 2016
Author: Robert Rubin
“It is hard to read a newspaper these days without coming across a story about the high and ever increasing cost of drugs. The Wall Street Journal named drug prices the top health story of 2015. Stories about drug prices fall into two general categories. The first are stories about generic and other manufacturers who are not focused on innovation (like Turing Pharmaceuticals and Valeant) but who acquire generic drugs and increase the price dramatically without adding value while also making it impossible for competitors to manufacture the drug by controlling the distribution. …The second category is drugs that provide a real therapeutic benefit but are perceived to be priced “too high.””
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Breaking Good? The Arc Of Antitrust Policy In The Health Sector

Health Affairs Blog, online 15 March 2016
Author: Barak Richman
“It appears that 2016 will follow 2015 as another year of massive consolidation in the health care sector. It therefore follows that 2016 will, also like 2015, be another year in which assorted health care industries receive significant antitrust scrutiny. Against this backdrop, it is timely and revealing to examine the current state and trajectory of antitrust law as it intersects and shapes health care policy.”
Find article here and links to related articles in series here.

U.S. appeals court ruling may clear barrier to generic OxyContin

Reuters, 1 February 2016
Author: Brendan Pierson
“A federal appeals court ruled Monday that four patents related to Purdue Pharma’s painkiller OxyContin are invalid, potentially bringing Teva Pharmaceutical Industries Ltd and others a step closer to introducing generic versions of the drug. Currently, the only generic versions of OxyContin on the market are so-called “authorized generics,” which are exact copies of the brand-name version authorized by Purdue.”
Find article here.

Ebola: $5m vaccine deal announced

BBC, 20 January 2016
Author: James Gallagher
“The Vaccine Alliance, Gavi, has signed a $5m (£3.5m) deal for an Ebola vaccine, to protect against future outbreaks of the deadly disease. The deal commits pharmaceutical company Merck to keeping 300,000 vaccines ready for emergency use or further clinical trials. It will also submit an application to license the vaccine by the end of 2017, which would the next step towards enabling Gavi to prepare a global stockpile.”
Find article here.

Australia’s offshore detention damages asylum seekers because it’s supposed to

The Guardian, 19 January 2016
Author: Ben Doherty
“Healthcare on Nauru and Manus comes a distant third to deterrence and profit, experts argue, which puts doctors asked to work there in an impossible position.”
Find article here.

Why Doctors Need To Have Answers For Patients’ Questions About Costs

NPR, 16 January 2016
Author: John Henning Schumann
“Like many doctors, what little I know about medical pricing comes from a combination of what my patients tell me and what my family and I experience personally. There was no formal training in medical school about health care spending or the cost-effectiveness of various tests and treatments. Instead, we were taught to ignore costs and focus on the best care and treatment we could provide. This was health care, American-style. No stone should go unturned in the pursuit of a diagnosis. Any and all resources should be brought to bear in treatment. Payment was almost never discussed in polite company.”
Find article here.