Archive for category The Pharmaceutical Industry

The Push for Data Transparency and Implications for Research

Bioethics Forum, the Hastings center, 24 oct 2013
Authors: Joan Rachlin, Avery Avrakotos, and Elisa Hurley
“Some of the most hotly debated questions making the rounds these days include who should interpret, distribute, review, and receive data, and with good reason. From WikiLeaks to National Security Agency whistleblowers, the problems of data privacy, data security, data accuracy, and data availability are making headlines. Over the summer, The New York Times ran a piece about Peter Doshi, a 32-year-old postdoctoral fellow at Johns Hopkins University, who has been pressing pharmaceutical companies to make their clinical trial data public.”
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Forget tea and biscuits, why should doctors get any gifts from pharma companies?

The Conversation, online 22 October 2013
Authors: Wendy Lipworth and Ian Kerridge
“The Australian Medical Association (AMA) and medical specialist groups are currently debating public disclosure of gifts received by doctors from pharmaceutical companies. The bone of contention is how valuable the freebies need to be before the doctor has to declare them.”
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Overdiagnosis: when good intentions meet vested interests—an essay by Iona Heath

BMJ 2013;347:f6361 25 October 2013

Author: Iona Heath

“Underpinned by webs of financial imperatives and conflicted interests, overdiagnosis and overtreatment have become disturbingly pervasive within contemporary medicine and are now deeply embedded within healthcare systems around the world. They have permeated and polluted the drug and medical technology industries, medical research and regulatory bodies, clinical practice, payment systems, guideline production, and national healthcare systems. They are the cause of an astonishing amount of waste and harm…”

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Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data

PLoS Medicine

Authors: Beate Wieseler, Natalia Wolfram, Natalie McGauran, Michaela F. Kerekes, Volker Vervölgyi, Petra Kohlepp, Marloes Kamphuis, Ulrich Grouven

“Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments.

Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs…”

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DRUG MONEY – Investigating the Marketing of Medicines in Australia

A series of articles published by The Global Mail investigating the marketing of medicines in Australia.

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Paul Komesaroff: Blurred lines

MJA Insight, 14 October 2013

Author: Paul Komesaroff

“THE practice of pharmaceutical companies paying physicians to deliver information about their products was questioned in a recent article published in Open Medicine.

Apparently, this occurs commonly in the US, where it often involves a contractual agreement by the doctors to adhere to company materials…

Although there are no data about the existence of a similar system in Australia it is clear that at least informal arrangements exist…”

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Execution drugs mixed by U.S. pharmacies draw challenges from death row

Reuters, By Carey Gillam, October 13, 2013

“Several U.S. states are turning to lightly regulated pharmacies for lethal injection drugs, prompting a host of court battles and at least one stay of execution because of concern tainted or impure drugs could inflict cruel and unusual punishment on inmates. The scramble for alternative supplies comes as major pharmaceutical companies, especially based in Europe, have clamped down on sales of drugs for executions in recent years in order to avoid association with the punishment.  Missouri on Friday abandoned a plan to use the anesthetic propofol to put an inmate to death after the German maker of the drug, Fresenius Kabi, discovered that some had been sold to the state for executions, and suspended shipments to a U.S. distributor in retaliation.”

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Missouri drops new execution drug after European opposition

Reuters, By Kevin Murphy, October 11, 2013

“Missouri on Friday abandoned plans to become the first U.S. state to use the anesthetic propofol in an execution after it drew strong opposition, especially in Europe, where 90 percent of the drug is manufactured.  Missouri Governor Jay Nixon, a longtime death penalty supporter, announced that propofol would not be used in an execution scheduled for later this month, and directed state officials to find another lethal drug for future use.  The action was a dramatic example of how opponents of capital punishment in Europe and the United States have exerted pressure on major pharmaceutical companies to cut off supplies of drugs for executions, forcing states to scramble for alternative supplies.”

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Maine allows importation of mail order prescription drugs

BMJ 2013;347:f6159 11 October 2013

Author: Michael McCarthy

“Residents of Maine can now order drugs from foreign pharmacies under a new state law that is the first of its kind in the United States.

The law, which went into effect on Wednesday 9 October, allows state residents to obtain prescriptions by mail order from pharmacies in Canada, the United Kingdom, New Zealand, and Australia…”

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Value based pricing: can it work?

BMJ 2013;347:f5941 11 October 2013

Author: James Raftery

“Having struggled to specify value based pricing, the government in June 2013 handed value assessment to NICE. Price negotiation remains with the Department of Health. Although the two proposed changes can be readily dealt with by amending NICE’s methodology guide,16 they raise two big concerns: one to do with the principles of the NHS, the other to do with unintended consequences…’

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