EU to suspend hundreds of drug authorisations after doubts over clinical studies in Hyderabad

BMJ 2015;350:h574
Author: Rory Watson
“The European Commission is preparing to suspend the marketing authorisations for more than 700 generic drugs after serious doubts emerged over the validity of the clinical studies conducted by GVK Biosciences in Hyderabad, India. The decision, which is expected within the next three to four weeks, will be legally binding.. throughout the 28 member European Union.”
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Drug Makers’ Data on Side Effects Is Called Lacking in a Report

NYT, 2 February 2015
Author: Katie Thomas
“The main system for keeping track of the dangerous side effects of prescription drugs is deeply flawed, primarily because drug makers are submitting incomplete information about the problems to the Food and Drug Administration, according to a new study by a nonprofit group that tracks drug safety issues.”
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Astra Zeneca drive to develop drugs from genome project

BBC, 29 January 2015
Author: Pallab Ghosh
“Astra Zeneca has announced a research programme to develop a generation of medicines to treat the genetic causes of many debilitating diseases. It will be the first concerted use of an emerging technique called Crispr to “snip out” specific disease genes in order to discover drugs.”
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Myriad Genetics Ending Patent Dispute on Breast Cancer Risk Testing

NYT, 27 January 2015
Author: Andrew Pollack
“Myriad Genetics has essentially given up trying to stop other companies from offering tests for increased risk of breast cancer, ending a dispute that was the subject of a landmark Supreme Court ruling that human genes cannot be patented.Myriad’s lucrative monopoly on testing for mutations in two genes linked to an increased risk of breast and ovarian cancer ended in 2013, when the Supreme Court ruled that human genes were not eligible for patents because they were products of nature.”
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Who Is Responsible For Antibiotic Resistance?

Forbes, 22 January 2015
Author: Judy Stone
“We commonly blame physicians for overprescribing antibiotics, patients for demanding them and, increasingly, agribusiness for squandering antibiotics as growth promoters. One less-often mentioned factor is a side effect of the manufacturing process itself, where pharmaceutical companies dump huge quantities of antibiotics into wastewater—which then goes into rivers, or is used in irrigation.”
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Rocketing vaccine cost warning

BBC, 20 January 2015
Author: James Gallagher
“The price of life-saving vaccines has skyrocketed leaving some countries struggling to fully immunise children, Medecins Sans Frontieres warns. A report by the charity says there has been a 68-fold increase in prices between 2001 and 2014.It accused the pharmaceutical industry of overcharging and highlighted cases where rich western countries were getting a better rate than poor ones.”
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Drug regulator must put patient safety ahead of Big Pharma profits

The Conversation,  16 January 2015
Author: Michael Vagg
“One of the much-heralded platforms of the Abbott government is its promise to business to reduce red tape and burdensome regulatory obligations. Pharmaceuticals are a multi-billion dollar global industry, so it’s not surprising the national drug and device regulator, the Therapeutic Goods Administration (TGA), is a key target. A committee tasked with investigating the options for red tape reform has released its first discussion paper to canvass the options. The paper raises some important implementation problems and potential reforms.”
Find article here. Find Expert Review of Medicines and Medical Devices Regulation discussion paper here.

Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs

N Engl J Med 2015; 372:279-286, January 15, 2015DOI: 10.1056/NEJMhle1409465
Authors: Jonathan J. Darrow, S.J.D., J.D., M.B.A., Ameet Sarpatwari, J.D., Ph.D., Jerry Avorn, M.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H.
“The authors review the FDA policies and procedures that permit some patients with serious conditions to receive investigational drugs before formal product approval and examine the legal and ethical issues associated with expanded access.”
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Drug regulator must put patient safety ahead of Big Pharma profits

The Conversation, 15 January 2015
Author: Michael Vagg
“One of the much-heralded platforms of the Abbott government is its promise to business to reduce red tape and burdensome regulatory obligations. Pharmaceuticals are a multi-billion dollar global industry, so it’s not surprising the national drug and device regulator, the Therapeutic Goods Administration (TGA), is a key target.”
Find article here.

Targeted therapies raise the number of subsidised high-priced drugs

SMH, 13 January 2015
Author: Dan Harrison
“The number of high-priced drugs being subsidised by the Commonwealth has dramatically increased in recent years as pharmaceutical companies produce more targeted therapies for smaller groups of patients. According to the federal Health Department, there are 61 drugs listed on the Pharmaceutical Benefits Scheme that cost more than $5000 each time they are dispensed.”
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