How The Feds Discourage Prescription Drug Competition

Forbes, 1 July 2015
Author: Scott Gottlieb
“There’s a growing refrain among those who pay for healthcare services that they want new products to deliver more value. When it comes to prescription drugs, this is usually interpreted to mean medicines that provide more benefit, at lower costs per increment of clinical advantage. But pharmaceutical competition usually turns on claims of absolute efficacy rather than the relative and comparative merits of a medicine. There is one obvious reason.”
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Lawsuit seeks access to data from hepatitis C drug trial

BMJ 2015;350:h3564
Author: Michael McCarthy
“Two health advocacy groups have filed suit to compel the US Food and Drug Administration to release clinical trial data submitted to the agency for the approval of the hepatitis C drugs sofosbuvir and sofosbuvir with ledipasvir. The plaintiffs also seek all FDA records relating to the clinical trials and correspondence between the agency and the US Department of Health and Human Services with companies developing the drugs.”
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Doctors Got $6.5 Billion From Drug, Device Makers in U.S.

Bloomberg, 1 July 2015
Authors: Caroline Chen and Zachary Tracer
“U.S. doctors and teaching hospitals got $6.49 billion from drug and medical-device makers in 2014, according to new government data on the financial links between the companies and the people who prescribe their products. The data released Tuesday range from the royalties paid to hospitals to help develop products to fees provided to medical experts to speak at a dinner with colleagues. By disclosing information on the payments, the U.S. is seeking to bring transparency to the financial relationships between drugmakers and health care providers.”
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Testing ground GDR: Western pharmaceutical firms conducting clinical trials behind the Iron Curtain

J Med Ethics 2015;41:529-533
Authors: Rainer Erices, Andreas Frewer, Antje Gumz
“Western pharmaceutical companies conducted clinical trials in the Eastern Bloc during the Cold War. Recently, media reports about alleged human experimentation provoked a wave of indignation. However, a scientific and objective account of these trials is lacking. The aim of this study was to describe and evaluate the clinical trials performed in the German Democratic Republic (GDR) based on archival material from the health system and the secret service.”
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Is It Bedtime for Benzos?

Huffington Post, 25 June 2015
Author: Alexander Zaitchik
“It’s been a tough few years for benzodiazepines, the pharmaceutical industry’s top-selling family of prescription drugs. Tough in every way, that is, except sales. It’s their reputation, long enjoyed, as harmless and effective medicines that’s taking a flurry of hits. For starters, researchers have recently posited a link between benzos and Alzheimer’s; they’ve documented an explosion in overdoses and ER visits by people mixing benzos and prescription opiates; and they’ve mapped out the disturbing brain-science of benzo dependency, addiction and withdrawal.”
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Big pharma attempts to cast off bad reputation by targeting the poor

The Guardian, 25 June 2015
Author: Tim Smedley
“Big pharma isn’t known for its fair dealing in the global South. The high cost of patented HIV antiretroviral drugs (ARVs) in the early 2000s priced out developing countries and millions died. Patent wars still rage, notably in India and South Africa, as the industry attempts to maintain monopolies on life-saving drugs. Now, pharmaceutical companies are creating new business models to meet the needs of the global poor. Is it enlightened self-interest or calculated profiteering?”
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Cancer Doctors Offer Way to Compare Medicines, Including by Cost

NYT, 22 June 2015
Author: Andrew Pollack
“Alarmed by the rapid escalation in the price of cancer drugs, the nation’s leading oncology society unveiled on Monday a new way for doctors and patients to evaluate different treatments. The release by the American Society of Clinical Oncology of what it calls its “value framework,” is part of a change in thinking among doctors who are now also starting to factor cost into their evaluation of drugs.”
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National Health Amendment (Pharmaceutical Benefits) Bill 2015 [Provisions]

Senate Community Affairs Legislation Committee, Parliament of Australia, online 15 June 2015
“On 15 June 2015 the Selection of Bills Committee referred the provisions of the National Health Amendment (Pharmaceutical Benefits) Bill 2015 to the Senate Economics Legislation Committee for inquiry and report by 23 June 2015.  Submissions close 19 June 2015.”
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Public rarely knows full reason FDA rejects new drugs

Reuters, 16 June 2015
Author: Lisa Rapaport
“Drug companies generally don’t disclose all the reasons new medicines fail to win U.S. marketing approval, even though regulators often reject treatments over concerns about safety or effectiveness, a study finds. Researchers compared the details companies made public in press releases with confidential documents from the U.S. Food and Drug Administration known as complete response letters, which explain why a new medicine can’t be sold. Often, companies made no announcement when a drug was rejected, or omitted most of the reasons the FDA cited for denying approval, the study found.”
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