Archive for category The Pharmaceutical Industry

A modest but meaningful decision for Indian drug patents

The Lancet, Volume 384, Issue 9942, Pages 477 – 479, 9 August 2014
Author:  Amir Attaran
“On April 1, 2013, the Indian Supreme Court released its long-awaited decision on Novartis AG v Union of India & Others, better known as the Glivec (Gleevec in the USA; imatinib mesylate) patent case. 1 Although neither the resounding victory for access to medicines that activists celebrated nor the terminal defeat that Novartis complained about, the Court’s decision will shape India’s burgeoning medicine market in coming decades.”
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Lethal But Legal: Corporations, Consumption, and Protecting Public Health

The Lancet, Volume 384, Issue 9942, Pages 485 – 486, 9 August 2014
Reviewer: Robert Beaglehole
“Nicholas Freudenberg’s compelling book, about corporations, consumption, and protecting public health, came at a perfect time. I was in the middle of discussions on how to work towards a Tobacco Free World by 2040, a world where the global prevalence of smoking everywhere would be less than 5%. …I had great hopes of this book and I was not disappointed. …Freudenberg focuses on six industries: tobacco, alcohol, food and beverage, pharmaceutical, automobile, and firearms industries. In Freudenberg’s view, the major problem is the lack of political will to implement the needed preventive measures; profit has overwhelmingly taken precedence over the promotion of health and prevention of illness. He illustrates how the impact of these industries on the evolving global patterns of death are more important than the control of infectious diseases or the ageing of populations.”
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Medical Marijuana, Physicians, and State Law

N Eng J Med August 6, 2014DOI: 10.1056/NEJMp1408965
Author: George J. Annas, J.D., M.P.H.
“As Massachusetts prepares to implement its new medical-marijuana law, agents of the federal Drug Enforcement Administration (DEA) have reportedly visited at least seven Massachusetts physicians at their homes or offices and told them they must either give up their DEA registration or sever formal ties with proposed medical-marijuana dispensaries. These encounters were meant to intimidate the physicians and to discourage them from taking an active role in medical-marijuana dispensaries, and they have apparently succeeded. But there are differences between state and federal law, between talking to patients and selling drugs, and between acting as a physician and acting as a marijuana entrepreneur. With medical-marijuana laws poised to come into effect in a majority of states, it seems worthwhile to put medical marijuana in historical and legal context.”
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Does $760m a year of industry funding affect the FDA’s drug approval process?

BMJ 2014;349:g5012
Author: Sidney M Wolfe
“In 1992, because of widespread concern that the US Food and Drug Administration was taking too long to approve drugs, the Prescription Drug User Fee Act (PDUFA) was enacted, authorizing the FDA to collect user fees from drug companies to expedite the approval process. Besides providing funding for an increased FDA staff, the act established performance goals during the approval process to ensure more rapid review. …The hypothesis posed in a study published this week was that “new black-box warnings and safety withdrawals have increased following PDUFA’s enactment, perhaps as a result of an expedited review process that may not adequately detect serious drug safety problems in the preapproval period.””
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Individual Patient Expanded Access: Developing Principles For A Structural And Regulatory Framework

Health Affairs Blog, online 31 July 2014
Authors: Darshak Sanghavi, Meaghan George and Sara Bencic
“Individual patient expanded access, sometimes termed “compassionate use,” refers to situations where access to a drug still in the development process is granted to patients on a case-by-case basis outside of a clinical trial, prior to completion of mandated clinical trials and approval by the Food and Drug Administration (FDA). …The Engelberg Center for Health Care Reform at the Brookings Institution recently invited senior leaders from several pharmaceutical companies, two bioethicists, a senior FDA representative, and a patient advocate to share experiences and discuss organizational strategies related to expanded access (see acknowledgements). A driving factor for this meeting was a recent flurry of highly public cases of desperate patients seeking access to experimental drugs, which lead to social media campaigns and media coverage.”
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GSK flu vaccine plant inspection finds 10 problems

CBC, The Canadian Press, 23 July 2014

“A recent Health Canada inspection of the country’s only flu vaccine production plant identified 10 issues that need to be addressed, a report from the regulatory agency reveals. The summary report of the June inspection said none of the problems found poses a critical risk to public health, but seven fall into the major observation category, meaning they are signs production is not consistently hitting required standards. The regulatory agency posted the summary report from the inspection of the GSK-owned plant on its website Tuesday evening after the end of the business day…”

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GlaxoSmithKline affirms policy of anti-corruption amid 14% profits fall

The Guardian, 23 July 2014
Authors: Julia Kollewe

“The GlaxoSmithKline chief executive, Sir Andrew Witty, has reiterated that his company has a “zero tolerance” attitude to the corrupt sales practices it is being accused of in China and other countries. Witty, who is battling to repair GSK’s corporate reputation, was speaking as Britain’s largest drugmaker announced a 14% fall in second-quarter profits to £1.3bn, missing analysts’ forecasts. The company’s shares fell nearly 5% to £14.81, making it the biggest faller on the FTSE 100 index. Profits were hit by competition from generic products and the strong pound. The firm now expects full-year earnings per share to be similar to last year…”

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Medicare Pressed to Bargain on Drug Costs

Author: Julie Appleby
Kaiser Health News, 24 July 2014

“Medicare could save billions if Congress overcame its reluctance to anger the drug industry and allowed the program to demand rebates or negotiate prices, Rep. Henry Waxman (D-Calif.) said Wednesday. He added that’s something polls show many Americans support… “We could save money, lower the deficit, and not ask seniors to pay more,” said Waxman, a long-standing drug industry critic who is retiring at the end of this session. “The only opposition is from drug companies because they will make a little less money if they have someone negotiating prices with them.” He spoke just hours before the maker of Sovaldi — Gilead Sciences — reported record sales of $5.7 billion in the first 6 months of the year. The drug industry has long opposed price controls, or allowing the government to negotiate for Medicare drug prices…”

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Gilead reports $5.8 billion in sales of hepatitis C drug

Washington Post, 23 July 2014
Authors: Chad Terhune and Eryn Brown

“Amid concerns over the high cost of its new treatment for hepatitis C, drugmaker Gilead Sciences Inc. reported $5.8 billion in sales for its blockbuster Sovaldi drug in the first half of 2014. The successful product launch boosted Gilead’s second-quarter results released Wednesday, but the drug’s price tag of $1,000 per pill continues to upset lawmakers, health insurers and state Medicaid programs worried about the negative effect on healthcare costs…”

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The Feds Go After FedEx for Shipping Drugs

Author: Karen Weise
Bloomberg Businessweek, July 18

“Shipping giant FedEx (FDX) has been indicted by the U.S. Department of Justice for delivering drugs for illegal online pharmacies. FedEx denies the charges, which could carry a fine of more than $1.6 billion. The case is the government’s latest attempt to hamper questionable online businesses by cutting off access to critical yet more established parts of their supply chains…”

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