Archive for category The Pharmaceutical Industry

Open letter raises concerns about NICE guidance on statins

Author: Jacqui Wise
BMJ 2014;348:g3937

“A group of leading doctors have written an open letter to David Haslam, chairman of the National Institute for Health and Care Excellence (NICE), and to the health secretary, Jeremy Hunt, raising serious concerns about the latest draft guidance on statins.1

The letter was signed by Richard Thompson, president of the Royal College of Physicians, and Clare Gerada, former chairwoman of the Royal College of General Practitioners. The letter said, ‘We urge you to withdraw the current guidance on statins for people at low risk of cardiovascular disease until all the data are made available. The potential consequences of not doing so are worrying: harm to many patients over many years, and the loss of public and professional faith in NICE as an independent assessor. Public interests need always to be put before other interests, particularly [those of] Pharma’..”

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EMA policy on transparency is “strikingly” similar to deal struck with drug company, say experts

Authors: Peter Doshi
BMJ 2014;348:g3852

“A US drug company seems to have influenced the European Medicines Agency’s (EMA) draft policy on access to clinical trial data, which academics have claimed keeps too much information hidden. Documents obtained by The BMJ under a freedom of information request showed a significant overlap between what the US drug giant AbbVie had agreed with the EMA could be released about its drug adalimumab (marketed as Humira) and the agency’s draft policy on providing public access to drug company data. In 2012 the EMA announced a new, “proactive” transparency policy that would give full public access to clinical trial data about drugs authorised for marketing in the European Union from January 2014.1 But draft policy documents on how the system will work have been criticised for being overly restrictive. For example, the “view on screen only” policy will prohibit saving, downloading, or transferring data, limiting how the data can be analysed…”

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Professor who sparked statins row says government should intervene

Author: Sarah Boseley
The Guardian, Saturday 14 June

“The Oxford professor who triggered a public row over statins says the Department of Health and other authorities should intervene to ensure the public gets accurate information on the risks and benefits of the potentially life-saving drugs.

Prof Sir Rory Collins said he had little confidence in an inquiry convened by the British Medical Journal to decide whether two papers it published last year that made an error on the extent of side-effects should be completely withdrawn…”

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Eight more people in UK sue Grünenthal and Diageo over thalidomide

BMJ 2014;348:g3806
Author: Clare Dyer
“A group of people who claim that they were damaged by the drug thalidomide before their birth have launched a compensation claim at the High Court in London, more than 50 years after they were born.”
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Serious Fraud Office launches criminal inquiry into GlaxoSmithKline

BMJ 2014;348:g3612
Author: Adrian O’Dowd

“The United Kingdom’s major fraud body has launched a criminal investigation into the drug company GlaxoSmithKline (GSK). The Serious Fraud Office inquiry, announced on 27 May, will focus on the commercial practices of GSK and its subsidiaries and comes just weeks after the company was accused of bribery in China…”

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Leave prescribing to doctors and nurse practitioners

The Conversation, online 16 April 2014
Author: Rhian Parker
“We started the week with a new proposal by the Grattan Institute to shake up the hospital workforce and allow nurses to take on more roles traditionally performed by doctors. But should registered nurses’ roles extend even further, to prescribing medication? …Australia already has a category of nurse specialists who can prescribe some medicines – nurse practitioners.”
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Pharmacy legislation: public protection or professional hindrance?

Author: Christopher A. Langley
Med Law Rev 2014 22: 87-108
“…one of the most high-profile legal cases involving a pharmacist in a professional capacity, R. v Lee, a pharmacist was prosecuted firstly for gross negligence manslaughter, later revised to offences under the Medicines Act 1968, for a single error relating to medication supply, and was given a suspended custodial sentence. Offences against sections 64 or 85 of the Medicines Act are absolute offences and there is no due diligence defence. Prosecution of a pharmacist for the supply of incorrect medication may seem a measured course of action to protect the public from the wrongful supply of potent pharmacotherapeutic agents; however, further analysis of Lee indicates that this approach may be counterproductive.”
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Financial Orphan Therapies Looking For Adoption

Health Affairs blog, March 6, 2014
Authors: Vikas Sukhatme, Kathy Fang, Andrew Lo, and Vidula Sukhatme
“There exist scientifically promising treatments not being tested further because of insufficient financial incentives. Many of these therapies involve off-label uses of drugs approved by the Food and Drug Administration that are readily available and often inexpensive. Pharmaceutical companies—largely responsible for clinical drug development—cannot justify investing in such clinical trials because they cannot recoup the costs of these studies. … it is essential that society finds ways to adopt these “financial orphans.” We propose several potential solutions for the non-profit sector, pharmaceutical companies, health insurers, patient driven research, and others to accomplish this goal.”
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From promises to policies: is big pharma delivering on transparency?

BMJ 2014;348:g1615 26 February 2014

Author: Peter Doshi

“…The greatest concern may be that the current industry framework continues to treat clinical trial data as the property of trial sponsors and not part of an intellectual commons to be maintained and governed by a third party such as a regulator.

But as the access-to-data debate has moved from promises to policies, procedures, and systems designed to facilitate wider access to clinical trial data, the onus to document how well the system is working falls on those requesting data…”

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Patent wars: affordable medicines versus intellectual property rights

BMJ 2014;348:g1533 17 February 2014

Author: Jacqui Wise

“The pharmaceutical industry is increasingly looking towards emerging markets, where demand for new drugs is rising rapidly alongside rates of chronic disease. But in recent years India, known as the “pharmacy of the developing world,” has led the battle for affordable drugs, using legal mechanisms to overturn patents so that its generic drug companies (which produce a fifth of the world’s generic drugs) can undercut the Western giants. Developing countries have followed India’s example, and battles over patent protection and prices have broken out from Indonesia to Brazil…”

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