Archive for category The Pharmaceutical Industry

US drug regulator proposes social media guidelines for drug and medical device industry

BMJ 2014;348:g4135
Author: Michael McCarthy

“The US Food and Drug Administration has issued draft guidelines for drug and medical device companies to use when posting information about products on internet platforms with strict limits on the number of characters allowed. Such platforms would include the microblogging site Twitter, which limits posts to 140 characters, and the sponsored links that appear with Google and Yahoo search results. In the case of drugs, for example, the FDA said that such posts should include the brand and chemical name of the drug, and, if the post makes a claim of benefit, must also present the drug’s most serious risks…”

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Consultations on adoption of European Union guidelines in Australia

From the Therapeutic Goods Administration:

“The EU guidelines below have been recommended for adoption or non-adoption by the TGA. These guidelines are open for comment on whether or not they should be adopted in Australia… Your comments on the proposed adoption or non-adoption of these EU guidelines, particularly your advice on whether you support the proposed action, would be appreciated.

This consultation closes on 29 July 2014.”

Find more information here.

Vaccine development and developing countries

The Lancet, Volume 383, Issue 9935, Page 2099, 21 June 2014
“Participation of patients in medical research requires that a balance is struck—between anticipated benefits and potential harms of the new treatment being assessed, and with a view to the broader value of evidence accrued for guiding clinical practice and future research. Tensions can arise, however. Research in low-income settings has sometimes been perceived to be of greater potential benefit to those in high-income countries, where a drug may be marketed after licensing. In an extreme case, at the time of an outbreak of influenza A H5N1 virus in 2006—07, researchers in Indonesia were unable to share clinical samples with their counterparts in high-income countries, owing to a perceived lack of reciprocity for the benefits of research. This disappointing, and unusual, event underscores the need for a shared and participatory agenda in health research. In today’s Lancet, Nita Bhandari and colleagues present an excellent example of successful clinical research in a developing country. …In an accompanying Viewpoint, Maharaj Bhan and coauthors describe the collaborative international process which led to the development of Rotavac.”
Find editorial here.

Communicating the harmful effects of medicines

BMJ 2014;348:g4047
Authors: John R Geddes, Andrea Cipriani, Rob Horne
“In 2004 the US Food and Drug Administration warned that antidepressants could increase suicidality in children and adolescents.1 Three years later it ordered that all antidepressants should carry an expanded black box warning, incorporating information about an increased risk of suicidal symptoms in young adults aged 18-24 years.2 These warnings were associated with widespread media coverage.3 4 5 Warnings from regulatory agencies about harms from drugs are known to reduce prescribing rates. In a linked paper Lu and colleagues (doi:10.1136/bmj.g3596) show that not only did prescribing rates decrease in this age group but there was a modest but significant increase in the rate of self poisoning, an important suicidal behavior.6 The net effect of the warning was probably counterproductive and led to more harm.”
Find extract and link to research here.

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.”
Find extract here.

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…”

Find article here.

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.”
Find article here.