15/01/2010 by admin.

England’s Department of Health has launched a consultation on proposals for automatic generic substitution, in which pharmacists could dispense generic forms of drugs instead of branded versions even if the prescribing doctor or nurse has written a prescription for a brand.

The consultation report outlines three options. The first is to keep the current arrangements, in which pharmacists are required to dispense exactly what is written on a prescription and cannot substitute a generic version for a brand name drug without prior agreement with the prescriber. The second would allow substitution of generic equivalents but would specify a list of exempt products. The third option, preferred by the health department, would allow generic substitution of a specified group of products.

Read article at http://www.bmj.com/cgi/content/extract/340/jan08_3/c135

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23/09/2009 by admin.

GSK has changed its policy on continuing medical education (CME) and will fund less, and only independent sessions with balanced information.

Read more at http://www.washingtonpost.com/wp-dyn/content/article/2009/09/21/AR2009092101342.html

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22/09/2009 by admin.

Former US defence secretary Donald Rumsfeld was talking about weapons of mass destruction and the war in Iraq when he referred to “unknown unknowns” in 2002, but he could just as easily have been explaining why drug companies have been able to make money out of the global flu pandemic. Within a few months of his comments, a series of events began to fuel growing international concern about a new pandemic. The mixture of fear and ignorance over its timing, nature, and severity soon sparked an unexpected bonanza for the manufacturers.

Since the emergence of swine flu in Mexico this spring finally triggered the first pandemic in four decades, J P Morgan, the investment bank, estimates that governments have made fresh orders for antiviral drugs of $3bn (£1.8bn; 2bn) and that recent or potential sales of vaccines are $7bn.1 All that despite signs that the virus is proving relatively mild, with potentially less impact than a standard seasonal flu outbreak.

One beneficiary has been Gilead, a fast growing US biotech business that initially developed the antiviral medicine oseltamivir (Tamiflu). In the three months to June this year alone it reported $52m in royalties on its drug. Another who gained was Rumsfeld, Gilead’s former chairman and continuing shareholder, who stressed that he disqualified himself from decisions that could have caused conflicts of interest.2

Read the full story at http://www.bmj.com/cgi/content/full/339/sep18_2/b3811

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04/09/2009 by admin.

Europe’s member states are at loggerheads over plans to relax current restrictions on pharma communicating with patients.

The plans tabled by Commissioner Verheugen would allow pharma to communicate directly with patients via mediums like the internet, though through a strict vetting system. This would end current rules which outlaw any communication with patients, but Europe is deeply divided on the issue.

The various governments divide into two broad camps  those who favour a more liberal approach to regulating pharmas communications, and those who demand more restrictions.

The UK, Sweden, and Denmark are among the most prominent countries who want a more liberal approach, while Germany, France and Spain take a more conservative approach.

The pharma industry’s European body EFPIA is keen to see a change to the status quo, but spokesman Colin Mackay is not optimistic of a breakthrough any time soon: “We probably wont see much happening this or next year,” he said.

Tuesday , September 01, 2009

http://www.pharmafocus.com/cda/focusH/1,2109,21-0-0-SEP_2009-focus_news_detail-0-493131,00.html

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01/06/2009 by admin.

MORE than 150 girls in Scotland have suffered adverse reactions after receiving the cervical cancer vaccine introduced last autumn, The Scotsman can reveal.

Campaigners are calling for the vaccination programme to be suspended, claiming there are unanswered questions about the long-term effectiveness and safety of Cervarix. They are concerned that official information refers to mild side-effects, when some girls have reported serious reactions to the jab.

The families of six girls in England are suing GlaxoSmithKline (GSK), the maker of Cervarix, after the girls suffered severe reactions resulting in partial paralysis, seizures and chronic fatigue. The Scotsman has learned two more have contacted the same solicitor after suffering severe painful swelling of joints.

The Scottish Government and GSK insist the number of adverse reactions experienced is in line with any mass vaccination programme. However, an investigation by The Scotsman has also discovered the guidance sent out on the £64 million vaccination programme was changed in several respects before being distributed to parents – after the intervention of a drug company.

http://www.scotsman.com/latestnews/Fears-over-reactions-to-cervical.5319871.jp

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07/05/2009 by Merav.

Have a read of this interesting guardian article about the benefits of tamiflu and relenza…

 http://www.guardian.co.uk/world/2009/may/07/tamiflu-swine-flu-drugs

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27/03/2009 by Merav.

The BMJ is now asking authors for data sharing statements at the end of each original research article. The statement will explain which additional data—if any—are available, to whom, and how. Those data could range from additional explanatory material to the complete dataset. People allowed access to the data might range from fellow researchers to everyone. And data might be available only on request, accessible online with a password, or openly accessible to all on the web with a link on bmj.com.

Data sharing means more than the open access publication of articles and the posting in online registries of study protocols and main results. Sharing allows other researchers—and perhaps scientists, clinicians, and patients—access to raw numbers, analyses, facts, ideas, and images that do not make it into published articles and registries. At its fullest extent, data sharing means free access for everyone. Many people would call this a moral obligation because most research is publicly funded and involves the public as participants. Other potential benefits include quicker scientific discovery and learning, better understanding of research methods and results, more transparency about the quality of research, and greater ability to confirm or refute research through replication.

For full article, go to BMJ 2009;338:b1252

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12/03/2009 by Merav.

Red tape is severely hampering clinical research in the UK and inadvertently “killing people”, leading researchers have warned. European legislation introduced in 2004 has led to fewer patients enrolled in clinical trials and has caused “huge delays” in research, they said. NHS bureaucracy is a further hurdle to treatments being quickly assessed, a team of UK academics added. Regulators agreed there were some problems with interpreting EU rules.

Despite increased funding in clinical trials in the UK, the number of trials being approved has stayed the same since 2004, when the European directive on clinical trials, designed to improve patient safety, came into force. Additional funding is being eaten up by paperwork, monitoring, and procedures such as detailed labelling of drugs, experts said. In 2002, 6% of trials worldwide were being done in the UK but in 2007 this was 2%.

BBC News 12/3/9

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12/03/2009 by Merav.

New guidance has been issued in March 2009. Have a look at http://www.abpi.org.uk/publications/pdfs/ABPI_Code_Guidance_Notes.pdf

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12/03/2009 by Merav.

The National Institute for Health and Clinical Excellence (NICE), the body that approves drugs for the NHS, will go head-to-head with pharmaceutical giant GlaxoSmithKline (GSK) on the issue of drug pricing at the 2009 Bupa Health Debate on 25 March. The debate pits Professor Sir Michael Rawlins, chairman of NICE against Simon Jose, senior vice president of UK pharmaceuticals at GSK, at a time when conflict between the two organisations escalates over Tyverb, a GSK breast cancer drug. NICE is refusing to approve Tyverb because it is “not a cost-effective use of NHS resources”, despite GSK’s offer to fund the drug for the first 12 weeks of treatment.

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