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NAPC News 19 July 2012
Glaxo Ends Hostilities With Bid For Human Genome Science
Human Genome Sciences, which partners GlaxoSmithKline on immune system disease medicine, is negotiating its sale to GSK.
GSK is understood to be negotiating behind closed doors with HGS for a deal, following its rejected $12 per share hostile bid in April. The Maryland company branded the offer ‘inadequate’ at the time and began searching for another buyer, for which the deadline for bids was Monday. The company is expected to announce, which other, if any, firms bid for it and to outline the next steps.
US Approves First Medicine To Reduce HIV Risk
The US Food and Drug Administration has approved a medicine to reduce the risk of HIV infection in adults who do not have the virus.
Truvada can now be taken once a day to reduce the risk of sexually acquired HIV-1 infection, the most common form of the virus, in adults who are at high risk of becoming infected. Its approval was based on the results of two large clinical trials, in which the daily use of Truvada was found to significantly reduce people’s risk of HIV infections.
In the first trial, the risk of HIV infection in gay and bisexual men and transgender women was cut by 42 per cent. The second trial found that the drug reduced infection risk by 75 per cent in heterosexual couples where one partner was HIV positive.
Dr Debra Birnkrant, Director of the FDA’s division of antiviral products, pointed out that while treatment advances had enable HIV to be viewed as a chronic disease most of the time, it was still ‘better to prevent HIV than to treat a life-long infection.’ She also added that Truvada should not been seen as a substitute for practising safe sex
Deadly Drugs Still Given To The Elderly
Official figures published on Tuesday showed that elderly patients in some parts of ~England were six times more like to be prescribed deadly drugs than in other areas.
The statistics disclosed that 13 per cent of dementia patients in the North West were being given antipsychotic drugs, which are often sued by care homes to make residents easier to handle. In London, however, only 2 per cent of patients receive them.
The figures form the Health and Social Care Information Service showed that the proportion of dementia patients across England being given drugs has more than halved since 2006, down from 17 to 6.8 per cent. While the prescription rate was 9per cent in Yorkshire and Humber, however, it was only 2 per cent in the North East.
Obesity Might Affect Breast Cancer Drugs
Women who are obese may respond differently to breast cancer medicine, raising the possibility that they might benefit from changes to their treatment according to research by the Institute of Cancer Research in London and the Royal Marsden NHS Foundation Trust.
Glaxo Pays $3bn For Control Of US Partner And Lupus Drug
GlaxoSmithKline has gained complete control of lupus drug, Benylsta, after buying Human Genome Sciences for about $3 billion, ending a long hostile takeover campaign.
The company has agreed to pau $14.25 a share in cash for the US firm, which until recently had steadfastly resisted its advances. The boards of both companies have approved the deal.
Ousted Astra Chief Will Get £4.4m Payout
David Brennan, the ousted chief executive of AstraZeneca, is to receive up to £4.4m in cash and shares and a pension worth just under £1m a year.
Despite the company’s recent poor performance, Mr Brennan has been one of the best paid chief executives in the FTSE 100, behind only Bob Diamond, formerly of Barclays B?andk, and WPP’s, Sir Martin Sorrell.
Clinical Trials Procedures Must Be Reformed
There is rather more than is readily apparent to the massive £1.9 billion fine imposed recently by a US District Court in Boston on Britain’s largest and most reputable pharmaceutical company, GlaxoSmithKline.
The regulatory authorities require, as we all know, that drugs must first be thoroughly evaluated in a series of clinical trials before being approved for public use. The catch, however, is that those trials are not just paid for, but also designed and implemented by drug companies themselves.
This, one might infer, could have some bearing on their outcome, as indeed proved to be the case with Glaxo’s antidepressant, Paxil (or Seroxat). The drug’s promotion for the treatment of depression in adolescence entail, the court heard, costly ‘educational’ conferences in exotic locations such a Hawaii, with some added inducement of deep-sea fishing expeditions and hot air balloon rides.
The evidence in Paxil’s favour seemed compelling enough, based on the findings of a large multi-centre clinical trial demonstrating its ‘remarkable efficacy and safety’. In reality, as it subsequently emerged, the situation was precisely the contrary – Paxil proved no better than the placebo with which it was compared, while paradoxically increasing the risk of suicide threefold.
In his recent book, Pharmageddon, the British psychiatrist, Professor David Healey, of Cardiff University, described in detail how this came about. The crucial point was that the control exerted by drug companies over the trials of their drugs extends to analysing the data and interpreting what it shows. This allowed them to select the good bits, omit the less favourable, and gloss over the hazards by, for example, categorising those subjects reporting suicidal thoughts as ‘non-compliant’ or ‘emotionally liable’.
GlaxoSmithKline then arranged for this imaginative reinterpretation of the original data to be written up as a scientific paper, which was duly ‘signed off’ by the psychiatrists involved in the study – and arrangements made for it to be published in the prestigious Journal of the American Acadmey of Child and Adolescent Psychiatry.
Professor Healey illustrated the inevitable tragic consequences of this, with the testimony at a public hearing of a mother whose daughter, Beth, consulted her family doctor over her anxiety and sleeping problems: ‘He prescribed Paxil and said she would feel better within a couple of weeks. Seven day later, Beth took her own life. (Dr James Le Fanu
Novozymes Calls For Greater EU Support For Development Of Bio-Economy
Lars Hansen, head of European operations at Novozymes, the world’s largest industrial enzyme company, has warned that Europe risks losing its edge in biotechnology, if it does not do more to support the nascent industry.
US Biotech Chief’s Warning Over European Price Cuts
George Scangos, the chief executive of the Boston based Biogen Idec, has said that European price cuts threaten the development of future medicines by squeezing drug companies’ research budgets.
Whooping Cough Surge Shows Need For Booster Rethink
Whooping cough booster vaccinations may be needed for at risk groups, as the largest surge of the illness in decades continues, the Royal College of General Practitioners has said.
The RCGP spokesman on immunisation said that government advisers needed to look again at whether at risk groups should be given extra vaccine doses.
There have been 1,781 confirmed cases of pertussis In England and Wales in the first five months o f2012, compared with 221 cases in the same period in 2011, Health Protection Agency figures show. This represents the largest surge in cases since the early 1990s.
In infants under three months, 138 cases were reported to the end of May 2012, including five deaths. The HPA, which released the data, said that waning immunity is likely to be contributing to the rise. HPA research has previously suggested that vaccinations should be given to adolescents, pregnant women and some adults to boost immunity and protect babies too young for vaccines.
Dr Mary Ramsay, head of immunisation at the HPA, said the HPA was very concerned about the ongoing increase in pertussis cases. The HPA has written to GPs to remind them of the signs and symptoms of this infection and stressed the importance of vaccination, she said.
The agency is also encouraging GPs to report cases quickly to reduce the spread of infection and make them aware of the HPA’s guidance for the management of whooping cough cases.
Chemicals In Personal Care Products May Increase Diabetes Risk
Controversial chemical found in some personal care products could increase women’s chances of developing diabetes, scientists say.
Researchers at Brigham and Women’s Hospital analysed the levels of chemical called phthalates in urine samples from 2,350 women, all of whom took part in the National Health and Nutrition Examination Survey in the US.
They found that women with high levels of phthalates in their urine were more likely to have diabetes than those with low concentrations.
However, lead researcher, Dr Tamarra James-Todd, whose findings are published in the journal, Environmental Health Perspectives, conceded that more research is needed. She went on to say: ‘We know that in addition to being present in personal care products, phthalates also exist in certain types of medical devices and medication that is used to treat diabetes and this could also explain the higher level of phthalates in diabetic women.
Phthalates are found in a number of products, including packaging, detergents, medical devices, textiles and food products. Many manufacturers in Europe and the US have stopped using them due to health concerns.