Boehringer announce that it is withdrawing its drug, flibanserin, for increasing femal sexual desire, from development. The company made the announcement after negative reviews from the US Food and Drug Administration.
BMJ 201, 341, c5701
There is concern that trade negotioations and industry lobbying will threaten the flow of affordable generic drugs to developing countries. A study in Journal of International Aids Society (2010, 13:35) shows that 91% of all antiretrovirals for children are Indian generics. However, the study warns that the free trade agreements that India is negotiating with the EU may increase the price of the antiretrovirals.
BMJ, 2010, 341: C5135
The European Medicines Agency publishe a major discussion paper highlighting that drug companies and doctors are continuing to conduct unethical research in developing countries. The paper is out for consultation until 30.9.10 (www.ema.europa.eu).
BMJ 2010, 341, 4984
An analysis in PLOS medicine (2010; 7(9): e1000335) states that review articles that were ghostwritten overstates the benefit of hormone replacement therapy. This finding is from an analysis of 1500 documents unsealed in recent litigation afainst former drug company Wyeth (now part of Pfizer) looking at how drug companies use ghostwriters to insert marketing messages into published articles in medical journals. The Wyeth ghostwriting archive is available at www.plosmedicine.org/static/ghostwriting.action
BMJ 2010. 341: c4894
This week’s BMJ has an interesting editorial on the rosiglitazone story. Recent hearings found that rosiglitazone has an 80% additional relative risk of myocardial infarction, comparable to previous concerns with COX2 inhibitor, Vioxx. However, as no licenting body demanded evidence on the risk of myocardial infarction, it is still impossible to accurately quantify the harm which we put patients in when prescribing the drug. The editorial outlines clearly the rosiglitazone story and the outlines the care that clinicians must take when prescribingnew drugs.
AstraZeneca are to pay out $198m to 17500 patients who claimed that anti-psychotic quetiapine (Seroquel) had caused them to develop diabetes.
BMJ 2010, 341, c4422
Health Action International are lobbying the European Medicines Agency to tighten its rules that require patient and consumer groups working with the agency to disclose any corporate funding they receive.
BMJ 2010; 341: c4459
The US FDA is looking to investigate a member of the panel that recently recommended restrictions on rosiglitazone for conflict of interest. Dr Capuzzi was one of the panel members who voted to keep rosiglitazone on the market. However, several news organisations have reported that Dr Cauzzi has been a member of GSKs speakers’ bureau.
BMJ 2010; 241:c4083
Danish drug company Novo Nordisk is to withdraw Mixtard30, a form of insulin used by 90,000 patients in the UK. DTB says this will be costly; if all patients switched to Novo Nordisk’s alternative Novomix30, this would cost the NHS £9M a year.
BMJ 2010; 341: c4210
Senator Charles Grasslet and the US senate committe on finance has called for tougher regulation on ghostwriting in medical journals. The report says that as journals influence prescribing, undisclosed funding by companies can lead to journals inadvertantly promoting sales of a company’s product. He goes on to state, that once strong policy is in place, the difficulty will be with compliance.
BMJ 2010, 340, c3504
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