20 June 2012
has reported that a member of the European Parliament, Michael Cashman, has asked the European Commission to consider bringing in legislation to stop companies conducting what they call post-marketing drug trials but that are, in reality, “disguised marketing.” The MEP has called for better regulation of clinical trials
to ensure a ‘proper balance’ between the commercial and clinical functions of such studies. The question follows an investigation by the BMJ about the purpose of post-marketing studies of new treatments for diabetes.
A paper, Post-marketing studies of new insulins: sales or science? published in the BMJ
by Edwin Gale, emeritus professor of diabetic medicine at Bristol University, looked at post-marketing trials carried out by the manufacturers of new forms of insulin for people with type 2 diabetes. The new forms, analogue insulins, are much more expensive than conventional human insulin but the National Institute for Health and Clinical Excellence (Nice) which examined the data on them in the UK found they did not offer much more benefit for most people. Gale’s paper noted that nearly 400,000 people have been recruited into post-marketing trials of these analogue insulins worldwide since 2005. Most of the studies were carried out in middle or lower-income countries and had limited scientific value, he alleges. He concluded that the studies had little scientific value and promoted the use of more expensive products.
In a second article, Post-marketing observational trials and catastrophic health expenditure, also published in the BMJ
, John Yudkin, emeritus professor of medicine at University College London, noted that most people would be likely to remain on the new more expensive insulins at the end of the post-marketing trial with the consequential rise in health costs for those patients. Post-marketing drug trials are often carried out in middle or lower-income countries where the cost of expensive medicines will often be a financial burden on households.
Leigh Day and clinical trials
and personal injury specialist lawyers at Leigh Day & Co have represented a number of clients who have been injured after taking place in clinical trials. The defective goods team at the firm has been top-ranked by both main legal directories for over a decade.
Partner Jill Paterson
is currently representing a number of individuals who have reported injuries including blindness and neurological damage after being involved in clinical trials for various medical devices and drugs.
Partners Martyn Day
and Gene Matthews
have represented participants in the high profile Northwick Park Drug Trial who suffered life threatening injuries following their involvement in the TGN1412 drug trial at the hospital.
To speak to one of our specialist claimant product liability solicitors please call or email Jill Paterson
on 020 7650 1219
for a free, confidential initial consultation.
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