The European Medicines Agency has suspended marketing approval for a number of medicines following allegedly flawed studies
Clinical trials lawyer Gene Matthews has welcomed action from the European Medicines Agency which has suspended marketing approval for a number of medicines which it had authorised based on information from clinical studies carried out at GVK Biosciences in Hyderabad in India.
Mr Matthews, who currently acts for an individual who has been left with a serious brain injury following his participation in a clinical trial, and who has previously acted for a number of people who were severely injured following their participation in the infamous TGN1412 clinical trial at Northwick Park Hospital, welcomes the move by the EMA which affects some 700 generic drugs.
A list of the affected drugs is available on the EMA website.
The ban of the marketing of these drugs comes into effect on 21 August and will apply to all member states of the European Union.
The EMA Committee for Medicinal Products for Human Use (CHMP) made its original recommendation in January this year, following an inspection of GVK’s Hyderabad site by the French medicines agency.
That inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years.
The integrity of the conduct of trials at the site, and on the reliability of the data generated was thrown into doubt. During a re-inspection of the site the CHMP concluded that concerns still remained.
The CHMP did note that there was no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences at Hyderabad and has stated that some of these medicines may remain available in some EU countries if they are of critical importance.
The CHMP has said that patients should continue to take their medicines as prescribed, and that national authorities in each country should make final decisions about whether to suspend or allow the medicines to remain available.
The action by EMA comes at the same time as AllTrials USA is officially launched. AllTrials USA is made up of 50 patient support groups, medical societies, universities and consumer groups. AllTrials is an international initiative to ensure that clinical trial data from all clinical trials are registered and published, and that the full methods and results are made public.
At present AllTrials claims that about half of all clinical trials have never been published, and that trials with negative results about a treatment are more likely not to be made public.
Gene Matthews, a partner in the consumer law and product safety team at Leigh Day, says:
“While in this case there are no safety concerns about the medicines listed by the EMA it is good to see that the integrity of clinical trials, which is of paramount importance, is properly interrogated by the European regulatory authorities.
“Pharmaceutical companies must ensure that existing international standards on drug trials are fully adhered to, particularly where drug companies chose to test their drugs outside Europe and the US.
“The campaigning work that AllTrials is carrying out is critically important as it lobbies to ensure that all clinical trial data is published. It is equally important that the methodology of all drug trials is scrutinised and fully transparent so that the integrity of drug trials, wherever they are held, can by relied on by medical and scientific professionals.”