European Medicines Agency recommends suspension of 79 UK drugs trialled at GVK Biosciences

Last week the European Medicines Agency issued a recommendation that the marketing licences for over 700 drugs tested at GVK Biosciences should be suspended.

The recommendation follows concerns raised by the Agence Nationale de Securite du Medicament et Sante (ANSM), the French Healthcare Regulator, after an inspection of company’s clinical facility in Hyderabad, India.

The ASNM’s inspection uncovered evidence of what appeared to be systematic falsification of electrocardiograms during clinical trials performed between July 2008 and 2013. Of 9 clinical trials inspected, The ASNM found evidence of falsification in each and every one, with at least 10 different individuals having been involved in manipulating the data.

In response, the EMA has recommended to the European Commission that all drugs trialled only by GVK should be suspended until the trial results are properly verified, with the exception of products for which there is no alternative to meet patient needs.

A list of the drugs affected appears on the EMA website, and currently includes 79 different products available in the UK, including many widely used medications such as the diabetes treatment Metformin, stomach acid treatment Esomeprazole, and the painkiller Tramadol.

The European Commission is expected to reach a decision on whether to suspend use of any or all of the drugs affected within the next two months. In the meantime, patients are advised to continue taking their medication as usual.

Expert Opinion

The scale of the problem in GVK’s Hyderabad facility is concerning. Patients are entitled to expect that the medication they take, which in some cases can mean the difference between life and death, is tested rigorously before it is made available for use. The finding that GVK have been routinely falsifying trial results is extremely troubling and raises the question of whether the medications trialled there are actually safe for public consumption at all. <br/> <br/>"If the EMA’s recommendation to suspend the licence for GVK tested drugs is accepted, it will lead to massive disruption for patients and prescribers. New prescriptions are likely to be necessary for patients, and prescribers will have to familiarise themselves with alternatives until the safety of drugs tested at GVK is verified. <br/> <br/>"Although GVK have described the EMA’s response as disproportionate, the reality is that the company has brought the situation upon itself through an appalling disregard for patient safety. <br/> <br/>"The efforts of the ASNM and the EMA to ensure patient safety in this case are impressive and should be applauded, but the resources of pharmaceutical regulators are limited, and the industry has demonstrated time and time again that patient safety does not take priority over profit. <br/> <br/>"Clinical trials are often not openly peer reviewed like other scientific papers, and many are kept confidential by the company. Greater transparency of clinical trials is needed to ensure that this kind of analysis is properly reviewed and checked to prevent this sort of problem happening again." Matthew Newbould - Associate