Letter sent for publication from Bina Rawal, ABPI Research, Medical and Innovation Director.
Your article (11 June 2014) detailing the letter to NICE on draft guidance on statins highlights a few unjustified concerns about the pharmaceutical industry’s sponsorship of clinical trials, ‘hidden data’ and conflicts of interest.
The pharmaceutical industry’s responsibility for medicines is not limited to commercialisation and in the UK alone we invest £11.5million per day on research and development, which is fundamental to ensuring that our discoveries and innovations save patients’ lives. Industry’s sponsorship of clinical trials is entirely appropriate. If a company makes a new medicine it is inevitable that they would need to see how it best fits into the patient pathway so that it can be developed further in the best interest of patients. However, It would simply be wrong for us to develop medicines in isolation and we are extremely proud to work with some of the world’s leading clinicians and healthcare institutions to ensure that there is robust expert input into the trials we undertake.
As an integral part of the medicines development process, it is completely appropriate to fairly compensate healthcare professionals for their time and expertise as long as the relationships between the industry and healthcare professionals are open, transparent and ethical. In this context, there is a clear legal framework, regulatory guidance and the ABPI Code of Practice (administered by the Prescription Medicines Code of Practice Authority). This has created the highest standard of ethical interactions in the UK between the industry and healthcare professionals. We must also not forget that clinical trial data is heavily scrutinised by regulators before medicines are authorised for patients’ use – a process which is completely independent from industry.
Our industry is a strong advocate for transparency in clinical trial data. A recent study shows a positive trend of increasing levels of results disclosure for industry-sponsored clinical trials, with almost nine in ten of clinical trials for recently approved medicines having results in the public domain. As part of a global industry, we are committed to continued engagement with our European and international counterparts, as well as many other stakeholders, so that we can continue on this positive trajectory.
Bina RawalResearch, Medical and Innovation Director, Association of the British Pharmaceutical Industry (ABPI)