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The European Medicines Agency (EMA) puts patient safety and commercial interests first by giving independent researchers access to clinical trial data.

By Anonymous on Jul 19, 2012

This landmark move to improve the transparency of clinical data pushes the EU ahead of the US whose recent Texas ruling added further hurdles in the move towards an informed, safer patient population. Following this decision, the EMA will hold a conference in November to discuss the different ways in which data can be made available to outside investigators at a quicker, more routine pace. All scientific data which includes the protocols (purpose, objectives, methodology etc) for each trial and full ‘raw’ data will be available for independent investigators to scrutinize.

This scrutiny of all data, whether positive or negative, means that the selective publication of drug results that ignores risks is less likely to occur. Furthermore, the EMA wants to develop guidelines that will ensure that only good quality information is made public. As a result, patients, doctors and other healthcare professionals have a better evidence base from which to make rational treatment decisions. Indeed, the importance of non-selective publication of data and independent research for patients should not be understated. As Professor Peter C. Gøtzsche, leader of the Nordic Cochrane Collaboration in Copenhagen, points out that selective reporting resulted in about 100,000 deaths from anti-arthritis Merck drug Vioxx.

Additionally, in 2009, independent researchers discovered that the scientific papers for Tamiflu were not written by academics but medical writers who communicated directly with Roche’s marketing department. This means that European governments wasted billions of Euros on a drug as a result of evidence presented by writers who selectively reported about the benefits of the drug. Very little was released about the effects, efficacy and complications of Tamiflu which resulted in irrational decisions being made by all concerned.

It is implied that the pharmaceutical industry is less likely to benefit from this change as their commercial secrets will be shared with independent researchers. However, these clinical trial secrets were never supposed to be their personal property. As a patient, I would be willing to share my personal information in trials because I believed that its results will be shared to improve healthcare for all. If my experiences are not used in this way, then I would have no reason to contribute to these trials. In the long-term, pharmaceutical companies would benefit commercially from this independent access. Unnecessary healthcare research on issues for which data already exists would not be conducted meaning that existing funds could be used for better purposes. Pharmaceutical companies could spend less time on research and more time on developing innovative medicines that could help different types of patients.

While the EMA should be applauded for this initial decision in patient safety, there is a lot more to be done. A standardised system for anonymising data as well as a set of protocols that detail how this data is to be used needs to be developed so that transparency and privacy issues are balanced equally. Although patients would be better informed about their treatment options through access to clinical data, they need to know that their private data will not be misused or distorted in any way. And this is the next hurdle that the EU faces in the ever difficult battle for patient safety.