Are The Europeans More Open About Safety?

By Author: Steven Johnson
Total Articles: 490
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As in the US with the FDA, the Europeans have a regulatory body called the European Medicines Agency (EMA). It is responsible to approving drugs for use and then monitoring their performance once released into homes and hospitals. The problem is always one of trust. How do we know either agency is doing its work properly and protecting us as consumers? The European Union has laws supposedly guaranteeing free access to information. So governments and NGAs should be proactive and release as much information as possible. If there are gaps, citizens have the right to request the release of the information. There's a European official called an Ombudsman who has the job of policing the system and ensuring all public bodies make as full a disclosure as possible. The EMA has a database of all the adverse drug reactions reported by all European hospitals, clinics and individual doctors. In 2008, an Irishman asked the EMA to release all the data on a particular drug his son had taken to treat his acne. Shortly after starting treatment, his son had committed suicide and his father wanted to discover whether there was a pattern suggesting ...
... this drug raised a risk of suicide. The EMA refused to release this information.

The EMA argued that, without understanding the context of each individual report and having the chance to evaluate the evidence, a disclosure of all the information could be very misleading. Parliament only intended the information to be disclosed after the EMA had completed an evaluation, which might show the reports did not show sufficient cause and effect to prove a "problem". The reaction of the Ombudsman is very interesting. Essentially, he dismissed all the legal arguments and said that, if the release of raw information might be misleading, all the EMA need do is add a short commentary explaining the documents and how reliable they were. He ordered disclosure of the adverse reaction data as requested.

One of the main issues with all drugs is that, once they are released on to the market, there is little incentive to the manufacturer to follow each drug's actual performance. If it turns out less than impressive, the regulator might order it withdrawn. So for any regulatory system to protect us as consumers, the FDA or EMA should have a formal plan to monitor the performance of drugs after release. Without a proactive process to collect information about drugs, real problems may go unreported and so patients may be injured or killed.

In fact, the drug involved is Accutane and, according to the FDA, there have been a limited number of case where teens have committed suicide while taking this drug. But there is no evidence showing cause and effect. Teens with acne are more likely to grow depressed and to consider suicide a way of escaping the bullying. Nevertheless, it is good to see the Europeans being insistent on all the raw data on Accutane being released. The FDA has no comparable policy of openness and never releases postmarketing surveillance information, alleging the information is commercially sensitive.