Gah, European bureaucrats

I’m not always in agreement with the ways of the United States. But what I do admire is what must be the greater openness of government agencies – in particular in comparison with lumbering, backward bureaucrats in the EU.

In the US, for example, there is far more public scrutiny of the process of approving new medicines than in the EU. Where there are tricky scientific issues at stake when the federal agency the FDA is considering approving a new drug it calls in the heavyweight experts – a different committee for every discipline. These experts – who are usually academic clinicians at the top of their fields – openly discuss the issues in a public meeting.

The meetings are public in the truest sense. Patients can stand up and say what a difference being on the product in a clinical trial has made to their lives. Or family members can express concern that the drug could have harmful effects on their relatives. The experts, meanwhile, bat scientific arguments back and forth and then decide on the balance of the evidence whether a drug is safe and effective.

Science is not all black and white, and there is often subtle weighing up of the pros and cons involved in approving a drug. Regulatory agencies must decide whether on the whole the drug’s benefits outweigh its risks.

But in Europe, things are done very differently. The European Medical Agency convenes a scientific advisory meeting to discuss each drug up for approval, sometimes also inviting in external experts. But this is behind closed doors and rather than the committee voting in favour of approval of a new therapy, it “issues a positive opinion”.

This bureaucratic mincing of language acts to obfuscate who is actually making a decision. Rather than allowing us to see that a committee of highly educated people teases out the good points and bad points of a potential medicine – taking into account their different areas of expertise, different particular schools of thought they have been brought up with, varying points of view that they have adopted over the years and perhaps personal prejudices and professional jealousies. “Issuing a positive opinion” removes this human element and makes us more reluctant to argue.

CLINICAL TRIALS

I think the best example of the difference in approaches is the way the agencies have responded to calls for greater public access to information on what clinical trials pharma companies are carrying out.

This has led in recent years to firms with studies running in the US pledging to register them on the US government website clinicaltrials.org. The site gives a snapshot of all the studies currently testing new asthma drugs or new typical of cardiovascular surgery, for instance.

But in the EU, it’s, surprise surprise, not that simple. While separate drug companies publish information on their websites, a pan-European website is only available to drug companies and other organisations running studies. And even they have to plough through a Machiavellian security system.

WHY?

Perhaps the EU fears making information on new drugs and trials available and opening the doors of its expert committees because of the possible misinterpretation of scientific argument…

But surely it is far better for all the arguments to be aired publicly in the first place, rather than leave the agency open to claims it overlooked, for instance, a key safety issue which rears its head in later years. The FDA is more transparent and allows the public and the media to see shades of grey.

When I contacted the European Medical Agency to ask whether I would be allowed access to the clinical trials database, I was told this was not allowed at present but there were exceptions which would make some data available in future.

“As these two derogations to the confidentiality of directive 2001/20/EC are still in the process of being implemented there is no current publicly accessible database at the EU level,” the agency continued with a brilliant example of the turgid bureaucratic language that makes it so difficult to get to the bottom of what’s going on. European bureaucrats should stop tying themselves up in linguistic knots and be as open as possible.