Clinical Trials Must be Open Data: Please Contact MEPs

Back in February, I noted that the UK's investigation into making clinical trial data freely available was somewhat subsidiary to the EU's major initiative on the same subject. The battle there between those who wish to keep clinical trials data...

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Back in February, I noted that the UK's investigation into making clinical trial data freely available was somewhat subsidiary to the EU's major initiative on the same subject. The battle there between those who wish to keep clinical trials data secret, for fear that it might show pharma companies in a bad light, and those who believe that it must be released to save money and – more importantly – save lives is now increasingly fierce.

The first of the big votes is happening in the European Parliament this week, on Wednesday. Specifically, it is taking place in the Environment, Public Health and Food Safety committee, whose UK representatives can be found on this page. The optimal situation is if one of them is your MEP: you can then write directly to them. If not, please contact your local MEP, perhaps using WriteToThem.com, asking them to pass on your views to the committee.

Since this is the first of several big votes on the issue, I thought it might be useful to explore in a little more detail why we need clinical trials to be released as open data. As I mentioned in a previous column, Ben Goldacre has written a splendid book that deals largely with this issue. Here's his excellent summary of the many problems we face:

Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques which are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don't like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects. Regulators see most of the trial data, but only from early on in a drug's life, and even then they don't give this data to doctors or patients, or even to other parts of government. The distorted evidence is then communicated and applied in a distorted fashion. In their forty years of practice after leaving medical school, doctors hear about what works through ad hoc oral traditions, from sales reps, colleagues or journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are too. And so are patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes, whole academic journals are even owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it's not in anyone's financial interest to conduct any trials at all. These are ongoing problems, and although people have claimed to fix many of them, for the most part they have failed; so all these problems persist, but worse than ever, because now people can pretend that everything is fine after all.

That's the bad news. The good news that there is quite a simple way to address most of these problems: by forcing drug companies to make clinical trials data publicly available.

If that happened, other scientists could look at the results and find out whether drugs were really safe. Statisticians could look and see if tricks have been used to get "good" results for a drug. We know from other situations that once people are certain that they will be found out for cheating, they generally stop. If drug companies were forced to release all the clinical trial data they would not be able to make claims that could not be confirmed by other people.

Making this information available would stop people taking medicines that don't work, and that might even be dangerous. For example, in a rare case of the true facts about a drug coming to light, it turned out that GlaxoSmithKline's diabetes drug Avandia could cause heart attacks: a scientist estimated that Avandia could have been responsible for 100,000 heart attacks in the US alone. What's worse is that GlaxoSmithKline knew Avandia had dangerous side effects: in November 2011 GlaxoSmithKline agreed to pay $3bn to the US government as a fine for concealing this important information.

That's just one recent case that we happen to know about. There are probably thousands of others, perhaps causing even worse harm to patients. If GlaxoSmithKline had released the clinical data, other scientists could have warned about the risks before those 100,000 people suffered heart attacks as a result of taking the new medicine.

Aside from the suffering and even deaths that this causes, there is another important reason why clinical data must be made available. Without it, we don't know if medicines are even worth buying or not. A good example is Tamiflu. During the swine flu scare in 2009, the UK government spent £500 million - around 5% of the entire £10bn NHS drugs budget – buying supplies as protection against swine flu. But Roche, the drug's manufacturer, has published fewer than half of the clinical trials that it has conducted on it, and has only now agreed to release important information about these trials, partly as a result of the current calls for opening up clinical data. So we don't know yet if Tamiflu is actually any better than paracetamol – and whether we have wasted £500 million buying ineffective medicines.

At a time when the NHS is being cut back, this kind of waste is completely unacceptable. Add to that the certainty that millions of people have suffered and died over the years from taking dangerous medicines, and that most of us have taken medicines that don't work, and you have a truly scandalous situation.

We need to make it compulsory for all clinical trials data to be published as part of the drug approval process. After all, the public has a right to this information: clinical trials are conducted on ordinary men and women who volunteer to take unproven new medicines not to make pharmaceutical companies richer, but to help make sick people better. If drug companies withhold this data, they are not only failing to keep their side of the bargain with those selfless volunteers, but we can only assume they have something to hide.

Here's what I've sent to me MEPs. I've kept it short, since this is only a preliminary vote, and none of my MEPs representing London is on the Committee.

I am writing to you in connection with the meeting of the Committee on the Environment, Public Health and Food Safety this week, during which the issue of clinical trials will be discussed. As you know, this is a crucially important topic that has implications for the health of all European citizens; it also has the potential to help governments and the public to save billions of Euros each year.

I would therefore be grateful if on my behalf you could please urge your colleagues to take the following actions when considering this matter:

(a) to support amendments that require the public disclosure of a complete clinical study report (CSR) as proposed by ENVI rapporteur MEP Glenis Willmott, rather than any less complete versions;

(b) to reject amendments strengthening the protection of so called "commercially confidential" or "commercially sensitive" information which would undermine the accountability of the European pharmaceutical regulation system.

It's important to remember that this is purely safety information – there is nothing commercially sensitive, except insofar as companies may be trying to cover up the presence of unannounced side-effects. Indeed, the only reason for keeping this vital data secret is if pharmaceutical companies have something to hide.

Assuming they do not, they should be welcoming this opportunity to show their readiness to do everything to promote the health and well-being of the public, which is their core business. Anything less would be a betrayal of the trust 500 million Europeans place in their products.

Thank you for your help.

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