A bitter pill to swallow? (Image: Aslan Alphan/Getty)

Should you have the right to know everything that drug companies know about the medicines you take? Researchers and transparency campaigners have been lobbying the European Medicines Agency (EMA), the body that holds this data, to make it publicly available.

They argue that holding back drug information makes it hard for patients and doctors to make informed decisions about treatment, and increases the chance that drug trials will be needlessly repeated, wasting money. Some drug companies are reluctant, citing concerns about commercial privacy.

Yesterday, the EMA announced what it plans to do.


What’s all the fuss about?

The EMA, which decides if new medicines can go on sale, has said that from January 2015 anyone can see the clinical trial data given to it by drug companies.

Doesn’t clinical trial data already get published in medical journals?

Journal articles don’t contain anywhere near all the information – only what the companies choose to include. A typical trial can generate thousands of pages of data, which get sent to regulatory agencies, such as the EMA, so they can decide whether to approve the drug for sale. What the EMA will start releasing are these much longer “clinical study reports”.

That sounds good. Why aren’t campaigners satisfied with this?

Companies can produce two versions of the clinical study reports – a full one and a redacted one with information removed that companies say is commercially confidential. Guess which one we get to see?

The redacted one?

You got it. Campaigners argue that this could allow companies to bury information about how often a drug causes side effects.

Surely drugs don’t get approved if the side effects are bad?

History suggests otherwise. Take the commonly used antidepressants known as selective serotonin reuptake inhibitors or SSRIs. Once seen as miracle drugs, it emerged that their use has been linked with a higher risk of suicidal behaviour, especially in teenagers. GlaxoSmithKline has paid out millions of dollars in compensation because its unpublished data showed that suicide risk was indeed higher in under-18s taking the drug than in those taking a placebo for one such drug, Paxil, or paroxetine.

Are there other examples of this happening?

Dangerous side effects from drugs do sometimes come to light. A popular pain-reliever called Vioxx, rofecoxib, was pulled from the market in 2004 because long-term use was found to increase the risk of heart attacks.

I don’t take these drugs, so how does this affect me?

Well, there’s a good chance you take statins – cholesterol-lowering drugs – or will be advised to at some point in the future. There’s been fierce debate over whether only people at high risk of heart attacks should take them or whether that should be extended to include people at lower risk. Opponents say the only way to know for sure if the benefits outweigh the risks is to see all of the data.

So why isn’t the EMA going to release all the data?

The agency say its current plans – to release censored versions of the clinical study reports – are a good compromise between researchers’ need for data and the drug industry’s need for commercial secrecy.

What happens next?

If the EMA doesn’t agree to publish all the data, it may have a fight on its hands. The plans have been criticised by members of the European Parliament, not to mention the vocal AllTrials campaign.

So if the EMA changes its mind and decides to publish unedited details of trials, there will be complete transparency?

No. The open access will apply only to drugs submitted to the EMA for approval from January onwards – not to the drugs we already use, the vast majority of which went on sale long ago. Campaigners want the open access rules to apply retrospectively.

AllTrials is also lobbying for all drug trials to be registered on a central website before they start, and the full results to be published afterwards. That would help stop firms doing lots of studies and cherry picking the data that presents their medicines in the best light.