Pharmaguy's Insights Into Drug Industry News

Calls for transparency in the pharmaceutical industry have grown in recent years, focusing on issues including pricing, access to medicine and how companies report finances. While these calls for transparency have come from healthcare professionals, investors and regulatory bodies, the cause for clinical trial transparency has had a vocal leader in Ben Goldacre.

Based on trends in social media discussion over the last three months, alva has identified the following risks to the pharma sector where clinical trial transparency is concerned:

1. AllTrials expansion in the US and beyond. Multiple tweets ask for AllTrials to “go global”, and recent articles in US news media signify that awareness of this issue is likely to grow
2. Emotional campaigning linked to topics including veterinary care and prevention of patient harm. Members of the general public have shared posts using this emotional messaging to boost visibility among a patient audience
3. Campaigns to “name and shame” universities not reporting clinical trial results as required. This poses a risk to individual pharmaceutical companies that are partnered with targeted institutions – and could augment criticism of individual firms

Though the issue of clinical trial transparency currently represents only a minor risk in relation to the general public, it is possible that increasing public awareness combined with Goldacre’s determination to “name and shame” will bring more individual companies – and their record on trial transparency – into the spotlight of public discussion.

The great tragedy for the pharmaceutical industry is that it keeps denying that it lobbies against transparency in clinical trials, says Ben Goldacre.

Ben Goldacre is a British physician, academic and author of the best-selling books Bad Science and Bad Pharma. He is also a leading figure of the AllTrials campaign to register and publish all clinical trials data, past and present.

He spoke to EurActiv's editor and publisher Frédéric Simon on the sidelines of the conferenceTransparency and public health - how accessible is scientific data?

What do you think of the EU’s clinical trials regulation in terms of transparency?

Well, I think the regulation is positive in many respects and it feels unkind to talk about its shortcomings when it was so hard won. Even that is progress. But the fact remains, it does not deliver all the methods and results of clinical trials, of all the uses, of all the treatments which are currently being prescribed by doctors.

You’re referring to the historical data issue?

It’s historical data, but it also does nothing to improve access to methods and results of clinical trials on uses outside of the marketing authorisation of a drug. Even though we know that drugs are very commonly and very sensibly prescribed outside of their marketing authorisation; out there in the real world, of doctors’ practices for patients across the whole of Europe, and the world. So it has several important shortcomings.

Lastly, I think there are very serious concerns around how all of these new changes are going to be implemented by EMA (the European Medicines Agency), because we know that they are going to be redacting clinical study reports on various different grounds such as commercial confidentiality and patient confidentiality.

Now that is reasonable in principle and the devil will be in the detail. Unfortunately, the only prior example we have to go on is what happened with AbbVie. In this case, even protocol changes had been censored from the clinical study reports on their drug Humira. It’s very widely used.

I cannot see how that can be commercially confidential information; a change in a protocol. But I can see that a change of a protocol is very important for any doctor or researcher trying to interpret the results of a clinical trial, because who knows what has happened with these protocol changes? Protocol changes can sometimes be done because somebody doesn’t like the way a trial is going. Perhaps they switch the way they are measuring an end point. Who knows what’s in there?

As a basic principle, protocol changes is something which doctors and researchers need to be able to see on any trial in order to understand what was done.  In order to understand whether it was a fair test of the treatment or not. So from the very first example we have had about how EMA had dealt with actions, there are good grounds for concern.

I think there are also grounds for concern in the secret meetings that we know now the industry has had with the EMA. We have to accept that lobbyists… It’s an ugly truth. They will have meetings with elected politicians. But for a statutory body like EMA, I think it’s very concerning to hear that they have had meetings which are un-minted and inaccessible. We can’t know what was discussed.