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EXCLUSIVE: The great tragedy for the pharmaceutical industry is that it keeps denying that it lobbies against transparency in clinical trials, says Ben Goldacre.
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.
You mean the meetings that took place in preparation for the EMA's pro-active transparency policy?
This is correct. The ones that have been complained about by Jim Murray [EU health blogger and former director general of the European Consumers’ Organisation] in his latest complaint to the EU Ombudsman.
There’s a mention in the new clinical trials regulation which says that clinical trial information can be withdrawn from reports if they can be considered as commercially sensitive. We did hear today though at the conference that the concept of commercially-sensitive information is pretty vague. How much of a concern is this to you?
I think it would be naïve to imagine that if the Parliament was to give a clear definition of what commercially confidential information then that would suddenly resolve all the disputes. I think it would open up a whole new raft of legal arguments, but I think it would at least be a step forward.
So I think it’s problematic that there’s not a clear definition of that. I have to be clear: there are many commercial aspects of a drug have absolute no interest for doctors, researchers or patients. It’s boring, banal and nobody cares.
However, sometimes people try to say that if a competitor has applied for information about clinical trials that must by definition be the kind of commercial activity that we should automatically regard as unacceptable.
I think that that’s mistaken, because sometimes the people who are in best place to spot shortcomings in your trial design, or perhaps even risk signals in your data, are your competitors. They are best placed because they have the same academic skills set that you have so they are able to spot methodological shortcomings or risk signals in data. They are also highly motivated to spot those adverse signals.
But that’s not going to happen…
That’s not commercially confidential information. That’s absolutely fine. Some people say that they are very angry that drug companies have applied for other drug companies’ clinical study reports. I say “well, fine”. Very often drug companies spot or give a platform to concerns about side effects of their competitors’ drugs. That is perfectly acceptable within their rich ecosystem of public discussion.
They would probably have an interest in not doing that publicly...
I think if a motivated and capable group of people are interested in spotting risk signals of side effects in another company’s information then that sounds like a very sensible use of everybody’s time. The whole point of science is about replication and reviewing it. It’s about showing your're working.
Unfortunately, we live in a world in which people are able to obfuscate the shortcomings of their trial design. They are able to obfuscate signals of harm from their drug. They do that for commercial reasons.
If you are asking me to suddenly feel upset that now there’s going to be a group of people who for commercial reasons are going to be enabled to help spot those risk signals which others have sought to hide, I would say that sounds fine to me. It’s a very different category of competitive commercial use of data to the things we can all agree on are unacceptable, like, for example, downloading one company’s clinical study report and then going to a developing country and getting a marketing authorisation for the same molecule. That is obviously unacceptable. And it’s very straightforward to put legal framework in place to stop that happening.
Similarly, I don’t think that we need to share any information in the discussion between a company and a regulator necessarily where they are saying “We’re thinking about applying for a marketing authorisation on x or y”, but if there’s clinical trials data that is germane to that commercial decision, then that trial data is also germane to treatment decisions being made by doctors and patients. So that should be made available.
A company’s commercial interest, I have absolutely no interest in. A company’s manufacturing methods, I have no interest in. But methods and results of clinical trials must always be in the public domain.
Full article here: http://www.euractiv.com/Graham
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