EXCLUSIVE: 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 spoke to EurActiv's editor and publisher Frédéric Simon at the sidelines of the conference Transparency and public health - how accessible is scientific data?
What do you think of the EU’s clinical trials regulation for example 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 about 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.
The meetings that took place about the 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 publically?
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.
A number of concerns were being raised today at the conference about the ongoing EU-US free-trade negotiations. Do you think it’s going to shape heavily the way that clinical trials transparency is being done in the future ,or are we sort of safe now that there is a regulation in place?
No, no, quite the contrary. I think the big risk here is that bear traps will be laid in the woods so that there will be catchall phraseology used in TTIP. I can certainly envisage a situation where these bear traps will be laid with apparently neutral wording that will seem sensible and then that will be used as the foundation of subsequent derailment of positive developments within the clinical trials regulation.
So, yes, I think it’s a real threat and I think it’s an interesting example. I think there’s inequality of arms. Every word in a document like that has been thought over and in many cases by a large number of motivated, highly-educated individuals who can see significance in every word. Losers like me are not as capable at either being heard or analysing risks of the wordings of those documents.
What do you make of the argument of personal data privacy?
I wouldn’t like to say anything about any individuals, but it is increasingly clear to me that this is being used as a deliberate rhetorical tactic to derail a serious discussion around how to share individual patient data, and it is remarkable not just here but everywhere to see organisations, which report to patients, that as soon as trials transparency is mentioned, there’s no serious discussion of the mechanics of how we can positively work towards delivering it. There’s no serious detailed discussion of the huge benefits, especially for people with orphan diseases. It leads immediately to this idea that patients can be re-identified. That is of course a risk, but it’s a risk we have been managing in the world of epidemiology for generations now.
Nobody is suggesting that medical records should be posted openly on the Internet. Everybody is very clear that you need to have an application process. You have to demonstrate that you are a serious researcher with a serious question. You have to ensure that patient privacy is protected. When you see people repeatedly raising this, apparently not having heard the reassurance that came earlier in the conversation, to me that looks like it's strategic, rhetorical derailment rather than a serious attempt to engage in a discussion.
It’s very worrying to see that coming from patient groups, especially when we have already seen the leaked memo from pharma and EFPIA in which they talked under the heading advocacy strategy of how they would in their words “mobilise patient groups” to raise concerns about privacy.
I think there are a lot of people with good intentions in industry and some people with not so good intentions of course. But one thing I find very disappointing is when people imagine that they can get away with being disingenuous in public. I find it tiresome that people would say “We haven’t lobbied against transparency” when it’s clearly true. It just doesn’t seem to me that it gets us anywhere.
It’s hard to have respect for people who do that. I’m not even sure it achieves what they hope. It just looks incredibly bad. It’s the great tragedy of this whole area. The pharmaceutical industry makes products that save lives on a biblical scale. There’s this huge prize of public gratitude that is waiting to be claimed by them and they managed to shoot it all away with this incredibly seedy behavior by paying patient groups, by cover secret behavior and suing regulators to hide information.
I don’t think the benefits of that behavior are as great as the downsides. The downsides are a long game and they are collective for the whole industry. For an individual company it may seem attractive in the very short term to behave as badly as you can get away with by the letter of the law, but I think in the bigger picture, they have destroyed the reputation of the industry in which should be one of our most prized. They should be up there with teachers. It’s just extraordinary that they have managed to do that. It’s extraordinary that they have managed to do it before your very eye.
Turning to the EMA and its role as a regulator, are they not in an awkward position asking for documents to be handed over to them, but also running the risk of being sued? What is your feeling about the agency’s role generally and its job as a regulator?
I think it’s very interesting how everybody is stepping up and becoming critical of EMA. I think that makes things very uncomfortable for them. I think big and well-paid organised lobbying organisations can do a better, slicker job of talking in a very collegial fashion about their colleagues in the regulatory profession and be lovely to and about them while encouraging them to do what they want.
I’ll just say that it’s not good enough what they are doing. To an extent I think we should remember that EMA in particular over the past few years, after Guido Rasi has taken over, has made enormous leaps forward and very clearly against the hailstorm of anti-transparency lobbying from industry which they have ridiculously denied.
As a regulator, you are paid to be in that mediating position of dealing with people with conflicting demands. All I would say is that frameworks and principles have to put have to put public health first. Especially when it’s absolutely clear that transparency doesn’t conflict with commercial success. Nothing that I ask for undermines a company’s ability to make money.