Swiss pharmaceutical Roche is set to publish clinical study results, after being accused of covering negative outcomes. DW spoke with Michael Doherty, Global Head of Regulatory Affairs at Roche.
DW: Roche has decided to open up or expand access to some of its clinical trials. Why exactly have you decided to do this now, apart from the fact that GlaxoSmithKline has also just said that it will take a similar step? To what extent does this have to do with the recent Tamiflu affair?
Michael Doherty: Actually, our position is more in response to the change in the EU legislation, and the fact that the European Medicines' Agency (EMA) is announcing that it wants to make clinical study reports available to the public. In the past, we haven't done this because our main underlying principle has been the protection of confidentiality of patient data - and that still is a principle we have to adhere to. But, since the environment, in terms of the legislation and the EMA is moving in that direction, it's the right opportunity for us to do the same.
So, you were concerned about patient confidentiality, rather than commercial confidentiality?
In the clinical study reports, you would say there is very little of what you would say is commercial confidentiality... The clinical study reports do not really contain anything that is commercially sensitive. If it does, we might have to remove it, but generally there will not be anything of commercial sensitivity. It's more a case of the fact that you could look at the data and identify patients - for example, a clinical trial center which only had a small number of patients, you might be able to identify who was who in that study report.
It's been noted that you plan to release, or make public, three particular reports relating to Tamiflu. Is that it, or are there other reports and studies that you are going to keep under wraps?
Our policy will be that any report that is used for regulatory purposes will be made available, so it's not specific to three Tamiflu reports. It could be to any report we've provided to regulatory authorities that has been used in the decision making around the drug.
Sure, so what you are saying is that there will be no reports left over that are not critical, basically, or crucial to a doctor's understanding of a drug and how that drug came to market?
That's right, yes.
I understand that you are going to be using an independent body to a certain extent. How are you going to go about releasing the data?
So, what we are recommending is that we support the EMA's position - that they will release the reports in full. So if anybody requests, then we will refer them to the EMA, since they are doing that. However, if it is something that the EMA cannot provide then we will provide that report. So, for example, if the requester was outside of Europe, and the EU did not feel required to respond, then we would do that. So, we will provide, without any independent assessment, any clinical study report. The independent assessment is a different thing, and I think it's probably worth making this distinction. This is for something else - this is for where people want to reanalyze the patient level data. And to do that, you need to have a team of statisticians and people who can program and so forth, and it is much more complicated than us just providing all of the data on paper. So, for that, it is quite a big investment as well from either party, and we want an independent panel just to make sure that we have an independent view that this is a scientifically valid purpose.
With this growing drive towards transparency within the European field, how do you think the landscape of the pharmaceutical industry might change? Are you worried that we may all of a sudden see a number of drugs disappear from the market because the results of the clinical trials are out there and we've discovered that perhaps they aren't so good?
I really doubt that. I think if you really believed that could be the case, you'd have to believe that the regulators aren't capable of doing their job. They apply very high standards.
But that was one thing that was seen with your drug, Tamiflu. The regulators had missed certain side-effects and issues with the drug, and that is what came out in the report from the Cochrane Collaboration - that the regulators had missed certain things. And it's not the only example of an instant in which the regulators do not see everything.
I think you might get into debates about interpretation of data, but I don't think it will be anything of a scale which would require a drug to be re-labeled or even withdrawn. It is very likely that if it did happen now, it would be quite outstanding to me. You might get into debates, however, and this sometimes might be rather pointless because it is down to interpretation.
There are some people who say that the current drive towards open access and transparency relates to drugs that have only recently come onto the market. But there are several drugs that came onto the market many years ago still being used for which certain details could be beneficial to doctors and patients if they could see inside the clinical trials data. Are you making a distinction about the kind of data that you want to release to the public? Are we talking about drugs that have come out in the last couple of years, or is this…
Our policy would go back to about 1997, which is when we think that the data - that was a time when our tools and systems - in the company were of adequate standard to be able to analyze them in a way that people might want to today. It would be very difficult to go back much further than that. I mean we have drugs where we can go back 50 years or more and they've been on the market. And you have to assume that the physicians who have been using them for many years know well how to use them and whether they want to use them. But, data going back to that kind of time would be almost impossible, so we go back as far as 1997.
Michael Doherty is the Global Head of Regulatory Affairs at Roche and is based in San Francisco, California.
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