Editorial Note: Neal Parker, Section Head Legal, Biologics Strategic Development at AbbVie, was an industry representative on a panel organized by EFPIA – The European Federation of Pharmaceutical Industries and Associates on August 27th in Bruxelles. Parker started off with a wonderful Freudian slip saying that AbbVie’s mission is to discover new diseases.
A video of the meeting is linked to the Trade Wars AbbVie v China post. The first half of the transcript is below – the second will run next week. A great deal of the commentary about Parker’s performance here says that he displays the ugly side of the pharmaceutical industry compared to the enlightened policies adopted by GSK. I can see no difference between AbbVie and GSK. What Parker outlines here appears to me totally consistent with GSK’s current position.
The transcript comes with some commentary – further comments would be welcome. We will make a version without what may be irritating interruptions available to download when the transcript is complete next week. We will also with your help make a translation available.
Meanwhile please consider signing the RxISK petition asking AbbVie to drop their legal action against the European Medicines Agency attempting to block the release of clinical trial data. Click here to do so.
Thank you for inviting me here today. This is my first time in Brussels. I’m enjoying myself very much.
Interests of public health and commercial confidentiality can be reconciled. Companies like mine protect their business assets “in order to maintain their ability to discover” and treat “new diseases” and help patients and we believe strongly that this is itself a public health interest that has to be protected for the good of us all.
Balance – someone else said it but I agree – suggests compromise. And the extreme positions on transparency – disclose everything to everyone or disclose nothing – are both untenable and they are both not in the public health interest. [This skillfully brands the norms of Science as extreme – this is like branding Christianity as extremism – proper Christianity would be like the Church of England or the whites only Churches once common in the US or S Africa].
Current law and practice results in the release of extensive amounts of information in the marketing dossiers that we submit to regulators [in a manner that makes it impossible for them to work out what is going on].
I have one slide but it’s only one slide. It does build.
Here is a list, this graphic, of everything in our applications that is made public right now. This is a busy slide but it’s supposed to be because there is a lot of information here including safety and efficacy approval documents that come straight out of our dossiers and safety reports and assessments. And our scientists also voluntarily present results and data at conferences and we publish the results in journals and so forth [largely maybe entirely ghostwritten with no access to the data]. And this means that there is a vast amount of [skillfully selected] information that gets released to both physicians and patients right off the bat without any controversy whatever.
Now, how we approach deciding how to release what is left over is the central question and it is very much a company specific product by product analysis. Each company [marketing department] must be permitted on its own to determine what information in which of its dossiers for which of its products it needs to protect in order to prevent competitive harm.
This is how we at AbbVie try to approach such disclosure issues. Here in yellow are certain categories of information which are present in marketing authorization dossiers that may depending on the circumstances constitute confidential commercial information, what we call CCI.
There is a very good much more detailed description of this yellow information in the Joint Pharma EFPIA principles but briefly subject level data is information on individual study subjects like demographic data, lab results, adverse events. Study level data consists of the subject level data organised into data sets to be used in interpreting the outcome of a study.
Now the information in yellow may be considered confidential because it can be used by other companies to get competing products approved more quickly and that makes the information commercially valuable to us.
With this yellow information we recognize however that access to it can be central to advancing public health. So AbbVie is committed to giving others in the scientific community reasonable access to this information in order to replicate results, prove or disprove what’s in the package insert right now, prove or disprove what we’ve tried to say is accurate before, generate new ideas and basically to move science forward. This is the fundamental way that science advances and AbbVie is 100% behind it and in favor of advancing science for patients [If the data were made fully and freely available, and AbbVie had not admitted it had not even shared data with FDA in a timely fashion].
But there have to be reasonable controls put on the release of this information in order to maintain the appropriate balance, the center position that we are talking about.
Information released without prohibitions on subsequent release to companies who want to exploit the information for their own commercial advantage undermines the public interest in release of the information in the first place.
Now here in white there is a third category of information I want to talk about. We may consider this CCI depending on the circumstances also. Interpretive analyses, judgments, these include a sponsor’s characterization, theories and conclusions regarding subject level and study level results [sponsors coding of suicidal events as emotional lability]. It also includes our individual, internal, tactical decisions on how we’re going to run a study, how we are going to engage with the regulators, how we are going to confront and solve problems and challenges that we have uncovered during our clinical studies [perhaps we can say it didn’t happen because it was not statistically significant] .
A good way to think about this white information is that it is subjective compared to the yellow which is more objective – it is more information of a factual nature. The white represents the intellectual output of our scientists which we consider among our company’s most valuable assets.
The only way to protect this information is to protect it from disclosure as CCI. This information cannot be patented and it is not entitled to non-patent regulatory exclusivity. This sort of information can give other companies a tremendous competitive advantage by revealing our subjective, strategic thinking for proving the safety and efficacy of our products [what our marketing department have decided – much the same as other marketing departments – needs concealing from the public and academics rather than other companies]. And significantly third party researchers do not need access to this sort of information to conduct robust independent analyses of our data and our products.
So AbbVie’s message for the panel to consider today is that the biopharmaceutical industry is committed to the scientific process and all that it entails including responsible data sharing to both replicate or challenge what’s been done before or to spark new research and advance science.
We believe in a balanced approach to categorizing and releasing information in our dossiers that is not already made public. So the objective study data and information needed by scientists, what I will simplify as the yellow stuff, should be released accompanied by appropriate conditions and safeguards. This balanced approach AbbVie suggests serves the public interest both by releasing information for responsible use by the scientific community [in a manner that keeps the scientific community onside] and also preserving the incentives that my industry needs to keep researching, developing and getting approved new products that cure disease and help us all.
When you talk about the yellow section and we take a clinical study report, if you talk about interpretive analyses and results do you refer to the discussion and conclusion? And if this is what is meant doesn’t that enter into your labelling?
Because if I look at what typically we write in a clinical study report conclusions and discussion generally reflects in the label. So I wonder what you are driving at here.
This is the right approach. I mean, it’s not constructive to look at categories of documents and say we’re going to release this – we’ll release Annex 1, 7 and 8 and a clinical study report. Because all three categories of information are interspersed throughout all of these documents and it takes a very fine analysis which it is the burden by the way of the company to do to identify what’s sensitive.
You are right that a lot of summary information in the label which is the product of all our work is in the blue stuff, it’s in the label, it’s in the e-bars, it’s in the summaries that FDA releases, it’s all out there, it’s enough to give independent researchers the end product of our conclusions [but not the data that so often turns out to be at odds with these labels].
But the detail of the give and take, of the problem solving which is reflected in the narratives of some of these clinical study reports is internal sensitive information which is nowhere reflected in the label.
The process of getting these products approved with the regulatory agencies is a give and take of issues, challenges, re-working of data in response to regulator’s concerns or concerns that we have identified and raised ourselves which needs to be explained and articulated in documents that we submit to regulators to get products approved [our marketing departments want as much room to maneuver as possible].
And if I’m a competitor to AbbVie and I’m in a competitive landscape where there are a lot of products on the market and I want to enter that market the first thing I want is AbbVie’s clinical study report because I want to know what problems I’m going to have to confront when I try to get a product approved. And that is a competitive advantage and that’s why we consider this information, depending on the circumstances, CCI.
Aginus Kalinus (Dutch Regulatory Agency)
Did I understand it correctly that when you were talking about the yellow stuff you were mentioning adverse events? You think that adverse events might be commercially confidential information?
It is commercially confidential information because if adverse events are reflected in either patient level data or in study level data that information can be in one instance photocopied and taken to – I heard a country, I’m just going to use this as an example that was raised before, Bangladesh – I can photocopy that data including the adverse events and perhaps do a bioequivalent study and I can get a product on the market. That steals my company’s data.
That means, yes. You say, yes. Adverse events might be commercially confidential.
Yes, but it’s very important to understand that does not mean that it can’t be released.
You are aware that you are working in the health care industry? With patients and human beings?
This is descending [interesting word] into discussion points and we’ll come back to that…
Hans-Georg Eichler (EMA Senior Regulator)
I’m sorry I’ve been a regulator for many years. But I’m totally flabbergasted. What exactly is in that white field? If we ask your company – give an explanation for a signal for carcinogenicity or whatever and there is a public health concern and then you respond to that, is that what you mean in the white circle?
There are internal deliberative processes, thoughts, product of our scientists that are used to frame data, present data, organize data and argue or present that data to the regulators in a fashion that we believe supports the safety and effectiveness of our products [this is how advised by former regulators we handle you guys who are currently in post].
That information, including adverse events, to respond to the previous question, is confidential commercial information because if released other companies could use it to help them get products approved.
Now again, I want to make sure I am crystal clear on this, that does not mean that we believe the public interest does not outweigh the release of that information. In fact for all the yellow information we think it should be released. We think that the public interest if it is released under the appropriate conditions – the main condition being I promise not to share it with your competitors – then that information can be released. (25.43)