Transparency is the future, but do ‘pharma’ have their heads in the sand?

Transparency has been one of the defining trends in biomedical research over the last decade. However, as the recent case of Richmond Pharmacology Ltd vs the UK Health Research Authority (HRA) shows, it is not without its detractors. Against the mounting pressure of public opinion and international regulation do these last holdouts have a specific agenda, or is it simply a fear of change?

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Resistance is futile: why pharma must prepare for a transparent future
Resistance is futile: why pharma must prepare for a transparent future
Wikimedia Commons

Following a landslide of evidence that as much as 85% of research is wasted due to poor reporting, publication bias, selective reporting of outcomes and analyses, HARKing (Hypothesizing After the Results are Known), poor methodological design, lack of data sharing and replication – the list goes on – public debate has inarguably shifted in favor of transparency in research.

This is particularly true for issues concerning the existence and design of clinical trials, and the results from them. The UK Prime Minister called for a G7 agreement on clinical trial transparency, the World Health Organization issued a Statement on Public Disclosure of Clinical Trial Results, and a huge number of organizations and individuals have added their signatures to the AllTrials initiative.

Resistance to transparency

However, that is not to say there are no holdouts, as the recent case of Richmond Pharmacology Ltd vs the UK Health Research Authority (HRA) shows.

Richmond launched a judicial review against the HRA in March this year, over their clinical trial transparency proposals, which include a requirement for all previous studies to be registered, to try to bring historical data to light.

The review spanned five months of intense legal arguments and cost hundreds of thousands of pounds. The eventual verdict was that the HRA has a clear legal right to check researchers’ compliance with ethical and legal requirements to register and publish clinical trials, but that their website was unclear.

While this is inarguably a coup for the HRA and for advocates of transparency – myself included – for me it raises an important question:

What was Richmond hoping to achieve?

Back in April, when this case had yet to become widely publicized, Fergal Ó Regan, the European Ombudsman, stated “it is important that the pharmaceutical industry understand that they lose out if confidence in the system is diminished”. To my mind that was the only possible result of this courtroom drama.

It is important that the pharmaceutical industry understand that they lose out if confidence in the system is diminished.


Fergal Ó Regan
European Ombudsman

The argument essentially came down to whether clinical trial registration was a legal or an ethical obligation. It seems to me that this line of argument could be interpreted as the company not viewing an ethical obligation as binding, which could reduce confidence in their research. (Incidentally, the eventual ruling was that it is currently an ethical obligation, at least until 2016 when the new EU Clinical Trials Regulation is enacted.)

In addition, following this ruling, it is all but guaranteed that the data from Richmond will be very closely scrutinized. Analysts will go through all their research outputs with a fine-tooth comb, and any issues that arise – even innocent mistakes – will be brought to light.

Even assuming a hypothetical situation in which the ruling was reversed, Richmond would have won their battle against transparency but still at the cost of undermining confidence in their research outputs. This is especially true considering, come 2016 and the new EU Clinical Trials Regulation, they will be required register their studies anyway.

A fear of change, or something more?

Transparency is not an end in and of itself. Complete reporting and ensuring all the data are in the public domain will not automatically make science ‘better’, but what it will do is allow people to actually see how good the science was.

The increasing evidence of the current ‘crisis’ in science makes the case that research is guilty until proven innocent – unless you can show your study free of bias and fully reported, people will assume it is not. So why are companies continuing to fight this trend?

The argument that is often bandied about is the tension between the private interests of trial sponsors to preserve commercial confidentiality for as long as possible, and the wider public interest favoring greater openness and transparency. However, this argument is only relevant in the current paradigm where data is kept private; if all data from all clinical trials are made available then everyone has the advantage, and therefore no one does. After all, they are not talking about scrapping patent law.

For companies, the very act of defending ‘commercial confidentiality’ and holding onto ‘how we’ve always done it, undermines the public’s faith in the system. This could have a far more damaging – and lasting – effect on their bottom line.

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6 Comments

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Adam Jacobs

“So why are companies continuing to fight this trend?”

Wait, “companies”? Plural? I thought it was only Richmond Pharmacology fighting it? Who else is?

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Daniel Shanahan

Thanks for your comment. You are correct that the Richmond vs HRA is the only legal case to date – at least that I’m aware of – but the resistance of companies can be seen in many other ways. Examples of these would be the ‘peeping Tom’ policy that the EMA introduced for the EudraVigilance database after pressure from industry stakeholders, or the position NICE has recently taken regarding requesting clinical trial data. Resistance doesn’t always have to be quite so overt or through the courts.

That said, many companies are choosing to embrace the trend, rather than fighting it, so it certainly isn’t all companies.

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Adam Jacobs

Thanks for your answer, though I’m afraid I remain a little confused. I have never heard of the “peeping Tom” policy for the EudraVigilance database, and I’m afraid a Google search on that left me none the wiser. Could you elaborate?

And as far as I can tell NICE are all in favour of greater access to clinical trial data, so I’m not sure why you’re mentioning them in this context?

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Daniel Shanahan

Sorry, ‘peeping Tom’ is the nickname, which came from these blogs:
http://blogs.bmj.com/bmj/2014/05/22/tom-jefferson-et-al-emas-data-sharing-policy-towards-peeping-tom-based-medicine/
http://blogs.bmj.com/bmj/2014/06/13/tom-jefferson-and-peter-doshi-emas-double-u-turn-on-its-peeping-tom-policy-for-data-release/

Essentially, EMA wrote a draft policy that would introduce barriers for researchers who want to scrutinise clinical study reports (CSRs), including allowing access to CSRs on screen only and allowing trial sponsors to decide what information to redact. This has since been changed, but it was initially proposed due to pressure from industry.

The issues regarding NICE are summarised here: http://www.alltrials.net/news/nice-to-allow-companies-to-hide-information-our-response/

Thanks.

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Adam Jacobs

Here’s what NICE themselves say about access to clinical trial data. I must say I find it puzzling that anyone would regard that fighting against transparency.

https://www.nice.org.uk/news/article/nice-to-seek-greater-access-to-clinical-trial-data-when-appraising-drugs

As for the EMA “screen only” policy (I was familiar with that, but hadn’t heard it called “peeping Tom” before, though I can see how it is apt), how do you know that it was a result of pressure from industry? Any company specifically?

paul

Great insight, While the case for transparency is pretty clear, the real question is: How open is open enough? Where the line gets drawn is a critical consideration. Committing to transparency shouldn’t be confused with sharing confidential information. Rather, it means providing some insight into your thinking and considerations, so that those around you can feel involved and empowered.

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