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Glyn Moody

Glyn Moody's look at all levels of the enterprise open source stack. The blog will look at the organisations that are embracing open source, old and new alike (start-ups welcome), and the communities of users and developers that have formed around them (or not, as the case may be).

Stop the EMA Backsliding on Open Clinical Data [Updated]

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Back in April, I noted that we had potentially a big win in the form of the opening up of drug safety data in the light of recent scandals that have seen big pharma companies hiding adverse effects of their products, often with fatal results. As I warned, we weren’t there yet, since the drug companies really don’t want their dirty washing for all to see, and they have been lobbying extremely hard to water down the provisions. And in fact, it seems they have succeeded, as the All Trials Web site explains:

The good proposals in the European Medicines Agency’s (EMA) draft policy on sharing clinical trial data could be at risk.

The EMA has produced a further draft of the policy which would introduce barriers to access to clinical trial data that would make the job of researchers who want to scrutinise it almost impossible.

The policy introduces terms of use which say that researchers can access the data on screen only with printing, sharing or saving of the data forbidden.

It allows the company who supplied the data to the EMA to decide which information to redact so researchers may never know what information is being kept hidden.

The EMA’s draft policy also asks researchers to agree that the companies who produced the trial data can take legal action directly against the researchers if the trial sponsor considers the researchers broke any of the conditions, introducing a new and unpredictable risk of high legal costs into routine academic work.

These are simply outrageous, and represent a real betrayal of the public by the EMA. The All Trials Web site suggests writing soon to the European Commissioner responsible for this area, using this form. I strongly urge you to do so quickly, so that we can show the Commission that this kind of backtracking is not acceptable when people’s lives and health are stake. Here’s what I am sending:

I was appalled to hear that the European Medicines Agency intends to water down its draft policy for sharing clinical trial data. This information is vitally important for guaranteeing the lives and health of European citizens: pharmaceutical companies have a duty to make it freely available for researchers to scrutinise.

This is not commercially sensitive data, since it refers only to the safety profile of the products. If the companies are not willing to allow independent researchers to download and analyse this data, we can only assume that the drug manufacturers are trying to hide problems of the kind that have caused thousands of unnecessary deaths around the world. Since they lack confidence in sharing that data, it would clearly be foolish to grant approval to these products, and they should be withheld from the market.

I would therefore like to urge you to instruct the EMA to follow the policy adopted by a huge majority of the European Parliament recently – a democratically-elected body, unlike some other European institutions involved here. If the current Director of the EMA feels unable to do that, I would like to suggest that he moves aside to make room for someone else who can. Thank you for your help in this vitally important matter.

Update: I was having problems submitting to the form linked to above – maybe you did too. So here is the direct email address for Paola Testori Coggi, the head of the directorate of the European Commission which oversees the EMA:

paola.testori@ec.europa.eu

Apparently the crucial meeting is on Thursday, so please write today or tomorrow at the latest. Here’s what I’ve sent, slightly modified from the above text:

I was appalled to hear that the European Medicines Agency intends to water down its draft policy for sharing clinical trial data. This information is vitally important for guaranteeing the lives and health of European citizens: pharmaceutical companies have a duty to make it freely available for researchers to scrutinise.

This is not commercially sensitive data, since it refers only to the safety profile of the products. If the companies are not willing to allow independent researchers to download and analyse this data, we can only assume that the drug manufacturers are trying to hide problems of the kind that have caused thousands of unnecessary deaths around the world. Since they lack confidence in sharing that data, it would clearly be foolish to grant approval to these products, and they should be withheld from the market.

I would therefore like to urge you to instruct the EMA to follow the policy adopted by a huge majority of the European Parliament recently – a democratically-elected body, unlike some other European institutions involved here – and due to come into force in 2016, I believe. If the current Director of the EMA feels unable to do that, I would like to suggest that he moves aside to make room for someone else who can.

As a journalist, I have been following (and reporting on) the emergence of the European Union as a global leader in openness and democratic accountability for some years; it would be a tragic mistake to reverse direction in a field where so many lives are at stake. Thank you for your help in this vitally important matter.

Follow me @glynmoody on Twitter or identi.ca, and glynmoody on Google

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