[Ip-health] We need your help - write to your MEP and ask for full transparency and a clinical study report on all trials

Florence VANDEVELDE fvandevelde at prescrire.org
Fri May 17 08:45:14 PDT 2013

Dear David and Síle,
We will.
Please find attached some material in case it can help.
Best regards

At present, half of all clinical trials are never published. Of those that are published, only a selection of positive results is disclosed and important harms are often omitted. 
Numerous recent drug disasters would have been avoided if public access to clinical data had been publicly accessible. In fact, disclosing key information allows timely and independent data reanalysis (scrutiny by the scientific community). 

In order to protect public health, we urge you to support amendments that require the public disclosure of a complete clinical study report (CSR) as outlined by ENVI rapporteur MEP Glenis Willmott (support AMs 21 and 59):
-	Public disclosure of clinical trials data is in the direction of history. The Clinical trials Regulation could represent a historic move towards better science and ultimately better therapy and less harm for patients; 
-	It would moreover give legal certainty to the European Medicines Agency (EMA) with the implementation of its 2010 policy to widen public access to documents. 
And we ask you to reject amendments strengthening the protection of so-called “commercially confidential” or “commercially sensitive” information which – if adopted - would be a major step back and undermine the accountability of the European pharmaceutical regulatory system (reject AMs 120, 166, 169, 539, 667, 668, 669). 

Our joint letter “Clinical Trials Regulation – Protect public health: Choose transparency!” (http://www.isdbweb.org/publications/download/175) outlines:
-	Why the publication of the summary of clinical trial results is not enough; and
-	How the disclosure of detailed clinical data (raw data or in Clinical study report (CSR) format) helps to advance biomedical research. 
The Joint Letter is available at: .

Opponents to transparency are invoking obstacles, which are but a long list of red herrings. 
Please find attached our one page briefing paper “Debunking secrecy myths which hinder transparency”, which answers the following questions:
1-	Are clinical trials data “commercially confidential” data?;
2-	Does the disclosure of clinical trials data put patients confidentiality at risk?;
3-	Does clinical trials data disclosure represent an added burden for academics or non-commercial researchers?;
4-	Will clinical trials data be misinterpreted and will that scare the public?

De : david at davidhammerstein.org [david at davidhammerstein.org]
Date d'envoi : vendredi 17 mai 2013 14:22
À : ip-health at lists.keionline.org; ip-health at lists.essential.org; echanges_sympa_acces-aux-savoirs.org at listes.infini.fr
Objet : We need your help - write to your MEP and ask for full transparency and a clinical study report on all trials

Dear Friends

Today the new head of pharmaceutical company Lilly UK Jean-Michel Cosséry said that patients don’t want companies like his to spend their money sharing “old data.” These “old data” are, of course, the results on which all treatments in current use are based! Perhaps he is hoping that AllTrials can be headed off into a siding, like all previous attempts to establish transparency.

A committee of MEPs will soon vote on proposals that would increase transparency of clinical trials. However, there are 350 lobbyists for the pharmaceutical industry at the European Parliament. MEPs are hearing Cosséry’s arguments against transparency (and others) every day. We have until 29th May to make sure they hear our arguments.

 *   The trust of patients who have volunteered for clinical trials is betrayed when findings generated by their participation are locked away
 *   Incomplete information means doctors could make bad treatment decisions and miss opportunities for good medicine
 *   Researchers don’t know what was found in previous trials, or even that some trials happened, so trials are repeated unnecessarily

If you are in Europe:

The committee looking at the clinical trial regulation has 67 MEPs from 22 different European countries. Their names, the countries they represent and their email addresses can be found here<http://www.europarl.europa.eu/committees/en/envi/members.html#menuzone>. http://www.europarl.europa.eu/committees/en/envi/members.html#menuzone

Please write to the MEP(s) from your country telling them why you want increased transparency. Let us know if you have written to them and if you get a response.

If you are not in Europe:

We know these kinds of discussions are going on with every regulator around the world. Please talk to us about how AllTrials can take off in every country.

Best regards



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