Drug trade bodies rally patient groups to deflect calls for full trial data

BMJ 2013; 347 doi: (Published 23 July 2013) Cite this as: BMJ 2013;347:f4702
  1. Adrian O’Dowd
  1. 1London

Two leading pharmaceutical trade bodies planned to secure the support of patients’ groups to try to resist growing calls for much greater transparency of clinical trial data, it has emerged.

An emailed memo sent to several drug companies from two trade association bodies, which was leaked to the Guardian newspaper on 22 July, showed that there were plans to recruit patient groups to resist moves that would force companies to publish more raw trial data.

The memo came from the European Federation of Pharmaceutical Industries and Associations and Pharmaceutical Research and Manufacturers of America.

Currently, drug companies publish only some results of their clinical trials, but the European Commission is seeking to change regulations in its clinical trials directive, while the European Medicines Agency is running a public consultation on the issue.

Proposed changes would mean that companies would have to publish all clinical trial results in a public database, regardless of whether or not a particular drug had proved to be effective and what side effects it caused.

Some companies have welcomed these proposals, but overall the industry is not enthusiastic, despite campaigns such as the BMJ’s open data campaign (, launched last year.1

The leaked memo from Richard Bergström, director general of the European Federation of Pharmaceutical Industries and Associations, was sent to companies such as AstraZeneca, Eli Lilly, GlaxoSmithKline, Merck, Pfizer, Roche, and Novartis.

It details an “advocacy plan” with four approaches, including a campaign that involves “mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data.”

The idea would be to encourage patient groups to campaign against the drive for all trial data to be made public because of fears that such information could be misunderstood, leading to unjustified health scares, and that patients’ confidentiality could be jeopardised.

The memo also sets out plans to talk to scientific associations about the possible risks of open data, to work with other business sectors that are concerned about the release of trade secrets and commercially confidential data, and to build a network of academies across Europe that could counteract the misuse of data and correct any misinterpretations.

Tracey Brown, managing director of the campaigning group Sense About Science, said, “We now have the prospect of really significant developments to end the secrecy and make clinical trial reporting a practical reality. In this context, the industry associations’ strategy to get others to raise further spurious problems is backward. It should embarrass anyone associated with it.”

Matt Bennett, senior vice president of Pharmaceutical Research and Manufacturers of America, said that the proposed European policies on opening up clinical trial information raised “numerous concerns for patients.”

He added, “We believe it is important to engage with all stakeholders in the clinical trial ecosystem, including the patients who volunteer to participate in clinical trials, about the issue. If enacted, the proposals could risk patient privacy, lead to fewer clinical trials, and result in fewer new medicines to meet patient needs and improve health.”

A spokesman for the European federation said, “We work with patient groups on a range of issues and value the independent perspective they bring.

“We consider it our responsibility to take into account opinions and views from all stakeholders involved in issues that have the potential to impact them directly—especially patients. In this case we have concerns about the EMA transparency policy.

“The industry supports improved sharing of research data to enhance public health while protecting the privacy of patients.”

Most of the drug companies contacted by the BMJ distanced themselves from the memo’s proposals.

GlaxoSmithKline said that it would not back the plan from the trade bodies. A spokesman said, “As a company we are absolutely committed to sharing clinical trial data, and we don’t support this approach.”

A spokesman for Roche said, “Before introducing our new data transparency policy at the beginning of 2013, we have consulted patient groups to understand their needs and concerns related to clinical trials. However, to our knowledge Roche has not been involved in any of EFPIA’s [the European Federation of Pharmaceutical Industries and Associations’] potential activity in mobilising patient groups.”

A spokeswoman for AstraZeneca said, “We have a longstanding commitment to making information about all our clinical research publicly available. We will continue to work with the industry, regulators, and a range of other interested bodies on proposals to publish full clinical trial data.”

A spokeswoman for Eli Lilly said, “Lilly is committed to working with Europe based patient advocacy organisations for the benefit of patients in a way that is true to the EFPIA code of practice and Lilly’s integrity in business policy.”


Cite this as: BMJ 2013;347:f4702


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