Pharma Enlists Patients To Prevent The Release Of Clinical Trial Data

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The pharmaceutical industry is quietly working on a concerted, behind-the-scenes effort to prevent the release of clinical trial data, a flashpoint of controversy in recent years over allegations that negative information is being withheld. Trade groups in the US and Europe have so far enlisted patient advocacy groups to discourage regulators from allowing the data to become public, The Guardian reports.
However, their plan also calls for reaching out to scientific organizations and businesses about the risk of releasing or sharing confidential data, and possibly creating a network of academics across Europe to act as spokespeople for the cause. The plan was outlined in a memo written by Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations.
The move comes as the debate over clinical trial data heats up. The European Medicines Agency, for instance, is pushing to publish clinical study reports that are filed by drugmakers, although AbbVie and one other drugmaker recently went to court to block the EMA from releasing data (more here). Meanwhile, the European parliament considers legislation to require data is published in a public database (look here).
The industry trade groups maintain that releasing such proprietary data may violate trade secrets and could also cause health scares if the data is misinterpreted, an argument advanced by the patient advocacy groups, which are often in the forefront of publicizing treatments and clinical trials for experimental drugs.
“EMA’s proposed policies on clinical trial information raise numerous concerns for patients. 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,” says Matt Bennett, a senior vp at PhRMA, in a statement. “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.”
Opponents counter that the inability to independently verify study results limits medical understanding and may even be harmful to patients if side effect information is not disclosed. This issue has been at the forefront of various safety scandals involving such prescription drugs as the Avandia diabetes pill sold by GlaxoSmithKline (GSK) and the Vioxx painkiller that was withdrawn by Merck (MRK). Recently, the American Diabetes Association called on several drugmakers to provide patient-level data about their diabetes drugs in response to safety concerns (see this, this and this).
We should note that it is not unusual for drugmakers to tap patient advocacy groups, some of which maintain close ties to the pharmaceutical industry, although funding has also caused controversy. Three years ago, the National Alliance on Mental Illness was widely criticized for accepting money from drugmakers while also coordinating lobbying and pushing legislation that benefitted industry (see this). Ironically, many patient groups do not hold drugmakers in high regard, according to a recent survey (more here).
The debate over trial data disclosure, meanwhile, has played out in interesting ways. For instance, Glaxo last fall agreed to publish case study reports for all of its medicines once they have been approved or discontinued from development and the results have been published. Glaxo will also publish reports for all approved medicines dating back to its formation, but confidential patient information will be removed.
The decision came after the drugmaker paid a $3 billion fine to the US government last year to resolve civil and criminal charges that included a failure to disclose trial data, among other things, and was cautiously endorsed by industry critics. But the Pharmaceutical Research Manufacturers of America lambasted the notion without expressly mentioning Glaxo.
The trade group did, however, lash out at the AllTrials online campaign, which was launched by Sense About Sciences, among others, and calls for registering trials, disclosing results and clinical study reports (back story). About 200 patient groups, representing some 365 million patients in 60 countries, have so far agreed to back the campaign. One proponent is BMJ, which recently adopted a new policy that studies would not be published unless data was made available.
In a statement today, Tracey Brown from Sense About Science says: “We now have the prospect of really significant developments to end the secrecy and make clinical trial reporting a practical reality and, finally, some sound commitments from parts of industry. In this context, the industry associations’ strategy to get others to raise further spurious problems is backward. It should embarrass anyone associated with it. I would say to the individual companies that they should publicly distance themselves from any association with EFPIA and PhRMA’s strategy now.”
Another drugmaker that has won cautious praise is Roche, which battled for more than two years with researchers from the Cochrane Collaboration in the UK over data for the Tamiflu treatment after trying to verify efficacy results. The drugmaker initially balked, but three months ago, acceded to withering criticism and agreed to make data available from all 74 trials (back story).