The pursuit of pharma data transparency

WASHINGTON, D.C.—The General Court of the European Union hasprohibited the European Medicines Agency (EMA) from releasing data from twoAbbVie and InterMune trials in an interim ruling, part of a challenge by thetwo drugmakers to the agency's decision to grant access to information thecompanies provided as part of their market approval applications relating toAbbVie's rheumatoid arthritis drug Humira and InterMune's Esbriet, a treatmentfor idiopathic pulmonary fibrosis.

In both cases, competitors of the companies were seeking thedata. In response to the court's action, the Pharmaceutical Research andManufacturers of America (PhRMA), through its senior vice president MattBennett, issued the following statement: "The biopharmaceutical industry isfirmly committed to enhancing the public health through responsible reportingand publication of clinical research and safety information. Companies publishtheir research, collaborate with academic researchers and disclose clinicaltrial information at the time of patient registration, drug approval and formedicines whose research programs have been discontinued.

"Biopharmaceutical companies support responsible datasharing that protects patient privacy, maintains the integrity of theregulatory review process and preserves incentives for biomedical research,"Bennett continued. "Unfortunately, the EMA's current and proposed policies failto respect these principles. Companies are committed to working withmultistakeholder groups' Multi-Regional Clinical Trials Center to facilitateresponsible data sharing that benefits patients."

Nearly 2 million pages of clinical study reports and otherdocuments have been released by the EMA, "and only two companies … havechallenged EMA's releases in court," Peter Doshi, a medical researcher at JohnsHopkins University in Baltimore, said in a statement distributed by Sense AboutScience, a charity dedicated to helping people make sense of scientificevidence, which in the past has invited qualified scientists to respond to someof the wilder pseudo-scientific claims championed by the rich and famous. "IfAbbVie and InterMune win their cases, there is a real chance that the EMA'srevolution in data transparency will come to an abrupt end, returning us to theold status quo of data secrecy."

Martin Harvey-Allchurch, head of communications at the EMA,says, "We just can't [provide access to documents] the way we had in the past.It's not a decision we have taken lightly." He adds that the EMA has releasedother documents since the court case, and that a public consultation on futureaccess to clinical trial data continues.

The challenges by AbbVie and InterMune are the first to bemade to the EMA's three-year-old access-to-documents policy. Since November2010, the agency has released more than 1.9 million pages in response to suchrequests. The ruling comes amid increasing pressure from medical journals andpatient advocates on pharmaceutical companies to provide complete transparencyand make public all of their clinical trials data. It also comes as the EMAreadies implementation of a new policy to proactively publish data fromclinical trials supporting the approval of new drugs once a decision has beenmade. The EMA says it will continue the process of drafting its policy onpublication of clinical trial data.

"The European Court's decision is enormously disappointingand a clear indicator that the fight for data transparency has a long way togo," says Mark Wilson, CEO of the Cochrane Collaboration, a U.K.-basedinternational network of more than 28,000 people from over 100 countries. TheCochrane group is a principal supporter of the AllTrials initiative, whichseeks comprehensive registration and reporting of every clinical trial, pastand present, conducted worldwide. "The court's decision forces the EMA into aconflicted position—not only with its own policy to release data proactivelyfrom clinical trials, but also, and more importantly, with the interests ofpatients. Regulatory agencies cannot make good policy decisions, and healthprofessionals cannot make good treatment decisions, without full access toresearch data."

Wilson adds that this and other recent developments in thecampaign for access to clinical trial data underscore the importance ofcontinued focus on, and broader discussion of, the complex issues involved inmaking research data fully available.

In a New York Timesop/ed piece, Peter Doshi and a colleague from the Cochrane Collaboration, TomJefferson, noted that the U.S. Food and Drug Administration, "guardian ofarguably more trial data than any other entity in the world, appears stuck inthe era of data secrecy." For its part, the EMA says it welcomes theopportunity for legal clarification of the concept of commercially confidentialinformation, but has expressed regret over the decision to grant interim reliefto AbbVie and InterMune. It said it is considering whether to appeal theinterim decisions.