Drugmakers Should Disclose More Trial Data

January 4, 2014: Doctors and researchers should have access to information from clinical trials related to all uses of medicines on the market, U.K. lawmakers said in a report to influence the government’s purchasing decisions.

The Department of Health should ensure that drugmakers register clinical trials and that methods and results of all tests are available for scrutiny, according to the House of Commons Public Accounts Committee .

The report adds pressure to the pharmaceutical industry to reveal any failures and lackluster results, in the interest of patient safety. AbbVie Inc. and InterMune Inc. sued the European Medicines Agency after the regulator said it would disclose, on request, trial data for every treatment it reviewed. The agency adopted the policy after demands for data on Sanofi (SAN)’s failed diet pill Acomplia, which was associated with suicide risks.

“Important information about clinical trials is routinely and legally withheld from doctors and researchers by manufacturers,” the panel said. “This longstanding regulatory and cultural failure impacts on all of medicine, and undermines the ability of clinicians, researchers and patients to make informed decisions about which treatment is best.”

Disclosure Increasing

Disclosure of the details of company-sponsored trials is increasing, according to research by the Association of the British Pharmaceutical Industry. Of completed studies associated with 53 new medicines approved by the EMA between 2009 and 2011, about 77 percent had results disclosed within 12 months, the ABPI review found. By Jan. 31, 2013, that proportion rose to 89 percent. The review didn’t assess the content of what was disclosed.

“It is misleading to suggest that the pharmaceutical industry routinely withholds clinical-trial data from doctors and researchers,” Bina Rawal, research, medical and innovation director at the association, said in a statement. “There is still work to be done and we are continuing on a journey to achieving greater clinical-trial transparency.”

The U.S. passed a law in 1997 requiring registration of clinical trials and expanded submission requirements a decade later. In 2012, GlaxoSmithKline Plc (GSK) pleaded guilty in the U.S. to one count of failing to report safety data about the diabetes drug Avandia.

Drugmakers including GlaxoSmithKline, the U.K.’s largest, and Paris-based Sanofi have proposed greater disclosure of test results for medicines. Those plans don’t go far enough because they don’t cover many past trials, which are relevant to products currently in use, the committee said.

Health Budget

The U.K.’s Department of Health, and the Medicines and Healthcare Products Regulatory Agency “must make sure, both prospectively and retrospectively, that clinical trials are registered and the full methods and results of all trials are available for independent wider scrutiny by doctors and researchers,” the panel said.

The state-run National Health Service spends about 10 percent of its 133.5 billion-pound ($220 billion) annual budget on medicines. The National Institute for Health and Care Excellence, which advises the NHS on which treatments offer value for money, should share information with the agency that regulates the safety of medicines, so both agencies have the information they need to do their jobs, the panel said.

Tamiflu Stockpile

The government spent 424 million pounds stockpiling Roche Holding AG’s Tamiflu in case of an influenza pandemic, despite a lack of consensus over how well the drug works, the committee said. There is disagreement over whether regulators received all the trial information on Tamiflu during the licensing process, and theCochrane Collaboration, a health-care analysis group, is now reviewing the evidence.

Once that review is completed, the government should “consider whether it is necessary to revisit previous judgments about the efficacy of Tamiflu,” the panel said. Meanwhile, before spending 49 million pounds for 2013-14 to maintain the stockpile, the health department should review the appropriate level of coverage compared with other countries.

Roche (ROG) expanded its disclosure policy last year and now releases all clinical study reports, periodic safety reports and summaries of data for all licensed, terminated or discontinued medicines via regulators, the Basel, Switzerland-based drugmaker said in a statement. Access to anonymous data on individual patients can be requested through a website as of yesterday, Roche said.

The National Audit Office reported in May that U.K. regulators are confident they have the Tamiflu information they need, the company said.

“We stand by the integrity and robustness of the data that supports the efficacy and safety of Tamiflu, and continue to strongly believe that medicines regulators should remain the gatekeeper for medicines assessment and approval,” Roche said..bloomberg