Health Committee Calling for a New Code of Practice
The Health Committee at the UK’s National Institute for Health and Clinical Excellence has urged the industry to rebuild trust with professionals and the public by making all clinical trial data available.
“It should be neither legal nor considered ethical to withhold research data about pharmaceutical products,” the committee wrote in the conclusion to a reportpublished earlier this month.
The Committee expressed their belief that “there should be both a professional and legal obligation” for the pharmaceutical companies to release data on safety and efficacy of their products into the “public domain”. While appropriate precautions must be taken to protect confidentiality, the Committee appealed for the companies to accommodate the need of other stakeholders to be able to access all the information about new treatments as part of their standard practice, without waiting to the new Clinical Trials Regulation – which aims to make all the trial application information, results and data publicly accessible – to be approved.
The report came as another one in a series of initiatives aiming to increase access to clinical trial data. Concerns over inability to independently verify findings about new treatments – voiced by academics, clinicians and regulators – sparked after a series of scandals where selectively presented figures jeopardized budgets of healthcare providers and put patient interests at risk.
Examples include Roche’s Tamiflu, that was stacked by the NHS despite lack of evidence for its efficacy, and AstraZeneca’s Seroquel – antipsychotic drug used to treat symptoms of schizophrenia and bipolar disorder – which has been prescribed off-label to war veterans suffering from PTSD costing the American Veteran Association overall US$125.4 mln. This happened while the manufacturer had access to a study that showed that Seroquel did not improve patient outcome and, more importantly, that 65% of trial participants suffered serious side effects.
“Negative trials often give you as much information that is helpful as positive trials,” reminded Stephen Whitehead, the Chief Executive of the Association of British Pharmaceutical Industry, cited in the report. Nevertheless, responses to the appeals within the industry vary. In spite of an on-going campaign launched by the British Medical Journal for Roche to hand over Tamiflu data to Cochrane Collaboration for independent assessment, and the company’s commitment to do so made in 2009, the full report is yet to be released.
“There is no doubt that we support enhanced transparency of clinical research and safety information. However, this must be balanced with the need to ensure that disclosure policies protect patients’ personal data, companies’ intellectual property rights and confidential commercial information We support the release of clinical trial data on reasonable request, via a transparent and accountable process, as a more pragmatic way forward” read a statement issued by the Association of British Pharmaceutical Industry.