Trial Transparency: Big Pharma Pressured to Reveal Hidden DataJanuary 21, 2014
Before we try a new product, we often search online or talk to other consumers to find out how well it works and if it lives up to manufacturer promises. We dig into its history and look for inconsistencies. Should we be any less vigilant when choosing a new medicine? In the U.K., lawmakers are demanding greater transparency from Big Pharma with regard to the results of clinical research and drug trials. The House of Commons Public Accounts Committee states that the methods and outcomes of tests should be available to the medical community and patients, so that they can make more informed therapy decisions.
What will pharma companies have to reveal?
The Committee is urging the Department of Health to ensure that drug makers register clinical trials and make both methods and results available for scrutiny. Under the new system, medical professionals and potential consumers would see data from various levels of pharmaceutical quality control. Companies would also have to make visible any failures or lacklustre outcomes, providing a fuller picture to patients contemplating using the therapy. The Committee considers the routine withholding of trial information a “longstanding regulatory failure,” and hopes the Department of Health will push for full disclosure in the interest of patient safety.
Lessons from past non-disclosure
The protection of patient safety became of primary concern for the European Medicines Agency in 2008 when it suspended sales of Acomplia, a diet drug made by Sanofi. Upon reviewing post-marketing data and the results from ongoing clinical trials, the EMA learned that Acomplia doubled the risk of psychiatric disorders in obese or overweight patients. In 2012, GlaxoSmithKline pleaded guilty in the U.S. for breaching the rules of pharmaceutical quality assurance – they failed to report safety information regarding the diabetes drug, Avandia. Both pharma giants have promised greater transparency for new drug tests, but full disclosure would not apply to existing therapies still circulating the marketplace.
The Canadian perspective
In May of 2013, the Canadian government launched its Clinical Trials Database, which will provide Canadians with access to information regarding new drug research and testing. The database is mandatory for industry and will include data on phase 1, 2 and 3 clinical trials. The new system is valuable for medical professionals and patients engaged in selecting a new drug therapy, as well as potential trial participants who want as much information as possible before signing up for a new study. Health Canada describes the program as an important “initial step that will help fill an existing information gap” between drug producers and consumers, empowering patients to better understand and manage their own health care.
Would you take advantage of the Canadian database and investigate a drug before beginning therapy?