In an open letter to all US presidential candidates published Thursday in the BMJ, a group of global health care experts assert that current research regulations allow drug companies to publish incomplete and misleading results. They ask the candidates to declare whether they support improved transparency measures that would make data on drug studies publically available and open to scrutiny.
“We call for a statement by all US presidential candidates on whether they support access to clinical trial data held by federal agencies, irrespective of topic, sponsor, country in which the trial was run or results. We ask that they state what measures they would put forward, if elected, to address the scandal of invisible and distorted clinical trials.”
Currently, medical studies in human volunteers are reported in the ClinicalTrials.gov registry, but the group claims that “study results posted on clinicaltrials.gov are, by definition, incomplete and unverified.” They add that physicians and patients, in order to make informed medical decisions, require access to data that is not currently reported on the registry.
“Medical experiments on humans (clinical trials) are carried out in the hope of improving health and furthering science,” they write. “No benefit can be derived from trials which are either invisible or reported partially or selectively.”
“US law and regulations globally affect organizational and professional behaviors with huge impact on health worldwide,” but despite several legislative efforts in the EU to improve transparency, “the US lags behind.”
To read the full letter and the list of signatories, click here
