re doctors prescribing medicine based on incomplete data? A global group of health care experts thinks so, and has called on the US presidential candidates to state how they will fix the problem.
In an open letter to the candidates published Thursday in The BMJ, a leading medical journal, the group says that too many drug companies report only partial results of clinical trial data. As a result, the experts say, doctors then decide which medicines to prescribe based on journal articles that don’t give an accurate picture.
The group wants all presidential candidates to say whether they support access to all clinical trial data held by federal agencies, regardless of what the trials were about, who sponsored them, what county they were conducted in, or what they found.
“Medical experiments on humans (clinical trials) are carried out in the hope of improving health and furthering science,” the group wrote. “No benefit can be derived from trials which are either invisible or reported partially or selectively.”
The experts declared that the United States “lags behind” a growing international effort to demand more transparency in clinical trials.
Dr. John Abramson, a lecturer in health care policy at Harvard Medical School, was one of the two corresponding authors of the letter, along with Dr. Tom Jefferson, a British epidemiologist and honorary research fellow at the Center for Evidence-Based Medicine at the University of Oxford.
“We’ve got a crisis in American medicine,” Abramson told STAT. “The problem is pretty straightforward. It’s that journal editors, peer reviewers, and often authors don’t have access to the data of clinical trials, but what’s published in the pages of peer-reviewed medical journals is taken as evidence-based medicine and becomes the gospel that doctors rely upon to practice medicine. This situation is untenable.”
The other signers include Dr. Marcia Angell of Harvard University, the influential former editor-in-chief of the New England Journal of Medicine, as well as professors from the University of Oxford, Australian National University, McGill University, Kings College London and the University of Toronto. The group also includes medical researchers and public health advocates from around the world.
They note that US law and regulations globally affect organizational and professional behaviors with a huge impact on health worldwide. And they point out that eight years after the passage of the Food and Drug Administration Amendments Act of 2007, a federal law that requires registration and reporting of basic results of many clinical trials of medicines and devices, “a very small number of results of registered trials have been made available and updated.” No detailed regulatory documents are available from the Food and Drug Administration, they add.