The U.S. Food and Drug Administration – the agency tasked with protecting public health via regulation of everything from food safety to prescription drugs – occasionally encounters serious instances of misconduct in biomedical research. According to an investigation published in the latest issue of the Journal of the American Medical Association, these cases include
...falsification or submission of false information... problems with adverse events reporting... protocol violations... inadequate or inaccurate recordkeeping... failure to protect the safety of patients and/or issues with oversight or informed consent... [among other violations]
Study author Charles Seife, an acclaimed science writer and professor of journalism at NYU, writes that "the FDA has no systematic method of communicating these findings to the scientific community, leaving open the possibility that research misconduct detected by a government agency goes unremarked in the peer-reviewed literature." In the course of his investigation, he identified fifty seven published clinical trials for which an FDA inspection of the trial site had turned up "significant evidence" for at least of the aforementioned problems.
Study author Charles Seife, an acclaimed science writer and professor of journalism at NYU, writes that "the FDA has no systematic method of communicating these findings to the scientific community, leaving open the possibility that research misconduct detected by a government agency goes unremarked in the peer-reviewed literature." In the course of his investigation, he identified fifty seven published clinical trials for which an FDA inspection of the trial site had turned up "significant evidence" for at least of the aforementioned problems.
The problem with these problems is that they are not reported. At least, not in any meaningful way. "The FDA has no systematic method of communicating these findings to the scientific community," writes Seife, "leaving open the possibility that research misconduct detected by a government agency goes unremarked in the peer-reviewed literature." By failing to make this information readily available, the FDA compromises the ability of scientists, doctors, and the public – that means you – to remain informed about scientific trials fraught with misconduct.
No comments:
Post a Comment