One-third of the human experiments for approved drugs failed transparency requirements.
“Right now, there’s a big push for evidence-based medicine. It’s impossible to have evidence-based medicine without the evidence,” Jennifer Miller, the lead author of the study, president of Bioethics International, and an ethicist at New York University’s Langone Medical Center, told The Washington Post.
Miller and her colleagues looked at clinical studies related to 12 new drugs approved by the FDA in 2012. Among the 318 trials, a median of 17 percent were subject to reporting requirements. While all of them were appropriately registered, only two-thirds complied with the law for publication. And half of the patients who volunteered for the trials never saw their results published.
Some firms performed better than others in being transparent. Johnson & Johnson, Gilead, and GlaxoSmithKline, for instance, were 100 percent compliant for the drug each company got approved. Pfizer was totally compliant for two drugs, and failed to follow the law for another. Genentech (owned by Roche) was also noncompliant for two drugs.