A new study published in the journal BMJ Open focuses on transparency among pharmaceutical companies, showing that a third of clinical trial results reviewed by the U.S. Food and Drug Administration (FDA) never become public. Researchers compiled the report by comparing the number of trials reviewed by the FDA to trials that were published or publicly reported, the Washington Post reported. The end result is a score that indicates how much evidence about the drug was made publicly available.
“Right now, there’s a big push for evidence-based medicine. It’s impossible to have evidence-based medicine without the evidence,” said Jennifer Miller, an assistant professor in the division of medical ethics at New York University School of Medicine, according to the Washington Post. “If the public evidence is partial or biased you risk having partial or biased [prescription] guidelines,” The study looked at a subset of 15 drugs approved in 2012. The narrow range of drugs is a limiting factor; additionally the researchers only looked at whether trials were reported and did not delve into what the data implied about the drugs.
The study authors gave the pharmaceutical companies a “Good Pharma Scorecard”. Gilead’s HIV drug Stribild received a grade of 21 percent, as 26 out of 34 trials presented to the FDA were never made public. A grade of 42 percent was given to Bayer’s colorectal cancer drug Stivarga (7 out of 12 trials never made public). Researchers graded Pfizer’s kidney cancer drug 100 percent.
Joseph Ross, an associate professor of medicine at Yale University School of Medicine and one of the authors of the study, said “To me the right number is 100 percent; if you’re selling a product on the U.S. market, the public and the clinical science community has a right to be able to review the results, and has a right to know on what basis”.
from Parker Waichman http://www.yourlawyer.com/blog/study-looks-at-drug-maker-transparency-clinical-trial-data-that-never-becomes-public/
No comments:
Post a Comment