I was reading John Mandrola's latest post, which is on trust in science and medical experts, see
He refers to falsification of evidence in clinical trials. I looked up the original paper:
and this mentions two of the new anti-coags, Apixaban (Eliquis) and Rivaroxaban (Xarelto).
With Rivaroxaban, the FDA inspections apparently uncovered evidence of various transgressions, such as “systemic discarding of medical records,” unauthorized unblinding, falsification, and “concerns regarding improprieties in randomization.”
With Apixaban it was found that a clinical site in China taking part in a large trial of the drug had apparently altered patient records. If data from the patients at that site was excluded, the claim of a statistically significant mortality benefit disappeared. For this reason, among others, the FDA wrestled with whether it was appropriate to allow the manufacturer to claim a mortality benefit. None of this discussion appears in the literature. The claim for the mortality benefit, which has appeared in the literature since 2011 consistently relies on the full data set, including data from the site at which the research misconduct allegedly occurred.
There's so much money to be made out of new drugs, particularly the NOACs which people tend to remain on for life, I do wonder whether there isn't a requirement for more independent trials.
I'm not sure it would necessarily change the recommendations, but I'd like to know whether NICE were aware of this evidence before they made their recommendations on the NOACs. Perhaps this is something the AFA can investigate. We have to have confidence that the drugs regime operates in our favour, not that of Big Pharma.