News
Review questions value of flu drug Tamiflu
Medpage Today
A new review of the influenza drug oseltamivir (Tamiflu) has raised questions about both the efficacy of the medication and the commitment of its maker to supply enough data for claims about the drug to be evaluated by independent experts.
It also raises questions about the entire process of systematic review.
Researchers led by Tom Jefferson, MD, of the Cochrane Collaboration, pored over 15 published studies and nearly 30,000 pages of “clinical study reports.”
But, they reported, the clinical study information – data previously shared only with regulators – was only a part of what internal evidence suggested was available. And many published studies had to be excluded because of missing or contradictory data, Jefferson and colleagues reported.
The drug’s maker, Switzerland-based Roche, had promised after a previous Cochrane review to make all of its data available for “legitimate analyses.” After a request for the data, Jefferson and colleagues reported, the company sent them 3,195 pages covering 10 treatment trials of the drug.
But, three of the reviewers noted in a parallel report in BMJ, the tables of contents suggested that the data were incomplete.
“What we’re seeing is largely Chapter One and Chapter Two of reports that usually have four or five chapters,” according to the BMJ article’s lead author, Peter Doshi, PhD, of Johns Hopkins University.
Roche did not immediately respond to a telephoned request for comment.
