Tamiflu Update from AMA

Researchers find little evidence Tamiflu reduces flu complications in otherwise healthy people.

The AP (12/9, Cheng) reports, "British researchers say there is little evidence Tamiflu [oseltamivir] stops complications in healthy people who catch the flu, though public health officials contend the swine flu drug reduces flu hospitalizations and deaths." In a review of "previously published papers on Tamiflu as used for seasonal flu," researchers "found insufficient data to prove whether the antiviral reduces complications...but concluded the drug shortens flu symptoms by about a day."
The review, appearing online in BMJ, notes that researchers were "unable to conclude that the drug is effective at reducing complications...because they do not have access to key data from eight clinical trials sponsored by the drug's manufacturer, Roche Laboratories Inc.," the Los Angeles Times (12/8, Maugh) "Booster Shots" blog reported. For its part, Roche "said that the data...simply duplicated the results from published trials and did not provide enough information to justify publication."
Bloomberg News (12/9, Cortez) reports that the finding challenges results from a previous study in which researchers concluded "that Tamiflu protects against complications." In an accompanying editorial, BMJ editor in chief Fiona Godlee noted that "the studies originally used to establish the benefits of Tamiflu were written by Roche employees and paid consultants," which "raises questions about how drugs are reviewed, approved, and distributed."
Godlee stated, "Governments around the world have spent billions of dollars on a drug that the scientific community now finds itself unable to judge," HealthDay (12/8, Preidt) reported. Study author Chris Del Marr, a professor at Bond University in Australia, wrote that "governments should establish studies to monitor the safety of Tamiflu" as "previous evidence about" its "effects on flu complications may be unreliable."
But, on its website, CBS News (12/8) reported that the World Health Organization "said data from countries around the world show that when given early, Tamiflu can reduce the severity of swine flu symptoms, though the agency recommends the drug be saved for people at risk of complications." Meanwhile, Godlee called for "new global legislation to ensure...'ready access to the raw data behind any analyses used to license and market a drug.'"
MedPage Today (12/8, Smith) reported that the editorial also "raised a series of issues...including who had access to data from Roche-funded trials, whether ghost writers were used to prepare journal manuscripts, and why some authors were not listed while -- in at least one case -- an author was cited who later said he can't recall performing the study."

Citation: AMA