The July 28 news story "FDA Approves New Drug to Battle Influenza" might better have been titled "New Flu Drug Ties in Battle With Placebo."

Many important facts about this drug, Relenza, were omitted, including the 13 to 4 vote by an advisory committee of the Food and Drug Administration in February against approving the drug for treatment of flu because of a lack of clinically significant effectiveness. One committee member stated that "there isn't sufficient efficacy to warrant me recommending this drug for my family or myself."

At that meeting, an FDA statistician presented evidence that during the clinical trials in the United States, people getting the drug were not able to return to work significantly more quickly than people who got a placebo. In addition, those who got Relenza had symptom severity scores on a 15-point scale that were less than one point better than in those who were given a placebo. In two foreign studies, the improvement was less than two points.

There also are safety concerns about the drug. In an FDA statement announcing the approval, the agency warned that Relenza "may carry risk, in patients with severe or decompensated asthma or chronic obstructive pulmonary disease. Bronchospasm [wheezing] was documented in some patients with mild or moderate asthma following administration of zanamivir."

The future discussion as to whether this drug prevents flu, as opposed to treating existing flu, must be based upon data not presented at the FDA meeting and not publicly available. For now, this drug has been wrongly approved by the FDA, despite a lack of effectiveness, for treating symptoms of a self-limited disease that is frequently confused with the common cold, thereby inevitably leading to even more inappropriate use.

There is no evidence that the drug lowers the hospitalization rate or death rate from influenza. The FDA has overridden the advice of its own advisory committee, lowered its standards and approved a drug that likely would not have been approved 10 years ago.



Public Citizen Health Research Group