At 6:30 AM, I kissed my 14-week-old son Joe on the forehead and headed off to work at the hospital. By 3 PM I was back in bed with a hacking cough and a fever. I had influenza.
As a doctor training in infectious diseases, I knew that the flu can be dangerous in vulnerable populations like little babies. I had visions of Joe being admitted to the pediatric intensive care unit, as I swallowed a pill of oseltamivir (brand name “Tamiflu”) and shivered under the covers.
Should I also give my little boy Tamiflu to prevent him from getting sick? The answer should be clear to an infectious disease physician-in-training, right?
I felt competing instincts. Paternal: to “do something” to prevent Joe from getting the flu. Medical: “do nothing,” as the rampant overuse of antibiotics in children has had negative consequences and the same might be true for antivirals.
As I researched the question further, I learned that the decision to give prophylactic Tamiflu is anything but simple.
Close contacts of people with the flu (including babies) can receive Tamiflu if they are at high risk for influenza complications. One Greek study of 13 newborns found that the drug was safe but did not address its effectiveness. Moreover, the number of babies who would need to receive Tamiflu to prevent one serious case of influenza is unknown.
In the fall of 2009, at the height of fears over swine flu, our research group discovered that a majority of clinical trial data for the anti-influenza drug Tamiflu ― data that proved, according to its manufacturer, that the drug reduced the risk of hospitalization, serious complications and transmission ― were missing, unpublished and inaccessible to the research community. From what we could tell from the limited clinical data that had been published in medical journals, the country’s most widely used and heavily stockpiled influenza drug appeared no more effective than aspirin.
After we published this finding in the British Medical Journal at the end of that year, Tamiflu’s manufacturer, Roche, announced that it would release internal reports to back up its claims that the drug was effective in reducing the complications of influenza. Roche promised access to data from 10 clinical trials, 8 of which had not been published a decade after completion, representing more than 4,000 patients from every continent except Antarctica. Independent verification of the data seemed imminent. But more than two years later, and despite repeated requests, we have yet to receive even a single full trial report. Instead, the manufacturer released portions of the reports, most likely a very small percentage of the total pages. (One of us, Tom Jefferson, has been retained as an expert witness in a lawsuit relating to some of these issues.)