When It Comes to Flu, What You Don't Know Can Hurt You

Here’s an interesting tidbit that came out of today’s Food and Drug Administration hearing on possible adverse events among kids who’ve taken Tamiflu, Hoffmann LaRoche’s blockbuster anti-flu drug: The U.S. does not track who gets the seasonal flu, who dies from it or how they die.

The spur for the hearing was reports out of Japan that at least a dozen kids who’d taken Tamiflu died from central nervous system disorders like brain swelling and convulsions. FDA reviewers, who tracked down the individual reports by consulting with Japanese regulators and its national health care service, concluded there were confounding factors in most cases. They and Roche promised the advisory committee they’d continue monitoring reports from around the world and issue an update in two years.

The presenters for both the FDA and Roche seemed to suggest that the instances of reported encephalopathy (brain diseases) in Japan may have been related to the flu virus itself and not the drug, perhaps like the brain swelling associated with West Nile Virus. They pointed out that Japan has been aware of this phenomenon for over a decade (i.e., before Tamiflu came out) and has a number of scientists studying it.

How could Japanese scientists tease out this phenomenon while Americans remain in the dark? It turns out their national health service with its comprehensive individual records provides an excellent database for scientists investigating medical outbreaks and outcomes. Japan’s national health service also does a far better job than us at diagnosing the disease. How else can one explain the fact that a country with less than half the population of the U.S. reported 18 million influenza cases during the 2004-05 flu season, twice as many as in the U.S.?

The result is that Roche’s partner in Japan, Chugai, sold 24.5 million Tamiflu prescriptions in Japan since its approval five years ago compared to just 6.5 million in the U.S. Among children, the ratio was an even more lopsided 11.6 million to 1.3 million.

Since so few American kids have been taking the drug when they get the flu, perhaps then the U.S. would be a good “control” for testing whether there are rare but noticeable cases of encephalopathy among children who catch the flu each winter here. Then we might know that it was the flu and not the drug.

Alas, Centers for Disease Control and Prevention epidemiologist David Shay told the hearing that influenza is not a reportable disease in the U.S. Moreover, without a national health service to provide a common database, the only way the CDC can construct its estimate for how many flu deaths there are each year is through sophisticated computer modeling. In other words, they’re guessing.

Moreover, our "best health care system in the world" does a miserable job identifying kids sick with the flu. It extends beyond the fact that millions are uninsured and never see a doctor. “We’re not all that good at diagnosing influenza,” complained Janet Englund, an advisory committee member from Children’s Hospital in Seattle. “We don’t do a rapid test for flu like the Japanese do.” Indeed, a child with the flu here is just as likely to be fed useless antibiotics as an antiviral medication like Tamiflu.

Paul Krugman of the New York Times has been writing some excellent columns this week on the emerging fiasco of the Bush administration’s senior citizen prescription drug plan. He correctly argues a national health plan would make it less costly and easier to navigate for seniors.

It’s really exciting that someone is finally putting the need for a single payer system – a national health plan – on the policy agenda. But one important issue he hasn’t talked about yet is how critical national health services are to understanding the state of public health and public health needs. This is especially crucial when nations are trying to figure out the best way to prepare for potentially worrisome disease outbreaks like avian flu.

Posted by gooznews at November 18, 2005 06:18 PM