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But there were some major catches. In the North American study, by far the largest, Relenza reduced the average duration of a flu case by only a day. When the FDA's statistician got through with the data, it looked more like half a day. And Kilbourne -- a scientist who is enthusiastic about the eventual deployment of an anti-neurominidase drug -- found even that misleading.

"In terms of the acute symptoms -- incapacitation and fever -- flu is a three- to four-day disease," he says. "So to say this drug reduces a seven-day illness to a six-day illness, when the symptoms at the end are rather trivial, is to make somewhat unfair claims of efficacy."

Furthermore, how many people could be expected to get to a doctor, get proper diagnosis of flu, and get the drug within the relevant 48 hours after the first symptoms? "Depressingly few," says Alan Sanders, an infectious disease specialist in Albany, N.Y.

Much to the astonishment of Kilbourne and other scientists, the FDA in July decided to ignore its panel's advice and approve the drug anyway. The July 26 approval memorandum from Heidi M. Jolson, director of the FDA's division of antiviral drug products, makes it clear she wasn't particularly impressed by Relenza. Glaxo's U.S./Canada study "was inconclusive in providing definitive evidence of efficacy," she writes.

Despite this, FDA officials seem to have given the thumbs up to Relenza and Tamiflu -- which is even newer and more untested than Relenza -- for another public health reason: The next time there's a flu pandemic, we need to have tested drugs available. And the only way to test these particular drugs is to give them a wider public outing than the clinical trials permitted.

Relenza, writes Jolson, "will offer an alternative therapeutic approach for an important public health problem." Adds CDC flu honcho Nancy Cox, in an Oct. 28 editorial in the New England Journal of Medicine, "Patients, clinicians and the public health community alike will be fortunate to have these new drugs. Now we must determine how they may best be used."

"I suppose the FDA felt there were so few drugs available that any drug was better than nothing," comments Kilbourne. "I don't think that's an adequate answer."

One issue the advisory panel agreed upon, which surely played a role in the FDA's decision, was the good safety profile of Relenza. (Although Relenza did appear to temporarily reduce the lung function of some asthmatics who used it, the company has put a warning label on its product, a dry powder inhaled via a spaceship-shaped device.) The FDA could more easily make guinea pigs of the public knowing that the drug was harmless -- even if it was also worthless.

That said, early tests have shown that Tamiflu, which comes in a pill, produced vomiting twice as often as the placebo.

Still, the drugs will certainly work for some people. The most encouraging use, though not the one listed on the drugs' labels, is as prophylaxis for family members of a flu patient. And the new medications may have the side benefit of lowering antibiotic use, which always increases in flu season and which contributes to the harrowing threat of antibiotic resistance.

"By treating people with something that makes them feel better a day or two earlier we'll be prescribing fewer antibiotics," predicts Sanders, the infectious disease specialist. "People want to leave the doctor's office with something and in this country that something is usually antibiotics. Now the doctors have something in their armamentarium specifically for flu."

And what about the problem of viral resistance? No one seems particularly worried about it -- yet. The flu virus is constantly evolving anyway, and there's no indication the neuraminidase inhibitors will promote the kind of radical genetic shift that would produce a pandemic virus.

"I don't see a problem of resistance with Relenza," says Kilbourne with a chuckle. "Most of the viruses are apparently fit enough to resist it already."

The next pandemic is what really worries flu scientists. They know it's coming; they don't know when, or from where.

In 1976, in an episode recounted in New York Times reporter Gina Kolata's new book, "Flu," a healthy soldier's death at Fort Dix, N.J., sent government officials into the panicked conviction they had a pandemic on their hands -- from a flu virus that originated in pigs.

They began a massive vaccination campaign for a swine flu epidemic that never came. It ended up also costing the government billions of dollars in payments to people who believed the shots gave them a crippling autoimmune disorder called Guillain-Barré syndrome.

Let's hope the FDA's apparently hasty approval of Relenza doesn't have such a sad ending.
salon.com | Nov. 22, 1999

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