Much Ado About Anything When it comes to money, anything is better than nothing. And when it comes to good health, anything is better than nothing. But when it comes to taking a powerful medication, patients who choose anything sometimes end up wishing they'd chosen nothing. All this double-speak can only mean one thing: It's time for more unintentional comedy from an FDA "expert" panel! Clear to partly clear In the final week of February, an FDA advisory panel voted to recommend that the agency approve a vaccine designed to prevent infection by the H5N1 strain of influenza - better known as bird flu. But to get that coveted FDA approval, any new vaccine must be judged to be both safe and effective. The panel voted yes on both counts. Here's where the fun starts. According to an Associated Press report, the evidence reviewed by the panel indicates that the vaccine "wouldn't protect most people." The AP also notes that an FDA spokesperson described the vaccine as safe, but "it remains unclear whether it's effective." Actually, the evidence so far IS pretty clear. In a clinical trial (unpublished, so specific details aren't available), the vaccine provided a "protective immune response" to less than half of the subjects given the highest dose. And that's no measly dose: The vaccine requires two injections (taken four weeks apart), which contain 12 times the amount of antibodies contained in a seasonal flu shot. Glass half full of nothing Of course, this new vaccine wasn't actually tested against H5N1. There's no way researchers could give subjects the vaccine, expose them to bird flu, and then stand back (WAY back) and watch what happens. In this single trial, they simply measured antibody response. And the response was so-so at best. Meanwhile, by most official accounts, H5N1 is a sleeping monster with the potential of wiping out millions in a horrific pandemic. So how can the FDA support a preventive measure that appears to be as effective as using a spatula to fight off a pack of wolves? Here's how Dr. Robert Couch (one of the advisory panel members) put it to the AP: "I am of the view that anything is better than nothing." How lame is that? Well, Norman Baylor, director of the FDA's vaccine office, managed to make it even lamer, saying that the vaccine still could prove better than nothing. See the difference? Dr. Couch states that anything (in this case, the vaccine) IS better than nothing, while Mr. Baylor will only commit to stating that the vaccine "could prove" better than nothing. Apparently Dr. Couch is the optimist and Mr. Baylor is the realist. Are you getting that warm, fuzzy, reassured feeling yet? Do the math You've got to wonder, who in the world would buy this vaccine with such a lowly outlook for its performance? Our government, of course! The AP notes that although Sanofi Aventis (the maker of the vaccine) has already produced six million doses, they won't offer them for commercial sale because the U.S. government plans to eventually purchase and stockpile 20 million rounds of the double shot vaccine. Hmm…let's see. After federal, state, and local elected officials and their families get their shots, and after all first responders (doctors, nurses, police officers, EMS personnel, Jack Bauer, etc.) get their shots, there should be just enough left for maybe…a four-man bobsled team? Ah well. No matter. The vaccine may be only slightly more effective than nothing, but if adverse side effects begin cropping up with this mega-dose med, nothing might turn out to be preferable to this particular something. | 
