Friday, December 08, 2006

Tamiflu And The Dancing Bear

#238


The most amazing thing about a dancing bear is not how well it dances, but that it dances at all. - Old Russian Proverb.


Hang around the flu forums and you will hear all sorts of opinions regarding our federal response to a potential pandemic, and few if any are complementary. The reactions are understandable. Once people start looking at the multiple failure points during a pandemic, their blood pressure begins to rise, and they begin to sweat.


For Americans, blaming the government first is an almost Pavlovian response. After all, during a crisis, they’re supposed to save us. That’s why we keep them around.


Now I enjoy taking shots at our government, mostly because they make it so easy to do. All too often, giving any government bureaucracy tax dollars and a mission is about as sensible as handing the family car keys and a fifth of whiskey to a teenager. The prospects of anything good coming out of it are slim.


But sometimes, you simply have to accept that there are genuine limits to what any government can do in the face of a pandemic. And the Department of Health and Human Service’s (HHS) Strategic Stockpile of antivirals is a prime example.


First, a little background.


Today, with the exception of palliative care, and the distant hope for a vaccine, the best weapon we have to combat an Avian Flu infection is the use of antiviral medications. There are only a handful that are believed to be effective against the H5N1 virus; Tamiflu, Relenza, and perhaps Amantadine.


None of these antivirals is a cure. It is hoped that when given early enough, these meds can reduce the severity and longevity of an infection. Early results from places like Turkey and Indonesia on human bird flu infections seem to indicate that Tamiflu, at least, may have some value.


This has set the world off on a mad dash to buy up as much Tamiflu as can be manufactured. Roche pharmaceuticals has ramped up production in order to meet the demand, but cannot produce enough to supply everyone.


Today, the United States reportedly has 20 million courses of Tamiflu in its strategic stockpile, and will add another 24 million courses over the next year. By the end of 2008, we hope to have 75 million courses in stock. Enough, it is claimed, to treat 25% of the nation during a pandemic.


A `course’ is defined as 10 pills, which has been the normal treatment for seasonal influenza. This will become important, as you will see momentarily.


While we get very little information regarding the treatment and outcome of avian flu patients, one thing that has consistently been mentioned is the need for a stronger and longer course of Tamiflu. The H5N1 virus is so overwhelming, 10 pills won’t cut it. It has been suggested that 20, 30 or as many as 40 pills per patient might be necessary.


This, of course, throws a real monkey wrench into our strategic stockpile. If it is determined that it really requires 40 pills per patient, suddenly instead of having enough to treat 25% of the nation, we have only enough for 6.25% of our citizens.


Or, I suppose we could limit the number of pills per patient to 10, ensuring that the maximum number of people gets an ineffective dose, but somehow I doubt many would find that a satisfactory solution.


Either way, we are looking at a shortfall. And if a pandemic were to erupt before 2009, when the stockpile is fully stocked, things will be even worse.


It would be easy at this juncture to point an accusatory finger at the HHS and complain bitterly over poor planning on their part. Unfortunately, the worldwide production of Tamiflu is limited, and we couldn’t buy enough to cover everyone with an effective dose if we wanted to. We in the United States are but 5% of the world’s population, and other nations have a peculiar notion that they too should be allowed to buy this drug.


The other potential fly in this ointment is the attack rate of the virus. For planning purposes, it has been widely suggested that 25% to 30% of the population could expect to be sickened during a pandemic. This number is based on our experiences with the Spanish Flu of 1918.


There are reasons to suspect that the H5N1 virus might have a much higher attack rate than we saw 88 years ago. Anecdotal evidence suggests that the attack rate in 1918 may have been moderated by a previously circulating H1N1 influenza during the 19th century, and that a milder version of the flu, which swept across the world in April of 1918, may have `inoculated’ millions against the deadly pandemic strain that hit in October of that year.


The truth is, a 30% attack rate is simply a guess, based on a dataset of one pandemic. What the next pandemic will bring in this regard won’t be known until it happens.


The bottom line here is that our Federal Government is caught in a terrible position. They are simply unable to purchase enough Tamiflu for the entire nation, and certainly not in the larger doses that are anticipated to be needed. Those drugs simply don’t exist, and won’t for years.


Assuming that the H5N1 virus doesn’t form resistance to Tamiflu, and the states are able to get the meds into the hands of infected patients early enough, the stockpile on hand will undoubtedly save many lives.


But it is unlikely there will be enough for everyone who needs them.


The HHS and the federal government will undoubtedly be blamed when this happens. Unfair, perhaps, but true. They’ve given the illusion that the stockpile will be sufficient, and perhaps that was a mistake, but they certainly aren’t responsible for the level of production of the drug or for the virulence of the virus.


Much like the dancing bear in the Russian proverb, that our government can do anything at all to mitigate a severe pandemic will be a bit of a miracle. They, like the rest of us, will be in the terrible position of having to make do with what they have.


And right now, should the H5N1 virus mutate into a pandemic, we haven't much.