#1922
The Institute of Medicine (IOM) is a advisory group setup to provide our government with "independent, objective, and evidenced based' advice on medical issues. The IOM was established in 1970 under the charter of the National Academy of Sciences.
On Friday this group released a report on our nation's antiviral stockpile, calling for clarification of how it will be used, and strongly suggesting that the quantity on hand will be inadequate.
Here is an excerpt from the CIDRAP (Center for Infectious Disease Research & Policy) reporting on the story, follow the link to read the entire article.
IOM: US likely to need bigger antiviral stockpile
Robert Roos News Editor
Apr 25, 2008 (CIDRAP News) – The US government will need to expand its stockpile of antiviral drugs if the goal is to have enough doses to treat all patients and provide preventive treatment for some others at risk in an influenza pandemic, the Institute of Medicine (IOM) says in a report issued today.
An IOM committee of experts asserts that the government needs to clarify its goals concerning antiviral use in a pandemic, because current planning documents are fuzzy on prophylactic use of the drugs.
The nation currently has about 71 million treatment courses of antivirals in federal and state stockpiles, with a goal of 81 million courses, the report says. But in a pandemic, it might take more than twice that amount to treat sick patients and offer preventive doses to people at risk for exposure on the job, it asserts.
In other key recommendations, the IOM report says:
- The Department of Health and Human Services (HHS) should launch a national effort to develop a prioritization plan for antiviral treatment and prophylaxis in a pandemic, similar to the existing program for pandemic flu vaccine allocation. The plan should be designed to be adjusted as needed during a pandemic.
- Healthcare and emergency workers who are in short supply and face repeated exposure to flu should be first in line for preventive antiviral treatment in a pandemic, followed by other healthcare and emergency workers and then by household contacts of flu patients.
- The government should set up a federal advisory panel, similar to the Advisory Committee on Immunization Practices, to provide advice on public health and medical responses to a pandemic, including antiviral use.
- The Shelf-Life Extension Program (SLEP) for antivirals in the federal stockpile—which extends the official shelf life for oseltamivir (Tamiflu) by 2 years—should be expanded to include state and private-sector antiviral stockpiles.
- The government should consider using recently expired drugs that are in supplies outside the SLEP if a pandemic causes a shortage.
The 109-page report, titled Antivirals for Pandemic Influenza; Guidance on Developing a Distribution and Dispensing Program, was prepared by an eight-member committee chaired by June M. Osborn, MD, president emerita of the Josiah Macy, Jr. Foundation.
The entire IOM report can either be ordered in paperback format, or read online, HERE.
Long time readers of this blog know I've tackled the Tamiflu question on several occasions, and I've questioned the size of our stockpile.
The idea that roughly 80 million 10-pill courses would suffice in a pandemic is based on two early assumptions, both of which are now called into question.
- The attack rate of a pandemic would be roughly 25%
- The 10-pill regimen of Tamiflu over 5 days is sufficient for H5N1
I suspect these original estimates were based more on what officials thought they could `sell' to their respective governments, more than on logic and science. Budgets are tight, and spending money to thwart a pandemic that might not happen anytime soon is politically risky.
Two years ago, the 10-pill course for 25% of the population may have been seen as about as much as pandemic planners could hope for. Better to get that, than ask for 3 times that much, and get turned down flat.
But we now know that the 10 pill course of Tamiflu is probably insufficient. And estimates of the attack rate, the percentage of people who are sickened in a pandemic, have escalated over the past couple of years, going from a conservative 25% to speculation that 50% or more of the population may be susceptible.
Right now patients are routinely given more than the 2 pills a day for 5 days (10 pill course) of Tamiflu, and still, many of them die. There are trials underway looking at whether a `double the dose for double the duration' will improve survival.
In other words, instead of 10 pills, a course would require 40 pills.
The United States, which hopes to have enough Tamiflu on hand to treat about 24% of the nation (at the lower dose), would be down to only enough for 6.25% at the higher dose.
Of course, we don't know if the higher doses will improve patient outcomes. Early data suggests that it might, but no controlled studies have been completed.
While we may find ways to extend our Tamiflu supply (Probenecid being one option), it is likely we will need at least twice as much Tamiflu as we have stockpiled in a severe pandemic.
Even at the heavily discounted price governments pay for Tamiflu, this is hardly chump change. We are talking billions of dollars to purchase, and it has a limited shelf life. Storage and distribution costs add to the bill.
One solution is to make Tamiflu easier for Americans to purchase. Right now you need a doctor's prescription, and the cost is very high. About $10 a pill. Reduce the price and eliminate the need for a prescription, and you solve a large part of your stockpiling problem.
Millions of American families would probably buy enough tamiflu for themselves if the price were reasonable, and the government was recommending it. That would move the burden of buying much of the tamiflu from the government to individuals, and it would also mean that the medicine would be in the hands of the public when a pandemic began.
Worries that the public isn't responsible enough to keep some Tamiflu in their sock drawer for a rainy day are misplaced. PSA's urging people not to use it unless a pandemic has erupted could be run on radio and TV stations, and would likely be very effective.
People aren't as dumb as their governments like to believe.
There is a risk that once it is put into play combating a pandemic, overuse could drive the virus to become resistant, rendering the remainder of the stockpile pretty much useless. And there are legitimate concerns about side effects, particularly among teenagers and children.
And finally, Tamiflu is not approved for children under the age of one.
So Tamiflu isn't a panacea.
But right now, we don't have a lot of options. We either fight using the tools we have, or we accept whatever a pandemic throws at us.
