By Chris Parker
By Jesse Marx
By John Baichtal
By Olivia LaVecchia
By Jesse Marx
By Olivia LaVecchia
By Tatiana Craine
By Judy Keen
I was very critical of those models that came out last fall that suggested you could put a blanket over this with Tamiflu. My whole criticism was practical—that you would never find this quick enough and confirm it. Despite the fact we now know Turkey was going on for weeks before we understood what was happening over there, it was only last week that the uncle's isolates were confirmed, almost eight weeks after the fact.
CP: There's been a lot of covering up by some governments, hasn't there? It's been repeatedly alleged of the Chinese.
Osterholm: Exactly. So my whole point is that before anyone will have even figured out that this is going on with any certainty, it'll be gone—the cow will be out the barn door. With influenza, that's just...it's something you can't pull back in.
CP: Periodically we see stories about the race to derive vaccines, but that's not conceivable, is it, until we know which viral subtype will break through?
Osterholm: Well, even that's a misconception, I think. The concern we have is that people all want to know if some new vaccine is "the answer." The problem is, we do need a new vaccine. We're dealing with a 1950s-technology vaccine with only one update. Right now, given the amount of virus needed to make vaccines for H5N1—it needs a lot more antigen [than typical flu strains]—our total worldwide capacity right now, in one year's time, is only enough vaccine to protect 100-200 million people worldwide. That's in one year after a pandemic starts. And that's it. You can't make any more, given the limited capacity we have.
So you know what? It doesn't matter if we invent vaccines if we can't manufacture them. This is a point I've tried to make over and over again. We also are approaching this from a very American-centric point of view, which in the end will be the death of us. What's going to happen is, even if we could produce vaccines for our country in a timely manner, this global just-in-time economy we live in today is going to see the rest of the world shut down. Eighty percent of all the drugs we use in this country—all the childhood vaccines, everything—come from offshore. Your cardio drugs, your cancer drugs, your diabetes drugs, 80 percent of the raw ingredients come from offshore. I could go through a whole laundry list of other critical and essential products and services that come from offshore. If the rest of the world experiences a pandemic, we're still screwed. That's what people don't understand. Somehow they have this attitude that we can wall ourselves off in the Eighth District of Minneapolis and be okay.
The bottom line is, it will be years, even at the accelerated rate we're going now, before we even get the right candidate-vaccines. Then they still have to be approved. No company's going to embark on building manufacturing capacity without the certainty of a market. And second of all, they have to know exactly what vaccine will be used and how they need to develop their plant. All this means that an influenza plant, from start to finish, would probably take three to five years to build.
CP: Why don't we have the capacity to produce more in the way of basic vaccines here in the U.S.?
Osterholm: Because it's all about the market. Today, many of the anti-infective antibiotics and vaccines are not considered blockbuster products for any pharmaceutical company. We have a number of our childhood vaccines that are down to a single manufacturer now. If you go to the Society for Health Care Pharmacists' website, you'll see a list of 42 drugs today that are in short supply because of the just-in-time supply chain. Now, you put on top of that products that are marginal in their [profit] return, and it becomes a loss leader for these companies [to make vaccines]. They want out of it.
This is not true just for vaccines, but also for antibiotics. There, we tell people to hardly use them, and only for specific purposes and limited periods. It's not like the lifestyle drugs, where you're taking your statins for the rest of your life. So they just don't see the profitability [in antibiotics]. We're in real trouble. And it's not just with respect to the flu.
CP: The one easy-to-use drug that's been shown to arrest H5N1 in humans is Tamiflu—
Osterholm: Well, that's not really true. There's no evidence that it makes a difference in H5N1 infection. I have a slide here showing that the case mortality rate in Vietnam was identical for those who got Tamiflu and those who didn't. I actually believe Tamiflu could work, but the problem is, we're applying it in the H3N2 [average seasonal flu] model. Seasonal flu grows up much slower in a human, so that if you get the drug into somebody two days after their onset, you can still have a pretty measurable impact on the severity of their illness and the likelihood they'll have complications. With the H5N1 virus, the virus storm that precedes the cytokine storm is so remarkable in those first 24 hours that if you don't have the drug onboard in those first 24 hours, it may only have limited impact.