The Journal Editorial Report | October 14, 2005 | PBS
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briefing and opinion
October 14, 2005

The Flu Shot Shortage
veterinary worker and geese
A veterinary worker holds geese to give them a lethal injection at a small farm affected by bird flu in the Siberian village of Oktyabrskoye, August 22, 2005. (AP/Sergey Ponomarev) Photo essay

Two elements combined to tell a story this week. The government, from the president down, scrambled to deal with the threat of an avian flu pandemic. And a poll showed that 87 percent of the public does not have confidence the federal government could deal with it. Influential fact, the system of creating and producing vaccines to protect us against threats like the avian flu seems to be broken.
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Mass producing the flu vaccines we already have probably would not be effective against the strain of flu being seen in Asia and Europe -- flus mutate. The present avian virus has been infecting primarily birds in Asia and Europe. Only 120 human cases have been reported with a death toll of about 50 percent.

While no human to human infections have been documented as yet it is predicted that this strain will steadily mutate, possibly acquiring changes it needs to spread easily from person to person. If that happens it could sweep around the world in a matter of weeks or months.

That's what happened in the 1918 flu epidemic, a purely avian virus mutated to infect people. 40 million people around the world died as a result. Until drug manufacturers know the ultimate genetic makeup of the mutant virus they cannot predict, produce or stockpile a vaccine sure to prevent it. Once the strain is identified it's expected to take between six months and a year to manufacture adequate stocks of the bird flu vaccine -- too long to be effective against a rapidly spreading pandemic.
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The one treatment currently believed to be useful against today's avian flu, Tamiflu, requires a manufacturing process of about 12 months and is most effective for people who already have the disease.

The U.S. will have enough Tamiflu flu to treat about four million people by the end of the year, but 90 million people might need treatment if the pandemic struck here.

Even if there were a preventative vaccine, who would make it? Pharmaceutical companies are being encouraged to voluntarily license their vaccines for generic manufacture. Roche, which owns Tamiflu, says it's willing to discuss allowing other companies to produce the drug, but doesn't believe other companies are capable of making it.

Drug manufacturers are also being asked to steeply discount sales to poor countries that cannot afford the high cost for the millions of doses that will be needed. The drug industry insists that if it did that, that would take away incentives for companies to undertake costly research on new vaccines against future health crises and they worry that potentially harmful side effects of a new vaccine could open them up to legal action.

DAN HENNINGER: Joining us to discuss all this are Kim Strassel, a senior writer for the editorial pages and Jason Riley, also a senior writer for the editorial pages. Kim, I've been talking to scientists for about a year now who have been warning that we ought to get prepared for this and yet 87 percent of the public thinks we're not going to be able to deal with it. Now I suspect they have instinctively smelled something that has been building for 20 years which is we've been eroding our vaccine production system, right?

KIM STRASSEL: Oh no, that is absolutely true. The vaccine market has been under assault for decades now. They face overregulation which makes costs very high for them. The government has been involved in buying vaccine which has pushed down profits and eroded any money they could make. There is intellectual property issues, people have been trying to strip them of their patents. They are under assault from tort lawyers. The result is that in 1967 we had 37 vaccine makers in this country. Today we have three.

HENNINGER: Let's start with the regulatory piece. Vaccine makers, like all drug makers, are regulated by the Food and Drug Administration. What has been the FDA's contribution to the situation?

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STRASSEL: Well, one part of it is that they have put in these new regulations. You do want vaccines to be safe. Vaccines are unusual in that they are one of the few things you give healthy people. So you don't want them to actually make people sick. So they have very strict standards and they should. But they have so ramped these up that the costs have become untenable for companies to comply with.

The other problem is that it's held back the sort of innovation we need if we're going to create vaccines quickly. Right now it takes about eight months to make a flu vaccine.

HENNINGER: Using chicken eggs.

STRASSEL: Using chicken eggs, right. You have to grow them basically in the chicken eggs. But there are other things, things called reverse genetics, other techniques that could actually cut this process down to two or three months. But our regulatory structure has not encouraged it and actually made it very difficult for the industry to use these.

HENNINGER: Rob, I wonder if you could talk a little bit about the incentives, or shall we say disincentives, that have been hung around the necks of some of the drug companies who are now being asked to step up and save us from the avian flu.

ROBERT POLLOCK: Drug companies for at least the last decade have been some of the favorite whipping boys of the politicians in Washington in all kinds of ways. Now we are looking to them again and saying "Geez, you know, we really need you to step up and do this."

One of the disincentives that we put to making vaccines, for example, was a program that started in the Clinton Administration, an initiative push by Hillary Clinton in fact. It's called Vaccines for Children. The idea was the government would buy vaccines to help defray the cost. But what's happened is that's taken some of the money out of that and that has been one of the contributing factors to the situation we're in today which is, as Kim said, we have only three companies that make vaccines.

STRASSEL: The cost differences are huge because of this government involvement. In 2001 if you got your child vaccinated with all the recommended doses, it cost $600 dollars to do it privately. It only costs the government $400 dollars. That $200 dollar difference was just swallowed by the vaccine companies.

HENNINGER: Jason, there are a essentially two anti-viral drugs to deal with this flu if it breaks out. One is called Tamiflu, it's made by Roche. A less well known one is Relenza made by Smith Glaxo Kline. But Tamiflu is the one that people are all hearing about now. Tell us a little bit about how Tamiflu works and how available it would be.
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JASON RILEY: First we don't want to over rely on Tamiflu and the intellectual property point that Kim was making earlier is very important. We want more companies in the business of making these drugs. People are pointing to modern medicine that if it happens we have drugs like Tamiflu out there and they say that what happened in 1918 for instance when millions of people were killed by the Spanish influenza can't happen today. We shouldn't be so sure about that.

We have a different demographic make up in society. We have more elderly people with more vulnerable immune systems for instance. We have people who have gone through radiation and chemotherapy, organ transplants -- again, millions of these people with compromised immune systems. They could be susceptible to a pandemic if one were to occur. So we shouldn't over rely on one drug.

And the other thing with Tamiflu is when the government says oh, we have 20 million doses of Tamiflu people shouldn't be confused about how a drug works, versus how a vaccine works. A vaccine you get a shot or two and you're all set. A drug like Tamiflu, to prevent getting the flu, you'd have to take every day and once you stop taking it you're susceptible to the disease again. So if the government says we have 20 million doses of Tamiflu that might help say 200,000 people deal with the drug for a 100 days. But these pandemics can last much longer than that, up to years in fact.

So, again, we want more companies in this business and the problem that we have today, the public policy has pushed companies away.

HENNINGER: Let's talk a little bit about what's known as intellectual property rights. People don't think about drugs as intellectual property rights but in fact there are patents that surround these drugs. And outside of a crisis like this there's been an effort to suppress or push back against that which makes the drug companies a little bit leery about getting involved in something like this. Maybe you could elaborate on that a little bit.

STRASSEL: Absolutely. You know we've had, especially in the AIDS field, Brazil for instance has threatened to override the patents of various companies that spent years and years and enormous amount of research money trying to come up with these, in the end, miraculous drugs. No company is going to be willing to reinvest more money into the next generation of these products or to new vaccines if they think that their products are going to be basically distributed for free in the end. And we should be concerned. Kofi Annan last week came out and his sort of contribution to this avian flu discussion was well he really hoped that intellectual property didn't get in the way of getting vaccines to people.

RILEY: That's an excellent point and it's not just international people or individuals who have been urging this thing. We have example of even U.S. officials, even republican U.S. officials who are supposed to know something about intellectual property after the anthrax scare a few years ago.

Tommy Thompson who was then the Health and Human Services secretary, came out and threatened Bayer who made Cipro which deals with anthrax. He threatened to take away their patent. So it's not just, it's the exact wrong thing we want to happen. Again, we want to encourage more companies to come into the field.

POLLOCK: And just this week a large Indian copycat drug company called Cipla announced that it was going to go ahead and copy Tamiflu and deal with the legal consequences later.

You can argue, maybe this is a sufficient emergency to justify that, but there's no doubt that there's a lot of people out there that are looking for any excuse to infringe on patents and intellectual property.

HENNINGER: Well, it strikes me it's a little bit like Katrina -- it's a test to whether the public sector can respond to a large evident threat. I think that's probably going to hold us for now.