Quotes of the Day
It isn't hard to understand how the U.S. wound up with a major shortage of flu shots this year. Making the vaccine is notoriously difficult, and the process is prone to production problems and manufacturing delays. In addition, only two companies — Chiron and Aventis Pasteur — were licensed to produce the injections for the U.S. market, compared with five in Britain, six in France and eight in Germany. When Chiron had to withdraw 48 million doses of vaccine in early October because of contamination problems, the remaining 55 million or so doses being made by Aventis simply weren't enough to satisfy everyone who wanted to get inoculated. That set off the panicky scramble for available shots that has drawn so much press coverage in the past few weeks.
What is harder to fathom is why this is happening again. After all, there have been supply problems with flu vaccines for each of the past four years. Several government and academic reports have addressed the issue since 2000, when manufacturing glitches resulted in an almost two-month-long delay in shipments of vaccine. And although the problems have come to a head in the past few years, their roots go back at least two decades. "A lot of people have been asleep at the wheel," says Dr. Frank Sloan, director of the Center for Health Policy, Law and Management at Duke University in Durham, N.C. "There are systemic problems that needed to be ad- dressed and haven't been."
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This being a presidential-election year — in case you hadn't noticed — it didn't take long for the political campaigns to start pointing fingers. John Kerry blamed the President, saying the Bush Administration had ignored repeated warnings that the situation was deteriorating. Bush blamed trial lawyers for driving so many manufacturers out of the market in the first place. But there wasn't much evidence that voters were buying any of it. Although 61% of participants in the latest ABC News poll say they are concerned about the shortage, the issue doesn't appear to be changing their minds about the candidates. "I mean, 40% of the people are going to blame the President for clouds in the sky," Karl Rove, Bush's chief political adviser, told TIME. "But by 3 to 1 and 4 to 1, this argument is being rejected by the country."
Congress turned out to be tone deaf in responding to the crisis. Not long after the Centers for Disease Control (CDC) asked doctors to vaccinate only those at highest risk of deadly complications — people over 65, pregnant women, young children and patients with chronic medical conditions — the office of Dr. John Eisold, the Capitol's attending physician, was still freely dispensing vaccine. Some House and Senate members defended the practice on the grounds they meet a lot of elderly and sick people and shake a lot of hands — despite the fact that both President Bush and Senator Kerry had announced that they, as healthy, civic-minded Americans, would forgo the shots. Only after some Republicans and Democrats protested did Congress decide to vaccinate just those at high risk and donate 3,000 leftover shots to local health services in the District of Columbia.
Determined to put the best face on the situation, Secretary of Health and Human Services Tommy Thompson held a press conference that went a long way toward reassuring the country that the shortage wasn't as bad as it seemed. He announced that government officials were working with their counterparts in other countries — including Canada, of all places — to see if they can buy a few million doses on the international market. For legal reasons, the Food and Drug Administration may have to give foreign vaccines temporary approval as investigational drugs. At the same time, Aventis reported that it should be able to manufacture and distribute an additional 2.6 million doses by January — giving recipients just enough time to build up some immunity before the flu season ends.
Later Thompson called a teleconference to give reporters a mini-seminar on vaccine distribution. "Everybody thinks all the flu vaccine is out there," he explained. "And if your doctor doesn't have it now, you don't have a chance to get it. That is not true. There's a lot of vaccine still to be shipped. So if you're out there and you don't have a vaccine or your doctor says they don't have any vaccine, please be persistent, call back, because over the course of the next seven weeks, we're going to try and get to as many hot spots as we possibly can."
Meanwhile, the presidential candidates seemed to have moved on to other issues. The Kerry campaign announced it was releasing a television ad blaming the Administration for the flu snafu but never aired it. President Bush mentioned the issue a couple of times in speeches last week, then ignored it in most of the others. Kerry aides insist they are satisfied that even if the attacks haven't driven Bush's numbers down, they have put the Administration on the defensive.
Still, the whole fiasco left many voters shaken, worried about what winter would bring. Even when flu vaccine is in plentiful supply, 36,000 Americans, on average, die of influenza or its complications each year — in part because the vaccine isn't as effective in the elderly as it is in the young and in part because only about half of men and women over 65 generally get the shots. One infectious-disease specialist speculated that there could be a 25% surge in deaths this year owing to the shortage. Economists calculate that it could cost the economy as much as $20 billion in lost productivity, about double the amount for an average flu season. But in truth, there's no way of knowing in advance.
A lot depends on whether Mother Nature cooperates. Sometimes the flu season peaks in December. Sometimes it peaks in January or February. So far, there's no indication that this will be a particularly rough year, and there's some reason to hope, based on the early cases of flu that have already been reported, that this year's version could be a mild one. There have been some troubling instances of bird flu in Thailand and Vietnam but no widespread outbreak among humans — which is good, given that there is still no vaccine for bird flu.
A lot also depends on how businesses and local governments respond. What most Americans outside the medical community probably don't realize is that a 50% cut in the vaccine supply does not affect all doctors, hospitals and clinics equally. To get a better price, many health groups contract with a single supplier for their vaccine. Indeed, some are required by law to do so. Most of those who were lucky enough to have ordered from Aventis had at least some vaccine on hand. But those who ordered exclusively from Chiron had none at all — and they include some of the country's leading hospitals. "We were wholly dependent on Chiron," says Dr. Herbert Pardes, head of New York-- Presbyterian Hospital in Manhattan. "We're trying to reach out to those who have supplies."
The CDC is working with Aventis to try to reallocate the remaining vaccine to people at greatest risk. In theory, there should be nearly enough vaccine to do the job. But the distribution system in the U.S. is so haphazard and complex, it seems unlikely that everyone in a high-risk group who wants a shot will get one this year. (One positive note: there doesn't appear to be a shortage of pediatric flu vaccine for children ages 6 months to 23 months, since Aventis was the only company licensed to make it for the U.S. market.)
But unless the U.S. does something to address the underlying issues, the country is going to face the same or even greater problems in the future. The bottom line is that flu vaccine, as it is designed and manufactured, is too expensive to make in the U.S. for the price at which it is usually sold. There are many competing interests that work to keep it that way, starting with the people who are rolling up their sleeves to get jabbed. "Consumers seem quite sensitive to the price of their flu shot," says Mark Pauly, a health economist at the University of Pennsylvania's Wharton School. "On one hand we're outraged that our measly $7 shot isn't available. But if it cost $70 a shot, I can guarantee it would be available."
At that price, of course, many seniors would just skip it. But when a panel of experts that included Pauly and Duke's Sloan proposed that the government pay for a broader vaccination system that encouraged everyone to get vaccinated and set a price high enough to bring more competitors into the market, federal health officials and the pharmaceutical industry balked. Government officials said they didn't have that kind of budget, and drugmakers objected to the idea of price controls.
Why does it cost so much to make flu vaccine? For one thing, it's hard to manufacture. The virus comes in many strains, only some of which cause problems in any given year. The strains mutate rather quickly, which means flu shots, unlike most vaccines, must be reformulated annually.
As if that weren't enough of a headache, the main technique for making flu vaccine hasn't changed much in five decades and remains tricky and time consuming. The viruses are cultured in fertilized chicken eggs, which are particularly susceptible to bacterial contamination. Moreover, eggs aren't the most reliable culture medium. Sometimes the virus takes; sometimes it doesn't. Manufacturers cover themselves by using millions of eggs to make up for any slow-growing strains.
Every year it's a race to the finish. It generally takes six to eight months to grow enough virus, chemically inactivate it and blend the strains to make the vaccine. Because it takes a few months just to figure out which viral strains need to be added or dropped from year to year, there's barely enough time to get a vaccine produced before the next flu season begins. Indeed, says Wayne Pisano, a vice president of operations at Aventis, the only way most pharmaceutical companies can produce enough vaccine on time is by making an educated guess in autumn about which strains will be prominent the following year and preparing their seed stocks accordingly. By March, when international health experts have decided which strains they believe will be likely to cause the most trouble, the industry is either on schedule or has to scrap its efforts and start again.
Product liability is both more and less of a problem than you might imagine. Manufacturers cannot factor into the price of their vaccine the cost of a potential lawsuit the way they can with blockbuster drugs because no one would buy the vaccine. But that means they are assuming some hard-to-measure level of risk. "[The industry is] not getting a lot of lawsuits," says Dr. Adel Mahmoud, president of the vaccine division at Merck, which hasn't made flu shots since 1986. "But it exposes you. It puts all the liability on the provider."
Lawmakers made some progress on the liability issue 20 years ago, when they created the National Vaccine Injury Compensation Program. It began as a kind of no-fault insurance program for childhood immunizations but has been expanded since then to include some vaccines for adults. Two weeks ago, Congress passed a bill that would add vaccines against flu and hepatitis A to the list; all it needs to become law is the President's signature, which is expected any day.
One of the reasons Germany has so many competing flu manufacturers is that the law shields them from product liability. As long as a company can show that the injury claimed by a patient is included in a list of potential side effects, it is not liable for any injury. It's up to state health authorities and the courts to determine whether a claim is valid and provide compensation.
A measure that might help Americans in the short run is a commitment by the U.S. government to buy back any leftover flu vaccine — a proposal that Secretary Thompson says he favors. "If that vaccine isn't sold, it expires by the end of the year," notes Dr. Peter Paradiso, vice president for scientific affairs at Wyeth. "In 2002 we in fact were only able to sell about half [our supply]." Wyeth had to destroy the excess, worth roughly $30 million, and shortly afterward decided to get out of the flu-vaccine business.
Guaranteeing a market is one of the measures British health authorities use to ensure adequate supplies of vaccine. They contract with manufacturers for a set number of doses, which they pay for no matter how many shots are actually given. Although there is no such agreement in France, a reimbursement system achieves much the same effect.
Ultimately, however, the only way to make flu-vaccine supplies more reliable may be to get rid of the chicken eggs. Several companies are studying methods of growing the virus in mammalian-cell cultures, and at least one biotech company is experimenting with using genetic-engineering techniques to streamline the process even further. But this kind of research takes a lot of resources and may lead to vaccines that are even more expensive to produce. In any event, the newer production techniques probably wouldn't be available for at least a decade.
In the meantime, some local health authorities are setting up lotteries to distribute their allotments of flu vaccine. Mary- land's Montgomery County, taking advantage of a hotline established after the 2001 anthrax attacks, started taking names on the telephone and over the Internet and the first day registered 14,000 residents for its 800 shots.
It is already time to start planning for the 2005-06 flu season, and it's still unclear whether the U.S. will be in any better shape next year. Chiron says it isn't sure its production problems will be resolved by then, and no other drugmaker has stepped forward to take up the slack. One thing is certain: if nothing changes, we'll have flu vaccine shortages for years to come.
- Christine Gorman