The Flu Shot Fiasco

If you needed a flu shot last week, southern California was not the place to find it. Three weeks into the great vaccine debacle of 2004, L.A.'s Cedars-Sinai Hospital was limping along on 10 percent of its usual supply. There was no flu vaccine at San Diego's Camp Pendleton Marine Corps base, and no word from the Pentagon on when or whether the facility's 60,000 personnel might finally get their shots. Across the border in Tijuana, meanwhile, Dr. Enrique Chacon was cheerfully administering freshly bottled Aventis Pasteur flu vaccine. There are no waiting lists at his well-scrubbed Grupo Pediatrico children's clinic, no restrictions on who can get a shot. And though many of Chacon's patients are locals, he stands ever ready to help a northerner in need. "Viruses cross borders without a visa," he says. "If there is influenza on one side, there will be influenza on the other. We need to vaccinate everyone."

If only we could. As recently as three weeks ago, health experts assumed that 100 million Americans would have access to flu shots this fall. That was before British authorities shut down a Liverpool production plant operated by the U.S. company Chiron. Overnight, the U.S. vaccine supply shrank by nearly half, prompting restrictions on access, a surge in demand and a mounting sense of panic among doctors, patients and parents.

Scalpers are now peddling scarce vaccine lots at 10 times the usual price. Hospitals are turning away old folks and cancer patients who could die from lack of a flu shot. And with the presidential campaign in its final weeks, both candidates are trying to sway voters on the issue. By President George W. Bush's account, the vaccine crisis is a reminder of the need for liability reform, but no cause for alarm. "We have healthy supplies of antiviral medicines and vaccines to help keep you safe from the flu and its complications," Health Secretary Tommy Thompson said in a press briefing last week. Sen. John Kerry chides the president for failing to prevent the fiasco--and prays that the administration's blithe reassurances will backfire. "People are red-in-the-face mad about this," his spokesman David Wade says. "When Bush said in the last debate that he just wouldn't get a flu shot, that crystallized the impression that he's out of touch."

The truth is, neither candidate had a lot to say about influenza, or the vaccine supply, until the system collapsed this month. The flu virus is a wily and dangerous foe. It strikes as many as 56 million Americans each year, causing 200,000 hospitalizations and 36,000 deaths. Routine vaccination can almost always prevent the condition. But profit-conscious drug companies have fled the business in droves in recent years, leaving the health system ever more vulnerable to shortages and interruptions in supply. Health experts have spent two decades warning that our system for producing vaccines is dangerously fragile and suggesting ways to make it more secure. Politics aside, they agree that the current crisis is not a fluke but a predictable consequence of inaction. "We've been on precarious ground for decades now," says Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. "The accident that was waiting to happen just happened."

With luck, the medical fallout could still be minimal this year. The anticipated strain of flu virus is a close variant of last year's, meaning that previously exposed people should have at least partial immunity. And though Chiron's withdrawal leaves only one major manufacturer, Aventis Pasteur, to pick up the slack, there should still be 61 million doses on the U.S. market this winter--58 million vials of injectable vaccine from Aventis, plus 3 million doses of MedImmune's FluMist nasal vaccine. That's considerably less than the 85 million doses administered last year, but federal health officials have developed a voluntary triage system to boost the effect of the limited supply. Instead of promoting vaccination for everyone older than 6 months, the U.S. Centers for Disease Control and Prevention are asking healthy people between 2 and 64 to skip their shots this year so that health workers can direct all the available vaccine to old folks, young children, pregnant women and people with chronic illnesses. CDC is also trying to work with Aventis to ship vaccine to health departments, VA hospitals and clinics serving high-risk patients.

A noble effort, to be sure, but Aventis and CDC had shipped only 5 million doses to targeted centers by the end of last week. Most of the nation was still a crazy quilt of surplus and scarcity. Clinics and hospitals whose wholesalers bought stock from Aventis had more vaccine than they needed. Those served by Chiron had none. And local health departments were hard pressed to fill all the gaps. For high-priority patients, it was one thing to qualify for a dose of vaccine, quite another to find one. At Miami's Jewish Home for the Aged, topic A in the dining hall, the beauty salon and the shuttle bus was the vaccine that couldn't be got. "I was told we have none!" 84-year-old Annette Mendelson said when asked if she'd managed to get a shot. "None! Zero! There are 700 people living here who are fragile and susceptible to respiratory infections. Of all places to get the flu vaccine, you would think this would be the first place, not the last."

She wasn't alone in that feeling. As the sense of crisis has spread these past few weeks, even normally complacent consumers have lined up by the thousands for a shot of protection. "Usually, on a busy flu-clinic day, we might have anywhere from 60 to 100 people," says Claude Campbell, a pharmacist at the Publix supermarket in Smyrna, Ga. When the same store held a Saturday clinic this month, crowds gathered at 4 a.m. to wait for the doors to open at 7. Campbell had enough vaccine for all 485 of that day's supplicants, but other communities are now turning away more eligible people than they're vaccinating. In Bloomfield, N.J., last week, the local health department held a lottery to see which of 8,000 seniors would get 300 available flu shots. Each winner will get a letter, listing a date, time and location. "I've gotten criticism," says Trevor Weigle, the city's health and human-services director, "but I didn't want our seniors out standing in those long lines. Why encourage 8,000 people to line up when you only have 300 doses?"

Weigle is having the contest professionally audited to prevent cheating, but a commodity this scarce is sure to inspire some. Theft has been rare so far (someone did steal 620 vaccine doses from the refrigerator at a children's clinic in Aurora, Colo.), and no one has spotted any counterfeit vaccine. But price gouging is another story. In a survey released last week, the American Society of Health-System Pharmacists found that 75 percent of hospital pharmacies had too little flu vaccine to cover their eligible patients. More than half of the pharmacy managers said vendors had offered them extra vaccine for at least four times the usual wholesale price (about $8 per dose). Thompson, the U.S. Health secretary, is now urging state attorneys to "thoroughly investigate reports of price gouging and prosecute those engaging in this immoral and illegal activity." But the laws vary from one state to the next, and some prosecutors can do no more than wag their fingers. "We have unscrupulous distributors charging over 10 times the normal cost for a vial of flu vaccine," says Arizona Attorney General Terry Goddard. "Unfortunately our state has no price-gouging statute."

The real challenge is not to control prices, of course, but to build a reliable system for producing needed vaccines. Why is the current system so fragile, and how could it best be fixed? The first question is fairly straightforward if you place yourself in a drugmaker's shoes. "You have a choice," says Dr. Martin Blaser, president-elect of the Infectious Diseases Society of America. "You can develop a vaccine that 50 million people will take once a year to prevent illness--or a drug they will take every day for life. Which would you choose?" Narrow profit margins are only the start of the problem. The influenza vaccine has to be redesigned annually to target the ever-changing virus, and most are still grown in the cumbersome medium of fertilized chicken eggs--one egg for every dose of vaccine. A large manufacturer can still prosper when all goes as planned. But demand is fickle, and surplus doses can't be shelved for later use. If they're not used during the season they're intended for, they simply go to waste.

Researchers have long believed that new technologies could change this dynamic, but private investors have lacked strong incentive to take the first step. Dr. Martin Myers, director of the National Network for Immunization Information, recalls asking an industry leader several years ago why his company was still using the old egg-based production system instead of working to develop a cleaner, faster approach that would use mammalian cells as a medium. "He said, 'Let me get this right'," Myers recalls. " 'You want me to spend $250 million to make a new vaccine so I can charge more than my competitor, and thereby lose sales?' " Several diehards have inched forward anyway, and some are now poised to introduce cell-based products in Europe over the next few years. The wait will surely be longer in this country, and both political parties are right about the reasons. Liability costs really are higher here than in other countries--and faith in private markets can preclude useful public investments. But the biggest obstacle of all may simply be the cost of conducting the huge trials needed to secure FDA approval for a product used in healthy people. "We're talking hundreds of millions of dollars," says Dr. Andrew Pavia, the University of Utah physician who chairs the Pandemic Influenza Task Force of the Infectious Diseases Society of America--"enough to increase the cost by a couple of dollars a dose."

Health experts have killed whole forests with proposals for reform, but the same basic themes always emerge. First, they say, the government should shield vaccine makers against fluctuating demand by buying up unused doses at the end of each flu season, or by expanding the government's stockpile (currently just 4 million doses of flu vaccine each year). "The math could work out well, even if the government pays a slightly lower price," says Pavia. "Say the government pays 50 cents a dose, while private providers pay 75 a dose. If 10 million doses don't sell, the company still recoups $5 million." A second point of consensus is that health insurers should have to cover common vaccines. A third is that the government should expand the National Vaccine Injury Compensation Program to cover adult vaccines as well as those made for children. Congress adopted this proposal this year, but the president has yet to sign it.

Many experts also believe that the Centers for Disease Control and Prevention should play more than an advisory role in crises like the current vaccine shortage. "People are lining up for blocks," says Shelley Hearne of the nonpartisan Trust for America's Health. "Doctors are frantic for guidance. Yet the CDC can't enforce its own guidelines locally." The agency's director, Dr. Julie Gerberding, would rather decline that honor. "Imposing federal control over this proc-ess would probably make a big mess," she says. "Our public-health partners are doing a great job."

The first challenge, of course, is to get through the current season. Even a relatively mild flu could cause major disruptions in the workplace this winter, as millions of unvaccinated adults drag the virus in and out of their cubicles. Simple precautions--washing your hands, covering your mouth, staying home when you're sick--can help slow transmission. And drugs like Tamiflu can make the flu less onerous. But none of this is fail-safe. All told, Harvard economist David Cutler estimates, the cost of this year's epidemic could hit $20 billion in medical payments and lost workdays, nearly twice the usual tally. It won't be pretty, but with luck it won't be deadly. The question is whether the experience will finally prompt the reforms needed to secure the nation's health. "What this shows," says Hearne, "is that we're not prepared for a health crisis, whether it comes from Mother Nature or from biological terrorism." If we miss the message this time, we'll have no one to blame but ourselves.

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