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Flu Vaccine Production System Shaky

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New York Times Syndicate

By David Wahlberg And Charles Seabrook

Sunday, October 10, 2004

ATLANTA -- The sudden, major flu vaccine shortage that shocked health authorities last week highlights two vulnerabilities in the nation's immunization system: a reliance on a few private manufacturers that use old technology, and government's faith that companies will make safe products and quickly report problems.

Insiders, who have long warned the fragile system needs reforms, say it could prove even more catastrophic if bird flu sweeps the globe or bioterrorists hit.

Since the 1970s, the number of companies making all vaccines has dwindled from 25 to five, even as the types of vaccines have doubled.

Vaccines against six diseases now have a single manufacturer, causing shortages whenever the companies encounter snags.

The Food and Drug Administration, which oversees the vaccine industry in the United States, relies on companies to come clean about most problems. But even though Chiron Corp. revealed contamination at its plant in England in August -- and the company started investigating deeper concerns in mid-September -- FDA officials admitted being caught off guard Tuesday when British authorities suspended all production. Chiron is one of two suppliers of U.S. flu vaccine.

The United States is on the brink of flu season with only half its 100 million doses of vaccine now expected, forcing health officials to call for voluntary rationing so that people at highest risk can be protected. Reports of price gouging of as much as tenfold have begun.

The dire situation is just a warm-up for what scientists really fear: a flu pandemic, likely to be caused by bird flu, or avian influenza, which has appeared again this fall in Southeast Asia. Such an outbreak could kill millions across the globe; a flu pandemic in 1918 killed at least 20 million people worldwide, including half a million Americans.

Researchers are scrambling to develop a bird flu vaccine, but a proven one does not exist. Chiron is among the companies working on that vaccine.

"If we had widespread disease at the level of a pandemic, we'd be in a lot more trouble, now that we understand how fragile the supply and distribution system is," said Dr. Gregory Poland of the Mayo Clinic in Rochester, Minn., a vaccine adviser to the Centers for Disease Control and Prevention in Atlanta.

Ordinary flu causes 36,000 deaths and more than 200,000 hospitalizations each year, mostly among the elderly, the CDC says.

Since vaccines, unlike most drugs, prevent disease instead of treating it, regulators -- and trial lawyers -- tolerate few side effects.

Companies must perform large clinical trials, which can cost $200 million, to demonstrate safety.

And they face a market subject to the whims of a public that demands cheap immunizations but is often lax about getting the $20 shots.

After 12 million doses of flu vaccine went unused two years ago, the manufacturers had to dump them and swallow the losses, leading one company, Wyeth, to get out of the flu shot business.

"We set the safety bar very high and squeeze out companies by forcing low prices," said Dr. Paul Offit of Children's Hospital of Philadelphia, who is writing a book about the vaccine industry. "We have this myth of invulnerability. We don't think (a disease) is going to affect us until it hits us." In just the past four years, the country has dealt with nine shortages of six vaccines, including the swift depletion of last year's 87 million doses of flu vaccine after influenza struck early and hard.

Experts have proposed systematic solutions -- tax incentives, government subsidies, insurance coverage mandates, vaccine vouchers for the poor and guarantees of buying back leftover doses. Others want to see the government take over vaccine production entirely.

But the proposals, particularly those calling for government buybacks, have gotten little traction, perhaps because paying for wasted vaccine would generate political heat.

"How do you survive the congressional hearings if you're tossing out 10 million doses each year and (government is) paying for them?" asked Dr. Walt Orenstein, former director of the CDC's National Immunization Program and now associate director of the Emory Vaccine Center.

"All of the steps are likely to have substantial cost implications.

Are we as a society willing to pay for them?" Not enough disclosure Along with the manufacturing vulnerabilities is the question of whether the FDA scrutinizes drug manufacturing closely enough. The FDA has been criticized for being too cozy with the pharmaceutical industry and for failing to guarantee drug safety by not disclosing its knowledge of side effects from medications for arthritis and depression.

Merck & Co., the maker of Vioxx, pulled the popular arthritis drug from the market last week after a study found it increases the risk of heart attack and stroke -- findings that had been suggested in earlier research. And after months of controversy, an FDA panel recently said the antidepressant Paxil should carry a warning about the possibility it causes suicide in children. Some FDA scientists were aware of the danger for many months, critics say.

Several members of Congress accused the FDA of suppressing information last month in a hearing about Paxil and other antide- pressants.

"There is something terribly rotten at the FDA," said Rep. Peter Deutsch (D-Fla.). "No agency charged with protecting public health should have behaved with such indif- ference." That the FDA didn't realize the full extent of Chiron's vaccine problems until Tuesday and may not have exercised the same level of safety concerns as its British counterpart is also troubling to some.

"I say thank God that the British made their decision and kept possibly contaminated products off the market," said Barbara Loe Fisher, director of the National Vaccine Information Center in Vienna, Va.

The vaccine industry's financial struggles are compounded by technological issues -- especially with flu vaccine, which uses a 50-year-old manufacturing system involving chicken eggs and guesswork that takes half a year to complete.

Each February, health officials select the three strains expected to circulate most the next flu season. Companies use "seed strains" to grow vaccine in eggs, which takes months. In late summer, they combine the three strains into one product, testing it for safety before delivery in early fall.

"If something goes wrong, like now, late in the process, it becomes very difficult to re-gear up the process," said Dr. Anthony Fauci, head of infectious diseases at the National Institutes of Health.

Researchers are studying two improvements: growing vaccine in kidney cells from dogs or monkeys instead of in eggs, and genetically engineering flu strains.

Vaccines grown in animal cell lines, like the polio vaccine, can be produced at almost any time because companies don't have to wait for a fresh supply of eggs, said Dr. Robert Webster, a flu expert at St.

Jude Children's Research Hospital in Memphis, Tenn.

In another approach, "reverse genetics," scientists are assembling the exact bits of virus desired for a flu vaccine, instead of mixing viruses and hoping they form the intended combination.

Webster has used reverse genetics to develop an experimental bird flu vaccine. It, along with candidate vaccines from the CDC and a lab in London, will soon enter clinical trials.

Congress appropriated $50 million this year for these vaccine developments and for more eggs. The Department of Health and Human Services has asked for $100 million for next year.

Previous vaccine shortages have sparked calls for reform that soon faded. A silver lining of the new vaccine emergency is that this time, the heightened attention could have staying power.

"This is the most significant shortage we have ever had," said Emory's Orenstein. "This time the pressure needs to stay on." Added Webster: "It's a bloody disaster . . . that the most affluent and scientifically advanced country in the world can't make our own vaccine. We'd better listen to this wake-up call." David Wahlberg and Charles Seabrook write for The Atlanta Journal-Constitution. E-mail: dwahlberg@ajc.com; cseabrook@ajc.com Editor Notes:Story Filed By Cox Newspapers For Use By Clients of the New York Times News Service



c.2004 Cox News Service

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