Flu vaccine shortage: only in America

The Brits jumped on the problem and found back-up supplies. We didn’t. How about some accountability?

There’s no flu vaccine shortage in the United Kingdom, where the Chiron plant that made the contaminated batch is located. Why not? Because the UK health authorities moved quickly in August, when Chiron missed its original shipping date, to secure back-up sources of supply, while U.S. authorities sat on their duffs.

[And now, apparently, are sitting on the documents showing how badly they screwed up until after the election. Republicans in Congress are helping. What else is new?]

Actually, it turns out that no other country in the world faces a flu vaccine shortage this fall: just the good old U.S. of A. Sorta makes you proud to be an American, doesn’t it?

So can someone please tell me in what sense this isn’t the fault of the current Administration? Their people were asleep at the switch. No, of course the President isn’t supposed to personally manage this stuff. But his folks at HHS are supposed to make sure it gets managed. They failed. People are going to die as a result. Looks to me like a legtimate campaign issue.

No flu vaccine shortage expected in England

BY MIKE MCGRAW AND DAVID GOLDSTEIN

Knight Ridder Newspapers

LIVERPOOL, England – (KRT) – At a public clinic, almost in the shadow of the Chiron plant near the Mersey River, a poster says to “make an appointment today for your free flu jab.”

Flu vaccine may be delayed in some locations, but the shortages America is seeing are not expected here, thanks in part to early action by British health officials.

Late this summer, at the first sign of new problems at the Chiron Corp.’s long-troubled plant, the British began searching for other suppliers of flu vaccine.

“When Chiron informed us of the potential problems at the end of August, we made contingency agreements,” said Alison Langley, a spokesperson for the Medicines and Healthcare Products Regulatory Agency (MHRA), the British equivalent of the U.S. Food and Drug Administration.

Armed with essentially the same information, however, U.S. officials relied on Chiron’s early assurances that only a small portion of the flu vaccine from its Liverpool plant here was contaminated.

It was not until Oct. 5, when the British pulled Chiron’s license, that they knew half the U.S. flu vaccine supply had just disappeared, producing the lines and shortages the country is now enduring.

No matter what, the United States would have had a tougher time solving the problem than England.

For one thing, the American shortfall is more than 45 million doses, but the British relied on the Chiron plant for only about 20 percent of their total flu vaccine needs, or about 1.2 to 2 million doses.

Compared with Americans, fewer people seek flu shots in England, where vaccinations are promoted primarily for young children, those over 65, persons with HIV or other compromising conditions, and health-care workers.

“Most healthy people here don’t get a flu shot,” said Hugh Lamont, with the government’s Health Protection Agency.

The British could also fall back on a half-dozen other suppliers that had been pre-approved by British authorities. The United States had only one other major supplier, Aventis Pasteur.

But some health experts now suggest that if U.S. officials had relied less on Chiron’s early assurances and acted more swiftly, they could have at least limited the damage caused by the loss of half the U.S. supply.

David Webster, a health industry consultant and former Aventis executive, said the FDA miscalculated the potential risk in the situation.

“I don’t think they fully predicted what the impact of either the manufacturing problem or an entire shutdown of the facility would cause,” he said.

Department of Health and Human Services spokesman Tony Jewell said the federal government saw no reason to begin looking for replacement supplies in August, when the British did.

“We had no indication from the company or MHRA until October 5 that the entire 48 million doses were in jeopardy,” he said. “As soon as we learned in October, we contacted Aventis Pasteur to purchase several million more.”

Chiron, headquartered in California, first told U.S. and British officials about contamination problems on Aug. 25, saying it planned to destroy 4 million doses of flu vaccine.

Langley, the spokesperson for the British MHRA, said the company reported back Sept. 13 that the problems were still unresolved. British officials toured the plant Sept. 28 to 30 and pulled its license a week later.

Chiron officials did not return phone calls for this story.

William Schaffner, a member of the federal government’s National Vaccine Advisory Committee, said officials with the Centers for Disease Control and Prevention spoke with Chiron officials on a weekly basis, and the company always assured them that the problem was “limited.”

“Shipments would be somewhat curtailed, but basically we were going to be getting all we needed from Chiron,” said Schaffner, chairman of the department of preventive medicine at the Vanderbilt University School of Medicine.

Jewell said that based on what the U.S. government knew at the time, officials saw no need to ask Aventis to delay its shipment in case the situation eventually required some degree of vaccine rationing.

“We were repeatedly assured that things were looking up,” he said, “so you’re talking about disrupting the shipment of the other half of the vaccine supply on something that our regulators had no indication was going to be a problem.”

Aventis began shipping its vaccine in early August. An Aventis spokesman said that if the company had been aware in August that half of the flu vaccine supply was not going to be available, it would have done what it did upon learning of the shortage on Oct. 5 – consult with the CDC about how to redistribute supplies.

In recent testimony before Congress, Julie Gerberding, CDC director, said her agency had been developing contingency plans for a “worst-case scenario” since late August but that those plans were hindered by the fact that most of the remaining supply had already been contracted to private distributors.

Acting FDA Commissioner Lester Crawford added at the same hearing that, even by late August, it was too late for vaccine companies to start a new batch of vaccine. “We obviously hoped for the best,” he said.

U.S. officials now are left to try to redistribute the remaining Aventis vaccine to those who need it most.

Already, long lines are forming at supermarkets, walk-in clinics and pharmacies where elderly and other at-risk patients are hoping, sometimes in vain, to get a dose of the vaccine.

In Liverpool, however, the vaccine is available. “We are starting flu shots about now; we’re in the thick of the campaign,” Lamont said.

As a result, many Liverpool residents are unaware that their Chiron plant is at the center of an American health crisis. Others have only a vague notion, as one police officer said, that “something went amiss out at the jab plant.”

(Knight Ridder correspondent Alan Bavley contributed to this report.)

October 26

FDA accused of withholding vaccine documents

BY PAUL JACOBS

Knight Ridder Newspapers

SAN JOSE, Calif. – (KRT) – A top Democratic congressman on Tuesday accused the Food and Drug Administration of deliberately withholding documents that he said described severe problems at Chiron’s flu vaccine factory until after next week’s presidential election.

In a letter Tuesday to the FDA, Rep. Henry A. Waxman of California, the senior Democrat on the House Committee on Government Reform, said that a confidential source inside the FDA told him that the office of acting FDA Commissioner Lester Crawford had received documents describing the FDA’s findings at the Liverpool plant and addressing “whether the flu vaccine crisis could be prevented.”

The agency has so far refused requests from Congress and the media for copies of FDA inspection reports and other documents describing problems at the Chiron plant, including the results of an inspection in June 2003, about the time Chiron acquired the facility.

Because of problems at the plant in Liverpool, England, almost 50 million doses of flu vaccine were withheld from the market this year, about half of the U.S. supply.

Waxman quoted the source as saying that Crawford or someone in his office had “made a decision not to release these documents to Congress until after the election.”

A spokesman for Waxman said that the source is an individual known to Waxman’s staff and that “we believe the person to be speaking the truth.” The individual’s name, however, is being withheld because of fear of recriminations, the spokesman said.

Crawford issued a brief statement Tuesday saying that his office was busy trying to identify additional supplies of flu vaccine and anti-flu medications and working with Chiron to correct problems at its British plant.

He said that “document production is still incomplete.”

The question of how well the FDA responded to possible signs of problems as early as one year ago at the vaccine manufacturing plant has become a hot political issue.

Waxman and the Republican chairman of the government reform committee, Rep. Tom Davis of Virginia, asked for the FDA documents on Oct. 13. But last week, Davis granted Crawford more time to produce the documents and refused to grant Waxman’s request to subpoena them, arguing that the FDA was too busy to assemble the requested documents.

Davis accused Waxman of playing politics, in a year when Sen. John Kerry has tried to pin the vaccine shortage on President Bush.

In a brief statement Tuesday, Davis said he agreed to a delay in the release of the information at Crawford’s request to “let the FDA focus for the time being on the problem of finding and distributing more doses of the vaccine – because our priority is public health, not election-year politics.”

But Waxman, in his Tuesday letter, denied that releasing documents would interfere with the FDA’s work, as Davis and Crawford contended.

“Millions of Americans who are at high risk of severe illness from influenza will not be vaccinated this year,” he said. “They and their elected representatives in Congress have a right to know whether FDA acted responsibly and what can be done to prevent this health crisis from happening again.”

The inspection at the Liverpool plant last year turned up undisclosed problems. However, there was no contamination found in that year’s vaccine and it was released in the United States on schedule.

But in August, Chiron found that eight lots of its vaccine were contaminated with disease-causing bacteria, and it voluntarily delayed the release of any vaccine until the company was sure it had isolated and eliminated the source of the problem.

Chiron’s chief executive, Howard Pien, testified before Congress Sept. 28 that the company still planned to ship all its vaccine in time for the coming flu season.

However, in a move that company officials say took them by surprise, British authorities suspended the license needed to export the vaccine to the United States, citing problems with good manufacturing practices at the Liverpool facility.

Author: Mark Kleiman

Professor of Public Policy at the NYU Marron Institute for Urban Management and editor of the Journal of Drug Policy Analysis. Teaches about the methods of policy analysis about drug abuse control and crime control policy, working out the implications of two principles: that swift and certain sanctions don't have to be severe to be effective, and that well-designed threats usually don't have to be carried out. Books: Drugs and Drug Policy: What Everyone Needs to Know (with Jonathan Caulkins and Angela Hawken) When Brute Force Fails: How to Have Less Crime and Less Punishment (Princeton, 2009; named one of the "books of the year" by The Economist Against Excess: Drug Policy for Results (Basic, 1993) Marijuana: Costs of Abuse, Costs of Control (Greenwood, 1989) UCLA Homepage Curriculum Vitae Contact: Markarkleiman-at-gmail.com

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