With Few Suppliers of Flu Shots, Shortage Was Long in Making

[sr_pacifica]

Michael Dwyer for The New York Times
Melvin F. Leon got a flu shot in Avon, Mass., last week. Some people at risk of illness who want flu shots have been turned away.

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Damian Dovarganes/Associated Press
A flu-shot line in Alhambra, Calif.





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With Few Suppliers of Flu Shots, Shortage Was Long in Making

Published: October 17, 2004

(Page 4 of 4)


But British regulators visited the factory again and on Oct. 5 suspended its license, saying it was not being operated in accordance with regulations on good manufacturing practice. Only after the suspension was the nature of the contamination revealed: it was a type of bacteria called serratia, which, though found in the environment and usually not harmful there, can cause illness if injected into the body, especially in a frail elderly person or someone chronically ill.
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The bombshell reached Chiron's California headquarters at 3 a.m. Company executives than called and awoke officials in Washington, who have said they were also shocked.

Chiron has said it is now under investigation by federal prosecutors in New York and by the Securities and Exchange Commission. The investigations are apparently concerned with whether the company misled investors and federal health authorities about the conditions at its factory. The company, while saying it would cooperate with the investigations, has denied any deception.

"Chiron did not at any time mislead public health stakeholders or the public," Mr. Pien said in written testimony to the House. He added, "The results of Chiron's internal investigations confirmed our belief that our product was safe."

But inspectors from both Britain and the F.D.A. disagreed, saying they could not be confident that Chiron had identified all the sources of contamination. On Friday, health officials in the United States said that none of the vaccine in the plant could be salvaged.

The remaining question is whether Chiron can repair its problems in time to prepare sterile vaccine for next year's flu season. The company has said it expects to do so.

Dr. Goodman said "a lot of hard work on their part" would be needed. But, he added, "I think they are serious about this business, and from everything I've heard I expect they will be eager and effective about addressing these things."

But he and other government officials said they were also looking for other sources of flu vaccine for next year.

Solutions

Many experts say one way to avert vaccine shortages is to charge more for vaccines, so that more companies will want to produce them. To some extent, that was already starting to happen. Aventis Pasteur, now the major source of flu vaccine in the United States this year, noted that prices for flu vaccines have been rising steadily in recent years and are likely to be higher next year. In 1996, they sold for $1.80 a dose. The list price this year is $8.50.

Several companies, including GlaxoSmithKline and ID Biomedical, a Canadian company, have said they hope to begin selling flu vaccines in the United States soon. Dr. Goodman said the F.D.A. was encouraging some foreign manufacturers to apply for licensing here.

Dr. Robert B. Belshe, director of the center for vaccine development at Saint Louis University, said many experts in infectious diseases and vaccination believe that ultimately, the only way to control influenza will be to vaccinate nearly all school-age children every year.

If the medical profession does make that recommendation, and the public follows it, there will be a greater need than ever for vaccines - and possibly a more stable market to tempt manufacturers.

Government health officials said in interviews that they would propose other ways to avert vaccine shortages to Congress within weeks. Among the possible initiatives, said Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, are measures to guarantee that the government will buy a certain amount of vaccine each year, buy larger vaccine stockpiles and increase research into different ways to make the vaccines.

The disease control centers this year for the first time bought 4.5 million doses of flu vaccine for $40 million as an emergency reserve. It was not nearly enough, acknowledged Dr. Bruce Gellin, director of the National Vaccine Program Office. The government may buy a bigger reserve next year, he said.

But flu reserves can be expensive. Unlike reserves for other vaccines, which can be held for years and refreshed with new product, a flu vaccine reserve must be used or thrown away and replaced every year.

Dr. Fauci said the Bush administration had increased financing for research and other efforts to fight flu to $283 million this year, from $47 million in fiscal year 2002. Among the initiatives is a $60 million effort to develop new ways to manufacture flu vaccines, which are currently made in a laborious process that requires the use of hundreds of thousands of eggs.

But those sums are small compared with what the nation plans to spend on vaccines against diseases that the government fears terrorists might use. William Schaffner, chairman of the department of preventive medicine at Vanderbilt Medical School in Nashville, noted that the Bush administration last year promised to spend $5.6 billion to help develop vaccines for anthrax and other biological agents.

"They're creating a very expensive program against diseases that don't exist anywhere in the world," Dr. Schaffner said. "What we need is an adult immunization program for diseases that kill tens of thousands every year."

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http://www.nytimes.com/2004/10/17/health/17flu2.html?hp&ex=1098072000&en=d2dfea7c2bb70b63&ei=5094&partner=homepage

[Gman]

1. They can make a lot more money selling medicine for people sick

with the flu than they can preventing people from getting sick. I think this was a very calculated way to "enhance the market" for drugs for people that are sick with the flu. Pharmaceuticals need people to be sick. Why would any corporation with an obligation to increase shareholder wealth pass up an opportunity to really increase sales of drugs for sick people with the flu? Unless that corporation happened to have a conscience, there's no reason whatsoever. I think they're a helluva lot greedier than we give them credit for. We heard the tapes of the Enron corporation laughing about gouging Grandma in California. I fully think there are a lot of execs at pharmaceuticals that will have some very nice bonuses from increased sales of infuenza fighting drugs. Just think... they may well increase sales 500% or more! How clever of them and how good for shareholder wealth!

This is the atmosphere that has been created in Bush's America.

[DemBones DemBones]

2. This issue is HUGE and may turn the election to a Kerry landslide!

http://www.democraticunderground.com/discuss/duboard.ph...


It mentions the obvious financial benefits to the government if a lot of people drawing Social Security don't survive this winter's flu season. That suggests a conspiracy by people who support eugenics, doesn't it? Could there be a few people like that amongst the Bush* administration and their supporters?


Even if not, the Bush* administration is guilty of MALPRACTICE in their duties to protect the American people.

They were warned three years ago about this sort of shortage and they did nothing.

They were told in September about this specific shortage and they did nothing.

In Britain, the Blair government was also told in September and made alternate arrangements to get flu vaccine for their people.