Saturday, October 16, 2004

More on the flu vaccine scandal

The NY Times has an in depth report, that outlines the real problem: the lack of a Federal public health infrastructure, along with the failure of capitalism to create a vaccine that will meet demand.

"We are in the middle of a crisis that could have been averted,'' said Dr. Irwin Redlener, associate dean of the Mailman School of Public Health at Columbia University and director of its national center for disaster preparedness.

In particular, public health experts have long cautioned against the country's dependence on a few vaccine makers, and yet this has become standard practice. There are now only two major manufacturers for the nation's supply of flu vaccine, and at least a half-dozen other vaccines are made by single suppliers. Britain, by contrast, has spread its order for flu vaccines among five suppliers, precisely to avoid the kind of predicament America now faces.

In recent years there have been many significant disruptions of vaccine supplies. Between November 2000 and May 2003, there were shortages of 8 of the 11 vaccines for childhood diseases in the United States, including those for tetanus, diphtheria, whooping cough, measles, mumps and chicken pox. There have been flu vaccine shortages or miscues for four consecutive years...

The heart of the problem, experts say, may be that no one person or agency is in charge of making sure the United States has an adequate vaccine supply. The production, sale and distribution of vaccines, particularly those for flu, are handled almost entirely by pharmaceutical companies.

Influenza = more than 10 9/11's per year in the number of deaths. An outbreak of a deadly pandemic would likely be the equivalent of hundreds of 9/11s.

This is a matter of national security, and the Bush junta has been asleep at the wheel on this, just like they were in August 2001.

Oh, and remember Chiron? Well Bush made a series of misstatements- heck, lies- in the 3rd debate:

F.D.A. officials have said the problems were corrected to their satisfaction, and they let the plant continue to operate. But one question likely to be raised by Congressional investigators is why the British found problems so soon after the agency had deemed them resolved.

Chiron announced on Aug. 26 that during routine testing it had found bacterial contamination in a small number of lots of flu vaccine that should have been sterile, a more serious contamination than what the agency had found a year earlier. It said it would delay shipping vaccine until early October and cut its supply forecast from about 50 million doses to between 46 and 48 million. Both the F.D.A. and its British counterpart, the Medicines and Healthcare Products Regulatory Agency, were informed.

Chiron began its own investigation and also began holding weekly conference calls with officials at the F.D.A. and the disease control centers to report on its progress.

In written testimony to the House Committee on Government Reform on Oct. 8, Mr. Pien said Chiron had completed its internal investigation on Sept. 27. The results, he said, confirmed that the contamination was limited to the initial lots identified. Indeed, on Sept. 28, a confident Mr. Pien told a Senate committee that Chiron expected to start shipping the vaccine in early October.

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.

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.

Bush implied in the debate a) the FDA found the UK's vaccine was unsafe (it was actually the Brits who did), b) Chiron was a Brittish company (it's American), and c) that they were going to get vaccine from Canada (the Canadians said they don't have any, and you do the math: they have 18 million people, and we need some 40-50 million doses).

But we know what we're dealing with here, and it's a good idea to get rid of Bush.

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