Criminal Stupidity Likely To Kill Tens Of Thousands Of Americans

[Gary Sisco]

Indeed, many more than Al Q ever will.

U.S. Knew Last Year of Flu Vaccine Plant's Woes

By David Brown

The Food and Drug Administration found serious problems of bacterial contamination at an influenza vaccine plant in England in 2003, 16 months before British regulators effectively closed the site and impounded its flu shots because of fears they were tainted.

Those earlier problems were among many revelations in about 100 pages of documents released yesterday by a House committee looking into how the United States lost about half this winter's flu vaccine supply just as the season for giving the shots began.

The documents, which include FDA inspection reports, letters and e-mails, also revealed that the agency was nine months late in giving Chiron Corp., the owner of the plant, a detailed report of the problems it found and then rebuffed the company's efforts to learn more about what it could do to fix things. At the same time, FDA managers overruled its inspection team and made its fixes voluntary rather than mandatory.

The new information appears to undercut the agency's assertions that it had no reason to suspect that past safety problems at the plant had persisted and might threaten its huge production capacity.

About 48 million doses of vaccine from Chiron's plant outside Liverpool were withheld from the U.S. market early last month after the British equivalent of the FDA denied the company a license to sell them.

The United States expected to have about 100 million doses of flu vaccine this winter. Instead there will be 61 million doses, with some not arriving until January. The shortage has caused widespread public anxiety and has forced health departments nationwide to laboriously reallocate vaccine after much of it already had been distributed.

Yesterday's revelations drew distinctly partisan responses at a congressional hearing.

"FDA's laxity has had a heavy cost. If FDA had ensured that the problems identified in June 2003 were fixed, this year's flu crisis might never have happened," said Rep. Henry A. Waxman (Calif.), the ranking Democrat on the House Government Reform Committee.

In contrast, Rep. Thomas M. Davis III (R-Va.), the chairman, twice elicited from acting FDA Commissioner Lester M. Crawford statements that no protocols had been violated in the agency's response to the problems at the Liverpool plant, which has had three owners in the past decade.

"If protocols need to be tweaked, then let's talk about tweaking them," Davis said.

Despite the revelation of problems dating at least to 2001, Crawford testified that except for the late delivery of its full report on the agency's June 2003 inspection, the FDA has done nothing wrong -- and it would do nothing differently if given the chance.

Specifically, he defended the decision not to send inspectors into the plant for 16 months after the 2003 visit (which found deficiencies in 20 production activities), arguing that regular telephone conference calls and other communications were a form of "re-inspection."

Furthermore, he told the committee there was "no connection" between the 2003 deficiencies and the ones that led British regulators to prohibit sale of the 2004 vaccine production, even though the contamination found this year involved the same serratia bacteria found in unfinished samples of vaccine in the past. When they did revisit the Liverpool plant last month, the agency's own inspectors reported that at least three possible sources of contamination were "not corrected from previous inspection of 2003," according to one of the documents.

The FDA chief told the committee several times that the fact that the plant's 2003 vaccine ultimately tested pure and was released for sale was evidence Chiron had fixed the earlier problems.

Some experts have said that if the problems at the Liverpool plant had been recognized earlier, American public health officials might have been able to seek other sources of influenza vaccine on the world market. But in response to a question from Rep. Christopher Shays (R-Conn.) about whether knowledge of the problems five months earlier would have made a difference, Crawford said: "We couldn't have done anything about it."

The events that led to the loss of Chiron's vaccine began on Aug. 25, when the company told the FDA that it had found bacterial contaminants in some of its finished vaccine. The Medicines and Healthcare Products Regulatory Agency (MHRA) -- Britain's FDA -- was notified at the same time.

Twice in the next month, on Sept. 13 and 28, MHRA sent representatives to the plant for multi-day inspections and data-gathering sessions. Except for a brief visit with an FDA official who was, by chance, in the plant on Aug. 25 on another matter, the FDA dealt with Chiron entirely from a distance, through letters, e-mails and telephone calls.

The FDA was apparently unaware of the more intensive response by MHRA because the British agency is forbidden by law from communicating with its U.S. counterpart without receiving permission from the company being inspected -- in this case, Chiron.

MHRA revoked Chiron's license to sell flu vaccine on Oct. 5, based on a report by its own inspectors and an internal investigation the company conducted into the contamination. For reasons that were not immediately clear yesterday, the FDA did not receive a copy of the company's report until after the British took action.

In response to a series of questions shouted at Crawford by Rep. Elijah E. Cummings (D-Md.), the agency official said: "FDA is not perfect. . . . We got the full report on October 5 and made the determination that this vaccine was not usable. . . . It never got on the market."

The one FDA action he said was a mistake was the agency's failure to send its full report on the June 2003 inspection to Chiron in September 2003. That was when the FDA decided to make its improvements voluntary, not mandatory. Chiron requested and received the full report in June 2004.

The company had asked for a meeting with FDA officials after the 2003 inspection, but the agency never granted one, apparently because it did not view it as necessary.



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Feeling feverish?

[walto]

Out of curiousity Gary, why would a conservative libertarian (small c, small l) be faulting a federal government for not being more vigilant with respect to the production of flu vaccine? Should be none of their business at all, no?

Originally Posted by walto

Out of curiousity Gary, why would a conservative libertarian (small c, small l) be faulting a federal government for not being more vigilant with respect to the production of flu vaccine? Should be none of their business at all, no?

It does seem to be a very liberal stance.

[Dr Dave]

This is the Grover Nordquist dream of dreams: Placate the Democrats with a regulatory agency, but don't let it actually regulate anything. Now Republicans can point to the FDA as ineffective, and therefore worthy of being shut down. I mean, who needs a bureaucracy that doesn't do anything? Bring that there FDA into the bathtub!

[Gary Sisco]

I'm not a statist so don't ask me. I'm not making politics. Just posting an article explaining why thousands of Americans will needlessly die of the flu this year, due to political, bureaucratic, and capitalist incompetence and, frankly, uncaring. There's no argument against the latter, given the time frames we're talking here, when known, life-threatening problems were allowed to continue for 18 months without intervention.

And in any case, this libertarian conservative finds nothing contradictory between his philosophy and government involvement with healthcare, at least in its oversight. Government exists, if there is any reason for it, to defend and *protect* the citizenry. Otherwise, there's no reason for it at all.

But, hey, this is the What, Me Worry? Era. I got my shot. The rest of ya mofos can curl up and die from a (largely) preventable virus. Why should I worry, or even care?

Of course, I had to use terrorism to get the shot, but the time is coming when that will be the only way anyone gets anything, given the do-nothing nature of people's "work" these days.

(In their wisdom, it was decided that Bronwyn, being a quadriplegic, was approved for the shot, but not me, the only one who can -- or will -- provide care for her 22 hours a day. In short, she might not have died of the flu, just of other things while I was unable to perform her routine care for having a preventable illness put me down for four or five days. Right. Like I was going to go along with that. And they have the nerve to imply that going without -- even though the shortage is nearly a planned shortage, in this case -- is some kind of patriotic duty. Clowns to the left of me, jokers to the right ....)

I second doing away with the entire bureaucracy that allowed this no-brainer to happen, no pensions, no benefits, nada. Just out here on the economy like the rest of us, having to fight and claw for even the simplest of things.

It's even more disgraceful, and even more proof of the uncaring nature of the state and those in charge of it, that there are all the flu shots we'd ever need and then some, right across the border in Canada, but, hey, allowing their importation would be to remove the protectionism the state has provided American extortion, er, drug companies for all these years. Wouldn't want to do that, would we? Nah. Citizens should have to live in a dog-eat-dog market, not the capitalists. They get the protection. We get the flu.

[Uli]

Originally Posted by Gary Sisco

In short, she might not have died of the flu, just of other things while I was unable to perform her routine care for having a preventable illness put me down for four or five days.

It's probably my calvinistic work ethics but I never had the feeling that the flu puts me down. Slowing down maybe.

Originally Posted by Gary

The rest of ya mofos can curl up and die

I love it when you get all huggy feely.

[Gary Sisco]

Uli -- Well, then, you've never had it. The flu (often confused with a bad common cold, though the two have entirely different symptoms) will knock your ass down. At least down enough so that you won't be caring for another human's every need around the clock.

Scott -- I'm just adjusting my view to my national surroundings. When in Rome ....

Hahaha.....................I getcha.


I, Me, Mine, baby!!

[walto]

this libertarian conservative finds nothing contradictory between his philosophy and government involvement with healthcare, at least in its oversight.

Hah! That's not libertarian with or without the capital letter. I'm reporting you to a Randian/Nozickian post-haste! (I think they've still got fraud in there as a baddie.)

[crawjo]

Replace the word "Criminal" with "Bush's" and you'd have a tailor-made Chris A thread title.

[Coda]

On average 36,000 people die in the US from the flu each year. That's a huge number. I would think most have pre-existing conditions that weaken their system, but still that's a lot.

[groover]

It's really nothing to worry about. Many of the people who are going to die would have lost their jobs due to overseas outsourcing anyway, or at least their children will. If we need more consumers or low-wage workers, we can always bring in more immigrants. Halliburton will still make money. God bless America!

[Coda]

Groover, I've got news for you. For the next 20+ years our US economy will continue to lose jobs overseas to underdeveloped countries. The rest of the world is behind us in terms of income and benefits. Only after they grow - through investment, education, etc. will they demand a higher standard of living as they then will have extra money to spend.

Believe it or not, the same exact phenonom takes place regularly within the US. We used to have iron workers make car parts, now we use composites. Displaced workers as the shift from one type of product to another. Had we propped up the iron worker by adding a terrif to the composite worker - you know, to even the playing field - we would have been left with no iron worker and no composite worker.

It's not a republican or democratic thing. Clinton had the same effect during his presidency and so would Kerry.

By the way, Halliburton is a public company. That means that the shareholders own the company. Halliburton is one of the most widely held stock in mutual funds, retirement funds, etc. It's likely that YOU own a piece of Halliburton.

[groover]

I'm going to have to ask some of my many Chinese and Indian co-workers why they chose to come here instead of staying in their home countries and demanding a better quality of life. They all seem pretty upset about the prospect of having their jobs here outsourced back to their native countries.

[Dr Dave]

Originally Posted by Coda

Groover, I've got news for you. For the next 20+ years our US economy will continue to lose jobs overseas to underdeveloped countries. The rest of the world is behind us in terms of income and benefits. Only after they grow - through investment, education, etc. will they demand a higher standard of living as they then will have extra money to spend.

Believe it or not, the same exact phenonom takes place regularly within the US. We used to have iron workers make car parts, now we use composites. Displaced workers as the shift from one type of product to another. Had we propped up the iron worker by adding a terrif to the composite worker - you know, to even the playing field - we would have been left with no iron worker and no composite worker.

It's not a republican or democratic thing. Clinton had the same effect during his presidency and so would Kerry.

By the way, Halliburton is a public company. That means that the shareholders own the company. Halliburton is one of the most widely held stock in mutual funds, retirement funds, etc. It's likely that YOU own a piece of Halliburton.

I applaud a fellow free-trader. On the other hand, the sooner Halliburton goes down the shitter, the better, as far as I'm concerned. I happen to know that I don't own Halliburton stock, and as the company is presently construed, I'd never own it. Companies like Halliburton are nothing without their political connections; they are vulnerable at all times to scandal. Same reason I'd never own Archer-Daniels-Midland (aka "Price Fixer To The World" and "The Nature of Who's For Sale").

[Gary Sisco]

Walter -- I guess I'll not care what late-comers like Rand or anyone else has to say. French anarchists invented the word "libertarian" in the 19th C, after the state outlawed the anarchist press. They substituted the word "libertarian" for anarchist and went on about their business. The Rands and the whoevers have to answer to them for expropriating the word; not the other way around. The Rands et al are actually 19th C Liberals, the truth be told, and not libertarians at all, if you want to get that technical about things.

[Brian Olewnick]

Point of historical order: Rand never belonged to the Libertarian party, didn't use the word and was often at odds with them. She thought they were entirely too non-objective and inconsistent. One comment I recall (said with an expression of disgust): "There are Libertarian priests!"

[Gary Sisco]

Brian -- True. Marx also said that, whatever he was, he wasn't a Marxist. People often have trouble with their epigones.

I don't agree with the Lib Party about anything once sociocultural issues are out of the way. I have long maintained that if they were to be honest, they'd simply call themselves The Property Party and be done with it. Their real concerns are property and taxes. All else is secondary.

For me, it's the other way around. Taxes are necessary to civilization as such (obviously, there are many alternative ways to tax than those that exist now, which I don't support, obviously), and property in capitalist circles has become an even more abstract concept than money. A time will come when someone claims a trademark on oxygen and charges the rest of us for breathing it.

The telephone company in Maine already charges you a fee for not having long distance service. The time will come when they'll charge you for not having a phone.

[bluenoter]

Originally Posted by Dr Dave

Same reason I'd never own Archer-Daniels-Midland (aka "Price Fixer To The World" and "The Nature of Who's For Sale").

But Dave, ADM sponsors all the talking-heads news shows! It's practically synonymous with high-minded yet lively civic discourse! A fine company, obviously.

Plus, it strews golden sheaves of wheat across my kitchen table as bluebirds flit about.

[Gary Sisco]

One thing I don't have to worry about is what companies might be in my portfolio.

[walto]

Originally Posted by Gary Sisco

Brian -- True. Marx also said that, whatever he was, he wasn't a Marxist. People often have trouble with their epigones.

I don't agree with the Lib Party about anything once sociocultural issues are out of the way. I have long maintained that if they were to be honest, they'd simply call themselves The Property Party and be done with it. Their real concerns are property and taxes. All else is secondary.

For me, it's the other way around. Taxes are necessary to civilization as such (obviously, there are many alternative ways to tax than those that exist now, which I don't support, obviously), and property in capitalist circles has become an even more abstract concept than money. A time will come when someone claims a trademark on oxygen and charges the rest of us for breathing it.

The telephone company in Maine already charges you a fee for not having long distance service. The time will come when they'll charge you for not having a phone.

Now there's some stuff I can get down with! Great post, Gary!

[Uli]

Originally Posted by Gary Sisco

and property in capitalist circles has become an even more abstract concept than money.

It has been a more abstract concept than money since Roman commerical law and probably even before that.

[bluenoter]

Years ago, when I worked at Cato Institute (for the money), Jim Dorn, the editor of the Cato Journal, explained to me that in the preamble to the Declaration of Independence, "the pursuit of happiness" means "the pursuit of property."

[Gary Sisco]

Uli -- No, it hasn't. There's nothing today that can't be considered "property" in some tortuous logic. In some corporations, they even claim their employees' ideas as corporate property for a number of years *after* they're no longer even employees, even ideas that weren't spoken aloud while they were employees. That's some abstract shit, right there, claiming someone else's unvoiced thoughts as private property. Never mind all the "private property" that no one could touch in any sense of the word that propped up the "new economy" that has since collapsed. All that traded in was the idea of property, trading on the idea of money. Nothing real was behind any of it but the power of the fetish. Which is real enough, of course.

BNer -- The reason for that was that most Americans in those days thought of owning property as a precondition of happiness, because if you didn't own, say, at least a bit of a homestead/farm, you were dependent on an employer and hence not an independent actor, politically speaking. They feared that people would make political decisions based more on who they worked for and what he wanted than on their actual political positions. And they were right, as it turned out. Nearly the whole of what's left of the proletariat (in the real sense of the word) now sees the capitalist class's interests as their own and vote accordingly.

Vermont's constitution, like that of many of the states that participated in the revolution, still says property instead of happiness, for that reason.

There is a lot to be said for the concept, actually, in personal property terms. Not being dependent on landlords, for instance, and not being economically dependent on one's boss(es) or their class.

Things have to be viewed in their historical circumstance to be understood, and so does change, to be understood.

[bluenoter]

Gary--

Notwithstanding the history involved, Jim Dorn of Cato was holding that "the pursuit of happiness" is properly taken to mean "the pursuit of property" still, in the present day. (I should have made that more clear.) And he was equating happiness with property, not defining property as a precondition of happiness (or liberty).

You'll have to trust me. I swear that I understood him perfectly well.

[Uli]

Originally Posted by Gary Sisco

Uli -- No, it hasn't. There's nothing today that can't be considered "property" in some tortuous logic. In some corporations, they even claim their employees' ideas as corporate property for a number of years *after* they're no longer even employees, even ideas that weren't spoken aloud while they were employees. That's some abstract shit, right there, claiming someone else's unvoiced thoughts as private property. Never mind all the "private property" that no one could touch in any sense of the word that propped up the "new economy" that has since collapsed. All that traded in was the idea of property, trading on the idea of money. Nothing real was behind any of it but the power of the fetish. Which is real enough, of course.

Oh yes it has, unless I don't know whatcha talking about.

The expectations of future value in the property may have partly fuelled the folly of "the new economy", the payout however (more measly money than expected) came because of the more abstract concept of property (in this case "ownership" of the company).

[Tom Storer]

Originally Posted by groover

I'm going to have to ask some of my many Chinese and Indian co-workers why they chose to come here instead of staying in their home countries and demanding a better quality of life.

Well, that's pretty obvious: because they can make so much more money in America. But for those who stay at home and accept outsourced IT jobs, for example, they're also making good money in the local context, hence improving their material quality of life.

Coda, I think you were wrong when you said, "Only after they grow - through investment, education, etc. will they demand a higher standard of living." It's as they grow that the standard of living increases.

I've always found it difficult to disapprove of outsourcing in principle. It seems like a call to close the door on better jobs and higher income to poorer countries in maintain the imbalance in the standard of living in our favor.

[Brian Olewnick]

Originally Posted by Tom Storer

I've always found it difficult to disapprove of outsourcing in principle. It seems like a call to close the door on better jobs and higher income to poorer countries in maintain the imbalance in the standard of living in our favor.

That's always been my view also. Makes it all the more baffling when the opposition comes from the so-called left.

[Nathaniel Catchpole]

The presidential candidate for the Libertarians (C-Span, when I was jet-lagged in NY at some ridiculous time in the morning), said the party essentially wanted everyone to have the rights to the products of their own labour.

That's put forward as an answer against tax, but I don't get why they can't extend it to rent and surplus value.

Brian, as resident, can you explain how rent and surplus value are the products of the landlord or employer's labour, not that of the tenant/employer?