FDA ignored warnings about flu-vaccine plant /second case of mad cow disease in US

[Guest guest]

http://www.spokesmanreview.com/nation_world/story.asp?ID=38425FDA ignored

warnings about flu-vaccine plant Agency left it up to Chiron to voluntarily

clean up contamination

Seth Borenstein

Knight Ridder

November 18, 2004

 

WASHINGTON – The Food and Drug Administration failed to heed repeated warnings

of contamination at Chiron's now-shuttered British flu-vaccine plant and the

urging of U.S. inspectors for a crackdown, documents released Wednesday show.

 

Instead of forcing the company to clean up its Liverpool manufacturing plant as

inspectors had recommended, the FDA left it up to Chiron to fix the problem

voluntarily.

 

When British health authorities intervened, they found widespread contamination

with a dangerous bacteria at the plant. Last month, the British government

yanked the license for the plant, which produced about half the American

flu-shot supply.

 

That created a flu vaccine shortage in the United States.

 

More than 1,000 pages of FDA, Chiron and British health-authority documents,

released at a congressional hearing, show that the agency failed to act after

noting contamination problems in 2001, 2002 and 2003.

 

Chiron Corp. Chief Executive Officer Howard Pien said his company was surprised

when British regulators suspended the Liverpool plant's license. Testifying

before the U.S. House Government Reform Committee, Pien said Chiron spent $15

million to clean the plant and is spending $100 million to build a new

flu-vaccine plant. Chiron is headquartered in Emeryville, Calif.

 

During Wednesday's hearing, Democrats and Republicans sparred over who's to

blame for this year's shortage.

 

Democrats pointed to lax FDA oversight while the GOP blamed litigious-happy

lawyers.

 

" FDA's laxity has had a heavy cost, " said Rep. Henry Waxman, D-Calif., the

ranking Democrat on the House Government Reform Committee. " If FDA had ensured

that problems identified in June 2003 were fixed, this year's flu crisis might

never have happened. "

 

Responding to nearly shouted questioning, acting FDA commissioner Lester

Crawford said his agency didn't make any mistakes in handling Chiron in previous

years, except for being slow in sending the company a letter detailing the

problems it found in 2003.

 

" We took the right action, " Crawford said.

 

A 2003 FDA inspection of Chiron's Liverpool plant raised the most warning flags

and prompted the questioning at Wednesday's hearing.

 

The FDA inspection team found 20 problems in June 2003, most of them dealing

with contamination, and noted that similar problems from 1999, 2001 and 2002

weren't fixed as Chiron had promised.

 

The 36-page inspection report repeatedly cited areas where promised fixes and

evaluations weren't undertaken. One major problem was " aseptic " processing

conditions, a technique bringing together multiple sterilized items. A quality

assurance report in 2002 found a problem with this process, and the 2003 report

said " there was little evidence that corrective actions were investigated for

sterility failure. "

 

The FDA, in an inspection report issued last month, cited aseptic processing

problems as the likeliest cause for contamination of this year's flu vaccine.

 

The June 2003 team that toured the plant recommended that the FDA file an

enforcement action, such as a warning letter. Instead, the FDA issued a

voluntary request.

 

Asked by Knight Ridder who at FDA headquarters decided to make only a voluntary

request, Crawford said he didn't know, but that it was done " collegially. "

 

" FDA's justification for failing to cite the facility is that the agency thought

conditions were improving, " Waxman said. " But conditions weren't improving; they

were deteriorating. Over the next 16 months, as production at the facility

increased, the problems found in June 2003 mushroomed. Yet during this entire

period, FDA never once revisited the plant to see if Chiron was correcting its

problems and making safe vaccines. "

 

Crawford said the 2003 inspection report had little to do with the contamination

problems that created the flu vaccine crisis.

 

Because flu vaccine is made from eggs, there's always a biological contamination

issue, Crawford said. And the contamination issue varies each year because the

flu vaccine is different each year, he added.

 

Chiron " responded very well. They corrected the (2003) problem. The vaccine

production that was ready for that year ... turned out to be OK, " Crawford said.

 

Even though Crawford said the problems of 2003 and 2004 were unrelated, the

FDA's inspection reports suggest otherwise. Four of the 14 problems cited in an

Oct. 15 post-plant closing inspection report referred to problems from last

year. In addition, the report twice cited problems " not corrected from previous

inspection of 2003 " and that there was " incomplete corrective action to the

previous inspection of 2003. "

 

One section of the report states: " Failure to adequately address root causes

during failure investigations, noted during the inspection of year 2003 has not

been adequately corrected. "

 

Relying on Chiron's assertions that the problems were fixed, Crawford said that

what happened in 2004 were new problems. FDA reports said they involved the same

bacteria entering the manufacturing process at the same point.

 

 

 

7:17 a.m. November 18, 2004

WASHINGTON – A second case of mad cow disease may have turned up in the United

States, Agriculture Department officials said Thursday.

The officials released few details, saying it would be four to seven days before

the possible case could be confirmed.

Mad cow disease, or bovine spongiform encephalopathy, attacks an animal's

nervous system. People who eat food contaminated with BSE can contract a rare

disease that is nearly always fatal, variant Creutzfeldt-Jakob disease.

The possible case comes 11 months after the United States had its first case of

mad cow disease. Japan and other countries are still maintaining bans against

U.S. beef as the result of the earlier case.

Suspicions about another case of the disease came because of an inconclusive

test result, officials said.

" The inconclusive result does not mean we have found another case of BSE in this

country, " said Andrea Morgan, associate deputy administrator of the USDA's

Animal and Plant Health Inspection Service.

She said the inconclusive results " are a normal component of screening tests,

which are designed to be extremely sensitive so they will detect any sample that

could possibly be positive. "

" It is important to note that this animal did not enter the food or feed chain, "

Morgan said. " USDA remains confident in the safety of the U.S. beef supply. Our

ban on specified risk materials from the human food chain provides the

protection to public health, should another case of BSE ever be detected in the

United States. "

In the only confirmed case, a Canadian-born Holstein was found to have been

infected, but just that one case caused Japan and more than three dozen other

countries to refuse U.S. beef. That hurt U.S. export sales and the farm economy.

Bush administration officials are now focused on trying to get those bans lifted

and with establishing a national identification system for tracking livestock

and poultry from birth through the production chain.

Such a system has worried producers who prefer to keep their records

confidential or run a voluntary ID clearinghouse that would provide government

officials with limited access.

 

On the Net:

U.S. Department of Agriculture: www.usda.gov

 

 

 

 

 

Karl Theis Jr

Medical Science Reporter

www.RealityExpander.com Ch.10 TimeWarner

Austin,Texas cell 512 297-9875

http://groups.msn.com/exposureofthetruth

 

madcowcoverup-

 

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