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Analysis: No check for unused flu shots

By AL SWANSON

CHICAGO, Feb. 1 (UPI) -- An attempt by Illinois' governor to obtain unapproved flu vaccine directly from Europe at the height of last fall's vaccine shortage has backfired, turning into a statewide embarrassment.

State Comptroller Dan Hynes said no check would be mailed to British wholesaler Ecosse Hospital Products Inc. because the U.S. Food and Drug Administration never approved the influenza vaccine sought by the governor for use in the United States. Illinois never received any imported flu vaccines.

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Hynes informed the governor's office of his decision Monday in a letter to Blagojevich's chief of staff saying he would not pay for 256,000 doses of imported flu vaccine located in October, after contamination at a Chiron facility in Liverpool, England, cut the U.S. vaccine supply by nearly half.

The crisis left Aventis Pasture the only licensed vaccine maker. Aventis, now Sanofi Pasture, and Medimmune, which produces nasal spray vaccine, were able to make 58 million doses when 100 million had been expected.

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The signed contract with Ecosse didn't reach the comptroller's office until Jan. 24, and with flu season half over. Hynes wants to know why the deal was signed.

"Perhaps there are side agreements that we don't know about. Perhaps they have verbal assurances that we don't know about," Hynes told Chicago Public Radio. "All I can work under is the written contract and I don't believe we owe the money."

Hynes said common sense showed the vaccine deal was bad from the beginning. Ecosse will have to sue for payment for vaccine it never shipped. Hynes, a former U.S. Senate candidate who plans to run for re-election in 2004, denies his stand is political.

The state comptroller is required by law to review the legality and terms of state contracts, and Hynes said he can't understand why the governor is resigned to paying for vaccine Illinoisans will never use.

"In this case, it just seems illogical for the governor's office to expect us to just pay $2.5 million without questioning the deal that they struck. Why are we paying $2.5 million for flu vaccine that we may never see?" he said.

Blagojevich, who led efforts by states seeking FDA approval of prescription-drug imports from Canada and Europe, announced last October that his staff had found 700,000 doses of flu vaccine in Europe. He arranged to buy it for $7 million and share the cost with New Mexico, Cleveland and New York City.

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Throughout the winter, Blagojevich pressured the FDA to approve the vaccine used throughout Europe, but that never happened. The national Centers for Disease Control restricted flu shots to those considered at high risk: the elderly, pregnant women, children 6 months to 23 months, chronically ill and healthcare providers who work directly with high-risk groups.

Many healthy people gave up the idea of getting a flu shot, and with a relatively mild flu season vaccine eventually was made available to anyone who wanted a shot. Illinois received 1.7 million doses of vaccine, and the CDC freed up 3.1 million doses stockpiled as an emergency reserve for children.

Widespread flu outbreaks were reported last week in 14 states: Colorado, Connecticut, Delaware, Kansas, Kentucky, Maryland, Minnesota, New Jersey, New York, Pennsylvania, Rhode Island, Texas, Vermont and Wisconsin, and regional activity in 17 states.

"It is now appropriate to use what's left of the limited vaccine supply to offer protection to as many people as possible," said Dr. Eric Whitaker, Illinois' public health director.

Flu vaccine is formulated annually to protect individuals from different stains of virus each season and cannot be saved from one year to the next.

Hynes said under terms of the contract the state should not have to pay for the unshipped vaccine in Europe because of "circumstances beyond its reasonable control including ... government regulation."

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He argues the governor exceeded his authority by ordering unapproved vaccine and said he had not seen any deals signed with New York City, Cleveland or New Mexico that would hold them liable for their share.

None of them want their 400,000 doses of imported flu vaccine any longer.

"Why are we assuming the risk (when) the federal government doesn't approve of the vaccines being imported?" Hynes asked. "And then, worst of all, why are we assuming the risk for supplying flu vaccines for citizens of other states and cities?"

The governor issued a statement saying the British wholesaler should be paid by the cash-strapped state because it acted in "good faith" to help the people of Illinois avoid a possible pubic health crisis.

"We made a decision last fall in the midst of an emergency vaccine shortage not to sit back and wait for help but instead to take aggressive steps to protect the public against what could have been a disastrous flu season," Abby Ottenhoff, the governor's spokeswoman, told the Chicago Tribune.

Was the vaccine purchase a political gamble by a publicity-seeking first-term governor that didn't pay off? Had the winter of 2004-2005 produced a horrible flu season Blagojevich would have said that he did everything he could to protect the people and was thwarted by a foot-dragging FDA.

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Because millions did not get sick the governor has egg on his face. Some think the comptroller is rubbing his nose in it. Hynes, a Chicago Democrat, and Blagojevich have clashed over the last two budgets because of the state's long-term borrowing to fund operations. Last year Hynes tried to block $2 million in payments to a consulting firm because it moved its headquarters from Chicago to Bermuda.

Illinois last week lifted all restrictions on who can get a flu shot acting on recommendations from the CDC, which fears millions of doses of vaccine will go unused this late in the winter.

Flu typically peaks in January and February but can persist into April. Anyone receiving a shot now would not be protected for at least two weeks.

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(Please send comments to [email protected].)

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