Kerry Ad Says Flu Vaccine Shortage Is Typical of Bush's Policy Blunders

Kerry Ad Says Flu Vaccine Shortage Is Typical of Bush's Policy Blunders

By Howard Kurtz
Washington Post Staff Writer
Sunday, October 17, 2004; Page A06

Sen. John F. Kerry jumped on the flu-vaccine shortage yesterday with a new television ad blaming the situation on President Bush.

In what may be the first presidential campaign commercial dealing with the flu, the Democratic nominee is trying to portray the vaccine squeeze as typical of the president's mishandling of health care. Bush campaign spokesman Steve Schmidt said that Kerry had opposed a legislative remedy and that his "incredible hypocrisy just demonstrates again his willingness to say whatever will benefit him politically."

In the ad, a narrator says: "Three years ago, medical experts warned George Bush that a dangerous shortage loomed. Instead of fixing the problem, production of the vaccine was sent to a factory overseas -- the vaccines were contaminated. Now Bush wants Canada to help, even though his own policies make it illegal for us to import medicine from Canada.

"Seniors and children wait. Not enough vaccines for pregnant women. A George Bush mess."

The spot, which features headlines from USA Today, The Washington Post, the Orlando Sentinel and the New York Times, is typical of the "crash ads" the campaign has been making lately to capitalize on breaking news.

In 2001, the General Accounting Office cautioned that ensuring an adequate flu vaccine supply had become more difficult because of a dwindling number of manufacturers and that problems at one of the two or three remaining vaccine makers could "significantly impact overall vaccine availability." The crisis was triggered 12 days ago when a British agency halted shipments from a Liverpool-based vaccine maker because of bacterial contamination.

Bush aides noted that Kerry had opposed legislation last year that would have immunized vaccine makers from punitive damages in lawsuits involving FDA-approved products. Most Democrats objected to the bill, which never came to a Senate vote, because it would cap non-economic damages at $250,000 in all liability cases. Kerry spokesman Chad Clanton said the senator supported a vaccine compensation law for injured patients that passed in the 1990s, adding: "The American people want flu shots, not more excuses why George W. Bush dropped the ball." The Bush camp, however, says spending on flu preparedness has grown from $39 million to $283 million during the president's term.


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Q: Does the government have the power to do this?

A: The arrangement with Aventis Pasteur is voluntary. The federal government has control only over vaccine contracts it has for hospitals like the Veterans' Affairs medical system. State governments control only what they distribute through state health departments. Laws vary from state to state about how much power the government has over privately owned medical supplies, such as vaccines.

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FDA says flu vaccine shortage was surprise

Washington, United States, Oct. 12 (UPI) -- Prospects of losing half of the U.S. flu vaccine came as a surprise to the U.S. Food and Drug Administration last week, the Washington Post said Tuesday.

Acting FDA Commissioner Lester Crawford denied media reports the agency had any early indications that there were serious problems at the Chiron Corp., a vaccine manufacturer in England that was supposed to supply the United States with some 48 million doses.

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Dr. Gerberding says the national vaccine supply is "fragile" and, indeed, it is beset by problems. Flu vaccine, for instance, is made with an antiquated process that involves growing virus in millions of chicken eggs. A modern cell-culture method for vaccine production is available, which could simplify and speed production. In addition, there aren't enough vaccine manufacturers, partly because pharmaceutical companies prefer to make more profitable drugs.

This year's shortage shows the need for the system to be fixed. CDC asked for $100 million to do so in the last federal budget, and Congress cut the request to $50 million. Congress should restore the money, and provide additional funding, if needed.

Nobody can accurately predict the severity of a flu season. With luck, 2004-05 will be mild and the country will have time to make repairs before this kind of shortage causes enormous suffering.

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Bacteria Causes U.S. Flu Vaccine Shortage
By CONNIE CASS
The Associated Press


WASHINGTON - The reddish bacterium to blame for this year's shortage of flu vaccine has a colorful history.

Until the 1960s, Serratia marcescens was considered harmless - so safe, in fact, that the military secretly dispersed it across U.S. cities in germ warfare studies. Today, Serratia is blamed for urinary tract infections, infected surgical wounds and pneumonia, usually spread among hospital patients.

The germ that tainted the flu vaccine at a British factory is a common contaminant in labs - and lots of other places. Serratia is found in people's intestines, and possibly growing as pinkish scum in the shower, too.

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Chiron's problem started in August, when it discovered contamination in 4 million doses. But less than two weeks ago, top U.S. health officials assured the public that close FDA monitoring of the rest of the supply showed it was fine and there would be no shortage.

British officials didn't explain why they disagreed - and the move took U.S. officials by surprise. Food and Drug Administration officials headed to Britain Tuesday to investigate, but wouldn't say if they would ask British regulators to specially release any of the shots for use here if the flu season proves to be a bad one.

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?We must ask ourselves why this nation now has just two major flu vaccine makers. Why is that? I believe it is due in part to litigation problems manufacturers face. Congress must address the litigation issue. But that's not all,? said Sen. Craig (R-Idaho). ?We must make sure that this doesn't happen again, and I believe that we can do that by adopting principles incorporated in the Flu Protection Act of 2004, of which I am a co-sponsor with Sen. Evan Bayh (D-Indiana).?

Craig said the legislation, S. 2038, would encourage an increase in vaccine production capacity by offering a tax credit for companies to invest in the construction or renovation of production facilities and for the production of new and improved vaccines. The legislation also contains provisions to encourage a greater volume of vaccine production, as well as to improve outreach and education about the importance of flu vaccination.

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The news means the United States will face "a significant shortage," said Dr. Anthony Fauci, the National Institutes of Health's infectious disease chief. Other countries, but not Canada, will likely face similar problems.

"The implications may be significant," said Dr. Klaus Stohr, influenza chief the World Health Organization.

British authorities suspended the licence of Chiron Corp. for three months because of problems at its vaccine factory in Liverpool, England. The action means the company can't supply any flu vaccines to any market during that time, and Chiron said it would provide no vaccine this year.

British officials didn't explain details for the licence suspension.

U.S. health officials were caught off-guard, learning of the developments only during a midmorning phone call. "We need to regroup," Fauci said shortly afterward.

Dr. Tony Holler, CEO of Canadian flu vaccine maker ID Biomedical, said his company has one million to 1.5 million excess doses of flu vaccine it could sell to the U.S.

"What we're going to do is we're going offer whatever excess we have," Holler said.

But he noted that last year, Shire Biologics - a vaccine company that ID Biomedical bought-had excess vaccine and offered it to the U.S., which had run out. But because Shire wasn't licensed in the U.S., the Americans wouldn't take it.

"Their view is if the product isn't approved in the U.S., there's no way we're taking any chances with it. It doesn't matter how many Canadians have taken it for how many years," Holler said.

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If any group is responsible for the flu vaccine shortage, look to the group that Kerry's running mate belongs to, tort lawyers.

Before the 1960s, most vaccines needed in the US were manufactured in the US. What happened? The policy of "liability without fault", where you can be held responsible for damages occurring from use of your product whether or not you were negligent. And since the insurance companies pay the awards, it seems okay to juries to award HUGE settlements. And we lost another industry.

Currently I'm working a project where my client is building a live virus vaccine manufacturing facility. It's phase one of a two phase project. Phase one should be completed by fourth quarter of 2007.

My fee alone is well over $300,000 for phase one. That's just for the design of the voice and data networks and the design of the pathways and spaces supporting those networks. This doesn't include the purchase of a single telephone, data switch or piece of cable. The estimated budget for the equipment is about $1.6 million.

I don't have the total cost for the project, but the buildings are modular, and are being built in Sweden. They'll be brought over on ships and assembled here.

The interesting thing about this is that my client already has an existing virus manufacturing site in another state that is perfectly capable of producing the new product. But since this vaccine is different than what is currently being produced there, the FDA decided that the facilities had to be separate.

Keep in mind that the new vaccine has not yet been developed. First the company has to build the new facility, then develop the vaccine, and get it through FDA approval before a product goes on the market. At the earliest, the product may be available in 2012.

Somehow, I guess it's Bush's fault that this product is not available today.