THE BANNED FLU VACCINE WAS PERFECTLY OK

Bureaucracy caused the problem

Headlines about shortages of influenza vaccine are becoming as much a part of autumn as the World Series. In 2000, manufacturing delays and plant shutdowns sent many people scrambling for the hard-to-get vaccine. In 2001, fears of anthrax poisoning drew unexpectedly high demand, as did a particularly nasty flu bug in 2003. But 2004's scenario was undoubtedly the worst. This year the trouble began after British health officials on October 5 suspended the license of Chiron Corporation's Liverpool, England, flu-vaccine plant for "failure to comply with the requirements of Good Manufacturing Practice [regulations] leading to concerns of possible microbial contamination of product." Just that quickly nearly half-around 48 million doses-of the anticipated U.S. flu-vaccine supply disappeared.

Not surprisingly, public-health officials, politicians, and editorialists are now calling for government to "do something" to prevent this from happening again. There are not enough makers of flu vaccine for the U.S. market, they argue. Government must take steps to bring more companies into the business. Health and Human Services Secretary Tommy Thompson wants Congress to promise to buy 100 million doses of vaccine annually, guaranteeing manufacturers a healthy market. Thompson has also wants government to purchase any surplus vaccine at the end of each season to ensure enough is made.

As with previous flu-and other-vaccine shortages, the common assumption is that the free market doesn't work. Or, in the words of a former New York city health commissioner: "This has taught us that the consequence of leaving it to market forces leaves the country as a whole without any rational distribution plan." But all this overlooks one very important fact: government itself caused the flu-vaccine troubles.

In 1999 there were four makers of injectable influenza vaccine serving the United States. That same year the U.S. Food and Drug Administration (FDA) began a new system of vaccine-plant inspections that resulted in numerous fines, plant shutdowns, and mandatory (and expensive) new investments. FDA suspensions and citations drove one vaccine maker, Parkedale Pharmaceuticals, out of the business in 2000 on the eve of flu-shot season. (See my "Weakened Immunity: How the Food and Drug Administration Caused Recent Vaccine Supply Problems," Independent Review, Summer 2004.) Another company that struggled with numerous expensive FDA mandates and a $30 million fine, Wyeth Pharmaceuticals, left the business in 2002. Makers of childhood vaccines were equally hurt. Between 2000 and 2003, shortages occurred for eight of 11 childhood vaccines-nearly all directly linked to FDA mandates....

British, not FDA, officials brought about this year's shortage, but they used the same regulatory weapon the FDA had used years earlier-so-called "good manufacturing practice" violations. Under these standards, inspectors examine a plant's entire manufacturing process, not just the end product. FDA officials went to England and suggested additional vaccine contamination was found, but they were unclear about who found it or whether it was in vaccine set for public use. (Sabin Russell, "All of Chiron's flu vaccine deemed unsafe, FDA checks firms plant, says no doses can be salvaged," San Francisco Chronicle, October 16, 2004.) In the end, FDA officials clearly stated only one thing: "The problems that we found in the plant in the UK were what we call good manufacturing practice violations."

In light of all this, it seems quite likely there was no evidence of any flaw in the vaccines Chiron was prepared for release to the U.S. market-just official objections to "manufacturing practices." Indeed, Chiron officials stated clearly after their license suspension that all vaccine slotted for release had been tested and found "safe." In the words of the company chairman: "I think this [license suspension] reflects a regulatory philosophy that "focuses more on `system and process' and less on `the end product.'" (Denise Gellene and Melissa Healy, "Anticipated Supply of Flu Vaccine for U.S. Is Abruptly Cut in Half," Los Angeles Times, October 6, 2004.)

Unfortunately, as it stands today, U.S. "regulatory hurdles" (not to mention the ever-present threat of protectionism) make it difficult for drugs and vaccines to enter the U.S. from abroad. ("Flu, that was close," The Economist, October 21, 2004.) Even in the midst of this year's crisis, when vaccine makers in Canada and Germany offered to help supply the strapped U.S. market, American health officials were "doubtful" any newly offered vaccine could get FDA approval in time. This despite the fact the CDC believes that for every one million elderly people vaccinated against flu, 900 deaths and 1,300 hospitalizations are prevented.

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For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation.

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