Tuesday, October 12, 2004

THE VACCINE SHORTAGE IS GOVERNMENT-CREATED

"Flu vaccine should be an attractive product for manufacturers - it is used every year, recommended for virtually everyone, and extremely safe. But like virtually all other vaccines, it isn't profitable. And that has so discouraged vaccine development that supplies of many lifesaving vaccines are in jeopardy. The fundamental problem is government policies that discourage companies from investing aggressively to develop new vaccines. Innovation has suffered, and producers have abandoned the field in droves, leaving only four major producers and a few dozen products. There are only two producers of injectable flu vaccine, for example: Chiron, unable to supply any product this year because of alleged contamination; and Aventis Pasteur, whose 54 million doses will be all that's available. (In addition, there will be another 2 million doses of FluMist, an inhalable nasal vaccine.)

This is not the first time we have had dangerous shortages of several essential vaccines. Some school systems have been forced to waive immunization requirements because there aren't enough vaccines available.

Vaccination to prevent viral and bacterial diseases is modern medicine's most cost-effective intervention. Although their social value is high, their economic value to pharmaceutical companies is low because of vaccines' low return on investment and the manufacturers' exposure to legal liability....

Federal bureaucrats, who seem not to understand the concept of carrots and sticks, can do much to encourage greater production of more and better vaccines in the long term. For example, the CDC, the largest domestic purchaser of vaccines, uses its buying clout to compel deep discounts for purchases.

Arbitrary and excessive regulation also blocks progress. Consider, for instance, the FDA position on a vaccine to prevent meningitis C, a bacterial illness that infects thousands of Americans and kills hundreds each year. No state-of-the-art vaccine against this infectious disease is approved for use in the United States, although three excellent products are available in Canada and Europe. The safety and efficacy of these vaccines have been amply demonstrated, with more than 20 million doses administered. Yet the FDA refuses to recognize the foreign approvals.

Moreover, the FDA has a history of removing safe and effective vaccines from the market based merely on perceptions of excessive side effects - a prospect terrifying to manufacturers.

We need a fundamental change in mind-set: The rewards for creating, testing and producing vaccines must become commensurate with their benefits to society, as is the case for therapeutic pharmaceuticals. First, our government should accept U.S.-European Union reciprocity of vaccine regulatory approvals. This would cut development costs significantly. Second, public agencies must stop extorting huge discounts for vaccines..... And finally, a regulatory-compliance defense should be allowed so that after a manufacturer meets the rigorous regulatory requirements for vaccine approval, any mishap from use of the product is considered to be nonculpable... "

More here.

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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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