- The Washington Times - Saturday, October 9, 2004

Every year in this country influenza kills tens of thousands and hospitalizes about a quarter-million.

In epidemic years, the numbers can be astronomical, even when there is enough vaccine to go around. This year there isn’t: The supply was cut in half last week when one of only two companies that make flu shots for use in the United States abruptly announced its 48 million doses were unavailable because of possible contamination problems.

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 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.

There are short- and long-term remedies that must be undertaken immediately.

In the short-term, there should be Centers for Disease Control and Food and Drug Administration clinical tests to see if the injectable vaccine is effective when diluted. If, as previous evidence suggests, the vaccine is still effective when diluted by a factor of 2, that would make available another 54 million doses. We could have those results within a month. That would, in effect, make a dire threat to public health disappear.

Second, the FDA should make it clear that though the labeling for FluMist, the nasal vaccine, indicates it is intended for recipients aged 5 to 49 years, it will likely also be effective in those younger or older. (The labeling reflects the relatively narrow patient population in whom preapproval clinical trials were performed.)

Finally, government health officials should make it clear. even if there are vaccine shortages, there are orally administered drugs that can prevent, and treat, influenza.

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.

Companies should be given tax credits to defray research and development costs. And vaccine developers should be guaranteed exclusive market rights for a fixed period. Health-care insurers should be required to exempt vaccinations from deductibles under their plans. 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, and damages would be compensated by the government.

These needed reforms won’t come easy. Getting the government to adopt them will be about as easy as dragging a child to the doctor for a painful shot.

Henry I. Miller, M.D., a fellow at the Hoover Institution, is former director of the Food and Drug Administration’s Office of Biotechnology. His most recent book is “The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution.”



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