Saturday, October 16, 2004

The Flu Vaccine Shortage

The Democrats have been quick to accuse the Bush administration of dropping the ball on the matter of flu vaccine supply, but this is an example of political opportunism masquerading as profound concern for human welfare.

The available supply was cut in half because that portion of it produced in England was found to be contaminated by a bacterium. This raises the question, of course, of why we have to rely on foreign manufacturers to supply our vaccine in the first place. The answer is that over-regulation by the FDA and the fear of litigation have made domestic production unprofitable. In 1988 there were twenty five companies in the United States producing vaccines. Today there are only two. The rest weren't able to make enough money to cover the cost of insurance and R & D, so they decided to get out of the vaccine business altogether, and we were forced to seek our vaccines abroad. As a result, possibly thousands of people, perhaps many of them children, will die this winter because there isn't enough medicine with which to innoculate them against the flu. It's a good illustration of how government screws everything up when it tries to control too much.

Another problem is that demand for flu shots fluctuates from year to year as public interest waxes and wanes. Last season brought huge demand for a flu shot; the year before saw little interest. But flu shots have to be made six to eight months in advance, so the manufacturers must rely on projections which puts them at risk of creating far more vaccine than there is demand for. Since they can't store it, whatever they can't sell is a total loss. Companies often have to discard millions of doses a year.

Yet a third problem is that the government has become the most important purchaser of vaccines and now controls the market. This is because public health agencies have stepped into the market to help the poor by providing low-cost vaccinations. While this sounds like a laudable goal, the "public customer" has come to dominate the market. This has lowered prices for these medications.

With prices low, the risks associated with vaccine manufacture have become relatively more important. Vaccine manufacturers continue to be sued in vaccine-related lawsuits. Over the past 15 years, such litigation has chased several companies out of the vaccine business altogether.

What we need is more companies making vaccines in the United States. That means it has to be more profitable with less liability risk and fewer economic restraints. These important medicines save thousands of lives each year. To burden the manufacturers with onerous pathways to regulatory approval, unrealistic standards and exorbitant and unreasonable legal judgments, and to depress profits and innovation with price controls, is to cheat the American people.

It's hard to see how the Bush administration, which advocates all of these measures, can be fairly held responsible for this year's vaccine shortage, but it's not hard to see that an administration in thrall to trial lawyers and "big government" regulation of industry will be a major part of the problem, not part of the solution. John Edwards, who, as a lawyer, has enriched himself by bringing suit against medical practitioners, and his running mate, John Kerry, have consistently opposed measures that would effect genuine tort reform and are also strong advocates of government regulation. Despite Senator Edwards' claim the other day to possess supernatural powers of healing, both his and Kerry's records give the beleaguered flu sufferer little hope of any future relief.