Vaccine Shortage Is Bad Omen

Published October 11, 2004

The Health and Human Services (HHS) health care bureaucracy has, for the third time in five years, demonstrated itself incapable of protecting the public health by delivering an inadequate supply of flu vaccine. Call me a skeptic, but this track record raises questions as to the government’s ability to run a national health care plan.

Lives at Risk

The health of children, seniors, and front-line health care workers has been gravely threatened this flu season by the loss of 50 million vaccine doses–half of the required national supply. The problem is the result of suspected contamination at a British manufacturing plant owned by Chiron Corporation of Emeryville, California.

During the 2003-2004 flu season the Food and Drug Administration (FDA) miscalculated which strain of influenza was most likely to infect our population. A combination of errors and poor public policy resulted in a limited supply of the right vaccine.

The shortage was made even worse by the Centers for Disease Control (CDC), which broke from standard practice by promoting universal immunization, regardless of age and risk status. At the onset of the 2003-2004 flu season CDC Director Dr. Julie Gerberding said, “This is the time for Americans to really step up to the plate and get vaccinated against influenza.” HHS Secretary Tommy Thompson told the nation, “There is plenty of vaccine to meet demand.” It wasn’t the right time then and there wasn’t plenty of vaccine.

Near Monopoly Market

The number of private-sector vaccine manufacturers in the U.S. has dropped from 20 to only three during the past 15 years, largely a result of relentless lawsuits filed on behalf of persons alleging negative reactions to vaccines.

According to legal expert Peter Huber, 50 to 80 percent of the cost of most vaccines is liability insurance. The risk of losing such cases, and especially the risk of losing a class-action lawsuit costing hundreds of millions or even billions of dollars, has forced many companies to leave the vaccine marketplace.

Up until now only three companies in America were licensed to produce the flu vaccine: Aventis Pasteur (Fluzone), Chiron Corp. (Fluvirin), and MedImmune Inc. (the nasal spray FluMist). If more private companies had been encouraged to make the vaccines, it is unlikely the current supply would have been so badly jeopardized. More vaccine could have been produced on an as-needed basis.

Government Newspeak

The national implications can’t be waved off with newspeak. On October 6, Gerberding told the Wall Street Journal, “Take a deep breath; this is not an emergency.” But a close look at the numbers from the CDC suggests otherwise: There are only 52 million needle doses available from Aventis, the lone supplier–but 185 million people are considered by the federal government to be at risk of flu complications.

MedImmune, the smaller supplier, is attempting to produce about two million doses of its nasal vaccine FluMist, but that cannot be used by patients with chronic medical conditions.

More from Less

There is little likelihood we can play catch-up on the supply side for the current flu season. It takes months to make a vaccine. The word from the infectious disease branch of the National Institutes of Health (NIH) is that the health care bureaucracy is investigating the possibility of splitting or diluting doses.

The government can’t ration the vaccine since it does not control the supply, so this difficult and quite frankly random process is left in the hands of suppliers and front-line medical professionals. While they attempt in good faith to follow federal guidelines, there remains the potential danger of counterfeiting, fraudulent representation of need, and preferential treatment.

Connect the Dots

In an effort to defend the his turf, Bruce Gellin, internist and director of the federal National Vaccine Program Office wrote on October 8 in USA Today’s editorial pages, “With increased demand [for the vaccine] we cannot continue to be handcuffed if companies encounter problems producing and delivering vaccines during the flu season.”

In addition to the scarcity of vaccine manufacturers, there are national budget priorities established by Congress. In each of the past two budgets HHS asked for $100 million for development of modern technologies to ensure a continuing supply of eggs used to grow the influenza virus and produce the vaccine. This year, again according to Gellin, Congress appropriated only $50 million.

While the government registered shock and awe over an even greater vaccine shortage this time around, I find it difficult to accept their reaction. HHS has had warning after warning, including two government reports, that we have major issues over inadequate vaccine supplies. Still, no appropriate action was taken to rectify the problem. According to the federal government’s own data, nearly 36,000 people have died every year of flu complications since 1999.

What has now become an unacceptable pattern of repeated gross mismanagement raises serious questions whether the federal health care bureaucracy (HHS, CMS, FDA, and smaller agencies) can administer the size and magnitude of a national health care plan any better than it can administer the national vaccination program.

This observer suggests it cannot because it has not.

Conrad Meier ([email protected]) is a senior fellow with The Heartland Institute, a Chicago-based think tank.