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Karen M. List Contrary to popular belief, the fault for the flu vaccine shortage doesn't rest on the shoulders of a single British factory, Chiron Corp., which was recently closed due to contamination. The truth is the flu vaccine shortage is a direct result of tort lawyers, government regulation and price controls. Let's start with the tort lawyers. Class-action lawsuits have been filed against vaccine makers for years. These cases were based on the legal premise "liability without fault," which held that a manufacturer was responsible for harm from its products, blameworthy or not. That is, any reaction to a vaccine, not just a bad reaction, was free game for the tort attorneys. Toss in awards for pain and suffering and punitive damages, and companies were forced to discontinue manufacturing vaccines to avoid the risk of such lawsuits. While these legal practices nearly bankrupted the vaccine makers in the 1980s, Congress stepped in and passed the Vaccine Injury Compensation Program in 1986 to curb frivolous grievances and provide protection to vaccine manufacturers. However, trial attorneys soon found loopholes in the program and have continued their remedial pursuits. In conjunction with the overwhelming number of lawsuits, health officials at the Food and Drug Administration became nervous and tightened policies in the manufacturing of vaccines, an industry with an already proven safety record. Increased government regulation also hinders innovation as approvals for new production processes and techniques face increased scrutiny by regulators and costs for research and development soar. Why didn't the vaccine manufacturers just increase the price of their vaccines to cover the liability and regulatory costs? Herein lies the third and most compelling reason for the flu shot shortage. In 1993, Hillary Rodham Clinton, in her quest for health care reform, was able to "socialize" the vaccine industry with a government-sponsored vaccine buying program called Vaccines for Children. The pitch was to provide free vaccines for all children, thus resulting in higher immunization rates. Congress stamped its approval on the idea, forcing huge discounts and imposing price caps. Less than 10 years later, the government was purchasing a majority of all children's vaccines at a cost of $400 per child. The actual cost to manufacture, distribute and administer these vaccines was $600 per child, with the vaccine manufacturers absorbing the $200 per child difference. And what about the proposed higher immunization rates? Vaccination rates for 2-year-olds have remained steady while adult rates have actually decreased. Furthermore, while the nation is ill-prepared for an influenza outbreak, we're also in danger of experiencing vaccine shortages for many other life-threatening diseases. Thirty years ago, there were 25 vaccine makers. Now, only two remain that make flu vaccines: Aventis-Pasteur and Chiron Corp., both located in Europe. According to the Centers for Disease Control, there's just one vaccine producer for the U.S. market for the following: measles, mumps, rubella, tetanus, polio, chickenpox, pneumococcal and meningococcal. Diphtheria, whooping cough and hepatitis A and B have only two vaccine manufacturers, just as influenza. If any direct blame can be assessed, we should turn to Washington, D.C. Effective tort reform has been avoided for years, which comes as no surprise, due to Congress being mostly composed of attorneys. Increased FDA regulation is strongly influenced by members of Congress and fear-mongering trial attorneys. Price controls, mandated by Congress, have provided vaccine makers limited opportunities for covering production costs. Finally, ponder this as you stand in line for hours to receive your flu shot: Many members of Congress and its employees, as well as prison inmates, have already received their flu shots for free, and they didn't have to stand in line. List lives in Salem and works part-time as an auditor. |
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A Feast
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