Trial Lawyers Didn't Block Flu Shots

On Oct. 11, 2004 the Houston Chronicle published a letter from an irate reader which began "This winter if you or someone you know gets the flu because they did not get a flu shot, make sure you thank a trial lawyer for making us dependent on foreign companies for our vaccines. It is their greed and avarice that made it impossible for American companies to provide for American needs." The writer then continues "Next, thank a Democrat for perpetuating the environment where the right to be compensated for vaccine interaction outweighs the lives saved."

Perhaps the argument would be stronger if it weren't for the fact that in 1986, Congress passed the National Childhood Vaccine Injury Act, which created the Vaccine Injury Compensation Program (VICP). This act is funded by a surcharge on vaccine doses, paid for by patients, and covers the cost of injuries due to vaccines. Also, most of the lawsuits were due to DPT (diphtheria, pertusis, typhus) vaccine, which was very risky. DPT has essentially been supplanted by DTaP (diphtheria-tetanus-acellular pertussis) which has a higher safety margin.

But there's another possible interpretation. The Republican Party, with its constant railing against taxes, has failed to indicate what services these taxes pay for. Yes, they pay for the armed forces and the FBI, but they also pay for the regulatory agencies that make and enforce rules. The rules include things like assuring that the air we breath is breathable, the water we drink is drinkable, and if a store advertises computers on sale, it actually has computers to sell. We place a lot of faith in these laws and the regulatory agencies that enforce them. We believe that the FTC, FCC, FDA, in fact just about anything that begins with F and stops short of 4 letters, is beyond politics and working in the public interest.

But the FDA, for all its theoretical good intent, is understaffed and underfunded. According to Understanding Government, a program of the School of Communication of American University, "Fewer than 1,100 FDA investigators must inspect about 120,000 domestic establishments, from mom-and-pop medical device companies in a garage to multinational food conglomerates and pharmaceutical giants. A lack of funding and personnel forces the agency to exercise inspectional triage ..."

Although the FDA is poorly equipped to monitor production of drugs and biologicals, many of the shortages have been related to Good Manufacturing Practices (GMP) compliance. That is, even with its inadequate surveillance, the FDA has found repeated failures by the manufacturers to follow recognized standards. While some writers have complained that these violations are simply matters of record keeping, the current shortage of influenza vaccine is caused by bacterial contamination of the vaccine supplies at Chiron's plant in England. That's not a trivial record-keeping problem. Some of the best-known companies in the industry have been cited for GMP violations. Abbott, Eli Lilly, Warner Lambert, Wyeth-Ayerst, and Fujisawa have all entered into consent decrees with the FDA as a result of breaches of GMP.

Since even limited inspections have turned up significant defects, including bacterial contamination, it seems clear that trusting to the good intentions of the vaccine manufacturers isn't practical. Unfortunately, fear of lawsuits, which has traditionally served as a back-up system to assure product safety, no longer constrains the vaccine manufacturers, since the VICP is picking up the tab. Vaccines are a low profit item for most manufacturers, and since the inspections are infrequent, and the VICP offers immunity from lawsuits, they have every inducement to cut corners.

We the people are picking up the tab for this protection against lawsuits, but since it's a surcharge on the price of the vaccines rather than a tax, we get to pretend that we're not paying taxes.

Perhaps we could give the money to the FDA so the agency could do its job properly, enforce Good Manufacturing Practices, and we could have the sort of consumer protection that we think we're paying for. Only that would be called a tax; better leave things alone.

Sam Uretsky is a writer and pharmacist living on Long Island, N.Y.

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