Consequences of the ban on thimerosal

http://www.independent.org/newsroom/article.asp?id=1374

"The effects of the new requirements were too drastic for many
pharmaceutical companies. Aventis Pasteur had to switch production of DTaP,
a vaccine for diphtheria, tetanus, and pertussis (whooping cough) given
primarily to babies, from multidose vials to tiny single shot vials to
eliminate thimerosal but maintain the vaccine's shelf-life. The new
requirement cost Aventis two years of development effort but also decreased
the company's vaccine production capability by 25 percent. Another
pharmaceutical maker, Wyeth, was unable to meet the thimerosal requirements,
contributing to its decision to stop producing DTaP altogether.

The decision of even one company to stop making a particular vaccine can
spark a crisis. Wyeth's exit from the DTaP market had large repercussions
because the company produced about one third of the nation's DTaP supply.
That case would not be an exception. There are only four pharmaceutical
companies that provide nearly all of the childhood vaccines used in the
United States-Merck (USA), Wyeth Pharmaceuticals (USA), Aventis Pasteur
(France), and GlaxoSmithKline (UK).

With so few companies producing vaccines, the United States is highly
susceptible to sudden vaccine shortages and equally sudden price spikes.
Instead of encouraging new companies to enter the vaccine market, the FDA's
expensive and time consuming approval process-as well as its cumbersome
manufacturing regulations-discourages new companies from making vaccines and
may even further decrease the total number of vaccine producers.

Barely one hundred years ago, more than one in ten American infants died
from vaccine-preventable diseases. Since the introduction of vaccines, the
incidence of these diseases has dropped by 99 percent. Under present law,
the FDA is responsible for ensuring that these vaccines are effective and
safe, but the FDA has an equal responsibility to ensure that it does not
hinder the market's ability to deliver enough vaccines to protect every
American child in need. Unfortunately, there is no inoculation from the ill
effects of a government agency unwilling to live by the Hippocratic oath."