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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." |
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