A MUST READ!! Lawsuit Alleges Irregularities With Vaccine

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http://www.immunizationinfo.org/pressroom/newsbriefs_detail.cfv?id=9835

Lawsuit Alleges Irregularities With Vaccine

Wall Street Journal C1

Hensley, ; McKay, Betsy

03/31/2004

Since its introduction to the market in 2000, the pneumococcal vaccine

Prevnar has grown in popularity as a protective barrier against the bacteria,

which

can cause brain infections and even death, yet its maker Wyeth has run into a

string of production problems that have left the company unable to meet demand

and prompting the Centers for Disease Control and Prevention to recommend

delays in children's four-dose immunization schedules so that infants can have

at

least some protection with two doses. The vaccine takes a year to produce, so

any improvement in Wyeth's production abilities is delayed on the market for

a year, leading to continued shortages that are expected through the summer of

2004, though the company claims that at that time, the troubles will be over.

In a twist, however, former Wyeth manufacturing manager Mark Livingston has

filed a lawsuit against the company and two employees, saying that in its drive

to get Prevnar to the market, Wyeth cut production corners that violate Food

and Drug Administration (FDA) rules and which could leave the vaccine

vulnerable to problems with quality control. Livingston brought up his concerns

at an

FDA meeting in July 2003, but he said that because he had not heard any

development from the agency since that time, he would go ahead with a civil

lawsuit

to bring more attention to the matter, claiming that Wyeth's actions amount to

fraud against its shareholders by not revealing problems with Prevnar

production.