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From the Editor:

In our featured Spotlight article, Dr. Paul Offit, author of The Cutter Incident and co-inventor of Merck's new rotavirus vaccine, discusses how lawsuits nearly bankrupted the vaccine industry and how the Vaccine Injury Compensation Program helped save it. The VICP, created by Congress in 1986, while not perfect provides a valuable model for medical compensation without involving lengthy and near-arbitrary jury trials.

Aside from vaccines, however, litigation against the pharmaceutical industry is lucrative and thriving. Plaintiffs' lawyers typically allege that companies hide information, inadequately test products, or improperly market them. One expert, quoted in USA Today, noted that "the lawyers have created almost an assembly line approach to use... against an industry that's in tobacco-land in terms of how much people hate it." A single company, Wyeth, is currently paying out $21 billion in settlement claims related to its weight-loss drug fen-phen; Merck's pending liability for the drug Vioxx is estimated at double that figure.

When science is dragged into the adversarial civil justice system, we all lose. Billions of dollars paid out in settlements, awards and lawyers' fees are funds lost to the research and development of treatments and cures. The VICP provides a fair and sensible alternative to the jackpot jury system that characterizes American civil litigation.

The pharmaceutical industry is the most heavily regulated industry in the world. Unfortunately, companies can never test products enough to rule out rare effects that only emerge in a sample of millions. Meanwhile, juries are ill-equipped to navigate the complexities of science. When push comes to shove, juries throw up their hands and give plaintiffs the benefit of the doubt. Industry compensates by charging higher prices to cover liability costs and by avoiding products that seem especially vulnerable to litigation.

Pharmaceutical litigation drives up health care costs and discourages life-saving innovation. Thanks to savvy marketing by plaintiff's lawyers and a credulous media, Americans spend as much time worrying about the small risks of medical research and treatment as they do the far greater risks posed by diseases and disabilities that afflict millions of Americans every day.

"There are no risk-free choices," Dr. Offit explains, "there are only choices to take different risks." In our quest to litigate perfect safety in the drug industry, we are choosing to expose ourselves to far greater dangers.

Spotlight

Public Health and Public Fears
A conversation with Paul Offit, M.D., on the challenges facing vaccine development

Paul Howard, Ph.D., Medical Progress Today, 8-30-06

Paul Howard: After reading your book, it struck me that our national obsession with vaccine safety dates back even to Salk's polio vaccine. Do you think that is true?

Dr. Paul Offit: I don't think that the public was obsessed with vaccine safety in the 1950s. Cutter Laboratories made a vaccine that had live poliovirus in it, probably in every dose at least for [the two lots mentioned in The Cutter Incident]. In effect, they were injecting live polio virus into children that was causing them to have polio and some of them to die. And yet the polio vaccination effort continued. I can think of no equivalent of that today. The Rotashield vaccine was withdrawn from the market in 1998 after only a single death.
Continue reading . . .

Featured links:

Vaccines Are Scarce. Why?
Peter Huber, Forbes, 9-4-06
http://www.forbes.com/free_forbes/2006/0904/150.html?_requestid=4494

TLI Health Care, Vaccination Litigation:  After almost killing the childhood vaccine market, Trial Lawyers, Inc. takes another stab at these vital medications.  2005
http://www.triallawyersinc.com/healthcare/hc04.html

Blame Congress
Robert Goldberg, New York Post, 10-22-04
http://www.manhattan-institute.org/html/_nypost-blame_congress.htm

Liable to Infection Flu vaccine in short supply partly because of trial lawyers and 'tort tax'
Jim Copland, Dallas Morning News, 12-14-03
http://www.manhattan-institute.org/html/_dmn-liable_to_infection_flu.htm

Solving the Vaccine Shortage: Market Solutions or Government Intervention?
MI Conference Series, 7-31-02
http://www.manhattan-institute.org/html/mics7.htm

Other resources:

Vaccine Product Approval Process
U.S. Food and Drug Administration
http://www.fda.gov/Cber/vaccine/vacappr.htm

Immunization Safety Review: Vaccines and Autism  (8th and Final Report) Institute of Medicine, 5-17-04
http://www.iom.edu/CMS/3793/4705/20155.aspx

National Vaccine Injury Compensation Program
http://www.hrsa.gov/vaccinecompensation/

A Proposal for Special Health Courts for Reliable Medical Justice
http://cgood.org/healthcare.html

For an alternative view:

Deadly Immunity
Robert Kennedy, Rolling Stone, 6-20-05 http://www.rollingstone.com/politics/story/7395411/deadly_immunity/


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Special Edition
August 25, 2006


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