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Swing modestly, sweet legislators
by Randall C. Willis  |  Email the author

I am not a golfer. Nor am I a tennis or baseball player. But I do understand the concept of following through and extending your swing to maximize the effectiveness of your effort. Unfortunately, unlike many other sports metaphors, following through and fully extending in other aspects of life don't always provide the best results. Nowhere is this truer than in healthcare, where the violently swinging pendulum of public opinion generally does more harm than good.
A couple of months ago, I read a new book about the discovery of the polio vaccine and the downstream events of its introduction to the U.S. marketplace. In its own way, The Cutter Incident tries to explain the history behind present-day vaccine shortages. Author Paul Offit, who is also chief of infectious diseases at Children's Hospital in Philadelphia, strives to add context to why we seem ill-prepared to face the pandemic that will inevitably arrive, whether this year or 20 years from now.
The title refers to the aftermath of technical and legal challenges that arose in the development of the Salk vaccine. A small amount of live virus contaminated several batches of vaccine, possibly leading to the development of polio in some children. According to Offit, the subsequent lawsuits filed by grieving parents against one supplier, Cutter Laboratories, set the stage for a legal landscape that made vaccine production commercially unattractive to this day.
Few can deny that the responses to these tragic events are unfortunate scars on an otherwise globally successful project that has saved millions of lives. This isn't limited to the vaccine market, either, as exemplified by the recent litigation over COX-2 inhibitors. And as the world is increasingly faced with news of oncoming pandemics and concerns over biothreats, the repercussions of these lawsuits is becoming ever more real to people and the governments who serve them.
Recent events in the United States, however, suggest this looming fear has prompted the pendulum to start swinging in the opposite direction. On October 17, U.S. Senator Richard Burr (R-NC) and five cosponsors presented Bill S.1873 to Congress that they hope will help to strengthen and prepare the United States to protect itself against deliberate, accidental, and natural disease outbreak.
If passed, the Biodefense and Pandemic Vaccine and Drug Development Act of 2005 will result in a new organization, the Biomedical Advanced Research and Development Agency (BARDA), within the Department of Health and Human Services. Essentially, BARDA will oversee the cooperation of commercial, government and academic organizations in the development of drugs, vaccines and other disease countermeasures.
What makes this new initiative unlike current efforts to develop drugs and vaccines, however, is that the work will be performed under a blanket of secrecy, out of the view of normal oversight and regulatory channels.
While there are many aspects of this bill that merit discussion—some of which may form the basis of future editorials—the one that connects best with our current discussion is the section that eliminates legal protections for persons affected by products or practices deemed necessary by the government.
As described in Section 6 of Bill S.1873, "a manufacturer, distibutor, or administrator of a security countermeasure or a qualified pandemic and epidemic product, or a health care provider shall be immune from suit or liability caused by or arising out of the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of a security countermeasure, or a qualified pandemic and epidemic product."
Perhaps I am naïve, but while I understand that the current litigious nature of the general populace has made it difficult for companies to sell their products and governments to do their jobs in the name of protecting human health, removing all mechanisms of redress for errant or wrongful treatment seems a little short-sighted. What is the point of individual rights and freedoms without mechanisms to defend those same rights?
It is important for everyone, including legislators, to realize that Bill S.1873 is just a starting place. There is a middle ground out there, between the wide swings of the pendulum. It is up to our legislators to find that middle ground to ensure that everyone—individuals, corporations, government agencies—is protected, and it is up to the rest of us to be sure that they do.



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