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Last Updated

17 Feb 2003

Source: Wall Street Journal, February 14, 2003


Litigation Pox


In a matter of weeks we will likely be at war with Iraq, a country that may already possess "weaponized" smallpox . Yet our best efforts to protect the public from smallpox devastation could be derailed by trial lawyers and the medical profession's fear of litigation.

Countless hours have been spent by our finest public-health officials at every level of government to coordinate a voluntary program of massive smallpox immunization. We do not live in a risk-free world. Health providers know too well that the horrible and the unexpected happen, even with our best attempts at minimizing tragic outcomes.

With any smallpox vaccination program there will be complications, including death. If this creates fodder for more litigation, doctors and health officials will run scared. Pharmaceuticals, already facing billions of dollars of litigation associated with pertussis and polio vaccines, will opt out. Yet, if we don't immunize and smallpox escapes the test tube, there may be nobody left standing to sue or be sued.

Make no mistake, smallpox is one incredible killer. Over the past dozen centuries the disease claimed over 500,000,000 lives. No human pathogen has been more deadly to the human species. The last known case was in Somalia in 1977, and with no known animal reservoirs that might hide the virus, this infectious disease was officially declared eradicated in 1980.

Required smallpox immunization for children ceased in the U.S. by 1969, and almost all vaccinations ended by 1974. Today, global immunity against smallpox is at an all-time low, equivalent to the Dow Jones Industrial Average being at 39, and dropping each day. More than 80% of the human population has never been immunized against smallpox . At no time in human history have we been more vulnerable to this virus.

The vaccine scenario is far from perfect. The current available vaccine is the same animal-tissue-derived vaccine used in the past. The U.S. has seven million doses of this 30-plus year-old vaccine that was kept in frozen storage in Pennsylvania. It is a live attenuated virus known as vaccinia, a cousin of cowpox and smallpox . It has significant side effects. One in 4,000 vacinees will suffer a serious side-effect. One in 300,000 will suffer a life-threatening reaction including encephalitis. One in 1.1 million will probably die as a complication of the vaccine. It is very important to screen potential vaccinees and not immunize those with immune deficiencies and certain skin disorders such as eczema.

It is estimated that if the U.S. immunized its entire population under controlled conditions, approximately 300 people would die of complications related to the vaccine. Some of these people would have undetected immune disorders with an already limited life expectancy, but nonetheless a tragic loss of human life. If immunization is initiated as a crash program because smallpox cases were already detected somewhere in the world, many more would die in a less controlled and less supervised emergency attempt to immunize the entire population within days or weeks.

Public-health officials are obligated to consider the worst-case scenario of a smallpox epidemic -- the release of this virus upon a non-immune population. If unleashed today, this highly communicable virus would race across the planet, infecting most of the world's population. Within a brief period of time hundreds of millions of people might die. None of us would want to be in physical contact with anyone else, or even share the same air with someone whose status we did not know. All health-care systems would be shut down. Hospitals would be closed. Doctors and nurses and their families would be infected and also going without care. All efforts at quarantine would be crushed. The living might envy the dead.

Our public-health officials are entrusted with preventing deaths from communicable diseases. Yet the guardians of our health behave as if they are paralyzed. Every medical decision in America, including the decision to immunize against smallpox , is now centered on what can happen to the health-care provider, public-health official, hospital, or pharmaceutical company if there are complications. Incredibly, some hospitals support the vaccine program, but not on their property where they would be liable -- better to prevent lawsuits than to save lives. With smallpox we are talking about the lives of millions.

It's time we put the common good of humanity above the common fear of litigation.

Dr. Savitch is a member of the Infectious Disease Association of California.