LITIGATION POX

Physician's Money Digest, March15 2003, Volume 10, Issue 5

In a matter of weeks, we will likely beat war with Iraq, a country that mayalready possess "weaponized" smallpox.Yet our best efforts to protect the publicfrom smallpox devastation could bederailed by trial lawyers and the medicalprofession's fear of litigation.

Countless hours have been spent byour finest public-health officials at everylevel of government to coordinate a voluntaryprogram of massive smallpoximmunization. We don't live in a risk-freeworld. Health providers know toowell that the horrible and the unexpectedhappen, even with our best attemptsat minimizing tragic outcomes.

With any smallpox vaccination programthere will be complications, includingdeath. If this creates fodder for morelitigation, doctors and health officialswill run scared. Pharmaceuticals, alreadyfacing billions of dollars of litigationassociated with pertussis and polio vaccines,will opt out. Yet if we don't immunizeand smallpox escapes the test tube,there may be nobody left standing tosue or be sued.

Make no mistake—smallpox is oneincredible killer. Over the past dozencenturies, the disease claimed over 500million lives. No human pathogen hasbeen more deadly to the human species.The last known case was in Somalia in1977, and with no known animal reservoirsthat might hide the virus, thisinfectious disease was officially declarederadicated in 1980.

Required smallpox immunization forchildren ceased in the United States by1969, and almost all vaccinations endedby 1974. Today, global immunity againstsmallpox is at an all-time low, equivalentto the Dow being at 39, and droppingeach day. More than 80% of the humanpopulation has never been immunizedagainst smallpox. At no time in humanhistory have we been more vulnerableto this virus.

The vaccine scenario is far from perfect.The current available vaccine is thesame animal-tissue-derived vaccine usedin the past. The United States has 7 milliondoses of this 30-plus-year-old vaccinethat was kept in frozen storage inPennsylvania. It is a live attenuated virusknown as vaccinia, a cousin of cowpoxand smallpox. It has significant sideeffects. One in 4000 vaccinees will suffera serious side effect. One in 300,000 willsuffer a life-threatening reaction includingencephalitis. One in 1.1 million willprobably die as a complication of thevaccine. It is very important to screenpotential vaccinees and not immunizethose with immune deficiencies and certainskin disorders like eczema.

It is estimated that if the UnitedStates immunized its entire populationunder controlled conditions, approximately300 people would die of complicationsrelated to the vaccine. Some ofthese people would have undetectedimmune disorders with an already limitedlife expectancy, but nonetheless atragic loss of human life. If immunizationis initiated as a crash programbecause smallpox cases were alreadydetected somewhere in the world,many more would die in a less controlledand less supervised emergencyattempt to immunize the entire populationwithin days or weeks.

Public health officials are obligatedto consider the worst-case scenario of asmallpox epidemic—the release of thisvirus upon a nonimmune population. Ifunleashed today, this highly communicablevirus would race across the planet,infecting most of the world's population.Within a brief period of time, hundredsof millions of people might die.None of us would want to be in physicalcontact with anyone else, or even sharethe same air with someone whose statuswe did not know. All health care systemswould be shut down. Hospitals would beclosed. Doctors and nurses and theirfamilies would be infected and alsogoing without care. All efforts at quarantinewould be crushed. The livingmight envy the dead.

Our public health officials areentrusted with preventing deaths fromcommunicable diseases. Yet the guardiansof our health behave as if they areparalyzed. Every medical decision inAmerica, including the decision toimmunize against smallpox, is now centeredon what can happen to thehealth care provider, public health official,hospital, or pharmaceutical companyif there are complications. Incredibly,some hospitals support thevaccine program, but not on theirproperty where they would be liable—better to prevent lawsuits than to savelives. With smallpox we are talkingabout the lives of millions.

It's time we put the common goodof humanity above the common fear oflitigation.

Dr. Savitch is a member of the Infectious

Disease Association of California.

Reprinted with permission of the Wall

Street Journal copyright 2003 Dow Jones

& Company, Inc. All rights reserved.