The Cutter Incident: How America's First Polio Vaccine Led to the Growing Vaccine Crisis
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《新英格兰医药杂志》
"Liability without fault" was the verdict in a 1958 lawsuit in the aftermath of the paralysis of children in the United States who had received a licensed polio vaccine manufactured by Cutter Laboratories. In The Cutter Incident, Paul Offit lays out the meaning of this verdict: that pharmaceutical companies are liable for damage without negligence, even if they make a product according to industry standards using the best science available.
Offit makes the convincing argument that this verdict has figured largely in the decision by many U.S. manufacturers not to develop or produce vaccines. He also provides a comprehensive history of the development, production, and wide use of the inactivated polio vaccine in the United States during the 1950s. By including in this clearly written book historical information about polio epidemics in North America and the paralysis of Franklin Delano Roosevelt, a description of the three types of virus that cause polio, and an explanation of the Salk theory of inactivation of the polio virus, Offit sets the stage for his discussion of the tragic events that led to, and the unfolding of, what is now known as the Cutter incident.
Offit also suggests other factors that may have influenced the course of vaccine development. These include the high cost of vaccine development and of compliance with the regulations of the Food and Drug Administration for biologic preparations and the relatively lower cost of the development of and compliance for drugs, which also have a larger and more sustained market. Add to this mix the low price of vaccines — with governments as the dominant purchasers for public health programs — and the litigation in the wake of the mass vaccination of U.S. residents against swine influenza in the mid-1970s, and there are even more factors with the potential to discourage vaccine manufacturers in the United States.
The verdict of nearly half a century ago has repercussions today for diseases that can be prevented with the use of vaccines. The development of the inactivated polio vaccine and global access to the live attenuated polio vaccine have brought the world to the verge of the eradication of polio. It is estimated that fewer than 2000 children were paralyzed by this disease in 2005, whereas when eradication efforts against polio began in 1988, an estimated 1000 children were becoming paralyzed each day. The World Health Organization's technical advisory groups on polio eradication have predicted that polio transmission worldwide could be interrupted in 2006. After the wild poliovirus is eradicated, there will still be a continued risk of paralytic polio from polioviruses in vaccines as long as the current live attenuated vaccines continue to be used — a fact that complicates the issue of polio eradication. Not enough funding or research and development has been invested to have resulted in a more stable live attenuated polio vaccine. In addition, Offit's book offers one explanation of why manufacturers may have shied away from developing such a vaccine.
At the same time, it is no surprise that until the recent advent of funding from the Bill and Melinda Gates Foundation and other philanthropic organizations, less than 10 percent of the financial resources for global health research were used to address health problems in developing countries. Yet AIDS, tuberculosis, and malaria, along with diarrheal diseases and respiratory infections in children, account for approximately 90 percent of deaths from infectious diseases in those countries. Nor is it surprising that manufacturers have not made large investments in up-to-date technology for the production of seasonal influenza vaccines. Such production still involves the time-consuming growth of viruses in chicken eggs with embryos and a gap of at least six months before marketing and subsequent use — a delay that is risky because another influenza pandemic could occur within that period. Infectious diseases remain a primary cause of human suffering and death around the world. As Offit so clearly outlines in The Cutter Incident, solutions must be found to the predicaments that contribute to the lack of vaccines against many of these diseases.
David L. Heymann, M.D.
World Health Organization
CH-1211 Geneva, Switzerland
heymannd@who.int(By Paul A. Offit. 238 pp.)
Offit makes the convincing argument that this verdict has figured largely in the decision by many U.S. manufacturers not to develop or produce vaccines. He also provides a comprehensive history of the development, production, and wide use of the inactivated polio vaccine in the United States during the 1950s. By including in this clearly written book historical information about polio epidemics in North America and the paralysis of Franklin Delano Roosevelt, a description of the three types of virus that cause polio, and an explanation of the Salk theory of inactivation of the polio virus, Offit sets the stage for his discussion of the tragic events that led to, and the unfolding of, what is now known as the Cutter incident.
Offit also suggests other factors that may have influenced the course of vaccine development. These include the high cost of vaccine development and of compliance with the regulations of the Food and Drug Administration for biologic preparations and the relatively lower cost of the development of and compliance for drugs, which also have a larger and more sustained market. Add to this mix the low price of vaccines — with governments as the dominant purchasers for public health programs — and the litigation in the wake of the mass vaccination of U.S. residents against swine influenza in the mid-1970s, and there are even more factors with the potential to discourage vaccine manufacturers in the United States.
The verdict of nearly half a century ago has repercussions today for diseases that can be prevented with the use of vaccines. The development of the inactivated polio vaccine and global access to the live attenuated polio vaccine have brought the world to the verge of the eradication of polio. It is estimated that fewer than 2000 children were paralyzed by this disease in 2005, whereas when eradication efforts against polio began in 1988, an estimated 1000 children were becoming paralyzed each day. The World Health Organization's technical advisory groups on polio eradication have predicted that polio transmission worldwide could be interrupted in 2006. After the wild poliovirus is eradicated, there will still be a continued risk of paralytic polio from polioviruses in vaccines as long as the current live attenuated vaccines continue to be used — a fact that complicates the issue of polio eradication. Not enough funding or research and development has been invested to have resulted in a more stable live attenuated polio vaccine. In addition, Offit's book offers one explanation of why manufacturers may have shied away from developing such a vaccine.
At the same time, it is no surprise that until the recent advent of funding from the Bill and Melinda Gates Foundation and other philanthropic organizations, less than 10 percent of the financial resources for global health research were used to address health problems in developing countries. Yet AIDS, tuberculosis, and malaria, along with diarrheal diseases and respiratory infections in children, account for approximately 90 percent of deaths from infectious diseases in those countries. Nor is it surprising that manufacturers have not made large investments in up-to-date technology for the production of seasonal influenza vaccines. Such production still involves the time-consuming growth of viruses in chicken eggs with embryos and a gap of at least six months before marketing and subsequent use — a delay that is risky because another influenza pandemic could occur within that period. Infectious diseases remain a primary cause of human suffering and death around the world. As Offit so clearly outlines in The Cutter Incident, solutions must be found to the predicaments that contribute to the lack of vaccines against many of these diseases.
David L. Heymann, M.D.
World Health Organization
CH-1211 Geneva, Switzerland
heymannd@who.int(By Paul A. Offit. 238 pp.)