Cutter Laboratories

Cutter Laboratories was a pharmaceutical company located in Berkeley, California. They were bought by the Bayer pharmaceutical company in the 1970s.

The Cutter incident

In 1955, Cutter Laboratories was one of several companies licensed by the United States government to produce Salk polio vaccine. In what came to be known as the Cutter Incident, a production error caused some lots of the Cutter vaccine to be tainted with live polio virus. The problem had not only been the carelessness of the Cutter company, but the lack of scrutiny from the NIH Laboratory of Biologics Control (and its excessive trust in the polio foundation reports).^[1]

The Cutter incident was one of the worst pharmaceutical disasters in U.S. history and caused several thousand children to be exposed to live polio virus upon vaccination.^[2] The NIH Laboratory of Biologics Control, which had certified the Cutter polio vaccine, had received advance warnings of problems: in 1954, staff member Dr. Bernice Eddy had reported to her superiors that some of the inoculated monkeys had become paralyzed (pictures were sent as well). William Sebrell, the director of NIH wouldn't hear of such a thing.^[1]

Numbers affected

The mistake resulted in the production of 120,000 doses of polio vaccine that contained live polio virus. Of the children who received the vaccine, 40,000 developed abortive poliomyelitis (a form of the disease that does not involve the central nervous system), 56 developed paralytic poliomyelitis and of these 5 children died as a result of polio infection.^[3] The exposures led to an epidemic of polio in the families and communities of the affected children, resulting in a further 113 people paralyzed and 5 deaths.^[4]

Administrative consequences

The director of the microbiology institute lost his job, as did the equivalent of the assistant secretary for health. Oveta Culp Hobby stepped down. Dr Sebrell, the director of the NIH, resigned.^[1]

Other incidents

In the 1980s, Cutter Laboratories produced unsafe blood products to treat hemophilia. The pharmaceutical product, which was produced from blood given by donors all across the US, was contaminated with HIV. These problems were the subject of lawsuits over the next twenty years.^[5]

A recent German documentary called "Tödlicher Ausverkauf: Wie BAYER AIDS nach Asien importierte" (Deadly Sale: How Bayer imported AIDS into Asia) researched the Koate product sold by Cutter Laboratories under full knowledge of its HIV contamination. Cutter ex-manager Merill Boyce expressed the opinion that the company should be made responsible and pay damages. Another ex-manager John H Hink, who was also in the team responsible for marketing Koate to Asia, expressed regret in the documentary that management had required that old stock be sold despite its knowledge of HIV contamination. Lexi J Hazan and Charles A Kozak are attorneys representing victims against Bayer AG in the Koate cases. Thomas C Drees is a consultant that researched the Koate Cutter case.

References

1. ^ ^{a b c} Edward Shorter, The Health Century, Doubleday, New York, 1987, pp 68–70 ISBN 0385242360
2. ^ Offit PA (2005). "The Cutter incident, 50 years later". N. Engl. J. Med. 352 (14): 1411–1412. doi:10.1056/NEJMp048180. PMID 15814877. http://content.nejm.org/cgi/reprint/352/14/1411.pdf. 
3. ^ Nathanson N. and Langmuir AD. (1963). "The cutter incident. poliomyelitis following formaldehyde-inactivated poliovirus vaccination in the United States during the spring of 1955. II. Relationship of poliomyelitis to cutter vaccine". Am. J. Hyg. 1963 Jul;78:29-60 78: 29–60. PMID 14043545. 
4. ^ Template:NEJM
5. ^ "Waage v Cutter Biological Division of Miles Labs (11/22/96)". http://touchngo.com/sp/html/sp-4434.htm. Retrieved 2007-12-03. 

External links

• Harpers Magazine article, August 1955