Cutter Laboratories
Encyclopedia
Cutter Laboratories was a pharmaceutical company
Pharmaceutical company
The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...

 located in Berkeley, California
Berkeley, California
Berkeley is a city on the east shore of the San Francisco Bay in Northern California, United States. Its neighbors to the south are the cities of Oakland and Emeryville. To the north is the city of Albany and the unincorporated community of Kensington...

. They were bought by the Bayer
Bayer
Bayer AG is a chemical and pharmaceutical company founded in Barmen , Germany in 1863. It is headquartered in Leverkusen, North Rhine-Westphalia, Germany and well known for its original brand of aspirin.-History:...

 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
Jonas Salk
Jonas Edward Salk was an American medical researcher and virologist, best known for his discovery and development of the first safe and effective polio vaccine. He was born in New York City to parents from Ashkenazi Jewish Russian immigrant families...

 polio vaccine
Polio vaccine
Two polio vaccines are used throughout the world to combat poliomyelitis . The first was developed by Jonas Salk and first tested in 1952. Announced to the world by Salk on April 12, 1955, it consists of an injected dose of inactivated poliovirus. An oral vaccine was developed by Albert Sabin...

. 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).

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
Vaccination
Vaccination is the administration of antigenic material to stimulate the immune system of an individual to develop adaptive immunity to a disease. Vaccines can prevent or ameliorate the effects of infection by many pathogens...

. 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.

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
Central nervous system
The central nervous system is the part of the nervous system that integrates the information that it receives from, and coordinates the activity of, all parts of the bodies of bilaterian animals—that is, all multicellular animals except sponges and radially symmetric animals such as jellyfish...

), 56 developed paralytic poliomyelitis and of these 5 children died as a result of polio infection. The exposures led to an epidemic
Epidemic
In epidemiology, an epidemic , occurs when new cases of a certain disease, in a given human population, and during a given period, substantially exceed what is expected based on recent experience...

 of polio in the families and communities of the affected children, resulting in a further 113 people paralyzed and 5 deaths.

Administrative consequences

The director of the microbiology institute lost his job, as did the equivalent of the assistant secretary for health. Oveta Culp Hobby
Oveta Culp Hobby
Oveta Culp Hobby was the first secretary of the US Department of Health, Education and Welfare, first commanding officer of the Women's Army Corps, and chairman of the board of the Houston Post....

 stepped down. Dr Sebrell, the director of the NIH, resigned.

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
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...

. These problems were the subject of lawsuits over the next twenty years.

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.

External links

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