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Cutter Laboratories was a family-owned
pharmaceutical company The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate sympto ...
located in
Berkeley Berkeley most often refers to: *Berkeley, California, a city in the United States **University of California, Berkeley, a public university in Berkeley, California * George Berkeley (1685–1753), Anglo-Irish philosopher Berkeley may also refer ...
, California, founded by Edward Ahern Cutter in 1897. Cutter's early products included
anthrax Anthrax is an infection caused by the bacterium ''Bacillus anthracis''. It can occur in four forms: skin, lungs, intestinal, and injection. Symptom onset occurs between one day and more than two months after the infection is contracted. The sk ...
vaccine A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifie ...
,
hog cholera Classical swine fever (CSF) or hog cholera (also sometimes called pig plague based on the German word ) is a highly contagious disease of swine (Old World and New World pigs). It has been mentioned as a potential bioweapon. Clinical signs Sw ...
(swine fever)
virus A virus is a submicroscopic infectious agent that replicates only inside the living cells of an organism. Viruses infect all life forms, from animals and plants to microorganisms, including bacteria and archaea. Since Dmitri Ivanovsky's 1 ...
, and anti-hog cholera serum—and eventually a hog cholera vaccine. The hog cholera vaccine was the first
tissue culture Tissue culture is the growth of tissues or cells in an artificial medium separate from the parent organism. This technique is also called micropropagation. This is typically facilitated via use of a liquid, semi-solid, or solid growth medium, su ...
vaccine, human or veterinary, ever produced. The company expanded considerably during
World War II World War II or the Second World War, often abbreviated as WWII or WW2, was a world war that lasted from 1939 to 1945. It involved the vast majority of the world's countries—including all of the great powers—forming two opposin ...
as a consequence of government contracts for blood plasma and
penicillin Penicillins (P, PCN or PEN) are a group of β-lactam antibiotics originally obtained from ''Penicillium'' moulds, principally '' P. chrysogenum'' and '' P. rubens''. Most penicillins in clinical use are synthesised by P. chrysogenum using ...
. After Edward Cutter's death, his three sons—Dr. Robert K. Cutter (president), Edward "Ted" A. Cutter Jr. (vice-president), and Frederick A. Cutter—ran the company. In the next generation Robert's son David followed his father as president of the company. The
Bayer Bayer AG (, commonly pronounced ; ) is a German multinational corporation, multinational pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world. Headquartered in Leverkusen, Bayer's areas of busi ...
pharmaceutical company bought Cutter Laboratories in 1974."Cutter Laboratories: 1897–1972. A Dual Trust"
The Bancroft Library, University of California/Berkeley, Regional Oral History Office, Transcript 1972–1974.


Cutter incident

On April 12, 1955, following the announcement of the success of the polio vaccine trial, Cutter Laboratories became one of several companies that was recommended to be given a license by the United States government to produce Salk's
polio vaccine Polio vaccines are vaccines used to prevent poliomyelitis (polio). Two types are used: an inactivated poliovirus given by injection (IPV) and a weakened poliovirus given by mouth (OPV). The World Health Organization (WHO) recommends all chil ...
. In anticipation of the demand for vaccine, the companies had already produced stocks of the vaccine and these were issued once the licenses were signed. In what became known as the Cutter incident, some lots of the Cutter vaccine—despite passing required safety tests—contained live
polio virus A poliovirus, the causative agent of polio (also known as poliomyelitis), is a serotype of the species ''Enterovirus C'', in the family of ''Picornaviridae''. There are three poliovirus serotypes: types 1, 2, and 3. Poliovirus is composed of an ...
in what was supposed to be an inactivated-virus vaccine. Cutter withdrew its vaccine from the market on April 27 after vaccine-associated cases were reported. The mistake produced 120,000 doses of polio vaccine that contained live polio virus. Of children who received the vaccine, 40,000 developed abortive poliomyelitis (a form of the disease that does not involve the
central nervous system The central nervous system (CNS) is the part of the nervous system consisting primarily of the brain and spinal cord. The CNS is so named because the brain integrates the received information and coordinates and influences the activity of all par ...
), 56 developed paralytic poliomyelitis—and of these, five children died from polio. The exposures led to an
epidemic An epidemic (from Ancient Greek, Greek ἐπί ''epi'' "upon or above" and δῆμος ''demos'' "people") is the rapid spread of disease to a large number of patients among a given population within an area in a short period of time. Epidemics ...
of polio in the families and communities of the affected children, resulting in a further 113 people paralyzed and 5 deaths. The director of the microbiology institute lost his job, as did the equivalent of the assistant secretary for health.
Secretary of Health, Education, and Welfare The United States secretary of health and human services is the head of the United States Department of Health and Human Services, and serves as the principal advisor to the president of the United States on all health matters. The secretary is ...
Oveta Culp Hobby Oveta Culp Hobby (January 19, 1905 – August 16, 1995) was an American politician and businessperson who served as the first United States secretary of health, education, and welfare from 1953 to 1955. A member of the Republican Party, Hobby wa ...
stepped down. Dr William H. Sebrell Jr, the director of the NIH, resigned. Surgeon General Scheele sent Drs. William Tripp and Karl Habel from the
NIH The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
to inspect Cutter's Berkeley facilities, question workers, and examine records. After a thorough investigation, they found nothing wrong with Cutter's production methods. A
congressional hearing A United States congressional hearing is the principal formal method by which United States congressional committees collect and analyze information in the early stages of legislative policymaking. Whether confirmation hearings (a procedure unique ...
in June 1955 concluded that the problem was primarily the lack of scrutiny from the NIH Laboratory of Biologics Control (and its excessive trust in the National Foundation for Infantile Paralysis reports).Edward Shorter, ''The Health Century'', Doubleday, New York, 1987, pp 68–70 A number of civil lawsuits were filed against Cutter Laboratories in subsequent years, the first of which was ''Gottsdanker v. Cutter Laboratories''. The jury found Cutter not negligent, but liable for breach of
implied warranty In common law jurisdictions, an implied warranty is a contract law term for certain assurances that are presumed to be made in the sale of products or real property, due to the circumstances of the sale. These assurances are characterized as war ...
, and awarded the plaintiffs monetary damages. This set a precedent for later lawsuits. All five companies that produced the Salk vaccine in 1955—
Eli Lilly Eli Lilly (July 8, 1838 – June 6, 1898) was an American soldier, pharmacist, chemist, and businessman who founded the Eli Lilly and Company pharmaceutical corporation. Lilly enlisted in the Union Army during the American Civil War and r ...
,
Parke-Davis Parke-Davis is a subsidiary of the pharmaceutical company Pfizer. Although Parke, Davis & Co. is no longer an independent corporation, it was once America's oldest and largest drug maker, and played an important role in medical history. In 1970 ...
,
Wyeth Wyeth, LLC was an American pharmaceutical company. The company was founded in Philadelphia, Pennsylvania, in 1860 as ''John Wyeth and Brother''. It was later known, in the early 1930s, as American Home Products, before being renamed to Wyeth in ...
, Pitman-Moore, and Cutter—had difficulty completely inactivating the polio virus. Three companies other than Cutter were sued, but the cases settled out of court. The Cutter incident was one of the worst pharmaceutical disasters in US history, and exposed several thousand children to live polio virus on
vaccination Vaccination is the administration of a vaccine to help the immune system develop immunity from a disease. Vaccines contain a microorganism or virus in a weakened, live or killed state, or proteins or toxins from the organism. In stimulating ...
. 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 inoculated monkeys had become paralyzed and provided photographs. William Sebrell, the director of NIH, rejected the report.


Expansion

Despite lawsuits resulting from vaccine-related cases of polio, Cutter Laboratories successfully expanded its business. Between 1955 and 1960, they purchased: * Veterinary product manufacturers Ashe-Lockhart, Inc. and Haver-Glover Laboratories of
Kansas City The Kansas City metropolitan area is a bi-state metropolitan area anchored by Kansas City, Missouri. Its 14 counties straddle the border between the U.S. states of Missouri (9 counties) and Kansas (5 counties). With and a population of more ...
* Plastic manufacturers Plastron Specialties, Pacific Plastics Company in
San Francisco San Francisco (; Spanish language, Spanish for "Francis of Assisi, Saint Francis"), officially the City and County of San Francisco, is the commercial, financial, and cultural center of Northern California. The city proper is the List of Ca ...
, and Olympic Plastics Company in
Los Angeles Los Angeles ( ; es, Los Ángeles, link=no , ), often referred to by its initials L.A., is the largest city in the state of California and the second most populous city in the United States after New York City, as well as one of the world' ...
* An animal feed farm, Corn King Company, in
Cedar Rapids Cedar Rapids () is the second-largest city in Iowa, United States and is the county seat of Linn County. The city lies on both banks of the Cedar River, north of Iowa City and northeast of Des Moines, the state's capital and largest city. ...
*A plant-derived allergy medicine company, Hollister-Stier, in
Spokane Spokane ( ) is the largest city and county seat of Spokane County, Washington, United States. It is in eastern Washington, along the Spokane River, adjacent to the Selkirk Mountains, and west of the Rocky Mountain foothills, south of the Ca ...
, Los Angeles,
Philadelphia Philadelphia, often called Philly, is the largest city in the Commonwealth of Pennsylvania, the sixth-largest city in the U.S., the second-largest city in both the Northeast megalopolis and Mid-Atlantic regions after New York City. Sinc ...
, and
Atlanta Atlanta ( ) is the capital and most populous city of the U.S. state of Georgia. It is the seat of Fulton County, the most populous county in Georgia, but its territory falls in both Fulton and DeKalb counties. With a population of 498,715 ...
In 1960, Cutter established Cutter Laboratories Pacific, Inc. in Japan. Annual Cutter company sales had increased from $11,482,000 in 1955 to $29,934,000 in 1962. In the early 1960s, Cutter's catalog listed more than 700 products, and in 1962, the company's assets were "80% greater than when the polio disaster had occurred." Cutter Laboratories was purchased by the German chemical and pharmaceutical company Bayer in 1974.


Other incidents

In the late 1970s through 1980s, numerous companies, including Bayer's Cutter Biologic division, produced unsafe blood products to treat
hemophilia Haemophilia, or hemophilia (), is a mostly inherited genetic disorder that impairs the body's ability to make blood clots, a process needed to stop bleeding. This results in people bleeding for a longer time after an injury, easy bruising, ...
. The pharmaceutical product, produced from blood from donors across the US, was contaminated with the
HIV The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune ...
virus at a time when HIV could not be screened out. These problems led to lawsuits over the next 20 years. A 2008 German documentary called (''Deadly Sale: How Bayer imported AIDS into Asia'') researched the Koate product for hemophiliacs sold by Bayer's Cutter division under full knowledge of its HIV contamination.


References


External links


Harpers Magazine article, August 1955
{{Authority control Defunct pharmaceutical companies of the United States Polio Drug safety 1955 in the United States Companies based in Berkeley, California 1897 establishments in California Pharmaceutical companies established in 1897 Technology companies based in the San Francisco Bay Area Pharmaceutical companies disestablished in 1974 1974 disestablishments in California 1974 mergers and acquisitions