A leading supplier of laboratory mice and rats will pay the federal government $7.2 million after the Indiana-based company admitted providing genetically defective rodents to the nation's top research institution and submitting false information that hid the problem.
The settlement announced yesterday by the U.S. attorney's office in Maryland marks at least the third time in the past decade that Harlan, Sprague, Dawley Inc. of Indianapolis has had to pay costs or damages for research compromised by genetic deficiencies in its widely used rats and mice.
In 1997 and 1998, Harlan signed contracts totaling more than $14.1 million with the Bethesda-based National Institute on Aging (NIA), part of the National Institutes of Health. Under the contracts, the company was supposed to breed and cultivate genetic-specific rodent colonies over a nine-year period for use in research on aging. One type of mouse used in the research ranges in price from $7.90 to $99.90 a piece, according to a chart on Harlan's Web site.
When the problem with Harlan rodents was first uncovered by researchers in 2002, the NIA sent out warning letters to at least 175 scientists, according to Maryland Assistant U.S. Attorney Michael A. DiPietro, who worked on the case. The letter cautioned that rats and mice from Harlan might be unreliable and a threat to studies using the animals.
Harlan officials would not answer questions yesterday but acknowledged in settlement terms that the company tested some of the animals and discovered genetic inconsistencies as far back as 1999 -- but company employees failed to report those defects to the NIA.
Harlan "falsely stated in semi-annual progress reports submitted to NIA for the contracts that genetic purity of all strains of mice raised under the contracts had been confirmed through biochemical genetic monitoring," according to the settlement signed Friday by prosecutors and company officials.
Hal P. Harlan, the company's chief executive officer, declined yesterday through an assistant to comment on the settlement, but the company released a prepared statement last night.
"Harlan entered into this settlement in order to resolve all outstanding issues promptly, and will continue its long history of service to the National Institutes of Health and other agencies," the statement said.
The National Institute on Aging conducts and funds research on a wide range of subjects, including the biology of aging and age-related diseases. An NIA spokesman said they could not respond yesterday to specific questions about the effect of the mouse and rat contamination on research or the steps the agency took to address the problem.
Federal prosecutors estimated that thousands of rodents could have been affected, but they said they believe only a small percentage of those rodents would have been defective. DiPietro added that as many as 250 researchers might have been affected, but he declined to say whether studies relying on the rodents needed to be shut down.
NIA officials provided replacement mice to researchers with ongoing projects in order to continue their studies, according to the U.S. Attorney's office.
The U.S. attorney's office in Maryland pursued a civil claim under the False Claims Act, rather than a criminal prosecution against the company.
"The genetic integrity of laboratory animals is critical in age-related research. We are pleased to announce this settlement which compensates the government for its time and effort ... and maintains the integrity of NIA's age-related research programs," Maryland's interim U.S. Attorney Allen F. Loucks said in a prepared statement yesterday.
Prosecutors said the $7.2 million settlement represents full reimbursement to the government for the cost of the research affected by the defective rodents, plus damages and penalties. But U.S. attorney spokeswoman Vickie LeDuc said that the contracts are still in effect and that only part of one was terminated as a result of the investigation.
Founded in 1931, Harlan, Sprague, Dawley Inc. produces more than 200 stocks and strains of mice, rats, hamsters, guinea pigs, gerbils, rabbits, cats and dogs. The privately held company has more than 1,300 employees and maintains outposts in nine foreign countries.
According to scientific journals, its animals have been used in studies in such areas as hypertension, HIV/AIDS and West Nile virus.
"Research demands quality animals supported by reliable reports ... ," the company's Web site states.
But problems with the reliability of its rodent populations emerged in 1992 with rats bred by Harlan especially for hypertension research.
Researchers discovered that the rats, known as Dahl salt-sensitive rats, were not reacting as expected. They were not developing high blood pressure despite a diet high in salt.
The reason, according to the scientists, was genetic impurities that occurred in the breeding process.