The documents, disclosed to OutsourcingPharma.com by Executive Director of SAEN, Michael Budkie, are said to have been released anonymously from a past or present employee.
They include reports on 16 incidences of fractures received by primates and one swine during handling between 2007 and 2009. Six of the primates and the swine are reported to have been euthanised as a result.
An Animal Welfare Concern Report, which appears to have been written by an MPI Research employee in 2004, describes the ‘ongoing incidences of lacerated fingers, toes and tails that occur during the removal of animals from the home cages for study functions’.
Technicians’ lack of experience with primates and excessive workloads are some of the risk factors for incidences suggested by the anonymous employee.
SAEN’s stance on ‘insufficient’ inspection
Speaking to OutsourcingPharma, Budkie added that “it is important to note that we did not seek out people inside MPI Research. These people have stepped outside of the system because they see that the regulatory system has failed.”
Confronting the fact that MPI Research has already been inspected by the USDA five times since February 2008, without any violations having been found, Budkie added that
“either the USDA was unaware of these issues, which would imply drastically insufficient inspections, or they willfully refused to enforce the law.”
Budkie describes the situation as an “overall system-wide problem,” adding that “in most instances any fines that are issued [by the USDA] are small enough as to be virtually meaningless.”
“Labs like MPI Research should be considered major problems for the pharmaceutical industry. If this facility cannot follow federal regulations, if it cannot accurately follow study protocols, [how] can it possibly accurately assess drug safety? These are all meaningful questions that must be asked,” said Budkie.
The USDA’s spokesman David Sacks told the Kalamazoo Gazette that it would need to investigate further before judging the situation.
“When we regulate the welfare of these (test) animals, it’s not natural for them to have bones broken,” continued Sacks, adding that “that’s something that’s going to get our attention.”
He went on to say that it wouldn’t be possible for USDA inspectors to analyse each record on each animal at large testing facilities such as MPI Research.
MPI Research’s response
MPI Research has responded by launching a “comprehensive internal investigation of SAEN’s allegations,” Joan Manners, Director of Marketing at MPI Research, told Outsourcing-Pharma.com.
She added that the investigation has found MPI Research’s activities to have “met or exceeded all federal and international standards for best practice animal care” and stated that its studies “are continually audited by the appropriate regulatory agencies as well as by our own customers.”
Manners said MPI Research’s attending veterinarian has already contacted the USDA about the allegations and “has invited them for a return visit if deemed necessary”.
Looking at the documents released by SAEN, Manners added that MPI Research has “conducted no studies for one of the companies mentioned, and for the other two, there has been no incidence of fractures.”
The company claims that its animals are provided the best care possible and that its ‘qualified veterinarians’ as well as ‘highly trained veterinary technical staff’ are ‘engaged at all times’.