Monday, January 20, 2020

UW-Madison's Self-Reported Animal Welfare Violations

These pages are a set of links to correspondence between the University of Wisconsin, Madison and the National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) concerning violations of the Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals.

NIH/OLAW rarely inspects laboratories. NIH/OLAW's oversight is primarily a matter of talking to a lab's representatives on the phone and responding to letters from them reporting on their violations and what they did in response.

PHS self-reports 3N to 3Z

PHS self-reports 4A to 4Z

PHS self-reports 5A to 5Z

PHS self-reports 6A to 6Z

PHS self-reports 7A to 7Z

PHS self-reports 8A to 8T

The lists are ordered by OLAW Case Number; in some instances the date on the OLAW response letter is out of sequence. Brief excerpts from OLAW's response letter are provided; a review of each file will provide additional detail. A handful of the reports are missing in my records. If I get them, I will put them in their appropriate spot in an effort to complete the record.

The entries are listed in this fashion:

OLAW Case Number
Date of OLAW response
OLAW's summary
OLAW's resolution

All laboratories using vertebrate animals in Public Health Service-funded research are required to periodically submit a document to NIH promising to adhere to Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals. This document is referred to as the entity's
"Animal Welfare Assurance." The correspondence is marked:

re: Animal Welfare Assurance
A3368-01 [OLAW Case Number]

A3368-01 is the University of Wisconsin, Madison's PHS Assurance number.

It is hard to find evidence of meaningful oversight in this correspondence because similar accidents, screw-ups, and violations occur repeatedly, and in every case OLAW answers with some version of: "OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

PHS self-reports 3N to 3Z


UW-Madison's
PHS self-reports
3N to 3Z


3N
4/11/2012

"... OLAW understands that on sixteen occasions anesthesia recovery records for nonhuman primates were not completed promptly or correctly and animals were not being checked regularly."

"... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance."

3O
4/11/2012

"... OLAW understands that thirteen mice received a higher dose of an experimental drug than described in the approved protocol over a period of several days."

"... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance."

3P
4/11/2012

"... OLAW understands that [10] mice failed to receive post-operative analgesics as described in the approved protocol."

"... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance."

3Q Missing

3R Missing

3S
4/11/2012

"... OLAW understands that a female rhesus macaque with infant had been left in a transport cage for an undetermined amount of time (1 day or more) following the conduct of an approved blood draw."

"...OLAW understands that measures have been implemented to correct and prevent the occurrence of this problem."

3T
4/30/2012

"... OLAW understands that a total of 45 adult and juvenile mice drowned after their cages filled with water due to an improperly docked cage which caused continuous activation of the lixit. Human error involving a different individual from the same laboratory caused the same problem previously..."

"...OLAW understands that measures have been implemented to correct this problem."

3U Missing

3V
4/17/2012

"... OLAW understands that two nonhuman primates on an approved fluid regulation study failed to receive their minimum daily fluid allotment on numerous occasions…. Also, a student working with the primates was not listed on the protocol."

"... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance."

3W
4/18/2012

"...OLAW understands the following about the incidents and the corresponding corrective actions: 1) A marmoset was used in a terminal profusion although this had not been described in the approved protocol. 2) An anesthetized cynomolgus monkey undergoing an approved MRI procedure sustained skin burns on its legs from the warming bags used to maintain body. 3) A rhesus monkey failed to receive water due to a miscommunication between research and animal care staff. 4) Blood samples were taken from a cynomolgus monkey although the approved protocol only described the procedure for a rhesus monkey."

"... OLAW is satisfied that appropriate actions have been taken in all three instances to investigate, correct, and prevent recurrence of the noncompliance."

3X
4/17/2012

"... OLAW understands that a water pipe froze and burst in an animal building and flooded 25 rooms. Some animals became wet but none sustained injuries or died."

"... OLAW understands that measures have been implemented to correct and prevent the occurrence of this problem."

3Y
3/13/2011

"… OLAW understands that the Letters and Science Animal Care and Use Committee (ACUC) did not conduct the fall 2011 semiannual facility inspection at a remote facility due to a failure to schedule a consultant to conduct the visit."

"... OLAW is satisfied that appropriate actions have been taken in all three instances to investigate, correct, and prevent recurrence of the noncompliance."

3Z
4/11/2012

"... OLAW understands that a cow used in a teaching protocol was subjected to a Caesarean section surgical procedure that had not been described in the approved protocol."

"... OLAW is satisfied that appropriate actions have been taken to investigate and prevent recurrence of the noncompliance."

PHS self-reports 4A to 4Z

UW-Madison's
PHS self-reports
4A to 4Z

4A
4/14/2012

"... OLAW understands the following about the incidents and the corresponding corrective actions: 1) A cage was not securely seated in the rack causing a lixit to leak into lower cages, resulting in the drowning deaths of 19 mice. Corrective action: All lixit nozzles were replaced with shielded water tips on all racks in the facility. 2) A rat was given repeated doses of pentobarbital due to difficulty in anesthetizing the animal. The individual performing the procedure was directed to euthanize the rat ... Intracardiac injection had not been approved in the protocol."

"... OLAW understands that measures have been implemented in both situations to correct and prevent recurrence of the problem."

4B
4/30/2012

"... OLAW understands that a significant change was made to a training protocol without prior approval from the Animal Care and Use Committee. Specifically, rats undergoing non-survival surgery were given saline instead of buprenorphine pre-operatively which constituted a significant change."

"... OLAW is satisfied that appropriate actions have been taken to correct and prevent the occurrence of this problem."

4C
7/18/2012

"... OLAW understands that an anesthetized cat undergoing surgery sustained a skin burn from the heating blanket."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

4D
4/30/2012

"... OLAW understands that two infant macaques failed to receive water for one day (although they dad received formula) and a mother with infant in the nursery also failed to receive water."

"... OLAW understand that measures have been implemented to prevent recurrence of this problem."

4E
7/14/2012

"... OLAW understands that a student failed to conduct the daily health check for two frogs for one day. The following day one frog was dead and the other lethargic. The conduct of heath checks was not being documented by the students."

"... OLAW understands that measures have been implemented to prevent recurrence of this problem."

4F
5/15/2012

"OLAW understands that 10 mice received tail snips without anesthesia when the were older than 21 days of age."

"OLAW is satisfied that appropriate actions have been taken to investigate this incident."

4G
6/19/2012

"... OLAW understands that five mice on a food restriction study were provide double their food supply on one day and none the next."

"... OLAW understands that measures have been implemented to correct and prevent the occurrence of this problem."

4H
9/12/2012

"... OLAW understands that an anesthetized rhesus monkey was not being observed at the interval described in the approved protocol. Problem with adequate staffing during the procedure contributed to the problem."

 "... OLAW understands that measures have been implemented to  prevent the recurrence of this problem."

4I
6/19/2012

"... OLAW understands that a young rhesus monkey died of suffocation after having its head trapped between the cage and squeeze back support."

"No preventative action can be taken as this was an unanticipated accident initiated by the animal's own behavior."

4J
6/12/2012

"... OLAW understands that four mice failed to receive a water bottle on their cage after being weaned."

 "...OLAW understands that measures have been implemented to prevent the recurrence of this noncompliance."

4K
8/8/2012

 "... OLAW understands that an anesthetized macaque sustained a burn from a heating bag used with a heating blanket to maintain body heat."

 "... OLAW understands that measures have been implemented to prevent the recurrence of this noncompliance."

4L
8/8/2012

 "... OLAW understands that two adult male rhesus monkeys sustained scratch wounds due to fighting after an animal caretaker inadvertently removed the divider between the two cages."

"... OLAW is satisfied that appropriate actions have been taken to investigate and prevent recurrence of the problem."

4M
8/22/2012

 "... OLAW understands that an anesthetized sheep undergoing surgery died due to a close pop-off valve on the anesthetic machine."

"... OLAW understands that measures have been implemented to prevent recurrence of this problem."


4N
9/27/2012

"... OLAW understands that the daily health check for a group of mice was not performed for one day."

"... OLAW understands that measures have been implemented to prevent recurrence of this problem."


4O
8/29/2012

"... OLAW understands that a lesion was created in the aorta of a pig although the approved protocol did not include this anatomical site."

"... OLAW is satisfied that appropriate actions have been taken to correct and prevent this recurrence of this noncompliance."

4P Missing

4Q
11/2/2012

"... OLAW understands the following about the incidents...: 1) A male and female rhesus monkey were inadvertently paired  and the female sustained a laceration. The male was subsequently given a higher dose of [an] anti-inflammatory drug  than required due to a misidentification of the animal. 2) A monkey escaped and two monkeys entered the same enclosure after pushing out a floor pan door and cage divider because locks had not been attached as required. One of the animals sustained injuries."

"... OLAW understands that measures have been implemented in both situations to prevent recurrence of the problem."

4R
12/5/2012

"... OLAW understands that laboratory staff performed a C-section on a mouse experiencing dystocia [difficult birth]. The surgery was not described in the protocol and was not authorized by the veterinary staff.

"... OLAW is satisfied that appropriate actions have been taken to investigate and prevent recurrence of the noncompliance."

4S Missing

4T
12/12/2012

"... OLAW understands that a student failed to promptly euthanize three mice with tail wounds as directed by the veterinarian. The mice were euthanized six days later."

 "... OLAW understands that measures have been implemented in both situations to prevent recurrence of the problem."

4U
2/11/2013

"... OLAW understands that 150 more mice were used than approved on the protocol."

"... OLAW is satisfied that appropriate actions have been taken to correct and prevent recurrence of this problem."

4V Missing

4W
9/13/2013

 "The Office of Laboratory Animal Welfare (OLAW) acknowledges receipt of your September 16, 2013 letter providing an update on a previously reported and closed problem with livestock feed at the University of Wisconsin-Madison. Pig and chicken diet prepared at a University feed mill was low in calcium. To ensure quality control of feed, a feed mill committee was formed, new standard operating procedures were established, and a new mill manager was to be hired. 
         '
"... OLAW understands that measures have been implemented to correct and prevent occurrence of the original problem."

4X
2/26/2013

"... OLAW understands that three cynomolgous monkeys were challenged with a viral dose that was one logarithm greater that the amount described in the approved protocol."

"... OLAW understands that measures have been implemented to correct this problem."

4Y Missing

4Z
5/9/2013

"... OLAW understands that a cow accidentally slipped into the auger channel in the automatic manure handling system and was severely injured.

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

PHS self-reports 5A to 5Z


UW-Madison's
PHS self-reports
5A to 5Z

5A
5/5/2013

"According to the information provided, a research staffer administered anesthetic to a mouse whose leg was swollen after becoming caught in the cage wire. The individual failed to notify the veterinarian about the injury or the administration of the drug."

"... OLAW is satisfied that appropriate actions have been taken to investigate and prevent recurrence of the noncompliance."

5B
2/26/2013

"... OLAW understands that a marmoset died while under anesthesia due to a veterinary technician closing  a port on the endotracheal tube which caused pneumothorax. Also, the anesthesia machine used was nor appropriate for this procedure." 

"... OLAW understands that measures have been implemented to  prevent recurrence of this problem."

5C Missing

5D
3/11/2013

"... OLAW understands that a rhesus monkey received an overdose of anesthesia based on body weight because the veterinary student responsible failed to verify the animal's identification."

"... OLAW understands that measures have been implemented to prevent recurrence of the problem."

5E
3/7/13

"... OLAW understands that two anesthetics used during a terminal pig surgery had not been described in the approved protocol."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

5F
3/13/2013

"... OLAW understands that several mice over 28 days of age were subjected to tail biopsies without anesthesia."

"OLAW understands that the protocol was not PHS-supported, but concurs that the incident was serious and concurs with the actions taken by the Animal Care and Use Committee.

5G
4/29/2013

"... OLAW understands that 15 mice died of suffocation after being transported between facilities in  cardboard containers without adequate ventilation."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

5H
5/29/2013

"... OLAW understands that one rat was subjected to glaucoma surgery in both eyes although the approved protocol described the procedure for only one eye."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

5I
12/18/2013

 "... OLAW understands that two additional rhesus monkeys were determined not to have received analgesia per protocol after being injected with subcutaneously with [redacted].

"... OLAW is satisfied that appropriate action was taken to investigate, correct, and prevent recurrence of the noncompliance."

5J
6/24/2013

"... OLAW understands that a young macaque died of asphyxiation after pulling a chain, holding an enrichment device, into the cage and wrapping it around its neck."

"... OLAW understands that measures have been implemented to prevent recurrence of the problem."

5K
11/20/2013

"... OLAW understands that several rats did not have access t water over a three day weekend because the bottles had been turned over to avoid leakage during cage transport."

 "... OLAW understands that measures have been implemented to prevent recurrence of this problem."

5L
6/24/2013

 "... OLAW understands the following about the incidents...: 1) Due to a transposition of animal weights by a veterinary technician, one nonhuman primate received an overdose of an anesthetic and reversal agent, while the other monkey was under-dosed with the drugs.... 2) A monkey broke its cage lock and escaped. 3) Two adult male macaques sustained fight injuries due to engaging eachother through an open cage divider. The animal caretaker had  failed to lock the divider and did not notice the problem during the cage checks."

"Both animals were treated, but one was euthanized under anesthesia due to cardiopulmonary depression." [Neither Google nor either of my two medical dictionaries mention "cardiopulmonary depression."]

"... OLAW understands that measures have been implemented in each situation to prevent recurrence of the problem."

5M
8/7/2014

"... OLAW understands that a jugular cut-down procedure was performed on an anesthetized pig to obtain blood although this procedure was not described on the approved protocol."

"... OLAW is satisfied that appropriate action was taken to investigate and prevent recurrence of the noncompliance."

5N
8/22/2014

"... OLAW understands that a zebra finch broke its leg after flying into the waste pan under the cage as it was being cleaned."

"OLAW concurs with the actions taken to address the situation..."

5O
10/31/2014

"... OLAW understands that two heifers drowned after gaining access to a manure pit."

 "... OLAW understands that measures have been implemented to prevent recurrence of this problem."

5P
10/31/2014

 "... OLAW understands that an individual was working with zebra fish for an extended period of time but had not been listed on the approved protocol."

 "... OLAW understands that measures have been implemented to prevent recurrence of this problem."

5Q Missing

5R Missing

5S
10/31/2014

"... OLAW understands the following about the incidents...: 1) Laboratory staff failed to provide a daily health check on 34 ground squirrels. 2) Two rats died from an overdose of anesthetic. Because the animals were were slow to achieve a surgical plan[e] of anesthesia, the laboratory staff administered additional doses of [the] drug although this had not be[en] approved in the protocol."

"... OLAW is satisfied that appropriate action was taken to investigate, correct, and prevent recurrence of the noncompliance."

5T
10/31/2013 [sic]

"... OLAW understands that two nonhuman primates were able to escape their cage because the lock had been incorrectly placed allowing the animals to open it. One monkey sustained hand wounds which required two partial digit amputations."

 "... OLAW understands that measures have been implemented to prevent recurrence of this problem."

5U
11/22/2013 [sic]

 "... OLAW understands the following about the incidents...: 1) on two separate occasions, two macaques sustained skin burns due to exposure to an intermittently malfunctioning heat lamp. 2) One macaque escaped its cage and injured its toes.  No problem was identified with the cage. A second  macaque died due to internal bleeding while undergoing an ultrasound guided liver biopsy.

"... OLAW understands that measures have been implemented in all situations to correct and prevent recurrence of the problem."

5V
1/3/2014

"... OLAW understands that one monkey escaped its cage by bending open the door and then bit another monkey's tongue."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

5W
12/11/2013 [sic]

"... (OLAW) acknowledges receipt of your December 9, 2013 letter reporting the suspension of three animal activities at the University of Wisconsin-Madison. OLAW understands that the School of Veterinary Medicine Animal Care and Use Committee (ACUC) took this action after determining that an investigator failed to submit protocol renewals in a timely fashion despite receiving numerous reminders. The protocols involved teaching activities using large animals."

"OLAW understands that the research was not PHS-supported but concurs that the incident was serious and supports the actions taken by the ACUC."

5X Missing

5Y
8/5/2014

"... OLAW understands the following about the incidents...: 1) a rhesus monkey failed to receive a single daily dose of post-operative antibiotics due to a failure to schedule the procedure by a veterinary technician. 2) A PET scan was performed on a monkey outside the time-frame described in the approved protocol."

"... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance."

5Z
8/5/2014

"... OLAW understands that a ground squirrel was administered an experimental radio-isotope by oral gavage although the approved protocol stated that this was to be given by intraperitoneal injection."

"... OLAW understands that measures have been implemented to prevent recurrence of this problem."



PHS self-reports 6A to 6Z


UW-Madison's
PHS self-reports
6A to 6Z

6A
8/25/2014

"... OLAW understands that four mice sustained dehiscences [reopening] of their cranial incision sites."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

6B
4/25/2014

 "... OLAW understands that two mice died and three required euthanasia after recieving an overdose of an anesthetic."

"... OLAW is satisfied that appropriate actions have been taken to investigate and prevent recurrence of the noncompliance."

6C
4/22/2014

"... OLAW understands that over a period of several months four rabbits received expired  anesthetics, analgesics, and euthanasia solution."

"... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance."

6D
3/27/2014

"... OLAW understands that a male macaque sustained mild facial injuries after escaping from its cage which had not been locked by the animal care staff."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

6E
4/25/2014

"... OLAW understands that two mice died and four required euthanasia after developing peritonitis caused by non-sterile intraperitoneal injection of a drug."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

6F
4/25/2014

"... OLAW understands that a field study on sloths included attachment of radio collars to the animals although this activity had not been described in the approved protocol."

"OLAW understands that the research was not PHS-supported but concurs that the incident was serious and supports the actions taken by the ACUC."

6G
4/29/2014

"... OLAW understands that a nonhuman primate escaped its cage after a student failed to follow standard operating procedure regarding appropriate locking of the cage. Although the animal sustained no injuries another monkey bit its cage mate in response to the escape."

"... OLAW understands that measures have been implemented to reduce recurrence of this problem."

6H
5/20/2014

"... OLAW understands that twelve mice died unexpectedly following surgery. ... The cause of death was not determined."

"... OLAW understands that measures have been implemented to reduce the likelihood of recurrence this problem."

6I
5/20/2014

"... OLAW understands that due to switched cage cards the wrong dog was used on an imaging procedure. The laboratory staff failed to verify the identity of the dog prior to use. The activity included anesthesia, catheterization, blood draw, and imaging."

"... OLAW is satisfied that appropriate actions have been taken to investigate and prevent recurrence of the noncompliance."

6J
5/28/2014

"... OLAW understands that a rhesus monkey sustained an injury from another monkey after moving the divider between the cages. The panel had not been properly secured by the animal caretakers."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

6K
6/6/2014

"... OLAW understands that mice received a different post-operative analgesic than described in the approved protocol."

"... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance."

6L
8/15/2014

"... OLAW understands that young turkeys and chickens on a nutrition study experienced slow growth and unexpected mortality due to low levels of micronutrients in the feed."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

6M
11/18/2014

"... OLAW understands that 10 young quail died or required euthanization after  undergoing poorly performed debeaking procedures."

 "... OLAW understands that measures have been implemented to correct and prevent recurrence of the problem."

6N
8/5/2014

"... OLAW understands that steers on a pasture feeding trial experienced bloat and were treated for two days with an outdated bloat drug after the unexpired supplement was depleted."

"OLAW understands that the problem was corrected."

6O
9/18/2014

"... OLAW understands that goats were given feed with a calcium-phosphorus ratio with too little calcium. Two goats developed obstructive urolithiasis and were euthanized. Ultrasound evaluation revealed bladder stones in other goats.... This activity was not PHS funded."

"OLAW is satisfied that appropriate actions have been taken to investigate these incidents and the additional actions taken to prevent recurrence are appropriate."

6P Missing

6Q Missing

6R
8/4/2014

"... OLAW understands the following...: 1) An anesthetized cynomolgus monkey was being carried by a technician when another caged animals grabbed and bit its tail. ...The tail tip was amputated... 2) A macaque was inadvertently fasted for one day because a food deprive tag had been left on the cage. 3) ... OLAW understands that five treatments for nonhuman primates were not performed due to human error by the technician. The treatments were for arthritis and a gastrointestinal problem ...

"... OLAW understands that measures have been implemented to correct and prevent recurrence of the problem."

6S
8/18/2014

"... OLAW understands that mice failed to receive post-operative analgesia as described in the protocol."

"... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance."

6T
8/15/2014

"... OLAW understands the following...: 1) A rhesus monkey escaped its cage while being moved to a clean cage and sustained injuries to its cheek and finger. The finger required a partial digit amputation... 2) two marmosets which had been removed from their cage for dosing and blood collection were put back into the wrong cage, fought with the other animals, and one sustained a mild injury."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of these problems."

6U
11/17/2014

"... OLAW understands the following...: 1) Two adult rhesus monkeys sustained skin wounds due to fighting after being placed into test cages that did not have a secured divider. ... 2) For over a three year period, 478 mice failed to receive analgesia following tumor transplant surgery."

"... OLAW understands that measures have been implemented in both situations to correct and prevent recurrence of the problem."

6V
11/17/2014

"... OLAW understands that five mice died and three required euthanasia after receiving fatty acids in ethanol gavage. The concentration of alcohol was not determined in advance and the mice died of ethanol toxicity.

"... OLAW understands that measures have been implemented to prevent recurrence of this problem."

6W
11/21/2014

"... OLAW understands the following...: 1) Mice were being bred and genotyped although this activity had not yet been approved by the animal care and use committee. ... 2) Rats on a water restriction protocol were not given water on one day."

"... OLAW is satisfied that appropriate actions have been taken in both situations to investigate, correct, and prevent recurrence of the noncompliance."

6X
12/3/2014

"OLAW understands that eight monkeys did not have access to water over a weekend due to a laboratory staffer turning off the drinking water line rather than the pan flush water line."

"... OLAW understands that measures have been implemented to prevent recurrence of this problem."

6Y Missing

6Z Missing

PHS self-reports 7A to 7Z


UW-Madison's
PHS self-reports
7A to 7Z

7A
3/3/2015

"... OLAW understands that a live research rat was found in the carcass freezer due to a failure to confirm death following exposure to isoflurane for euthanasia.

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

7B
1/5/2015

"... OLAW understands the following...: Two macaques sustained facial wounds from fighting after contacting one another after opening the cage divider. ... 2) A macaque inadvertently received two doses of an analgesic within minutes of each other because the research staffer did not know the treatment had already been given by the animal care staff."

"... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance in both situations."

7C
3/11/2015

"... OLAW understands the following...: 1) Two rhesus monkeys escaped from their cage and injured three other monkeys in the room... 2) Mice were overcrowded in a cage in a CO2 chamber being used for euthanasia.

"... OLAW understands that measures have been implemented in both situations to correct and prevent recurrence of the problem."

7D Missing

7E Missing

7F Missing

7G Missing

7H Missing

7I
7/30/2015

"... OLAW understands the following...: 1) Two marmosets were inadvertently confined to their nest box for 17 hours after approved pair testing.... 2) Four macaques received a challenge inoculation of pathogenic SIV although this had not been described in the approved protocol.... 3) Mice older than 28 days were anesthetized and subjected to tail clipping but did not receive analgesia as per protocol."

 "... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance in all three situations of noncompliance."

7J
7/30/2015

"... OLAW understands that a cage of adult rats and pups were not checked daily and were found without water.

"Although the animals were not dehydrated, they were euthanized due to concern over using them in a study."

"OLAW concurs with the actions taken by the institution to comply with the PHS Policy on Humane Care and Use of Laboratory Animals."

7K
8/17/2015

"... OLAW understands that the animal [a female ferret] accidentally died after getting its head stuck in the cage door."

"The incident was considered an unusual accident and no further action was taken."

7L
11/5/2015

"... OLAW understands that nine rats on a water restriction protocol failed to receive water for one day and one animal died.

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

7M Missing

7N
11/20/2015

"... OLAW understands that the primate sustained thermal injuries to both thighs from a warm fluid bag used to provide heat during an MRI scan."

"As this was an accident, no further preventative measures were taken."

"OLAW concurs with the actions taken by the institution to comply with the PHS Policy on Humane Care and Use of Laboratory Animals."

7O Missing

7P
12/24/2015

"... OLAW understands that a macaque required euthanasia due to illness caused by lack of water resulting from a disconnected water line." [Three animals were affected.]

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

7Q
3/1/2016

"... OLAW understands that two Peromyscus californicus housed in an investigator managed procedure room were not checked over a weekend. One mice [sic] died and required euthanasia."

"... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance."

7R
3/1/2016

"OLAW understands the following...: 1) A rhesus monkey escaped its cage after the lock failed. The loose monkey and four others sustained minor wounds while one monkey sustained serious injury to a finger." [The finger was amputated.]... 2) A marmoset failed to receive a second daily anesthetic dose following surgery.

"... OLAW understands that measures have been implemented in both situation to correct and prevent recurrence of the problem."

7S
10/13/2016

"... OLAW understands that twelve rats were subjected to a surgical jugular blood draw although this activity was not described in the approved protocol."

"... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance."

7T
3/15/2016

"... OLAW understands that four mice died after being treated topically with an agent whose dose was incorrectly calculated." [Eight others were euthanized]

"... OLAW understands that measures have been implemented to correct and prevent recurrence of the noncompliance."

7U
10/27/2016

"... OLAW understands the following...: 1) Four mice died of dehydration because the sipper tube on the water bottle was too short... 2) Sixteen mice failed to receive analgesics following surgical pellet placement."

"... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance."

7V
10/27/2016

"... OLAW understands that six mice died after receiving an experimental compound not approved in the protocol."

"... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance.">

7W
6/8/2016

Correspondence with OLAW about the results of a campus-wide survey of labs performing survival surgeries on rodents. The university reported that few problem were discovered.


7X
10/20/2016 "According to the information provided, OLAW understand that five mice died due to lack of food. The mice were on a special diet and were inadvertently not fed."

"... OLAW understands that measures have been implemented to prevent recurrence of this problem."



7Y
7/21/2016

"...OLAW understands the following...: 1) A sedated macaque sustained burns to its chest and abdomen due to a faulty MRI coil... 2) A single macaque failed to receive single dose of post-operative analgesia... 3) A macaque failed to receive one post-operative analgesic ...".

"... OLAW understands that measures were implemented to correct and prevent recurrence of the problem in each situation."

7Z
10/11/2016

"...OLAW understands that two undergraduate students conducted animal activities with mice [over an eighteen month period] that were not listed on the protocol. The students had not received institution-based training or approval."

"... OLAW understands that measures were implemented to correct and prevent recurrence of this problem."

PHS self-reports 8A to 8T


UW-Madison's
PHS self-reports
8A to 8T

8A
10/13/2016

"... OLAW understands that a Peromyscus mouse on NSF funded study (IOS-1355163) escaped while being transferred to a procedure hood by a student. The mouse then hid in a hole in the wall.

"... OLAW understands that measures were implemented to correct and prevent recurrence of this problem."

8B
10/20/2016

"...OLAW understands the following...: 1) A power outage prevented staff from accessing the Wisconsin National Primate Research Center Electronic Health Records which resulted in missed treatments of nutritional supplements... 2) Two rhesus monkeys manipulated their cage and one escaped. Three other monkeys sustained minor injuries from fighting with the escaped animal."

"... OLAW understands that measures were implemented in both situations to correct and prevent recurrence of the problem."

8C
5/25/2017

"...OLAW understands that mice were used in a pilot study which involved injection of cells, however, the procedure was not described in the approved protocol."

"... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance."

8D
2/13/2017

"... OLAW understands the following...: 1) Four monkeys failed to receive their daily water ration due to miscommunication between animal care staff... 2) A monkey sustained minor wounds after it escaped its cage when a part malfunctioned."

"... OLAW understands that measures have been implemented in both situations to correct and prevent recurrence of the problem."

8E
2/13/2017

"... OLAW understands the following...: 1) Two macaques removed the cage divider due to a broken lock which allowed them to come in contact and fight. One animal sustained an injury... 2) A macaque was subjected to an approved cerebrospinal fluid collection but was not given the required post-procedure analgesic."

"... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance."

8F
3/14/2017

"...OLAW understands the following...: 1) A macaque was fasted for 30 hours due to a scheduling error.... 2) Two monkeys being treated for a skin infection failed to receive one of their twice daily doses of an analgesic."

"... OLAW is satisfied that appropriate actions have been taken to investigate, correct, and prevent recurrence of the noncompliance."

8G
5/31/2017

"...OLAW understands the following...: 1) Five mice died because no food had been placed in their cage following weaning.... 2) Eight rats died from lack of oxygen after the computer and controller of the hypoxia chamber malfunctioned...."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of these problems."

8H
5/25/2017

"... OLAW understands that a cage door was not properly locked, allowing a macaque to escape. The animal sustained a finger injury at this time."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."


8I
5/25/2017

"... OLAW understands that an infant macaque inadvertently received a dose of a non-steroidal inflammatory agent."

"... OLAW understands that measures have been implemented to prevent recurrence of this problem."

8J
7/17/2017

"... OLAW understands...: 1) A macaque received an additional analgesic dose due miscommunication between veterinary and research staff. ... 2) Two marmosets were misidentified and placed in cages with other marmosets and fighting occurred which caused injuries to both animals. ... 3) A macaque escaped its enclosure due to equipment failure, entered another enclosure, and fighting occurred which caused injuries to both animals. ... 4) A macaque received an intracranial dose of expired contrast agent..."

"... OLAW understands that measures have been implemented in each situation to correct and prevent recurrence of the problem."

8K
8/29/2017

"... OLAW understands that 20 rats died due to a power outage which impacted the ventilated racks...."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of the problem."

8L
12/7/2017

"... OLAW understands that a marmoset's foot was accidentally injured in its enclosure door."

8M
4/24/2018

"... OLAW understands that two rats died in a hypoxia chamber after an oxygen sensor failed and the chamber filled with nitrogen."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

8N Missing

8O
3/7/2018

"OLAW understands the following...: 1) Two marmosets escaped their cages because the door was not completely locked and one animal sustained a small hand laceration. ... 2) Two macaques escaped their cage after the attached tunnel came off and one animal was injured. Two other animals in the room were also injured by the escapees. ... 3) A macaque was given a contrast agent although this had not been described in the approved protocol. ..."

"... OLAW understands that measures have been implemented in each situation to correct and prevent recurrence of the problems."

8P
5/3/2018

"... OLAW understands that on two different occasions two different rhesus monkeys received expired valium..."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

8Q
4/23/2018

"... OLAW understands that three mice died and two were in poor condition after not receiving food after weaning. A second cage also had no food but the mice were in good shape."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

8R
7/7/2018

"... OLAW understands that on two separate occasions, two different macaques received an expired analgesic/sedative drug."

"... OLAW understands that measures have been implemented to prevent recurrence of this problem."

8S
5/7/2018

"... OLAW understands that on two days in a row more blood was taken from a macaque than was approved in the protocol."

"... OLAW understands that measures have been implemented to prevent recurrence of this problem."

8T
5/7/2018

"... OLAW understands that an animal caretaker failed to lock a cage divider which allowed two macaques to escape and one became injured."

"... OLAW understands that measures have been implemented to correct and prevent recurrence of this problem."

Saturday, December 28, 2019

UW-Madison Swindles Taxpayers Again

It's the old bait-and-switch con.

In 2014, Christopher Coe was awarded $440,094 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to develop and test a “medicinal food” to treat anemia in children and young women of childbearing age. Coe is the director of the Harlow Primate Laboratory which is adjacent to the Wisconsin National Primate Research Center. He has yet to report on the development or to test such a food.

Coe says that his research is addressing a public health concern:
PUBLIC HEALTH RELEVANCE: Nutritional deficiencies compromise the wellbeing and developmental health of infants worldwide, including many infants in the United States. Our project will determine the value of an innovative medical food, nutritional yeast modified to express human ferritin, for treating anemia. The core hypothesis is that ferritin will outperform the traditional treatment with ferrous sulfate for delivering iron to the brain, and thus provide a more effective approach to managing iron deficiency and preventing the adverse neurodevelopmental effects of untreated anemia.

He has repeated this statement every year for the past five years and has so far received $2,132,528 in tax dollars from NICHD. In his grant abstract, he explained his goal and how he would test the food’s efficacy:
Our primary goal is to investigate the benefits of a new medical food supplement for treating anemia. We will establish the utility and safety of providing iron in yeast biotechnically modified to express human ferritin. One advantage of this modification is that yeast can acquire therapeutic levels of iron in a bioavailable form without significant change in texture or palatability. In addition, ferritin is a highly conserved protein enabling us to provide a natural tissue storage form of iron using yeast as the delivery vehicle. To test its efficacy, we take advantage of a well-characterized nonhuman primate model of infant anemia. Three studies will be conducted in young rhesus monkeys under controlled laboratory conditions, empirically verifying the value of this yeast-ferritin complex in infants, a likely target population in humans. We will directly compare its benefits to a common standard of care: oral treatment with ferrous sulfate.

It seems that he planned to genetically modify yeast to produce an iron-containing protein that could be added to foods. Once the modified yeast was produced, he would feed some anemic young monkeys the special yeast and treat some anemic young monkeys with the standard treatment, and then compare the results.

Over the five years of the grant he has published five papers, which on its Research Portfolio Online Reporting Tools website, the NIH lists as the results of the project.

Here are the titles and a few pull-outs from those papers:

1. “Metabolomic analysis of CSF indicates brain metabolic impairment precedes hematological indices of anemia in the iron-deficient infant monkey.” [Nutritional neuroscience. 2018 Jan; 21 (1) :40-48]

Objectives: Iron deficiency anemia leads to long-term neurodevelopmental deficits by altering iron-dependent brain metabolism. The objective of the study was to determine if iron deficiency induces metabolomic abnormalities in the cerebrospinal fluid (CSF) in the preanemic stage and to ascertain the aspects of abnormal brain metabolism affected.

2. “Maternal Perceived Stress during Pregnancy Increases Risk for Low Neonatal Iron at Delivery and Depletion of Storage Iron at One Year.” [The Journal of pediatrics. 2018 09; 200 :166-173.e2]

Objective: To investigate the impact of maternal stress during pregnancy on newborn iron and Stage 1 iron deficiency (ID) at one year of age.

3. “Social Influences on Prevotella and the Gut Microbiome of Young Monkeys.” [Psychosomatic medicine. 2017 Oct; 79 (8) :888-897]

Objective: Our aim was to evaluate the bacterial profiles of young monkeys as they were weaned into peer groups with a particular focus on Prevotella, an important taxon in both human and nonhuman primates. The weaning of infants and increased social contact with peers is a developmental stage that is likely to affect the gut microbiome.

... Typically, in a natural troop, this progressive movement away from the mother is gradual and takes place over several months, but in captive settings, such as a laboratory, it is common to re-house an entire group of weanlings on the same day. This social transition in young monkeys results in a period of behavioral agitation and activates stress physiology for several days followed by recovery as they become familiar with the new environment and with peers.

4. “Gestational Timing of Prenatal Disturbance and Fetal Sex Determine the Developmental Outcomes.” [Neonatology. 2016; 109 (4) :314-20]

Objective: To determine the impact of a delimited period of moderate maternal stress on infant growth, emotional reactivity and neurobehavioral maturity in a nonhuman primate model.

Methods: Eighty-three infant rhesus monkeys were generated from disturbed pregnancies, either Early or Late Gestation, and compared with 51 Undisturbed infants. Maternal stress was induced with an acoustical startle protocol for 25% of gestation. Infant weights, anthropometrics, and neurobehavioral data were obtained. Analyses focused on differential effects of prenatal stress on male and female infants.

... Female rhesus monkeys were exposed to controlled stress lasting 5-6 weeks, either early or late during their 24-week pregnancy. The immediate impact was assessed by determining maternal cortisol levels at the end of the daily manipulations.

5. “Maternal Obesity Affects Inflammatory and Iron Indices in Umbilical Cord Blood.” [The Journal of pediatrics. 2016 05; 172 :20-8]

Objective: To determine the impact of maternal obesity and gestational weight gain across pregnancy on fetal indices of inflammation and iron status.

There is no mention of yeast in any of the papers.
For decades, it has been possible to diagnose and fully reverse the anemia of iron deficiency at a relatively low cost. Unfortunately, iron deficiency has maintained itself as the most common anemia and nutritional disorder worldwide. This seemingly inexplicable paradox of high prevalence despite effective treatment represents a major challenge to public health efforts. Multiple obstacles involving economics, cultural barriers, and infectious diseases converge and make eradication of this disease more difficult. The additional challenges that are encountered by certain human subpopulations in select geographies need to be overcome to achieve therapeutic success in the global community. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3685880/
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Iron deficiency anemia most commonly affects babies 9 through 24 months old. Breastfed babies need less iron because iron is absorbed better when it is in breast milk. ... Infants younger than 12 months who drink cow's milk rather than breast milk or iron-fortified formula are more likely to have anemia. Medline Plus Feb 19, 2018.

Suppose a scientist asked you for a donation to help them develop a way to increase the amount of iron in yeast to help alleviate iron deficiency in women and children?

An informed response might be something like, how will you get the yeast into the hands of African and Asian mothers, since the prevalence of anemia in infants and young children (birth to 5 years of age) is greatest in Africa, 64.6% and in Asia, 47.7% The prevalence in the North America is only 3.4%. Moreover, according to the NIH National Heart, Lung, and Blood Institute, people with mild or moderate iron-deficiency anemia may not have any signs or symptoms.

But let’s say that you decided to give them a donation. And over the ensuing 5 years, others donated a combined total of $2,132,528. When you learn how much they got, you decide to see how the project is coming along. You find out that the scientist used all the money and has published five papers paid for by those donations, but no where in them is there mention of a new medicinal food for treating anemia.

Where, you might ask, did the claim about wanting to make iron-rich yeast go? Indeed.
Project Number: 5R01HD080201-05 Contact PI / Project Leader: COE, CHRISTOPHER L
Title: NOVEL MEDICAL FOOD FOR TREATING INFANT ANEMIA AND IRON DEFICIENCY IN THE CNS Awardee Organization: UNIVERSITY OF WISCONSIN-MADISON
Abstract Text: DESCRIPTION (provided by applicant): Iron deficiency is the most common micronutrient deficiency worldwide, and is particularly significant for women of child-bearing age and rapidly growing infants. Conventional methods of treating iron deficiency orally are inadequate as evidenced by poor compliance and the periodic need for iron injections. Our primary goal is to investigate the benefits of a new medical food supplement for treating anemia. We will establish the utility and safety of providing iron in yeast biotechnically modified to express human ferritin One advantage of this Modification is that yeast can acquire therapeutic levels of iron in a bioavailable form without significant change in texture or palatability. In addition, ferritin is a highly conserved protein enabling us to provide a natural tissue storage form of iron using yeast as the delivery vehicle. To test its efficacy, we take advantage of a well-characterized nonhuman primate model of infant anemia. Three studies will be conducted in young rhesus Monkeys under controlled laboratory conditions, empirically verifying the value of this yeast-ferritin complex in infants, a likely target population in humans. We will directly compare its benefits to a common standard of care: oral treatment with ferrous sulfate. Beyond traditional hematological tests and iron- related measures in serum, several novel endpoints will be determined in cerebrospinal fluid, including quantitation of iron management proteins and two important protein indices previously identified by proteomic analysis to be abnormal in anemic infants. Prior proteome and metabolome analyses revealed that when infant anemia is not resolved, it impacts functional proteins in the developing CNS, including prostaglandin D2 synthase and amyloid beta A4 protein-like, and impairs brain energetics. In addition to verifying the effectiveness of this innovative treatment, we will determine the safety if an iron-sufficient infant were to consume yeast containing iron, a critical prerequisite for human clinical trials. Measures of the heme and intrathecal compartments will be determined before, during, and after treatment. Based on previously found behavioral differences in anemic Monkeys, emotional reactivity, motor activity, and cognitive performance will be assessed after supplementation. The core hypothesis is that this yeast-ferritin complex will provide iron in a readily absorbed form, and most significantly, that direct provision of ferritin will replenish the iron-deficient CNS more effectively. Using a multi-tiered nutritional and developmental neuroscience approach, several novel aspects of iron delivery and utilization will be investigated. The research has a clear translational relevance with the potential for establishing a new therapeutic modality. It will set the stage for a Phase I/II clinical trial and, at the same time, validate new biomarkers for tracking how anemia and iron supplementation affect the developing brain. Our capacity to carry out this unique inter-disciplinary project is based on a history of collaboration between two laboratories with the essential resources and expertise.

Public Health Relevance Statement:

PUBLIC HEALTH RELEVANCE: Nutritional deficiencies compromise the wellbeing and developmental health of infants worldwide, including many infants in the United States. Our project will determine the value of an innovative medical food, nutritional yeast modified to express human ferritin, for treating anemia. The core hypothesis is that ferritin will outperform the traditional treatment with ferrous sulfate for delivering iron to the brain, and thus provide a more effective approach to managing iron deficiency and preventing the adverse neurodevelopmental effects of untreated anemia.

------

But after five years of separating baby monkeys from their mothers, frightening pregnant monkeys, and reporting on the already known fact that obesity in pregnant humans can have deleterious consequences to their offspring, Coe has yet to provide any evidence that he has spent even a moment trying to make an iron-rich yeast.

Sunday, November 3, 2019

Screw-ups lead to deaths and more suffering in Madison, WI labs.

Facsimiles of USDA APHIS inspection reports found on the USDA Animal Care Public Search Tool.
University of Wisconsin Madison

USDA APHIS ROUTINE INSPECTION
09-JUL-2019
2.38(f)(1) CRITICAL REPEAT
MISCELLANEOUS.

-Improper lock placement caused two incidents (3/1/2019 and 4/25/2019) of non-human primates (NHP's) getting out of their enclosure and the uncontrolled interaction with other NHP's in the secure room led to injuries that required surgical repair (suturing, partial digit amputations, and distal tongue loss). Involved animals received veterinary treatment. These incidents were reported to the overseeing ACUC and OLAW and the facility has implemented changes to decrease incidents of NHP's exiting their primary enclosures.

-In relation to an ACUC-approved handling procedure a marmoset sustained a femur fracture that required amputation. The injury was successfully treated resulting in the marmoset being able to ambulate well (observed in inspection). Bone fractures cause pain and the loss of a limb is considered a serious adverse effect to an animal. This incident was reported to USDA, the overseeing ACUC, and OLAW. Corrective actions were implemented to prevent further recurrences.

-On 10/25/18 the facility found a peromyscus mouse was found to have got its head caught between the polypropylene enclosure and the lid. Necropsy findings had signs of rapid hypoxia. It wasn’t clear how the mouse got its head caught, possible warping in enclosure might have contributed to the incident. Increased attention to enclosure warping and the manner in which enclosure lids are closed were corrective actions reported by the lab.

This is the first incident of this type that the lab is aware of and reports no further occurrences of entrapment have happened since. This incident was reported to overseeing ACUC.

Correction: Ensure corrective actions are followed to prevent further occurrences of incidents.

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University of Wisconsin Madison
USDA APHIS ROUTINE INSPECTION
12-JUN-2018

2.38(f)(1) CRITICAL REPEAT
MISCELLANEOUS.

Since the last full inspection of the non-human primate facilities (11/1/2016) there have been five incidents with non-human primates that resulted in the need for wound closure (suturing) and partial digit amputations. Four of these incidents occurred with macaques getting out of their primary enclosures due to human error or enclosure failure. The macaque(s) were able to get out of their enclosure and then either sustained or caused injuries in the course of uncontrolled interactions with other macaques housed in the same secure room. Incidents of primary enclosure exits that caused injuries needing sutures and/or partial digit amputations occurred on 2/13/18 (1 macaque affected), 3/15/18 (1 macaque affected), 3/3/17 (1 macaque affected), and 5/24/17 (2 macaques affected).

One incident involved a marmoset getting its right hind foot closed in an enclosure door on 10/18/17 and 11/6/17. Both incidents caused injuries to its right hind foot and required partial digit amputations of the affected foot. The affected marmoset was observed on the inspection and found to ambulate without problem and adjustments to the enclosures to prevent further incidents were observed.

Note: Affected animals were treated promptly by clinical veterinary staff. The facility previously identified these incidents and reported them to the overseeing ACUC and steps to prevent future occurrences were taken.

This was an inspection of the animals and records maintained under the College of Letters and Sciences and a review of the records pertaining to animals maintained under the WNPRC and the overseeing ACUC's records.

This inspection was conducted on 6/12 - 6/13 and the exit interview was conducted with facility representatives on 6/14/2018.

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USDA APHIS FOCUSED INSPECTION
21-MAY-2019
Covance Laboratories Inc
3301 Kinsman Boulevard
Madison, WI 53704

2.38(f)(1) CRITICAL
MISCELLANEOUS.

Two incidents of non-reparable orthopedic injuries in non-human primates have been identified by the facility since the previous inspection. Handling procedures are attributed to being a factor in causing the injuries. Orthopedic injuries can be painful for animals and handling methods must not cause orthopedic injuries. Handling of animals must be done as carefully as possible to avoid physical harm to the animals.

Note: Clinical veterinarians were promptly notified of these incidents and affected animals were humanely euthanized. These incidents were reported to the attending veterinarian and the facility has taken corrective action to prevent future occurrences. Correction: Ensure corrective actions are followed.