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Diary of Michelle
The Diary of Michelle Rokke -|
the poor work standards witnessed
The following extracts are from the diary of
Michele Rokke which illustrate the poor standard of
work that she witnessed at the New Jersey HLS
(i)When there is reference to animals being 'sacrificed', this refers to
the animal(s) being killed.
(ii)'Obbed', 'Obbing' or 'Ob' which frequently occur in the diary refer to
'Observed', 'Observing' or 'Observe'.
9/22/96 Sunday HLS
While I was cleaning room 456 Kathy came in with a
clipboard from room 451, a room containing pigs.
She told me to date and initial the last column on
the paper. I told her I had initialled that I had
cleaned the room yesterday morning.
She said I had to initial that I had given the pigs
fruit - they get half an apple after the room is
cleaned. I told her I didn't know that and she
thrust the clipboard at me and told me to initial
it. I told her I didn't give them any fruit because
I didn't know and she still made me initial the
A few minutes later Kathy returned with the
clipboard from room 455. She told me I had to
initial the column marked fruit. I told her I
didn't give them fruit either because I didn't know
I should. She handed me the clipboard and said I
had to initial it.
Kathy bled the pigs this morning. When she looked
at pig #8 she said, 'Yeah, he really does have a
thrombosis going on.' I asked what a thrombosis was
and she said It just means someone didn't hold the
vein off long enough after the blood was taken. She
didn't say any more about it and took the blood
from the pig's jugular anyway.
9/25/95 Wednesday HLS
I saw an escaped primate in room #956. He was
standing on top of his cage fiddling with the
Gene Lysko said when he started in June there had
not been regular maintenance done on the equipment
for a long time and therefore a lot of it didn't
function. He said Sandoz dropped in for a surprise
inspection on a Thursday - they had a 28 dog study
scheduled to start the following Monday.
They didn't like what they saw and cancelled the
study. He said they asked to see maintenance
records for equipment and there weren't any. He
said the department had been badly managed and they
could have at least written it down even if they
didn't do it would at least look like they cared
enough to write something down but there was
He gave an example about when he started it was so
bad he had anaesthetized rabbits and the equipment
they needed didn't function at all. He said Sandoz
cancelling the study meant a $280,000,00 loss to
the company. They went somewhere else.
9/26/96 Thursday HLS
From E-Mail: 9/26-27 Texaco, meeting to address a
poor quality assurance audit (QA #6716) about our
unit (cardio) producing poor quality data for study
Kathy said to Irene 'Thanks for verifying the
dose.' Irene said 'Well, I saw you with the stuff I
hope you went into the right room.' Kathy said 'Me
too,' and they both laughed.
10/6/96 Sunday HLS
The test materials are supposed to be kept in the
pharmacy until they're used and returned to the
pharmacy immediately afterwards. I heard one of the
technicians tell another technician who was going
to the pharmacy to 'pick up everyone's'.
Wednesday 10/9/96 HLS
In one study, Jennifer Fine grabbed the wrong
syringe and dosed a primate with the wrong amount
and strength of test material resulting in a
10/13/96 Sunday HLS
There was a glass blood collection tube lying in
the bottom of the 'extra' male dog's cage. The tube
was hand labelled 2685.
10/16/96 Wednesday HLS
They had the beagle's head in an anaesthesia mask
when I entered I was told the cocktail hadn't
relaxed him enough. Jennifer and Mahsa had already
started practicing on 1067. Jennifer cut into the
artery and blood sprayed all over her face.
Al, the supervisor, immediately tried to sponge off
Jennifer's face - she said loudly 'Don't worry
about me! Attend to the dog - do I have the vessel
clamped off or not?' After Jennifer had the
catheter in the vein, she pushed a long metal tube,
called a trocar, up under the dog's skin starting
from the incision she had made on her inner leg
along her side and eventually forced it out through
a small cut she had made near her shoulder.
As she was doing this, the dog started coughing and
gagging and Jennifer yelled, 'She's waking up.' Al
held the dog's mouth shut around the tube and
turned the gas up. It took several minutes for 1067
to reach a surgical level of anaesthesia again and,
in fact, I'm not sure if she ever did.
10/20/96 Sunday HLS
In study 3274, I round a capsule in 2565's
10/23/96 Wednesday HLS
Kathy trained me to 'ob' (observe) the pigs in
L-wing, Bristol Myers Squibb study 3321. She said,
'If the pig is alive it's fine - if it's dead it's
not. That's all there is to obbing pigs.' She said
I'll find out she does things 'the Kathy way.'
10/26/96 Saturday HLS
In room 908, study 3274, I found an intact capsule
about one inch long in the bottom of 4067'5 (USDA
2633311 colony 702) cage.
10/31/96 Thursday HLS
It's my responsibility to go through the surgical
suite and pull expired drugs. There was a roll of
catheter tubing that expired in 1994, and some
catheters that expired in June '96. I also found 2
boxes of sutures that expired in May of 95.
I gave them to Gene who said it was a shame they
were stamped because it was stuff that didn't go
bad it's just the FDA requires expiration dates on
things used in people and animals. I asked what I
should do with these items he said 'Just leave them
with me I'll find a use for them.'
11/2/96 Saturday HLS
Everyone tells me it's best to be as vague as
possible when writing anything down. If it gets too
specific, that's when QA and other monitoring
agencies start questioning things and it's hard to
explain them away if it's specific.
11/7/96 Thursday HLS
Dr. Rubin was there today examining eyes. Prior to
his arrival Lynn 'dropped' the dogs eyes with
something that lasts three to four hours. The
sponsors were there. One flew in from California to
see the ophthalmologist read eyes.
Carol, the study director, was escorting the
representatives from Ligand pharmacy. Lynn and Lisa
told me the dogs are expected to have vision
problems as a result of the test material.
11/13/96 Wednesday HLS
I held dogs from study 96-3323, room 910, for
ECG's. The leads always touch because there are
seven wires and only one person holding. Lisa ran
the ECG machine and Nick took the blood
I told them the SOP said the chest wires shouldn't
touch the cart the dog was on and last time we
actually had them under the dogs. She paused for a
moment and said, 'Well, there's no other way we can
do it because the wires aren't long enough.'
11/17/96 Sunday HLS
One of the monkeys from 3314 (a pilot study for
Proctor and Gamble) died right after dosing. Kathy
was dosing and Lynn was holding. The dosing method
is naso-gastric - a tube is shoved up the primate's
nose and forced down into the stomach; the test
material is pushed in with a syringe.
I was with them when they both watched the necropsy
to see if they had killed him by giving him a 'lung
shot'. Brian, from necropsy, had already opened up
the primate when I went in. Kathy saw all the blood
pooled in his chest cavity and ran to get a vac
tube for a sample. When Brian got to the lungs he
squeezed out foamy liquid and looked at Kathy. She
immediately claimed it wasn't 27 mls of fluid which
is what the dose is and it wasn't pale pink.
Brian said he thought they would call it dose
related death - gavage related death. Kathy asked
him to open up the stomach because they had been
fasted and it should be obvious if the dose was in
the stomach. The stomach was full of biscuits and
there was no evidence of pink fluid. Kathy said
this monkey had dropped dead right after dosing and
another monkey in the study wasn't doing well. She
said she hadn't killed anything (via improper
dosing) for five years and didn't want to ruin her
She said, '[she] got suspended once for 3 days
because she was holding off vein on a little
monkey's leg and the monkey went one way and she
still had the leg pointing straight up. Whoops! So,
[she] had kind of killed that one because they had
to euthanase it.' She told me suspension wasn't bad
- she got to take a day here and a day there. She
got off for her sister's graduation, took a Friday
I asked what she would do with the time off this
time and she said '[she] wouldn't get anything for
this because it was accidental - the other thing
was cruelty.' [Brian Crane told me later she should
have been fired for that.
The real story was that they were all in a room
bleeding, Kathy had a monkey's leg held off and she
was screwing around and did a little pirouette with
it - holding the monkey's leg in one hand and
spinning under it like they were dancing. He said
they all heard the bone snap and knew right away
what had happened. She had broken the primate's
leg. When he said she should have been fired Irene
agreed with him.]
11/20/96 Wednesday HLS
A guy from QA (Quality Assurance) came to monitor
the blood sampling. He watched the first two dogs
and then left. He came back and watched the last
one being bled. He was surprised we were through so
soon, and said, 'I guess that's good. I saw the
first and the last.'
He made a few notes and left. The short time he was
there, Kevin talked to him about a party he was
having. The techs often brag about diverting QA's
attention when they're being monitored.
Kevin 'dropped their eyes' (put eye drops in to
dilate their pupils) because Dr. Rubin was coming
to look at them.
Stephanie, Rachel, Lynn and Lisa were joking at
lunch about all the monkeys dying in the extra
colony. Stephanie said, 'Terry doesn't know why but
then she doesn't know the cages haven't been
changed for like a year. Have you heard of
12/5/96 Thursday HLS
I helped set up for surgery. At the pre-surgery
meeting Gene said he would put one dog 'under'
[anaesthesia] using just propofil on a syringe
pump. Later, Brian told me Gene had really had to
fight Terry, the vet, to get approval to try this
anaesthetic. He said she definitely DID NOT want
Gene to use it.
They sent me to get the first dog from the extra
colony, dog number 11?? When I got her from her
cage at about 10:00, I saw her food bowl was about
one-third full. Brian, Jennifer, Yao and Gene were
all in the prep room when I brought the dog in. I
asked if the dogs should have been fasted prior to
surgery and told them they had all been fed
Everyone just looked at each other until, finally,
Gene said yes and looked at Jennifer, whom he had
put in charge of prepping things for surgery. She
said she thought we would start earlier and that
the dogs are not fed until the afternoon so she
didn't let anyone know to fast them.
The way the schedule's been lately, the extra
colony is, to my knowledge, always obbed, fed and
cleaned in the morning. Gene said it would be all
right we would just have to watch them closely in
recovery and he motioned for the dog to be brought
Jennifer had trouble putting a catheter into the
vein of dog number (the first dog); this is put in
to administer the 'cocktail', prior to the
isoflurane. Gene examined the tip of the catheter
after she tried to get it in and told her she bent
the tip on the dog's skin.
He told her she should make a little cut in the
surface of the skin first, to make getting the
needle in easier. Jennifer's expression was of
disbelief. She said she didn't want to do that.
Gene said he knew she didn't want to, but she
should try it and see how much easier it made
Jennifer finally got the catheter in, without
slicing open the dog's skin, as Gene had suggested
she do. She administered about half of the dose.
The dog was still sitting upright so she injected
the rest of the dose, and then the dog was hooked
up to the portable anaesthesia machine. Gene told
me the dog was just hooked up to oxygen.
When Yao was shaving the dog, Gene asked him how
the dog was doing and then said the dog wasn't
breathing. Yao continued to prep the dog. Gene
expressed concern over the situation several times
and pumped the air bag into the dog three times. It
took Yao and I several minutes to shave and scrub
Jennifer came in and upon hearing Gene express his
concern over the dog not breathing, said, 'Just
turn the isoflurane down. It's up to three.' Gene
didn't know the dog was hooked up to gas and
exclaimed over why that was. Jennifer told him we
always do it that way, keep them on gas until
they're brought into the surgical suite. Gene
didn't think it was necessary, the cocktail should
be enough for prepping.
Another dog was hooked up to isoflurane in the
surgical suite, her legs tied and Jennifer made the
incision for the catheter. Brian and Gene were
adjusting the gas flow when the dog started taking
deep breaths and moving around on the table.
Jennifer had to lie on her to keep her still. Both
Brian and Gene were fiddling with dials and
exchanging information on the way they were used to
doing things while the dog, with a one inch cut
through her skin and muscle struggled on the
Finally, Jennifer said 'The heck with sterility!'
and turned a dial on the machine and squeezed the
bag into the dog's lungs. The dog, mercifully,
quieted down almost immediately. While Jennifer was
doing this, Gene was yelling, 'Wait! Wait! Do you
know what you're doing? What are you doing?'
Jennifer said she always did that. They had a
disagreement over what she had done. Obviously what
Gene was doing was not getting the dog back under
and what Jennifer did, did put the dog back under.
She re- scrubbed and within a few minutes the dog
wasn't breathing and her colour was poor.
After several more minutes of adjustment, and
fiddling, and conversation, Gene re-intubated the
dog and upon checking the tube that was in her
trachea originally, found that only half of the
cuff was inflated. Jennifer said she had checked
them all prior to surgery. This may be true, but,
clearly, half of the cuff was not inflated.
Jennifer finished implanting the catheter. This dog
cried and howled as she woke up and her
vocalizations continued long after she was placed
in the cold metal cage.
I worried about the dogs' well being, when I saw
they were placed directly on the cold metal floor
grate of the cage immediately after they were
extubated, still groggy from the anaesthetic. I've
read and been told by veterinarians that it's
imperative the patient be kept warm until fully
recovered from anaesthetic.
The next dog operated on when through the same
stormy recovery period, howling and crying.
The third dog, a female was brought in. Jennifer
looked at her and said, 'Oh, I like this dog, she
always likes to have her tummy rubbed. She's so
sweet.' I held the dog so Gene could catheterise
her for the anaesthetic. He announced he would show
us his technique. He dug into her skin with the
needle, cutting through her skin until she
The dog cried and tried desperately to get away. I
couldn't hold her still, she was struggling so
much. Jennifer ended up holding her while Yao and
Brian and I all helped. At one point, as Jennifer
held the dog in midair (she had jumped, and
Jennifer just had to go with her) and Yao and Brian
tried to hold different parts of her still, and
Gene was following them, catheter poking and
jabbing at the bleeding dog, Brian rolled his eyes
and said 'I can hear the circus music
The dog was deeply anaesthetised and she took a
long time to wake up. Gene said she was much, much
deeper than necessary.
While waiting for her to wake up, Gene pulled hard
on her whiskers. Getting no response, he snapped
his fingers loudly next to ear several times. As he
was doing that, Brian pinched her toes hard and she
straightened her leg. Still she wasn't getting up,
so they continued pulling and tugging at her. Gene
periodically pulled at her whiskers and clapped his
hands right next to her ear.
In fact, he did this so often he looked like a
senile old man, repeating the same task over and
over again because he forgot he had just done it.
The clapping was so loud and the pulling and
pinching so extreme, I winced each time they tried
getting a response from her.
Brian told stories about previous studies. One was
a study that a European company ran for a product
that was already on the market over there. He said
the test material made the dogs' mammary glands and
prostates get swollen, hard and blue. The dogs also
lost a lot of hair. He said it was just horrible,
after dosing he went into ob and one of the dogs
was standing up one minute and fell over dead the
The test material raised their body temperatures
really high. The company claimed it was U.S. dogs
and not the test material, so one night Brian and
someone else waited until around midnight for dogs
to come in from the Netherlands.
12/8/96 Sunday HLS
I found eight capsules on the floor in 920. I don't
know if they were accidentally spilled and replaced
for dosing or spilled and not replaced. Most of
them were lying close together near the drains,
partially under nearby cages. As if someone had
tried to dispose of them after they spilled.
12/12/96 Thursday HLS
Kevin was mad because someone told Terry the pigs
hadn't had a cage change for over six weeks.
They're supposed to be changed every two weeks. He
said several times he'd like to know how she found
out. I asked him if it had really been that long.
He laughed and said it had probably been
12/28/96 Saturday HLS
On her last day working at Huntingdon, Jennifer
Fine told me 'All of the studies are so screwed up
all the time because no one cares. No one cares if
stuff gets done right and there's always problems'.
Irene told me we use two blood pressure machines,
one on each leg, because it's faster and we don't
have to wait so long to get the readings we need.
Irene told me 'The blood pressure cuffs are
disposable but with this company we reuse
The Velcro wears out so we have to secure it with
extra strips of Velcro wrapped around the entire
cuff. Brian told me we really shouldn't use the
extra Velcro because it alters the reading.
1/9/97 Thursday HLS
While talking about ECG's in 3314, Walter and Irene
were joking about how long we could get away with
using two blood pressure cuffs when doing ECG's
before we got caught.
1/15/97 Wednesday HLS
Several of the technicians, including Kathy, Irene,
Brian and Justin had joked throughout the week
about how many monkeys would die as a result of
'lung-shots' - if the naso-gastric tube is
improperly placed in the animal's trachea and lung
instead of their oesophagus and stomach, the animal
receives the test material in the lung and dies
Justin brought it up again during ECG's and went on
to tell me about having a 'platinum club' in the
past. He said I should ask Brian about it, he might
still have the list. If you killed an animal you
were in the club. He said he had the most kills. He
said he killed a dog once - 'It just dropped over
after dosing.' He said he broke a monkey's arm once
and it had to be euthanased.
1/16/97 Thursday HLS
Yao sedated the primates with Ketaset. Irene and I
weighed them and Brian did the tb tests. He grabbed
one primate by the scruff and while he held her in
one hand he injected the tb solution under her
eyelid. He did it in midair without laying the
primate down. He told me 'You didn't see that. It
never happened. You can't prove it. You're not
supposed to do it that way.'
1/22/97 Wednesday HLS
These primates have been used in many different
studies and each now has three tattoos and at least
one ear-tag.Al took some individually sterilized
instruments into the operating room but he didn't
have a complete set. He came back in the prep room
and waited by the autoclave.
Meanwhile the two primates were fully
anaesthetised. I saw AI push the timer on the
autoclave ahead so it would 'ding' before the
process was complete.
When the second pack was through being autoclaved I
rushed it into the OR and saw Brian was halfway
through the surgery on his primate but he was using
the operating table that Al had been using. He
declined the new pack and motioned to the
instruments all around him saying he was fine. He
had apparently just moved his primate to Al's table
and used his dirty instruments.
During the meeting in the tech room today Kathy
announced that she had seen injuries on every one
of the monkeys in room 958 yesterday - from broken
tails to nearly- severed fingers, all caused from
people handling them improperly during tests and
Kathy said she found a primate cage in the extra
room that did not have the water hooked up. She
said she had not checked the water on Sunday when
she cleaned. Both Eleanor and Kathy tried to figure
out how long the four primates had been without
water and they decided they had probably been
without it since a week ago, Wednesday, when there
was a cage change.
2/12/97 Wednesday HLS
Before we prepped the last two dogs, Gene told me
we would be a little short on propofil for the last
dog. He said we would be about .1ml's short because
the bottle was empty and it didn't pay to open a
new bottle since you can't save it once it's
He told me we would really have to work fast to get
the dog intubated and on isoflurane as quickly as
possible. They cut the primate's chest open and
took a blood sample before retrieving the sponges.
While Jim did that, Brian wrote his initials in the
blood on the table.
2/20/97 Thursday HLS
Gene said Huntingdon is using outdated practices
that have been around since the 60's and it's time
to move forward and progress.Irene and Brian told
Rodney stories about finding racks or rats and mice
dead after they were mistakenly left in their cages
and put through the automatic cage wash
Brian told him about a room of rats left in C-wing
and forgotten about. No one fed them or anything
and they were found a couple or weeks later during
room checks - dead, of course. He said it didn't
happen that long ago. Irene said Al mistakenly
killed a whole room of rats once because he thought
they said, 'Go kill them' instead of what they
really said. She said they were off test but they
were going to be used in another study.
3/12/97 Wednesday HLS
Gene was unable to successfully find the vein in
one dog (after slicing the dog's leg open) and
after three tries with the abo-cath, decided to
mask the dog down with isoflurane instead of trying
the other leg or asking someone else to try. The
dog fought and resisted the iso mask.
Brian and Rodney both asked me later why Gene had
masked the dog down. When I told them he'd been
unable to find the vein, they both asked if he had
tried the other leg. When I told them he hadn't
they both shook their heads and said they still
didn't understand why he'd done it. Brian, in
particular, was upset about it because it's his
study and Gene broke the protocol.
3/15/97 Saturday HLS
The vet request was written on the sixth of March.
Terry recorded that she thought it was a fracture
but was unable to x ray it because there are no
In room 902, the ceiling is falling in. A long
piece of sheet-rock tape is hanging from the
ceiling over some of the dogs' cages. There are
pieces of the ceiling that are patched in places
and that's what's falling into the cages. I found
several chunks of plaster and a lot of dust in one
of the group two dog's cages from the ceiling.
3/16/97 Sunday HLS
Brian forged some documents and some husbandry
records, telling me as he did it 'We don't do
this...' even as he told me to help him do it.
3/19/97 Wednesday HLS
The pharmacy was unable to properly mix the group
four-dose solution. They used a water-based
solution that doesn't mix with the oil-based
vehicle the test material is mixed with and it
started to separate.
As a result, the group four dog was dosed at least
an hour later than the others. Irene told me the
day before they had trouble with her Magainin rat
study 97-3621. She said the group two test
materials separated in the syringes. Lisa had asked
her why the material was two different colours -
clear and milky.
She said they panicked because the test material
was already being delivered to the rats and they
didn't know if they were getting straight test
material all at once, or air or what. She said they
ended up giving the group two rats group three test
material at a slower rate. I asked if that wouldn't
really alter the results. Irene shrugged and said
they didn't know.
He said, 'For one thing, the lipid and test
material need to be mixed with a special machine
and it wasn't.' I asked why it wasn't. He said we
didn't have the machine.
The pharmacy techs and Brian talked about what
could get incinerated and what couldn't. Brian
mentioned an Acea material that was floating over
Pennsylvania even as we spoke, and everyone groaned
and laughed nervously. Dian said again, 'I don't
want to know! Don't you guys get it? If I don't
know I can just plead ignorance, but if I know, I
have to tell you not to do it. So don't tell
This thought process of 'what [people] don't
know...' is commonplace at Huntingdon, and in fact
seems to be the only thing that keeps the lab in
operation. I have seen many of the people I work
with at the lab routinely alter 'little' bits of
information, intentionally leave information out
when documenting or relating data, intentionally
create vague responses to problems and anticipated
problems, routinely write memos to add to study
files explaining why the rules weren't
This is extremely common and because they have all
the rules spelled out in SOP's everything always
looks correct on paper and if/when queried.
3/22/97 Saturday HLS
She told me 'These dogs are crap dogs. Rejects.'
She told me '[she] had told Cathy Kelly, the study
director they shouldn't be put on study.' Terry
told her 'They are not healthy dogs and should not
be used and if they were used it would be a poor
Terry said, 'You know what's going to happen if you
take a dog with foot sores and wrap it up in a
splint? That tissue's going to get all black and
stinky and it's going to get worse and never heal.'
She said 'Cathy is going to get half-way through
the study and realize it and regret it.' She said,
'Cathy Kelly told me 'They're dogs! They're going
to have problems. What do you expect?'
3/26/97 Wednesday HLS
Terry said the inspector wasn't happy about the
x-ray machine being in the surgery suite (where
it's always kept.) Rodney answered the inspector's
questions about cleaning schedules and asked him
about the x-ray machine.
Rodney told her we had cleaning logs and after she
left he said laughingly, a couple of times, 'She
doesn't know we ALWAYS keep the x-ray machine in
the surgery suite - she thought it was just in here
Rodney said he knew an approximate dosage of the
ace/ketamine mix - 1 CC per k, but they didn't have
dosage calculations for it. They had dosage calc
figured out for the xylazine/ace mixture but not
ketamine/ace. Rodney asked Terry what to do about
it when the inspector was across the hall.
Terry said, 'That's ok, can't you just quick write
it out?' Rodney said again he didn't know the exact
dosage, just what usually worked for him as a
ballpark. Terry told him 'Just put the Ketamine/
Ace in your pocket and if the [USDA] inspector asks
just tell her you're using xylazine/ace and show
her the calc you have.' Rodney nodded knowingly and
said he'd wondered if he should do that as he
placed the bottle of Ketamine/ Ace in his breast
Terry left the room but turned and came right back
saying to Rodney and Lisa 'Just remember when you
falsify data use the same colour ink!' Everyone
laughed and nodded. Later, the inspector came in
and when she walked through surgery she looked at
the calc sheet and the bottles of drugs on the
table. Rodney stood next to her with the bottle of
drugs they were really using hidden in his
3/30/97 Sunday HLS
I helped Brian do vet treatments in 3282. He
checked WNL for all the dogs without even walking
the length of the room. He did not look in any of
the cages before he checked WNL.
4/5/97 Saturday HLS
On or about this date, Lisa left me a note about
counting digits and telling me not to write that
there were sores on the dogs' faces.
4/13/97 Sunday HLS
I sent Mike Toth an e-mail telling him we're out of
unicide, the disinfectant we're supposed to clean
the cages with. We've been out for over two
4/23/97 Wednesday HLS
Irene said I thought we were supposed to save the
tubes and reuse them - he did that all day
yesterday too. Gene said, 'Ya know - I just asked
him where all the tubes were from yesterday and he
said he didn't know.'
This and the oxygen tank incident last week are
just two more examples of how commonplace it is for
people at HLS to lie and say they've been doing
something when they haven't or don't know something
when they obviously do.
4/30/97 Wednesday HLS
Irene told me they've had to repair four of the
catheters in the Magainin catheter dogs for study
3627. She said the catheter material they used this
time is very stiff and has 'memory' if it gets
twisted or kinked at all it stays twisted and the
doesn't allow the saline or eventually the test
material to flow through. If there's blood in the
catheter it clots up easily when the test material
isn't flowing through. Gene ordered this material
because it's cheaper.
5/7/97 Wednesday HLS
Brian complained to me about how hectic the
schedule is and how we don't have enough people to
do the work. He told me about the primate surgery
for P&G saying, 'Frankly, I didn't even read the
protocol before the surgeries...'
/10/97 Saturday HLS
I asked Lisa about the way things are done at HLS.
I told her 'It's like no one let me in on the
secret. No one ever really told me what the point
is because it seems like every time I say something
about the animals or try to correct mistakes I'm
told 'not to worry about it', 'it doesn't
Lisa sympathized and told me, '[she's] always the
one at start up meetings saying what is this stuff?
And what's it going to do - what's it supposed to
do?' She said sarcastically 'They love me, too.'
She told me about the grievance with 3318 again. I
asked her what the point was I said 'This is all
for human safety, right? But if we aren't obbing
things and doing the tests accurately, what's the
point? Just to make the sponsor's drug look good?'
She said, 'It's to please the FDA and regulatory
agencies.' She said, 'That's the important
She said, 'It doesn't really matter if the
information's accurate or not.' I said again, 'But
it's for human safety right?' and she said, 'Yeah,
but a dog's not exactly a human, you know? And just
because it causes a problem in a dog it might not
cause the same problem in a human. Something might
happen to a human taking that drug that didn't show
up in the animal.' She said 'The data we get
doesn't necessarily translate into something usable
for human beings.'