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 laboratory.

(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 paper.
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 florescent lights.
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 nothing.
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 #96-3609.
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 mis-dose.

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 cage.

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 pressures.
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 record.
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 off....
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 bacteria?!'

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 already.
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 in.
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 it.
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 the dog.
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 table.
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 bled.
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 starting.'
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 next.
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 longer.
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'.

1/2/97 Thursday
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 them.'
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 within minutes.
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 procedures.
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 open.
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 machine.
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 x-ray supplies.
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 me!'
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 followed.
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 quality study.'
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 today.'
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 pocket.
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 pocket.

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 weeks.

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 matter'.'
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 thing.'
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.'