“But, honey, I just don’t know what to do.” During Tilly’s weekly calls, it was usually her daughter who was looking for advice. “This morning, Roscoe stood at the edge of the bed for quite a while, just staring at the floor, before finally jumping down. As soon as his front paws hit the carpet, he yelped. His old legs are so stiff that any sudden movement or impact hurts a lot. I guess that I’m going to have to take him in to Dr Spenser again but, honestly, nothing he does seems to help much. But I know one thing. If he tells me it’s time, I’m walking right out of there. I’m not putting Roscoe to sleep, even if I have to carry him in my arms.” The thought of losing Roscoe upset Tilly, so she ended the call.
At 86, Tilly was a spry and active widow. She still drove, played bridge twice a week at the town senior centre, went to the local Y every morning for “Elder Exercise,” and volunteered at the elementary school where she had taught reading to second-graders for more than forty years. In fact, her teaching had made her somewhat of a celebrity.
In one of her earliest classes, she had noticed that some of her pupils were very anxious, which hindered their learning. Frustrated at her inability to solve this problem, she decided to bring her Golden Retriever, Jasper, to class to see if he could ease her students’ tension. To her delight, it worked like a charm. However, it took four meetings of the town’s board of education before the school would allow her to bring Jasper on a regular basis. Her story was covered in the local newspaper, then was picked up by one of the news services and published nationwide. That prompted an interview on a national television news show, which resulted in many invitations to visit other schools to help start similar reading programs.
Tilly had always had dogs in her life, and she couldn’t imagine living without one. For the last twelve years, Roscoe had been her constant companion. But now, his age seemed to be catching up with him.
As they sat together in Dr Spenser’s waiting room, Tilly and Roscoe watched the younger dogs tug at their leashes, sniff every square inch of the floor, and bark at just about anything. Roscoe leaned against Tilly, with his head resting in her lap. Just as his eyes started to close, Dr Spenser’s technician, Sarah, called Roscoe’s name. His ears stood up and he turned toward Sarah, but it took a few minutes for him to get back up on all four feet. Tilly wiped a tear from her cheek as she led Roscoe into the exam room.
“Ah, Tilly,” Dr Spenser said as he entered the room. “I hear that Roscoe is still having a tough time moving about. I can give him another shot, but I’m not sure that it will help much.” “You’re probably right,” sighed Tilly. “But there must be something else you can do to ease his pain. I’ve had him since he was eight weeks old and I promised him that I would never let him suffer.” Tilly hugged Roscoe and wiped her tears.
“Tilly, you take better care of your dogs than anyone I know. But I’ve done just about all I can for Roscoe. Maybe it’s just…”
“Michael Spenser, you stop right now.” Tilly had gone to school with Dr Spenser’s father, Tom, and had watched Michael grow up, go to school, get married, and then take over his father’s practice. His son had been one of her students. “It is not Roscoe’s time! It’s not in his eyes. There must be something else you can do.”
Dr Spenser rubbed his chin for a few seconds and then said, “There is one thing that might help.”
“What’s that?” asked Tilly.
“There is new treatment for canine osteoarthritis that is being tested in a clinical trial,” Dr Spenser said.
“What’s a clinical trial?” Tilly asked.
“It’s a research study that is designed to evaluate an experimental therapy to treat a certain condition. In this case, it’s a study for dogs with osteoarthritis, just like Roscoe.”
Roscoe’s ears perked up when he heard his name.
“How does that work? Are you saying that Roscoe would be one of those research dogs in a lab? I would never do that to him. Would you?”
Did he say I was going to play with a Lab? I hope not. Labs are boring. I prefer Poodles.
“Of course not! The study was developed by Spritzer Pharmaceuticals, the same company that makes Roscoe’s heartworm medicine,” Dr Spenser explained. “Over the last few years, we’ve done several of their studies right here in the clinic and everyone has enjoyed them.”
Tilly’s brow was furrowed as she asked, “OK, tell me more. I’m not agreeing to anything, mind you. But, if it would help Roscoe, I might consider it. Are you the only veterinarian doing this study?”
“Oh, no,” Dr Spenser laughed. He grabbed a big white binder labelled ‘STUDY’ from the shelf behind him, opened it, and showed Tilly a list of ten clinics that were participating in the study. He also showed her the protocol. “Tilly, this is a description of the study. It’s like a very detailed recipe of everything that I am supposed to do during the study.”
Tilly reached into her purse to find her reading glasses. Once perched on her nose, she read that the study compound already had been tested for safety and effectiveness, both of which were proven. “So, it looks like you give me the study drug to take home and I give it to Roscoe every morning with his food. Is that right?”
Food? Now we’re talking! It’s about time this place started serving food. Maybe I can share some with a Poodle.
“That’s right. Sarah will explain to you how the product should be given to Roscoe, when, and how you should record both the time you give it to him and what improvement, if any, you observe. Also, in the unlikely event that Roscoe has some kind of side-effect, I would want you to call me right away. I am required to record all side-effects, regardless of severity.”
Tilly looked pensive. Dr Spenser asked, “Is everything OK? Did I say something that concerns you?”
“No. It’s just that, if I’m going to do this, I want to make sure I understand everything.”
“I’m glad that you feel that way. Some clients think a clinical trial is a piece of cake, so to speak, but it’s not. Everyone involved has very serious responsibilities.”
He said “cake!” I love cake. When I was much younger, I jumped up onto the kitchen counter and ate most of a cake with yummy icing. Later, I threw up a lot, but then I felt much better and I was hungry again. I bet Poodles like cake, too.
“Where do we go from here?” asked Tilly.
“Well, if you think you might like to participate, I should describe the study to you in more detail. I need to make sure that you understand everything that’s going to happen, what your responsibilities are, and the risks of participating. At that point, if you still want to proceed, you’ll sign a consent form. Then, I’ll give Roscoe a complete physical exam, take a small sample of blood, and check it to make sure that Roscoe doesn’t have any problems that might prevent him from being in the study. Next, I’ll do what’s called a ‘lameness exam,’ and I’ll also take X-rays to confirm that he has osteoarthritis in his hip. I’ll then ask you questions about his normal day, what he’s doing when you think he’s in pain, and his eating and elimination patterns. After all that, I can determine if Roscoe’s eligible for the study. If he is, we’ll give him his first treatment here and then schedule his next three appointments for follow-up exams and assessments.”
“Oh, boy,” sighed Tilly. “This sounds like a very expensive process. I’m not sure I can afford all those tests. Can’t you use some of the tests you did during his last visit? If I remember correctly, that was a pretty big bill.”
Dr Spenser smiled. “I’m glad you brought that up. If you agree to enroll Roscoe in the study, all of the tests and exams are free. In addition, because Spritzer realises how important you and Roscoe are to their evaluation of this new drug, they will reimburse you for your time and travel costs. And, if Roscoe receives the study drug and does well, it’s likely that he’ll feel much better. It’s a win-win for everyone.”
“What do you mean ‘if Roscoe receives the study drug’? I thought that, if he participates, he gets the experimental drug.”
“Not quite, Tilly. This is a placebo-controlled study. That means that Roscoe has a one-in-two chance of receiving the study drug. Each new study subject like Roscoe is randomly assigned to either the study drug or the placebo.”
“You know Roscoe has pain. Why can’t you just assign him to the study drug and see if it works?”
“I wish I could do that for all participants, Tilly, but then I wouldn’t be following the study protocol. Most studies are designed with what are called ‘active’ and ‘control’ or placebo compounds to eliminate bias and other extraneous factors. You needn’t worry, though. If Roscoe is not noticeably better in a week or so, I’ll take him off the study and treat him with another pain medicine so that he’s more comfortable.”
Why are they arguing so much over which food to give me? Food is food. Bring it on! I can’t romance a Poodle on an empty stomach.
“I see. Well, that makes me feel a little better. Roscoe, what do you think about all this?” Tilly asked.
Sounds good to me. When do I eat? And when do I get to meet a Poodle?
Roscoe looked up at Tilly with love. Tilly knew what she had to do.
“I’m going to give it a go. We’ve got our paws crossed that he gets the study drug but, if not, at least he’ll get something to ease his pain. Where do I sign?”
Dr Spenser handed Tilly a consent form and asked her to read it carefully before signing it.
Tilly looked over the top of her glasses and asked, “What’s a necropsy?”
“In the unlikely event that Roscoe died while he was still in the study, Spritzer would like to know why. A necropsy is the veterinary version of an autopsy. You would have to give permission for the necropsy to be performed. It would be solely your decision. However, you do not have to tell me now.”
Tilly took off her glasses and reached down to pet Roscoe. His head was resting on her feet. “If you think Roscoe is going to die while in this study, I don’t want any part of it. I will not allow you to experiment on him!” she exclaimed.
“I know how you feel, Tilly,” Dr Spenser said in a soft voice. “I would never suggest that you even think about this study if I would not enroll my own Lucy in it.”
Lucy? Is Lucy here? She’s one of my favorite friends. She’s not a Poodle, but she is very pretty. Maybe we can go outside and play with that Kong toy, but only if they fill it with peanut butter. I love peanut butter. Then, we can take a nap in the shade.
“Explain to me how you will protect Roscoe and keep him safe. I will not do anything that will harm him. He’s all I’ve got left,” Tilly said, her voice trembling.
Dr Spenser reached for the tissue box and put it down next to Tilly. “I’ll show you the data from studies Spritzer did before they approached me for this trial. This table shows the safety data. There were very few side-effects, and all of them were mild … or what I consider to be mild. See? There were two cases of increased lethargy, but that could have been due to many things. Maybe it was a hot day. Or maybe the dog had been playing hard.”
“Or maybe it was the study drug?”
Tilly asked. “Yes, that always is a possibility. But I will evaluate every symptom you observe to make sure Roscoe is not being harmed. I promise you that, Tilly,” Dr Spenser said. Tilly reached for Roscoe, rubbed his ears, and said softly, “What do you think, big boy? Are you willing to take a chance? Because if you are, so am I. But I’m going to watch you like a hawk!”
A hawk? Do I have to start looking for hawks again? We haven’t seen hawks since the people next door ate all those chickens in their yard. I always wanted to go over there and play with those chickens. They looked so cute when they ran away from me. I only barked a few times.
“Let’s see,” said Dr Spenser. “We’ve reviewed the purpose of the study and how it might help Roscoe feel more comfortable. If the study drug doesn’t help him, I’ll take him out of the study and treat him with something else. Each time you come in for a study visit, you will receive reimbursement for your time and travel costs. I can give you cash, or I can give you a clinic credit toward future services. Which would you prefer?”
“How nice! But if you give me cash, I’ll spend it before I get home. So, if you don’t mind, just give me the credits,” said Tilly.
“That’s fine,” said Dr Spenser. “Sarah will keep track of them in your account records.”
Just then, Sarah knocked on the door and came in. Roscoe wagged his tail. Dr Spenser explained that Tilly had signed the consent form and was ready to start the study. Dr Spenser completed the exams and collected the blood sample. Sarah gave Roscoe his first dose of study drug without a problem. “You must have liked that,” observed Tilly, as she rubbed his ears. “Did you think it was a new kind of cookie?”
I love cookies, and this one was yummy. I wonder what I have to do to get another. Maybe Mama put them in the pocket of her coat. I’ll check when she’s not looking.
Sarah gave Tilly instructions for giving Roscoe the study drug and a diary to record when she gave it, as well as any observations or comments. Tilly thanked both Sarah and Dr Spenser before she and Roscoe left the clinic.
After a few days of receiving study drug, Tilly noticed that Roscoe seemed to be more energetic. He definitely was more alert, barking at squirrels, and he actually tugged on his leash during their walks.
At their first follow-up visit, Tilly reported on Roscoe’s improved condition. Dr Spenser looked pleased and gave Roscoe a cookie.
I must be doing something right because I keep getting cookies. I wonder what I have to do to get another one.
By the end of the study, both Roscoe and Tilly had an extra zip in their step. Dr Spenser told Tilly that Roscoe had indeed received the study drug.
“I just knew it,” exclaimed Tilly. “Thank you so much!”
“Thank Spritzer for developing it,” Dr Spenser countered. “I understand that the trial went very well at all ten clinics and that the drug could hit the market in another year or so. In the meantime, if Roscoe seems uncomfortable, I will find another way to treat him so that he can continue to enjoy life and play with Lucy and his other friends.”
That Lucy … she’s a lot of fun to play with. But I’d still like to meet a Poodle.
As Roscoe pulled Tilly out to her car, Dr Spenser and Sarah smiled at each other. “What a great pair those two make,” sighed Sarah. Dr Spenser agreed and added, “Sights like that make all of the trial work worthwhile. I can’t wait for that new drug to get approved so we can help our other lame dogs.”
And that is the heart of the matter!