Updated: Sep 12, 2018
Clinical Trials: A Patient Perspective
Interview by Sam Bott
You’re a patient, you’re not feeling well, you know something isn’t right…you have some procedures, some lab work and there you are…your Dr. tells you that you have an illness, an illness that requires special treatment. Your Dr. says, “you’ll feel better, and as your Dr., I will work with a team of industry experts to get you what you need.” That is a lot to take in!
Vivaleas had the opportunity to spend some time with a patient diagnosed with Hypoparathyroidism. Our patient is a 58 year old male. From OTC Tums, to a minor surgery to enrollment into clinical studies and prescription medications we learned the when, where, how, why behind their journey and the experiences that come with exploring the vast world of specialty through a patients’ eyes.
Q: What was your first thought when you found out that you had Hypoparathyroidism?
A: Well at first, as for the condition itself, it’s really not talked about much. Talk to any normal doctor, and they won’t know what hypoparathyroidism is so you have to tell them. The parathyroid hormone, which is what I’m short on, is what converts the precursor to vitamin d…vitamin e?...vitamin d, which allows your gut to absorb the calcium, so if you don’t have the vitamin d, you can’t get the calcium.
Q: How did you learn about Hypoparathyroidism?
A: The World Wide Web. It’s a magical thing. There’s one man, James Sanders, I believe from Idaho who’s battled this for most of his life. He was one of the first ones to be treated.
Q: How did you manage the condition?
A: When I was first trying to find ways to manage with hypoparathyroidism, they told me that I may feel tingly in my tongue and lips and to just take a Tums. If you have low calcium, you expect to have high parathyroid hormone and vice-versa. So then that started the weekly, every two week trips to the doctor and taking Tums. So we were throwing 1g of calcium carbonate, that did nothing. 2g, 3g, 4g, 5g, then at 6g he said that I should really go see an endocrinologist. The one thing that he did do was get me on calcitriol. That’s the pre-curser to vitamin D, and it seemed to work better than the Tums, but my insurance kept telling me to get OTC vitamin D, and I kept explaining to them that it’s not the same.
Q: Were you offered option to enroll in a clinical trial? How did that come about?
A: Back to the WWW at www.hypoparathyroidism.com. When James Sanders was treated in the clinical trial, he said it was the first time he ever knew that anyone else was like him.
Q: Who helped you enroll in the trial?
A: I was put in connection with a research nurse in Cincinnati and what I needed to send and where I needed to send it. She was my travel agent. I probably wouldn’t have continued with the trial had they not handled it the way that they did.
Q: Could you describe your experience during the clinical trial? What worked? What didn’t work?
A: Well, for me it was all about the travel, and that was my choice. On a yearly basis, it was basically my decision to continue with the trial, or bail. I never dealt with anyone from the Manufacturer, but just the doctor and the research nurses. When I first started the study and injected the drug, I had to go to track when I took my calcium, and it was connected to your phone and every night, it would ‘phone home’ and deliver data on what you did. I was apart of another study, a quality of life study. It was the depression and the brain fog that were the biggest complaints. And they talk about the quality of life and how it just keeps going down the longer it goes…it’s better on Natpara, not gone away, but better.
Q: How was the transition from clinical trial to the ‘real-world’?
A: The only thing from going to the clinical trial to the pharmacy is that it’s so up in the air on dates. I had no idea when I would be switching over from the trial to the pharmacy. The drug was already available, but the pharmaceutical company…you would probably know more about this… they’re the only ones that put it out and then it goes through the pharmacy and then it goes to you. You know, it has the black-box warning on it for osteosarcoma, so I’m sure there’s more hassle with that. And I use OnePath which is my go-between between Shire, CVS, and Aetna, and I have a lady that helps me out. For some people, they’re right on the edge of running out of drug, and if there is a shipping or insurance problem it can mean that they’re out of drug, and they can end up in the ER because of it.
Q: Were you concerned about insurance coverage for Natpara?
A: Yes, I’m concerned about insurance coverage, but it has not been an issue so far. They have stood up tall.
Q: Had you been offered any financial support; through a copay program or other? Could you talk a little about that experience?
A: I don’t pay anything. They said that the people in the clinical trial would get free drug for the rest of their lives…provided that their insurance company would cover it. They didn’t say that explicitly, but that’s how I read it.
Q: What have been some of the highs’ and lows’ since being diagnosed?
A: Well, the biggest low is to know that I went from hyperparathyroidism, which yes it has its issues to hypoparathyroidism, which is even worse. There’s a whole lot more to it. They refer to hyperparathyroidism as “Moans, Bones, Groans, and Stones”. Groans because your bones hurt, and your long bones particularly are the ones that hurt the most. Your bones went from hurting to just aching with hypoparathyroidism. You have no energy. You have brain fog, where you really can’t think, and can’t put a thought together. The biggest high is knowing that you’re not alone, knowing that there are others that are going through the same thing. I’m one of the lucky ones, you know, if you can call it that. Others have it much worse than me and for some, the drug doesn’t work very well. And finding the clinical trial, and staying on it. You know that feeling, you’re doing it for yourself, but you’re also doing it for the scientific advancement. It just makes you feel good. And the people that run the clinical trial. You get to treat them like your family, and they know all about you and you know all about them.
Q: What are your hopes for the future of treatment of Hypoparathyroidism?
A: I would love to see the same way I have a glucometer, a calcium meter. That would be the best thing in the world. You know I see this stuff for diabetes, and the only reason I don’t have this for hypoparathyroidism is there aren’t that many of us. You know, if we had the patients and advocacy that they have, it would be a whole different ballgame.
As Specialty Pharmacies, Manufacturers, and Providers make innovations in technology, channel logistics, and tightened networks, it is imperative to keep the most important concept in mind…the patient’s view point. Hearing the patient’s path from diagnosis to present day, including both the highs and lows, has given us valuable insights into what the patient is feeling through the whole process. With these insights, we take home three important points from the interview:
Patients want to know that they are not alone. Show them that they have a support system.
Being innovative with technology is great, but be certain that it is making your patients’ lives simpler.
Transparency can be the difference between a patient being treated and the patient feeling as though they are a part of their own care team.
A special thanks goes to our blinded Patient who took the time to provide us with these valuable insights; from a patients’ perspective.