March 20, 2018
The members of the PMCQ celebrated the first day of spring by discussing how new growth is happening in Pharma’s own backyard, especially in immuno-oncology (IO), the new and exciting field of cancer therapy that is going to help us conquer cancer. We learned about how IO works and how we as an industry can better serve patients and medical oncologists.
Zeshan Farooqui, a PMCQ Director and Senior Clinical Site Manager at Bristol-Myers Squibb, opened the meeting by covering a few points of business:
Christine Kor, a PMCQ Director and Clinical Site Manager at Bristol-Myers Squibb, then introduced each speaker:
What is IO? Dr. Wendy Hauck
The immune system is unique in each individual and changes with time, making it hard to predict how the body will react to an immune threat.
Immunity is a balance; some cells are pro-inflammatory and some are anti-inflammatory (meaning some turn the system “on” and some turn it “off”). There are two types of immune responses: 1) adaptive response, which consists of the cells that travel around the body and find foreign invaders, signalling them for destruction; 2) innate response, which consists of the cells that then destroy the foreign invader. Normally, what the immune system does is that it has some immune cells (e.g., antigen presenting cells) that float around the body. They identify and flag foreign agents so that the other cells (i.e. T cells, NK cells, macrophages etc) can come and destroy these foreign agents.
Normally the immune system destroys tumour cells, but that isn’t the case in patients who develop cancer. Some tumours turn on the immune system “brakes”, which means the tumour is not being recognized or destroyed. In order to irradiate the tumours, the IO treatments available work either by taking off that “brake”, while others work by “adding gas”, resulting in increases in the signalling ability of the adaptive response cells. The main thing to remember is that cancer immunotherapy is treating the immune system so that it can treat the cancer by boosting what the immune system does naturally.
Because of IO, more cancer patients are surviving longer, but there is a catch: not all patients respond. It depends on the status of the immune system. Not all immune systems recognize tumours. This is now the focus of current research.
How IO has changed oncology Dr. Wilson Miller
To understand the promise of IO, look back to how it changed the treatment of melanoma. Melanoma is a deadly disease that used to kill 50% of patients after six months, even with chemotherapy. Then a new drug came along. It didn’t benefit all patients, but 30-40% had good long-term overall survival, even 10 years later.
Melanoma is now the poster child for IO because these agents work the best in this disease. We have moved to combinations of IO agents, which could result in 50% of patients with metastatic disease surviving a long time, maybe even curing them. This is a statistically significant improvement over chemotherapy. There is a lot of research striving for improved responses in other tumour types similar to what we are seeing in melanoma. There is a lot of research to combine different IO agents to make cancers more immunologically active. Some of these cancers start off “immunologically dead” but we can manipulate them with other IO agents to make these tumours more immunologically active. The downside of IO is its toxicity, particularly auto-immune toxicity. Nonetheless, IO is making its way into other cancers, such as GI, lung, renal, and bladder cancer.
What does that mean for our country? The prices of IO drugs are steep. Something needs to be done about the rising cost now that IO has moved beyond melanoma (which has a fairly small patient population). Every year we hear about novel pricing ideas such as paying for performance. Maybe we should consider paying for the patients that respond to therapy and not charge for patients that fail after two cycles. People agree that this is a good idea but nothing ever happens. No cancer drug is priced that way. That’s one thing we need from industry. We need to find a way to make pricing more rational.
What are things that the industry can do to help medical oncologists?
Interview with Natalie Richardson Moderated by Josée Pelletier
Question: How did you learn about IO?
Answer: My cancer diagnosis came out of the blue and was a complete shock, so I didn’t know anything about it before. You just try to learn everything you can. I had a great medical team. A clinical trial was the only option I had and I am grateful every day to be part of that clinical trial.
Q: How was the experience navigating through the healthcare system
A: It’s bewildering to be diagnosed in the first place. Then, you have to learn a lot of different things. It was overwhelming and confusing. Not all patients have a good medical team like mine. A lot of information can be lost/forgotten because of trauma. It is important to ask a lot of questions.
Q: Did you connect with any patient groups to get information?
A: I asked my medical team a lot of questions. I was referred to a patient group, but it wasn’t the right time for me to connect as a patient. Some patients want to connect right away with others in a patient group, some want to connect later, while some want to keep their situation private. I found the Save Your Skin Foundation by chance and received the support and information that I needed at the time. Then I began volunteering for them by blogging for them.
Q: What kind of support can industry offer to better support patients?
A: As a patient, I would have liked to have had the opportunity to connect with the company that manufactured the treatment I was receiving. I received a consent form about 17 pages long and this document was thoroughly explained to me on the clinical study I would be a part of. I understand that you have to provide that paperwork but I would have liked more personalized information from the manufacturer. My oncologist, nurse, coordinator explained to me the options I had, which included clinical trials. I had questions about the study I was participating in, and my research team was helpful, but it would have been nice to have been able to ask the manufacturer some questions. I was given a medic-alert bracelet and alert card which came in handy when I went to the emergency room to notify healthcare professionals that I was part of a clinical trial. I wanted to call the phone number listed on the alert card, which was the manufacturer, but understood this was only for my healthcare professional. An online presence by the manufacturer such as through social media and website would be helpful—either to connect patients receiving the treatment to each other in that clinical trial, or to connect with the manufacturer directly. An informative clinical trial brochure or card that was accompanied with the consent form would be helpful. A lot of patients don’t know anything about clinical trials and there is a lot of negative perception about Pharma, unfortunately. Since patients don’t understand clinical trials, patient are reluctant or afraid to be part of clinical trials so anything you can do to communicate with patients directly might be helpful.
Q: Is there any specific kind of information you are seeking from the manufacturer to better serve you as a patient?
A: Information about side effects. I was educated about side effects during the consenting process of my clinical trial but would have liked to have more information about side effects while I was in my clinical trial. I would have liked to be able to talk to someone like a nurse or someone at the manufacturer that was an expert with my treatment to know if I was experiencing something and learn what to expect and how to handle it. My oncologist was very supportive but they did not have that kind of specific help from the centre where I was treated, and I did not live close to the centre anyway. I would have appreciated to have more information and background on how to manage my side effects in my clinical trial.
Q: In terms of the informed consent process in clinical trials, do you have recommendations for how to improve it based on your experience?
A: It was a painful process but I appreciate being well informed. When the idea of entering a clinical trial was first introduced to me, it was a high-level overview by my medical team and I had to make a personal leap to trust my medical team. Then, when I spoke to the research associate, the woman literally read every single word on the page of the consent form, which is probably the normal process, but it’s anxiety-inducing for me and my family. It was a long process—probably half an hour. It would have been good to get a summarized version which would have improved my comprehension of the form. There could have been more lay-person language in the form. Being able to call someone at the manufacturer if you have questions when you’re 6 months into the trial and you forget what you were told during the consent process would be helpful. Having a card from the manufacturer with a phone number I could call with my questions would be so helpful.
Q: Regarding the consent process, would you have preferred a video format instead of a paper form?
A: Yes, that’s a very good idea. Provide it in different languages for those whose first language is not English.
Q: When you had side effects during the study, what support and resources helped you get through them?
A: It was just the motivation from knowing that if I stopped the trial then I wouldn’t get the treatment or the great support I was getting from my healthcare team.
Q: Current regulations and policies prevent Pharma companies from communicating directly with patients. As a patient advocate, what do you see that we can do to change policy in this area?
A: Advocates can help by being honest and open with our own experiences and hope that others can learn from them
Q: What advice would you give someone who is overwhelmed with all of the information they need to consider when choosing a trial?
A: I would tell a patient to keep asking questions and get a second or third opinion, if necessary if you don’t understand. Email your healthcare team and other teams your questions. So many patients don’t ask questions and go through the process blindly. Connect with other patients on the internet.
Tuesday, December 15, 2020
GENDER DISPARITY IN CLINICAL HEALTH RESEARCH
Time: 12:00 p.m. - 1:00 p.m.
Tel: (514) 486-3458
Fax: (514) 486-4794
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