Medical Hero Story: Rev. Donna J. Matlach & Eosinophilic Asthma

“My sister Roseanne and and I love the movie, ‘The Wizard of Oz’. I told Roseanne I felt like I was going to see the Wizard. There was so much that happened before I got to see her, just like a lot happened to Dorothy in the movie, recounts Reverend Donna J. Matlach, about meeting Dr. Sally Wenzel of the University of Pittsburg Medical Center to consult about Donna’s severe eosinophilic asthma. My granddaughter, Phoebe, even said ‘Nana is going to see the wizard!’” Donna’s medical journey has been arduous and at times, terrifying, (Donna has had severe eosinophilic asthma for more than a decade) but her upbeat nature shines through during our conversation about her experience with clinical research participation.

“It can’t be controlled with the typical medications that are used with other types of asthma. It’s another level of asthma – it goes up in levels. Mine is severe, which is the highest level. It took many years to figure out why it couldn’t be controlled,” explains Donna. “I was in and out of the hospital, 3 to 4 times a year, and in the doctor’s office 3 to 4 times per month. I was on mass quantities of corticosteroids taken orally and by inhalation.” The steroids impacted her overall health, including weight gain and brittle bones leading to several fractures.

The severity of her symptoms sapped Donna of her physical strength, but not her inner fortitude. Taking matters decidedly into her own hands, Donna went on a cross-country journey in order to find medical advice and effective treatment. Conducting a lot of research on her own, Donna visited 28 doctors, the majority being pulmonary specialists, in 12 hospitals, nationwide. In a frustrating turn of events, they all provided different diagnoses and advice. To make matters worse, the nebulizer and cortiscosteroid medications Donna was taking were not adequately controlling her illness.

“My asthma was so misdiagnosed that at one point, doctors from a major medical facility told me I should see a psychiatrist. I was on a nebulizer every hour to stop the coughing and wheezing,” says Donna. “I’ve had over 600 allergy tests. I’m not allergic to anything.” Donna continued on her quest for relief from her symptoms. Donna consulted with a physician in Colorado who recommended she meet with Dr. Wenzel.

“Dr. Wenzel is the guru. She founded the University of Pittsburgh Asthma Institute,” says Donna.

During one of her many visits to Pittsburghwith Dr Wenzel, Donna had video assisted thoracic surgery to take biopsies and view her lungs with a camera. “I woke up with a tube in my chest to prevent my lungs from collapsing. The pain was so bad I ended up having a full-blown asthma attack, even with the pain medication pump. I’ve had a lot of surgeries in my life, including two C-Sections, and this was the worst!” says Donna.

Donna has had two 6-hour surgeries on her sinuses in the past several years. Both times, her sinuses were evaluated to be 98% blocked. “I had no taste or smell for 3 years because the sinuses and asthma were impacting each other. Everything is connected,” says Donna. When Donna arrived for the first surgery, she was told her lungs were too weak to undergo the procedure. Dr. Wenzel was concerned she would not survive the anesthesia. When Donna was able to have the first sinus surgery, several months later, Dr. Wenzel advised Donna that the positive results she was experiencing would last about three years.

“Wouldn’t you know it, it was just about 3 years to the month and I needed to have another surgery. Dr. Wenzel was right – that’s why I call her The Wizard,” says Donna. The second sinus surgery removed a bone from the left and right side of Donna’s frontal sinuses.

Dr. Wenzel advised Donna to investigate participating in clinical research to find other ways to manage her asthma. Dr. Wenzel assisted her with this process, but Donna was told she was not sick enough to participate in the first clinical trial to which she applied. This was perplexing to Donna because, she recounts that “I have been catching pneumonia twice year!”.

Dr. Wenzel located another clinical trial and Donna qualified as a participant. The clinical trial site was in California.

“I flew from my home in Arizona to California, once a month, at my own cost, for three years. I ended up being a poster child for the sponsoring company. I now speak at lectures for them about my experience, in New York City and other places,” says Donna.

The medication she received in the clinical trial in California was not immediately effective. “It took about 6 months to get into your system. At first it was an IV medication, and then it became an injectable,” says Donna. “My asthma is like a firecracker. It will either fizzle out or it will explode.” A couple of years later, that treatment stopped working.

During this time, Donna’s health was also being monitored in her then-home-state of Arizona. “I was at the Mayo Clinic in Scottsdale, waiting for a lung function test, and while I was there, I had a severe asthma attack. It came out of the clear blue sky. I ended up in the ER. God put me in a place where I could be helped and I wasn’t alone. I’ve had three near fatal episodes because of the asthma,” Donna recalls.

After the clinical trial that Donna participated in, Dr. Wenzel prescribed a biologic that had recently come to market. “It took 4 months for it to start working and I took it for a year. But I was still back and forth with ER visits that always turned into a hospital stay, unfortunately,” says Donna.

During her hospital stays, Donna continued to work on her studies towards her Masters of Divinity. Even though she was very ill, Donna says that “God told me… You’re not done.” She subsequently studied several more years and received her Doctorate in Ministry and Master’s in life coaching.

Dr. Wenzel then prescribed a third biologic medication, which was not part of a clinical trial.

“I go to Pittsburgh twice a year to see Dr. Wenzel and we’ve become close friends. I love her. My heart told me, when I met her, that this was going to be the best doctor I could possibly see,” says Donna, smiling.

Donna’s family was supportive of her decision to join a clinical trial. She looked for patient advocacy organizations for severe asthma, and there were none established at that time. In response, Donna co-founded the Severe Asthma Foundation with Dr. Wenzel and Brenda, another severe asthma patient of Dr Wenzel’s.  Donna served as president until they were subsequently invited to merge with the Allergy and Asthma Network where Donna serves on the Board of Directors as an asthma advocate.

Donna has experienced, first-hand, the serious impacts of severe asthma. “It’s not just physical. It effects your emotional well-being. It effects your family, your day-to-day life, your finances. No one ever asked me about those things, in doctor’s appointments – not until I met Dr. Wenzel,” says Donna.

When asked if she would recommend clinical research participation to others, Donna enthusiastically responds “Absolutely. It can be life saving. Why would you not? You could have side effects, but for me, how could it be any worse, since I was having near fatal episodes? You have to keep searching. Clinical trials can be the answer. Why would you not want to try it? This is why I am a patient advocate. I love sharing information about clinical trials with people. That’s why I went into the ministry. I know God has a purpose for my life to reach out to people with similar physical issues as a friend, minister, and counselor. ”

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Medical Hero Spotlight: Rev. Donna J. Matlach & Eosinophilic Asthma

“My sister Roseanne and and I love the movie, ‘The Wizard of Oz’. I told Roseanne I felt like I was going to see the Wizard. There was so much that happened before I got to see her, just like a lot happened to Dorothy in the movie, recounts Reverend Donna J. Matlach, about meeting Dr. Sally Wenzel of the University of Pittsburg Medical Center to consult about Donna’s severe eosinophilic asthma. My granddaughter, Phoebe, even said ‘Nana is going to see the wizard!'” Donna’s medical journey has been arduous and at times, terrifying, (Donna has had severe eosinophilic asthma for more than a decade) but her upbeat nature shines through during our conversation about her experience with clinical research participation.

“It can’t be controlled with the typical medications that are used with other types of asthma. It’s another level of asthma – it goes up in levels. Mine is severe, which is the highest level. It took many years to figure out why it couldn’t be controlled,” explains Donna. “I was in and out of the hospital, 3 to 4 times a year, and in the doctor’s office 3 to 4 times per month. I was on mass quantities of corticosteroids taken orally and by inhalation.” The steroids impacted her overall health, including weight gain and brittle bones leading to several fractures.

The severity of her symptoms sapped Donna of her physical strength, but not her inner fortitude. Taking matters decidedly into her own hands, Donna went on a cross-country journey in order to find medical advice and effective treatment. Conducting a lot of research on her own, Donna visited 28 doctors, the majority being pulmonary specialists, in 12 hospitals, nationwide. In a frustrating turn of events, they all provided different diagnoses and advice. To make matters worse, the nebulizer and cortiscosteroid medications Donna was taking were not adequately controlling her illness.

“My asthma was so misdiagnosed that at one point, doctors from a major medical facility told me I should see a psychiatrist. I was on a nebulizer every hour to stop the coughing and wheezing,” says Donna. “I’ve had over 600 allergy tests. I’m not allergic to anything.” Donna continued on her quest for relief from her symptoms. Donna consulted with a physician in Colorado who recommended she meet with Dr. Wenzel.

“Dr. Wenzel is the guru. She founded the University of Pittsburgh Asthma Institute,” says Donna.

During one of her many visits to Pittsburghwith Dr Wenzel, Donna had video assisted thoracic surgery to take biopsies and view her lungs with a camera. “I woke up with a tube in my chest to prevent my lungs from collapsing. The pain was so bad I ended up having a full-blown asthma attack, even with the pain medication pump. I’ve had a lot of surgeries in my life, including two C-Sections, and this was the worst!” says Donna.

Donna has had two 6-hour surgeries on her sinuses in the past several years. Both times, her sinuses were evaluated to be 98% blocked. “I had no taste or smell for 3 years because the sinuses and asthma were impacting each other. Everything is connected,” says Donna. When Donna arrived for the first surgery, she was told her lungs were too weak to undergo the procedure. Dr. Wenzel was concerned she would not survive the anesthesia. When Donna was able to have the first sinus surgery, several months later, Dr. Wenzel advised Donna that the positive results she was experiencing would last about three years.

“Wouldn’t you know it, it was just about 3 years to the month and I needed to have another surgery. Dr. Wenzel was right – that’s why I call her The Wizard,” says Donna. The second sinus surgery removed a bone from the left and right side of Donna’s frontal sinuses.

Dr. Wenzel advised Donna to investigate participating in clinical research to find other ways to manage her asthma. Dr. Wenzel assisted her with this process, but Donna was told she was not sick enough to participate in the first clinical trial to which she applied. This was perplexing to Donna because, she recounts that “I have been catching pneumonia twice year!”.

Dr. Wenzel located another clinical trial and Donna qualified as a participant. The clinical trial site was in California.

“I flew from my home in Arizona to California, once a month, at my own cost, for three years. I ended up being a poster child for the sponsoring company. I now speak at lectures for them about my experience, in New York City and other places,” says Donna.

The medication she received in the clinical trial in California was not immediately effective. “It took about 6 months to get into your system. At first it was an IV medication, and then it became an injectable,” says Donna. “My asthma is like a firecracker. It will either fizzle out or it will explode.” A couple of years later, that treatment stopped working.

During this time, Donna’s health was also being monitored in her then-home-state of Arizona. “I was at the Mayo Clinic in Scottsdale, waiting for a lung function test, and while I was there, I had a severe asthma attack. It came out of the clear blue sky. I ended up in the ER. God put me in a place where I could be helped and I wasn’t alone. I’ve had three near fatal episodes because of the asthma,” Donna recalls.

After the clinical trial that Donna participated in, Dr. Wenzel prescribed a biologic that had recently come to market. “It took 4 months for it to start working and I took it for a year. But I was still back and forth with ER visits that always turned into a hospital stay, unfortunately,” says Donna.

During her hospital stays, Donna continued to work on her studies towards her Masters of Divinity. Even though she was very ill, Donna says that “God told me… You’re not done.” She subsequently studied several more years and received her Doctorate in Ministry and Master’s in life coaching.

Dr. Wenzel then prescribed a third biologic medication, which was not part of a clinical trial.

“I go to Pittsburgh twice a year to see Dr. Wenzel and we’ve become close friends. I love her. My heart told me, when I met her, that this was going to be the best doctor I could possibly see,” says Donna, smiling.

Donna’s family was supportive of her decision to join a clinical trial. She looked for patient advocacy organizations for severe asthma, and there were none established at that time. In response, Donna co-founded the Severe Asthma Foundation with Dr. Wenzel and Brenda, another severe asthma patient of Dr Wenzel’s.  Donna served as president until they were subsequently invited to merge with the Allergy and Asthma Network where Donna serves on the Board of Directors as an asthma advocate.

Donna has experienced, first-hand, the serious impacts of severe asthma. “It’s not just physical. It effects your emotional well-being. It effects your family, your day-to-day life, your finances. No one ever asked me about those things, in doctor’s appointments – not until I met Dr. Wenzel,” says Donna.

When asked if she would recommend clinical research participation to others, Donna enthusiastically responds “Absolutely. It can be life saving. Why would you not? You could have side effects, but for me, how could it be any worse, since I was having near fatal episodes? You have to keep searching. Clinical trials can be the answer. Why would you not want to try it? This is why I am a patient advocate. I love sharing information about clinical trials with people. That’s why I went into the ministry. I know God has a purpose for my life to reach out to people with similar physical issues as a friend, minister, and counselor. ”

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

 

Medical Hero Story: Desiree De Luca-Johnson & Breast Cancer

“I am a lawyer, my husband is a pathologist, and I had no idea that there were hospitals that just treated cancer,” says Desiree De Luca-Johnson, an attorney, breast cancer survivor and patient advocate. At the age of 40, just when she was ready to go back to work after staying home with her young children, Desiree was diagnosed with breast cancer. Desiree’s road to being a clinical trial participant is reflective of her legal training. “I made a plan. I had a white board. I decided that if ‘A’ happens, then we would move on to ‘B’. I’m passionate about clinical trials.”

Desiree was diagnosed while living in a military community in Virginia, and her husband was deployed. “I was exhausted, and literally crawling upstairs to put my kids to bed,” Desiree recalls. Her oncologist at the time was a military physician and the treatment plan recommended for Desiree was conservative in nature. She was not told about clinical research as a healthcare option.

“I got 200 pages of where I could get free makeup and wigs, and not one page on clinical trials,” says Desiree. “I discovered that oncologists have different attitudes about treating cancer and I wish someone had told me about this. My oncologist was not aggressive about different treatment options.” Desiree recalls she was willing to deal with a higher level of side effects when her doctor told her she had an 80%/20% chance of survival.

“I was suicidal because of the anxiety. I found out (in addition to the breast cancer), I had a benign brain tumor,” says Desiree.

When she posed a question about clinical trials, Desiree’s doctor told her she was not sick enough to be in a clinical trial.

Desiree’s background as an attorney had honed her research and investigative skills. She decided to take definitive action.

“I made lists of cancer hospitals. I investigated their websites. I learned about ClinicalTrials.gov, which is a hard website to navigate. My husband was opposed to me doing a clinical trial, so I was doing this research all alone. But it was keeping me alive,” says Desiree. (Desiree’s husband ultimately embraced her decision to participate in clinical trials). “After 40 or 50 hours of work, I found BreastCancerTrials.org, where I found 6 clinical trials I might be eligible for. We have a saying in the law. When you’re repeating your results, you have done your research. I was ready to apply to clinical trials,” says Desiree.

Her oncologist in Virginia was not supportive of Desiree’s decision, and voiced a level of concern about clinical trial participation. Undeterred, Desiree pursued clinical research options and other avenues for her health and wellness.

“The most important thing about choosing to enroll in a clinical trial, for me, were childcare and the affiliated travel costs,” says Desiree. “I became my own doctor, in a sense. I read that doing yoga was good when you have cancer, so I did yoga. I read that exercise was good, so I hired a health coach,” says Desiree.

And, she participated in clinical trials. “I did an early-stage trial,” says Desiree. “The big barrier, again, was childcare. The navy has a program so my husband didn’t have to deploy during my treatment, so he could take care of our children.”

Desiree’s sister, who lives in Boston, recommended looking at Massachusetts General Hospital for relevant clinical trials to join. Desiree enrolled in a one-year treatment clinical trial. At the end of this clinical study, it was deemed a negative trial, meaning that the results demonstrated that the new treatment was inferior to standard treatment. (1) Overall, the experience was still a positive one for Desiree.

“I felt safer in a clinical trial because I had a better relationship with my research oncologist and oncology nurse in Boston. We were all up to date on the same research,” says Desiree. “I was grateful to be at a top research hospital. I was able to feel safe for a year – it gave me some time to breathe and research my options.”

“Through my clinical trial participation, I got access to other treatments for other conditions, such as bone density, and I was able to access other clinical trials,” says Desiree. Her research oncologist became her primary oncologist.

“Now I am in a trial to monitor for re-occurrence and I can make an action plan for quality of life,” says Desiree.

“Before participating in clinical research, every single day my first thought was, how will I know if my cancer has returned? Now I wake up and feel free,” says Desiree.

Desiree and her children have relocated to her home state of Vermont, in order to be closer to Massachusetts General Hospital, the clinical trial and family. “The relationships really matter,” says Desiree.

Desirae’s clinical research journey has brought her full circle, professionally. She currently works full-time at BreastCancerTrials.org as Outreach and Operations Manager.

Desiree advises people considering clinical research that, “When it comes to your oncologist, it’s a fiduciary relationship. It was my job to know the consequences of the decisions I was making to help them reach their goals. You have to be your own best advocate. No one is going to care as much about your life as you do.”

To search for medical conditions in a specific location visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Sources:

  1. https://www.rxlist.com/negative_clinical_trial/definition.htm)

Medical Hero Story: Phyllis Kaplan & Type 1 Diabetes

Phyllis has a vague recollection of waking up in a hospital with tubes attached to her body, and a distinct memory of saying “Take the tubes out!”. At the age of two, she was diagnosed with type 1 diabetes, an autoimmune disease, typically diagnosed in childhood, but can manifest at any age. Diabetes has led Phyllis on a path from patient to advocate, to clinical research participant.

“I have been an advocate since I was 12 years old. It started in junior high school, in a gym class when the teacher made me take off my medical alert bracelet, due to a ‘no jewelry in gym class’ rule,” says Phyllis. When she went to retrieve the medical bracelet from the gym locker after class, she discovered it had been stolen. This incident spurred Phyllis to write a letter to the town Superintendent of Schools, demanding its replacement and a change in the rule to allow medical-related items to be worn. By the time the letter had been delivered, the bracelet had been anonymously returned to the school’s Lost & Found box. Phyllis was allowed to wear the bracelet moving forward.

The most important thing to understand about type 1 diabetes, says Phyllis, is “The patient or caregiver has to make so many decisions about the disease, every day with no break. With diabetes, every day is different.”

Type 1 diabetes develops quickly. The body’s immune system attacks and destroys beta cells in the pancreas that create insulin. The body cannot produce insulin without these beta cells. A peptide hormone, insulin helps your body metabolize fats, proteins and carbohydrates through glucose (a type of sugar) that is released into the bloodstream when you eat food. The glucose is then absorbed from the blood in the liver, fat and skeletal muscle cells. Type 2 diabetes develops more slowly, over time. The body produces insulin, but cannot use it effectively. (1)

Decisions about how much medication to take is based on many variables including food, exercise, change in weather, change in personal schedule and stress.

“That’s why education is so important,” says Phyllis. “If I am going to exercise, I have to plan ahead, at least a couple of hours before, as exercise impacts blood sugar. There are so many hidden things to know about diabetes that impact your decisions.”

Phyllis has participated in three clinical trials, two for rescue medications for severe hypoglycemia and one for a medical device. “As a longtime advocate, I felt that participating in a clinical trial was the ultimate form of advocacy,” Phyllis explains.

“The trials were very different from each other,” says Phyllis. “Two of the three were very easy. One involved two full days in clinic, and that was really hard, with 9 hours of ongoing blood tests. Those were physically difficult days, but worth it. The other two clinical trials were less invasive.”

When considering the 2-day in-clinic trial, Phyllis and her husband reviewed the protocol together. “I wouldn’t participate without consulting him,” says Phyllis. He accompanied her to the two in-clinic days, to be with her during the 9 hours of ongoing tests and to lend additional support.

When asked if she faced any concerns from family or friends about her clinical research participation, Phyllis says “No, quite the opposite. People were really interested in the ‘why’ of what I was doing and what the outcomes were.” Phyllis didn’t seek any advice from patient advocacy organizations, because of her own experience as an advocate. She is a brand ambassador with Medtronic Diabetes to share her experience with their medical device and  also volunteers with JDRF (Juvenile Diabetes Research Foundation), and ADA (American Diabetes Association)

Phyllis advises individuals considering clinical research participation to “Ask all the questions you have when meeting with the nurse/study lead. No question is too silly. Read the protocol and informed consent, which can be confusing. Use a highlighter to mark items in the protocol or use Post-Its to make notes. Keep asking questions throughout the course of the study. At times the research staff may not always be patient-centric, and if you’re not getting the answers to your questions, ask to speak with someone else on the study team. Be your own best advocate and keep pushing. Researchers are not always prepared to answer patients’ questions. If something doesn’t sit well with you, voice it.”

Phyllis’ advocacy work has also led her to CISCRP, where she is Senior Manager, Events & Community Engagement. CISCRP’s mission to informing and engaging patients and the public about the importance of clinical research resonated with her. Phyllis leads CISCRP’s Aware for All free clinical research educational programs, which have pivoted from in-person, city-specific events to regional, virtual programs with the advent of the pandemic. You can learn more about AWARE for All here.

Her experience as a clinical trial participant has strengthened Phyllis’ commitment in sharing information about the importance of clinical trials to everyone. Phyllis is adamant and passionate about participating in clinical research again if the opportunity presents itself, reiterating, “Absolutely. Without clinical trials new treatments can’t happen and without clinical trial participants, clinical trials can’t happen.”

To search for medical conditions in a specific location visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Sources

Medical Hero Spotlight: Desiree De Luca-Johnson & Breast Cancer

“I am a lawyer, my husband is a pathologist, and I had no idea that there were hospitals that just treated cancer,” says Desiree De Luca-Johnson, an attorney, breast cancer survivor and patient advocate. At the age of 40, just when she was ready to go back to work after staying home with her young children, Desiree was diagnosed with breast cancer. Desiree’s road to being a clinical trial participant is reflective of her legal training. “I made a plan. I had a white board. I decided that if ‘A’ happens, then we would move on to ‘B’. I’m passionate about clinical trials.”

Desiree was diagnosed while living in a military community in Virginia, and her husband was deployed. “I was exhausted, and literally crawling upstairs to put my kids to bed,” Desiree recalls. Her oncologist at the time was a military physician and the treatment plan recommended for Desiree was conservative in nature. She was not told about clinical research as a healthcare option.

“I got 200 pages of where I could get free makeup and wigs, and not one page on clinical trials,” says Desiree. “I discovered that oncologists have different attitudes about treating cancer and I wish someone had told me about this. My oncologist was not aggressive about different treatment options.” Desiree recalls she was willing to deal with a higher level of side effects when her doctor told her she had an 80%/20% chance of survival.

“I was suicidal because of the anxiety. I found out (in addition to the breast cancer), I had a benign brain tumor,” says Desiree.

When she posed a question about clinical trials, Desiree’s doctor told her she was not sick enough to be in a clinical trial.

Desiree’s background as an attorney had honed her research and investigative skills. She decided to take definitive action.

“I made lists of cancer hospitals. I investigated their websites. I learned about ClinicalTrials.gov, which is a hard website to navigate. My husband was opposed to me doing a clinical trial, so I was doing this research all alone. But it was keeping me alive,” says Desiree. (Desiree’s husband ultimately embraced her decision to participate in clinical trials). “After 40 or 50 hours of work, I found BreastCancerTrials.org, where I found 6 clinical trials I might be eligible for. We have a saying in the law. When you’re repeating your results, you have done your research. I was ready to apply to clinical trials,” says Desiree.

Her oncologist in Virginia was not supportive of Desiree’s decision, and voiced a level of concern about clinical trial participation. Undeterred, Desiree pursued clinical research options and other avenues for her health and wellness.

“The most important thing about choosing to enroll in a clinical trial, for me, were childcare and the affiliated travel costs,” says Desiree. “I became my own doctor, in a sense. I read that doing yoga was good when you have cancer, so I did yoga. I read that exercise was good, so I hired a health coach,” says Desiree.

And, she participated in clinical trials. “I did an early-stage trial,” says Desiree. “The big barrier, again, was childcare. The navy has a program so my husband didn’t have to deploy during my treatment, so he could take care of our children.”

Desiree’s sister, who lives in Boston, recommended looking at Massachusetts General Hospital for relevant clinical trials to join. Desiree enrolled in a one-year treatment clinical trial. At the end of this clinical study, it was deemed a negative trial, meaning that the results demonstrated that the new treatment was inferior to standard treatment. (1) Overall, the experience was still a positive one for Desiree.

“I felt safer in a clinical trial because I had a better relationship with my research oncologist and oncology nurse in Boston. We were all up to date on the same research,” says Desiree. “I was grateful to be at a top research hospital. I was able to feel safe for a year – it gave me some time to breathe and research my options.”

“Through my clinical trial participation, I got access to other treatments for other conditions, such as bone density, and I was able to access other clinical trials,” says Desiree. Her research oncologist became her primary oncologist.

“Now I am in a trial to monitor for re-occurrence and I can make an action plan for quality of life,” says Desiree.

“Before participating in clinical research, every single day my first thought was, how will I know if my cancer has returned? Now I wake up and feel free,” says Desiree.

Desiree and her children have relocated to her home state of Vermont, in order to be closer to Massachusetts General Hospital, the clinical trial and family. “The relationships really matter,” says Desiree.

Desirae’s clinical research journey has brought her full circle, professionally. She currently works full-time at BreastCancerTrials.org as Outreach and Operations Manager.

Desiree advises people considering clinical research that, “When it comes to your oncologist, it’s a fiduciary relationship. It was my job to know the consequences of the decisions I was making to help them reach their goals. You have to be your own best advocate. No one is going to care as much about your life as you do.”

To search for medical conditions in a specific location visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Sources:

  1. https://www.rxlist.com/negative_clinical_trial/definition.htm)

Out of the Dark: A Journey Through Postpartum Depression, Part 2

Authored by Melissa E. Daley, Communications & Marketing Manager, CISCRP

& Emma Kane, Senior Clinical Research Coordinator, Clinical Operations & Development, Sage Therapeutics

NOTE: CISCRP hosted a 2-part webinar series on postpartum depression (PPD), in collaboration with Sage Therapeutics, Inc. This is Part 2 of a 2-part article series, providing an overview of the second webinar, which focused on PPD, clinical research, and shared perspectives from a PPD survivor/patient ambassador, medical professionals, and a patient advocate. You can access Part 1 of this article series here (link to be created).

“The best-planned life can turn as quickly as a rainstorm on a summer’s day,” shares Chelsie, a PPD (postpartum depression) awareness ambassador and moreover, a survivor. Married to her high school sweetheart, she had accomplished many goals on her way to starting her family: she loved her job as an elementary school teacher, had purchased a home and was financially stable. “Everything fell into place according to plan. Teaching students was my passion, but motherhood was my calling,” explains Chelsie. Three years into their marriage, she and her husband were delighted to learn that Chelsie was expecting. Her pregnancy was typical until her 36th week, when she was diagnosed with pre-eclampsia and put on bedrest until her delivery.

Chelsie gave birth during a storm, “…amid tornado sirens and pounding rain,” she recalls. “Even more miraculous, the sun broke through and created a glorious rainbow just minutes after our son Weston was born.”

But almost immediately, Chelsie felt that something was wrong.

She did not feel an instant connection to Weston and she realized her maternal instinct was not taking over. Instead, Chelsie’s mind was swirling with questions about her baby’s welfare, as well as her own. Her anxiety escalated when her first attempts to nurse Weston were unsuccessful.

Chelsie did not know it yet, but she was beginning her journey with PPD.

A few days later Chelsie returned home with Weston. “I was physically weak and emotionally drained.” Everyday tasks were overwhelming. She was nervous, and her baby could feel her tension. “I was wracked with anxiety. I didn’t feel like I could even hold him,” says Chelsie.

A week after returning home, Chelsie was rushed to the emergency room with a racing heart and unresolved pre-eclampsia. Recognizing that Chelsie needed sleep, her OB/GYN prescribed a sleeping pill. Chelsie and her mother hoped rest would help. Still, she felt that her mind would not rest. “The next night would prove to be the start of the worst time of my entire life. I cried until I couldn’t cry anymore, and what came next was an utter lack of emotion. I knew I wasn’t myself, and I spoke up,” Chelsie shares.

“With my mom, dad, and husband in the living room, I explained I felt no connection to Weston. I felt like a terrible person and mother,” says Chelsie. Her family consoled her as best they could and suggested she speak with a cousin who had suffered with PPD. Her cousin advised Chelsie to call her OB/GYN. Chelsie’s OB/GYN had never treated anyone with PPD, and recommended a psychiatric facility.

“I felt nothing,” Chelsie says, as she left her six-day old son in her mother’s care. After an evaluation at the hospital, she voluntarily checked herself into a psychiatric hospital where she was officially diagnosed with PPD. She was prescribed medications to help with anxiety, depression, and insomnia.

“The longer I stayed (in the hospital), the worse I got,” says Chelsie. She was transferred to a second hospital.

In the span of 30 days, Chelsie had given birth, been diagnosed with PPD and had been a patient in two psychiatric hospitals. But there were glimmers of hope. “Even when PPD broke me down, I was gently reminded of a higher purpose for my life,” recalls Chelsie. Her parents found the right help for Chelsie, and eventually, with an adjustment of medication and the assistance of a mental health professional, Chelsie began to recover.

“I opened up to my doctors and therapists and we built a relationship where I could tell them anything. They helped me find solutions for whatever I was dealing with,” says Chelsie. Her recovery was challenging, but with assistance from her family, she began to focus on the victories she was starting to have as a mother. Returning to teaching scaled Chelsie’s confidence as well. She joined a local PPD support group and met other mothers navigating the same issues.

“Power in community is so precious. The key to my recovery was not a simple one. I needed the right therapy, medication, and family and friends to support me. Recovery takes time. I love my son more than I can put into words. PPD is nothing to be ashamed of or embarrassed about,” says Chelsie.

Chelsie is active in a non-profit organization focused on serving and building community with moms along with providing them with resources for PPD, regardless of their ability to pay.

There is an unmet need in treating PPD. Dr. Bassem Maximos, OB/GYN, explains that “A lot of physicians don’t recognize it (PPD) and even if we do recognize it, it’s difficult to find resources to point our patients to get the treatment they need.”

 Standard-of-care options for the treatment of PPD can be outlined in three categories.

“It takes a long time to find that therapist that you can trust, work with, and open your heart and mind to allow them to help you in your journey,” says Dr. Maximos. “It’s an ongoing treatment,” he adds, “and also sometimes you need other supportive therapies with it.” He also explained that unfortunately, it can be challenging to find a therapist, depending upon the community where you live and the resources that are available. In some regions, there are not many mental health professionals, and the few that are in the area may have so many patients that they are not able to assist new ones.

While it may be challenging to find these groups, Dr. Maximos stresses the importance of supportive psychotherapy and mother-infant therapy groups. “We’ve found in our practice if we get moms to see other moms that have gone through the same experience she’s going through, or have experienced PPD, they are more willing to open up and talk about their experiences – it takes away the fear or stigma.”

Peer support can also be found through groups active on social media when it’s difficult to find professional support. The COVID-19 pandemic has scaled the importance of this channel, with the need for social distancing measures to limit the spread of the virus.

“We’re still not screening our moms enough,” says Dr. Maximos. “The American College of Obstetricians and Gynecologists has been putting a lot of effort into encouraging obstetricians and gynecologists to screen for postpartum depression during the pregnancy and afterwards by giving them screening tools.” But there is still progress to be made.

There are organizations working to escalate access to support mothers suffering with PPD.

Tonya Fulwider, Associate Director for Mental Health America of Ohio and Program Director for POEM (Perinatal Outreach & Encouragement for Moms), says “We work with frontline providers, OB/GYNs, pediatricians and home health professionals. We have a team of certified peer support specialists who work as care navigators. We serve as that single-entry point of care for any birthing person who is struggling with a mental or emotional health complication.” The healthcare provider can reach out to the POEM team and directly connect the patient to receive assistance from a care navigator or peer

support specialist. They can offer a menu of options to address their needs, “…recognizing that she is the expert in her life,” says Tonya.

Sage Therapeutics has conducted multiple clinical trials in PPD over the past several years, and is currently conducting a trial studying an investigational oral tablet to treat PPD. A full listing of clinical trials for women with PPD is available at clinicaltrials.gov.

If you’re considering participating in a clinical trial, Dr. Gus Alva, a psychiatrist focusing on neuropsychiatric conditions with over 27 years of clinical trial experience, advises “Always be informed.” He explains that in his practice, they provide patients with a consent form, a standard clinical trial document which explains the trial in detail and confirms a patient’s willingness to take part in the study, and have them  take it home with them. They encourage patients to discuss it with their primary care doctor or other professionals in the medical field. “The consenting process,” he adds, “entails pros, cons, alternatives, and being well-educated.”

There is a regulated process that takes place in not just PPD clinical research, but in all clinical trials.

“There are several inclusion and exclusion criteria that are tied to all studies,” explains Dr. Alva. Inclusion and exclusion criteria are requirements that must be met in order to take part in the study. “Going in and getting screened would certainly be a good option.” He adds, “the nice thing about being involved in a clinical trial is that it’s not binding. There’s no penalty to withdrawing consent at any point. It’s a matter of trying to figure out whether this is a good fit or not, but not necessarily feeling that you are now bound to it.”

Individuals considering clinical research should consult the medical professionals involved in their care.

Dr. Maximos explains that before signing up for a clinical trial, “patients should speak to their physician, whether it’s their OB or psychiatrist.” Clinical research sites also conduct outreach efforts to community healthcare providers to raise awareness about clinical research participation opportunities.

“Be a question-asker,” advises Tonya Fulwider, saying that the care navigators she works with often encourage patients to write questions down as they come up so they can address them with their health care providers, whether it’s their OB/GYN, mental health professional or someone on the clinical trial team.

COVID-19 has impacted clinical trials across the board. Very strict guidelines have been put in place at all clinical trial sites, such as taking temperature readings, requiring masks, social distancing, and disinfecting of surfaces continually.

“Individuals that do come in know that we’ve placed into play a lot of different modalities to ensure that there is appropriate disinfecting, minimal touching of door handles or other objects, and that if they’re coming in, there’s a very specific purpose,” Dr. Alva explains. “We take every precaution possible to keep patients safe,” Dr. Maximos adds, including that his entire staff is now vaccinated in addition to the other precautions they’ve put into place over the course of the pandemic.

“Of course, COVID-19 has impacted everything about everyone’s lives, and it certainly has impacted mothers,” says Tonya. “Being able to continue to converse with them and talk about their concerns –   that’s really the most important thing.”

To learn more about postpartum depression, access the webinar series, “Postpartum Depression & Being Informed” here. You can also learn more about the Skylark study for PPD here, or access resources from Sage Therapeutics here.

ABOUT SAGE THERAPEUTICS

Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain. We are pursuing new pathways with the goal of improving brain health, and our depression, neurology and neuropsychiatry franchise programs aim to change how brain disorders are thought about and treated. Our mission is to make medicines that matter so people can get better, sooner.

ABOUT CISCRP

CISCRP (Center for Information and Study on Clinical Research Participation) is a Boston-based, globally focused, non-profit 501(c)(3) organization providing public and patient education and advocacy.  CISCRP’s mission is to inform patients and the public about clinical research and the important role that it plays in advancing public health and to help stakeholders in drug development engage with patients and the public as clinical research partners (www.CISCRP.org)

Out of the Dark: A Journey Through Postpartum Depression, Part 1

Authored by Melissa E. Daley, Communications & Marketing Manager, CISCRP

& Emma Kane, Senior Clinical Research Coordinator, Clinical Operations & Development, Sage Therapeutics

NOTE: CISCRP hosted a 2-part webinar series on postpartum depression (PPD), in collaboration with Sage Therapeutics, Inc. This is Part 1 of a 2-part article series, providing an overview of the first webinar, which focused on PPD, and shared perspectives from a PPD survivor, medical professionals, and a patient advocate. You can access Part 2 of this article series here (link to be created).

“I did not want to move. I did not want to breathe. And I did not want anyone to know,” explained Alexis, about her experience with postpartum depression (PPD). PPD is one of the most common medical complications during and after pregnancy[i]. PPD is more severe in scope than the “baby blues” that many mothers experience, which generally occur within the first few days of delivery and resolve without treatment in 2 weeks[ii].

Symptoms of PPD may vary, but can include:

  • Changes in mood, including sadness, emptiness, hopelessness, irritability, persistent doubt, feeling overly anxious and thoughts of suicide
  • Changes in the body including fatigue, difficulty sleeping or sleeping too much, aches and pains, and changes in appetite
  • Changes such as trouble concentrating, remembering details or making decisions
  • Social differences, such as withdrawing from family and friends, and distress or impaired ability to functional in social or work settings[iii]

“Clinically, we basically say that if someone has had an episode of depression during pregnancy or the postpartum year, we’re going to call it postpartum depression,” explains Dr. Constance Guille, Associate Professor, Department of Psychiatry & Behavior Sciences; Director of the Women’s Reproductive & Behavioral Health Program, MUSC. “Postpartum depression and baby blues are two very distinct entities.”

It’s estimated that about 50-80% of woman are affected by the “baby blues” after childbirth[iv].

“The symptoms are not severe, and they do not impact activities of functioning in any way,” explains Dr. Guille about the baby blues.

Alexis had an unexpectedly difficult delivery, but her daughter was healthy. From the outset, she had problems bonding with her baby. “I looked at her like I was holding an alien from another planet,” Alexis recalls. Initially, she blamed it on exhaustion, but it quickly became apparent to her that there was something more serious happening. With the support of her husband and parents, Alexis sought medical assistance. She ended up switching psychiatrists and medications many times, and nothing seemed to be working. Alexis voluntarily admitted herself to a psychiatric hospital where she remained for a month.

“At one point, I was sitting and waiting to see the doctor, when I overheard the social worker telling the counselor that I was faking it,” says Alexis. “I slid even further into the abyss. If they did not believe me, who would?”

After she left the hospital, her depression deepened.

“I struggled with thoughts of not wanting to be alive anymore,” says Alexis.

The stigma around experiencing PPD is real. However, there are healthcare providers who are working to change attitudes and perceptions around postpartum depression and individuals suffering with it. One approach adopted by medical professionals is to routinely ask about a patient’s mental wellness, both before and after delivery.

“You see a patient during her pregnancy about 20 times,” says Dr. Jason James, OBGYN, Private Practice in Miami. “For me to ask how she’s doing, how is she coping, is she feeling down or depressed, is she feeling anxious or guilty, all the kind of non-judgmental questions – if I ask it all the time and get lots of “No’s”, it normalizes the situation.” Routinely checking in with a patient about her mental health can reinforce her comfort level about transparently sharing any changes she may be experiencing.

“The more that people can share their stories, the more that other people can look at that person and say, ‘Oh gosh, I’m just like them!’, the better off we’ll be,” says Dr. Guille.

Providing a robust familial and social support system to postpartum mothers is key to assisting them in their recovery.  “Having a baby is emotionally, psychologically, physically and financially depleting,” says Dr. Guille.  Finding time to relax, getting enough sleep, and ensuring proper nutrition is essential.

Heather Dopp is a patient advocate and Mom Ambassador with 2020 Mom, a national organization with a mission to close gaps in maternal mental health care. She is a mother to two children. Her advocacy work is spurred by her own experience as a survivor of perinatal anxiety, depression, and suicidal ideation during her second pregnancy. Heather’s advocacy has taken her from the halls of the Utah State Capitol to the United States Capitol, with the purpose of improving awareness and increasing resources available to mothers facing maternal mental illness within the United States.

“From a non-clinical point of view, I have an acronym we like to use with maternal mental health. It’s SUNSHINE, and it’s a great way to remember the basic things you can help with for the mother struggling, so she can manage everything she is going through and hopefully try to thrive,” says Heather.

“For many women that I have talked to across the United States, we don’t know about postpartum and perinatal mental disorders in the first place. When it happens to us, we’re already experiencing ‘mom guilt’, and we don’t want to own up to it, because maybe we’re the only ones… we haven’t heard our friends talk about it, and we haven’t heard our providers mention anything about it.” says Heather.

Other patient barriers to discussing symptoms include:

  • Mistrust and fear of being judged
  • Lack of insurance coverage
  • Time constraints
  • Access to childcare during postpartum visits
  • Lack of awareness regarding impact on own health and infant health
  • Lack of information regarding where to seek treatmentv

Alexis changed physicians and treatments many times and took the time to do research and learn everything she could about PPD given there were very few medical professionals specializing in PPD in her location. Eventually, Alexis found a counselor and psychiatrist who supported her. They developed a treatment plan to best address her symptoms and over the next year, she was able to begin the healing process.

“I began to truly laugh and smile again. Life became brighter, more colorful and the darkness began to drift away,” Alexis recounts. Her daughter has no recollection of Alexis’ struggle with PPD, and they are very close.

Alexis says that PPD has taught her five important lessons:

  1. Never give up; postpartum depression doesn’t last forever.
  2. Don’t be embarrassed. Reach out and find a support system.
  3. Self-care is essential and it doesn’t have to cost money. It can be as simple as reading a book or taking a bubble bath.
  4. Do your best not to feel guilty.
  5. Tell your story, when the time is right, because it can help you heal, and also help others.

“I did not give up. I made it out of the darkness. And through the pain, I found a strength and courage that was always there, but needed some prompting to come out,” says Alexis.

To learn more about postpartum depression, access the webinar series, “Postpartum Depression & Being Informed” here. You can also access resources from Sage Therapeutics here and from 2020Mom here. Your healthcare provider should always be your primary source of information about diseases or disorders and treatment options. Please contact your healthcare provider with any questions pertaining to a medical condition.

ABOUT SAGE THERAPEUTICS

Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain. We are pursuing new pathways with the goal of improving brain health, and our depression, neurology and neuropsychiatry franchise programs aim to change how brain disorders are thought about and treated. Our mission is to make medicines that matter so people can get better, sooner.

ABOUT CISCRP

CISCRP (Center for Information and Study on Clinical Research Participation) is a Boston-based, globally focused, non-profit 501(c)(3) organization providing public and patient education and advocacy.  CISCRP’s mission is to inform patients and the public about clinical research and the important role that it plays in advancing public health and to help stakeholders in drug development engage with patients and the public as clinical research partners (www.CISCRP.org)

Sources:

[1] Ko JY et al. MMWR Morb Mortal Wkly Rep. 2017;66(6):153-158.;  Martin JA et al. National Vital Statistics Reports; vol 68 no 13. Hyattsville, MD: National Center for Health Statistics. 2019.;  DeSisto CL et al. Prev Chronic Dis. 2014;11:E10.; Centers for Disease Control and Prevention. Updated June 12, 2018. Accessed May 5, 2021 https://www.cdc.gov/reproductivehealth/maternalinfanthealth/diabetes-during-pregnancy.htm; Centers for Disease Control and Prevention. Updated February 28, 2019. Accessed May 5, 2021 https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pregnancy-complications-data.htm; Roberts JM et al. American College of Obstetricians and Gynecologists Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013;122(5):1122-1131.; Callaghan WM et al. Am J Obstet Gynecol. 2010;202(4):353.e1-e6.

[1] 1. National Institute of Mental Health. Accessed May 5, 2021. https://www.nimh.nih.gov/health/publications/postpartum-depression-facts/index.shtml; American College of Obstetricians and Gynecologists website. Frequently Asked Questions: Postpartum Depression. Accessed May 5, 2021. https://www.acog.org/patient-resources/faqs/labor-delivery-and-postpartum-care/postpartum-depression; Thurgood S et al. Am J Clin Med. 2009;6(2):17-22)

[1] American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arlington, VA: American Psychiatric Association, 2013.; National Institute of Mental Health. Accessed May 5, 2021 https://www.nimh.nih.gov/health/publications/postpartum-depression-facts/index.shtml)

[1] Thurgood S et al. Am J Clin Med. 2009;6(2):17-22)

v Prevatt BS et al. Matern Child Health J. 2018;22(1):120-129.; Byatt N et al. Arch Womens Ment Health. 2013;16:429-432.; Santora K et al. NIHCM Issue Brief. 2010. Accessed May 5, 2021 https://www.nihcm.org/pdf/FINAL_MaternalDepression6-7.pdf; Goodman JH. Birth. 2009;36(1):60-69.

Medical Hero Spotlight: Melvin Mann & Chronic Myelogenous Leukemia (CML)

Melvin Mann with his wife, Cecelia, and their daughter, Dr. Patrice Mann

Written by Melissa Daley

“CML (chronic myelogenous leukemia) is supposed to be a disease that strikes people in their sixties, and I was in my thirties,” recalls Melvin Mann. A family man and Army major, Melvin was stunned to learn he had CML at the age of 37.

His symptoms had started out as back pain and fatigue, which he had been treating with medication and physical therapy, to no avail. In a visit with his physician at a local military clinic, an MRI was ordered requiring Melvin to drive several hours to another military base that had the MRI equipment. It would be a month before Melvin learned the results of the full-body scan.

It was January of 1995. Melvin received the diagnosis of CML, which was confirmed by a second opinion he sought. Melvin was advised by his doctor that without a successful bone marrow transplant, his life expectancy was about three years. The best bone marrow matches are with a patient’s relatives, but if they are not a match, a donor must be of the same ethnicity. No relatives matched, nor did any registered donors. At that time, there were a limited number of African Americans on the bone marrow donor registry. Melvin began the treatment prescribed by his physician, which were daily injections of interferon.

Melvin thought about his wife, Cecelia, and his daughter, Patrice, who was just five years old and decided to take action in the search for a donor. Working with marrow donor organizations, and the Department of Defense (DOD) Marrow Foundation, marrow drives were launched within the military. Melvin participated in these outreach efforts, which scaled to include college campuses, malls and churches, radio and television interviews, as well as military bases. His experience as an Army recruiter and public relations officer and degree in public relations propelled him to forge ahead, even when he didn’t find a match. Melvin medically retired from the Army in 1995 and continued his outreach efforts with bone marrow drives, as his health would allow.

At a marrow drive organized by his aunt in April of 1996, Melvin had a life-changing meeting with a local businessman who had seen Melvin’s TV promotions for the event. This individual had been gravely ill with hairy cell leukemia and had been treated at MD Anderson Cancer Center in Houston, Texas, with excellent results. He urged Melvin to contact them.

Thus began Melvin’s experience with clinical trial participation. It had been 16 months since his diagnosis of CML, and none of the medical professionals involved in his care had broached the topic of clinical trials. The bone marrow drives he was involved with were finding donors for many patients, but not for him. Melvin decided that participating in a clinical trial was his next step towards fighting the illness.

Over the next two years, Melvin traveled between his home in Atlanta and Houston, trying different combinations of vetted and clinical trial medications through MD Anderson. At the outset of the Imatinib clinical trial, he had to stay in Houston for three months. Over time, the interferon and other clinical trial medications stopped working. A lifelong competitive runner, his body weakened and he suffered intense fatigue. He was, however, eight months past his original prognosis of surviving three years, when he had the opportunity to participate in an Imatinib clinical trial. The Phase I trial tested for the drug’s safety in humans, dosage level and evidence of efficacy.

The Imatinib clinical trial had three locations: MD Anderson, Oregon Healthy & Science University in Portland and UCLA Medical Center in California. Melvin’s medical care continued to be seated in Houston.

“It was for quality of life – not a cure. I was hoping for a better outcome,” Melvin explained. He also thought about how his participation would help other cancer patients.

The process was rigorous. In the first week, Melvin had blood drawn up to 10 times per day. He was required to keep a detailed record of side effects, the time he took the medication, his energy level, diet and other daily details. He experienced severe nausea and was prescribed medication to alleviate it. Melvin’s effort, perseverance and grit paid off. The drug was a game-changer for him. In June of 1999, nine months after starting the clinical trial, Melvin participated in fundraising events for the Leukemia & Lymphoma Society by running a marathon in Alaska and a few months after that, cycling 111 miles in Tucson, Arizona.

Melvin has been taking Imatinib ever since. The medication was approved for use in CML in May 2001 by the United States FDA (Food and Drug Administration). Melvin participated in another clinical trial to see if he could come off the medication, but he could not. Over the past 26 years, Melvin has participated in three clinical trials for different combinations of medications.

“Trials have changed over the years,” said Melvin. “The last (Imatinib) trial I was in was in 2017. I had to travel every three months to the trial site, although some testing was done at home. The COVID-19 pandemic has increased that whatever you can do at home or with a local doctor, in terms of aspirations and blood draws.”

For some patients, particularly members of the Black and African American communities, the specter of the unethical Tuskegee Syphilis Study still influences opinions about the safety of clinical research, despite vast advances in oversight and regulation made in subsequent years by the United States government to ensure the safe and ethical treatment of all patients. It is important that patients are asked if they would like to participate in a clinical trial.

Melvin advises patients and the public that “It’s vital to know that clinical trials are an option. There can be benefits from a clinical trial. You are getting more attention because the studies often require you to be watched more and seen by staff more frequently. In oncology clinical trials, you’re not getting a placebo, you’re at least getting the standard of care treatment. It’s important to weigh your options. Can you get the support you need from family or a caregiver? Ask questions of the study staff. There are risks involved, so ask about them. You have the choice to stop being in a clinical trial, whenever you decide.”

Melvin is now the world’s longest living Imatinib and tyrosine kinase inhibitor CML survivor. Melvin had a MBA, but in 2000 he decided to change his career focus. He returned to higher education and earned an BA in English Literature, M. Ed. In Secondary English and a teaching license, all within the span of three and a half years. He and Cecelia continue to volunteer for various cancer and bone marrow donation organizations. Melvin continues to participate in marathon and half-marathon events, and sometimes 10Ks with his wife and daughter, Dr. Patrice Mann, a psychiatry specialist, graduate of Harvard College and Emory Medical School.

“I recommend clinical trials, at least to ask about them. It’s also important for doctors to ask patients if they want to participate in clinical research,” said Melvin.

To search for medical conditions in a specific location visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

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Medical Hero Spotlight: Phyllis Kaplan & Type 1 Diabetes

Phyllis has a vague recollection of waking up in a hospital with tubes attached to her body, and a distinct memory of saying “Take the tubes out!”. At the age of two, she was diagnosed with type 1 diabetes, an autoimmune disease, typically diagnosed in childhood, but can manifest at any age. Diabetes has led Phyllis on a path from patient to advocate, to clinical research participant.

“I have been an advocate since I was 12 years old. It started in junior high school, in a gym class when the teacher made me take off my medical alert bracelet, due to a ‘no jewelry in gym class’ rule,” says Phyllis. When she went to retrieve the medical bracelet from the gym locker after class, she discovered it had been stolen. This incident spurred Phyllis to write a letter to the town Superintendent of Schools, demanding its replacement and a change in the rule to allow medical-related items to be worn. By the time the letter had been delivered, the bracelet had been anonymously returned to the school’s Lost & Found box. Phyllis was allowed to wear the bracelet moving forward.

The most important thing to understand about type 1 diabetes, says Phyllis, is “The patient or caregiver has to make so many decisions about the disease, every day with no break. With diabetes, every day is different.”

Type 1 diabetes develops quickly. The body’s immune system attacks and destroys beta cells in the pancreas that create insulin. The body cannot produce insulin without these beta cells. A peptide hormone, insulin helps your body metabolize fats, proteins and carbohydrates through glucose (a type of sugar) that is released into the bloodstream when you eat food. The glucose is then absorbed from the blood in the liver, fat and skeletal muscle cells. Type 2 diabetes develops more slowly, over time. The body produces insulin, but cannot use it effectively. (1)

Decisions about how much medication to take is based on many variables including food, exercise, change in weather, change in personal schedule and stress.

“That’s why education is so important,” says Phyllis. “If I am going to exercise, I have to plan ahead, at least a couple of hours before, as exercise impacts blood sugar. There are so many hidden things to know about diabetes that impact your decisions.”

Phyllis has participated in three clinical trials, two for rescue medications for severe hypoglycemia and one for a medical device. “As a longtime advocate, I felt that participating in a clinical trial was the ultimate form of advocacy,” Phyllis explains.

“The trials were very different from each other,” says Phyllis. “Two of the three were very easy. One involved two full days in clinic, and that was really hard, with 9 hours of ongoing blood tests. Those were physically difficult days, but worth it. The other two clinical trials were less invasive.”

When considering the 2-day in-clinic trial, Phyllis and her husband reviewed the protocol together. “I wouldn’t participate without consulting him,” says Phyllis. He accompanied her to the two in-clinic days, to be with her during the 9 hours of ongoing tests and to lend additional support.

When asked if she faced any concerns from family or friends about her clinical research participation, Phyllis says “No, quite the opposite. People were really interested in the ‘why’ of what I was doing and what the outcomes were.” Phyllis didn’t seek any advice from patient advocacy organizations, because of her own experience as an advocate. She is a brand ambassador with Medtronic Diabetes to share her experience with their medical device and  also volunteers with JDRF (Juvenile Diabetes Research Foundation), and ADA (American Diabetes Association)

Phyllis advises individuals considering clinical research participation to “Ask all the questions you have when meeting with the nurse/study lead. No question is too silly. Read the protocol and informed consent, which can be confusing. Use a highlighter to mark items in the protocol or use Post-Its to make notes. Keep asking questions throughout the course of the study. At times the research staff may not always be patient-centric, and if you’re not getting the answers to your questions, ask to speak with someone else on the study team. Be your own best advocate and keep pushing. Researchers are not always prepared to answer patients’ questions. If something doesn’t sit well with you, voice it.”

Phyllis’ advocacy work has also led her to CISCRP, where she is Senior Manager, Events & Community Engagement. CISCRP’s mission to informing and engaging patients and the public about the importance of clinical research resonated with her. Phyllis leads CISCRP’s Aware for All free clinical research educational programs, which have pivoted from in-person, city-specific events to regional, virtual programs with the advent of the pandemic. You can learn more about AWARE for All here.

Her experience as a clinical trial participant has strengthened Phyllis’ commitment in sharing information about the importance of clinical trials to everyone. Phyllis is adamant and passionate about participating in clinical research again if the opportunity presents itself, reiterating, “Absolutely. Without clinical trials new treatments can’t happen and without clinical trial participants, clinical trials can’t happen.”

To search for medical conditions in a specific location visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Sources