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Is It Safe to Donate Blood in a Pandemic?

Laurie Kelley October 11, 2020

In the U.S., the first full week of September is designated National Blood Donation Week, to promote blood donations and the need for blood, for emergences and for therapeutic drugs. I normally post something about it, but with Covid-19 taking center stage, overlooked it this year. I just read The Source magazine, from the Protein and Plasma Therapeutics Association (PPTA), and found the welcome, called “Outlook,” by new president Amy Efantis, very compelling. Please have a read of this excerpt, and go to “the source” itself, to download your own copy here. Remember that some of our community members still use plasma-derived products, as do many in developing countries. Is it safe to donate blood in a pandemic?

Outlook by Amy Efantis

“… in those early days of this crisis, my committed and experienced colleagues recognized even before the scourge of Coronavirus SARS-CoV-2 was officially declared a pandemic that patients might have concerns about plasma-derived therapies (PDTs) and the safety of those therapies due to COVID-19. Our member companies’ leading pathogen safety experts came together to assure patients of the safety of PDTs. They outlined the extensive safety measures that industry follows for donor recruitment and validated pathogen removal/inactivation steps during the manufacturing process, providing assurance to patients and providers about the safety of PDTs. Our statement detailing these protocols was published on our website in several languages and has been frequently cited.

“PPTA sprang into action to make sure that plasma centers, center employees, and donors were deemed essential to perform their daily activities by authorities in the U.S. and in Europe. After appeals from PPTA, the European Centre for Disease Prevention and Control defined plasma as an essential substance of human origin and encouraged plasma centers to continue collection to ensure the continuity of production of plasma-derived therapies. PPTA also engaged in efforts to make sure that PDTs, and the essential goods needed in the collection of plasma as well as manufacturing of therapies, were considered essential to ensure the movement of goods between and among countries during the pandemic. This included appeals to authorities to make sure centers received priority for personal protective equipment and medical supplies.

“In the U.S., our efforts resulted in the President’s Coronavirus Guidelines for America noting the special responsibility of the pharmaceutical supply chain, including the important role of plasma and plasma donors. In fact, donors and staff were explicitly identified in every iteration of the federal government’s advisory list of essential critical infrastructure. But even as officials at the U.S. Department of Homeland Security and the European Commission issued guidance that deemed plasma centers, staff, and donors as essential, PPTA was called upon to engage directly with local, state, and national level authorities who were not aware of or did not understand the guidance, to ensure that centers remained operational. To assist in this effort, PPTA developed a repository of documented exemptions that plasma centers could have on hand if questioned by authorities during periods of restricted movement.

“We recognized early on that plasma donors, who are essential for addressing the clinical needs of patients for PDTs, might have concerns about their safety given anxiety surrounding the contagious nature of COVID-19. PPTA facilitated the development of a preparedness checklist for centers in the early days of the pandemic. PPTA member companies took immediate actions to accommodate the safety of donors in their centers with new protocols for increased screening, the use of personal protective equipment, social distancing, and the availability of disinfectants.

“Because of government-imposed restrictions in movement, our typical inspection paradigm was disrupted. In keeping with our historical commitment to standards, PPTA submitted a proposal to the European Medicines Agency (EMA) requesting remote good manufacturing practice (GMP) inspections and parallel inventory holds, which were agreed to by EMA’s GMP/Gross Domestic Product Good Distribution Practice Inspection Working Group. We adapted inspections in our International Quality Plasma Program to virtual models, and we advised auditors to match the U.S. Food and Drug Administration’s relaxed inventory hold period from 60 days to 45 days for purposes of PPTA’s Quality Standards of Excellence, Assurance & Leadership program. These efforts reflect our willingness to be nimble in a crisis with our abiding commitment to the highest possible standards.

“PPTA’s work with other stakeholders has meant increased attention to the urgency of plasma collection. Our partnership with the Platform for Plasma Protein Users and the European Plasma Alliance resulted in the European Commission launching a call for blood and plasma donations. It also prompted the EU Health Commissioner’s issuance of a statement recognizing for the first time the importance of plasma and its use in treating rare conditions, as well as its role in fighting COVID-19.

“In the U.S and in Europe, the patient community weighed in with local and national policymakers on issues supporting Source plasma donors and shined a bright light on the urgent need for plasma to treat rare disease patients. We are proud of our efforts during the COVID-19 crisis. PPTA has seen positive results in our responses during the pandemic. But this is not the end of the story.

“Concerns over plasma availability have now replaced initial anxiety around the safety of finished product. In March and April, plasma collections were down, understandably, compared to 2019 due to government-imposed restrictions on movement in the U.S. and Europe. But the expectation was that a recovery would occur as COVID-19 cases declined… in the U.S., as quarantine protocols were loosened, there was a resurgence of COVID-19 cases in several states, including Florida and Texas, states with a strong presence of plasma collection centers. Though a recovery continues, it is far less robust than expected. So now the real work begins.

“Just as it has been challenging to predict what will happen next in the pandemic, the same holds for the future of PDTs. But we do know this much today — donations NOW will mean better outcomes in the future. To meet patient clinical need, we encourage you to:

• Contact policymakers about the urgent need for plasma donations.

• Speak out about ending outdated regulations and call for the coexistence of the private sector with the public sector to collect more plasma.

• Use your own social media channels to spread the word about the ongoing need for plasma donations.

• Donate Plasma if you are an eligible, healthy adult — patients are counting on you!

“Let’s come together to show our commitment to patients.”

The Plasma Protein Therapeutics Association (PPTA) represents the private sector manufacturers of plasma-derived and recombinant analog therapies, collectively known as plasma protein therapies and the collectors of source plasma used for fractionation.

Pain Is Not the Problem…It’s the Solution

Laurie Kelley October 5, 2020

by Corey Pierce , November PEN 2020

The bleeding disorder community has a pain problem, but it’s not the problem of too much pain. The real problem is a misunderstanding of pain and its importance for our survival. Many people with bleeding disorders have come to devalue pain, because pain is often characterized as a mysterious and uncontrollable inevitability. A fallacious concept like “spontaneous bleeding” has sowed a seed in many minds that the actions we engage in are divorced from how our bodies respond. If the pain we experience is seen as inevitable, or with clouded causes, then we’re left with no other option than to manage the best we can, or trick ourselves into thinking the pain doesn’t exist.

If given the option to never feel pain again, many people would take this deal in a heartbeat. But only later would they truly understand the horrors of living without pain. What if you took this deal? Well, rare medical conditions like congenital insensitivity to pain (CIP) suggest that you shouldn’t be too attached to your fingers and toes. And you’d better hope to never get an infection or have heart failure, because you’ll be without the best warning sign nature ever created: pain. In short, your life would end much sooner. Living without pain is not a blessing—it’s a tragic, brutal curse.

If you want to understand pain, know that it results from a set of factors. Pain doesn’t arrive out of nowhere, and it’s rarely attributable to a single cause. For example, the mild ankle pain I am experiencing as I write this is not only the result of countless past ankle bleeds, but also the result of (1) standing for two hours straight while making an elaborate meal yesterday; (2) wearing “cool” shoes with no heel drop yesterday; (3) running three days ago even though I was sore; (4) eating inflammatory foods yesterday; (5) being dehydrated today; (6) slightly twisting my ankle on a tree nut while intently looking at a mailbox on a recent run; (7) not being able to ice myself after physical activity (my roommate has needed the ice more after his recent surgery); (8) not yet knowing my mileage limit while running (running is new for me since COVID-19); (9) switching to a new running shoe (is it helping or hurting?); (10) walking a mile on uneven sand recently. And so on…

If you look critically at what contributes to pain, you’ll see that it’s possible to improve your underlying condition by changing how you navigate through this world. By examining the obvious—and subtle—contributing factors to pain, you can create a template in your mind for what you should be doing and also avoiding. In my earlier example, there are complex interactions between my physical awareness, my activity level, and my shoes that I can monitor and refine over time, as I get used to my new activity—running. This introspective, reflective process is often at odds with the objectives of using pain medications.

Sadly, many people with bleeding disorders have been offered pain medications as the only solution to their pain. Too much reliance on pain meds may be nothing more than a deception that obscures the true problem(s). While effective over the short term in tamping down pain signals (the effects), pain meds also disguise the complex set of underlying factors (the causes). If we don’t address the true causes of pain, and instead focus solely on the effects with pain medication, the condition or behaviors at the root of pain will get worse, not better.

So, is pain your enemy, or is it your collaborator? If you want to live a long and healthy life, pain can’t be reduced to your tormentor Don’t let your pain be in vain by seeking remedy only through pain medications. You can’t arrive at the underlying causes of your pain when you are literally numb to them. Our pain is not what ruins life; it is what prolongs life, but only if we listen and learn from it.

Corey Pierce is a PhD candidate in public health at Oregon State University. He is currently completing his PhD dissertation, which explores how pain attitudes are connected to the experience of pain and use of pain medication. Corey has severe hemophilia A. He is active in the bleeding disorder community as an advocate and teacher of yoga, and he serves on the board of Pacific Northwest Bleeding Disorders.

James’ Story: Why Preparedness and Support Matter

admin September 27, 2020

I’ve spent the last 24 years working in developing countries, helping families and nonprofits gain access to better healthcare for hemophilia. The story below touched my heart as I have been to the Philippines, and we now are partners in progress for better hemophilia care. Read James’s story below to see how his life changed with proper treatment!

Submitted by Takeda

James has hemophilia A. He’s found balance in the peaks and troughs of his life through profound relationships with both his wife and his care team.

This is James experience, but your experience may be different.

Learning, Living, and Growing

Born and raised in a rural village in the Philippines, James grew up in a careful household. Losing one brother to complications from hemophilia at a young age and living far away from any access to proper healthcare, his parents taught him to be cautious throughout his childhood. “My parents would limit my activities a lot. They loved me, but wanted to make sure I couldn’t hurt myself,” James recalls. When James did have a bleeding episode, the family would have to travel miles and miles to the nearest hospital to get him a blood transfusion.

James and his family moved to Los Angeles when he was 16 for one reason: his hemophilia. For the first time in his life, James learned more about hemophilia and the importance of maintaining factor levels. He began factor replacement therapy after his care team recommended a prophylaxis regimen.*

Learning and connecting with his hematologist, James realized his hemophilia was only a part of him, not who he was. “[He] helped me change my perception of hemophilia, my understanding of hemophilia. It gave me a little bit more confidence.”

*James’ regimen was based on his needs as determined by him and his care team. This was his experience, but your experience may be different.

“Without her, the healing process would have been much slower.” —James, on Carla and why her support matters

Caring and Giving

Through surgeries, physical activities, and personal adventures, James found support in his wife Carla along with his care team. Having gone through surgery twice, he learned that preparedness is key. “Before both procedures there was a lot of discussion around how I’d be kept at a sufficient factor level. And for me, we decided to use factor prophylaxis during both surgeries, so they could continue to track my levels.” James could trust that his care team had his back in the operating room and Carla was there to help during recovery. “I wanted to be active again, to go out with her like we did before the surgeries. She was a big part of my recovery,” James remembers.

Post-surgery, Carla assumed the role of caregiver and ran with it. She partnered with James’ care team, including his physical therapist, planned his recovery, and learned how to help administer factor through a port.

Since recovering from his surgeries, James has been able to maintain an active lifestyle. Once he received the green light from his hematologist, James made a plan to stay fit. Through his preparedness and the support from his care team, James has been able to participate in bike events, including a charity ride with his friends.

“Crossing the finish line was such a great moment… tiring, but also rewarding. I was so proud of myself.” To James, crossing the finish line meant more than just finishing the ride. It was also a testament to the dedication of his care team and of Carla. Having their support, he learned he could trust his body again.

Today, James remains active and continues his adventures with Carla as they travel to many parts of the world. Together, they stay active in their local hemophilia community, sharing their story of recovery and resilience.

Adapted from Hello Factor magazine.

Visit bleedingdisorders.com to read more about patients like James and their stories.

Any factor and physical activity regimens mentioned were developed for James only after consultation with his care team, and may not be appropriate for all patients. Your factor regimen may be individualized after consultation with your care team.

This is a paid public announcement from Takeda and does not constitute an endorsement of products or services. When you click on the links in this blog entry, you will be directed to the bleedingdisorders.com website. LA Kelley Communications always advises you to be a savvy consumer when contacting any company; do not reveal identifying information against your will.

Copyright © 2020 Takeda Pharmaceutical Company Limited. 300 Shire Way, Lexington, MA 02421. 1-800-828-2088. All rights reserved. TAKEDA and the TAKEDA logo are trademarks or registered trademarks of Takeda Pharmaceutical Company Limited. US-NON-2025v1.0 08/20

Women, the community, and hemophilia B

admin September 20, 2020

There are many facets to our community. I think you could say there are as many facets as there are people with bleeding disorders. People may identify by the type of bleeding disorder they have, or the treatment they are on. But it’s important to remember this is a community in every sense of the word. That means everyone is important. And we should take a moment whenever we can to show our gratitude for the people who help hold everything together. Please read the public-service message below from Medexus to see what one company is doing to honor those people.

Here’s what’s happening in the hemophilia B space!

Medexus Pharma, the people behind IXINITY^® [coagulation factor IX (recombinant)], has launched a webpage specifically to honor the remarkable women they are calling the Heroines of Hemophilia B. These are women who advocate for themselves—as women with hemophilia B—or have made an impact lending their support to others.

The work women do as healthcare professionals is absolutely essential. And many times, the key provider of care in the family setting is also a woman. Then there are the women who have hemophilia B. As a patient population, these women are often overlooked. It’s time they got the care and support they deserve.

One of the great things about the Heroines of Hemophilia page is that it gives you a way to show your gratitude by nominating someone in your life. If you know of a woman who has courageously taken a stand to advocate for herself, or gone over and above in the care of someone else, go to www.HeroinesofHemophiliaB.com and nominate her as a Heroine of Hemophilia B.

This is a community in every sense of the word. Here’s a way to show to it.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

What is IXINITY^®?

IXINITY [coagulation factor IX (recombinant)] is a medicine used to replace clotting factor (factor IX) that is missing in adults and children at least 12 years of age with hemophilia B. Hemophilia B is also called congenital factor IX deficiency or Christmas disease. Hemophilia B is an inherited bleeding disorder that prevents clotting. Your healthcare provider may give you IXINITY to control and prevent bleeding episodes or when you have surgery.

IXINITY is not indicated for induction of immune tolerance in patients with Hemophilia B.

IMPORTANT SAFETY INFORMATION for IXINITY^®

You should not use IXINITY if you are allergic to hamsters or any ingredients in IXINITY.
You should tell your healthcare provider if you have or have had medical problems, take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies, have any allergies, including allergies to hamsters, are nursing, are pregnant or planning to become pregnant, or have been told that you have inhibitors to factor IX.
You can experience an allergic reaction to IXINITY. Contact your healthcare provider or get emergency treatment right away if you develop a rash or hives, itching, tightness of the throat, chest pain, or tightness, difficulty breathing, lightheadedness, dizziness, nausea, or fainting.
Your body may form inhibitors to IXINITY. An inhibitor is part of the body’s defense system. If you develop inhibitors, it may prevent IXINITY from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for development of inhibitors to IXINITY.
If you have risk factors for developing blood clots, the use of IXINITY may increase the risk of abnormal blood clots.
Call your healthcare provider right away about any side effects that bother you or do not go away, or if your bleeding does not stop after taking IXINITY.
The most common side effect that was reported with IXINITY during clinical trials was headache.
These are not all the side effects possible with IXINITY. You can ask your healthcare provider for information that is written for healthcare professionals.

Please see click here for full Prescribing Information.

You are encouraged to report side effects of prescription drugs to the Food and Drug Administration. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Aptevo BioTherapeutics LLC, Chicago, IL 60606

IXINITY® [coagulation factor IX (recombinant)] and any and all Medexus Pharma, Inc. brand, product, service and feature names, logos, and slogans are trademarks or registered trademarks of Aptevo BioTherapeutics LLC and Medexus Pharma, Inc. in the United States and/or other countries.

Wheels for the World 2020: A Win-Win

Laurie Kelley September 14, 2020

The pandemic has put a halt to in-person fundraisers for nonprofits like Save One Life, and yet we are extremely dependent on these events for overhead revenue. We receive program funding from grants, but for regular overhead, like salaries, rent, utilities and services, we often have to raise our own funds. Save One Life is starting to be known for its “adventure” fundraising, like cycling, mountain climbing and even hiking!

**Saturday’s riders: social distancing!**

This past weekend we honored Barry Haarde, a man with hemophilia and HIV who cycled across the US six times in as many years, raising over $250,000 for Save One Life. Barry passed away in February 2018, a huge loss personally and professionally to us. He was one of a kind, a deep, sensitive soul with a heart as big as the state he lived in, Texas. We decided to first do a bike ride in 2018 to remember him, and now we continue that tradition each year to honor him and his favorite cause, helping children with hemophilia in developing countries. Save One Life was one of his top favorite charities.

Our “Wheels for the World” went virtual this year, and we opted for an in-person cycling ride (with proper masks and social distancing) starting from historic Ipswich, Massachusetts. We had eleven riders participate on Saturday to do 23 miles, including an 11-year-old! Pretty gutsy!

With lots of water and donuts, we headed out into the crisp, New England air. The course took us through the lush green farmlands and horse stables that populate this area, and past solid, magnificent colonial-style homes, some dating back to the 1600s! Along the route a small grey vole darted madly across the road, just missing my tires; a white-tail deer stood like a statue in a golden field, ears alert like radar shields as it watched us pass; and sadly, I saw a very flat chipmunk, a victim of the waning sun and probably extra body fat as he readied for hibernation.

We all returned together, and after congratulations (no hugs!), we went to True North Ale House for a complimentary beer, or in our case, blackberry Izzy drinks. I especially enjoyed chatting with Oliver, a tall young man who just started working at uniQure three weeks ago, and who is responsible for making the viral vectors into which the human gene for factor VIII is placed. He is working on the cure for hemophilia and we surely hope he is successful!

On Sunday, we reconvened on another bright, warm day, with a smaller group. I was also supposed to ride this one, 62 miles, but had woken up Friday with a back spasm. I worked it out, and was able to ride the 23 miles (which was actually 27 for us, as we got a little lost) but today, it came back with a vengeance. No way could I do 62 miles when it felt like there was a little ball with spikes sitting in my lower right back. I showed up in my gear, ever hopeful, but bailed at the last minute, my back sending warnings. I watched the six riders shove off. Jodi, Karen and I were waiting for maybe two more, and after 20 minutes a car pulled up. Was it Dan Leonard of uniQure, or Scott?

I watched as a handsome man got out of the car and approached. He said, “You don’t recognize your own brother?” My brother! All the way from the Springfield area, two hours away. I hadn’t seen him in over a year and hadn’t known he had registered! Imagine if I had not had the back spasm, and took off on the 62-mile ride. I might never have seen him that day. Jim and I hugged and chatted, and then Dan Leonard arrived. So now they both had someone to ride with. They opted for the 23 mile one that we did yesterday. And off they went!

The day was successful and I know we raised a lot of money from the wonderful sponsors, and from the dedicated riders. I didn’t even know some of the riders—two from Worcester, Massachusetts—who were college student and friends of someone in our community. They loved the ride and pledged to participate next year.

In fact, everyone had a great time. I heard from quite a few people that this year had been so strange, that they had not had a chance to ride outside at all. Injuries, work, childcare issues, COVID… this fundraising ride gave them the boost to dust off the bike (my brother’s literally had cobwebs on it!) and get out in the glorious autumn sunshine to enjoy the beauty of this state. We made new friends, reconnected with old friends, and helped Save One Life.

As Doug and I drove into downtown Ipswich, to get a bite to eat on Saturday, a tall, lean cyclist pulled right in front of us, not even staying to the side of the road, but directly in front (legally fine). I was struck by his position and body type. Incredibly, this rider had Barry’s long torso, and thin, powerful legs. The way he held his handlebars and leaned over… I had ridden enough with Barry to know his stance anywhere. It was as if he materialized to ride with us once more time…. and then he was gone. But I managed to snap a photo.

His spirit is always with us, challenging us to be better versions of ourselves, and leading us into a future where every child with hemophilia will have access to medicine. That’s why we ride, and that’s what we work for at Save One Life. RIP Barry. And thanks to everyone who sponsored, rode and supported Wheels for the World 2020!