Blood

Is It Safe to Donate Blood in a Pandemic?

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.

Blood: From Vitalism to Vampires

Halloween has passed, and though it’s fun to see our friends’
and family’s children dressed in costumes on Facebook, there are plenty of
“shock” photos circulating on the internet of dummies smeared with blood—one
even prompted a 911 distress call, so realistic was it. Halloween conjures up
images of Friday the 13th movie characters as well as vampires.
Transfusion: Now that’s scary
Our business in hemophilia is blood. Blood at once attracts and horrifies; it is the stuff of legends
and tales, myths and medicine. I recently read the classic Dracula [read the book review below] and was amused to read how Dr.
Van Helsing wanted to help the young Lucy, a victim of a vampire, by giving her
a transfusion of blood. “Is it you or me?” he asks Dr. John Steward, about who will roll up their sleeve to donate; Steward who
replies, “I am younger and stronger, Professor. It must be me.”
Steward offered his blood based on the concept of vitalism, that blood contains the traits
of the being in which it flowed—a concept that was unchallenged for fifteen
hundred years. Later in the book, Van Helsing says to Lucy’s fiancé Arthur, “John was to give
his blood, as he is the more young and strong than me…. But now you are here,
you are more good than us, old or young, who toil much in the world of thought.
Our nerves are not so calm and our blood so bright than yours!”
Not so picky: Any old blood will do
So Arthur becomes the better blood donor because he is calm and not scholarly! Of course, this is nonsense, but author Bram Stoker fell for the widespread belief in vitalism when he wrote his book. Dracula isn’t so picky; he pretty much would drink anyone’s blood.
Douglas Starr tells us in his book Blood that the Egyptians saw blood as the carrier of the vital
human spirit, and would bathe in it to restore themselves. Roman gladiators
were said to have drunk the blood of their opponents to ingest their strength. “Our
own culture attaches great value to blood, with the blood of Christ as among
the holiest sacraments, blood libel as the most insidious slander, the blood-drinking
vampire as the most odious demon.”*
Vampires… which are repelled by
garlic and crucifixes (the two seemingly have nothing to do with one another).
Yet rather than secure eternal spiritual life by consuming wine that has been
transformed into Christ’s blood during Christian mass, Dracula drinks human
blood to extend his physical life. 
The only thing scarier than vampires is the
proliferation of teen movies about vampires!
*Starr, Douglas (2012-09-05). Blood: An Epic History of Medicine and Commerce (Kindle Locations
97-101). Knopf Doubleday Publishing Group.
Great Book I Just Read
Dracula  [Kindle]
By Bram Stoker
I haven’t read this book since high school, and forgot how
wonderful and visionary it is. A classic, as it has spawned an entire genre of
books and movies. Jonathan Harker, a young English lawyer, is summoned to Castle
Dracula in Transylvania to finalize a real estate transaction with the eerie Count
Dracula, who is purchasing property in London. Harker is warned by local
peasants, who give him crucifixes and other charms against evil. As a guest,
Harker soon notices strange things: the Count has no reflection, is never
present in daylight, and scales the castle walls downward, like a lizard.
Unable to escape, Harker is soon a prisoner, until the Count reaches London,
with 50 boxes of earth. The novel is told only through letters and diary entries
of the main characters, including: Harker’s fiancée, Mina Murray; her friend
Lucy Westenra, who is bitten by Dracula and slowly turns into a vampire; Dr.
John Seward, Lucy’s doctor and once beau. Harker reappears in Budapest and eventually
returns to London. Dr. Van Helsing, an expert on vampires, is called in from
Holland to help save Lucy. Everyone realizes Dracula’s scheme to populate
London with the “Undead”—vampires. When Mina is bitten, and begins to turn into
a vampire, the men sterilize the boxes of earth, set about London. Dracula,
having no haven to stay when dawn comes, flees back to Transylvania, while the
men pursue him. This is a fantastic story, though the language is not lofty or
even that clever, with memorable characters, and cleverly told in letters and
diaries. Perfect Halloween reading. Five/five stars.

The Bloody Wars: When War Advanced Blood Transfusion

Dr. Norman Bethune

Scientists and physicians in
the warring nations during World War II struggled to save soldiers bleeding to
death on the battlefield. Dragging injured soldiers back to field hospitals resulted in too many lost lives. But what other alternative was there?
One of the early medical innovators of mobile blood
transfusions was Dr. Norman Bethune, a Canadian surgeon, who wondered: why risk
men’s lives by bringing them back to hospital when blood should travel to them?
Funded by an organization, he went to Madrid at the outset of the Spanish Civil War in 1936, where he developed a mobile blood transfusion service.
With charismatic enthusiasm and caring, he wrote:
“This is great! Isn’t it grand to be needed, to be wanted!” He had a high
proclivity to risk-taking and civil duty: he was involved in the war-time evacuation
of families and children. He was always concerned with the socioeconomic
consequences of medical services on the plight of the poor, and pushed for
socialized medicine.

In
Spain, he seized on this innovative idea: to take the blood donated by civilians in bottles
to wounded soldiers near the front lines. Being highly adaptable and effective,
Bethune’s service is regarded as one of the most significant military-medical
achievements of the Spanish Civil War. A benchmark in
the history of mobile medical achievements, his work later inspired MASH units.

This was not the first time this idea was proposed, but it was far
reaching. A similar service had been established in Barcelona by a Spanish hematologist,
Dr. Frederic Duran-Jorda, and had been functioning just months before.

The more precise and cautious
physician, Duran-Jorda ran a sophisticated operation in Barcelona. He collected only O blood; oxygenated the bottles; and ensured high standards of safety by testing rigorously. He had vehicles fitted with refrigerators to transport the blood to front line hospitals. In February 1939, Duran-Jorda fled to England, where he helped the British develop their blood banks for the front line.

And the Germans, who had practiced
the highest level of medical research in the world, regressed into medical myth
when the Nazis came to power. Blood now represented racial purity—with the
belief that only pure German blood could be used in German soldiers to save
their lives. This would cost the Germans thousands of lives. 

Fantastic Book I Just Read
Wind, Sand and Stars by Antoine de Saint-Exupery

I had long heard that this story was a classic in travel reading. The story of Saint-Exupery’s flights over Africa as a mail carrier for the French postal service, Aeropostale in the 1930s. Told in the first-person voice, Saint-Exupery shares his views from the airplane seat, and from his fertile mind. The text is lyrical, mesmerizing, fluid. An adventurer, he writes: “The call that stirred you must torment all men. Whether we dub it sacrifice, or poetry, or adventure, it is always the same voice that calls. But domestic security has succeeded in crushing out that part in us that is capable of heeding the call. We scarcely quiver; we beat our wings once or twice and fall back into our barnyard.” His crash and struggle to survive in the Sahara is riveting. A rousing five/five stars. Read it!

Those Very Special Inhibitor Families


Inhibitor families are a special lot and my admiration for them just continues to grow. For the past six months I’ve been interviewing parents and patients for my new book on inhibitors and I have learned what amazing hardships they face, and with such courage. Though I helped facilitate the Novo Nordisk Consumer Council for the past two years, I still didn’t have a full appreciation of their lives. This past week in New York City we inaugurated a new group of parents and patients for the Consumer Council, and I feel better able to represent their needs by knowing more about the medical care, parenting concerns and social issues they face.

We had a wonderful time on Friday. Meeting at the Westin Hotel Times Square for a full day, the marketing team at Novo Nordisk and I presented questions and listened to nine consumers share their experiences, thoughts, suggestions and concerns. None of them had ever met one another, as inhibitor patients are pretty rare and in a country as big as the US, it is hard for them to meet. The Novo Nordisk Inhibitor Summits brought inhibitor patients together for the first time two years ago, and yes–for all who are reading this–there are going to be two more this year.

We had breakout groups, exercises and ice breakers. One ice breaker–meant to help us get to know one another–asked each participant to identify themselves with an animal. Everyone chose different animals, from a kangaroo to a dog to a lion. But Schlander chose an ant–unusual because almost no one in these types of exercises ever chooses an insect. Why an ant? Because though small, they are strong in groups and can accomplish something that seems impossible, given their size. Given that this group will be together for two years, it was a perfect animal to choose to highlight what a small team of dedicated people might and will accomplish.

Great Book I Just Read: Blood, by Douglas Starr. Four stars! This book took me a while but it was well worth it. Fantastic overview of the history of blood. It starts with the story of a madman running naked through the streets of Paris… reads like a novel but is packed with information about the meaning of blood in society, medicine and business. Learn about its incredible importance during World War II, and how much we advanced our knowledge of blood because of the war. Fully half of the book is devoted to the hemophilia holocaust, and I read with sadness and pride about our community, and its fight to bring safer measures of blood treatment and justice to the victims. It was startling and impressive to read about the leadership and courage of people like Bruce Evatt of the CDC, and Corey Dubin and Dana Kuhn of COTT, true heroes in our midst even today. I had read the history of the HIV infection before, and even watched the HBO movie about it, and still see Corey and Dana at events. But.. time goes on, and being human, we all tend to forget the past. This book reminded me of how privileged we are to have these warriors; how lucky my son and anyone born after 1985 are because they benefited from their perseverance to get a settlement from the government and drug companies, and have safer measures. And they still persevere in protecting our blood supply even today. Blood is required reading for anyone involved in the hemophilia community on any level.

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