Blood Donations

Plasma Awareness Week

This week marks the first ever International Plasma Awareness Week, an opportunity to recognzie the importance of plasma in our lives, and the need to donate blood to provide the life-saving liquid to those in need. It’s especially important to many with hemophilia throughout the world as donated blood donations can be fractionated into factor VIII and IX for many hemophilia patients who use plasma therapy.
You learned this in high school science class but here it is again: Plasma is the clear, straw-colored liquid portion of blood that remains after red blood cells, white blood cells, platelets and other cellular components are removed. It is the single largest component of human blood, comprising about 55 percent, and contains water, salts, enzymes, antibodies and other proteins. It is a clear, straw colored liquid that is 90% water and serves as a transporting medium for cells and a variety of substances vital to the human body.
In the US, we often think only of recombinant factor when we think about treating hemophilia, but plasma therapies remain the mainstay for many with hemophilia, those with inhibitors and undergoing ITI, and those with von Willebrand disease patients.
In addition, plasma protein therapies are used to in emergency and surgical medicine.Plasma protein therapies are not interchangeable and have been defined by regulators as sole-source biologic products because no generics or substitutions exist. In addition, their biological nature demands storage and handling requirements by specialty distributors that ensure their safety.
Source plasma is plasma that is collected exclusively for further manufacturing through a process called plasmapherisis. Recovered plasma is collected through whole blood donation which has been separated into its cellular components.
Safety and quality of plasma protein therapies is the top priority of the plasma protein therapeutics industry. Both collectors and manufacturers adhere to strict regulatory policies and have instituted Good Manufacturing Practices in every step of plasma collection and manufacturing processes.

Plasma-derived therapies depend on the generosity and commitment of healthy donors. Source plasma is collected in over 450 specialized donor centers in the U.S., Canada, Germany, Austria and the Czech Republic. Source plasma collection in the U.S. is regulated by the Food and Drug Administration and by the European Medicines Agency and national regulatory authorities in Europe. Additionally, 436 plasma collection centers are also certified by the International Quality Plasma Program (IQPP), a rigorous, voluntary program that goes beyond regulatory requirements to help ensure donor safety and further improve the quality of plasma used to manufacture therapies.
This is a good week to donate blood then! If you can make the time, please visit your local blood donation center and give the gift of life.
See www.donatingplasma.org and www.pptaglobal.org  for more information.

International Plasma Awareness Week is sponsored by the Plasma Protein Therapeutics Association and its member companies.

The Bloody Ban


According to the CDC, 4.9 million Americans require a transfusion of blood or blood products daily. Is our blood supply safe enough to infuse into them?

That’s the debate raging right now. At issue? Whether gay men can be allowed to donate blood. The FDA has a policy that men who have had sex with another man (MSM), even once, since 1977 are deferred indefinitely from donating blood. On June 11, an advisory committee to the Department of Health and Human Services, composed of health experts from around the country, voted 9-6 to maintain that bans. Is this fair, unfair, discriminatory, accurate?

Mark Skinner, president of the World Federation of Hemophilia, and a lawyer, believes the ban should be upheld. He writes in an article in US News & World Report (posted July 26, 2010), “Recent CDC data indicate that while U.S. HIV infection rates are falling in heterosexuals and intravenous drug users, they are rising among men who have sex with other men and are 44 times that of other men. Additionally, other pathogens that might also be transmitted through high-risk sexual behavior are not fully understood.” Mark stresses that the safety of a recipient of a blood donation comes first. Looking at the scientific data only, the rise in HIV rates and their pattern, the ban should stay for now.

Alternatively, some believe the ban is unfair, needless and discriminatory. Representative Mike Quigley, Democrat from Illinois who sits on the House Committee on Oversight and Government Reform, voices this concern in a counter piece to Mark’s. The ban was put into place during the HIV contamination of the nation’s blood supply in the 1980s. Yet, a man who has had sex with an HIV-positive woman can donate after waiting a year. Fair? Quigley is concerned that there is not enough blood to be donated, and that the gay community represents a willing source of blood donations. Quigley wants a way to separate the high risk gay donors from the low risk, so that at least some in the community can participate.

Not good enough for Mark Skinner, who puts the focus on the recipient’s safety. But he bridges the debate by adding, “While many perceive a disconnect between leading gay rights and end-user patient organizations, these groups have more in common than recent discourse reflects. Both have been disproportionately impacted by the HIV epidemic and for most of the past quarter-century have worked toward shared goals including preventing the virus’s spread. Both share a strong commitment to a safe national blood supply.”

There’s no right or wrong answer at this point, but you can read more about this by Googling “blood donor ban.” If anything, it’s a great exercise in tolerance, science, altruism and politics. I wonder if anyone has interviewed the recipients about how they feel?

Great Book I Just Read
Undaunted Courage by Stphen E. Ambrose

Christopher Columbus may have put America on the map, but Meriweather Lewis put a map to America. One of the great adventure stories of all time, the amount of courage needed by this 30 year old, setting out to discover what lay beyond the Mississippi River, was immense. A close confident of Thomas Jefferson, who had unbridled expansionist plans, he set out in 1803 to find the fabled water passage to the Pacific Ocean. There was none, but Lewis (and Clark!) had an adventure like no other. From Philadelphia to St. Louis through Idaho and eventually Oregon in two years, they charted and mapped the US under the most primitive of circumstances, and discovered new species of plants and wildlife. They met and negotiated with the Indians, the most terrifying of which were the Sioux. A great study in leadership and courage, it has a sad outcome for Lewis in the years following his celebrity status. An amazing American hero. Four stars.

Safety versus Science: Do We Allow Blood Donations by Gay Males?


Remember the 1980s? For those with hemophilia, we remember fear, lack of understanding, being labeled part of the “Four-H Club”: the groups who seemed to get AIDS most predominantly were heroin users, homosexuals, hemophiliacs and Haitians. Fast forward to the Millennium and one group still seems to be held under a microscope: homosexuals. A lifetime ban was placed on homosexuals in 1983 due to the spread of AIDS through blood donations. Homosexuals were social activists and quite altruistic. They often donated blood. Before HIV was identified, their donations contributed to the spread of HIV to those with hemophilia.

So why are they still banned from donating blood? Is there a scientific or medical reason–or just plain discrimination?

Apparently 18 senators think it’s discrimination. A letter signed by all was sent to the Food and Drug Administration (FDA) last week, requesting the FDA to modify its policies on donors. They asked the FDA for the same deferral policies for heterosexuals engaged in high-risk behavior–usually a 12 month waiting period. In plain language: if you are a gay or bisexual man, you could donate blood if you have not had sex with a man in the past 12 months.

What do the nation’s blood bank organizations have to say about that? They’ve been open to changing policy since 2006. The AABB, America’s Blood Centers and American Red Cross all support a 12 month deferral. And the CDC says transmission of HIV through blood donations are extremely rare – less than 1% of all new HIV infections.

But Mark Skinner, president of the World Federation of Hemophilia, cautions that the focus should be on the safety of the recipient, not the altruistic needs of the donor. Blood-donor rules are discriminatory by design, Skinner says in the Washington Times. He noted that people with hemophilia can’t give blood, so it’s not about discrimination; it’s about scientific vigilance.

The FDA reports that homosexual males have an HIV prevalence 60 times higher than the general population, 800 times higher than first-time blood donors, and 8,000 times higher than repeat blood donors.

In a statement released February 19, the WFH stated that donation policy must be based on the Precautionary Principle, which asks that in the absence of scientific consensus, decisions must err on the side of caution. Here, not to cause any unnecessary risk to recipients of blood donations.

This is a fascinating discussion about safety and science, and one that has not ended yet. Surely it is difficult to be a gay male and not to be allowed to donate blood, which is a highly altruistic and socially conscious act. But due to our history, the hemophilia community may defeat efforts to change the current blood donation policies.

For more info, see: Washington Times – Senators ask FDA to lift gay blood donor ban
http://www.washingtontimes.com/news/2010/mar/05/senators-ask-fda-to-lift-gay-blood-donor-ban//print/[3/6/2010 10:50:41 PM]

A Week That Shook the Hemophilia World

I am writing from Europe, which is an interesting place to be right now as a member of the hemophilia community. Just this past week the first evidence of variant Creutzfeldt-Jakob disease (vCJD) transmission in an 70+ year old British person with hemophilia was confirmed, according to leaked information. The United Kingdom Health Protection Agency (HPA) has since confirmed this. There are a lot of emails and news wires being fired off. It’s important to note the facts:

1. The patient died of other causes, not vCJD.
2. The patient had not shown any symptoms of vCJD.
3. The HPA says it is still unclear how the man became infected with the prion protein that causes vCJD.
3. The patient had received British plasma-derived clotting factor concentrates before 1999, before rules were introduced to limit contagion, when the risk of transmission was not known.
4. The patient was treated with a British made product that was manufactured from the plasma of a British donor who went on to develop symptoms of vCJD.
5. It is the first time that vCJD has been found in the approximately 4,000 British hemophilic patients who received plasma-derived clotting factor concentrates between 1980 and 2001.

Up to 4,000 British hemophilia patients have been warned by authorities they could be at risk of vCJD. Authorities also state they run a low risk of developing the disease.

What we know about vCJD:

1. CJD is a fatal brain disease first classified in the 1920s.
2. In 1996, doctors reported a variant of the disease, vCJD, the result of exposure to the agent that causes Bovine Spongiform Encephalopathy (BSE, or mad cow disease) in cattle.
3. There is no test that can screen for vCJD.
4. There is no treatment for vCJD.
5. vCJD is rare.
6. Since 1995, 164 people in Britain have died from vCJD, with just one death last year.

UK plasma has not been used in the UK or elsewhere since 1996 for the production of the clotting treatment.

A statement excerpt from David Allsop, professor of neuroscience at Lancaster University, UK: “The only real cause for concern is for other hemophilia patients who received clotting factors from the same infected human donor, at around the same period of time; and they can presumably be traced and given specialist advice.”

A statement excerpt from Chris James, Chief Executive of the Haemophilia Society (of the UK): “Unfortunately, the risks are higher than they might have been because Health Authorities in England and Wales continued to use products derived from human blood to treat haemophilia long after most other developed countries had switched to safer, synthetic recombinant treatments.” (Note that all clotting products, both plasma-derived and recombinant, that are licensed for sale and distribution in the US are currently considered safe)

A statement excerpt from NHF’s MASAC, in its Medical Advisory #409 on February 18: “No Added Risk Seen for U.S. Patients. It is important to note that only individuals exposed to UK-sourced plasma infused between 1980 and 2001 are considered to be at elevated risk for vCJD compared to the general population… there should be no change in the safety profile of US-licensed products or in any treatment recommendations.”

A statement excerpt from the Committee of Ten Thousand (COTT): “This means that all 4,000 persons with hemophilia in the UK are at risk of contracting vCJD from the plasma-derived clotting factor they used during the 1990s. It also raises serious questions about the risk of CJD and variant CJD transmission in the American hemophilia/bleeding disorders community… COTT is angered that the US Department of Agriculture has failed to conduct a substantive and wide reaching surveillance program for cows in the US.” (Note: the COTT statement implies but does not specficially state that the product used by the patient was a brand of British plasma-derived clotting factor, created from pooled British plasma, which included the blood donation from a British donor infected with vCJD. These products have never been used in the US)

A statement excerpt from the Plasma Protein Therapeutics Association (PPTA): “… the industry has implemented the deferral of donors from areas of high risk of bovine spongiform encephalopathy (BSE) and its human equivalent, vCJD, for the past ten years… Therefore, this incident involved products that do not reflect the safety profile that has underpinned PPTA plasma protein therapies for the past ten years. Patients receiving these products can rest assured of their enhanced safety. The PPTA supports the conclusions of patient groups and government authorities that the use of current products to preserve the health of plasma protein recipients should be maintained.”

There you have it: an event that shook the hemophilia world this week. Facts should be read completely. Various statements by leading patient organizations, reflecting nuances in opinion, which our readers should analyze carefully for content, history, perspective, source and purpose. Read more by going to: www.hemophilia.org, www.ppta.com, www.cott1.org, www.haemophilia.org, and above all, speak with your hematologist and HTC staff if you have questions about the news reports.

Also see: http://www.hpa.org.uk/webw/HPAweb&HPAwebStandard/HPAweb_C/1234859690542?p=1231252394302

The Price of Blood


There is an ever constant debate throughout the worldwide blood community about whether blood donors should be paid or voluntary. There are all kinds of implications. I found the history of blood donation fascinating, as blood developed from a charitable service to a global industry. Here’s a snippet of what I read in Douglas Starr’s excellent and must read book Blood.

In the early 1900s, transfusion of blood was a clumsy, laborious process. No one stored blood in a blood bank. When a patient needed blood, he himself had to find a donor (this must still be the the case in some countries). One day in 1921, Percy Lane Oliver of the British Red Cross got an emergency call to find a donor. He realized this was stressful and inefficient, trying to find random donors when someone was already in trouble. So Oliver decided to create a registry of volunteers. More astonishingly, he ran it from his home! Oliver became a man on a mission, obsessed, and his idea was a stroke of genius. He worked seven days a week, recruiting, filing paperwork, and phoning people. Everything he did was free. His services were in so much demand, he could never get away even for a day. (You can imagine there was so much joy in being able to help when no one else could) Oliver even changed doctors’ practice of slicing open the arm and exposing the vein to insert a needle: all they needed to do was insert a needle now! Eventually, Oliver registered 2500 donors, all of whom were unremunerated. Britain led the way: soon donor panels were started in other countries. Dr. Arnault Tzanck established the Emergency Blood Transfusion Society in France. And he was also an energetic, tireless, and positive thinker. He wrote: “The man is truly poor who does not know how to give.”

Americans adopted the blood transfusion services, too, but were different: remuneration was ok. So paying for blood began in America. And Oliver? The man who created the idea of a registry of blood donors, who worked endlessly, helping to save countless lives, never received any recognition in his lifetime! Thanks to Starr, he is now recognized as revolutionizing blood transfusion services.

(I’m headed for England next week, a country with many medical firsts, especially in any fields related to blood. I’ll blog from there next Sunday)

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