[GRG] Understanding the mechanics of apheresis & plasma production

Here are resources that may help in understanding how apheresis
(plasma replacement):

 

http://ift.tt/1NAgac4

 

Excellent resource for information plasma, research and clinical:

 

 http://ift.tt/1FzIc23

 

This text is dated, but should provide some insight into commercial plasma
production:

 

http://ift.tt/1NAgac4

 

Where plasma comes from:

 

http://ift.tt/1NAgd7N

 

and:

 

 

http://ift.tt/1isNcJ3

The Twisted Business of Donating Plasma

Since 2008, plasma pharmaceuticals have leapt from $4
billion to a more than $11 billion annual market.
Donors desperate for the cash incentive from high-frequency “plassing” may be
putting their health, and the public’s, at risk.

I needed the cash.

That was how I found myself laying in a plasma “donation” room filled with
about 40 couches, each equipped with a blood pressure cuff and a centrifuge. A
white-coated attendant (workers aren’t required to have medical or nursing
degrees) pricked my arm. He separated my plasma from my whole blood into a large
bottle, and returned my protein-depleted blood, which flowed back into my arm to
rebuild my nutrient supply.

“My house is so noisy with four kids so I come here for my relaxation,” said
a middle-aged, haggard-looking woman on the next couch, the plasmapheresis
machine at her side whirring. A clinician instructed us both to pump and relax
our fists, like cows milking our own udders.

Before leaving I received a calendar that mapped out my pay, if I maintained a twice-weekly
schedule for subsequent donations. Even a $10 bonus on my next visit!

How did I get here? My rent was due. I had insufficient funds in the bank. I
was 48-years-old, a journalist running short on cash from writing assignments
and odd jobs. That was when I saw an ad offering $50 per plasma donation: blood
money, or more specifically, payment for my time and any small pain involved in
the process of having protein-rich plasma extracted from the blood. Regulars
call it “plassing.”

The ad I’d seen featuring smiling attendants suggested an experience similar
to one at a sedate hospital. The facility I entered buzzed like a school
lunchroom. There were first-timers waiting to complete the initial medical exam,
and regulars hurrying to check in at automatic computer terminals. Easily 50 to
60 “plassers” were present at any given moment, the crowd continually ebbing and
flowing. All were like me—hopeful, needy, and impatient to get paid.

I received an oral examination. I was not surprised by the many questions
about my sexual behavior, but I was taken aback by repeated questions regarding
tattoos. Three times I was asked if I had lied and “really” had tattoos. After
the clinicians tested a blood sample for protein levels, I underwent a
bare-bones medical checkup. But I questioned its efficiency given that my
examiner ran through scores of questions so fast I had to ask him to repeat
himself. I spotted a sign: NO PAYMENT UNLESS DONATION IS COMPLETED.

“Plassers” receive payments on a special debit card that extracts a surcharge
whenever they use it. Curiously, while my examiner hurried me through the
screening, he did patiently lay out the payment
scheme. Did he know how desperate I was? His “Don’t worry. You’ll pass” attitude
may have expressed condescension, unprofessionalism, or benevolence.

My extraction went smoothly. I left with a ray of hope that I could “plass”
next month’s rent money. The literature provided at U.S. centers ubiquitously
states that “donating plasma is safe.” Its side effects are limited to “mild
faintness and bruising.” (My brochure also added, “Other possible side effects
will be explained by our medical staff,” though I can’t say any such
explanation stayed with me.) But the following day my body received an impromptu
schooling in the price tag of the world I had entered.

It happened at about five o’clock the next day. Unexpectedly, with no
apparent cause or logical relationship to physical exertion, I felt my legs go
rubbery. I was Silly Putty. This was something more than “mild faintness” and
particularly disturbing because of the aspect of a random attack. I suddenly
felt so weirdly fatigued that I couldn’t stand on my feet. I barely reached the
couch before I passed out for five hours straight. Luckily, I was safely
ensconced at home. But since I substitute teach as well as freelance write I
woke up wondering: What would I do if that happened at my day job?

What had happened? I had received my welcoming to the subtle physical
changes, possibly exacerbated by work and poverty, which may be the upshot of
plassing. And my research began.

* * *

Biotest, CSL Plasma, Yale Plasma. These are some of the funny
corporate names that dot my state, New Mexico, and maybe yours. Or OctaPharma.
Or Biolife.Plasma reaped from paid U.S. donors makes up about
70 percent of worldwide
collections. The United States is conversationally known in the industry as “the
OPEC of plasma collections.”

But why plasma?

Proteins in the plasma collected at places like Biotest are necessary for the
manufacture of a wide range of pharmaceuticals produced by for-profit
corporations. The industry burgeoned in the 1950s thanks to a boom in new drugs
for hemophiliacs. Plasma centers have historically worn the scarlet letter in
the blood-collection universe.

Hospitals, Red Cross units, and nonprofit agencies relying on voluntary
donations reject the plasma center model because cash incentives for whole blood
may give donors an incentive to lie, heightening risks of a tainted supply. Such
risks are higher overall for whole blood, too.

Prior to the AIDS crisis, plasma collection practices were often under the
table, but the medical community still operated under a general assumption that
those standards for plasma were good enough. The assumption proved disastrously
wrong. Industry practices eventually cost the hemophiliac community dearly.

Throughout the ’60s and ’70s, plasma companies minimized their own overhead
costs by relying on chancy prison populations paid a pittance: $5 to $10 dollars
per “plassing” donation. Roughly 50 percent of American hemophiliacs contracted
HIV from bad plasma-based pharmaceuticals (a much higher infection rate than
that suffered by gay men at the time), making worldwide plasma medication HIV
outbreaks the industry’s most publicized scandal.

People with hemophilia filed class-action suits. These included substantial
evidence that a major plasma company continued to distribute “old supplies” of
bad medications after becoming aware of the AIDS infection. The public was
dismayed to discover that the industry operated under the protection of federal
and state blood shield laws, limiting its liability.

By the 1990s, the industry’s public reputation reached a low point, with
American collections dwindling, U.S. federal regulators clamping down, and
revelations coming to light that spoke poorly of industry oversight and
humanitarianism. Even before the AIDS crisis devastated U.S. plasma collections,
other controversies, such as incidents of hepatitis C infection in plasma
pharmaceuticals, led corporations to keep overhead low and avoid regulation by
transporting the payment-incentives collections system to penniless countries
abroad.

In the 1990s, China attempted to develop a plasma market to compete with
Western companies by touting money for plasmapheresis in China’s most
impoverished province, Henan. Villagers that were too poor to afford condoms
soon realized they could earn more money by selling plasma than by farming the
land, but the facilities offered substandard sterilization techniques, needles,
and blood bags. By 1995, Henan Province had become a blood farm built on a
criminalized plasma economy. Thousands of Chinese donors became infected with
AIDS and Hepatitis C.

Today, many plasma products for hemophiliacs have been outdated by medical
advances, but the industry thrives producing albumin for burns and intravenous
immunoglobin, used to treat immune disorders and neurological conditions. The
industry has returned to the United States in a big way with the help of
brighter, user-friendly advertisements that include appeals to public service
and reminders of the economy’s downfall to encourage donors. The number of
centers in the United States ballooned during the Great Recession, with 100 new
centers opening and total donations leaping from 12.5 million in 2006 to more than
23 million in 2011.

Monopolization has transformed the industry, which now consists of five
international corporations operating in the United States under Food and Drug
Administration regulation: Baxter International of Deerfield, Illinois; CSL of
Australia; Talecris of Research Triangle Park, North Carolina; Grifols of Spain;
and Octapharma of Switzerland. A possible sixth big player is Biotest AG, the
for-profit arm of a Dutch nonprofit corporation, Sanquin. Since 2008, plasma
pharmaceuticals have leapt from an approximate $4 billion to a more than $11 billion annual market.

* * *

Santa Fe, New Mexico, where I live, has a crowded but reasonably clean
Biotech Plasma center. But the state’s largest city, Albuquerque, population
552,804, has three plasma centers that would have challenged my willingness to
“plass” no matter how needy I was. Yale
Plasma, located on a strip where panhandlers convene, resembles
a pawn shop. The exterior window sports a motto for in-house lotto games; the
interior is remarkably cramped. Another Albuquerque center, CSL Plasma, is
larger, but has no chairs. Donors crouch on the floor, or stand in long lines
until they plass. Asking a young man if he minded squatting, I’m told CSL
removed the complementary seating to “keep the bums out of
here.”

Plasma is “pooled” or collected in containers to prepare it for a process
called “fractionation,” which will render it usable. The bigger the plasma
pools, the cheaper they will be to process—which Dr. Lucy Reynolds, a research
fellow at the London School of Hygiene and Tropical Medicine, cites as an
example of the industry cutting corners.

Large pools maximize profits. Furthermore, although large pools are subject
to advanced safety analyses (21st-century viral testing has made Hepatitis C and
AIDS contamination rare) health officials have raised the concern that as market
plasma spreads globally, the harm that could result if another AIDS-like
pathogen infiltrated the system would be exponentially greater.

“Certain governments are people and people’s-rights centered,” says Reynolds,
who recently published a
paper castigating the plasma
trade. “In those places they make the plasma corporations play by the rules;
sometimes they just choose to have as little as possible to do with them. But
the United States is a corporate country”—that maintains the Western world’s
least restrictive plasma regulations.

U.S. centers also have a policy assured to reel in those with an ongoing,
immediate need for small sums of cash: $50 for the first five donations, then
$60 a week if you willingly go under the needle twice a week.

“I call it a grubby business because they knowingly endanger the health of
donors in the U.S. by harvesting them twice a week, while in every other place
in the world you’re only allowed to donate fortnightly, ” Reynolds says.

I interviewed plassers in Albuquerque but, given that my questions included
asking if they lied to pass medical examinations, the people I spoke with often
asked me not to use their last names.

“Going into the center makes me feel like a lab rat,” says Ron, a 33-year-old
single father and unemployed schoolteacher, who began regularly plassing six
years ago to make ends meet for his new son. He was disqualified at a local
center because he had many visible tattoos, but accepted at another center “that
was less picky.” Ron reports no particular bad side effects but still worries.
“They tell me there are no long-term effects but the answers they give at these
places are so robotic.”

A haggard man with bloodshot eyes standing outside the CSL center identified
himself as “Bubba,” and said he was homeless and an alcoholic. He had suffered a
serious head injury in youth and had been plassing for nearly 15 years with no
ill effects other than “sometimes my arm hurts really bad.” He also continually
falls asleep on the couches. In fact, Bubba once collapsed in the standing lines
at CSL, but he appreciated the extra cash. He says he was unhappy when he had
been drinking too much to pass the protein level test, but claimed he later
discovered, “If I swallow ketchup before going in I can pass any test they throw
at me.”

Bubba was cognizant that donors who were
homeless, alcoholic, or had suffered head injuries like his own were, in theory,
barred. “Everybody lies,” he said.
“Nobody is honest on all those questions.”

I left the conversation wondering whether Bubba was an example of why other
nations don’t want to expose their citizens to the commercial plasma trade, and
many make (increasingly unsuccessful) efforts
to limit imports of commercial
plasma from the United States.
Should a homeless alcoholic be banned from plassing for his safety and ours?

Gabriella, a 51-year-old mother of three, began plassing eight years ago
after she was laid off in a cut-back of state government employees. She admits
to having lied to pass the screening after realizing that she had become too
thin to pass the weight test, and “put on extra
clothes, just to squeak past the weight minimum” of 110 pounds. Gabriella knows
other regular plassers, often homeless, who use ankle weights.

Kevin Taylor, a 27-year-old student at the University of New Mexico, plassed
to meet expenses, but found that over two years of plassing he lost 15
pounds.

“I definitely wasn’t eating regular meals, and I think the pressure of
keeping up my two donations a week was making me sick,” he says.

Kevin Crosby, 48, began plassing 10 years ago to provide for his six-year-old
daughter.

“Every time I’ve had this weird hollowed out feeling. And a lot of times the
next day I will have serious fatigue,” he says. “Then, about five years ago when
I was working night shift at a security job, I had that weird fatigue. I don’t
know what hit me but I woke up on the floor. They accused me of falling asleep;
I know I blacked out.”

Crosby has had several blackouts, including one that hit when he was
driving.

“I had to pull over,” he says. “I had to sit there several minutes in a daze.
It really freaked me.”

The fact that other Western nations adopt a “better safe than sorry” attitude
(when they sanction commercial collection centers at all) by insisting on
two-week intervals between donations should raise eyebrows about U.S. practices.
Many people I interviewed left me questioning whether, when poverty is the
primary motivation, the advisability of twice-weekly plassing should be
reconsidered. Not to mention the other likely health complications donators may
suffer from, including stress, poor nutrition, and inadequately or untreated
medical conditions.

All told, I interviewed almost three-dozen regulars at CSL and Yale Plasma.
More than half of them confessed to frequent, bizarre tingling sensations,
pains, rubbery legs, and severe dehydration, as well as to having been homeless,
having lied to pass medical exams, and having used “tricks” that allowed them to
pass protein-level tests. They lived in circumstances that made plassing a
hardship, but said, “I can’t eat if I don’t plass.”

I described the experiences above to medical historian Harriet A. Washington,
author of Deadly
Monopolies and Medical
Apartheid: The Dark History of Medical Experimentation on Black
Americans. Washington
said, “Our blood supply is now very safe, although not perfectly so.” Hepatitis
C and HIV infection are as rare as 1 in
every 1 million blood
recipients.

Washington is not opposed to payment centers that observe safety standards
and adhere to regulations. Neediness and economic hardship don’t necessarily
make a donor unsafe, which is a historic prejudice. The crux, Washington says, “is how we screen
donors.”

“If these companies are winking at donors’ deception, then they’re putting us
all in serious danger. In an ideal world, I’d want more government oversight to
closely monitor these collection sites.”

Why do donors, including myself, suffer fatigue akin to blackouts? During plasmapheresis, centers often use a chemical,
sodium citrate, to keep blood from clotting, Washington explains.

“Sodium citrate and other citric-acid
derivatives bond with the calcium in your blood, and afterwards the calcium is
no longer available to your body. We know that some people respond badly to
sodium citrate. The worst case is rare: extreme hypocalcaemia, which can be
fatal. But more often, people will suffer fainting, tingling and numbness,
muscle contractions, or even seizures. Walking around with depleted calcium can
be extremely dangerous. It can lead to serious healthcare issues.”

These issues include: heart arrhythmias,
seizures, osteoporosis, eye strain, breathing problems, brittle bones, and
chronic kidney conditions.

A summary of a 2005
report by Jeffrey L. Winters
published in the Journal of
Clinical Apheresis states
that “the most common aphaeresis-specific reaction is hypocalcemia due to
citrate anticoagulation, which, while usually mild, has the potential for
severely injuring the donor.” In fact,
Winters writes, compared to whole-blood donations, “the risk of reactions
requiring hospitalization is substantially greater.” Plasma centers that don’t
inform donors of these risks are abrogating patients’ medical rights—yet none of
the people I interviewed who experienced “funny fits” or weird tingling
sensations were knowledgeable of the possibility of hypocalcaemia.

Several reported that they had inquired about
such symptoms at centers but were given absolute guarantees of safety. And it
seems preposterous to expect them to diagnose themselves when centers
prominently display statements like the following one from a Baxter Inc. press
kit: Donating plasma is a low risk procedure with minimal or
no side effects.

I sat in a pizza parlor with Kevin Crosby near the Yale Plasma center. He
rolled up his sleeves and showed me a huge sore where 10 years’ of needles have
gone into his arm.

“I never in my life thought I would have to do this to survive,” he said.
“A lot of the staff aren’t competent with the
needles. People get jittery talking about that stuff, but a lot talk about how
much money they make off us. I say, if they’re going to exploit us they could at
least pay us. I say they could pay us $100 for twice a week.”

Crosby has also always been pestered by doubts:
Why does he have black outs, and how safe is this plasma? Looking at the suspect
patrons, “you can tell something is wrong with them,” he says.

I tell Kevin about the industry’s history of negligence: the tragedies in
South America, the American prison collections, and the AIDS outbreak among
hemophiliacs who received medications tainted because the industry put market
share above safety controls. I explain that today the monopolized industry
harvests in the U.S. because only the FDA will allow them to reap enough plasma
to support an international market. Nowhere else in the West believes
twice-a-week donations are advisable, and the international community isn’t as
sanguine regarding detrimental health effects. Kevin’s blackouts are probably a
bad reaction to an anticoagulant, sodium citrate.

“I have read every word of every paper I’ve signed at CSL and Yale,” Kevin
claims. “I haven’t seen a mention about this.”

Critics today still question the wisdom of cutting costs by maintaining
massive plasma pools. Safer systems operate on a not-for-profit basis, and only
require sufficient amounts of plasma to meet domestic needs. A 2005 report published
by writers at Ghent University in Belgium says that in Belgium, “approximately
5,000 donations are mixed into such pools. In Germany, pools containing up to
60,000 donations are considered.” In the United States, “some donor pool sizes
are in excess of several hundred thousand [donations]. ”

The authors recommend alternative pooling strategies because the “risk of
contamination of these pools increases rapidly with the pool size.” Zealous
precaution today could spare us untold misery tomorrow.

“Hearing all this,” says Crosby, “I never want to walk into those places
again.”

This piece was supported by the Economic Hardship Reporting
Project, a journalism non-profit dedicated to stories about
inequality.

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About Johnny Adams

My full-time commitment is to slow and ultimately reverse age related functional decline to increase healthy years of life. I’ve been active in this area since the 1970s, steadily building skills and accomplishments. I have a good basic understanding of the science of aging, and have many skills that complement those of scientists so they can focus on science to advance our shared mission. Broad experience Top skills: administration, management, information technology (data and programming), communications, writing, marketing, market research and analysis, public speaking, forging ethical win-win outcomes among stakeholders (i.e. high level "selling"). Knowledge in grant writing, fundraising, finance. Like most skilled professionals, I’m best described as a guy who defines an end point, then figures out how to get there. I enjoy the conception, design, execution and successful completion of a grand plan. Executive Director Gerontology Research Group (GRG). Manages Email discussion forum, web site, meetings and oversees supercentenarian (oldest humans, 110+ years) research. CEO / Executive Director Carl I. Bourhenne Medical Research Foundation (Aging Intervention Foundation), an IRS approved 501(c)(3) nonprofit. http://www.AgingIntervention.org Early contributor to Supercentenarian Research Foundation. Co-Founder Geroscience Healthspan Forum. Active contributor to numerous initiatives to increase healthy years of life. Co-authored book on conventional, practical methods available today to slow the processes of aging – nutrition, exercise, behavior modification and motivation, stress reduction, proper supplementation, damage caused by improper programs, risk reduction and others. Fundamental understanding of, and experience in the genomics of longevity (internship analyzing and curating longevity gene papers). Biological and technical includes information technology, software development and computer programming, bioinformatics and protein informatics, online education, training programs, regulatory, clinical trials software, medical devices (CAT scanners and related), hospital electrical equipment testing program. Interpersonal skills – good communication, honest, well liked, works well in teams or alone. Real world experience collaborating in interdisciplinary teams in fast paced organizations. Uses technology to advance our shared mission. Education: MBA 1985 University of Southern California -- Deans List, Albert Quon Community Service Award (for volunteering with the American Longevity Association and helping an elderly lady every other week), George S. May Scholarship, CA State Fellowship. BA psychology, psychobiology emphasis 1983 California State University Fullerton Physiological courses as well as core courses (developmental, abnormal etc). UCLA Psychobiology 1978, one brief but fast moving and fulfilling quarter. Main interest was the electrochemical basis of consciousness. Also seminars at the NeuroPsychiatric Institute. Other: Ongoing conferences, meetings and continuing education. Aging, computer software and information technology. Some molecular biology, biotech, bio and protein informatics, computer aided drug design, clinical medical devices, electronics, HIPAA, fundraising through the Assoc. of Fundraising Professionals. Previous careers include: Marketing Increasing skill set and successes in virtually all phases, with valuable experience in locating people and companies with the greatest need and interest in a product or service, and sitting across the table with decision makers and working out agreements favorable to all. Information Technology: Management, data analysis and programming in commercial and clinical trials systems, and bioinformatics and protein informatics. As IT Director at Newport Beach, CA based technology organization Success Family of Continuing Education Companies, provided online software solutions for insurance and financial professionals in small to Fortune 500 size companies. We were successful with lean team organization (the slower moving competition was unable to create similar software systems). Medical devices: At Omnimedical in Paramount CA developed and managed quality assurance dept. and training depts. for engineers, physicians and technicians. Designed hospital equipment testing program for hospital services division. In my early 20’s I was a musician, and studied psychology and music. Interned with the intention of becoming a music therapist. These experiences helped develop valuable skills used today to advance our shared mission of creating aging solutions.
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