Dr. Louis Katz has witnessed the growing use of plasma-based protein therapies to treat life-threatening conditions, and it is a trend, he said, that makes it impossible for volunteer whole-blood donation centers to keep pace.
“The whole-blood sector can’t supply anywhere near enough plasma to support the need,” said Katz, executive vice president of the Washington, D.C., advocacy group America’s Blood Centers.
It is this increased demand for plasma, he said, that has prompted BioLife Plasma Services to begin construction of a second paid donation center in Fort Wayne, this one on Getz Road just south of Illinois Road.
Brian Kyhos, spokesman for Deerfield, Ill.-based Baxter International Inc., the parent company of BioLife, confirmed Katz’ assertion about the spike in plasma demand.
“Global demand for plasma-based therapies,” Kyhos said in an email, “continues to increase due to improved diagnosis and increasing awareness of immunodeficiencies.”
Numbers help tell the story of what is happening with plasma-based therapies. Kyhos said BioLife has “about 60” plasma donation centers nationwide — a review of the company’s online listing of locations places the number at 61 — and BioLife plans to open at least four more soon in addition to the one in Fort Wayne. The others are planned for Cedar Rapids and Waterloo, Iowa; Waite Park, Minn.; and Green Bay, Wis.
Nationally, according to the Annapolis, Md.-based Plasma Protein Therapeutics Association, the number of certified paid plasma centers has grown from 315 in 2006 to 402. The number of plasma donations, meanwhile, grew from 12.5 million in 2006 to more than 23 million in 2011, the latest year for which PPTA figures on donations were available. Baxter International officials offered few specifics about the new Fort Wayne center, which will augment another BioLife center at 7921 Coldwater Road.
They said BioLife centers average about 15,000 square feet each and the typical capital investment is $3 million to $6 million. The number of employees at a BioLife facility, Baxter officials said, ranges from 25 to 50.
Kyhos said the Getz Road center is expected to open “by the end of the year.”
Frequent BioLife plasma donors — those who donate up to twice a week — can expect to earn up to $200 a month, he said.
Plasma, a pale yellow liquid, makes up about 57 percent of whole blood. It is used by Baxter International to develop therapies to treat such conditions as hemophilia and provide support for immune systems through immunoglobulins, or antibodies, delivered intravenously.
The nonplasma cellular components of blood, such as red blood cells and platelets, are returned to plasma donors.
The more than 600 nonprofit whole-blood donor centers operated by members of Katz’ organization and American Red Cross blood donor centers also collect plasma as part of the total donation, but the priority uses for that blood are transfusions at health-care facilities.
If any plasma is left over, Katz said, it is sold by blood donation centers to companies that run paid plasma operations.
“That’s our end of the deal,” Katz said. “We have a moral and ethical obligation to our donors not to waste. We’re not going to throw away plasma we don’t need.”
One of the key differences between whole-blood and plasma collections is that the vast majority of people donating whole blood are not paid, and that underscores a long-running philosophical divide.
Katz and the American Red Cross believe paying donors runs the risk of passing along contaminated blood.
“When you’re answering health history questions, there is the possibility of giving false information so you can get paid,” said Christy Sabaka, spokeswoman for the Ohio Blood Services Region of the American Red Cross. “We want to provide the safest blood supply, and we believe the way to do that is if people don’t receive a monetary payment for their donations.”
Katz said paid-donation companies like BioLife are doing a “wonderful job” of putting into place procedures that ensure safety: “The way we screen and test donors (makes safety concerns) much less relevant.”
“But,” he added, “what about the next emerging infection we don’t have a test for?”
Baxter’s Kyhos, meanwhile, called donating plasma a “low-risk procedure with minimal or no side effects.”
He said that before a person is accepted as a BioLife Plasma Services donor, he or she must pass a medical examination, and a survey of the donor’s medical history is performed by a member of BioLife’s medical staff. During each subsequent visit, he said, “a staff member checks the donor’s vital signs and the donor answers questions about their medical history.”
In addition, periodic tests are performed on each donor to ensure donor health and acceptability for the plasma donating process.
Once donations are collected, Kyhos said, they are sent to a BioLife laboratory and tested for indicators of viral infections, including hepatitis and human immunodeficiency virus.
The U.S. Food and Drug Administration also vouched for the safety of donated plasma.
“There are numerous points at which safety measures are in place to minimize the risk of exposing recipients of blood products to infectious agents,” FDA spokeswoman Heidi Rebello said. “(The) FDA views the entire process as a continuum of interrelated steps. At each one of these steps, the agency has recommended or required safety mechanisms to decrease the risks associated with the use of blood products.
“As a result of these actions, we believe the United States has one of the safest blood supplies in the world.”
The safeguards that exist today and where plasma donor centers are being located, Katz said, may help dispel old stereotypes of plasma donors: indigent people from poor neighborhoods, some of whom are not healthy.
“To a degree,” Katz said, “that reputation was justifiable. (The centers) tended to attract people we didn’t want.”
Today, he said, plasma centers are locating in better areas “where donors are less likely to be infected.”
“It’s explicit,” he said. “It’s in their materials. It’s what they’re doing. I guarantee you, they’re not putting centers in crummy areas anymore.”
Kyhos said that is not a strategy of BioLife.
“BioLife centers,” Kyhos said, “attract a wide mix of individuals: blue- and white-collar workers, stay-at-home parents, professionals and individuals in the military, people from all walks of life.
“Donors have varying reasons for giving, including the self-fulfillment of knowing they are helping others and the opportunity to receive extra money, as well as the social aspects of donating.”
Whatever the case, Katz said that while it’s hard to predict the future needs for plasma, it’s possible plasma donations and the centers that collect the fluid will continue to grow.
“There are clinical trials in process using intravenous immunoglobulin for Alzheimer’s,” Katz said. “There are many other things being looked at, but nothing with the potential impact of that.
“One of the reasons they’re building that new center where you are is that they’re anticipating that level of increase.”