Is Money Tainting the Plasma Supply?
By ANDREW POLLACK
December 6, 2009, Eagle Pass, Tex.

Hundreds, probably thousands, of Mexicans come to the United States to trade their plasma for dollars at the border.

WHEN the tips her husband earned as a waiter began dwindling a year ago, Esmeralda Delgado decided to help support her family.

Twice a week, Ms. Delgado, the mother of three young girls, walks across the bridge from Piedras Negras, Mexico, where she lives, to Eagle Pass and enters a building just two blocks from the border.

Inside, for about an hour, Ms. Delgado lies hooked to a machine that extracts plasma, the liquid part of the blood, from a vein in her arm. The $60 a week she is paid almost equals her husband’s earnings.

“This is like another income,” she says.

Hundreds, probably thousands, of Mexicans like Ms. Delgado come to the United States to trade their plasma for dollars. Eagle Pass, a town of 27,000 that bills itself as the place “where yee-hah meets olé,” has two such plasma collection centers. There are about 15 others in border cities from Brownsville, Tex., to Yuma, Ariz.

The centers are run by pharmaceutical companies that transform the plasma into life-saving but expensive medicines for diseases like immune deficiencies and hemophilia.

Some border centers are new while others have been around for many years. They account for only a small percentage of the plasma collected by the industry, with the rest coming from collection centers throughout the United States.

But they have stirred debate in recent years because they illustrate the workings of the $12 billion plasma products business, a fast-growing industry that has depended on the blood of people hard up for cash. Based on typical industry yields and prevailing prices, it appears that a single plasma donation, for which a donor might be paid $30, results in pharmaceutical products worth at least $300.

Away from the border as well, many plasma collection centers have historically been located in areas of extreme poverty, some with high drug abuse. That troubles some people, who say it might contaminate the plasma supply or the health of people who sell their plasma.

“Why in the United States do we have to depend on people who are down and out to donate?” says Dr. Roger Kobayashi, an immunologist in Omaha who uses plasma products to treat many patients. “You are taking advantage of economically disadvantaged individuals, and I don’t think you are that worried about their health.”

Dr. Kobayashi, who also teaches at the University of California, Los Angeles, says the collections on the Mexican border skirt the policy aimed at keeping plasma products safe from pathogens by prohibiting imports of plasma. “If you can’t import the plasma,” he says, “why not import the donor?”

But the plasma companies and federal regulators say the practice is legal, ethical and safe. There have been no known cases of an infectious disease being transmitted through plasma products for more than a decade. And since the body quickly renews its plasma, the process is considered safe for donors if properly monitored.

“It’s not like giving up a kidney,” says Dr. Jay Epstein, director of blood research at the Food and Drug Administration, which regulates the collection centers and the plasma products.

The industry says the same precautions are taken at the border as everywhere else. “I don’t understand the difference between having a center in El Paso and having a center in Columbus, Ohio,” says Bruce Nogales, who runs plasma collection for Talecris BioTherapeutics, owner of the center that Ms. Delgado visits. Nine of Talecris’s 71 collection centers, including four new ones, are on the border.

Still, the industry has made a lot of efforts in recent years to shed its skid row image by building some centers in middle-class areas and by promoting altruistic reasons for donating plasma. Companies say donors now come from various walks of life.

The United States is one of the few countries that allows plasma donors to be paid. (And even here the plasma industry says it pays donors for their time, not for the plasma itself.)

But many of the countries that prohibit compensation do not collect enough plasma. So they rely on plasma or plasma products made from the blood of people who donate in the United States, which supplies more than half the world’s plasma.

“The U.S. is the OPEC of plasma,” says Jim MacPherson, chief executive of America’s Blood Centers, a network of blood banks.

FOR the plasma industry, times have been good. Growth has averaged 8 percent a year over the last two decades.

Talecris, a leader in the business, just raised $1.1 billion in an initial public stock offering. The transaction represented a handsome return for Cerberus, the private equity fund. Cerberus acquired what is now Talecris from Bayer in 2005.

To satisfy demand for plasma-based medicines, the industry has increased the number of collection centers to 408, from 299 in 2005, according to the Plasma Protein Therapeutics Association, the industry trade group. Paid donations in the United States rose to 18.8 million in 2008 from 10.4 million in 2005.

There are even a few signs that in areas hardest hit by the economic downturn, people who once donated blood without compensation to organizations like the Red Cross are selling plasma instead. “I know of five or six people who are multi-gallon donors who have switched to plasma,” said Doug Klynstra, recruitment manager for Michigan Blood, a nonprofit blood bank. He said the bank’s donations are down 10 percent this year.

The blood banks generally collect whole blood, which is separated into red cells, platelets and plasma and often used for transfusions. They almost never pay for donations because that might induce donors to cover up health problems that could make the blood unsafe.

The plasma companies, which collect only plasma, say that is less of a concern for them because their manufacturing process can kill many viruses and because they have more time to screen donors.

One donor who switched, despite Mr. Klynstra’s pleading, was his sister-in-law, Tina Dykstra, a 52-year-old grandmother. She started selling plasma two years ago when income from her husband’s electrical contracting business in Grand Rapids began falling. She makes $50 a week. But bonus payments she once received for being a frequent donor have been eliminated.

“Now, because it is so busy, they don’t have to give you incentives anymore,” Ms. Dykstra said.

Plasma contains infection-fighting antibodies as well as hundreds of other proteins. They are extracted from the plasma at plants like one in Los Angeles owned by Baxter International. There, steel tanks two stories high are filled with yellowish liquid — the plasma from thousands of donors — being slowly stirred by huge blades.

Among the products are albumin, which is used to help treat trauma and burn victims, and blood-clotting proteins used by hemophiliacs.

But the star product is intravenous immune globulin, or IVIG, which is used to treat an estimated 35,000 Americans with immune deficiencies. It can also help restore movement to some people with paralyzing neurological conditions and is being tested against Alzheimer’s disease.

Carter Dougherty, a 4-year-old from Lincoln, Neb., was constantly ill because his body lacked antibodies. “He had pneumonia three times in one year,” says his mother, Melissa Dougherty.

But since Carter started on IVIG in February, she says, “He’s naughtier than sin because he feels so good.”

IVIG can cost tens of thousands of dollars a year per patient. Clotting proteins for hemophiliacs can cost $100,000 to $350,000 a year. And many of the uses of IVIG are not approved by the F.D.A.

Insurers are becoming more reluctant to pay for such treatments, or are requiring higher co-payments, according to patient advocates. Ms. Dougherty was rejected three times before the insurer paid for Carter’s treatment, which costs $864 a week.

Another challenge could be antitrust scrutiny. The number of plasma product companies has declined from 13 in 1990 to 9 in 2003 to 5 now — Baxter International of Deerfield, Ill.; CSL of Australia; Talecris, of Research Triangle Park, N.C.; Grifols of Spain; and Octapharma of Switzerland. And the companies now own most of their own collection centers instead of buying plasma from independent collectors.

The industry “operates as a tight oligopoly, with a high level of information sharing,” the Federal Trade Commission said earlier this year in a lawsuit that broke up a planned $3.1 billion acquisition of Talecris by CSL. The lawsuit said that Baxter and CSL, the two biggest players, “even have explored means of punishing firms that dare to ‘break ranks’ and chase market share.” The F.T.C. dropped its suit when the deal was abandoned in June. But about a dozen hospitals have filed class-action suits charging that industry collusion has driven up prices of plasma products.

CSL said in a statement that the F.T.C. “did not claim that our company ever engaged in wrongdoing,” adding, “There is no question that the plasma industry is intensely competitive.” A spokeswoman for Baxter said the company had no idea what the F.T.C. was referring to and that the charge was not substantiated in the government’s complaint.

If there is a cartel, it is likely to be tested over the next few years because after several years of rapid expansion, plasma supply seems to have caught up to demand and could soon exceed it.

One sign is that in Eagle Pass, payment for two weekly donations has dropped to $60 from $80 earlier this year.

Early on a recent Tuesday evening, about 40 people were in the Talecris waiting room in Eagle Pass, sitting under a big sign reading: “Save lives. Earn money. Feel good.” Many of the people had just finished their shifts at Mexican factories.

In an adjacent room, about 70 people rested on vinyl beds, with a line connecting a vein in one arm to a machine. Many of the donors are regulars. “It’s kind of like ‘Cheers,’ ” said Ruben Duran, the center’s manager. “They come here and know each other.”

In 2007, Octapharma, which does not collect on the border, threatened to quit the plasma trade association, saying in a letter to the association that the border collections “compromised the fundamental ethics of our business.” But the other companies defended the practice and the matter was dropped.

One issue is whether novel pathogens that perhaps are found in Mexico but not in the United States might enter the plasma supply.

“That’s scary for the end users,” said Corey Dubin, chairman of the Committee of Ten Thousand, which represents hemophiliacs who, like Mr. Dubin himself, got H.I.V. or hepatitis in the 1980s from plasma products, before treatments were introduced to inactivate these viruses.

THE other issue is the safety of donors. Plasma is collected by drawing blood, separating out the plasma by centrifuge, and then returning the red cells, white cells and platelets to the body.

Some Americans have been giving plasma this way as often as twice a week for decades, with no apparent ill effects. But there have not been many studies devised to detect long-term effects. Germany allows people to give plasma this way only 38 times a year, compared with 104 in the United States.

The Mexican donors need visas that require they have a job and a permanent address. The donor’s health is checked on each visit, and each donation is tested for five viruses. Most of the Mexicans interviewed said they had no problems with donating, though it can sometimes leave them lightheaded if they don’t have adequate nutrition.

Reynaldo Bueno Sifuentes, who began giving plasma a year ago when overtime was cut at the auto parts factory where he works, said he did not take the recommended vitamins because they were expensive. He said the donations left him tired, and that when overtime was restored three months ago, he stopped selling plasma.

But many of the Mexican donors are worried less about their health than the possibility that immigration officials will decide the donations constitute work in the United States, in violation of their visas.

Some advocates for Mexican border workers see the plasma donations mostly as evidence of inadequate factory wages. “It provides a little escape valve” from economic hardship, says Ricardo Hernández of the American Friends Service Committee, which works closely with a Mexican organization, Comité Fronterizo de Obreras.

 Juan Carlos Torres, a 35-year-old father of three, started selling plasma when he lost his factory job three years ago. But he has continued to do so even after finding a new job because he doesn’t want to give up the extra income. To him, he says, “It’s a business now.”    

You can also read the story at this link: http://www.nytimes.com/2009/12/06/business/06plasma.html?pagewanted=1&hp

Note: the photographer took 100’s of photos and there is a multimedia slide show at the above site.