From:

The Boston Globe

August 8, 1999

Banking of cord stem cells stirs blood feud

By Tinker Ready, Globe Correspondent,

      When Dr. Michael Greene delivers babies, he usually removes the umbilical cord and sends it to the medical waste bin. But when he brought Heidi Maye’s son into the world in June, he reluctantly took an extra step. The obstetrician inserted a needle into the cord, drained it and emptied the blood into a sterile plastic bag.
    Maye had decided to pay a $1,000 collection fee and $95 a year to store her baby’s cord blood in a freezer in Arizona, even after Greene advised her against it. The odds, he said, are incredibly low that one of her three children will need the precious blood, which can be used instead of bone marrow to treat some cancers and a handful of other medical conditions.
    “I told her it was a waste of money,” said Greene, who practices at Massachusetts General Hospital.
    But Maye and her husband, both Andover-based high tech consultants, decided to do it anyway. “If I didn’t do it and something happened, I know I would torture myself,” Heidi Maye said. “So for us, it’s an insurance policy. What if someone you love is one of the statistics?”
     So goes the emotional and often bitter debate over the practice of saving a baby’s cord blood. Some doctors and scientists think cord blood companies, private firms that agree to bank the blood for possible future use, prey on parents’ worst fears to sell them something they’ll never need.
     Others think they offer a valuable, potentially life-saving service.
    All of this springs from the fairly recent discovery that cord blood can be used in transplants as a substitute for bone marrow. Like bone marrow, cord blood is rich in healthy stem cells, which doctors use to rejuvenate patients after high dose chemotherapy kills off diseased cells. As soon as scientists started getting results with cord blood transplants in the mid-1990s, in which typical rejection rates seemed to decline, storage companies with names like CryoCell, Viacord and Lifebank started setting up shop. Now they advertise their services in parenting magazines, physician waiting rooms and on the Internet.
     “When you save your baby’s umbilical cord blood, you may be saving your baby’s life,” reads the literature from Cord Banking for Life, a New York company.
   “May” is the operative word. Scientists have had remarkable success with cord blood transplants, but most of the research focuses on the use of blood from anonymous, unrelated donors. Several public cord banks collect the blood for anyone who needs it, including one now run by the American Red Cross at the University of Massachusetts in Worcester.
     But the key questions surrounding the practice of storing cord blood for family members remains unanswered. The transplants are still uncommon and experimental. They only work for a handful of relatively rare diseases. No one knows how long the frozen blood will remain viable. And, most important, no one knows yet whether your own stem cells - or those from a sibling or offspring -will work any better than those from a stranger.
     Still, the private banks are betting on it. “Except in the case of a few diseases, everyone knows that it is better if you have your own cells,” said Cynthia Fisher, the 38 year-old founder of one of the largest private banks, Boston-based Viacord. “The fact that the science is evolving only shows that it’s a very hot area.”
      But the few scientific studies that exist are inconclusive, say scientists in the field. Except for a single study of 145 patients, there is still no published data to compare the value of related cord blood to that from anonymous donors.
     Some researchers think the private banks are ahead of the science when they claim you’re better off banking a family members’ blood. But they face a quandary.
      “There is no data to say its worthwhile and no data to say it’s not worthwhile,” said John Wagner, a cord blood researcher at the University of Minnesota School of Medicine.
     But Wagner said it is essential for the private banks to be clear about what we know and what we don’t know.
That’s not happening in every case said Mildred Solomon, the director of The Center for Applied Ethics and Professional Practice at the Education Development Research, a Newton think tank.
     The group examined the industry’s advertising at the request of the National Institutes of Health. What they found, Solomon said, was troubling.
     “There were excessive claims that went beyond the current state of the science,” she said. “They implied far more experience in humans than had actually occurred”
     Still, for a handful of families, cord blood offers nothing short of a miracle.
     Kathleen DeJoria’s five-year-old son, Sonny, interrupted her while she talked on the phone to ask if he could eat his Cheerios outside in the yard while he played. Until recently, she wouldn’t have even considered it. Sonny was born with a genetic bleeding disorder and at one time, a bump on the head could prove fatal.
     “I would literally run after him, wait for him to fall and catch him,” the Oregon mother of two said. “I can now sit and watch him play.”
     That’s because doctors used cord blood from Sonny’s little sister to cure the boy. Before they heard about the procedure, the DeJorias had given up hope. Without a bone marrow transplant, the condition threatened to take Sonny’s life before his 20th birthday. They searched, but couldn’t find a matching donor.
    Kathleen was pregnant with her second child when she saw a television newsmagazine report on cord blood transplants. She was elated but her doctors were not. They told her it was experimental and dismissed it as an option.
   “Finally, somebody gave me a brochure and it was Viacord,” she said.
     The staff at Viacord put her in touch with doctors who tested her unborn baby. Although the odds were one in four, she was a perfect match for her brother.
     Looking out the window as Sonny chases one of the llamas Kathleen raises on her land, she said: “We spent years looking for a donor and right here inside me was the match...We feel blessed every day.”

    Dr. Greene, whose clutter-free office is located deep inside the maze that is Mass General, has no problem with parents who bank cord blood for a child who is already sick.
    “That makes all kinds of sense,” he said. “But to store the blood on the possibility that your child might develop one of the problems is way out. You’re really talking about very small numbers.”
    But Cynthia Fisher, the founder and enthusiastic promoter of Viacord, isn’t convinced. A fresh-faced former blood bank manager, she has invested a million dollars in family money in the business and has worked for years without salary because she is “passionate” about saving lives.
    Fisher said she has yet to make a cent.
    Her credentials include an MBA, not a PhD or an MD, but she can rattle off complex medical terms and refers to some of the top cord blood researchers by first name.
    “There will always be some that are skeptical and some who will be leaders in the field,” she said.
    She takes stock in the baby pictures and letters from satisfied Viacord customers that adorn the walls in her office. Since its inception in 1993, Viacord has banked blood for about 3,100 couples.
    About 70 percent of her clients have no disease in their families and, so far, none of them have needed transplants. The four transplants that used Viacord banked blood involved families whose already had a sick child. Two more operations are pending.
    For those who are banking on the future, Fisher is convinced that the current scientific evidence says that blood from relatives works better than blood from stranger. To back that, she points to a 1997 report in the New England Journal of Medicine that looked at death rates for transplant patients who received cord blood from strangers and those who received blood from family members. The one-year survival rate for the 78 patients who received cord blood from unrelated donors was 29 percent. For the 65 patients who received blood from relatives, mostly siblings, 63 percent were alive a year after the procedure.
    Viacord’s brochures cite the study, stating that cord blood transplants work better if the newborn and the transplantee are related.
    Scientists, though, warn against drawing conclusions from a single study, and the critics of private banking say that this particular study is far from the final word. It looked at a small number of patients and those who received unrelated transplants were much sicker than those who used cord blood from siblings.
     Like many other expecting mothers, Connie Rivera had to sort through conflicting reports and evidence to make her decision. She was 15 weeks pregnant with her first child when she picked up a Viacord brochure in her doctor’s office in Scituate. “We read up on it and none of the information was 100 percent yes or no,” she said. “The chance is so great that we’ll never use it so, for the money, we decided not to.”
    But at least she had the option, said Dr. Harvey Klein, the chief of the Division of Transfusion Medicine at the National Institutes of Health Clinical Center. He thinks that those who want to shut down private banks are being unfair.
    “What they’re saying is that we’re not going to give you the opportunity to make that choice, “ he said. “You don’t tell people that they can’t use a plastic surgeon if they don’t like their face. In some ways, this has larger health implications.”
    Klein worries more about quality - that some companies fail to collect the right amount of blood and fail to transport and store it properly. The Food and Drug Administration is still working on rules for cord blood banks that won’t be final for at least a year. In the meantime, private cord banks remain virtually unregulated.
    While Eva Guinan, director of the Bone Marrow and Stem Cell Transplantation program at the Dana-Farber Cancer Institute in Boston, agrees that we don’t know enough about related cord blood, she can appreciate its potential.
    “It’s easy to say they may be ahead of the game, but if you have a kid with a genetic disease, you’ve made a very wise decision,” she said.
 
This story ran on page C01 of the Boston Globe on 08/23/99.
© Copyright 1999 Globe Newspaper Company.