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By Jennifer Huget
When Cheryl Behler of Bear, Del., gave
birth two months early to her son Matthew in December 1999,
the last thing on her mind was sharing her breast milk with
someone else's baby. Then she saw the other infants in the
preemie ward at Christiana Hospital in Newark, Del., where
3-pound 6-ounce Matthew spent his first month.
"Some were crack babies, and some
were wards of the state," she says. "Some didn't
have a mommy. I felt really bad for them." Behler, whose
breast milk was abundant, says, "I thought it would be
nice if these babies could have some of my milk."
At almost any other hospital in the nation,
Behler's wish would have remained an idle one. But Christiana
was one of five hospitals in the United States (and the closest
one to Washington) that maintained a donor
milk bank; Behler was able to donate some 120 ounces
of milk.
While she never met its tiny recipient,
Behler says, "I felt so relieved that Matthew was healthy,
and I had joy in my heart. This was my way of giving back."
Elena Taggart Medo of Temecula, Calif.,
wants Behler's experience to become commonplace. Medo is raising
$6 million to launch Prolacta Bioscience Inc., an enterprise
that she hopes will make donating
milk as routine as giving blood.
The enterprise also could help fuel research
into potential applications for breast milk derivatives; some
believe these could have a use in drug therapies for autoimmune
diseases and the reduction of opportunistic infection after
transplant surgery. None of these applications can be fully
explored, says Medo, without a steady and reliable source
of human milk.
At the heart of the undertaking is an
emotional but contested presumption: that breast milk -- even
that which doesn't come straight from the source, but is pooled
with milk from other donors, sterilized and stored -- is uniformly
better than formula.
Medo holds that this is true. Others,
including William Klish, head of pediatric gastroenterology
and nutrition at Texas Children's Hospital in Houston, are
less sure. Says Klish, a former chairman of the American Academy
of Pediatrics nutrition committee, "I'm not sure the
risk/benefit ratio is in favor of the infant in using donor
milk."
Beyond overcoming such reservations, Medo
will have to reverse a decades-long trend to realize her vision
of having a nonprofit, hospital-based donor milk bank in every
major U.S. city. AIDS-era fears of infection have whittled
the US milk-bank community from dozens of facilities in the
1970s to the few that remain today.
That small number no longer includes even
Christiana Hospital: Citing financial and staffing issues,
the nation's oldest milk bank has stopped banking donor milk,
though it continues to help moms collect and store breast
milk for their own babies.
Medo's proposition faces significant business
challenges: As the nation's nonprofit milk banks (located
in Denver, Raleigh, San Jose and Austin) know, setting up
milk banks and keeping them funded, staffed and equipped is
costly.
In Denver, the Mothers' Milk Bank relies
on Presbyterian/St. Luke Medical Center for space and support
services it values at about $100,000 a year. Beyond that,
the milk bank's annual operating budget, including salaries,
lab work and screening, is $150,000.
To turn a profit for investors while funding
and advising the new milk banks, Prolacta aims to collect
a processing fee from banks in exchange for Prolacta's assuming
their operating expenses: Banks -- new or old -- would be
required to follow newly established protocols for donor screening
and milk processing.
Medo hopes also to sell a variety of human
milk-based products for medical uses other than feeding infants.
But this last part, in particular, goes
too far for old hands in the milk banking world, to whom it
smacks of paternalism -- or maybe maternalism.
"I am dismayed by the implication
that milk banks aren't following guidelines," says Mary
Rose Tully, chairwoman of the Human Milk Banking Association
of North America (or HMBANA, the organization comprising the
operating milk banks in the United States and Canada) and
director of lactation services at the University of North
Carolina hospital.
"That's simply not true."
All current milk banks, says Tully, have
physicians for medical directors and follow US Food and Drug
Administration (FDA) guidelines for screening donors (through
verbal health histories and blood testing), pasteurizing donated
milk, and examining processed milk for bacteria and viruses.
The conflict suggests that there are obstacles
to building a national milk donor network that
are easily as daunting as the business ones. Among the biggest
challenges faced by Prolacta and existing milk banks alike:
raising public awareness of donated milk's availability, utility
and -- most essentially -- its safety.
A Precious
Commodity?
A cell biology major in college and the
mother of four grown children, Medo, who develops medical
equipment for use by obstetricians and gynecologists, has
spent time in lots of hospitals. That experience, she says,
has convinced her of the value of human milk and made her
an evangelist for its use.
But evangelism, for all its emotional
appeal, doesn't always mesh with science. Consider Medo's
pitch for the benefits of breast milk:
"There
are at least 56,000 very low birth-weight kids born each
year who have a bad chance of survival if they don't get
human milk," Medo says.
"The immunoglobulins in breast milk
are the body's first defense against any kind of attack,"
she contends, adding that studies have shown that "breast
milk is the best thing for treating babies with necrotizing
enterocolitis," a digestive tract disorder that is a
leading killer of premature infants.
But Klish doubts whether donor milk, whose
quality is altered by pasteurization, confers any advantages
on preemies, and he says not enough is known about necrotizing
enterocolitis to determine the best course for its treatment.
Undaunted, Medo cites data from a 1988
study in the New England Journal of Medicine showing that
babies fed human milk containing "therapeutic levels"
of immunoglobulins -- the kind of protein-concentrated product
Prolacta will peddle -- get out of the hospital an average
of 21 days earlier than their formula-fed peers.
Drawing statistics from several other
studies, she calculates that feeding such a product to those
56,000 extra-tiny preemies alone would save $4.2 billion a
year in hospital charges.
While wide variations in the consumer
cost of formula make ounce-per-ounce cost comparisons tricky,
donor milk, which costs consumers about $3 an ounce, is generally
less expensive than highly specialized preemie formulas but
considerably pricier than standard formulas.
However, says Medo, the nutrients, proteins
and immunologic benefits of breast milk give it an edge over
formula. And while she allows that "mother's own milk,
fresh, is always going to be better than any processed product,"
she says donor milk poses no "issues of biological incompatibility,
like with blood typing," she says.
But nobody is yet sure that pasteurization
kills all the viruses that might pose threats to babies.
One place where formula does have an undisputed
edge over donor milk is in nutritional labeling, but Medo
hopes to erase that advantage by analyzing the components
of Prolacta's powdered milk and listing them. "That would
be interesting," says Klish.
"The Children's Nutrition Research
Center [affiliated with the Texas Children's hospital] has
spent a lot of time just trying to figure out what's in human
milk. . . . I don't know how [Medo] would construct a label
that would be meaningful."
Medo hopes her efforts to strengthen the
donor network will also encourage
more new mothers to nurse their own babies -- an
idea whose value no one contests. But some women, she says,
"don't or can't provide milk for their own babies.
Sometimes the mom has become ill, or has
been in an accident. . . . Some [new mothers] have a sharp
drop-off in supply after about three weeks. Some mothers who
can't be with their babies try to pump," but encounter
difficulties; others face "a drug habit, or another extreme
socioeconomic disadvantage."
And some women simply find the whole notion
distasteful. "With some moms, the neonatologist has to
take them aside and say, 'I don't care how disgusting you
think this is. You've got to produce at least a little bit
of milk for your baby,' '" Medo says, adding that when
that tactic fails, donated milk is the next best option.
Wet
Nursing Redux
"We feel like we're pioneering a
new area," Medo says, "Actually, though, it's an
ancient area that's been untapped and undeveloped."
Lois Arnold, a founder, former chairwoman
and current board member of the Human Milk Banking Association
of North America, says milk banking is a natural extension
of the practice of wet-nursing, which remained common in the
United States through the early 1900s.
Wet nurses, she explains, provided their
services either as businesswomen
paid to suckle other people's babies or through informal arrangements
among families and friends.
Arnold claims such arrangements still
exist in this country, but since they aren't sanctioned socially
or medically, they generally are kept private.
Wet-nursing is still widely practiced
in such countries as Cuba, Arnold explains, though the standard
practice there is for the "cooperating mother" to
express milk to bottle-feed, rather than directly nurse, the
receiving infant.
In the early 1900s, Arnold says, breast
milk was found to be the best treatment for infants' diarrheal
disease. This led to two different approaches to meeting the
growing demand for human milk, she explains.
In one instance, unwed mothers were given
free housing and pay in exchange for their wet-nursing services.
In the other, milk-bank representatives traveled through cities
collecting excess milk from nursing mothers to provide to
needy infants.
The latter method -- the first to separate
the product from the producer -- became the model for modern
milk banks.
This separation became the key to milk
banks' success -- and to wet-nursing's waning popularity.
As germ theory took hold in the late nineteenth century, hygiene
and screening issues arose. The advent of pasteurization,
which kills bacteria, gave milk banks the edge: Donated milk
could be pasteurized, while milk provided directly by a wet
nurse could not.
Milk banks
grew in number as the practice of wet-nursing dwindled early
in the twentieth century.
The emergence of neonatology in the 1970s,
with its promise of saving many premature babies, contributed
to milk banks' continued success, and by the mid-1980s, Arnold
says, there were as many as 30 in the United States.
That trajectory was abruptly reversed
when the AIDS epidemic sparked new concern about exchanges
of bodily fluids. At the same time, formulas were developed
to meet premature infants' needs.
"Overnight, the milk banks vanished,"
Arnold says.
Restoring
the Faith
In 1990 the few remaining milk banks worked
with the CDC and the FDA to develop safety guidelines that
might restore faith in donated milk.
Voluntary donor screening processes were
developed, and pasteurization
-- which kills bacteria and some viruses -- became
standard procedure. But the guidelines aren't enforceable:
Milk banks are free to follow them -- or not. The FDA "does
not regulate human milk banks right now," Medo says.
In the absence of federal oversight, Medo
suggests, hospitals may be understandably reluctant to use
donated milk, as they would be liable for any adverse outcomes.
One of Medo's chief goals is to work with the FDA to establish
universal safety standards and protocols (to be patterned
after the American Red Cross's blood collection procedures).
Lois Arnold currently serves as president
of the National Commission on Donor Milk Banking convened
by the American Breastfeeding Institute, a nonprofit organization,
to investigate quality issues in the collection and storage
of donor milk and recommending quality standards. (While she
and Medo both make clear that they have no official ties to
one another, Arnold acknowledges that her organization might
someday apply to Prolacta for grant money.)
As Arnold points out, the existing system
whereby milk banks voluntarily abide by self-imposed guidelines
leaves open the possibility that one or more of them might
opt not to follow the rules. And if one lets down its guard
when it comes to donor screening or pasteurization, the whole
system is threatened.
Although she and others note that there
are no known instances in which a baby has been sickened by
donated milk, Arnold isn't satisfied. If one baby were to
die because of bad donor milk, she says, milk banking in the
United States would come to a crashing halt.
Georgetown University Hospital ran a milk
bank until 1998, when corporate regrouping and lack of funding
shut the facility down. The hospital's new management is considering
reinstating the bank.
Nitin Mehta, a professor of pediatrics
at Georgetown and president of the National Capital Lactation
Center, says that with triple-screening (including scrutiny
of the donor's medical history, a physical examination, and
blood tests to rule out diseases and infections) in place,
he and colleagues "subscribe to a positive notion with
regard to the use of donor breast milk."
Mehta points out that although pasteurization
may compromise some of that milk's proteins and enzymes, the
other nutrients and fats don't seem to be affected by the
process.
"In the past 10 to 20 years we have
found more information about what is the goodness of human
milk," Mehta says. "The benefits seem to outweigh
the changes from heat treatment."
Still, Mehta explains that medical opinions
vary as to the safety of donated milk "because of things
we speculate, but don't know, about donors" and their
health.
Creating Demand
Despite such lingering questions about
safety, human milk banking has been on the rise during the
last three years: About 410,000 ounces were dispensed in North
America in 2000, up from about 225,000 in 1998, Arnold says.
While supply
and demand ebb and flow unpredictably throughout the year,
Medo says that the current problem isn't one of supply. "Milk
banks get more than enough donors. Women have been unbelievably
willing to donate." But processing the milk takes time
and money, resources that many milk banks find hard to come
by.
If supply isn't a problem, demand can
be. Ruth A. Lawrence, a neonatologist at the University of
Rochester School of Medicine and a member of the professional
advisory board for La Leche League International, a breast-feeding
advocacy group, notes that donated human milk is available
only by prescription, which means a doctor has to initiate,
or at least agree with, the decision to use it.
One of the biggest benefits of Medo's
scheme, she says, would be raising physicians' awareness of
donated milk's availability.
"Unfortunately, neonatologists don't
consider banked milk unless there's a bank in their community,"
Lawrence says. Even when a physician does believe human milk
could be a life-saver, she says, under current circumstances,
"somebody has to scramble around and find out where the
nearest bank is and how soon they could ship it out."
"If more milk were easily available
by calling one number, doctors would be more apt to use it
and their hospitals could start developing protocols for its
use," Lawrence says.
Nonsense, says Klish. "If they really
feel it's important for a patient to have human milk, any
pediatrician could find it," he says.
On the other hand, he acknowledges, targeted
marketing, as opposed to vague awareness-raising campaigns,
might boost donated milk's use.
That's just what Elena Medo has in mind.
So far, she says, Prolacta Bioscience Inc. has attracted about
10 investors, and the initial $6 million is nearly in hand.
Next she'll start raising the $17 million
she needs to build the plant (she plans to process only California
milk for the first five years) and start bringing out milk-derived
products. Some of that money will eventually come from processing
fees, she says; the rest, she'll have to raise.
Washington
Post September 4, 2001; Page HE01
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