Since there has been some discussion of Prolacta 
on the list, I thought you might be interested in 
this article that appeared in the San Diego 
Union-Tribune.

http://www.signonsandiego.com/news/northcounty/20060212-9999-
lz1n12milk.html

Breast-milk enterprise raises concerns among those who view
collection and distribution as a philanthropic endeavor

By Deborah Ensor
UNION-TRIBUNE STAFF WRITER
February 12, 2006

Two North County businesses are part of a nascent effort to
commercialize human breast milk, needed for babies who are not
thriving or whose mothers can't supply it.


LAURA EMBRY / Union-Tribune
Machinery to process donated breast milk is tested and observed by
(from left) Raymond Ortega, Jose Maldonado and Armando Montoya at the
Prolacta Bioscience facility in Monrovia. The company intends to sell
its product to hospitals to feed low birth weight and critically ill
babies.
The milk they are collecting from volunteer donors in Escondido and
Encinitas will become a branded product, marketed to hospitals and
doctors at about 10 times the cost of milk now provided through
nonprofit community milk banks.

The two collection centers are affiliated with Prolacta Bioscience, a
privately held California company selling its own brand of milk,
Prolact-22.

"What we are doing is a very large paradigm shift in the way people
think about milk banking," said Elena Medo, 51, of Murrieta, founder
and chief executive officer of Prolacta. "In a couple of years, there
will be hundreds of milk banks. Every community that has sick babies
should have milk banks."

Prolacta's enterprise has raised concerns among those who view the
collection and distribution of human milk as a philanthropic
endeavor.

"If somebody is doing this as a for-profit thing, this is a major
shift," said Pauline Sakamoto, vice president of the nonprofit North
American Human Milk Banking Association. Founded in 1985, the
association and its 11 member milk banks previously provided all of
the U.S. supply.

Sakamoto is also executive director of Mothers' Milk Bank in San
Jose, which has been in operation for 31 years. It is the only
nonprofit processing and distributing facility in California.

"We are not making a profit. That's not our goal," Sakamoto said. "We
are providing a service to the community. It really is a labor of
love and a balancing act."



LAURA EMBRY / Union-Tribune
In addition to feeding her 1-month-old son, Hudson, Tracy Daugherty
pumps an extra 4 to 5 ounces a day and donates it to Two Maids A
Milking in Encinitas, a for-profit business affiliated with Prolacta
Bioscience. "It's along the lines of giving blood," Daugherty said.
One fear is that Prolacta, with the potential for many more
collection sites and with advertising clout, will compete for a
limited number of donors.

Prolacta's first affiliates in San Diego County, The Pregnancy Care
Clinic Milk Bank in Escondido, which operates out of a nonprofit
clinic, and Two Maids A Milking, a for-profit business in Encinitas,
opened in December.

Medo said they are just the beginning – a dozen more are set to open
within the next few months, from Alaska to Alabama. More than 60
hospitals have signed up to house the collection centers and to use
Prolacta's milk; another 60 are ordering the company's product.

Previously, Sharp's Mary Birch Hospital for Women in Kearny Mesa was
the only state-licensed facility in the county where mothers could
donate breast milk. The Mary Birch collection center ships the
donations to Mothers' Milk Bank in San Jose.

"This is set up as a kind of adversarial thing," said Dr. Nancy
Wight, a neonatologist and medical director of lactation services at
Mary Birch. "It is setting up a competing collection system. ... It's
a little disconcerting to those of us in the nonprofit world."


A better breast milk?
Donated breast milk is most often prescribed for low birth weight and
critically ill babies. The mothers of premature babies often can't
produce enough milk, or sometimes any.

A doctor must write a prescription and the cost is covered by most
insurance programs. The milk sells for $3 to $3.50 an ounce, which
the milk bank association said doesn't cover the cost of processing
it.

In 2005, Sakamoto's San Jose milk bank dispensed more than 103,500
ounces. Nationwide, the output was more than 700,000 ounces. Those in
the nonprofit industry say there is enough supply to meet the current
demand.

Now doctors can order from Prolacta.

Elena Medo
Prolact-22 is formulated for very low birth weight babies who weigh
less than 1,500 grams, about 31/4 pounds, the company said. A dose of
Prolact-22, about one-third of an ounce in a syringe, costs $10.
Premature babies use 8 to 10 doses a day.

Prolacta contends its milk is superior to that from nonprofit banks
because it is pasteurized and processed in large tanks rather than
small bottles, allowing for consistent levels of calories, protein
and fat, all stated on a nutritional label.

Prolact-22 has 22 calories in each 10-milliliter dose, compared with
a range of 15 to 20 calories for generic breast milk, because fat is
separated out and added back later.

"Neonatologists really want a nutritional label," Medo said. "They
want to know that what they are getting today is the same as what
they will get tomorrow."

Medo's company is convinced there is a vast breast milk market to be
served. If all very low birth weight babies in U.S. hospitals were
given breast milk instead of the current standard of a formula
designed for premature babies, Prolacta said, the existing nonprofit
milk banks could supply less than 1 percent of the demand.

The company said it plans to produce 1 million doses, about 330,000
ounces, this year and can process up to 30 million doses – enough to
feed 100,000 premature babies for a month.

To reach its goals, Prolacta is targeting doctors who prescribe
formula, reasoning that they may have doubts about the safety of the
donated breast milk currently available.

Medo said samples from each batch of Prolacta's product are sent to
independent certified laboratories to test for viruses and validate
the nutritional label. This testing, Medo said, is what warrants the
higher price and is why doctors will buy it.

"They are responding to us because they like our approach, a
biopharmaceutical approach with all the testing and safety," she
said. "We are just raising the bar."

Those in the nonprofit world say they already follow strict quality
and safety standards.

"There is a set of guidelines that (the milk bank association)
updates every two years, adding new research," Wight said. "Prolacta
is trying to imply that milk being gotten already is not safe, but
it's as safe as we can possibly make it."


Mom is businesswoman
Medo's interest in breast milk began after she had her third child.
She was working for the stock exchange in Canada and had to use a
breast pump. She found the device difficult, so she designed her own.
It became so popular she started a company and patented the pump in
1986.

Medo's dream to modernize the donor breast milk industry grew from
there. In August, her company opened a $4 million, 15,000-square-foot
processing facility in Monrovia, east of Los Angeles.

To collect milk, Prolacta is creating a network of centers across the
country. It invests up to $20,000 per site, supplying all the
equipment – blood-testing devices, freezers, breast pumps, computers
and a donor-management system – as well as the training and licensing
fees. Prospective donor mothers are screened, given donor numbers and
tested for HIV, hepatitis and other diseases. They must have
permission of both their own physician and their baby's doctor. They
receive a free breast pump, and freeze their excess milk at home for
up to a week. Then they take it to a local collection center.

Mothers are paid nothing for their milk, but Prolacta pays its
centers – some are nonprofit, some are small for-profit businesses –
from 50 cents to $2 an ounce.

Karen Plevyak, director of the new Escondido clinic, said the revenue
it makes from selling milk to Prolacta will help fund a nonprofit
pregnancy clinic and free parenting and breast-feeding classes.

"Our goal as educators is to encourage moms to breast-feed to a
year," said Plevyak, also a certified lactation educator.

Norma Castillo, who donates at the Escondido clinic, said she
remembers when she was 10 watching her mom go back and forth to the
hospital every day, taking milk to feed Castillo's sister, Alicia, a
twin born 3 months premature. The other twin, Elena, didn't survive.

Alicia, now 26 and healthy, is why Castillo is donating milk now. "It
feels so good to think of all these little babies in the hospital
getting help," Castillo said.

Two Maids A Milking in Encinitas offers free classes to moms and free
milk pick-up.

"We want to help as many babies as we can," said Kim Henson, the co-
founder.

Its first donor, Tracy Daugherty, is nursing her baby, Hudson, and
pumping an extra 4 to 5 ounces a day.

"It's along the lines of giving blood," Daugherty said. "It's
something I can give. Maybe I don't have a lot of money, but I can do
this. I know I'm going to help a lot of little babies."


Business shift needed?
Like Daugherty, most who donate do so out of a sense of altruism.

"Women who become donors are very much the same as philanthropists,
but they are using milk as currency," Medo said. "They are not
wealthy, but really, really rich in generosity and good milk supply."

The nonprofit association worries that making milk a commodity might
put donating mothers and their babies in danger.

"A medical institution, which is given incentives to provide a
specific volume of milk, may pressure mothers of patients to become
donors regardless of their own infants' needs," the association said
in a statement.

Medo said she understands the concerns but doesn't see any other way
for the industry to thrive.

"Whether or not anyone agrees with our way of doing things, we have
done more for the development of human milk than has been done in the
last 50 years," she said. "We have spent more time, energy, research
and money to make sure there is a donor milk doctors can trust. ...
There is no way to provide the type of product we wanted to provide
under a nonprofit business model."

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