Wednesday, October 30, 2013

Bovine colostrum marketers - modern 'snake oil' salesmen?

The term "snake oil salesman" has become so ubiquitous, most of us don't really even think about how it came about. We're a long way from the days when travelling hucksters crossed the continent peddling secret formulas for dubious supplements designed to cure all that ailed us.
Travelling "snake oil" salesman.


Or are we?

The modern version of the snake oil salesman is alive and well and living on the Internet. Fronted by "non-profit" entities, these folks will sell you pills, recipes, cookbooks, lifestyle plans, all sorts of cures for what ails the modern man, woman, and child.

It's not illegal to push a lot of these products, and they often pose more of a hazard to your pocketbook than your  health. Caveat emptor. But some products can pose a hazard to human health.

Last week we had headlines warning families against the purchasing of human milk from anonymous sources via the Internet. "Moms beware..."  "Dangerous bacteria..." "Breast milk sold online may have harmful bacteria..." blared the headlines. (See my blog post "Something smells off and it's not the milk."

This week we have a helpful not-for-profit organization with the "vital health news" that donor breast milk is "contaminated." The CDC says so! (Not.) Oh no! But wait, there's more. Bovine colostrum to the rescue! You don't have to buy that dangerous, icky, filthy human milk. You can purchase quality cow colostrum for your baby!

Product sales website warning of "New CDC Research showing "contaminated" donor breast milk.
Our regulatory agencies have spent quite a bit of energy warning families of the dangers of feeding their babies human milk that is not obtained from milk banks.

These same bodies govern how infant formula is manufactured. In 81 countries around the world of there are outright laws preventing the marketing of products like this. In North America our health authorities have declined to ban the marketing of these products, but they have asserted their regulatory authority over the kinds of ingredients that can be included in breast milk substitutes, and they monitor the manufacturing of infant formula to try to keep dangerous pathogens from harming newborn infants.

The FDA was pretty quick to warn families about milksharing and the concerns about of the anonymous purchase of human milk when the practices first hit mainstream news. But it provided no guidelines to help families reduce their risk - they just said nope, don't do it, even though they don't actually regulate the donation or sale of human milk. (They considered it in 2010, and the study that generated the headlines above has called for the FDA to consider their research in any future discussions on regulation.)
Emma Kwasnica, founder of HM4HB,
wet-nursing her the child of a friend
hospitalized for a health emergency.
Peer-to-peer milksharing
networks drew warnings from
Health Canada, the FDA, and
France's health authority when they
became popular 3 years ago.

So, the question is, how fast will the FDA jump to warn consumers about the dangers of using this product as a substitute for mother's own milk? China has banned bovine colostrum as an ingredient in infant formula. Will the FDA move to bring this product into compliance with its rules?

Monday, October 21, 2013

Something smells off and it's not the milk!


We learn at a pretty young age that milk left out on the counter, or too long in the fridge, goes off. I don't have a single child that doesn't eyeball the carton before they pour milk onto their cereal, and they give it a sniff if they're not sure. And if it's been sitting out? Nope, they're not touching it. In fact, my kids are very likely to go "eww" if a carton of yogurt has gone past its best before date, despite my protests: "It's yogurt, it's supposed to be full of bacteria. It's healthy bacteria! That's a BEST BEFORE date, it doesn't automatically go bad at midnight. Gaah!"

Yet, apparently, when my children become adults, and then parents, they will have lost every bit of wisdom they've learned growing up and they'll become incapable of determining how to safely feed their babies. They will have no capacity to distinguish between borrowing a cup of milk from the neighbour, and grabbing a carton that's open and been sitting in a dumpster.

At least, that seems to be the conclusion drawn by some after reading a new study published in Pediatrics today out of the Nationwide Children's Hospital in Ohio. Researchers looked at several hundred classified ads listing human milk for sale and offered to buy. They responded only "to ads from sellers who did not ask about the infant receiving milk and who did not require a phone call before a transaction was made" and directed sellers to ship the milk to a PO Box in Ohio. Some of the milk was shipped in a liquid state, some frozen milk wasn't protected during shipment and thawed before arrival, and it appears that some sat for as long as six days before being tested. Nobody knows how the milk was collected or stored. It's not clear if they even checked to be sure it was human milk as advertised. The study concludes the purchased milk:
"exhibited high overall bacterial growth and frequent contamination with pathogenic bacteria, reflecting poor collection, storage, or shipping practices. Infants consuming this milk are at risk for negative outcomes, particularly if born preterm or are medically compromised. Increased use of lactation support services may begin to address the milk supply gap for women who want to feed their child human milk but cannot meet his or her needs."

The results are not revolutionary. The milk of any species will rot if it's left to sit around in the heat. The study is meaningless when applied to the real world of moms who don't have enough breastmilk to feed their babies, unless we needed someone to tell us not to drink milk left lying around, or that shady characters = shady behaviour = increased risk.

I saw a copy of this study before it was published and it frustrated me greatly that the authors' conclusions were applied to peer-to-peer milksharing, even though the study has nothing to do with milksharing. Concerns expressed prior to publication have resulted in some wording changes and the final news release is clearer. Still, some people are pointing to this study and warning families not to purchase milk via the Internet, even though the study's methodology is hardly what families unable to access donor milk and turning to riskier milk purchase would employ. Others are saying milk that isn't from a milk bank is dangerous and are urging families to feed infant formula if they can't get screened milk. That is sound advice - but it ignores that families are quite capable of screening and even processing milk on their own.

These warnings may be well-intentioned, but they are incredibly disrespectful. Do families really need to be warned about this? Do families actually feed their children unscreened milk purchased from shady characters who ship to anonymous PO boxes? Of course not.

Researcher Karleen Gribble recently wrote:
"research by Thorley (Thorley, 2011) and myself (as yet unpublished) supports the proposition that recipient mothers of peer-to-peer shared milk take enormous care in deciding to feed their child the milk of another, and in managing the risks involved. Despite the absence of institutional involvement, there is nothing casual about the process. Mothers, however, would benefit from greater support from health workers in assisting them in their decision-making."

It would be much more valuable for researchers to explore how families who seek human milk for their children actually behave. How do they screen their sources? What kind of hygiene guidelines are out there for mothers who express their breastmilk for their own babies (because that is how most milk that winds up being made available for someone else's baby - it starts as a freezer stash intended for mom's own baby.)

And yes, families who have problems breastfeeding need greater support from health workers. Those health workers in turn need greater support from their guiding bodies. And Health Canada and the FDA and the like to get off the pot and adopt harm reduction strategies if they want to address concerns about feeding human milk that doesn't come from from a mother's breast directly to her baby's lips, and doesn't come from a milk bank.

If we're going to get all excited about milk selling, how about looking at the growing number of for-profit corporations out there offering to buy milk from moms so they can create highly formulated human milk products for sale to hospitals.
US company Prolacta milks donors, charity partners

Because that's what stinks about this whole issue. Some would have you believe that milk from the mom-next-door is "dirty" and not fit to be fed to babies. But at the very same time, slick marketing campaigns are convincing the same mom that her milk is a scarce and precious commodity that will save the lives of babies.

Same moms. Same milk.

A selection of news coverage:

Breast intentions? New study spurs debate over online breast milk sales -- Verge.com, Oct 21, 2013
Is it really possible to purchase breast milk online? - Huffington Post, Oct 21, 2013
Breast milk donated or sold online is often tainted, study says -- New York Times, Oct 21, 2013
Online milk sharing carries health risks from bacterial contamination: study -- New York Daily News, October 21, 2013

Sunday, October 20, 2013

Significant corporate developments in the US human milk marketplace

The founder of Prolacta Bioscience, an oft-criticized company that uses breastmilk given for free by moms to produce products it sells for profit to hospitals –for premature infants – has started a competing company.

Elena Medo says she sold her stock last year in Prolacta and says "worldwide the only competition have is my old company."

Medolac Laboratories (Neolac) will sell human-milk derived fortifier and other human-milk based products for use in both hospitals and at-home use. Prolacta, which recently expanded its facility to allow it to store as much as 110,000 litres of frozen human milk, sells its fortifier at a price of $6.25/ml, or $185/ounce.

Medo has secured suppliers of human milk by partnering with two organizations:
Current ads on Only The Breast, Oct. 20, 2013
•  Only The Breast, which up until now has operated an Internet-based classified ad human milk selling site, said in a news release Friday it is abandoning that model and will work to direct its stable of sellers to Medo's new firm. Of note, Only The Breast is under fire in a soon-to-be published research report published Oct. 21 which found high rates of bacteria in samples purchased from people selling human milk from its site.

Image from Mothers Milk Cooperative website.
Mothers Milk Cooperative, founded in May 2013 and described by Medo as a "sister company" that will provide the "supply-side" for Medolac, allows women to donate in a "Pay It Forward" model, or to directly sell their milk for "Milk Money" at $1/ounce. Mothers Milk Cooperative plans to set up hospital-based milk bank sites.

The ethical problems with Prolacta's model are obvious. The jury's still out on Medo's new model.

Sources: Interview with Medo, August 2013
PRNewswire, Medolac Laboratories and Mothers Milk Cooperative announce agreement 
Elena Medo Linked-In Profile
News Release, Only The Breast announces innovative new milk banking partnership - Oct 18 2013 (via a receiving journalist)

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Previous Human Milk News posts on Prolacta.
Previous Human Milk News post on Only The Breast.