Execs in Desperate Need of Donor Breast Milk (part 4)
Posted February 12, 2010
Part 4: Milk Money
Will informing donors about the manufacture of costly therapeutics from their milk mean paying them, too?
This question is hard to answer. First, because I have no idea whether Prolacta has far more milk than they need or just enough to squeak by. Of course, if the donor milk supply is exceedingly high, there will never be any need to pay donors.
How much milk?
So, how much breast milk does Prolacta currently have in its possession? For that matter, how much total milk is collected in the US every year? What percentage of that milk is processed and sold back to hospitals at cost by non-profits and what percentage goes to the development and manufacture of Prolacta products? If anyone out there has access to these numbers, I'd love to know them. I can only find the odd report here and there - nothing comprehensive.
One number I can find is on the IBMP website, which says they've collected 262,682 oz. of milk for Africa. If the milk split described on their How It Works / Donation Process page holds true (25% to Africa and 75% to "critically ill babies in the US," aka Prolacta), than that particular bank has provided Prolacta with 788,046 oz (=6,156 gallons =22,305 L) of breast milk. Add to that 100% of the milk collected at all the other Prolacta milk Banks, and that could be a lot. Or maybe it's barely enough?
How will donors feel?
The next question is - how will donors feel about giving milk to a for-profit enterprise that is also a life-saving one? This is hard to predict. I hold to my statement in Part 2 of this post: For every mom who wants her milk to be non-profit all the way, there will be others who don't really care as long as they are helping someone with their extra milk (probably the majority of moms) and still others who want to see as many lifesaving medications developed from human breast milk as possible.
Will the milk river dry up if moms learn more about where it's been flowing? I think there would likely still be plenty of donor milk forthcoming. Let's assume, however, that if Prolacta milk banks started being called just that (with little displays of Prolacta products inside and "Prolacta Bioscience" T-shirts and totebags for all the donor moms) that the moms would stop giving milk without compensation. Would it be so bad?
Can Prolacta afford to compensate donors?
Would it really hurt Prolacta to compensate donors? I'm sure they've invested a lot in establishing so many milk banks across the US. With this milk collection infrastructure already in place, it would seem the cost of compensating donors, if necessary, wouldn't break the bank. And what about those T-shirts? Wouldn't Prolcata benefit greatly from being out in the open, happily marketing their brand and making donor moms feel like part of the Prolacta team? If the fear of paying for milk (as other for-profit "bioscience" companies pay for human plasma) is what’s keeping Prolacta in the closet, it hardly seems worth all the hiding.
A recent study published in The Journal of Pediatrics shows the valid medical benefit Prolacta's HMF has for severely premature babies. This paper, paired with their recent agreement with Abbott Nutrition (makers of the Similac cow-milk HMF) will make hiding in the shadows of their milk banks not only wrong but also exceedingly difficult for Prolacta.
Other issues related to compensating donors
Of course, there are more important issues than money when it comes to paying breast milk donors. One is the concern that non-profit milk banks will never see another ounce after donors hear about the awesome deal down the road. I don't think this would be a major problem because many moms feel strongly about giving milk as a charitable donation. Many women in the US who currently breastfeed are well-educated, fairly well-off, and in a position and a mind-set to make this kind of charitable donation.
The non-breastfeeding community
Now let's consider the women in the US who aren't breastfeeding (the majority of mothers), and the general public. Sadly, unscrupulous members of the food industry have been very successful in portraying breastmilk as a questionable, cheap, and even gross alternative to the gold standard of formula to many of these people.
Maybe Prolacta paying moms for milk, because it can be used to make valuable, life-saving medical treatments, would help to change that. Maybe the only force powerful enough to fully stomp out the bad image of breastfeeding perpetuated by the corporate powers-that-be will come from the corporate powers-that-are-coming - like Zeus defeating Cronus. It's not ideal, but it's practical.
Placing a monetary (and medical) value on breast milk would have a positive impact on how "Joe Public" regards breastfeeding. Mothers who now consider formula an expensive but worthwhile investment in their child's health (and there are lots of moms like this) may start to think twice when they hear the news that breastmilk is valued at some dollar amount per ounce and used to make medicinal products.
Some of these same moms may also benefit from the extra income their own extra breastmilk could earn. Paid milk donation would then doubly encourage these moms to work hard at establishing and continuing breastfeeding their own children, not only to have highly-valued, premium nutrition for their babies but also to be able to donate milk for extra income. Whatever the motivator is, the numerous benefits of breastfeeding will be enjoyed by each new mom willing to try (and her baby).
Would moms sell their milk and feed formula?
The argument that moms who would have breastfed otherwise will instead sell all their breastmilk and feed formula doesn't make sense. Why would they spend an enormous amount on formula when they can make more breastmilk, which they know is superior, for free. A strict screening process for paid donors and limits to the volume a donor can provide could also be imposed to ensure that this is not a problem.
Other Issues related to compensated donation of human fluids
The arguments against compensation of blood donors don't seem to apply here either - these are the possibilities of over-donation causing severe bodily harm and payment attracting a disproportionate number of desperate, diseased drug addicts.
First of all, moms can't risk their lives by over-donating milk as a blood donor could, and with only one company in this business it would be easy to impose and enforce the limits and pre-screening mentioned above. Milk donation is certainly less physically taxing and risky than blood plasma donation, which is legally compensated by many plasma banks.
The plasma collection process takes only part of a donor's blood, and it occurs both with compensation (when given to for-profits) and without (when given to non-profits) in the US. Interestingly, the collection of both plasma and blood products without compensation by the Red Cross has also come under fire – demonstrating on a much bigger and more complicated scale how unhappy donors are to find that their donations are being used in an undisclosed or poorly disclosed way to turn a profit. My thanks to a commenter (Lindsay) for bringing this up.
It’s also easier to prevent the spread of pathogens through breast milk (which is naturally safer and can be pasteurized) than through blood. Although I might worry about desperate souls selling off their blood, I find it hard to envision the same people hatching a plan to become pregnant and bear a child for some limited amount of milk money.
Bankers - breast milk bankers, that is
So although I wince a bit at the phrase "corporate breast milk bank," I realize they are already out there. At the same time, I see the potential for positive outcomes from these banks and the company behind them. Run properly, they could help reshape the way many in our culture view breastmilk and breastfeeding and possibly improve breastfeeding rates, not to mention develop important therapeutics from breast milk both now and in the future.
I just hope that Prolacta is dedicated to biotherapeutics. I hate to think of a future with very expensive formulas made from processed human milk - like a wet nurse in a can (with many key components long since destroyed during processing, plus an unhealthy dose of can-liner chemicals).
If this ever did move away from therapeutics and toward food products, I hope moms would realize that they can make real "liquid gold" far superior to anything processed in a plant. Remember that Prolacata, or any company making pasteurized, processed human milk products still cannot keep many of the critical antimicrobial biomolecules (which our mammary glands originally evolved to deliver) viable and active through processing.
Recent Posts
Comments
Prolacta's human-milk based infant formula
Is the recent Journal of Pediatrics study on Prolacta's human-milk based infant formula for premature infants a valid study? This was not a study whose base/control group was exclusive breastfeeding, This was a comparison of exclusive human milk- based fortifer versus a cow's milk fortifier. Is this study devoid of financial interest? No. One of the authors, Richard J. Schanler was funded by Prolacta. Paula Meirer in the past has been funded by Abbott. Martin L. Lee is the Chief Scientific Officer of Prolacta and David J. Rechtman is the Chief Medical Officer of Prolacta. There is a large measure of financial interest in this study.
Let's take a reality check. What Prolacta is doing is creating a human-milk based infant formula. This is not a milk banking operation. Although, it is specifically designed for premature infants, it is possible that this could be the springboard for a human-milk based infant formula for all babies. After 10 years of researching human milk component patenting, I would suggest that this direction is probably being considered, particularly since Abbott is now collaborating with Prolacta.
Human milk components are already being used in food products, as well as being used as pharmaceuticals. They are being used in the dairy industry as yogurts. Human milk is prebiotic and probiotic because it creates the beneficial bacteria that protects the immune system. Human milk components are genetically engineered but the base knowledge for these components is research done on human milk. Human lactoferrin (a human milk component), genetically engineered, is being studied in various hospitals as an antibiotic. Human lactoferrin is being used in dental products and eye drops. The Red Cross owns a patent on a human milk component to be used in bandages to stop the bleeding.
Ten years ago I gave a three-ring notebook to a member of the US Breastfeeding Committee on human milk component patenting and the industries that were involved. I was told that this would be presented to the Committee and discussed. This never happened. I learned much later that the notebook was given to a government official. I was told I could not attend a US Breastfeeding Committee meeting. Lactnet, the professional listserve for lactation consultants, does not allow discussions of patenting of human milk components. I was effectively silenced some years ago by all of the breastfeeding organizations. Why?? Basically what I said back then, is coming true with a vengence. The lack of transparency of non-profits is an issue that never seems to be addressed. Non-profits talk about their fiduciary duties, which amounts to a huge amount of silence.
The question that must be asked is will this business endeavor promote and protect breastfeeding? After 10 years of research on this issue, I think we are deluding ourselves, if we believe that the creation of pharmaceuticals, foods, infant formula, and supplements derived from human milk components will promote and protect breastfeeding. The reality is that patenting creates monopolization and secrecy.
Therapeutics versus formula from donor breast milk
Hi Valerie,
Thanks for your comment and your blog which has a lot of discussion on this topic, including many issues not covered in my posts. I also think the question of whether or not Prolacta's product for severely premature infants made from human milk actaully provides a medical benefit is an important one. As far as the Journal of Pediatrics paper and the study it describes, there are certainly financial and medical interests involved. The data presented, however, supports the hypothesis that for severely premature infants (who currently receive cow milk fortifier in addition to their mothers' breast milk), those given human milk fortifier instead have fewer cases of necrotizing enterocolitis (NEC).
Unless the data is flatly fabricated, which would be a grave transgression that would essentially ruin the careers of everyone involved and would require a conspiracy involving everyone from the parents and hospital staff to the doctors and authors, HMF from human breast milk is something I'd want if I had a 2 pound baby baby struggling to survive in the NICU. Having said that, and as I stated in the last part of this post, I agree with you 100% that formula created from human breast milk would be bad for many reasons.
When I consider the possibility of formula from human breast milk, however, it just doesn't seem to make business sense. Even if milk donors fail to wise up and demand compensation or donate only to transparent non-profit banks, there are still huge costs in testing the moms and the milk, running the banks, and processing the milk. Formula made through this process would cost hundreds of dollars per can, at least. Formula is already expensive, presumably due to processing and testing costs as well as high mark-up, and it's made from woefully cheap starting materials. Unless the products Prolacta (or any other company) creates from human breast milk have verified medicinal properties and can be sold as high cost therapeutics (and covered by insurance), the whole elaborate process wouldn't make sense financially.
Regarding the issue of making drugs or therapeutics based on research of human breast milk, my response got so long I'm making it a post. I do feel that products made using donated milk versus those produced in a lab are different as far as the role of breast milk donors. My focus in the first of these posts, and what led to my interest in the whole story, was the many complex components of breast milk that cannot be reproduced in a lab and the subsequent need for (at this point largely unwitting) donors in order to obtain them. Thanks again for you comment and your blog which is one of the few places to find a current discussion of topics related to donor milk and where it goes.
Heather
Research and financial stakes
Heather,
I am enjoying reading your blog and your take on the issues of donor milk. I don't agree with you on some issues but certainly enjoy having an actual discussion about it. I hope you don't mind but I felt the need to clarify what I believe regarding research and financial stakes in outcomes beneficial to those who have footed the bill. You wrote that if you had a 2 # baby in the NICU, you would want them to have HMF. Here's where we differ, I would want my 2# baby to have "my" breastmilk only--no fortification, no pasteurization. And this is the crux of the problem in this research at Prolacta. The control group should have been infants receiving breastmilk only--not fortifed. But this was not done because previous research had shown that tiny premature infants need fortification. That research was heavily funded by the infant formula industry and in my estimate was questionable. Thus, this scientific research that benefits Prolacta had only their product versus cow's milk fortifier. What might have been seen, if only fresh breastmilk was used as the control?
This research is based on the belief that breastfed premature infants must have fortified milks. Yet a patent by Nestle, has declared an interest in a human milk component that increases bone growth and density. So why do we believe that preterm human milk is deficient in calcium? I don't think the whole story on this issue is being told.
Efforts in NICU's should be made to get stable babies to the breast. Yet this doesn't happen enough. More often mom's with NICU babies go home with babies that have never been to the breast. With human milk fortifiers will efforts increase in getting babies to the breast? I don't think so. We will be lulled into the belief that we are using a safe product and attempts at breastfeeding while good are not really necessary.
I believe that science is easily lost when it is heavily funded by those who benefit from its results. I don't think in most instances it is some grand conspiracy. It is what I call the blinders we put on, when a company pays us for our expertise. If your research is paid for by some corporation, will you have a critical eye regarding the product you are testing? How you are paid influences what you say publicly and even privately. I think it is most difficult to have a critical eye, when your income may be impacted by such criticism. Yet, science demands that we unleash those blinders, that we open our eyes to our blind spots. A difficult task for anyone who wants to get to the truth, to the reality of our world.
The need for HMF and Skewed Research
Valerie,
I will say I have worked under the assumption that fortifier (HMF) is necessary for severely premature babies. Could breast milk alone have enough calories to meet the high nutritional needs of babies who should be getting much more via the placenta throughout the third trimester? I guess there is also intravenous feeding of "total parenteral nutrition" (TPN) for the very premature. Would it be better to stay on the IV longer and have breast milk only? I took it as a given that HMF was a necessary or beneficial part of the process, either the during the transition to eating like full a term baby for those who start on IV, or as an alternative to IV for those with a borderline need for it.
Is there only one study about this? I'll have to check it out. It enrages me that there is so little access to scientific literature for anyone who doesn't work in a lab. I wish PLOS would just take over. The public pays for most research (at least the critical first stages) and then journals charge us a ton to read the papers describing that research. The possibility of no fortifier is an interesting point. I guess it just depends on if there are any major downsides to IV feeding up until the babies nutritional needs are more in line with those of a full term baby.
As far as the skewing of research and conflict of interest goes, I suppose it could happen at the upper upper levels. Those in charge (not that I have ever been there) can choose which experiments get done and which get left on the notepad. There is a peer review process, though. Other scientists, often your competitors, get to read your work before it gets published and say what changes you have to make and additional experiments you have to do for the work to be valid and make sense.
Unlike cops and doctors, scientists don't usually cover each other or stick together. Instead they tend to be "skeptical and antagonistic" (the actual nickname of a guy in my lab) as well as very competitive. Now, I have never done research in a for-profit lab (just academic and government) and I have always done basic research - no animals, just tubes and far, far away from clinical trials. When a bench worker like me runs a sample and generates data, it is what it is. The bands on the gels and peaks on the charts have a callous disregard for ones hopes and dreams and hypotheses.
Thanks again for your comment. I wrote these posts more to ask questions than to answer them, since so much information about donor milk and where it goes is not available and not discussed.
Heather
Preterm breastmilk
Preterm breastmilk is different from term milk. It is higher in protein and in some studies higher in fat. Slightly higher in calcium. Dr. Ruth Lawrence states in 1994 edition of "Breastfeeding: A guide for the medical profession, "Fat digestion is very efficient in LBW (low birth weight) infants who receive their own mother's milk fresh and untreated. Fat absorption is decreased by calcium supplementation, however, and by sterilizing the milk." (pg. 411) She does go onto say that rickets occurred in LBW who were not supplemented, but none occurred in babies over 1500 grams. I have not seen the studies that determined this and wonder how one isolates the cause when LBW would be given various meds that might impact calcium absorption. She states that VLBW require additonal copper. Since this is an old text, things may have changed. But preterm milk is very different and almost seems geared to the preterm baby. Pooled donor milk is often term milk or milk from mothers of older babies.
Peer review does not always happen. Margaret Heckler, head of the US Department of Health, made a dramatic announcement back in the 80's. She announced that Dr. Robert Gallo had discovered that hiv caused aids. His work was not peer reviewed. On the same day that this announcement was made the US Department of Health filed two patents (Gallo being one of the inventors) regarding the hiv retrovirus. This later became a fiasco because it was learned that Gallo was not the discoverer, it was the French team of scientists.
The belief that hiv is transmitted in breastmilk is the initial reason I started doing my research. Its how I ran across the initial patents on human milk components--to treat and prevent hiv/aids. I don't believe that hiv is transmitted by breastfeeding.
Some years ago I heard an English midwife, Chloe Fisher speak on her quest to find the original study that proved that breastfed infants needed supplemental water. (big issue years ago). She traced medical references back to the 1900's. She found no study. Suddenly this belief appeared in a medical textbook, never questioned. And from the original text it continued on to the present day, unquestioned. Few people question what they find in a text book, authorities, or experts. We believe what we believe because we are told it in school or by some expert.
Great blog!! Thanks for letting me participate :)
Preterm Milk and Breastfeeding with HIV
Valerie,
Thanks for the info about preterm milk. It seems like one option for moms with babies over 1500 g who want to avoid using HMF and begin enteral feeding would be to have their milk tested to see if it meets the caloric and nutritional requirements of their particular infant without supplement.
As for your stance on breastfeeding an HIV transmission, I'm not sure I completely understand your position. Of course, HIV is not always transmitted though breastfeeding. When transmission of the virus occurs, the exact mechanism of infection my be blood to blood (small cracks in the nipple small cuts in or around the babies mouth) and not always through breast milk. The exact route of a virus is always hard to map. I have no background in this particular field, but it seems like a lot of people are now coming around to the idea that advising HIV positive moms not to breastfeed is not always good advice, since the relative risk of not breastfeeding has to be measured against the risk of HIV transmission. This recent review has a nice summary of these issues.
Breastfeeding in HIV-positive women: What can be recommended?
These are public health issues, but of course the decision of whether or not to breastfeed for any HIV positive mother must be assessed by her physician according to her specific situation.
-Heather
Decision-making
Hi Heather,
You wrote that, " the decision of whether or not to breastfeed for any HIV postive mother must be assessed by her physician..." I am not sure I understand this statement. Physician's can make recommendations but ultimately the decision of whether to breastfeed or not resides with the mother. Human lactation is the norm. Thus anyone who persuades a woman to not lactate should be very aware of the consequences to not only the mother but the child, too. The mother will increase her risk of breast cancer and her child's, she will be at risk for ovarian cancer. Her infant will be put at risk for a wide range of diseases and death. Breastfeeding clamps down the uterus after birth, decreasing a mother's risk of bleeding severely. The recommendation of infant formula carries a financial burden not only of the cost of infant formula, bottles and nipples, but also the medical costs of a sicker child. A mother who exclusively breastfeeds will most likely be infertile for 6 months or longer and also not need to buy sanitary pads, etc. These issues may seem small or unimportant but to a family on the margins of surviving, it makes a big difference. For a society, the economic burden of bottlefeeding is far larger than is currently understood.
I will try and not take up too much space with my views of hiv and breastfeeding. Luc Montagnier of the Pasteur Institute (France) was the discoverer of hiv in 1984. He recently won the Nobel Prize for this discovery. According to various articles I have read, he believes that oxidative stress is the cause of cancer and hiv. The immune system is the key and good nutrition is the goal. He co-authored a book on this issue. One chapter is on the good things of humanized milk protein (whey). I have these little alarm bells going off. So here is a man given the ultimate prize in science for his work on hiv/aids. And he believes that people should be building their immune system with "humanized milk proteins." No one is intrigued by this?? No one questions the why of this??
Most studies done that supposedly proved that hiv was transferred by breastfeeding had a built-in error. The studies had mothers who were breastfeeding and also formula feeding. How does one determine a cause when mothers are mixed feeding?? They have never found hiv in samples of breastmilk. Why? It is believed that certain components in breastmilk inactivate the virus (funny those are the components that are being patented). Some of the researchers that did those studies were at one time or another funded by the infant formula industry.
My understanding of health care policy regarding hiv and breastfeeding is that only in resource-poor nations are women encouraged to exclusively breastfeed. Hiv-positive mothers in the USA are actively discouraged from breastfeeding. There have been cases of hiv-positive mothers losing custody of their infants for breastfeeding. Yet we could argue that in the USA there are areas that have infant mortality rates similar to resource poor nations. In my county in Florida, the black infant mortality rate for 2008 was about 24 per 1000 (Florida Vital Statistics). The white infant mortality rate was about 8 per 1000. I believe that in my county a hiv positive black woman will be counseled to bottlefeed.
Hiv-testing is another big issue. Antibody testing has a high degree of false positives when used on healthy populations (pregnancy can cause a false positive reading). The test kits were never meant to be used as a diagnostic (test kits state this). Rather they were intended to be used as a confirmation of illness. Healthy people should not be given antibody tests. Sick people need the testing to determine what is causing their illness. Yet we are witnessing broad scale mandatory testing on healthy populations. There is alot more money being spent by the US Government on hiv/aids than on other diseases that impact more people. Babies in my county don't die of hiv/aids, they die from pneumonia, septicemia, gastroenteritis, SIDS, etc. Those diseases are preventable by exclusive breastfeeding.