Pharmaceuticals From Breast Milk

Creating New Medications Based on Human Breast Milk Components

Previously, I've written about the possibility of making therapeutics directly from donor breastmilk, such as Prolacta's HMF (the need for HMF has been discussed in the comments of another post about Prolacta).  But what about individual breast milk components being recreated in a lab for use in medicinal products?  In my first post on this topic I focused on the irreproducibility of breast milk, but what about the individual components that are reproducible - the ones that can be made in a lab?

This topic, though related to the question of how breast milk might be used by those who collect it (in this case, for research), spreads out into questions about biological patents and intellectual property (IP).  True to being a bench scientist, I know little about patents, IP, business, money, etc. That's how they get us to work as postdocs to work for almost nothing.

What I do know is that if a biomolecule like the antimicrobial lactoferrin can be identified and characterized through the study of breast milk and used to prevent illness, I'm in (lactoferrin was brought up in a comment).  If what we can learn from breast milk increases our understanding of human biology and allows us to develop effective medications and therapeutics, I support that.

Creating medicines based on the intricate, elegant molecules made by living organisms (as opposed to the relying on the random luck of screens or using sledgehammer drugs with global affects on the body) is tricky work. It's something we have been struggling to do this century because it is finally becoming possible through the sequencing of DNA (genomics) and study of it's gene products (proteomics). 

As we move forward, we will be able to create more effective medications with fewer side effects than traditional drugs. Stories like this one about the drug PLX4032, which was created through research and understanding of the biomolecule B-RAF, show how the process works.  Medications created like this are the future of treating cancer, cardiovascular disease, altzheimers, autism, HIV and other ailments that lead to human suffering.

If biomolecules discovered in human breast milk (and made in a lab) can be part of that and lead to therapies that improve outcomes for babies in the NICU or even adult patients suffering from something totally unrelated, I think that's great. 

What inspires individuals and organizations to do the kind of difficult, expensive research it takes to develop these medications? Three things, really: a desire to help people, a desire for academic prestige and glory, and a desire for money. The individuals tend to focus on helping people and getting glory while the larger, more powerful organizations tend to focus on the money. 

The current system for rewarding successful research with money is through patents.  Patents allow those who generate new, useful ideas and information to limit anyone else from using them to make money for some period of time.  Patents, especially biological patents can get very complicated in how they are issued and legally enforced.  Of course, there's lots of controversy and deviousness that goes on around patents, like anything else that involves a lot of money.  Valerie McClain, who has commented here, addresses more issues related to this in her blog.  Incidentally, the academic glory reward system isn't perfect either, so to be a happy scientist you really have to work on something you believe will contribute to the common good. 

In another life, I walked straight from the Cornell Chemistry Department over to the Law School the day after getting my Master's and became a patent lawyer instead of a PhD.  In that life, I make way more money than I do now and know all about biological patents.  As it is, I know only the basics, but I can still see that there are flaws in the system.  Maybe we will find a better system someday.  For now, we have patents, and to get them big companies spend about a billion dollars each bringing medications to market.

If some of those medications are designed based on therapeutic components of breast milk and created and delivered to the people who need them (a big "if" in the current US healthcare system), that's a good thing.  However clumsily, we will have used our ingenuity to alleviate human suffering and to help or even (dare I say) cure the sick.  That gives me hope, the only truly reliable reward for good biomedical research.

What About Formula?

Of course this all brings up another, much more breastfeeding-centric question: What about using this kind of research to make "better" formula? Is that a good thing or a bad thing? Although I don't  see how any company could afford to use donor breast milk in the manufacture of formula, they could use what they learn from the research of breast milk to identify components (like DHA and ARA) that can be added to formula.  Perhaps more important additives could be included to make formula a little less unhealthy.  The question is, do we want unhealthy formula - to keep moms from seeing it as a suitable substitutre, or more healthy formula - to improve the health of those babies forced to drink it? What do you think?