Wednesday, March 16, 2011

Makena: Public Policy & Private Consequence

I don't actually believe the universe is out to get me, but I can't help but wonder if in this case I might be forgiven if I did.

Recently a drug company known as Ther-Rx sought and received approval for the first FDA approved treatment to reduce the risk of preterm birth in pregnant women.  Ther-Rx is a wholly owned subsidiary of KV Pharmaceuticals, a St. Louis based company.  The drug will be sold under the name "Makena" and was available to be prescribed the week of March 14th.  Makena is actually alpha-hydroxyprogesterone caproate injection, prior to Ther-Rx's involvement, it was known popularly as 17P.  Among women and doctors who deal with prematurity, 17P was well known and was given to women as a weekly injection starting around the 16th week of pregnancy and continuing to the 36th week.  The announcement of FDA approval was hailed by the March of Dimes as a step forward in the prevention of premature birth, which undoubtedly helps women and babies.  Ther-Rx also announced that the price of Makena would be around $1500 a dose, so with a typically course of treatment running 20 doses over 20 weeks, the cost would approach $30,000.  A large sum of money, to be sure, but relative to the costs of treating prematurity and the potential life long health effects that can result from a preterm birth, this price may actually represent a tremendous deal.

This description of Makena reads like a medical that a local news station might slot for late in the half-hour, or a pitch to potential investors looking for a company on the cusp of taking off.  So why does the announcement of Makena make me feel like the universe is conspiring against me?  The short answer to that question is that my wife is 13 weeks pregnant, all of our children have been born early, four of them early enough to require hospitalization, and we were both counting on using 17P injections during this pregnancy to help avoid another premature delivery.

If you want to read more about our experience with premature birth and how our attitude toward family size has changed over the years (including much more personal information than I usually go into on this blog), click below.  Otherwise, in the next post (or two) I'll look at how KV came to be the beneficiary of this sudden increase in the price of 17P and the possible implications for public policy.

In 2000 my wife and I had one child, a daughter, and were anxious to have more children.  She had been subject to irregular cycles for a number of years, but no doctor had seen anything serious enough in her condition to investigate further.  This was also the year that we moved to Wisconsin and my wife began to stay home full time, rather than work outside the house.  Neither my wife nor I are apt to blindly accept information from experts, including well-intentioned doctors, if we don't understand what they are telling us.  I like to think of it as a healthy skepticism, and this case was no different.  My wife's own research suggested to her that she was suffering from polycystic ovarian syndrome (PCOS) and this was eventually confirmed by her doctor.  One of the symptoms of PCOS is eggs that would normally be released during ovulation aren't, and they can form small cysts on the ovaries.

With this diagnosis in hand, we at least knew what the problem was, and we moved on to response.  We decided to try Clomid, a drug that can produce ovulation.  This was successful and in 2002 we had our second child, a son.  He was born at 38 weeks, but aside from a precipitous labor that required an ambulance ride to the hospital, everything else was fine.  Given the success with Clomid, we decided to try again.  By 2004 my wife was pregnant again.........with twins.

I'm not exaggerating when I say the prospect of having twins was dizzying.  Elation was replaced one January morning when my wife woke me up and told me that her water broke.  Trouble was that she was only about 30 weeks pregnant.  A few exciting hours later (ask me to tell you the story some time) my twins were born.  They each weighed around 3 pounds, and were admitted to the neonatal intensive care unit (NICU).  For the next several weeks we watched as they made slow and sometimes halting progress from tiny people who couldn't breathe or eat on their own to really small people who could breathe on their own and drink from a small bottle.  Parents of preemies who have watched a child's skin go ashen when they stop breathing during eating will know what I mean when I say our twins weren't always able to do both at the same time.  With help from friends and family we made it through the weeks of hospitalization without any major effects from premature birth and the twins are now healthy seven year old boys.

In the time after the twins came home and life returned to a new normal.  As it did, both my wife and I really began to think hard about issues around family and child bearing.  It's not that we didn't think about these things at all before, but looking back I think we approached them with a self-centered attitude (we wanted to have children) rather than a God-centered attitude (what did He want for us).  Family size became a topic of regular conversation in our household and eventually we decided that it was important for us to turn this part of our lives over to God and that we would no longer try to consciously control the number of children we had.  This meant no more Clomid AND no more birth control.

For some this might seem like a bold step, but given my wife's medical history it's not clear that we were really surrendering anything meaningful.  Soon though, we found out just what can happen when you stop trying to lean on your own understanding and turn important parts of your life over to God.  In May of 2005 we found out that my wife was pregnant again, this time the old-fashioned way.  It's hard to remember exactly how we felt at the time, but my memories include a mixture of excitement and fear at the prospect of another baby.  The baby was due in January, which meant the twins would be less than two years old when we added to the family. 

We had assumed that the preterm birth of our twins was related to the fact that they were twins, but when my wife gave birth to our fifth child at 33 weeks, we began to doubt that was the case.  At around four pounds, this boy was bigger than the twins at birth, but still had trouble breathing on his own.  Back to the NICU we went.  This stay was shorter than that of the twins, but I recall it as being more frustrating since it was primarily feeding issues that prevented my son's departure from the hospital.  Eventually he figured it out and we came home.  Again, another preemie had escaped any serious health issues and joined his brothers and sister at home.  Rather than causing us to second guess our decision, our fifth child only strengthened our resolve.  For me, it seemed clear that we had made the right choice in being open to the blessings of more children, premature delivery and all.

That was November of 2005.  By late December of 2006 my wife was pregnant with our sixth child.  During this pregnancy we were diligent about efforts to prevent a premature delivery.  At the time the 17P injections were not common in our area so we did not get them, though she did get an alternative progesterone treatment.  Despite our efforts, our sixth child (fifth boy if you are keeping score at home) was born at 35 weeks, weighing 5 lbs. 10 oz. and still required about ten days in the NICU.

While all four of these boys received "intensive" care, it was really only the twins, born at 30 weeks, who experienced what I imagine most people think of as time in the NICU.  The other two boys were fragile no doubt, but their treatment primarily monitoring and supplementing the growth process that they were trying to complete, now outside of the womb.  It was no fun to be sure, but not nearly as scary as the experience with the twins.

So that was four years ago.  Since then we have not changed our attitude toward family size, but we haven't had any more babies.  People still ask me quite often if we are going to have any more kids, and I always tell them it is possible.  Most of them probably don't believe me and suspect that we have been preventing pregnancy for the last four years.  For my humorous description of how the world sees a family with five small boys, be sure to check out this post from 2009.

As to what the future holds for us, I can't really say.  I can say that my wife and I have been called to love every child that He has blessed us with and that we believe in the biblical mandate to be fruitful and multiply.  What, exactly, does that mean?  I wouldn't presume to tell you that means you should have two children or twenty, as I suspect there is not a single answer.  For a good discussion of this issue, with a biblical foundation and a humble approach, I recommend the blog of the Jeub Family

The other thing I can say is that too many people let family size be a passive rather than active decision. They take their cues from the culture at large and do what they think they are supposed to be doing.  Few people realize this and even fewer admit it.  Our natural tendency is to go with the flow, not only in the area of family size, but in almost all aspects of life.  It takes an effort of will, and I would say a measure of faith, to fight our natural tendencies to get along and instead to live intentionally.  That would be my challenge for anyone who reads this.  Think about the areas in your life that have been shaped without much effort on your part, like a canyon taking its shape from wherever the river leads, and take the time to examine these areas and make changes where necessary.

As I said, my wife is expecting in September and both of us had high hopes for the 17P injections when it came to preventing another premature birth.  Now that we are only three weeks away from when they would start, I was surprised to learn of KV Pharmaceutical's brand new patent on Makena, it's new price of $1,500 a dose, and the federal government's role in how this came about.

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