Pregnancy Update: Week 15

The biggest pregnancy news is, of course, that we will be getting our 17P shots! My full 20 week supply arrived last week. Not only were we able to get them but at the lower cost (saved $29,700)! I get my first shot next week. I'm going to have the doctor give me the first one but haven't decided if I'll go into the office each week or get someone else to do it for me. (You still willing Lisa?)

 There was good news yesterday for other mom's in need of this drug. The FDA issued an unusual statement: "In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate..." This means that despite giving KV Pharmaceuticals exclusive rights they won't stop the compounding pharmacies (like the one I ordered from) from making it. Not sure who would buy Makena for $1500 a shot when there is an alternative available for only $10-$15 per shot. KV's stocks dropped drastically yesterday at the news. Can't say I feel to bad about that.

I am feeling much, much better now than I was a few weeks ago. I still have an off day here or there but overall I think we are past the morning sickness stage. Yay!

I am looking forward to feeling the baby move sometime in the next couple weeks. I've noticed that with each pregnancy I show sooner and feel the baby move later. Speaking of showing, I have been having a pants problem. My regular pants are too tight and the maternity pants are too baggy (and generally not as comfortable as I remember them being). That leaves me one pair of pants that I find comfortable and an old, very worn pair of jammie pants. Most days I'm in one or the other. Both were dirty today and I stood in the closet for 10 minutes wondering what I would wear. I think I'm going forget the maternity pants and try and find some more comfy jammie pants!

Most of you know I have a sweet/snack tooth. Previously, pregnancy never really stopped that. This pregnancy has been a bit different. Chocolate... no thanks. Desserts... maybe just a little bite. Chips... blah. It's actually kind of strange. What does sound good? Hard boiled eggs, cabbage, celery, dried fruit, a piece of rye bread with butter. Not all at once, of course! Every week after grocery shopping I boil a dozen eggs for snacks. I don't eat them all... Jerry likes them too, but I have had my fair share! Raw cabbage is better than chips... I tear off leaves and munch away at the crunchy deliciousness.

With the morning sickness, I lost weight at first. Now that I am eating (somewhat) normally again (and keeping it down) I am starting to gain. Thanks to all those crazy cravings though I am eating healthier than ever and not gaining much, only about a 2-3 pounds so far.

I put a pregnancy app on my iPod touch and Wesley enjoys reading about the baby's progress each week. This particular app gives the measurements of the baby and compares them to a familiar veggie or fruit. This is an especially helpful visual for the boys. This week the baby is the size of large navel orange! It's so sweet to see how excited the boys are for a new sibling. How big the baby is, possible name suggestions, and stories about each of them as babies are frequent topics of conversation. My favorite though is to hear one of the boys pray for the baby to come safely during bedtime prayers. That's my prayer too!

A Quick Trip to the Wildlife Sanctuary

Last Friday, it was cloudy and not too cold so we decided to take a little "field trip" to the Bay Beach Wildlife Sanctuary. The boys LOVE going there to feed the ducks and geese as well as look at the various other creatures. We decided spring must really be coming because we saw several birds that normally leave for the winter. We had seen robins in our yard at home but seeing the red wing blackbirds at the sanctuary gave us hope that winter really is almost over.

After feeding the ducks and geese, we walked around the bird exhibits and then drove over to look at the big animals. We were surprised to see that the mountain lion was no longer there. A fisher was in it's place. Anyone know what happened? I'm guessing the mountain lion died of old age since he has been there for as long as I can remember. [Update: Dago the cougar died last July. Thanks JJC!]

Here are some shots of the boys feeding their feathered friends:

Before we drove into the Wildlife Sanctuary we decided to drive past Bay Beach to see how far construction has come on Green Bay's new roller coaster. The Zippin Pippin is really coming along nicely. It is much bigger than I expected! The boys were super excited. Now we just have to wait to see who will be tall enough to ride it.

Makena Update: Good News! (for us anyway)

Hope you read Jerry's three part series about Makena (aka 17P). I am now 14 weeks pregnant and am supposed to start taking these weekly shots the first week of April. I am hopeful these shots will make a difference for two reasons: 1) the research is very promising and 2) during my pregnancy with J.D. I used progesterone suppositories and made it two weeks farther than I did with Hayden. If the suppositories helped and the shots are supposed to be even more effective then that makes me hopeful they will help in my case. Every day of pregnancy means less (or maybe no) NICU time!

After the whole Makena mess, I thought we were going to be a day late and a dollar (or $29,700) short, but it looks like that won't be the case! Actually, we had pretty much decided to get the shots regardless of the cost, as long as it is covered by insurance, because we would only have to pay for them up to the out-of-pocket max, which with our high deductible plan is still a hefty sum but worth it if it works. I figured it this way... meet the out-of-pocket max with the shots and have a chance at avoiding the NICU OR meet the out-of-pocket max in NICU charges. If we're going to spend the money either way, let's spend it trying to take our baby home and avoiding the NICU.

I spent some time calling around last week trying to figure out our options. For most of the options, I was just assuming the cost would be around $1500 per weekly shot. The first good news came from a home health agency we were considering that gives these shots... they told me it was "business as usual" for them and that the shots would cost me about $200 per weekly shot. That cost included both the medication and a home visit from a nurse to administer the shot. The bad news was things could change at anytime and there was a risk that the compounding pharmacy they work with might not be able to continue making the shots at the lower cost.

I talked to my doctor's office yesterday to see what they had to say. I know Green Bay is not known for being on the cutting edge of anything but the first time my doctor's office had heard anything about this whole 17P/Makena business was from me during that phone call. I asked the nurse to call the compounding pharmacy that they order the shots from and see if they were still making it and what they said about cost.

The nurse called me back a few minutes later and said that this particular pharmacy was well aware of the situation but had not yet received a cease and desist order. The pharmacy said they would continue to compound the shots until someone came knocking at the door and told them to stop. Cost: ~$12 per weekly shot. They normally ship half the doses right away and send the second half at a later date. Knowing that the pharmacy just may get that knock at the door any minute, I had the nurse ask if I could get all 20 doses right now and they said I could.

So, my shots are ordered/paid for and in a few short days I should have in my hand all the medication I need for my whole 20 week course at a cost of... are you ready?... under $300!! I have two options for shot administration: 1) weekly office visits to the doctor at a cost of about $50 per injection or 2) have a family member or friend give them to me. Either option is considerable savings over the home health company and super, mega savings over the prescription Makena... like $29,700 savings!

They say "timing is everything" and I think that is the case here. I'm guessing in a few months (or maybe even days/weeks) time the method we used to obtain these shots will no longer be an option for other at-risk moms. I sincerely hope that is not the case, but there is a lot of money on the line. Guess we'll just have to wait and see what happens...

Makena and Big Government

This is part III, for some background read part I & part II first.

"I'm from the government and I'm here to help."  President Reagan called these the some of the scariest words in the English language.  The newly FDA approved drug Makena is a clear example of just how right Reagan was.

My wife and I are expecting our 7th child. Since my wife has a history of premature labor, we were hoping this time around that she would be treated using a form of progesterone known as 17P.  This drug was not specifically made for treatment of premature labor, but in recent years its use for this purpose has increased following some studies demonstrating its effectiveness.  Also, 17P was relatively inexpensive, in some cases costing as little as $10/dose. Sadly, our plan has been called into doubt due to a recent development.  Under a federal law known as the Orphan Drug Act, KV Pharmaceuticals sought and won FDA approval for their version of 17P, known as Makena.  Along with this approval comes 7 years of market exclusivity (that is, only KV can sell this drug) and the announcement that KV would sell Makena for $1,500/dose.

You can read my previous post on why the moral outrage over this dramatic price increase should be directed at KV, a distressed company that saw an opportunity to get healthy with a safe bet on Makena.  But who created the conditions that allowed them to make the bet in the first place?  Clearly in this case, the answer is the federal government.

Whether or not my wife is treated with Makena, the $1,500 price tag will mean that some women who need it won't get it.  Some people will look at circumstances like these and think they require a government intervention, but it was government intervention that allowed for the price increase in the first place. Some problems are not the result of "greedy business" or "heavy-handed government," but are actually the result of these two elements combining.  The Orphan Drug Act, a federal law, allowed KV to become the sole supplier of  a drug that was widely available at a relatively low cost simply by pushing it over the finish line of FDA approval.  Many people fear, and are willing to denounce, the market distortions that come with private monopolies, why shouldn't we be just as concerned over those created through government intervention?

Even if you prefer markets over government solutions, there is no need to demonize the federal intervention in this case.  It is not at all hard to believe that the lawmakers who crafted the Orphan Drug Act did so with the best of intentions in an effort to promote drug development for rare diseases. Because these diseases affect a relatively small number of people, markets for these drugs may not be large enough to entice private investment in research and development (I'm not sure premature birth really qualifies as rare).  But the result in this case is not a victory for anyone except KV Pharmaceuticals, since they will benefit from a government granted monopoly.

Unfortunately, what should be a cautionary tale about unintended consequences and the dangers of government intervention, will likely be used to call for even further government involvement (of one from or another) in this case.  This is a response that simply boggles my mind.  The opportunity for KV to profit from the marketing of Makena was a direct result of government intervention, so now we need more intervention to try and correct what went wrong the first time around?  It kind of reminds me of that children's song about the old lady who swallowed the fly.

I believe that markets are superior to government planning when it comes to deciding what we produce as a society and how much what we produce costs.  That is not to say the government can't or won't ever be involved in markets, it will.  When we contemplate government action we need to recognize that there will be unintended consequences. Some of which we will be good at anticipating and some of which will come as a complete surprise.  Given the power of markets and the potential dangers of government intervention, there should be a very high bar for government involvement in markets and an even higher one for times when the government is going to grant monopoly powers to a private business.

The story of Makena will have a human cost.  It will be reflected in the children born too soon because their mothers never received 17P, which just a few weeks ago was widely available at a fraction of the current price.  It is also the story of a private business seeking extra profits by using the power of the government.  Finally, it is a story that will be repeated many times over whenever big business sees an opportunity to use big government as a weapon to be deployed in pursuit of profits that would never exist in a competitive market place.

Toothless

Justus finally caught up with his twin brother and lost a front tooth! I guess it's not fair to compare since Eli didn't just lose his, it was knocked out!

Makena and the Orphan Drug Act

This is part II, you may want to go back and read part I for some background.

When my wife was a child she and her sister shared a beloved record of the the songs from the musical Annie.  At some point, one of them, I'm not sure who, left it out in the summer sun and it melted.  The fact that this story is still told, and told with no small measure of sadness, attests to just how traumatic the experience was.  This week it's another kind of orphan that has my wife upset.

She is 13 weeks pregnant with our 7th child.  She has had a spontaneous preterm delivery before.  During this pregnancy my wife and her doctor had decided she would be treated with 17P injections from week 16 through week 36. 17P is a form of progesterone and is used to prevent premature delivery.  Even at around $200 a dose when delivered in our home by a home health company, this cost seemed like a bargain compared to the cost, both monetary and emotional, of having a preemie.  At 13 weeks, we are only about 3 weeks away from the beginning of the treatment.  On Monday, I read this on one of my favorite economics blogs, Marginal Revolution:

Makena is a drug used for premature birth therapy. It’s been available off-label for a long-time but KV pharmaceuticals ran a clinical trial and applied for FDA approval under the Orphan Drug Act (ODA). Under the ODA, KV is entitled to seven years of market exclusivity, this is even stronger than a patent because it gives KV the right to exclude from the market any drugs (not just similar drugs) that treat the same condition.

Now that KV has a monopoly—enforced against compounding pharmacies by threats from the FDA—the price will rise from about $10 to a listed price of $1,500. Naturally a lot of people are outraged.

I'm not exactly outraged, but I am a little bit sad since a treatment my wife and I had put so much hope in will now be substantially more expensive.  As someone who comments on the consequences of public policy from time to time, it's not that hard for me to set aside my personal feelings for a minute and ask whether or not granting a monopoly to KV in this case makes sense, and I'm not sure that it does.

First, it is important to remember what we are NOT talking about here.  This is not a case where KV developed and brought to market some entirely new treatment that was previously unknown. The patent protection given to new drugs is a related issue, but it is not a factor in this case.  As noted in the quote above, Makena has been given off-label for a long time. This means it hasn't been approved by the FDA as treatment of the condition for which it is being prescribed (in this case preterm delivery).  Given the fact that it has been in wide use, it would seem the standard arguments about patent protection for new drugs wouldn't apply to Makena.  Here is drug researcher Derek Lowe:

What's irritating, to someone like me who works at a "find a new drug" type of company, is that these no-name generic outfits (KV in this case, URL Pharma for colchicine) are doing pretty much what critics of the industry think that we all do, all the time. That is, walk up to situations where other people have done a lot of the work, a good amount of it with public/NIH money, and step right in and profit. Now it's true that these companies have to basically run Phase II/Phase III trials to take the data to the FDA, and that's a significant amount of money. But their risks in doing so have been watered down immensely by the history of these drugs in the medical community.

So KV has some risk in that they have to perform the final series of trials and then go through the FDA approval process, but is this cost proportional to the benefit?  In this case seven years of exclusivity, and the tremendous run up in price that comes with it.  History suggests that what KV added to the Makena story may not have been that valuable to anyone other than KV since the durg had been gaining popularity as a treatment for preterm labor at least since 2003 when a study demonstrated Makena's effectiveness.

The Orphan Drug Act, under which KV has gained the exclusive rights to Makena, is a law intended to promote drug development for rare diseases.  According to the March of Dimes more than half a million babies a year are born prematurely.  Given those numbers, it's not clear to me how prematurity still qualifies as a rare disease.

Finally, there are the circumstances around the company now selling Makena at $1500/dose, KV Pharmaceuticals.  This is from the St. Louis Post-Dispatch:

Staring down at the former chief executive of KV Pharmaceutical Co. — what used to be among St. Louis' most successful companies — the federal judge portrayed Marc Hermelin as an example of capitalism gone awry.

"What I see when I see Mr. Hermelin is greed, abuse of power, recklessness," U.S. District Judge E. Richard Webber said Thursday. "He had this great company of 1,700 (employees), and once diverted, he was sending pills across the country that were twice the strength of their labels."

...By 2008, KV was considered one of the most successful publicly traded companies based in the St. Louis area. But the criminal case against Ethex resulted in a two-year shutdown of KV's production facilities and layoffs of three-quarters of its work force. Now, the drug company is hoping to revive itself with a new prenatal drug, Makena.

KV is a distressed company making a bet on Makena.  But how much does KV really have at risk?  Given the fact that 17P was in wide use and there were studies demonstrating its effectiveness, it would appear they weren't risking much.

It is still not clear if we will be able to get a compounded form of 17P or if we will have to buy Makena at the new higher price.  Even at the higher price, my wife will likely still get Makena.  It just means we will hit our out of pocket maximum this year.

If there is any shame in this situation, and I believe there is, it belongs to KV and KV alone, but it would be a mistake to ignore the government's role in this. Without federal intervention in the form of the Orphan Drug Act, women would continue to get 17P and prematurity would have an effective and low cost treatment.

Makena: Public Policy & Private Consequence

This is a post from Jerry's blog that I wanted to share here as well. This is part one of three:

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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), keep reading.  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.

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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.