Makena Drama: I Will Never Escape

It almost makes me sick to be dealing with this yet again. I confirmed with my doctor's office that the FDA was allowing compounders to create 17P (hydroxyprogesterone caproate), and asked my CVS/Caremark pharmacy not to send me another $100 (copay) refill for the last 5 shots of Makena. After all, why spend $100 (and let my insurance pay KV Pharmaceutical) when my compounding pharmacy could produce the same drug and make a profit with just me paying them about $35 for the same amount?

I have had a bit of a cold, so I put off calling my local specialty pharmacy until Friday, thinking they could get the drug to me by Tuesday, when my 32-week shot is due. Last time they filled the scrip it was the same day I brought in the order. The pharmacy rep told me that they could no longer compound 17P. "Aha!" I said, "but the FDA reversed that decision, and now compounding pharmacies can make 17P!" Seriously, am I the only person in Colorado on this drug? And then the other government issue shoe fell.

She told me that the Colorado Board of Pharmacy would not allow them to compound it. I looked up the board—it's the state pharmacy licensing agency, responsible for (a) licensing, and (b) enforcing laws through licensing, not licensing, revoking licenses, etc. They're not a legislative agency, so I was confused as to how they'd have anything to do with me and my 17P. Naturally, since I have nothing better to do, I called the state professional licensing organization and they connected me to a very nice man at the Pharmacy Board.

He directed me to the Colorado Revised Statutes (i.e. Colorado legislation), namely CRS 12-22-121(18)(c):

(I) A prescription drug outlet shall not compound drugs that are commercially available except as provided in subparagraph (II) of this paragraph (c).
(II) A pharmacist may compound a commercially available drug if the compounded drug is significantly different from the commercially available drug or if use of the compounded drug is in the best medical interest of the patient, based upon the practitioner's drug order, including, without limitation, the removal of a dye that causes an allergic reaction. If a drug is compounded in lieu of a commercially available product, the patient shall be notified of the fact.

Translation: unless I'm allergic to the commercially available form, I HAVE to buy it.

It's really not a bad law. It's made to protect manufacturers from compounding pharmacies simply stealing away business by making whatever drugs they want. When you look at the way most drugs go through the processes of creation, approval, patenting, going generic, etc., it makes total sense. This whole Makena thing is just so F'd up that the only way for the commercial drug to have competition was through compounders, since no other commercial options are available. The drug is over 50 years old!

The problem stems from KV Pharmaceutical "developing" a drug that already existed, and from the FDA's promise of orphan drug status that would give them a monopoly. Orphan drug status, of course, only goes to drugs that affect a small number of people. Thanks, FDA, for screwing those of us in the minority with the "rare" problem of preterm labor. At least they shaped up in the end, but unfortunately I am still screwed into getting another rush order of the expensive stuff.

I'm going to say that if KV couldn't make the drug at a competitive price, they shouldn't have made it in the first place.

I continue to be baffled by the high price of Makena. I get the difference between the compounded version of hydroxyprogesterone and the commercial version: KV Pharmaceutical is mass producing the drug, ensuring that dosing standards are met exactly, and regulating the quality of the drug. Mass production is usually a cost-saving measure. It's because of mass production that factory-made items are less expensive than hand-made items. Efficiency cuts costs.

But what if mass production isn't efficient and doesn't cut costs? The high price of Makena is a result of one or both of two things: price gouging because Makena had the "orphan drug" monopoly that eliminated competition, or high production costs, meaning Makena is produced less efficiently than at compounding pharmacies. If it's so expensive solely because of inefficiency of production, then we need to look at whether the dosing and quality regulation they do is really worth the added expense over the dosing and quality control individual compounders do. Certainly compounders are held accountable for any mistakes, as was made clear when the FDA began to allow compounding pharmacies to compete with Makena again so that women could get this important drug. Essentially they said that though they'd allow pharmacies to compound the "orphan drug" without punishment, these individual pharmacies would still be held accountable for the safety, quality, and sterility of their products. I don't know about you, but I trust a smaller local firm with a lot to lose over a giant pharmaceutical company that has a lot more resources and power to fight or hide anything substandard in their product.

So the benefits offered by Makena, in all its commercial glory, have debatable value. No, since the FDA seems to think the commercial production is valuable, I'll say they have definite value. But shouldn't the consumer be able to decide how much value? Can't I say how much mass production and standardization is worth to me? It's not worth as much as Makena costs, that's for sure. And now laws that were made to protect both consumers and drug companies from knockoff drugs are keeping me, yet again, from getting the meds I need at a fair price.

My Mom

There are lots of moms out there, of lots of different types. There are moms who can cook anything, and my mom can do that, though by the time I could appreciate an excellent meal without flopping down at the kitchen table and saying "EW!" my father had taken over much of the cooking so my mom could get her business degree.

There are moms who are smart, and my mom has always been one of those. Shockingly so. She has the ability to think critically, analyze situations, and make plans of action like nobody else I've met. I used to help her study for classes by drilling her with her own notecards as we drove around town, and as a result my understanding of economics was quite well established by the time I hit college. And that's not the only thing my mom taught me. She is singlehandedly responsible for my knowledge of algebra (though that was more of an endurance/persistence/patience effort than intelligence on her part), and actually got me liking math. I mean to the point that I would do it in my spare time, and wound up actually enjoying multivariable calculus at 16. Enjoying it. And I'll lay that squarely on my mother's shoulders.

My mom was ahead of her time in mothering skills. She practiced attachment parenting before it was cool, and fostered our intellectual growth at home both before we entered formal schooling and after. She read my brother and me books and helped us participate in sports and learn musical instruments. She put us to work around the house and showed us how to clean, cook, gather kindling, prepare firewood, and start fires (in a totally safe, non-arson type way). She took us outdoors and showed us birds and animals and crazy awesome dangerous nature things. She taught us to stand up for ourselves and others, and to keep values that were difficult or unpopular growing up.

You'd think a mom with outdoors skills and brains and patience wouldn't be one a girly-girl either, but my mom was. She taught me about makeup and skincare and proper nail painting techniques. We still sometimes get to shop together for clothes or makeup.

And that's the part of my mom I discovered as an adult. She is a fantastic friend. We watch reality TV together, shop together, eat together. We discuss books and news. She is always, always there to help me when I need it. She is interesting and thoughtful, so we never run out of things to talk about. She is a good advice giver, but knows when not to advise. She is generous with everything she has.

Her mother could have named her Prudence or Hope or Charity or any of those other somewhat terrible "value" names, but instead she named her Rose. Roses are beautiful and strong, with thorns to protect themselves and solid roots to grow tall. They climb toward light, and bloom so fantastically that no other flower quite compares. Of all of the good things my grandmother could have called my mom, I think she picked the most fitting name, because my mom truly is a Rose.

Destruction!

Sometimes it feels like my life is falling apart. Other times, it just feels like the stuff I need to live my life is falling apart.

Like Saturday, when I had a lovely trip to the zoo with my family and friends, and came out to find my windshield broken by a stray golf ball. And by "stray," I mean it was irresponsibly driven across two lanes of traffic, a superwide ramp down to a parking garage, and the fences/nets put up by the golf course—oh wait! there weren't any!—into the car we traded down to to get rid of our car payment. You know, because we need that money for the baby we're expecting in about two months.

I would've loved a "golf course nearby" sign. Or maybe even three feet of fence over the parking lot wall that would have saved me from this whole problem. Instead I got a nasty windshield replacement bill, and a lesson to purchase a lower deductible plan for my auto glass, because I have zero control over what happens to it.

And Sunday I got Finley's cold. It took him a solid 3-4 days of fever to start showing symptoms, but it hit me like an unwelcome golf ball when in the morning I woke up with a massive headache, sore throat, crapped out sinuses, and a really tough time speaking. I figured a couple of days would see me through the worst of it, and by Tuesday I really felt awesome for my 30-week check up (all is well, baby is good, and even a very on-time delivery is starting to loom close enough to make detailed plans for).

Naturally after the doctor's appointment high, my cold fell right back into place. Super. So that second thing I need to live my life, that is a face I can breathe through, is totally broken too.

Then, at 11:30 PM tonight, when my very average sized husband threw himself exhausted onto the bed, the bed riser broke. And it scraped the crap out of our bed leg. AND it somehow pulled a screw out of the bed and discombobulated the entire corner support. Unfortunately since most of the storage in our house is under that bed, and it's not exactly bed-riser season at Wal-mart, I had to use my superhuman pregnancy strength to recombobulate the bed corner and find the exact right old textbooks to prop up the bed leg so we could at least sleep for the night.

Here's my crossed fingers and toes hoping it doesn't collapse again before we can get it more permanently fixed.

My windshield, my face, my bed—this is starting to seem like either a really weird dream or a set of nasty omens. Or on the other (and more likely) hand, it probably seems that way because of the congestion-interrupted sleep I've been getting (and not getting).

But fortunately, the thing that isn't falling apart is my happy little fetus and her well-sealed home. My stretch marks are definitely growing, but the fantasy of an eventual tummy tuck is enough to comfort me (who knows if that will actually happen). By biggest pregnancy worry is VBAC or repeat CS (yes, they do both suck), and that's simply fantastic. Also fantastic is having the strength and ability to walk around for hours, play with my son, and occasionally have a night out with the hubs. Some things might be falling apart, but I, for once, am not.

Stretch

I think my favorite part of pregnancy ever is the cute belly. Maybe it's because when I struggled with infertility I was so jealous of that rich, round sign of impending baby. And maybe it's partly because I felt cheated out of showing off my belly when at 17 weeks I was bedbound for the remainder of my last pregnancy, and because I didn't get nearly as big as I would have liked to.

In any event, I love having a belly, and watching my bellybutton shallow out to a faint star in the middle of a heavy mass of mama, and trying to walk like a normal person when there is another person hanging out the front of my abdomen.

So now, finally, I am starting to get that nice, big, third-trimester belly. I'm carrying round. The rest of me is roughly proportional to my pre-pregnancy self (you know, from the two weeks I got back into those size 8 jeans before having to surrender them to the "clothes that won't fit for another year" trunk). Oh, and my second chin has even retreated a bit! But my belly has stretched the front of me from boobs to C-section scar with shocking evenness. And while I'm lucky not to look too chubby from the front, the belly definitely takes up the width of my abdomen too. I am by no means carrying small.

And I thought I'd paid my genetic dues last time, when I stretched from upper thighs to belly button in big, red streaks the cocoa butter was just barely starting to fade into shiny lines. I supposed that the postpartum shrinking had effectively nail polished the ends of the giant runs in my skin, so I could continue wearing it without worry that my runny-stocking skin would tear through the rest of me.

Naturally, I was super, super wrong about that. Now that I'm passing the limits of my prior belly stretch, I'm starting to get growing pains once again, and to top it off last night after my bath I found a new, tiny tear sprouting from the top of one of my old ones. It hit me instantly: I am going to have giant stretch marks from head to toe. By the time I carry this baby to term (and I WILL carry her to term), I will be that old stocking you thought you could wear one more time, but by the end of the night it was only a scrap of barely-held-together nylon gossamer, embarrassing you with its complete decrepitude.

Which brings me to a strange realization. Before that tiny rip appeared in my otherwise good-enough-after-delivering-twins belly, the technology that had most inspired my gratitude for living in this particular time was indoor plumbing. Screw the internet. But now, another holy blessing of invention shares that spot: cosmetic surgery.

Say what you will. Before this decade is over, I am going to see about having these shiny marks tattooed back to my normal skin color, and then having some of them just completely removed. I'm talking tummy tuck. I don't need a bikini body, but hey, I know when it's time to buy new stockings.

Dear Pepsi,

I am a fan of many caramel-colored, caffeinated, cold, carbonated beverages. Colas have been a tradition in my family for as long as I can remember. And though I had my youthful flings with orange soda and cherry syrup, the classics remain my favorite: Coca-Cola, Pepsi, and Dr. Pepper still top my list.

Dr. Pepper wins for unique flavor. Pepsi takes second because everyone carries it and it's better than Coke (sorry Coke). But Coca-Cola gets the nod because (a) Mexican Coke has cane sugar instead of higher GI corn syrup, and (b) Mexican Coke is somehow way tastier than Mexican Pepsi.

But along with my fancy new unsweet tooth, I've gotten a heightened sensitivity to caffeine, so I've been struggling without my Mormony equivalent of booze the way some women suffer for red wine when they're pregnant. It's not a bad sacrifice, but I still want the good stuff if I can get it. Pregnancy exhaustion/stress plus wrangling a one-year-old who is not as mobile as he really, really wants to be leaves me extra needy for the little joys in life.

So today, Pepsi, you have won my affections. Pepsi is the only caffeine-free version of my favorite drinks easily located at stores outside of Utah, and there it was, on the shelf at King Sooper's, for only a dollar per two-liter bottle. And it was SOOOOOOO good. Without the caffeine heightening the sugar taste, the flavor was beyond perfect, at a time when everything else I eat tastes just a little wrong.

Knowing that I won't be up all night made it even better. I have another bottle and a half left to enjoy, preferably before my glucose tolerance test results come back. The next few days should be totally awesome.

Breaking the Trail

I haven't been to this part of a pregnancy before. Baby girl is due in 3 months, or 13 weeks from today. She's got enough uterus time for some serious advantages in life, including a better than 90% survival rate outside the womb if she were born this week. The even better news: she probably won't be born this week.

Which brings me to my point: Suddenly this pregnancy seems to be going on forever, and I'm in the part of it I've never technically experienced. Of course, every pregnancy is different, and this one is doing some strange things. I can't complain about a long pregnancy, but if history has taught us anything, we should know that I can find something to complain about.

It's my sweet tooth. It's been injured. I tend to love sugar. I crave it, I eat it, and I thoroughly enjoy it. Hormones have taken away the two most important parts of that equation. I don't crave sugar. It's the best candy season of the year, and while some of my favorites catch my eye when I walk through Wal-Mart, I just don't have the same desire I once did. On the other hand, I still occasionally buy and eat it. Robin Eggs, Pay Day bars, Cadbury Creme Eggs, chocolate covered marshmallows - and that's just in the last few weeks. It may not be a complete accounting of my indulgences, either.

Full disclosure of my sugar binges is not important; the problem is that though I continue to eat sugar, it has become rather awful. I never wanted to know why some people don't like Hostess products and cheap candy, and I do, and it's terrible. This must be what drug addicts feel like when their regular dose stops delivering a high. And that thought is even more depressing, because I realize how much I use sugar to change my mood. It is my drug of choice.

Now that I'm seeking out snacks and easy foods that don't have tons of sugar, I'm finding out how sugar-infused American non-perishable grocery items are. Even beef jerky, that pinnacle of easy protein, is coated in sickly sugar. Do not want. So snack foods are limited, and since I am awful at keeping veggies good long enough to remember to cook them, and since I am far too lazy to actually cook up a piece of meat when I need to eat lunch, I am seriously struggling with meals.

Yesterday and today: tacos for lunch. Easy because Tim made the meat and everything else is pretty simple. During the week: I find things around the house. Cheese. Crackers. Nothing. And half the time I'm too tired, busy, and braindead to even remember to eat, and then I end up having a nearly-passing-out episode in the middle of relief society. Because I ate a cupcake for breakfast after only a few hours of decent sleep. Depending on the calendar you use this is about the first day of my first third trimester, and I already suck at it.

Okay, One More

Update about the 17P situation that is. After I finally heard from my insurance, I was satisfied with a price for me of about $200 for the rest of my shots. That doesn't seem too bad until you compare it to the $100 I paid for Finley's whole 13-week NICU stay. Yes, it would be cheaper for me to just have this baby out now. That screwed-upness lies somewhere between the insurance company and Ther-Rx/KV Pharmaceutical, but I do not let the makers of Makena off the hook for their ridiculous pricing.

Fortunately, neither does the FDA. Just a couple days after my order for 1 $100 refill of 5 Makena shots went in (rushed), today I found that the FDA will be allowing compounding pharmacies to continue making the inexpensive 17P I've been enjoying for the last 10 weeks. That still leaves me and my insurance with paying those criminals at Ther-Rx for 5 shots, but I had to do what was necessary to keep this pregnancy safe.

But of course, life is never so simple. My last precious milliliter of 17P wound up being only .5 mL. That doesn't mean the pharmacy shorted me (of a $3.50 value! Oh no!), it just means that somewhere in the last 10 shots, .5 mL got lost in mixing needles or stuck to the sides of the vials. It's normal. And at $7/shot, I can afford little losses like that.

So even though I moved as fast as I could to make sure I'd get my shots, I'm still anxiously awaiting the rush shipment from my CVS/Caremark specialty pharmacy so I can make up for the lost dose amount. And hopefully not need a progesterone suppository, which my OB's office has threatened if I don't get my shipment before Friday. I'm just hoping that if I do need the suppository, it goes in the shipping and receiving door and not the, uh, emergency exit (for evacuation only). Are you as sick of my metaphor as I am?

So that's the story. The hope is that in another month, I will get my last 5 mL from the compounders at a totally reasonable price. I haven't called the compounding pharmacy to check up on it, but I can't imagine the hassle they've been going though between the angry pregnant ladies and the greedy pharmaceutical reps. In fact, I'm pretty sure that's a worse place to be than between rock/hard place, frying pan/fire, mama bear/cubs, bull elk/harem.

I'm not stressing about the situation much now, mostly because I'm wondering if I'm the only little girl who got the "don't get between a bull elk and his harem" speech.

For the record, after 2:34 AM tomorrow morning, I will be the most pregnant I have ever been: a full 25 weeks and 4 days!