Makena controversy makin’ me think twice

Posted on March 17, 2011 by Mark

The March of Dimes saved my son’s life. There is no debate about that. If it weren’t for decadron, surfactant, and other medications, therapies and treatments whose development was supported and championed by the March of Dimes, The Kid would be buried next to Benjamin.

Ever since The Kid was born and I discovered the role that March of Dimes had played, I have been a big supporter of the organization. After a few years of just donating to the organization through SEFA, the State Employees Federated Appeal (the NY state worker United Way program), I decided to get off of my butt and help some more. Over the last five years, between my personal donations and the money raised through my participation in the WalkAmerica/March for Babies event (the name changed a few years ago) I have put around $20,000 into the organization’s coffers. It’s something that I feel very proud of, and I have been a staunch supporter this whole time.

That’s what makes this blog post especially hard to write. The last week has injected quite a few misgivings about the direction of the organization. You may have heard about the controversy surrounding the “new” drug, Makena. Previously available through compounding pharmacies (pharmacies that mix “custom” drugs that are not manufactured by large drug-makers) and known then as 17P, this synthetic progesterone has helped to prevent one in five women who had previously gone into premature labor from doing so again, allowing them to carry subsequent babies to full term. The drug carried a cost of $10-$20 per shot, which—at the standard course of 18-20 weekly injections—cost up to $400 per pregnancy. March of Dimes championed the use of this drug, and helped to save many babies over the years that it has been used.

On February 4 of this year, the U.S. Food & Drug Administration (FDA) approved the manufacture of the synthetic progesterone as an “orphan drug,” a designation for medications targeted at a smaller population in order to give a drug company exclusive rights to manufacture the drug for 7 years, aimed at allowing them to recoup their research and development costs before generic pharmacies can start creating their own versions. The FDA granted approval to a company called Hologic, Inc. Hologic’s pursuit of the approval was funded by K-V Pharmaceutical Corporation and its Ther-Rx Corporation affiliate, who had an agreement to acquire the rights to produce the drug from Hologic.

Greg Divis, head of K-V and Ther-Rx, trumpeted the approval as “a significant step forward for the thousands of women whose families have been impacted by preterm birth.” The March of Dimes, which receives hundreds of thousands of dollars a year from the company, was also prominent in the press release. The organization’s medical director, Dr. Alan Fleischman, noted that “The approval of this new treatment is a breakthrough in our fight against preterm birth.” Great news, right? The wonder drug will now be mass-produced and therefore consistently and widely available.

Fast-forward a month. On March 8, K-V issues a press release about a “Comprehensive Patient Assistance Program for Makena,” which talks about the financial assistance that will be made available for women meeting certain criteria “to ensure that all eligible women have access to FDA-approved Makena.” Not apparent from the press release, and only leaking out through other sources, was the fact that K-V planned to charge a whopping $1,500 per shot, or as much as $30,000 for a single pregnancy, and had warned all compounding pharmacies that they would face legal action if the attempted to continue making the drug themselves. To justify the price of the drug, the company didn’t even try to invoke any costs incurred by them, but rather compared it to the cost of bringing home a premature baby.

Now, K-V did not spend money to develop the drug. They didn’t even spend money to conduct clinical trials of the drug. That was done through a study by the National Institutes of Health released in 2003, that was supported by the March of Dimes! All K-V did was to buy the rights to produce it from Hologic and help to get it approved. But the company, in financial trouble after a number of problems, “including the criminal conviction of a subsidiary for shipping oversize painkillers, a two-year manufacturing shutdown and mass layoffs,” needed the huge profits from the astounding cost to try to dig themselves out of a hole.

Many maternity and prematurity advocates were busy pointing out that, the high prices might keep low-income women from getting the drug, and that the cost to health insurers and government programs might lead them to shy away from paying for it, both of which would lead to fewer women getting the treatment and more babies being born prematurely.

Meanwhile, the March of Dimes said practically nothing. A post on the @marchofdimes Twitter account on Thursday avowed that “The March of Dimes plays no role in the pricing of products.” and claimed that the patient assistance program from Ther-Rx would make sure that everyone who needed the treatment would get it. A further series of posts on Friday (concatenated here) noted:

Thank you to everyone who has shared their concerns about the cost of Makena. We agree that the price of Makena is too high. We’ve shared our concerns about the price with Ther-Rx in the past and will do so again today. Ther-Rx has promised that every eligible woman will get care regardless of their ability to pay and we will hold them to that promise. We will also work with insurance companies and Medicaid to be sure that there is coverage. The needs of moms and babies are our only priority and your voices will be heard.

To many of us, it still sounded like “we don’t like it, but we don’t want to do anything that will jeopardize our donations from them.” The organization that was the unflinching advocate for doing anything to prevent prematurity was still dancing around the issue, rather than baring its teeth and digging in to fight. And they want us to join them in lobbying lawmakers on prematurity issues later this spring? In what kind of fight?

Finally, under continuing pressure, on Tuesday the March of Dimes released a letter sent late the previous day from March of Dimes President Dr. Jennifer Howse and SVP/Medical Director Fleischman to Divis and Ther-Rx making it sound as if they were caught off-guard by the pricing and noting that “we respectfully request that you reconsider the market price of Makena and commit your company to the promise that every eligible woman who is offered the drug will receive it without regard to ability to pay.” A related Twitter post stated that “We want you to know that MOD is committed to ensuring that all women who are prescribed the drug are able to get it.”

Still not huge teeth, but at least a direct request to K-V/Ther-Rx instead of a “we’ll trust that they’re going to do the right thing.” But this letter should have been written (and publicized) last Thursday when the pricing became apparent and all news media were still hot with the story, and should have been followed up with stronger wording when Ther-Rx showed no concern that the price was an unfair burden.

Boy, I’ve written about 1200 words, and I still haven’t gotten to the point. OK, here’s the bottom line. The March of Dimes is an advocacy organization. When a company that provides a significant chunk of money to the organization via donations decided to save it’s financial butt on the backs of at-risk patients who don’t have the power to fight back, the March of Dimes gave a limp response and didn’t make a big deal about the astounding increase in cost that would likely reduce access to the  medication.

In fact, I just read an account from a woman who was informed by her insurance company that due to the cost to them for Makena, it counted as a medical benefit and not as a pharmaceutical; therefore, she’s responsible for a 20 percent co-payment, making her cost of Makena $385 per week. (Which brings up the point that $385/week is 20 percent of $1,925 per week, not $1,500 per week.) And since she’s insured, she doesn’t qualify for the assistance plan. I don’t think that’s an acceptable compromise on price.

Why did the organization wait to take the strong stance, especially as supporter concerns were rising on Thursday and Friday? Why did it wait nearly five days, well past the peak of the news cycle on the story, before sending that letter? Are the donations from K-V/Ther-Rx enough to silence advocacy? Did they really not believe that the high price might cause resistance? With their connections to the company, did they really not have a clue that K-V/Ther-Rx would price the drug so outrageously? Or do they blindly trust a company in financial trouble to provide sufficient financial assistance to all?

If this is what the March of Dimes’ advocacy is going to be like in the future, I seriously have to consider how (or whether) I’m going to continue to support it. This pains me to no end to even have to think about this. My support of the March of Dimes has been unwavering, because I want to help prevent others from going through what we had to go through with Benjamin and with The Kid. I don’t like that I’m now considering dropping my support, especially because there is no other group that has done as much to help expecting and new parents and premature children.

But for now, I’m holding off sending out emails for donations and campaigning at my office for the March for Babies because of this. I will continue running the requests for donations in the MousePlanet WDW Update and on the MouseStation podcast for consistency’s sake and because it’s a pain to pull it out and put it back in, but will not yet ask for donations on this blog, via email, or via standard interpersonal communication for a while yet. I’m going to wait another week or two to see how much further the March of Dimes will go to protect the access to the medication for those who have the least say (and most need) in the matter.

It pains me to do so, but this whole situation has me wondering about the organization’s principles and ability to do strategic thinking when it comes to the motives and plans of partnering pharmaceutical and other companies. I’m not closing the door, just pausing to re-evaluate. Let’s see what develops.

What do you think? Am I off-base? Am I over-reacting? Let me know in the comments below.

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Posted in Makena, March of Dimes, Preemies | 13 Comments

Heaving a deep sigh of relief

Posted on February 2, 2011 by Mark

It’s been a while since I’ve posted here, and I’ve got a lot to post about, but things have been very busy around here and other writing needed to take precedence in my limited writing time.

I had hoped to come back with something more deeply meaningful, but something happened that I felt that I needed to share with more than my family and it was too long for Twitter.

While driving my son home from dance class tonight (in round three of our lovely snowstorm), we were traveling along a dark local road. It’s a 3.1-mile straightaway, so while I was very alert and even a bit uptight driving that road, I still felt pretty confident despite the fact that the visibility was severely limited and the road was covered with slippery snow. My son, in the back seat, was babbling on about something inconsequential in his post-workout decompression.

We crested a hill, and there about 50 feet away were two dogs running RIGHT AT THE CAR! I hit the brakes, which locked up and caused me to skid on the packed snow. I tried to steer the car toward the right, as the dogs were near the center of the road. The dogs kept running RIGHT AT THE CAR! I thought that I might get past them on the right, but then I heard and felt a THUMP from the front of the car on my side as we reached the dogs.

“Oh, crap!” I said tersely, as the car finally came to a stop.

“What?” came from the back seat.

“I think I just hit a dog.”

The Kid started making whimpering sounds. (He’s very partial to animals, even though he’s allergic to fur and feathers.)

I looked in the mirrors and couldn’t see anything but darkness. There were no cars approaching from either direction, and there was a driveway just ahead and to my left. I started slowly turning into the driveway, intending to turn around and go back to see what had happened.

As I started getting into the driveway and swiveling my head both ways to see if the road was still clear of oncoming traffic, I saw two dogs running at me from behind. I stopped and watched as the dogs ran past the car, heading back in the direction that they had come from.

“Oh, thank God!” I thought (which is a strange thing to think for an agnostic, but I’ll analyze that later). I slowly backed out, back into the traffic lane, and carefully followed them up the road.

Both dogs appeared to be trotting normally, at least to my eyes, and they continued up the road in front of me, in my lane, as I slowly followed.

The dogs moved toward the oncoming lane just as a car began to approach from the other direction. I flashed my brights to alert them to slow down, and the dogs came back into my lane before the car arrived. It was probably about a quarter mile to half mile up the road when they took a quick right and ran up a driveway, though it seemed like an eternity. I guess I did an OK job escorting them home.

I’m still not sure what I would have done if I had gone back and one of the dogs was hurt or dead. I just knew that I had to do something. I’m so grateful that I didn’t have to find out how I’d handle it, but I’m also glad to know that—when something happened—I did the right thing. I just hope that I never have to find out what I’d do if I accidentally hurt or killed an animal.

I’m still a little shaken up, but the muscles in my neck are finally starting to loosen up a bit and my nerves are becoming a bit less frazzled.

I guess this is just a note to everyone driving in inclement conditions: Don’t be overconfident in your ability to handle the road conditions, even if you know the road very well. You never know when you’ll run into hard-packed snow and dogs running right at your car.

Has anything like this happened to you? Any insight that you can share? Please comment below.

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Turning the Corner, with Help from Disney

Posted on December 6, 2010 by Mark

OK, I realize that last week’s post was kind of a downer, about hitting the bottom of depression, losing perspective, deep denial of feelings, and the need to stop and turn things around. It even got me feeling more depressed again. But while it was necessary to exorcise those demons and warn against letting them into your life, it’s time to turn back again. It’s time to get back to repairing the breach in your life (and mine).

Let’s talk a bit about how I really started making the breakthrough to turn my perspective around and to start deciding to move forward again. For starters, a lot of it is thanks to some Disney and Disney/Pixar movies.

“What? Animated movies helped to turn your life around? How can Disney movies change your outlook on life?”

Obviously, if you asked those questions, you don’t know me very well.

Disney movies – well, Disney everything – is a big part of my life and has been for a long time. From the time that I rediscovered Disney in college to the point where I started sharing my love for Disney with my wife, with The Kid, and eventually the world through my writing at MousePlanet, my connection to Disney keeps growing. And their recent animated features, especially those done up in Emeryville, CA (home of Pixar Animation Studios), have really resonated with my emotions. They’re not just great animated films, they’re great films period.

So what actually resonated with me to help me turn my emotions around?

Let’s start with a movie called Meet the Robinsons. An unlikely candidate? Probably. But there were a few interesting points that stood out for me. I had been feeling particularly bad about myself at the time. There’s a point in the movie where the concept of “Keep Moving Forward” is explained to the hero, Lewis. The eccentric Robinson family talks about how they would never accomplished any of their oddball achievements if they didn’t shrug things off and keep moving forward.

Later, Lewis finds out that the villain, the Bowler Hat Guy, is actually Mike Yagoobian, his former roommate at the orphanage. It seems that “Goob” blames Lewis for the mess that his life had turned into, and was dedicating his life to destroying Lewis. Lewis tells him “Look, I’m sorry your life turned out so bad. But don’t blame me you messed it up yourself. You just focused on the bad stuff when all you had to do was let go of the past and keep moving forward.“

You just focused on the bad stuff when all you had to do was let go of the past and keep moving forward. Smack to the forehead! Ignore those trees, there’s a whole forest here! I started trying to focus on the mantra “Keep Moving Forward.” I even made it my computer password for a while so that I’d have to type it in every day and reinforce the idea. (Don’t try it, I don’t use it any more.)

That started me on the path back and gave me something to focus on. But it wasn’t quite enough yet. I could try to keep moving forward, but there was still something holding me back. Something in the past wasn’t allowing me let go of it. It would take another movie a couple of years later to help with that.

Up was released in May 2009. Until then, I really couldn’t fathom just how much a movie – let alone an animated movie – could affect me with no words being spoken. But the opening sequence of the movie, wordless through most of Carl and Ellie’s life together, had me in tears. From the time that they find out from the doctor that they can’t have kids through the time that Ellie dies, it just grabbed my heart. We then meet Carl as an elderly man, angry that he was never able to have children with Ellie, and angry that he was never able to provide her with the adventures that she craved, never seeing Paradise Falls with her as she had always dreamed.

I inhabited Carl as he went on his Quixotic quest to at least bring their house to Paradise Falls, to fulfill her dream on his own, and to at least bring her picture to the falls. It was a crazy dream, born of the feeling of loss and duty, and the only way that he could constructively deal with his emotional pain.

And then, in his darkest moment, he comes across the journal that Ellie had planned to fill with souvenirs of all of her adventures. When he had gone through it earlier in the movie, he had gotten to a point where the entries stopped, as if her ability to attempt any adventures was gone. But this time, he finds that Ellie had added more to the book that he hadn’t seen. It showed their life together and everything that they had done, even if it wasn’t the high adventure that they had originally planned. And on the last page, she had written: “Thanks for the adventure. Now go have one of your own.”

She had given him permission to leave the pain, the unfulfilled dreams, and the guilt behind, and to move forward in a new direction. I don’t think my eyes were dry for the next 5-10 minutes as I went through this catharsis. (In fact, there are tears in my eyes as I type this, a year and a half later.) It was as if Benjamin was releasing me from my pain, unfulfilled dreams and guilt. It was OK for me to go on with my life without Benjamin being there. It was OK. I could live my life again.

From that day, I’ve been doing what I can to put my life back together again. To do things the way that I want to do them without feeling bad that Benjamin was dead. My life could be (mostly) complete without him. I’ve been working hard to open up my emotions again, to allow myself to feel the good and the bad, and to be a full part of my family again. There have certainly been bumps along the way, and habits and behavior patterns that had developed over the years still intrude at times, but on the whole I think that things have been improving tremendously, and I can only hope that they continue.

What has helped you to make changes in your life? Have you undergone a cathartic experience that helped you to come to terms with a loss or other major life event? What was the trigger and how did it help? Please share, so that others can benefit from your experience.

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Fortress Around My Heart

Posted on November 29, 2010 by Mark

After four posts the prior week and dealing with the death of my uncle, I completely missed my weekly post last week. Time to get back on the horse.

Today, I want to talk about losing perspective after a loss, and how difficult it can be to regain it. As I mentioned earlier, when we lost Benjamin I basically went about not acknowledging how deeply I was hurt. I tried to carry on and put on a good face in hopes of convincing myself that I was OK. The depth of the denial made the pain go on much too long, and it would prove to hurt much more than my recovery.

I wrote a few weeks ago that I have a tendency to build walls around my emotions to avoid being hurt. I built an extra wall when we lost Benjamin. Six years later, when The Kid was in the Neonatal Intensive Care Unit (NICU) for 10.5 weeks after his birth and my wife was in the regular ICU for a couple of days, I was in great fear of losing one or both. In my typical fashion, I built yet another wall around the feelings.

I mentioned in that same post that I’ve had a recent “How’s that working for you?” moment that called that tactic into question. But while that covered the topic in general and noted that I’m now trying to fix it, I want to talk more about the years in between building the wall and the start of the attempt to dismantle it. The walled-off years. Specifically, I want to talk about the toll that it takes. If you are in this box now, I hope that I can show you that you need to get the hell out of the box now before it causes more damage.

So The Kid had been in tough shape while in the NICU, and we were both very scared for his well-being. The NICU staff did a wonderful job, and we quickly worked ourselves into his care routine and made sure that we were well-informed about his conditions, treatments, and so forth. When he finally came home, he had to go right back in the next week for hernia surgery. My fears were reinforced. I was afraid that we’d just have problem after problem and we’d eventually lose him too.

My wife’s mothering instincts went into overdrive, and she slowly formed a kind of protective bubble around The Kid. He was her entire reason for being. My sublimated fear of loss provided enough oomph to make me back out of a co-primary role in his care, letting me become comfortable with playing the backup role, deferring to my wife on all matters of care and diagnosis, and in many ways avoiding sufficient bonding with him. Instead, I found other things to occupy my time and concentration.

Backing out may have been easy for me, but it came at a tremendous cost. Not only did I deprive myself of the full measure of enjoyment of my son, I deprived him of the full measure of my presence in his life.

While I kept saying “I’ll do that someday,” I kept putting things off until I wasn’t sure if I could still do them. For example, I was going to do a special baby book detailing all of the preemie problems that we had to conquer, and including notes to him from his NICU nurses, etc. That never happened. The short videos that I was going to record every week/month/year/whatever to tell him what I was feeling about being his dad and what was happening with us? Yeah, that didn’t happen either.

As he continued to stabilize, gain strength and mature, I continued to avoid doing things that would increase my connection with him for fear of incurring greater pain. So many missed opportunities to let my guard down and enjoy his amazing personality. I paid attention to his school work, his dancing, his musical performances and his antics around the house, but I was too detached to really make any connection over them. My comments on his actions would always be more critique than celebration. I would relate intellectually instead of emotionally. In many ways, I acted in a manner that would have integrated well with a child who was as emotionally isolated as I was as a child. I was sweeping all empathy under the rug because it came at too high a price (or so I subconsciously thought at the time).

I’m still working to rectify the deficiency and to become more emotionally a part of his life. I’m taking a more active role in managing his care, rather than just providing it. My wife tells me that I’m making a lot of progress. But I still wonder what might have been had I been able to make this leap twelve years ago. I look at all of the missed opportunities and wish that there was a way to go back in time to change my approach.

But I needed to be ready to change first. I had to really know that the walls needed to come down. It took a bit of a breakdown to come to that conclusion, but now that I’ve started I’ve become very impatient with myself when I find that I’m blocking something. I find that I’m also less patient in general with situations where nobody is making any movement toward resolving an issue.

I’m now working at tearing down my walls, and I’m glad that I finally have made that philosophical change. Unfortunately, there’s no way to get those lost moments back. No way to get back inside my head twelve years ago and retroactively record those feelings in a book. No way to take more pictures of him as he grew and changed. No way to record what he used to act like, or walk like, or talk like.

If you find yourself walling off your feelings after a loss, stop what you’re doing! First of all, it will delay your ability to move on, because hiding your feelings away prevents you from coming to terms with them. Secondly, while you’re busy not feeling anything, you will miss out on so much of your life, whether it involves new arrivals, ongoing moments with people already in your life, or just enjoying your day to day existence.

On another note, I’m glad that I was able to make this change before my uncle passed away, as I was able to better appreciate the time that I spent with him during a couple of his last days.

It’s not easy; trust me, I know that. But in hiding your emotions away, you’re depriving yourself of the ability to enjoy and take charge of your life. The first step is to admit that things aren’t OK, and that things are not as rosy as you pretend they are. Once you make that leap of faith, as it were, the rest becomes possible.

Did this post speak to how you handle feelings of loss? Does someone you know respond like this? How do you handle your feelings? Please share in the comments below.

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Posted in Kids, Life, Loss, Preemies | 2 Comments

Fight for Preemies Day – Benjamin’s Eulogy

Posted on November 17, 2010 by Mark

As I’ve noted earlier, we buried Benjamin with the plush turtle we had bought for him on our cruise that summer and the blanket we bought for him a day earlier. The night before the funeral, I wrote a poem/eulogy for him. I only had time to write out one copy longhand, and so I did not put it into his little styrofoam casket with him even though I felt a little guilty about it, because I had a feeling that someday I would want to publish it. As it turns out, that day is today: Bloggers Unite to Fight for Preemies Day.

Join me in the Fight for Preemies!Today, we post to mobilize people to help fight prematurity. Every year, 13 million babies are born prematurely worldwide. One million of them die. Many survivors are left with major disabilities. While Benjamin (born at 22 weeks) was one of the unlucky preemies, our second son (born at 28 weeks) was much luckier. While The Kid has severe asthma, impaired vision and other minor issues, he is mentally and emotionally gifted. He is physically talented, as well, being a wonderful dancer. But we need to shrink the number of babies being born prematurely, and to help make sure that those who are born too soon have a future more like The Kid and less like Benjamin.

The March of Dimes has made tremendous strides in fighting prematurity and for helping premature babies to survive. It was treatment regimens and therapies developed through the March of Dimes that helped The Kid to survive. You can help by supporting the March of Dimes. Just click one of the links on the right-hand side of this page. If you’re viewing this post with an RSS reader and don’t see the right-hand side of the page, you can click here to donate to my March of Dimes fundraising campaign or here to donate generically to the March of Dimes.

I hadn’t even read this poem/eulogy since I read it at the funeral until I typed it in to post on the blog. It’s funny how some of the little points had escaped my memory over the last 18 years. Now I choose to share those memories with you. If they move you, please help other preemies to survive. Meanwhile, grab a few tissues. Don’t say I didn’t warn you.

Hello Benjamin.

I am your father.

I wrote this last night
because there are some things
that I need to say to you
before I say goodbye to you.

Your mother and I
always loved you
and will always love you
more than words could ever say.

We were so looking forward
to meeting you, and
getting to know you.

You were so anxious to meet us
that you forgot to wait
to grow the lungs
you needed to breathe.

You came to join us,
but you weren’t ready yet.
Five minutes later,
you had to move along.

We weren’t prepared to say “hello”
let alone “goodbye,”
but “hello” and “goodbye”
must be said.

I saw you when you first
came into the world.
It looked like you were
waving your arm at me.

Be the time we were
able to hold you,
you were already gone.

Your mother says you
look like me.
I’m not so sure,
but she’s usually right.

You looked so perfect in my arms.
You really are a beautiful boy.
Your little body was so
exquisite, yet fragile,
and the little triangle bruise
on your nose was the cutest thing.

We had so many plans
and hopes and dreams for you,
but they will never come to be.

The strangest things
make me think of you.
A book I planned to read to you…
A park we were going to play in…
Some of my old things that I was going to give to you…
Even the construction that I hoped would be complete
before the time I expected to be rushing to the
hospital to meet you.

Your mother and I bought a turtle
for you when we first
found out you were
on your way to meet us.

We thought about putting it away
for your first brother or sister
to come along.

But we decided that you should have it
to take with you into that
great unknown that you enter.

Please remember that it carries with it
all the love and care we used
when we picked it out.

You were born, you lived, you died.
Many dreams died with you.

You will eventually have brothers and sisters
who will never know you,
but your mother and I
will tell them about you,
and about the love that surrounded you.

They will also be loved greatly,
but you are special.

You are our first-born son.

Your brief life also did
another wonderful thing.

It brought your mother and father,
and all your relatives
even closer together,
and also helped your parents
realize what wonderful friends they have.

We weren’t even ready for “hello”
but now we must say “goodbye.”

Your life was short,
but you had time enough to give.

We will always love you.

Goodbye, Benjamin.

Goodbye, my son.

Sleep peacefully.

I love you.

Love,
Daddy

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Posted in Life, Loss, March of Dimes, Preemies | 5 Comments