We Are Family... Or Are We?

Perhaps it was the milestone birthdays that Eliza and I had this year (5 and 50), but I have been thinking a lot about what really makes up a family. Is it the people we share a blood relationship with only or is it comprised of friends who have become like family to us? Can a distant cousin be more of a sibling to me than my own sibling and does that cousin become a more important family member? Can a cousin who lives overseas be more involved in Eliza's life than family members who lives nearby?

When I was growing up our family (first cousins, second cousins and some third and fourth cousins) were relatively close by and we spent weekends, birthdays and holidays together. Our parents and older cousins had jobs, sometimes two jobs, but no one ever seemed too busy to find time for family. We quarreled and drew lines in the sand (a few fist fights even broke out) but at the end of the day sat down, we laughed at ourselves and shared a good meal. Are we really that much busier today and that much more focused on ourselves that we can't think beyond our own needs? Have we forgotten that family does matter?

When you ask Eliza who her family is she will tell you: "Mama, Nana, Peter, Matthew, Adriana, Aunt Bonnie, Aunt Cindy, Aunt Mal, Aunt Carolyn, Nana Wilda, Cerissa, Uncle Ken, "the cousins" (Nicole's and Tracey's children), John, Patti, Bosley and Pumpkin (don't ask)." If you know my immediate family, you will realize there are some notable absences from the list. I find this very sad because Eliza does not, and likely will not, ever get to know these people, people I grew up with and people who I watched grow up. How busy can people be that they can't make time to spend with a 5 year old? Very, very, very busy I am told. At what point am I permitted to stop trying to include actual family who can't be bothered to get to know Eliza?

Some people may argue that it isn't Eliza that they don't like, but rather it is me they would prefer not to share an afternoon with. Fair enough, but there is nothing stopping someone from taking Eliza out for an afternoon (trust me on this one) or even acknowledging her birthday with a simple card. But what is a parent to do? Do I keep telling Eliza who her family is and have her disappointed when they don't show up for events or show up in body but not spirit? Or do I let her craft her own "family" from the people who love her and want to be an active part of her life, but who are not even related to her?

Family does matter. Right?

As the Dime Turns

Apparently in response to the outcry from parents, patients and fund raisers, the MOD has written to KV Pharma/Ther-Rx regarding its concerns about the price of Makena. Here is the MOD's letter:

March 23, 2011

Greg Divis, President
Ther-Rx Corporation
One Corporate Woods
Bridgeton, MO 63044

Dear Mr. Divis:
Thank you for your letter of March 17th. I am pleased to learn that you are ‘listening carefully to stakeholder concerns about list price, patient access, and cost to payers’. Thank you for considering additional steps to ensure that Makena is available to all eligible women, and for convening stakeholders from the March of Dimes, the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and the Society for Maternal Fetal Medicine next week.

In advance of that meeting, I want to go on the record that March of Dimes expects Ther-Rx to come to the table with substantive commitments including:

1.A significant reduction in the list price of Makena.
2.Adjustments to the patient assistance program to ensure adequate coverage of all patients, insured, uninsured and underinsured.
3.A method for reporting on a regular basis to stakeholders on the patient assistance program to ensure that it is meeting needs in a timely and adequate way.
4.A justification or rationale for your pricing based on your investment in the product, savings to the health care system, or other appropriate methodology, which you are prepared to make public.
Without these elements, I do not believe that Makena can succeed in the current marketplace environment, and as a result, at -risk women will be denied access to a safe and effective treatment to reduce preterm delivery. Therefore if you are unable to make a clear commit-ment to significantly address the above issues at the meeting, the March of Dimes will need to pursue alternative strategies for ensuring that this proven intervention to prevent preterm birth is made available to all medically eligible pregnant women, and we will step away from our longstanding and productive corporate relationship with Ther-RX. Thank you for your consideration of this critical matter.

Sincerely,

Jennifer L. Howse, PhD
President

Sadly the letter is pretty toothless.

The MOD's "threat" is that if KV Pharma/Ther-Rx does not justify the ridiculous price or lower the price, the MOD will "pursue alternative strategies for ensuring that [17P] is made available to all medically eligible women."

Well, exactly how does the MOD plan to "ensure" this? The MOD does not manufacture or distribute the drug. Currently KV Pharma/Ther-Rx has an exclusive license, so how does the MOD plan to ensure every eligible woman gets the drug? It can't. Nor has the MOD identified one single "alternative strategy" which it intends to use.

According to Charity Navigator (which gives the MOD a pretty poor one star rating), the MOD had over $211,000,000 in revenue in 2009. You can read about it here. I think the MOD needs to spend some of the $211,000,000 on a PR firm. Or maybe Dr. Jennifer Howse can use some of her $633,000 salary to help fund a PR campaign? Just a thought.

Happy Birthday Eliza Grace

We celebrated Eliza's 5th birthday surrounded by great family and wonderful friends.

We had balloons courtesy of Aunt Bonnie:

We had great cakes thanks to the wonderful efforts and talents of Adriana, Matthew, Peter and Dana:

We had beautiful views:

We had some really great food:

We had plenty of dinos:

New friendships were forged:

Young love blossomed:

Notice the death grip Eliza has on Otto :)

We had lots of arts and crafts:

There was a T-Rex Pinata and one brave soul (thank you James) who agreed to hold it on a stick so 30 kids could swing a bat at it:



We made sure everyone got lots of candy:



There was mayhem at the ceremonial blowing-out-of-the-candles:

(notice the "step away from my cake" face)

(Adriana does not need another upper body work out for a while)

We all ate the cakes:



Maybe too much cake:

And did I mention the very generous gifts:

But the most important part of the celebration was the people:






Thank you for helping to celebrate another year in the life of one amazing little girl.

The March of Dimes and KV Pharmacueticals

Unless you spend time in preemie-land this article may not have caught your attention: Premature labor drug spikes from $10 to $1,500

Up until this week there was a drug known simply as 17P which was used to prevent premature labor in certain pregnant women. It was a compounded drug, widely available, at a cost of about $10 to $20 per injection. In the world of pharmaceuticals this was a bit of a bargain drug. This past week a drug company, KV Pharmaceuticals won FDA approval to be the exclusive manufacturer of this drug which KV Pharma has named Makena. KV Pharma, by all accounts, has a pretty shaky past, only recently having avoided bankruptcy and whose CEO was recently sentenced to prison. You can read about KV Pharma here and here, but I am sure you can find many more tidbits on your own.

KV Pharma seemingly performed no research and development into this drug but got lucky when it purchased the rights to Gestiva (now known as Makena) in 2008. You can read the press release here.

So what does all this have to do with the March of Dimes you ask?

The following is a post from Dr. Davis (a specialist who places Transabdominal Cerclages (TACs) which was posted on "Abbyloopers" (a yahoo support group for incompetent cervix).

As many of you have become aware, KV Pharmaceuticals has received FDA approval to be the exclusive distributor for P17. They are planning to charge $1500 per injection for a total cost, per pregnancy, of $30,000!!!!

The current cost is $10 per injection, or $200 per pregnancy.

There are several points that I would like to emphasize.

The rationale for a commercial manufacturer is to ensure a standard concentration. In theory, this can be a problem with compounding pharmacies although the vast majority of the compounding pharmacies producing this product tat present have extremely exacting standard. The March of Dimes has, unfortunately, bought into this rationale with absolutely no proof that a variation in strength is of any clinical significance. By law, once a drug is commercially available, compounding pharmacies must stop production of that drug.

We have been using P17 for the past ten years from these compounding pharmacies with obvious beneficial effect. So where is the rationale for this change?

March of Dimes receives several million dollars a year in support from KV Pharmaceuticals - I wonder why! This suggests to me that March of Dimes can be bought. I, personally, have informed the March of Dimes that I am ceasing all support of their organization, financial and otherwise, until they divorce themselves from KV Pharmaceuticals and support for Makena. They do not realize that they are going to cause an increase in the preterm birth rate, not a decrease. At best, there will be no change other that a massive over-expenditure of health-care dollars.

You have seen the propaganda stating that no-one will be denied the medication because of ability to pay. However, what they don't tell you is that they are going to use very strict criteria. In essence, the only women who will qualify is those who have had a prior preterm birth before 32 weeks secondary to preterm labor. To illustrate this more fully, Aetna/US Health care (one of the largest insurers in the country) covers this therapy when patients meet their strict criteria. Currently, they are paying for P17 for only 1,000 women nationwide per year! There are 4.2 million births in the US annually. 10 - 15%, or 420,000 to 610,000 are premature. And Aetna is only going to cover 1,000 of these women.

30% of all prenatal care is covered by Medicaid. An additional 10% is covered by charity care. KV is going to insist that since this care is not coming out of the patient's pocket, the cost should be borne by Medicaid and charity care. Currently, we can provide good prenatal care for about $2,000 per pregnancy. So for every patient placed on P17, we have to somehow find away to cover an additional 15 pregnant patient. And who pays the medicaid and charity care bill? We all do through higher taxes and higher healthcare premiums!

Studies show that approximately 30 women need to be treated with P17 to prevent one preterm birth. At $200 per patient, this is very cost effective. That is an expenditure of $6,000 to save the average of $51,000 per preterm delivery. With current pricing, we will have to spend $9 million dollars in P17 therapy to save $51,000. Does this make sense? And people want to know why health care costs so much.

Most of you (greater than 90%) who will be on P17 now will be faced with doing without or paying $1500 per injection out-of-pocket. If you are currently on this medication, make sure that your doctors order enough for you right away to cover the entire pregnancy. You could have as little as one week. If you are early in pregnancy or planning a pregnancy soon, talk to your doctors about getting this now to have on hand. Most suppliers warrant the drug to be effective for one year.

So, what can you do?

Firstly, contact KV Pharmaceutical and voice your displeasure:

KV Pharmaceuticals Contact Information: investorrelations@ kvpharmaceutical.com

Second, notify your local media outlets about this issue.

Third, write or email your congressman and senator:

http://www.senate.gov/general/contact_information/senatorscfm.cfm

https://writerep.house.gov/writerep/welcome.shtml

Fourth, contact the FDA and find out why they elected to give KV exclusivity for this product. Competition will bring down the price dramatically.

http://www.fda.gov/AboutFDA/ContactFDA/default.htm

Fifth, write to the president:

http://www.whitehouse.gov/contact

Sixth, contact your state Medicaid offices and your insurance carriers. Get them involved

Seventh, get as many of your friends, family members, co-workers, etc. as possible to do the above.

Eighth, feel free to cut/paste/email the above to as many contacts as you can. Let's make this issue go viral!

If we can get enough of a protest mounted, we stand a chance of averting this "rape" of the healthcare system that is motivated almost entirely by a profit motive. Even if KV decides to not manufacture the drug for fear of losing money, we will be better off than with what they are currently planning.

Thank you.

Dr. D

When the public, or at least the public in preemie-land got wind that the MOD endorsed the proposal to give KV Pharma the exclusive manufacturing rights, there was, well, outrage. All was not well in preemie-land. Many parents of preemies, like myself, had raised tens of thousands of dollars for the MOD and we were disappointed to see that the MOD had made such a bone-headed and irresponsible (and possibly deliberate) decision to endorse KV Pharma's exclusive rights to manufacture this drug.

There are only a few reasons that the MOD blindly endorsed KV Pharma's application to be the exclusive manufacturer of Makena. Either (a) the MOD was so tickled pink with the continued contributions from KV Pharma and its subsidiaries that it ignored the fact that having an exclusive manufacturer of the drug would lead to a price increase (particularly a manufacturer that seems to have had its recent share of financial troubles); (b) the MOD, despite being a huge corporate entity, felt no obligation to perform any due diligence into whether or not the granting of exclusive rights to KV Pharma would be beneficial to the very population the MOD purports to serve or (c) someone at the MOD was so naive as to think that switching to an exclusive manufacturer and thereby creating a monopoly would not have an ill effect on the price of the drug (under this scenario one must accept that no one in the employ of the MOD majored in history or has a law degree).

The MOD's response to the outcry today was posted on the MOD's Facebook page:

Thank you to everyone who has shared their concerns about the cost of Makena. The March of Dimes agrees that the price of Makena is too high. We have 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.

The MOD also stated on its Facebook page that:

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.

The MOD's responses are nonresponsive to the question of why the MOD chose to endorse this decision. Now the MOD shares its concerns about pricing? The MOD is relying on the promise of a subsidiary of KV Pharma (Ther-Rx) to provide the drug to "eligible" women who can't pay for it? The MOD is going to "work with" insurance companies to be sure there is coverage? Exactly how does the MOD plan to do this? The MOD can't even get insurers to offer Synagis to babies who need it so why should anyone have faith in the MOD's newly found powers of persuasion?

My decision to no longer fund raise for the MOD was made last year, before this latest debacle. There are many charities that perform admirable work toward preventing birth defects and prematurity and which support families of premature babies in ways far more effective than the MOD. Those charities and non-profits are no doubt not immune from problems, but at least so far none of them to my knowledge have contributed, directly or indirectly, to the financial burdens already faced by families raising premature children or who are having an already difficult (and therefore more costly) pregnancy.

Does Time Ever Really March On?

The down side to keeping a journal or a blog is that you prevent yourself from forgetting since you have carefully cataloged life's events and they are there for your easy reference. As March 15 approaches I thought this would be the year that I finally could stop reliving the anxiety and abject terror that consumed me for the 25 days preceding Eliza's birth. But no such luck. I thought this year, the fifth year, would be the first year that I could stop remembering the fear that struck every 6 hours like clock work for 25 days when the doctor would come in and tell me how I and my baby were doing (never good) and whether this was the day I would be forced to give birth so I could survive. Pre-eclampsia is not just an inconvenient illness for pregnant women. It kills them. So when someone you know is hospitalized with pre-e and its later incarnation HELLP Syndrome, it is not simply so they can get some rest and keep their feet up. They are at risk of dying. Not just losing their baby, but dying. And as we know, dying sucks.

For five years I have tried to ignore the comments from pregnant women who think 36 or 37 weeks is "good enough" since they are uncomfortable, or the equally ill-informed comments that bedrest is such a great thing since who wouldn't want a license to lounge around and presumably eat bonbons (note: I am not really sure what a bonbon is). The list goes on (and often has gone on at length on this blog).

Time may march on for many things, and maybe the pace of the march has quickened in the past five years, but not quick enough for me to be able to relinquish my grip on the bottle of xanax or the therapist's phone number this time of year.

Soles4Souls

Eliza's Aunt Mal is participating in fund raising for Soles4Souls.org which is a great organization that distributes shoes to those in need, whether it be to the Gulf Coast in the aftermath of Katrina, or to Haiti, where Mal will be distributing a load of shoes to those in need, some of whom have never had a decent pair of shoes in their lives.

If you would like to contribute to Mal's fundraising for the trip, please visit her Soles4Souls page:

Make Me Up A Story Mama

One of the things that I think is great about Eliza is how she asks every night to have me make up a story. She loves having a book read to her, but much prefers a made up story starring, well, Eliza.

But the stories are not just about Eliza alone.

There are recurring themes, like making up a story about "Eliza's House on the Hill on Saba" or "Eliza's Dog Cookie and His Best Friend Bingo" (Cookie is a one-eared stuffed dog and Bingo is a real dog owned by Nana Wilda on Saba.), "Eliza and Her Iguana" and "Eliza and the Scarlet Macaw."

But her latest favorite story line is "Otto the Tortoise and Eliza the Hare."

Otto is one of Eliza's best friends from school. He is a lovely little boy who, much to Eliza's delight, will take her hand to hold when she asks, share his iPod with her, share his Bunny Fruit and even sit through a not-too-thrilling hour at a craft shop with her. Plus Otto is really cute too :)

When I first started making up Otto the Tortoise and Eliza the Hare stories, I would alternate who would finish the journey first. And they do go on some seriously fun journeys. They have been to Coney Island, the rain forest on Saba, the beach on St. Maarten, the Carousel in Central Park and the Monkey House at the Bronx Zoo.

But after the first few stories, Eliza told me the ending was wrong.

She told me Otto the Tortoise and Eliza the Hare had to end the adventure "together."

I asked Eliza why and she said...

"so they could take each other's hand and both win the race."

Now if that isn't true love and friendship, I don't know what is.