Welcome back to my blog. I say that to me as well as to you, since I have been neglecting the poor thing. I hope that this is the resumption of a healthy relationship.

In any case, I want to take a different tack for World Prematurity Day today. So often we talk about the problems of premature birth, and struggles in the NICU, the need for more research and better medicines, and the fight to keep fragile babies alive. Today, however, I want to talk about what happens when the tiny preemie makes it and manages to grow and thrive.

Sometimes we get so caught up in making it through the day-to-day that we forget about the big picture. The Kid was sick both the week before his Bar Mitzvah and the week after. By some miracle, he was mostly healthy for the weekend.

My wife and I were going crazy trying to lasso all of the myriad details into submission, and we still were not done by the morning of the Bar Mitzvah. We worked through the night before the Bar Mitzvah, neglecting to take the time to write the speeches that we’d give to The Kid during the service. My wife was able to write something quickly that morning before the service, but I was so busy wrangling parents and friends for the walkthrough that I didn’t really think much about mine.

When the point in the service came for us to deliver our speeches before giving him his new talit, I had to make it up on the spot. Thankfully, I often do some of my best work in those situations, and this was one of those. Here (transcribed from the video) is what I said to my wonderful preemie at his Bar Mitzvah:

When we lost your brother, we were completely lost. We did not see brightness ahead of us. And then six years later, we were gifted with a miracle. And you have been a miracle your entire life, whether it be your singing and dancing around the house, your writing songs, your strength of will, your strength of character. To know what’s right — and what’s right for you — and not letting anybody shake you from knowing what you want to do and what you feel is right are strengths that anybody can admire, because you are one of the most amazing people that I have ever met.

And I am so proud of you. I am so proud that you are my son, and if I never do anything else in my life than give the world you, I’ve left the world a better place. I love you.

He is an amazing young man, and he has an amazing sense of what is right.

His Bar Mitzvah project was to raise money for the March of Dimes by writing a song for the occasion and giving a CD with that song and three others to anyone who donated at least $5 to his fundraising campaign. I’m extremely proud to say that he’s raised over $1,000 in this initiative, with more still coming in.

He did an awesome job with the music, but asked for some assistance with lyrics. I helped out late one night when struck with inspiration, as I was with the Bar Mitzvah speech a couple of weeks later. Together, we made some tweaks to the wording to help it fit more closely to his vision for the song, so I credit both of us with the lyrics. It is so awesome to hear him play and sing this. The CD also includes an instrumental version of the song, a four-hand sonatina that he wrote, and two other pieces that he’s written as part of a musical that he’s working on.

Today, I’ll leave you with the lyrics and the thoughts that I am so thankful and grateful that this miracle has become part of my life and my wife’s life, and that the March of Dimes was able to develop treatment, therapies, and medical regimens that kept him alive. Enjoy:

Never

(words by M. Goldhaber, J. Goldhaber; music by J. Goldhaber)

I’m a living miracle,
I nearly wasn’t here.
Like my brother Ben before me,
I was born too soon, I fear.
Preemie fears have always been
We’d never make it through.
“Never” is a word that frightens
Preemie parents too.

“Never” gonna breathe
“Never” gonna see
“Never” gonna make it
“Never” gonna be
“Never” gonna grow
“Never” gonna live
Never will forget
And I’m gonna help to give

He was born at 22 weeks,
I was born at 28.
I’m here to tell our tale, though
That it’s not just due to fate.
Many years ago, my chances
Wouldn’t have been worth two cents
But the March of Dimes was working
And that’s made the difference.

“Never” gonna breathe
“Never” gonna see
“Never” gonna make it
“Never” gonna be
“Never” gonna grow
“Never” gonna live
Never will forget
And I’m gonna help to give

While preemies still have it tough
And it often takes a lot
To keep us going in the face
Of the issues that we’ve got.
The March of Dimes has led the fight
To help give us a chance
And now I’m writing music
And I can sing and dance.

<instrumental chorus>

So I bring my songs to you
To help the March of Dimes.
Let’s give more kids a fighting chance
To live productive lives.
Let’s change the preemie focus
And turn the words around
Instead of “never” being tough
Let’s give it a new sound!

Never giving up!
Never lose a beat!
Never let it stop us!
Never cry defeat!
Nothing’s gonna stop me!
My mission here is key:
Help the March of Dimes
Help others just like me!

Never giving up!
Never lose a beat!
Never let it stop us!
Never cry defeat!

But since they’re here,
You’re hearing this song.

Tonight, the New York State Senate passed the Marriage Equality Act by a 33-29 margin.

Republican Senators Stephen Saland, Mark Grisanti, Roy McDonald and Jim Alesi crossed party lines to vote “yes,” more than offsetting Democratic Senator Ruben Diaz’s “no” vote. I’m thrilled that my state is now #6 to allow same-sex marriages. I suppose at this point, I should put into writing what I’ve been saying for years on this topic.

As a way of moving into this, I’ll note that the act was passed after being amended to allow for religious exemptions, basically stating that civil actions could not be brought against clergy who refused to perform religious services for same-sex marriages. And that’s as it should be. The separation of church and state says that the state can’t tell religions what they can and can’t do.

The big problem in all of this is that the law and religion use the same term. Therefore, when the law defines “marriage,” it takes on all of the overtones of the religious definition(s) of “marriage.” If the law had used a different term all along, we might not have had such a tug-of-war for all of these years. While there would still have been those opposed, the use of the emotionally-charged and religiously-linked word “marriage” pushed many hot buttons. If, years ago, government had made a decision to have all legal references instead use the term “civil partnerships” or “domestic partnerships,” there would have been much less rancor. “Domestic partnership” would be a legal term and “marriage” would be a religious term. Everyone would have a domestic partnership whether or not their religion would marry them. However, because the law used the word “marriage” all along, to change the legal definition to use “domestic partnership” for all would have raised much resistance from those who didn’t want to lose the use of “marriage” as a legal term. It was too late.

Now, after enough time has passed that the majority of Americans—and the majority of New Yorkers—understand that homosexuality is not a choice and that all people deserve the same rights, we have taken that step in my state to acknowledge the fact and to allow some of the disenfranchised to enjoy the same comforts and protections of the institution of marriage that the rest of us already have.

To those who claim that the purpose of marriage is to procreate, I say that I know a number of heterosexual couples who have no intention of reproducing. Does that mean that they should not be allowed to marry? Should all marriages of couples who find that they are unable to have children be automatically annulled as a rule? I don’t think so. Does it mean that two parents of the same sex can’t be good parents, either of children that they previously had with a member of the opposite sex or of children that they adopt? I know several people who would serve as great examples to the contrary.

To those who claim that allowing same-sex couples to marry makes a mockery of the institution of marriage, what do you say about those who marry and divorce repeatedly? Those celebrities whose marriages are measured in days? And how do you justify saying that a homosexual couple that has been together for 20 years makes more of a mockery of marriage than those with “disposable marriages”?

If you’ve been reading my blog for a while (and I know that I have been lax in updating lately), you know that my Uncle Fred was an activist for gay rights for decades. I feel sad that he passed away less than a year before the state of his birth legalized same-sex marriage. Fred had survived more than one long-term partner, despite being HIV positive for decades. He lost one to cancer. One died of a severe asthma attack. But I’m sure that all of them are having a party somewhere celebrating this historic legislation.

New York is the sixth state (plus the District of Columbia) to legalize marriage. Six down, forty-four to go. Let’s see who’s next. In the meantime, New York did me proud today.

2011 is the sixth year that I’m walking to raise money for the March of Dimes. I’ve gotten a very late start this year due to the Makena controversy, which left the March of Dimes scrambling to return to their values after a bad decision that shook my confidence in the organization. I’ve written quite a bit about the role of the March of Dimes in the Makena controversy.

In the end, though, after a number of communications with the March of Dimes Senior VP for Strategic Marketing & Communications, I think that they are back on track, and I don’t know that there’s another organization out there that provides as much support for research and development of ways to reduce prematurity and treat complications in those who are born too soon. That doesn’t mean that I won’t be watching closely to make sure that there are no further major gaffes, but I think that continuing my support (while maintaining scrutiny) at this time is the most productive direction for my fundraising.

So why do I walk?

I walk for my two sons, one who made it and one who didn’t. I walk so that other people won’t have to go through what we’ve gone through.

Benjamin was born at a “women’s hospital” that had no clue how to handle our premature labor situation and did not seek to transfer my wife to a larger hospital with a Neonatal Intensive Care Unit (NICU). They were so unaware that they didn’t even have a way to communicate our loss to the staff at the nurses’ station outside the LDR room, who wished us “congratulations” as my wife was wheeled out. They looked stunned when I replied “no” to them. Benjamin was born at 22 weeks gestation weighing less than a pound. He lived for five minutes. He would’ve turned eighteen last October. There’s still a hole in my heart from losing him that will never go away.

The hospital has undergone a management change since then, and now reportedly does have a serviceable NICU. I’d like to think that our experience there had some influence on that improvement.

My second son (“The Kid”) was born at a hospital well-versed in caring for moms going into labor prematurely and babies born way too soon. My wife was admitted and under direct care for weeks before delivery. Medications whose development was supported by March of Dimes were administered during that time to help The Kid’s lungs develop. When he was born, at 28 weeks gestation, he weighed 2 pounds, 1.4 ounces, and went to the NICU. More medications supported by the March of Dimes helped him survive and develop. He didn’t leave the hospital for 10 ½ weeks, and had to go back the next week for minor surgery. He came home on a heart monitor, which he wore until he was six months old, and we’ve had to watch his health closely ever since.

The Kid is now 12 years old and is a caring, intelligent, talented and charismatic kid, thanks in part to the March of Dimes (and the great staff at St. Peter’s Hospital). He’s not only academically gifted, but he’s also quite talented at dancing, playing musical instruments, writing music, acting and performing arts in general. He wants to design theme parks when he grows up, and I don’t doubt that he’ll do it.

But my sons are only two of the millions of stories to be told about premature babies. Thousands are born every day. Some are lucky, like The Kid. Some are not. Many who survive still suffer from many medical conditions and need a great deal of help to live what even approximates normal lives.

I walk for the March of Dimes because I want to help prevent premature births, and to help support cures and care for the afflictions of those that are born prematurely. Parents should take their children home from the hospital, not to the cemetery. And when they get them home, they should be able to live without lingering medical conditions.

Every year, I am dumbfounded by the support from my friends, family, co-workers, and (especially) my MousePlanet family. The people who read the stories I write and listen to the podcasts I record have been stupendously generous in supporting my fundraising to support this cause.

Last year, thanks to your contributions, I was a top walker in Northeastern New York for the third year in a row. More than one-third of that money came from donations of $50 or less. Nearly one-quarter came from donations of $25 or less.

Every dollar counts. Please give generously, and help the March of Dimes to give every baby a fighting chance. Go to my fundraising page and support this worthy cause.

Thank you so much for your support.

I was hoping that it wouldn’t come to this, but when it happened I was very pleased to see it unfold the way that it did.

Earlier this week, KV Pharmaceutical/Ther-Rx met with the March of Dimes, American College of Obstetrics and Gynecology, American Academy of Pediatrics, and Society for Maternal and Fetal Medicine. As a result of that meeting, Ther-Rx agreed to significantly modify the pricing of Makena, and said that they would announce the new pricing today. Because the drug was so outrageously priced, a “significant” decrease could result in anything from a reasonable price to still being extortionist. Many of us awaited the announcement, hoping that it would be the former.

If you’ve been following this story, you’re already aware that the initial list price of Makena was $1,500 per dose, a 7,400%-14,900% increase over the previous price of $10-$20/dose from compounding pharmacies. This is especially heinous because a standard course of treatment for an expectant mother who has gone into labor prematurely on a prior pregnancy is 18-20 doses. That means that a full course of treatment went up from $200-$400 to a whopping $30,000! While a significant price increase was not unexpected, and Ther-Rx will have substantial expenses related to the drug, there’s a difference between making a profit after recouping your investment and financially raping pregnant women, insurers and other payers.

Ther-Rx announced their new price today: $690 per dose, a 54% price cut. That makes the net increase over the compounded version $670-$680 per dose, or 3,350%-6,800%. As I wrote in yesterday’s post, there’s no reason that Ther-Rx shouldn’t make a profit. They’re entitled. There are limits to everything, though. A price of $200 per dose, as anticipated by some drug outlook services during Makena’s application process, would have been just fine, and would have given Ther-Rx an estimated $533 million in net revenue, as opposed to the $4 billion that they were extorting. $690 per dose? $13,800 per course? Not acceptable.

And the March of Dimes agreed. The March of Dimes first issued a press release stating that the price drop was a step in the right direction, but that “the March of Dimes has decided to exercise our right to terminate our current contract and sever all professional relationships with Ther-Rx.” They also condemned Ther-Rx’s approach, noting that their “handling of the launch of Makena, and the initial list price, were highly unsatisfactory and unacceptable to the March of Dimes and the families we represent.”

March of Dimes then sent a letter to Ther-Rx President Greg Divis making it official. The letter, from March of Dimes President Jennifer Howse, thanked Ther-Rx for their support of fundraising efforts and the NICU Family Support Project over the past several years, and then informed them that the March of Dimes was “exercising our option to terminate our agreement with Ther-Rx Corporation, and hereby provide you with thirty days written notice of such termination. We ask that you immediately cease and desist the use, distribution or publication of or reference to the March of Dimes name and/or logo on any and all materials or communications in connection with KV Pharmaceuticals, Ther-Rx and Makena.”

The letter went on to note that “Access to 17-P is and always has been our paramount concern. We hope to continue to work with you to address the issues discussed by stakeholders over the last several weeks, and to ensure the intention you strongly expressed: that this therapy is accessible and affordable to all clinically eligible women.”

The contract being terminated was a more-or-less standard sponsorship contract, in which Ther-Rx provided funding for the NICU Family Support project in exchange for getting their logo on materials and announcements related to the program. The contract also stated that March of Dimes would participate in the announcement of Makena’s approval, though they would not endorse the product.

It’s likely that—when Makena’s price was first revealed—March of Dimes wanted to try to preserve the partnership, and work within the bounds of their relationship to quietly convince Ther-Rx to make the price more reasonable. They said that they also relied quite a bit on assurances that Ther-Rx’s patient assistance program would cover the costs of the treatment. But as word of $385/week and $1,900/month copayments emerged, confidence in that program eroded and March of Dimes started being more vocal. First, they released a letter “respectfully requesting” that Ther-Rx revisit the pricing structure. After there was no movement, a stronger statement was released, warning that continued lack of response would result in termination of the contract.

Now, with the contract at an end (or, at least, after the 30 days notice has concluded), the March of Dimes is free to take a more adversarial approach with Ther-Rx and rightfully separate themselves from the situation that they found themselves embroiled in after Ther-Rx surprised many with their price point.

It should be noted that Ther-Rx’s latest press release contained the promise of a series of other cost-containment measures, such as capping the cost of treatment for health insurance plans and state Medicaid agencies to 15 doses (instead of the full course of 20), promising supplemental rebates in addition to the standard Medicaid rebate of 23.1%, and expanding the patient assistance program. But really, why are they creating all of these artificial adjustments to the price if they really are planning to reduce the actual cost of the medicine? Why don’t they just cut the price further in the first place? Could it be that these reductions aren’t really going to do what they say they will? I don’t know. I don’t have enough familiarity with the industry to know. But I do know that “rebates,” especially to consumers, are frequently not submitted and/or paid, due to laxness in consumers submitting rebate forms and restrictions on filling out forms in a specific fashion.

Instead of putting forth the array of rebates, price caps, and patient assistance programs, why not be more straightforward and just cut the price of the drug? I don’t buy Ther-Rx’s plan, and neither does the March of Dimes. And that’s why I’m a March of Dimes supporter. They tried to work collaboratively with Ther-Rx, and when that didn’t work they realized that the only way to accomplish anything was to switch to a confrontational approach and terminated their relationship.

I’m back on board. I applaud the efforts and stance of the March of Dimes against the outrageous pricing of Makena, and I will restart my March for Babies fundraising appeal, with the added emphasis that more money is needed to help fill the funding gap left by the termination of the Ther-Rx contract. Let’s raise more money so that the March of Dimes doesn’t feel the loss of money from Ther-Rx. Let’s raise more extra money than Ther-Rx was giving. If you’re already walking, use this as a rallying cry to increase donations. If you’re not already walking, please consider signing up. If you won’t walk, please donate. You can click on the donation badge above and to the right to donate to my walk (or to join my fundraising team), or you can go to the March of Dimes website to make a direct donation.

You can also donate directly to the NICU Family Support Program, the program that will be directly losing the money from Ther-Rx. Now, more than ever, the March of Dimes needs your support. Let’s fill the gap created by the March of Dimes taking a stand against Ther-Rx and more!

If you’re willing to lend your voice, sign up for one of the organization’s advocacy programs. Talk with your local chapter to find out when the next advocacy day is with your state or local governments. Ask whether there will be any public activities to bring light to the Makena situation and get involved with it. Blog, tweet, post on Facebook or use any other email or social media channel to spread the word about the outrageous pricing of Makena and demand that something be done. We’ve got Ther-Rx on the run now, and maybe we can get Makena to a price point that we can actually support. If not, then support the use of compounding pharmacies to distribute 17P for the next seven years until an official generic version of Makena is available.

What do you think? Is the action of the March of Dimes in alignment with your expectations? What do you think is the next step? Did I miss anything, or is my logic flawed anywhere? Please comment below!

Since my last regular post, there’s been a bit of a pressure on KV Pharmaceutical and their Ther-Rx subsidiary, and their pricing of Makena. Forces from the U.S. Congress and the FDA have weighed in, with supportive statements from the March of Dimes and the American College of Obstetricians and Gynecologists (ACOG).

On Friday, Rep. Henry Waxman (ranking member of the House Committee on Energy and Commerce), sent a letter on behalf of the committee to Ther-Rx president Greg Divis, cosigned by Rep. Frank Pallone, Jr. (ranking member of the Subcommittee on Health) and Rep. Diana DeGette (ranking member of the Subcommittee on Oversight and Investigations) demanding that Ther-Rx provide:

1. Any fiscal or other contributions made by Ther-Rx to the two National Institutes of Health studies that were used to gain approval for the drug.
2. Any additional research costs to date incurred by, or studies conducted by TherRx in obtaining FDA approval for Makena, and the expected costs of ongoing research, including all information about clinical trial officially listed with the government, and for any published study information.
3. Any research or data on similarities between Makena and the compounded versions of 17P or any previously FDA-approved versions of the drug (such as Delalutin).
4. How much Ther-Rx has spent on promoting Makena, and details on how that money was spent, for past, current and anticipated future expenses.
5. Ther-Rx’s total cost, and estimated unit costs, to manufacture Makena, and a breakdown of those costs.
6. Ther-Rx’s expected revenues and profits from sales of Makena.
7. Ther-Rx’s anticipated revenues and profits from sales of Makena to government programs such as Medicare, Medicaid, and other federal or state health care programs.

This was whipping out the big stick and threatening KV big time. Basically, Waxman is telling KV/Ther-Rx that “you used government studies as the primary means to get approval for your product, and now you’re soaking the American public on the price of the drug, including soaking the same government that funded the studies that you’re using in the first place. How much are you planning to overcharge us as a show of gratitude?”

KV Pharmaceutical released a preliminary response to Waxman and the advocate groups:

KV Pharmaceutical Company Response to Letter from Democratic Leaders.

Ther-Rx Corporation takes very seriously the concerns raised about the list price of Makena™ (hydroxyprogesterone caproate injection) by Members of Congress and other stakeholders. Ther-Rx has received a letter from Members of the Committee on Energy and Commerce and will respond to the letter. Ther-Rx is committed to ensuring that this significant, FDA-approved medication is covered at an affordable cost and available to all women who are prescribed Makena, and looks forward to cooperating with the Members of Congress on these issues.

Ther-Rx Corporation to Address Cost of and Access to Makena^TM with Key Stakeholders

Ther-Rx Corporation has been carefully listening to all stakeholders following the announcement of the list price for Makena™ (hydroxyprogesterone caproate injection). We recognize the concerns that have been raised regarding the list price, patient access, and potential cost to payors of this important orphan drug. The company already has established a Patient Assistance Program with the goal of ensuring that every woman who is prescribed Makena will be able to access and afford it. However, we have heard clearly from various stakeholders that we need to do more because the cost of therapy remains a significant concern.

Ther-Rx is fundamentally committed to the community of women, children and families whom we serve. We are scheduling meetings with key audiences – including payors and national organizations that are committed to the advancement of obstetric care and infant health. We hope to meet with them at the earliest possible dates to discuss and address all of their concerns. We are committed to working closely with all parties to develop and implement plans that will ensure that this important, FDA-approved product will be covered by the payor community and available to all women who are prescribed Makena at an affordable cost. Visit www.makena.com to learn more.

Tuesday, KV met, as scheduled, with the March of Dimes, ACOG, the American Academy of Pediatrics (AAP) and the Society for Maternal & Fetal Medicine (SMFM) to discuss the pricing of Makena and the extent of the patient assistance program. No news came immediately from that meeting.

Wednesday, the U.S. Federal Drug Administration (FDA) released a press announcement that basically cut the feet out from under Ther-Rx:

On February 3, 2011, the U.S. Food and Drug Administration approved the drug Makena (hydroxyprogesterone caproate) for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. KV Pharmaceuticals, the drug’s owner, received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug’s effectiveness. It also obtained seven years of exclusivity under the Orphan Drug Act, obtained approval under FDA’s accelerated approval program, and received expedited review.

For many years, a version of the active ingredient of Makena, which is a synthetic progestin, has been available to patients whose physicians requested the drug from a pharmacist who compounded the drug. Generally, FDA has exercised enforcement discretion with respect to most products made through traditional pharmacy compounding. This has included products made from the active ingredient in Makena, hydroxyprogesterone caproate.

Because Makena is a sterile injectable, where there is a risk of contamination, greater assurance of safety is provided by an approved product. However, under certain conditions, a licensed pharmacist may compound a drug product using ingredients that are components of FDA approved drugs if the compounding is for an identified individual patient based on a valid prescription for a compounded product that is necessary for that patient. FDA prioritizes enforcement actions related to compounded drugs using a risk-based approach, giving the highest enforcement priority to pharmacies that compound products that are causing harm or that amount to health fraud.

FDA understands that the manufacturer of Makena, KV Pharmaceuticals, has sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. This is not correct.

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 based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products. As always, FDA may at any time revisit a decision to exercise enforcement discretion.

In other words, the FDA recognizes that Ther-Rx is overcharging for Makena, has recognized that KV is trying to use the FDA to threaten compounders into stopping production of the generic version of the drug that has been made by them exclusively for years, and is not going to stand for it. The FDA basically told KV that “we’re not your lap dog and stop using us to threaten the compounders.”

The FDA’s announcement was met with immediate support from ACOG and March of Dimes. The statement from March of Dimes went a bit further with their statement, noting that “To date, Ther-Rx Corporation’s handling of the launch of Makena has been unsatisfactory to the March of Dimes and to the families we represent. We’ve asked Ther-Rx in writing and in discussion to substantially lower the price of Makena and to expand coverage for patient financial assistance. We’re waiting for their public statement on this matter, which we expect will occur within the next week.” It’s nice to see them stay on the attack.

Following these actions, Ther-Rx released their own press announcement yesterday, entitled “Ther-Rx Corporation Commits to Take Action Regarding Makena Pricing.” In the press release, Ther-Rx states that they have “invested or committed over a quarter of a billion dollars to-date to bring Makena to market, including more than $50 million in research and clinical trial costs, including those associated with conducting major, multi-year follow-on health studies of Makena involving 1,700 mothers and more than 500 infants.” One point that it doesn’t note is that $199.5 million of that is the amount that Ther-Rx has paid or committed to pay to Hologic for the rights to Makena.

Now, don’t get me wrong. I don’t think that anyone denies KV/Ther-Rx the right to make money on their investment. It’s just that it’s one thing to earn a profit and another to try to extort money from a captive population. A reasonable price of $200, as anticipated by some drug outlook services during Makena’s application process, would probably not be challenged. While still 10 times what it had cost previously, it would have been reasonable for recouping the cost of getting the drug approved and purchased from Hologic. And the ability to have an FDA-approved use of 17P to prevent premature labor would be a tremendous boost to the ability of women throughout the country to receive the drug, since many still have to deal with doctors that will not prescribe 17P for off-label use. It’s just that it’s one thing to make a fair profit, and an entirely different thing to charge an outrageous price for the sole purpose of digging yourself out of a financial hole that you put yourself in through misconduct and trying to use the government to strongarm legitimate small manufacturers out of competition with you, especially when you only had a limited role in getting approval for the drug in the first place.

KV probably started their involvement in Makena (then called Gestiva) with reasonable expectations for profits from the drug. Several months later, when they got into trouble with the FDA, resulting in a two-year shutdown and having to agree to a consent decree, then watched their stock plummet along with their finances, that they decided that they needed to milk Makena for everything that they could.

Now, it’s time for KV/Ther-Rx to get hit with the reality stick.

Let’s do some math. If I understand what I’ve been reading correctly, the average cost of initial health care for a premature baby is estimated at $51,000. (While many cost a tremendous amount more, many babies considered to be premature do cost less.) Spending $30,000 to save $50,000 would seem to be an easy choice for insurers, except for the fact that 17P is reportedly effective in approximately 1 out of 5 cases. That makes it an expense of $150,000 to save $50,000. A price of $200 would give Ther-Rx gross revenues of an estimated $533 million per year (instead of $4 billion), and would cost insurers $15,000 to save $50,000. Those numbers work much better.

In another development, which I’m deciding to believe is not any type of official action on the company’s part, a KV employee posted a comment on the first of my Makena-related posts, trying to discredit me. I originally thought that this was a person in a position of some responsibility in the company, but I’ve since gotten some information from a person knowledgeable in the industry that this person’s position is really just to ensure that documents prepared by others are properly formatted, and then submitting those documents to the federal authorities using an automated tool. While his position would put him in a position of responsibility for ensuring that KV’s submissions were done properly, there is no product, testing, or other technical responsibility for the products at all. And since he’s apparently an IT guy, I’m surprised that he didn’t do a better job of covering his tracks. I find it hard to believe that KV Pharmaceutical does not have an official policy about their staff posting on social media about the company from the company’s computers. I think the guy may have been upset at everybody beating up on the company and felt that he had to lash out against me, and may have been unsure about company policy.

Moving forward, I’m looking forward to seeing Ther-Rx’s response to Rep. Waxman’s letter, and to the March of Dimes/ACOG/AAP/SMFM meeting. It’s starting to look like this is becoming a one-sided battle, but it’s not over yet.

What do you think? Has enough been done by others and it’s time to wait for KV/Ther-Rx to respond? Should more pressure be put on in the interim? Is there a sound justification other than “we need to dig ourselves out of debt” for KV/Ther-Rx to be charging $1,500 per dose? I’m looking to gain knowledge and understanding. Please share your thoughts in the comments.