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.