Questions for the March of Dimes about Makena

The senior vice president (SVP) of marketing for the March of Dimes (MOD) reached out to me via e-mail on Monday about Makena pricing. He wanted to let me know the March of Dimes is “doing all we can to ensure access for all women,” (which apparently includes a rather tepid letter from the President of the March of Dimes to the CEO of Ther-Rx expressing serious concerns about the price). Ther-Rx has agreed to meet with MOD in Washington next week to hear concerns about price point and the effectiveness of the financial assistance program.
The SVP thought from my posts that I “may still have some concerns about how we approached this and why.” That he would be, “happy to try to answer any questions,” and lastly that he hopes I will give the MOD the opportunity to win back my trust.
My reply was that to win back my trust I need answers to the real questions. The hard questions. I am still waiting to hear back (but it’s only been 24 hours, after all). 
So for the record, here are my questions for the March of Dimes.
1) Every industry insider I spoke with picked a $1500 price point for Makena (that is how orphan drugs are priced). The colchicine fiasco should really have given you cause to think of the ramifications, after all, prematurity costs a lot more than gout. Expressing your concern about the price after the fact just tells me that no one thought it through. Your total income as a 501(c)(3) is $228,756,000 so you deal in big dollars every day. I would like to think you are all a little better at business decisions, and you know, basic math skills. Did none of you think about doing the math in advance on how much Makena might actually cost?
2) Your president (Dr. Jennifer Howse Ph.D.) makes $641,000 a year. Do you think she is the person to be discussing price point (considering the median household income in the U.S. is about $44,000)? And I don’t care of that is on point with other non-profits, an FDA application that was backed by the March of Dimes is taking money out of the pockets of desperate families (one mom I spoke with had her co-payment jump from $10 to $750). BTW, what do you think is a reasonable price point for a medication that was previously at most $30 a week?
3) Why did the March of Dimes support this application by KV Pharamceuticals? Telling me you wanted “everything made on the same equipment” just won’t fly because mixing 17OP is not the hardest thing a compounding pharmacists does and there have been no reports of compounding issues. Did you feel post marketing surveillance was required for a drug that has been used in pregnancy since the 1950′s? If so, why? That’s a preety inexpensive study, so why wasn’t it simply funded by The March if Dimes. After all, you have reported more than $43 million in net assets.
4) When did KV Pharamceuticals begin contributing to the March of Dimes and how much are their donations? While it may not be true, it looks as if KV Pharamceuticals gave money to the March of Dimes to try and get in with the cool kids. If you told me they had been giving you large amounts of money for the past 10 years because their CEO had a grandson who was a preemie, I would of course thing nothing about their donations. If they just started supporting the March of Dimes in the past 2 years, I might have a different opinion.
So if you want to win back my trust, I need some answers. I know I am not the only one asking these questions. 
Do you have questions for the March of Dimes?  Leave them in the comments section.
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8 Responses to Questions for the March of Dimes about Makena

  1. So I picked up the phone last week and spoke with the executive director of the Oklahoma City chapter of March of Dimes (MOD). She just finished a phone conference with national MOD and I gathered it was an emergency meeting regarding the allegations of MOD’s complicity with KV Pharmaceutical. After I expressed my concern for MOD’s reputation and donor base, I asked her to relay that concern to the national organization. Several hours later, I received a phone call from Dr. Alan Fleischman, MOD’s Medical Director, and had the opportunity to express my sentiment to him and his staff directly. He listened and I appreciated the personal attention from a colleague. A casual comment from one of his colleagues (I think it was MOD’s PR director) during our phone conference bothered me, though. When I commented that the FDA and MOD did not do their due diligence about KVP, the response was that MOD is in the business of preventing prematurity, not about due diligence of pharmaceutical companies. I think he meant that they are so dedicated to their mission that this one simply “slipped by”. I immediately snapped back and said:”Don’t ever say this in public; single-mindedness, even for a noble cause, is fraught with explosive negative consequences- look at you now!”
    So Jen, or anybody that cares: pick up the phone and call national MOD! Even if they read your blog, they won’t respond until you speak to them directly. They depend on advocates (and donors) like you!

  2. Pingback: March of Dimes knows it messed up, is trying to earn back trust | Nowhere Special

  3. …And BTW- your questions to MOD are very poignant. Putting myself in their position, though, I imagine that they may be too tough to be answered candidly. I truly hope that more physicians communicate their concerns to MOD as you so boldly did, and hopefully directly to Fleischman or Howse!

  4. Jennifer Gunter says:

    I doubt anyone there would lower themselves to speak with me. After all it was the marketing dude that contacted me, not a peer. He can only give me the prepared answers and I don’t like tripe. I want the real answers and if the MOD actually understood how angry people are, they would put on their big kid underwear and make this right. Admitting you were wrong is sometimes the best answer. The problem? The time for that was at least a week ago.

  5. Jennifer Campbell says:

    Jennifer – Thank you for the post and your good questions. I think question #1 raises a very good point. I would like the answer to “What got us here in the first point?” What is the primary cause that got this ball rolling? From what I gather (though I’m not 100% sure,) it seems like getting the “orphan status” in the first place started this. When I read the definition for orphan status, I’m not really sure if 120,000 women/year who qualify for 17P really puts this in a “rare disease” category….nor does KV/Ther-Rx need to recoup R&D money, which Orphan Status was supposed to help do. It seems to me, that the pharmaceutical company found a type of loophole in the gov’t system and took advantage of it. All legal, but questionable ethically. Basically the gov’t gave them a monopoly on this! I am glad that consumers and doctors are outraged by the price-gouging, as they should be. However, my stance is that more gov’t regulation would be wrong. Gov’t involvement is what created the monopoly in the first place! I believe that KV/Ther-Rx should own up to their egregious price structure, and the MOD should take a stand on getting the Orphan Status (i.e. monopoly) of this drug removed, as well as pressuring KV on the price structure.
    If/when KV has a rebuttal that they provide an Assistance Program, I would argue “just lower the price so people don’t need the assistance in the first place.” Ask KV if they help fund this Assistance Program. From what I have researched, it is a separate entity funded by private donations (which, could possibly include KV donations, but I don’t know, and/or could be standard industry practice, but I don’t know.) My feeling is that these assistance dollars are being diverted from other great medical causes, to help assist mothers with Makena, while KV makes most of their profits from insurers and government/Medicaid footing most of the bill.

  6. Malie says:

    Dr. Gunter- Great questions. I just can’t get beyond MOD’s role in this debacle. If they had a case to make for supporting KV’s application for orphan drug status, then they should share it with all of the families who will suffer as a result of the astronomical price increase.

    Dr. Reshef- I was struck by this part of your comment above: “When I commented that the FDA and MOD did not do their due diligence about KVP, the response was that MOD is in the business of preventing prematurity, not about due diligence of pharmaceutical companies.” WOW. Doesn’t the accessibility of a drug to prevent prematurity deserve their due diligence? They really don’t get it. MOD is an non-profit with a multi-million dollar budget. If they didn’t know anything about the FDA approval process and pharmaceuticals, then they had two options: either stay out of it or do their homework. Instead, they jumped into a mess they didn’t understand (or were blinded by KV’s contributions) and sold out the families they were supposed to support.

  7. Let’s face it: both FDA and MOD messed up. I was told by Alan Fleischman that the FDA checked KV Pharmaceutical’s ability to market the drug and concluded that it is on solid ground. A semi-thorough Web search of KV Pharmaceutical’s recent shenanigans reveals a disturbing picture of improprieties and financial instability (Marc Hermelin, are you in jail yet?) I called Oklahoma’s MOD Executive Director early this am. She was in Dallas in a meeting with Fleischman and I assume that it was a nationwide meeting. Once again I relayed the frustration of the medical community with MOD and asked her to punt it upwards. I think MOD heard our message loud and clear and published their letter to Ther-Rx later today realizing they must respond more emphatically. Is it strong enough? Probably not, but it goes way beyond the March 14th one. I am trying to recruit my colleagues from other states to join the protest.

  8. PAS says:

    @Jennifer Campbell

    The orphan status is very much the key point in this debacle. It’s important to remember though, that the Orphan Drug Act was passed in 1983, shortly after the Hatch Waxman act which created enormously powerful legal tools for generic makers to break drug company patents and introduce generics decades earlier than would have been possible under previous law. The Orphan Drug act was a counter to this – something to incentivize drug companies to keep working on new treatments for patients who would otherwise be neglected by the threat of this new route to making generics.

    The Orphan Drug Act pegs the threshold of Orphan Status at less than 200,000 patients per year. Since Makena is estimated at around 120-138k patients per year, it clearly falls into this category. The FDA has its hands legally tied, and a law designed to protect patients is now being used to exploit them – because this sort of thing really wasn’t foreseen back in the 1980s.

    It’s interesting to note, that without the orphan protection, Makena would have literally no protection from generic competition. You can take a look at this at the FDA Orange Book here:

    Compare this to a drug like Nuvigil:

    Even if you’re not terribly familiar with these laws, you can see the dramatic difference in there.

    Unfortunately, Orphan Status is quite difficult to revoke. For all intents and purposes, it doesn’t happen. You can look at the relevant portion of the laws here:

    Specifically § 316.29
    Effectively, the FDA would have to somehow discover that KV lied in their drug application in some very significant ways, or find that there are more than 200,000 people within the means that the drug is labeled.

    The only other means that an Orphan designation can be bypassed to my knowledge is if a competitor were to perform a head to head trial of their competing product vs Makena, and demonstrate clinical superiority. At this point, the FDA could kick the orphan designation out the window.

    In the mean time we’re likely to be relying on the compound, as it exists totally outside all of these regulations.

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