The March of Dimes really responds to Ther-Rx and price of Makena, well, sort of…

Today (March 23rd) Dr. Jennifer Howse of the March of Dimes (MOD) finally responded to the egregious price gouging/extortion that is Makena (17 Alpha-hydroxyprogesterone caproate, or 17OP, newly packaged as an orphan drug). As we all know, this travesty was blessed by the March of Dimes. I and others have blogged about our concerns, not only with KV Pharmaceuticals/Ther-Rx and their pricing (and woefully inadequate patient assistance program), but also about the March of Dimes involvement.

The March of Dimes initially issued the blandest of statements about the price. Now, almost two weeks later they are issuing a more strongly worded letter. Although, it is very interesting to me that there has yet to be a press release concerning this letter. I received a copy from Mark Goldhaber, another concerned blogger, who was in contact with a SVP of marketing for the March of Dimes (the SVP was in contact with me as well, but I wanted different answers, so all I have heard in return is crickets).

The letter is posted at the end of this blog. Maybe there is no press release because legal is still working on it, who knows. I mean who knows anymore with the March of Dimes, because the longer they take to really set the record straight the more they sound like a big corporation trying to shore up the bunker and less like a non-profit whose primary mission is to help babies.

And about that letter? Saying you want a significant price reduction means nothing. That’s like saying you want sex more often. Is more often once a week, once a month, or once a year? Not to be flippant, but seriously guys, your failure to commit on this issue (or my guess, even consider the financial ramifications for the pregnant women of America) is one of the things that got you into this mess in the first place. If you actually trusted KV Pharmaceuticals to sell the stuff for, I don’t know, $200 a  pop, then you clearly know nothing about the pharmaceutical business. This is why getting into bed with Big Pharma is never smart.

And asking Ther-Rx to justify their pricing? That’s pretty Junior High of you. They are a business and this is a capitalist society, they don’t have to justify their pricing to you or anyone (see above, why you shouldn’t get into bed with Big Pharma). I don’t agree with the pricing one bit, but private corporations don’t generally have to justify price unless the Federal Trade Commission is willing to do something about it (I’m not holding my breath).

But my major issue with this letter is that it deflects all the “problems with Makena” onto Ther-Rx/KV Pharmaceuticals. We must not forget that the March of Dimes supported this application and clearly did not consider the ramifications. They made a very poor decision, and might I add, they made that decision with the dimes and dollars people have collected one walk at a time.

These are the questions that should have been addressed in the letter:

  1. Why didn’t MOD didn’t think about the price of an orphan drug before colluding with Ther-Rx/KV Pharmaceuticals.
  2. Why MOD thought a drug that has been available since the 1950′s needed to be FDA approved “all of a sudden.”
  3. Why the MOD didn’t just fund a follow-up study of babies whose mothers received 17OP (because the post marketing surveillance was part of the FDA approval).

Until those questions are answered, my money will go to the Perinatal Homeless Project in San Francisco, because at least I know it will be used to buy strollers and other useful things for new mothers who have nothing, not to fund a bunch of corporate big wigs who seem woefully out of touch with the very people they are supposed to be helping.


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 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 commitment 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.


Jennifer L. Howse, PhD

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9 Responses to The March of Dimes really responds to Ther-Rx and price of Makena, well, sort of…

  1. PAS says:

    The only time you want to tangle with Big Pharma is when you’ve got a staggering mass of expertise and technical knowledge behind you, and very large amount of money behind it as well. Ironically, this is the sort of business the PBMs are in.

    I will give them credit. In the context of regulation, insurance, and the pharmaceutical industry, this letter is a very, very aggressive slap across the face to Ther-Rx/KV. While demanding a justification of pricing may be rather juvenile, and unlikely to garner any sort of satisfactory response, it is very much throwing down the gauntlet.

    Actually, reading that fourth question again, they’re virtually calling out the bullshit. This is really not done in this sort of official communication. Even when we know things are bullshit, like say, Nexium vs Prilosec, we have to hold discussions within the general framework everything operates in. I’ll be interested to see if they get any response to this.

    I’ve been rummaging through some of the drug outlook services, both that we operate or subscribe to. There’s a great deal of mulling about the price point, back when the drug was known as Gestiva. There appears tob e some implication that the drug could have been marketed in the ~$200 price range. However, the drug seemed to get tied up several times in the approval process. There’s very much a ‘wait and see where the drug lands in regulatory space.’

    Reading between the lines of some of the FDA’s regulatory processes here, I get the impression the FDA had an understanding of where the drug would land, and doesn’t appear to be happy about this. However, that’s only what’s implied to me, through reading several third party reports of the drug’s progress through approval.

    The basic issue here is that Makena, unlike the majority of orphan drugs, is not a complicated difficult to produce product. It does not require genetically engineered cell lines, complicated chemical synthesis, quality control or purification steps beyond what’s normal for a small molecular entity. It does not have hundreds of millions to billions of dollars invested in its development, and it is inconceivable in even the most extreme worst case scenario that it is this costly to produce. It doesn’t exist in the sort of grey areas that plague Lovenox or Insulin. It doesn’t have the legal oversight of the Thalidomide family or Xyrem.

    There in fact, appears to be very little to justify Makena’s price other than the Orphan designation, and KV’s financial woes.

  2. Shelly says:

    I found your blog because of this whole Makena mess. I just have to say that while I don’t expect any big pharm company to listen to us, I surely expected the MOD to do a better job of helping us out. Individuals like me don’t have the clout to fight a big company but the MOD sure does.

    As a preemie mom, I have been a big supporter of MOD. I have donated myself and raised money by sending out mailers for many years. Not anymore. I just don’t understand the MODs weak response when they should be OUTRAGED!

    PS I am currently 15 weeks pregnant and will be starting the compounded 17P shots next week. No Makena for me!

  3. Malie says:

    I’m unimpressed by MOD’s letter. They have to explain themselves, and answering the questions you posted above would be a start. I’m the mother of 26 weekers who has enthusiastically raised money for the MOD in the past. But we will not be “marching” this year. We will not march in support of MOD’s incompetence and greed (they’ve never really explained their financial connection/contracts with KV). It sickens me that MOD used their massive resources–to which my family and friends contributed in honor of my preemies–to bolster KV’s profits at the expense of preemie parents. It’s disgusting, and we deserve a direct apology and thorough explanation from MOD.

    As an aside, you say, “Maybe there is no press release because legal is still working on it, who knows.” It’s probably PR working on it, but it makes me laugh to think MOD has a functioning legal department. Where were they when MOD should have been researching the FDA approval process? Maybe MOD should have used some of its 21 million dollar administrative budget to hire a lawyer familiar with the FDA process and pharmaceutical industry. Alas, it seems it was more important for them to continue paying its President (Jennifer Howse, Ph.D) more than $600,000 a year. She must be the highest paid psycholinguist in the world.

  4. I think you have asked all the right questions and I would like to hear the answers as well. I encourage you to support an organization like Preemies Today. We work tirelessly to support families affected by prematurity in the Washington D.C. area and beyond. We empower parents with resources and parent to parent support. We deliver care packages as well as kangaroo care chairs to different hospitals. We do a lot with a small budget. Each and every donation makes a difference.

  5. Jennifer Campbell says:

    The Orphan Drug legislation was established to help rare diseases with a small population, and to help drug companies recoup their R&D. Yet, we have a drug like Makena getting approval under that regulation, and it clearly doesn’t meet the spirit or intent of the legislation (at least 120k women/year qualify for the prescription, and the R&D was done by National Institute of Child Health and Human Development – taxpayer funded!) KV/Ther-Rx was given a golden ticket — a monopoly! I agree with the above statements that asking KV to “justify” their pricing will get us nowhere. This drug was performing beforehand on the free market, and was being sold at $10-20 per injection. That free market was stripped away, and now KV can charge whatever they want.

    So, the easy solution would appear to be to modify the Orphan Drug legislation to keep the intended and discard the unintended. In the meantime, I would urge KV to dramatically reduce the price of Makena. We don’t need to build another layer of consumer protection or anything so grandiose. We simply need to correct an error in legislation or in implementation of that legislation.

  6. Fresh from Washington DC:

    Price of Premature-Birth Prevention Drug Draws Waxman’s Ire
    By Rebecca Adams, CQ HealthBeat Associate Editor
    The House Energy and Commerce Committee’s top Democrat sent a sharply worded letter Thursday to a company charging $1,500 a dose for a drug to prevent premature births, up from $10 to $85 for a similar product made in stores by pharmacists.

    Henry A. Waxman of California demanded to know how much money Ther-Rx Corp. of Missouri believes it will earn from sales and how much it spent to bring the drug, known as Makena, to market. The company did not conduct its own studies to develop the drug, Waxman said, but relied on investigations by the National Institutes of Health to show that it is effective and safe.

    Ther-Rx Corp. also has been criticized by Senate Democrats, including Sherrod Brown of Ohio and Amy Klobuchar of Minnesota. (See related story, CQ HealthBeat, March 18, 2011).

    Company officials said earlier this month that they hoped to meet with critics to discuss their concerns.

    In his letter, Waxman asked the company seven questions about the drug’s development costs and potential profits. He requested a response by April 1.

    “Ther-Rx did not invent this drug, or the use of the drug to prevent premature births,” Waxman wrote in the letter to Ther-Rx Corp. CEO Gregory J. Divis. “But this has not stopped your company from charging extremely high prices.

    “It appears that the price of this drug is not being set on the basis of the cost to produce or research the drug, but at the maximum level that providers are willing to pay,” Waxman wrote.

    The company is the only one that has received approval from the Food and Drug Administration to manufacture the drug. For years, pharmacists made a similar treatment by hand. The insurance trade association America’s Health Insurance Plans has asked the FDA to clarify whether those treatments can still be sold.

  7. Pingback: How did we get where we are with Makena? | Nowhere Special

  8. M MacDonald says:

    My office deals with gov’t rulemakings, albeit in a different industry. The process for the gov’t to issue an approval of anything involves a long process where industry and “stakeholder” input is gathered and considered. Cost benefits are also considered. Lots of meetings are held involving interested parties. Therefore, most industry associations (lobbyists and non-profits) have economists on staff that look at pending actions and legislation to determine how it will affect the association they work for and it’s people. I would bet MOD has such economists (esp based on the data and statistics they themselves release) and if they had done their research, could have fairly accurately forecasted a price such as this by considering factors such as impending bankruptcy for this company and previous orphan drug cases. I just don’t buy it that MOD was blindsided by this. That’s just not the way these groups deal with each other. Makena would not have surprised one of their main supporters in this process. They all scratch each other’s backs. Therefore, the only conclusion I can personally come to right now is this: MOD and Makena never thought the media would grab this like they have. They assumed there might be some heat from doctors and insurance companies but that in the end they’d just shell out the extra money and move on to other issues. They thought it would all fly under the radar.

    Frankly, if I had been at the MOD/Makena mtg where the financial asst program was discussed, my first response would have been along the lines of “wait a minute, just how much are you going to be increasing the price of this to the point you need an assistance program??”

    Lesson learned for MOD and Makena – don’t tick off the mommies.

  9. Erica Deetscreek says:

    I supported MOD prior to becoming the mother of a premie and even more so after as my child benefited from a drug researched with money from them. I recieved the forms for MOD walk teams for my daughters school today and I felt so torn. I want to yell and scream and know if her school is even aware of the Makena situation. I will allways be grateful for the surfactant that helped my daughter but I may not be able to continue to support MOD.

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