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:
- Why didn’t MOD didn’t think about the price of an orphan drug before colluding with Ther-Rx/KV Pharmaceuticals.
- Why MOD thought a drug that has been available since the 1950′s needed to be FDA approved “all of a sudden.”
- 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
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