Boycott Makena: March of Dimes responds to KV Pharmaceuticals
The recent hulabaloo with KV Pharmaceuticals and Makena continues, with multiple news and blog articles popping up every day. Senator Brown is trying to get the FTC to do an anti-trust investigation. The FDA is interested, but sadly they have no purview in pricing of drugs. Many newscasts have done pieces on the issue, the vast majority leaning towards condemning KV for their pricing of Makena. One aspect of the issue has been March of Dimes’ initial support of KV getting the FDA approval for the product.
The March of Dimes has been a positive organization for decades, and generally does a lot of good work. This one really blew up in their face. MOD was a major player in pushing the FDA to give orphan drug status to 17-OHP, paving the way for KV to bring Makena to market. Jennifer Howse, PhD, president of MOD, has stated that the MOD had no idea of the planned pricing structure, and I believe her. Nonetheless, the MOD has suffered a great deal of bad press and in some cases decreased donations because of their association with KV and Makena.
Today the March of Dimes delivered a letter to KV Pharmaceuticals, saying a lot of the things that we have been saying. It must have been a tough letter to write, given the amount of financial support KV has given to MOD, and the potential for that to end. While I don’t think the letter was perfect, I think it was pretty good for a major organization that has a lot of difference issues to keep in balance. Here it is:
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 President
While some folks on the internet have been critical of this letter as not strong enough, I feel like it is a pretty strong statement. MOD has had a financial relationship with KV for some time, and they are threatening to end that if KV does not address these issues. Their threat of “pursuing alternative strategies” certainly reads as endorsement of continued use of a compounded product. For an organization as large as the MOD, I think this is as close to a smackdown as they could get. For that I say bravo.
The only concern I have is the idea of KV being asked to “justify their pricing rationale” based on “savings to the health care system”, as any comparison to the cost of preterm birth is completely spurious. Health care needs to become less expensive. Fixing something that costs 100 with something that costs 90 is not a savings when the previous fix only cost 1. Claiming that it does is a ridiculous assertion – yet there is no doubt that KV will continue to make such claims.
I also think that some have been a little hard on MOD. I am concerned about their previous financial relationship with KV, but they have such a strong track record of positive contributions to pregnant women that I am willing to give them the benefit of the doubt, particularly after this letter. KV, on the other hand, has a track record of unethical behavior for which they are still paying fines.
While I appreciate MOD’s letter, in the end it doesn’t change my feeling towards the situation at all. No matter what the outcome, KV is deserving of a total boycott of Makena. They have behaved in a completely unethical manner, and deserve to go bankrupt for it. They have attempted to mug the women of this country, aiming to force the healthcare system to pay them billions of dollars a year for nothing that they didn’t already have. No matter how they respond to this issue, it will not change the fact that they are corporate muggers.
If somebody tries to mug you in an alley and you catch them in the act, they don’t get off the hook just because they gave you your money back.
Please join me in a total boycott of Makena. Companies like KV do not deserve to stay in business.