Making sense of the mess over Makena. Who wins and who loses?

It started in February. KV Pharmaceuticals submitted an application to the FDA to make Makena (17 hydroxyprogesterone or 17OP) an orphan drug. The application was endorsed by the March of Dimes. The actual quote from the medical director of the March of Dimes, Dr. Alan Fleischman, was “There will be consistency and high quality. This makes it a breakthrough not only that it’s FDA approved and doctors will be comfortable in recommending it, but also there will be high quality and consistency for women as they take it.”

Keep in mind, there were no reports of quality of consistency issues. None at all. And no doctors I know were uncomfortable prescribing it. That is why the March of Dimes whole hearted support of the misadventure is so mind boggling. Oh, well, not really, it turns out they were getting quite a bit of money from KV.

And then, of course the price of Makena was announced. $1500 a shot (more expensive than gold) – a $4.2 billion addition to the already $30 billion or so a year we already spend in this country on prematurity.

The March of Dimes issued a weak statement. Maybe it was hard for Dr. Jennifer Howse, president of the March of Dimes who makes over $600k a year, to understand how people, you know, might now not be able to afford the drug. The same drug that was once a very affordable $10 a shot.

I blogged all along that pharmacies would still be able to compound 17OP. Because Makena was approved under the Orphan Drug Act and not patented (you can’t patent a hormone that has been around for 50 plus years) it would be up to the FDA to police the compounding pharmacies. My two industry insiders assured me the FDA didn’t have the stomach or the resources to wade into that quagmire. Especially as important politicians, like Rep. Waxman were now getting involved.

Public outrage and scrutiny from the medical community as well as politicians was high, so to save face, the FDA formally announced they would take no action against compounding pharmacies. I mean, the FDA already made their money from KV Pharmaceuticals’ application (I’m guessing the FDA does not have a money back guarantee), so they had nothing to lose and everything to gain by stating the obvious. That compounded 17OP is just fine.

The March of Dimes took forever to act. Finally, when the price drop to $690 a shot was announced, the March of Dimes severed ties with KV Pharmaceuticals. Actually, they severed their contract. And now the March if Dimes says it’s OK for women to get the compounded 17OP, you know, the stuff they felt wasn’t high enough in quality on Feb. 4th.

So I’m confused.

The March if Dimes said 17OP compounded wasn’t good enough, but now it’s OK. Is it really OK, or just, “we were getting too much bad PR so now it’s OK”, OK?

And they had a contract with KV Pharmaceuticals? That makes me sick that they would sell their name and endorsement to Big Pharma, especially without considering how the drug might be priced in the first place. Although, then again, they have a lot of corporate salaries to cover before they get around to, you know, helping babies.

So here’s the deal. None of this was needed. And that makes me really angry, because a lot of pregnant moms (and their partners) got really, really worried about cost. A lot of health care professionals got really, really worried about the cost to the system. And a lot of people got really, really worried about their health insurance premiums.

The winners in this are the people. There was enough public outrage that politicians got involved. I mean even  The New England Journal of Medicine promptly issued an editorial decrying Makena’s price. I truly believe the power of the Internet made a difference.

The losers? Well, KV Pharmaceuticals learned a lesson in corporate greed. No one is going to prescribe Makena at $690 a pop when the FDA has ok’d compounding pharmacies to continue mixing it up for less than 1/10th the price.

And The March of Dimes. Taking so long to take a stand told me that you were only interested in your pocket book. You can’t have it both ways. If Makena was as important as you felt back in February, they you should really be committed to fighting for a lower price. But by taking your sweet time in severing ties with KV Pharamceuticals, it seems to me that The March of Dimes is saying one of two things…

  1. Pregnant women should really have Makena over compounded 17OP, but we can’t take the drop in donations and bad PR. We never, ever thought to research the pricing of orphan drugs or even discuss the concept of price with KV pharmaceuticals and KV is just not paying us enough to make it worth our while. We can sure talk about the price of corporate donations!
  2. Makena was never really needed in the 1rst place, and we can’t take the drop in donations and bad PR. KV is just not paying is enough to make it worth our while.

And I don’t know which is worse.

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2 Responses to Making sense of the mess over Makena. Who wins and who loses?

  1. A well written and thorough piece explaining this sad and sorry state of affairs. To think that the huge cost, and I’m not only meaning financial cost, of prematurity on women, babies and families, as well as society as a whole, was given no thought in the drive to satisfy corporate greed is difficult to reconcile.
    Thank you for the clarity in your explanation.

  2. Sarah Mitchell says:

    Did you know that compounding pharmacies are not regulated by the FDA so there for they do not have to report any problems or adverse reactions to their compounded products? And if nothing is being regulated it stands to reason that short cuts are being made. Look at the recent problems with compounded IV nutrients in Alabama. Those products were to be mixed in a sterile environment just like 17P. 8 people as of now have died and more are expected. Makes you wonder in what environment 17P is being mixed, and no one will ever know because they are not regulated. If you read the press release from the FDA, they never said they endorsed the use of 17P they only said they wouldn’t prohibit them from making it and they can and may revisit their decision at any time. I would have also hoped you looked at the 2006 study the FDA did in regards to compounding drug. They found that a third or 33% of those tested were either not potent enough or to potent. 67.5% to 268.4%. As a mother of 2 preterm births I can not hope the next time I get the right mixture or that it doesn’t have some sort of harmful microbe floating around in it. I have to know and a FDA product assures as much as possible that I am really truly getting what my baby needs to stand a fighting chance. And even if you think Doctors won’t prescribe Makena based on principle, they also know that FDA products are better. I hope doctors prescribe the best product because to them the life of their patients and unborn babies are more important than making a politic stance. I will only take Makena with my next pregnancy and I will pay out of pocket if I have to. I think those with influence in the media should do their research, before they frantically whip out an article in ignorance.

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