Thursday, March 10, 2011

Makena: Or, How to Make-na Some Bucks from Women Who Have Already Paid the Highest Price

So I'm putting today's soggy, largely unread newspaper (Good Lord, this suspended priest issue is upsetting) in the recycling bin this evening when a headline catches my eye:

"Cost of Drug Preventing Preterm Labor to Soar."

Oh, like I needed that kick in the crotch.

Here's the situation as I understand it having surfed around and found a few more articles:

Apparently there's a synthetic-progesterone-based injection that doctors have prescribed for years in order to prevent pre-term labor. It's generally given from about week 16 through the end of the pregnancy, and has shown to be quite effective. Generally, a pharmacy can mix up this concoction and charges somewhere in the neighborhood of $15-20 per dose. In sum, people know how to make it, it works, it's very cheap. Yay babies not being born early!

Then Big Pharm company KV Pharmaceutical comes along and requests FDA approval of this drug they're calling Makena. It's the same fucking thing as before, but now probably in fancy packaging. (I'm guessing a lovely gender neutral purple.) Zero dollars were spent doing R&D because everybody and their mother already knew about it and how to make it, but I'm sure some bucks went into marketing. The FDA approved it, which means KV has a lock on it for the next number of years, they're going to make pharmacies cease and desist making it, and they're going to charge . . . .

$1,500 per dose. Which comes out to about $30,000 per pregnancy.


Obviously the doctors and insurance companies are beyond alarmed. One doctor in the article is outraged, another "breathless." Everyone is worried sick that women who lack insurance, or whose insurance refuses to pay it (pre-existing condition anyone? Because obviously you need to experience a pre-labor catastrophe in order to conclude that you have a problem, and may need this drug), or who get government-assistance (the government is a bit cash strapped of late, in case you've been preoccupied) will not get it. (The company claims it will offer assistance. I'm not sure where that leaves people who are independently insured but whose insurance companies don't cover pregnancy. Like mine.) Insurance companies are dry-heaving because of course they want to cover this, but now they'll have to (big surprise) raise rates across the board in order to cover this. One Aetna rep in one of the articles I perused claimed that she knows of 1,000 people or so who get this drug per year in her system.

The drug company? They defend the outrageous price hike with the following statement:

KV Pharmaceutical chief executive Gregory J. Divis Jr. said the cost was justified to avoid the mental and physical disabilities that can come with very premature births. The cost of care for a preemie is estimated at $51,000 in the first year alone.

"Makena can help offset some of those costs," Divis said. "These moms deserve the opportunity to have the benefits of an FDA-approved Makena."

Let me get this straight. You're going to charge mothers $30,000 to offset a potential $51,000, thus saving the health care system $21,000 per child.

Aren't you so fucking sweet. Because until you came along, the cost of the drug per pregnancy was $400, making the savings $50,700.

And those are the "lucky" ones (not) (not remotely) whose children are born outrageously early who live. Who suffer some really awful consequences and life-long disabilities.

I guess the ones who die, since they don't cost $51,000 the first year, aren't costing the system anything. Which means KV is making $30,000 in pure profit, essentially putting a price on a live child (because we? were all wondering).

To employ new math: It's not about the OFFSET you asshole, it's about taking a child to term. It's about HAVING A CHILD WHO LIVES. These moms don't deserve some fancy-ass package that your marketing team spent precious power point time dreaming up, they deserve a chance at a full-term pregnancy. THEY DESERVE A BABY WHO LIVES. Regardless of their income, or their insurance situation.

And that's not factoring in what I anticipate to be a rise in premature labor in lower income groups and those with government or private insurance because they won't be able to afford the same-old-drug in your fancy ass box. You aren't offsetting, you're going to cost. You're going to cost a lot. According to the March of Dimes,

Preterm birth is the leading cause of death in the first month of life in the United States. The preterm birth rate has increased about 20 percent since 1990, and costs the nation more than $26 billion a year, according to the Institute of Medicine report issued in July 2006.

I'm honestly apoplectic and don't know where to dump this other than here. You can read more about this decision to screw pregnant women over on NPR and numerous blogs, such as Bizmology and Contentenique.

Reaching KV is more difficult; if you feel this is an "investor Relations" issue, you can email them at I'd be more inclined to see this as "an adverse event or side effect" in which case you can email them at

Show some outrage, if you have a few moments. Women who have gone into labor prematurely and lost children -- or are living with the consequences of a child born way, way too early -- have already paid enough, a few lifetimes over. They don't owe big pharm jack squat.


Michele said...

THANK YOU for posting this. I have a post up from today as well, and have put it out on all my social networking sites. To say I'm pissed is putting it lightly.

G Love said...

I just sent an email to investorrelations blah blah. Sigh. As if it will help.

Sara said...

I am thinking I will send them four photos. Natan and his grave. Samuel on the day he was born, and Samuel on his 3rd birthday.

Bastards. They can go to hell. Evil fucking bastards.

Sue said...

I am so angry I have no words.

Sue said...

Although, I will second Beruriah.

Emily said...

Pure evil. God damn the drug industries.

Hope's Mama said...

That's when over here we say: "only in America". I've read similar posts like this in a few places today, and I'm really fuming about it, even though this will have absolutely no impact on me. You need a wider audience for this post as you've constructed it brilliantly and made your points so well. I hope you find an avenue to get this published elsewhere.
Really, I'm just shaking my head here at the entire debacle of a situation.
Love to anyone who will be affected by this. And I'm so sorry.

Mandy said...


Thank you for your post on this topic! You have put into words what I truly feel about this. I was on these shots for about 4 weeks as a way to try to stop my pre-term labor. And it cost me about $10-$15/dose since it was made at a local pharmacy. Unfortunately, I lost my daughter at 25 weeks due to chorioamnionitis. In future pregnancies, I will probably have to use this drug as a precaution. And I am terrified that my insurance company either will not cover it (pre-existing condition?) or that the co-pays for it will be huge since it will be a "brand name" drug. Either way, I am screwed.

I hope you don't mind, but I think I will link to your post from my blog when I get a chance later today.

Mary Beth said...

I posted a link to a story about this on my FB page. My head is about to explode I'm so outraged by this. And it makes me even more mad to think NO ONE GIVES A SHIT who can actually do something about it.

I don't know whether to go effing ballistic or sit and cry.

A.M.S. said...

I haven't been able to stop spluttering and ranting like a mad woman to draft a coherent response to this. It offends me so deeply. I took 17-p. I saw at my weekly cervical checks how well it worked.

I was going to say I can't believe someone would try to make a profit off of mothers who are already in such a stressful place in their lives, but sadly, I CAN believe it.

Pharmaceutical companies would do well to remember that the mills of the gods grind slowly and exceedingly fine. I'm just sorry that's small comfort to the mothers who won't get 17-p when they need it.

erica said...

Well, one of my goals for 2011 was to swear more. This will surely help.

Thanks for the very cogent summary. I wish there was some way to hold KV accountable, but I suspect like most big pharma companies, they're more interested in their stocks than in real R&D or preventing preterm deliveries or neonatal deaths.

Anonymous said...

I'm sorry, but no, that's not how the FDA or the drug industry or patent law works. It just does not happen like that.

You cannot obtain a patent on anything unless your invention is genuinely new. In fact, it's often very difficult to obtain or defend a patent even if your invention is genuinely new.

This new drug is expensive no doubt because it's under patent; the previous drug is cheaper probably because its patent expired; but no, the more expensive drug is NOT "exactly" the same as the old. The PTO will not issue a patent for "exactly" the same old drug, they just won't.

The Patent and Trademark Office does not issue a patent unless the invention is truly new. if the PTO does issue a patent that can be challenged, competitors will challenge -- and sometimes succeed in invalidating -- a new patent.

Think about it: that's the way the marketplace works. A patent is a limited-term, legal monopoly to make use or sell an invention. Competitors have a strong incentive to break that monopoly if they can. Patent law is very strict and these monopolies are very narrowly enforced and very strenuously scrutinzed. (This is one of the reasons it's so expensive to develop new drugs -- you have to have teams of lawyers just to handle the intellectual property issues.)

The press very often does not have a sophisticated understanding of intellectual property law; they very often do not understand how drugs work or why a novel drug is patentable; and it is currently fashionable to demonize drug companies.

And of course a new drug does not automatically elbow out all other previous, cheaper drugs. Doctors are at liberty to prescribe whatever available, legal drug that is on the market.

The new drug may become the standard of care, but doctors can and often do still prescribe a different, older, cheaper drug.

Take statin drugs, for example. Many of them are still under patent and are still expensive. Some patients can't afford the co-pay or don't have insurance that will cover it. For those patients, doctors can prescribe an alternative (niaspan) which is essentially a megadose of niacin and costs mere pennies.

I could go on and on, but the sad truth is, sometimes the press manipulates and sensationalizes the facts.

Trust me, a drug company CANNOT force consumers to pay a huge price for exactly the same cheap off-patent drug that's been around for decades. It just doesn't happen.


Sara said...

Why should we trust you, Victoria? Tash can "think," as can the rest of us, as can the doctors quoted in the many articles printed about this issue, as can Senator Brown. I am hostile about this issue because it matters greatly to me personally as well as many others. I see no reliable sources supporting what you say.

We're all well aware of problems with the presses. I think we can trust them, however, more than we can trust a pharmaceutical giant that's already seen a CEO convicted for hideously immoral behavior.

Sara said...

Excuse me, Tash, for this.

But also, why the opening "I'm sorry," from you Victoria? If what you're saying is true, believe me, I'd be comforted.

You're talking to families who have lost children here Victoria and could lose more. I don't know your history, so I won't be presumptuous. But we and our concerns are on the side of good.

Searching said...

I saw that the other day but liked the link you sent for my non-medical friends to understand a bit better. Thank you!

It really, really upsets me that this could put so many babies at risk & add to their suffering and pain. Absolutely I feel awful for the moms who could lose their babies, but if we only knew all the pain a 24wker in the NICU goes through... Every DAY they spend in utero is one less day in the NICU on life support, tubes, lines, shots, treatments, on and on. A little bit longer to develop and maybe avoid massive brain damage, blindness, years of therapy, never being able to speak, etc. It is something that should be avoided if at all possible. It is so rough on the little guys. The most vulnerable babies, how dare they do something that will hurt them more!! It is never the baby's fault that they were created. They should not suffer for their mother/father not being rich, employed, or having good enough medical coverage. :(

moplans said...

holy crap tash. i can't stop the screaming in my head.

and victoria... puhleeze.
I'd be rolling my eyes even if my friends who work for drug companies hadn't been telling me the opposite of what you claim.

Tash said...

Victoria, I appreciate your concern for the drug industry. I actually know a lot of Pharma people living where I do, and so I've come to some state of peace in my head that companies that do the R&D and pay for the trials do in fact deserve a bit of the money at the end, and that only in a fantasy universe do we then give away AIDS drugs for free. And if KV had in fact gone out and developed a brand new drug, I'd be down on my knees and finding religion because I honestly don't want to see anyone else looking up my blog with another sob story about losing a child at 24w after doing everything right.

But I've read numerous stories now and either the media is just outright lying or perhaps you're not familiar with this particular case. The progesterone compound, formerly known as P17 I believe, was given "orphan drug" status when it was found to work, and compound pharmacies have been making it now for over a decade for a very small price. Incidentally, much of this research was funded by the government, aka, our tax $.

KV has filed a patent for this particular form which can be given monthly and is suspended in a particular form of oil. Yes, this exact form was previously made by pharmacists -- it was not developed in a KV lab -- and now according to one article (cite below) "Now, KV Pharmaceutical Company, the maker of the new drug called Makena, has warned compounding pharmacies that they face FDA action if they continue to sell nonbranded versions of the drug, technically known as 17-hydroxyprogesterone caproate." As anyone here who taken Progesterone can tell you, it comes in multiple forms -- suppositories, pills, injections of various types -- and those other forms will still be available. They will need to be taken daily instead of monthly, and I'm guessing did not meet the study's "best" standard; that is, the progesterone is likely not absorbed as well in these other forms.

Furthermore, doctors will be hesitant to now prescribe another form that perhaps didn't test as well, AND, KV wisely gave a ton of $ to the March of Dimes who now stands behind this new drug. And that is a marriage with the devil that will likely be the subject of another blog post.

In short, it's exactly the fucking same. Exactly. They now own the patent for about a decade. Doctors can prescribe another form of progesterone, but it will need taken daily and probably doesn't have the absorption rates of hydroxyprogesterone caproate.

You can read more media hyperbole here and here.

Anonymous said...

As a bereaved mother who spent eight years working in pharmaceuticals I can honestly say that this mad me jaw drop. I understand every aspect of how a pharmaceutical company works, what it takes to make a profit, and how important R&D is (that is what makes new drugs down the road. I also know exactly when and how to call bullshit. This is infuriating.. what I truly do not understand is how the company gained the right after all this time to issue the cease and desist.. it just makes me so angry.. and it defies logic. Tash I read your last comment here about how the ingredients used are the same in both the old and new versions, which explains a few things..
What I can say is that I hope OB/GYNS will have the balls to try their hardest to somehow get around this... One can always hope..
I also have an anger towards the March of Dimes at their frivolous support of this expensive drug when it already existed in such an inexpensive compound. Part of me thinks I should give them a piece of my mind on this unfortunate and, in my mind, destructive 'partnership'.

CLC said...

I hope you don't mind but I shared this with my brother who is a reporter for a big business newspaper you have heard of. And he covers healthcare. I want him to cover this more....don't know if he will find a new angle though. It's truly disgusting.

Oh, and my borther explained to me that what happened is the same understanding you have in your entry. So I don't know what Victoria is talking about. This isn't the first time this has happened.

Anonymous said...

It seems very unlikely to me that Makena is charging a huge price on a drug that is exactly the same as the generic alternative.

In order for that scenario to work, no fewer than four groups of people would have to cooperate with Makena:

(1) the PTO had to be persuaded that Makena's drug is better, newer, nonobvious than the previously available drugs, and issued a patent;

(2) the FDA had to be persuaded that Makena's drug is safe and more effective than the drugs already on the market, and permitted it to be marketed for this particular use;

(3) the insurance companies had to be persuaded that the price of this drug is reasonable and necessary because the cheap generic is not as effective, and agreed to pay it;

(4) the prescribing physicians had to be persuaded that Makena's drug is better than the cheaper generic alternative, and elected to prescribe it.

It's not a very likely scenario.

I can believe the drug company will charge a lot of money for a new drug, but I can't believe that the FDA, the PTO, insurance companies, and prescribing physicians have all been deceived into believing that Makena's drug is not actually better than the generic alternative.


Sara said...
This comment has been removed by the author.
Sara said...

There is no generic. Makena is an orphan drug. I, too, would've thought that what's happening never could. But it can, has, and is happening.

The following are some links from experts in the field expressing their concerns and outrage.

A letter from the presidents of The American College of Obstetricians and Gynecologist, The American Academy of Pediatrics, and the Society for Maternal-Fetal Medicine:

A blog post on the projected costs of Makena for Medicaid:

I tried to post some more but Blogger apparently has rules and issues with long lists on links in comments.

Sara said...

Also, Victoria, as a friend just pointed out, the PTO office isn't involved, because it's not about patenting, it's about orphan drug status.

christina said...

Did you have a chance to read this? Apparently the FDA isn't stopping it from being produced per-pharmacy. Ha. Take that Makena!

Anonymous said...

I looked into the whole Makena controversy a little bit, and it turns out the company is charging a higher price not because it obtained a patent, but because it obtained monopoly rights under something called the Orphan Drug Act (Congress incentivizes drug companies to manufacture drugs for very small patient populations [<200,000] with a right to 7 years' exclusivity).

It's true, the drug was available before, but only "off label." The FDA had not approved it as safe; some early studies indicated it caused severe birth defects. Doctors who prescribed it did so without the ordinary safety guarantees that they have with FDA approved drugs.

Later research seemed to indicate a better risk/benefit profile for some patient populations. Makena then sponsored further trials and obtained FDA approval. If I understand the story correctly, Makena did add value, not in the form of coming up with a new invention, but in terms of improving our understanding of the drug's safety.

Insurance companies have agreed to pay for the drug, and Makena is providing it at low cost for those who are uninsured, with the result that everyone (unless their insurance company refuses) who was able to obtain the drug before can still obtain it.

Still, this is probably not the result that was intended by the Orphan Drug Act. This expense makes insurance more costly for all of us, and although Makena added value, it didn't make the kinds of investment in basic research, or take the kinds of risks, that ordinarily justify very high proces on new drugs.

I don't know much about this area of law, but it sounds like the regulatory system needs to be tweaked. I don't think Makena is evil for acting as it has: it's just a rational actor, motivated by profit, like every other competitor in the marketplace.

Rather than blaming Makena for obtaining a big margin on this product, I think we should look to our legislators to amend the Orphan Drug Act and/or regulatory system.


Anonymous said...

I have to apologize. I see from some of the comments that I came across as though I thought other commenters are not smart, or not good people, for being upset about the Makena controversy.

I am really sorry about that. It's not what I intended. Obviously I shouldn't have assumed that Makena had gotten a patent. (I had very little awareness of the Orphan Drug Act before this.)


Natalie said...

W.T.F. My eyesight has little anger spots, I think. I'd like to put some words to this but I just... can't. WTF man. WTF.

Busted said...

As an update, the FDA has taken away the marketing exclusivity on Makena, so pregnant women can continue to obtain it from compounding pharmacies at the lower prices they've historically paid. This is huge. Makena has lowered the cost in reaction, but it's still exorbitant.,0,4544966.htmlstory

ivfcycler said...

and the ny times also finally published something in the paper paper (a blog post a little earlier), but i'm pretty shocked that they didn't do so from the start.