Astonishing

[catsittingstill]

A drug for high-risk pregnant women has cost about $10 to $20 per injection. Next week, the price shoots up to $1,500 a dose, meaning the total cost during a pregnancy could be as much as $30,000.

That's because the drug, a form of progesterone given as a weekly shot, has been made cheaply for years, mixed in special pharmacies that custom-compound treatments that are not federally approved.

But recently, KV Pharmaceutical of suburban St.Louis won government approval to exclusively sell the drug, known as Makena (Mah-KEE'-Nah). The March of Dimes and many obstetricians supported that because it means quality will be more consistent and it will be easier to get. NPR article here

This is, ah, startling. I get that KV Pharmaceutical wants to make a profit, but 1,490 dollars on a 10 dollar shot seems excessive.

Supposedly any uninsured woman with a household income under 100,000 will be able to get the drug at a reduced cost. Being very slightly acquainted with medical paperwork, I wonder how well that will work out.

I do see a quick solution here. KV Pharmaceutical didn't invent this drug. The government gave them a monopoly--probably before they mentioned how much they intended to charge. That monopoly should simply go away. Let the $1,500 shot compete with the $10 shot compounded by local pharmacies. If the consistent quality is really worth that much more, people will vote with their dollars.

Comments

[smallship1.livejournal.com]

Somehow I have the feeling that will not happen.

Looking into KV's history as given here, it's hard to see why any administration would have trusted them with a monopoly on any essential medicine. I also notice that last summer they laid off 42 per cent of their staff and fired their CEO, David van Vliet. I don't know if any of this means anything, but something seems fishy.

[randwolf.livejournal.com]

It does have the look of a fix, doesn't it? My mother's family is from St. Louis; the city has an offbeat culture of corruption and racism that I only know a bit about. I wonder just who in the FDA made the decision.

$1500 Makena Shots

[(Anonymous)]

KV Pharmaceutical's monopoly should be ended and the politicians that gave it to them should be investigated. Possibly it was the 30% increase in stock price or future campaign contributions that prompted the move. The whole situation is utterly disgusting!!!!!

[filkertom.livejournal.com]

Big Pharma is, like so many of the other corporate monsters, becoming more brazen every day. I don't even know what they intend to do with all the money -- at the levels they're playing at, it's basically going for a high score.

[billroper]

If you read the article carefully, this looks like an FDA problem to me. (I have numerous problems with the FDA.)

The company apparently is dropping more than a hundred million dollars on a research study into the drug's efficacy. That's why the FDA has handed them a monopoly on the drug under the Orphan Drug Act.

The question of whether the study was needed, given that the drug was commonly used for this problem already and appeared to be effective, is a damn fine one. But note that the FDA almost always errs on the side of having more studies. And given the long-term effects of drugs like DES that were commonly prescribed to pregnant mothers (not to mention the better-known Thalidomide), you can sort of understand their position.

I disagree with their position. However, they're incented to be risk-averse. And this is risk-averse behavior taken to a stupid extreme...

[catsittingstill.livejournal.com]

When I read the article carefully, I note the *source* for the claim that the company is spending so much on research.

I don't want to seem cynical, but I would like to see that information verified by someone who doesn't stand to make a %14,900 profit.

Then we can fiddle with questions like "is the FDA being unreasonable to want more studies on a drug that has already been approved?"

[billroper]

I know that drug efficacy studies can be ungodly expensive. And I'm going to make a reasonable guess that the FDA has a good idea of what this particular study is costing.

[catsittingstill.livejournal.com]

The *FDA* didn't say anything about how much the study would cost, at least not in this article. The president of the company that plans to charge $1,500 per $10 shot was the source of this claim.

[billroper]

Yes, I understood that from your first response.

My point was that the FDA probably has a pretty good idea of how much this study is going to cost, which is why they would be willing to grant the company exclusivity for seven years under the Orphan Drug Act. If the FDA felt that the study was not required (and the FDA almost always would prefer that there be another study, especially when the drug is being prescribed off-label for the original approval) then none of this would have been necessary.

As it is, the FDA can make this very reasonable sounding statement (whether they did or not, I can't tell you, but this is pretty much what the FDA would say):

"The off-label prescription and usage of the drug Makena in an attempt to reduce premature labor has never been the subject of a properly-controlled FDA-approved study to determine the long-term effects on pregnant women and their offspring. As we are well aware from our experience with Thalidomide and DES, the short and long-term results of administering medication to pregnant women, even with the best of intentions, are difficult to predict.

As things previously stood, pregnant women were effectively being used as experimental subjects by every doctor who wrote these off-label prescriptions. Now, with the study being commissioned by Random Drug Company, we will learn much more about the effects of this particular drug so that pregnant women are not unnecessarily placed at risk by their doctors.

As we all know, the Orphan Drug Act was passed by Congress to provide pharmaceutical companies with the appropriate incentives to carry out this kind of vital research on drugs whose patents have expired. Accordingly, we have granted Random Drug Company a seven-year exclusive right to sell and market Makena to compensate them for the substantial costs involved in conducting this research."

Now, doesn't that sound better? After all, you don't want to be giving untested drugs to pregnant women, do you?

If I seem less outraged than you are, it's simply because I expect this sort of stupid behavior from the FDA. It is exactly the same sort of thing that we have given them every incentive to do, so it's no surprise when we get that type of behavior.

If you want different behavior from the FDA, change the incentives.

[billroper]

By the way, here's a good article on the subject by someone who actually works in the industry and writes well. (And his opinions generally seem to be well-informed too.)

For amusement after reading this article, take a look at his section on "Things I Won't Work With" on his blog. If you scroll down, you'll find the article on chlorine azides and then you can click on the category to find more such...

[billroper]

Makena is a synthetic form of the hormone progesterone that first came on the market more than 50 years ago to treat other problems. Hormone drugs came under fire in the 1970s, following reports they might damage fetuses in early pregnancy. In the 1990s, the early incarnation of Makena was withdrawn from the market.

But the drug got a new life in 2003, with publication of a study that reported it helped prevent early births to women who had a history of spontaneous preterm deliveries.

Actually, the FDA is entirely reasonable in wanting efficacy studies for this purpose, because -- as we see above -- the drug was never approved for this particular purpose and was being prescribed "off-label". Well, at least they're being reasonable by FDA standards...

[hsifyppah.livejournal.com]

Unfortunately, just revoking the "exclusive" part of their license to manufacture it wouldn't allow the cheap versions to reappear - compounding pharmacies are not allowed to make any product that is available commercially, with very few exceptions - if the commercial product is backordered and temporarily unavailable, or if you are making a variation for medical reasons, eg, a preservative-free version for a patient with an allergy. This has not to do with patents and licenses so much as regulations involving who is considered a manufacturer, and the legal scope of practice of small-scale compounders. Major changes to the laws that govern compounding would be required in this case. Meanwhile, the FDA takes a somewhat hostile stance toward compounding pharmacies, very aggressively going after pharmacies who, as they see it, try to circumvent their regulatory authority by making products that the FDA has not approved. For instance, breastfeeding moms used to be able to buy compounded domperidone, a harmless stomach drug which is over the counter in many countries (and which increases the supply of breastmilk as a side effect) but which is not currently marketed in the US. The FDA threatened to shut down stores that were compounding this product because they hadn't approved sales of domperidone - this was very surprising to the stores involved, as it's not that different from a variety of other compounding practices that the FDA has no problem with. Now there's a black/grey market in imported domperidone from Vanuatu because of this regulatory weirdness. The relationship of the FDA, commercial drug manufacturers, and compounding pharmacies in the US is complicated and strained.

[jenrose]

So tell me... should the fact that they're making it in a base of castor oil be making me raise my eyebrows? Castor oil put me into labor twice, but I'm assuming that it works by mechanically irritating the intestine, which wouldn't apply to a shot?

[hsifyppah.livejournal.com]

Castor oil works directly in the intestine, yes, by drawing fluid in to the bowel and thus indirectly stimulating muscle contractions. That hygroscopic effect wouldn't amount to anything when injected, even if you used a comparable amount to the oral dose, which of course you wouldn't, ouch! It's generally pretty inert and not a common allergen, making it more suitable than the peanut oil base that some other progesterone preparations are made with, IMHO.

[jenrose]

I've taken the peanut oil progestrone preparations in the past. I suppose that injection is the only way?

[hsifyppah.livejournal.com]

There are vaginal suppositories sometimes used instead of injections for some kinds of infertility and for preventing early first trimester miscarriage, but I'm not sure they'd have the same effectiveness for preventing pre-term labour. Until now they've been more expensive, mind you, and you have to dose them once daily or more, not weekly, so those reasons might be why the shot has been used. You'd have to ask an obstetrician for the rationale. And it might be that it hasn't been studied and no one knows whether alternate delivery methods are useful in this case or not - it's an ethically difficult area to study.

[jenrose]

If I were in that position, I'd be totally up for being a guinea pig, at that price. Crazy.

[maiac.livejournal.com]

I'm waiting for the "pro-life" people create a firestorm of protest over this. After all, pricing the drug out of reach of so many pregnant women threatens of the lives of their "pre-born children".

I'm awaiting, but I'm not going to hold my breath.

[catsittingstill.livejournal.com]

I'm not going to hold my breath either.

[hofdave.livejournal.com]

This sucks. And from Canada, I can only look at what "our" expert, Brooke says on the subject (and what it means for us and our friend in the US). Even so, this sucks!!!

(Not So) Astonishing

[ndrosen.livejournal.com]

We'll make a libertarian out of you yet, Cat.

Or if I don't, maybe the FDA will. This is what happens when you give regulators their heads. The FDA has "protected" people from drugs that might save their lives, and has forbidden the publication of truthful information. By delaying the use of beta blockers in the United States for year after they were available in Europe, the FDA killed more Americans than the Viet Cong and NVA (at approximately the same time).

Re: (Not So) Astonishing

[jenrose]

Libertarian schmibertarian. This is what happens when you don't have enough government oversight of drug pricing.

Re: (Not So) Astonishing

[ndrosen.livejournal.com]

This is what happens when you have the government grant a drug monopoly, and make competition illegal. Prices were much lower before, not because businessmen are all saintly, but because if someone tried to overcharge, customers could geta better deal elsewhere.

Re: (Not So) Astonishing

[catsittingstill.livejournal.com]

Thank you, I've played Eve Online. A libertarian universe is basically an asshole convention, and why would I push to have the real world be any more like that than it already is?

Even generally useful and competent entities sometimes make mistakes. The FDA may have made a mistake on this one. Probably their mistake was trusting a corporation to behave the way a decent human being would.

The solution to the behavior of corporations sure as hell isn't less regulation.

Re: (Not So) Astonishing

[ndrosen.livejournal.com]

But this corporation could get away with its extortionate prices precisely because regulation now suppresses competition. And I recommend reading about some of the FDA's other decisions before calling it necessarily "useful and competent." (I am not claiming that it is always in the wrong.)