Yesterday, March 9th, the price of gold was $1,429.74 an ounce. That same day KV Pharmaceuticals announced the drug 17 Alpha-Hydroxy Progesterone Caproate (17P), a hormone that can prevent preterm delivery, will now cost $1500 a shot. One injection of 17P is 250 mg (0.009 ounces for the metrically uninclined), so gold is relatively cheap by comparison. Until the FDA awarded KV Pharmaceuticals the patent for 7 years of exclusive production, 17P was made for about $10 a pop in compounding pharmacies.
Perhaps KV Pharmaceuticals should change their name to KV Alchemists. Or better yet, KV Extortionists.
17P shots are indicated for women who have had a previous preterm delivery. A woman who delivered her previous baby prematurely has a 55% risk of another premature delivery, with the shots that risk drops to 35%. Put another way, for every 5-6 women who receive 17P, one premature delivery will be prevented. All told, 17P injections could prevent 10,000 premature deliveries a year in the United States, reducing the incidence of premature delivery by 2%. Considering 500,000 babies are born prematurely, it is certainly not the answer, but for some women it will make a difference. And if your baby was born at 26 weeks? Well, you are desperate for any difference, that is if you are even brave enough to chance getting pregnant again.
So what was the problem with the old system of having the drug made up in compounding pharmacies? Quality control was apparently an issue, and so many thought if the drug were made uniformly those concerns would disappear. No one thought the price tag would be a $20,000 blood letting. Most women who get 17P shots receive about 15 during their pregnancy (give or take), so prior to the FDA allowing KV Pharmaceuticals to extort money from pregnant women and insurers alike, a course of progesterone was a manageable $150 per pregnancy, now it is $22,500. If that’s not spinning straw into gold, I don’t know what is.
The price hike is especially eyebrow raising, because most pharmaceutical companies cite research and development as a major expense. I’m not defending Big Pharma in any way, but it does cost a lot of money to get a drug to market and often they don’t pan out or they make it all the way to the FDA and then fail to get approved.
But KV Pharmaceuticals didn’t spend a dime on getting 17P to market (okay, maybe they spent a few bucks photocopying their application and getting their lawyers to review the paperwork), but you and I paid for the pivotal research because it was funded by the NICHD (National Institute of Child and Health Development). In addition, 17P is already recommended by the American Congress of OB/GYN, so they don’t need to do any marketing. All KV Pharmaceuticals has to do is get their factory up and running and do some post marketing studies. They are laughing all the way to the bank. To protect this gold mine, the Associated Press is reporting that KV Pharmaceuticals has already sent cease and desist letters to several compounding pharmacies.
It gets better. In 2009, the FDA took action against KV Pharmaceuticals for marketing, producing and distributing unadulterated and unapproved drugs. In 2010, KV Pharmaceuticals was near bankruptcy. Now they have a veritable license to print money. I’m betting a company that wasn’t near bankruptcy last year would have had a lower price point. Nice tactic, climbing out of your financial hole on the backs of desperate, pregnant women.
This is so wrong on so many levels. It’s wrong that you and I paid for the research and Big Pharma will profit. It is criminal that a drug that was once $10 in now more expensive than gold. And we will ALL pay for this obscenity, because adding more than $20,000 to a few hundred thousand pregnancies a year will raise the price of health care for everyone.
Worst of all? Women with high co-payments or no insurance will now go without the therapy. KV Pharmaceuticals is quick to point out that they will have a “patient assistance program” for those with no insurance and making less than $100,000 a year. Well, if people making $99,000 a year can’t afford your drug, that’s a problem. Just do the right thing and price the drug so you don’t need an assistance program.
What can we do about it?
Spread this story to everyone you know. This is wrong. We must curtail the obscene health care costs in this country. We can argue a lot about what care is needed and how much its should be, but I think everyone on the planet, except perhaps a few people at KV Pharmaceuticals, would agree that a drug that once cost $10 to make should not now cost $1500. That’s not capitalism, that’s a crime.
If I were Supreme Empress of Medicine (and in my mind, at times, I am), I would reverse the FDA decision (do these people not know anything about business?) and award the patent to a generic manufacturer. That is the right thing to do. For women. For babies. For everyone.
I don’t have that power, but I do wield the lasso of truth, and let me tell you, it’s aimed squarely at KV Pharmaceuticals. Help me get it cracking.