Paul Browne and I discuss two companies that did some foolish things (KV and Sequenom), the link between terbuataline and autism (not so much), how nulliparous inductions don’t increase cesareans (if you make a bad enough study), and a few other odds and ends.
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:
This month KV Pharmaceuticals gained FDA approval for their drug Makena, or 17 Hydroxyprogesterone Caproate, for use in prevention of preterm birth. This drug has been shown in randomized studies to moderately decrease the rate of preterm birth in women with previous preterm deliveries.
While this is the first FDA approved product for this indication, this very compound has been available on the market for many years, generated by compounding pharmacies nationwide for as little as $9 a dose. One major supplier, Wedgewood Pharmaceuticals, provides the product in vials every bit as professional looking as anything you would get from a major Pharma manufacturer.
The big problem, as most already know, is that KV Pharmaceuticals has decided to price their drug at approximately $1500 a week. Furthermore, they are extending legal power to prevent compounding pharmacies from creating any more of the drug.
This is outrageous. This is a well studied drug, already having gained acceptance in the community based on the landmark 17-OHP trial published in 2003. Millions of doses have been given nationwide without adverse effect. The fact that it has become FDA approved has done nothing for women or infants. The only effect has been that KV now has legal protection to price the drug at 200 times the previous price and block out competitors who previously had been providing the same drug at a tiny fraction of the cost.
An article was recently written in the New England Journal decrying this usurious pricing scheme. In their analysis, they write “For every dollar spent for compounded 17OHP, $8 to $12 in health care costs related to pematurity are saved.. by contrast, Makena will require $8 to $12 in drug spending for every dollar in such prematurity costs avoided.” Further editorials have been published in both print and digital media, such as this, this, and this. My friend @drjengunter weighs in here
KV has responded to the criticism, pointing out that they have a patient assistance program. To be fair, they are willing to give the drug for free to uninsured women making less than 60,000 a year, and at a small copay for women making less than 100,000. But to be fair to women and the world, this isn’t nearly enough. No matter what individuals are paying for the drug, the medical system will be paying billions of dollars for something that used to cost a few million a year.
Positive spin on Makena has promoted it as the first drug to decrease the rate of preterm delivery. This is an agregious mistruth. The drug has been on the market for over 50 years, and has been used for the indication for almost a decade in the United States.
At the core, KV Pharmacueticals is a leech on the blood of our society. They are providing nothing of value, but through our bureacratic process have been guaranteed that they can extract billions of dollars a year from our healthcare system – all to get a benefit we already had. They didn’t even have to do the research; it was done for them and published in 2003 (with compounded drug.) The idea that their particular FDA approved product is somehow better or safer than the compounded product is completely theoretical, cannot be justified by any data. Furthermore, the underlying efficacy of the drug KV claims has immeasurable benefit is worthy of some skepticim despite the 2003 trial, as since it went into widespread use the preterm birth rate has risen from 12.3% to 12.7%.
So what are we to do about this. I am doing this.
I will not write a single dose of Makena, and I call for you to do the same.
If I can, I will continue to use compounded 17-OHP. If I can’t, I will recommend daily vaginal prometrium, which very likely will have the same effect as 17-OHP. Its off label, but so was 17-OHP before KV got ahold of it. If a patient asks, I will politely explain that I refuse to give in to KV Pharmaceuticals and their piracy. The cost of healthcare is destroying this country, and this is an area in which we cannot afford to give in. Patients need to understand that these are the kinds of decisions that drive the cost of healthcare, and that we are all responsible for protecting our country’s healthcare future.
I encourage everyone over which I have any influence to refuse to write Makena for any reason, and to pass this message on to anyone who will listen.
Thank you for being there for patients around the world, fixing and cleaning their teeth and gums. Thank you for your training and your wonderful set of skills which we all need.
But today I have a bone to pick with you.
For the one thousandth time today I was asked to write a note for a patient with an obviously infected tooth, giving my permission for you to treat her. For the one thousandth time, I sat before my suffering patient, cursing your name, and wrote this ridiculous note. And now my patient can go back to you, and now you can do the job you should have done when she first came to you with her painful tooth.
As an obstetrician, I am expected to be expert in all things pregnancy. Not only that, but I am expected to understand how all things not pregnancy affect all things pregnancy. It was for this that I went to medical school and trained long in my field.
You are much the same.
As a dentist, you are expected to know all things oral cavity, and furthermore how all things not oral cavity affect all things oral cavity. It was for this that you went to dental school and trained long in your field.
And in this training, you no doubt learned something about the dental care of pregnant women. You probably learned that local anesthetics are not harmful to a pregnancy, and that the narcotics you prescribe for pain and the penicillin based antibiotics you use for infection are also safe. You probably learned that the millirads of radiation your oral films use are trivial compared the amount of radiation it would take to harm a fetus, and if you’re really on it you might even know that an obstetrician would do a 3 rad cat scan right through the fetus if he or she thought it was important enough. At the least, you know that the big lead apron you use is going to block anything that might get to the fetus anyway. You might have read that obstetricians are actually quite interested in oral health, and that we think that chronic oral disease may ironically be a contributing factor to the preterm labor you hope to avoid involvement with by refusing to treat oral disease in pregnancy women.
At the very least, you know that a fetus is kept in the uterine cavity, not in the oral cavity.
Since you already know these things, really what is going on is that you want your ass covered if under some strange coincidence something bad happens to a pregnancy after you treat a patient.
This is nonsense, and I am tired of it.
So forever more, here is a note for all the pregnant ladies of the world.
1. There is nothing you can do under local anesthesia that will hurt a fetus.
2. Penicillin antibiotics are safe in pregnancy
3. Local anesthetics are safe in pregnancy.
4. Narcotics are safe in pregnancy.
5. Oral xrays are safe in pregnancy. Shield the baby like you would any patient.
If after reading this you ever again send away a pregnant patient in pain because they need a note from their obstetrician, I have only this to say:
Grow a pair. You are doing your patient a disservice. Excercise the wonderful skills you spent years cultivating, and help your patient.