Quite some time ago Micky Morrison, a physical therapist and author, send me a copy of her book Baby Weight. I promised to give it a prompt review, and then promptly put it on my desk for about six months. As the fans that are still aware of Academic OB/GYN know, the blog and I have been pretty quiet. I did a fellowship, and now am building a new practice.
But now I have finally got to the book. And it is BABY WEIGHT!
A fellow web doc wrote a fantastic article on perinatal transmission of HSV. Check it out.
Two years ago, I penned a post entitled “Delayed Cord Clamping Should be Standard Practice in Obstetrics”, which was read by many. Later I gave a grand rounds on the topic, which was viewed by many. In doing so, I contributed to a growing movement towards delaying cord clamping after the birth of preterm and term neonates. This was all well and good. But something else happened as well.
In the eyes of many, I became an “Expert in Delayed Cord Clamping”, worth quoting to others, and even name dropped as some sort of trump card – “Well, Dr Fogelson says….” So let me set the record straight. I am not an expert in delayed cord clamping, if such a person even exists. I am certainly not an activist for the idea, not am I sure that such activism could be justified in the literature.
What I am is this:
1. An educated person with access to the literature and training in interpretation of medical research.
2. A physician with intellectual expertise in maternal health, and first hand experience in its practice
3. A person with a platform where his opinion would be heard.
4. A person who chose to express said opinion on that platform.
Today I had the pleasure of talking shop with my brother’s mother in law, Joni Dawning, a very experienced direct entry midwife in Eugene, OR. Joni has been attending births for over twenty years, and she has been a great resource to me over the years I have known her. I hold her in great respect, as she is the kind of midwife that I think is a great resource to her community. She provides a service to her clients that is greatly desired, but at the same time sees herself as a part of a larger system of birth service provision that includes hospitals and obstetricians. Unlike some direct entry midwives (or CPMs in some communities), she respects the limits of what she can offer, and does not see a hospital transfer as a failure in any way.
Recently in Oregon there have been some deaths during attempted breech deliveries at home, all attended by various home midwives of varying skill. Following this there was a discussion in the legislature about whether or not licensed midwives should be completely banned from intentionally attending breech births at home. Joanie wrote a passionate letter about the topic. She shared this letter with me, and to my surprise the letter was not in support of breech birth at home, but rather a plea that the legislature ban breech homebirth. She felt that too may midwives believed that they understood how to deliver breeches, not because they had experience, but because they were just ignorant of the potential risks and the techniques required to succeed. I some cases they just “believed in birth” and felt that the baby would deliver if one would just stand by and watch. Read more…
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.
I recently gave Grand Rounds on Delayed Cord Clamping. If you have an interest and a spare 50 minutes, take a look!
This is a nice photo of a diamniotic/dichorionic placenta, part of a pregnancy involving two separate embryos in the same uterus.
Note the thick intervening membrane and lack of blood vessels traveling between the two placental discs, both characteristic of a di/di placenta.
Continuous fetal heart rate monitoring is at its core an almost laughable idea. We are checking a single vital sign and using that vital sign to extrapolate a host of ideas and meanings. OBs that have read strips for years can make some sense of them, but would we give so much meaning to any other single vital sign? Would we do it with an adult? Of course not, but there are people who do. In fact, there are entire countries where this is a major methodology for determining the etiology of illnesses.
But the people doing this are not physicians – they are the healers of various cultures. Throughout the world there are practitioners who claim to divinate illness through feeling a person’s pulse for several minutes. This is particularly prominent in Asia. They describe using the rate, strength, and character of the pulse to make all manner of determinations. This practice is fairly laughable to physicians, as it seems crazy to get so much meaning from feeling someone’s pulse.
But is this so much different than EFM? In fact its quite similar. Given that traditional healers are probably hit and miss with their diagnoses, its no surprise that EFM technology is similarly lacking.
In this episode we talk to Dr Jennifer Gunter about her new book “The Preemie Primer”. I also pick Dr Gunter’s brain about some difficult problems in reproductive infectious disease.