As a physician, I occasionally encounter patients who feel like they know a great deal more about medicine than they actually do. Sometimes its a family member of a patient. Occasionally they are right, in that they have a particular cache of knowledge about a particular condition that surpasses me. In those circumstances, such patients or family members are able to augment their care. Far more often, however, their expertise is far less than they think.
For example, I once cared for someone who clearly needed a blood transfusion. A family member was in strong opposition, mostly because that family member was Jehovah Witness, even though the patient was not. That family member presented all kinds of information about alternatives to blood transfusion, and clearly right from a pamphlet they had read. At a fundamental level, said family member believed that there was always an alternative to blood transfusion and it was never actually necessary.
Today I saw a patient for a preoperative visit and went through the ritual of “informed consent” and the signing of the surgical permit. We had decided to do a hysterectomy to treat her problematic fibroids, and she very much wanted to proceed. Having discussed the alternatives, we now had to go through the legal ritual of the surgical consent.
As usual, I discussed what we could expect to gain from the hysterectomy. There was a 100% chance that she would no longer have any bleeding, and a very strong chance that any pain that originated in her central pelvis would get entirely or mostly better. Anemia that resulted from the bleeding would improve. Other symptoms, like urinary pressure and frequency, and lateralized pelvic pain, would likely improve though it is not as strong a likelihood as the other symptoms.
We also discussed the risks. “You could have bleeding during the surgery, potentially enough to need a blood transfusion before or after surgery. You could get a communicable disease from a blood transfusion. You could develop a wound infection or abscess, which sometimes is easy to treat and other times quite complicated. Anything in the abdomen could be damaged during the surgery, such as the bowel, bladder, ureters (“which carry urine from the kidneys to the bladder” I always say), blood vessels, or other structures. Anything damaged can be fixed at the time by myself or a consultant. There is a possibility something could be damaged but we do not recognize it at the time, or that there is a delayed injury. If this occurs you might need further surgery, antibiotics, or hospitalization. Though extremely rare, you could die or be injured from an unforeseen surgical complication or complication of anesthesia.”
At this point she looked white as a sheet, as usual, and then I tempered with “but all of this is extremely unlikely, less than 1% of cases for major issues, and I have to explain it all for legal reasons. I am well trained to do this surgery and will do my absolute best for you.” I answered her questions, the consent is signed, and we had our pre-op.
I was recently at the golf course working with a clubfitter on selecting a driver that was optimal for my game. We went through lots of different clubheads and shafts, hitting each on a very advanced radar system that exactly measures launch characteristics and ballflight. I was struck at how quickly he was moving through different ideas, having me hit each variation only a few times before moving on to something else. Having fit clubs for many tour professionals, the gentleman I was working with clearly knew what he was doing – but at the same time I was struck how little he understood the mathematics of what was going on, and wondered if his advice was really as valid as he thought it was.
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.
nec·es·sar·y: being essential, indispensable, or requisite
One thing I have learned by being active in the obstetrics and birthing blogosphere is that there are a whole lot of people out there that think that most cesarean deliveries are unnecessary. While most of them will admit that some cesareans are medically required, its pretty rare that the ones that have had a cesarean looks at their cesarean that way.
A popular term bandied about is “Unnecesarean”, a catchy little phrase that implies the underlying belief that most cesareans are unnecessary. Frequently, commenters state that they had a cesarean that they didn’t want, and that at some point later in their life someone let them in on the secret that their cesarean wasn’t really necessary, and this is completely accepted as fact. In some cases, people believe that they were robbed of the vaginal birth they were destined to have, or even that they were somehow raped by the their physician.
Frankly, I am tired of it.
I have noticed that a number of bloggers have made it a habit of creating posts that are mostly if not entirely lifted from another blogger’s creative work. On a number of occasions it is my creative work that has been lifted. This is improper.
My first experience with this was with the response to my article Delayed Cord Clamping Should be Standard Practice in Obstetrics. After I wrote this article, a lot of other bloggers linked to it in support. This was appreciated. What was not appreciated were the bloggers who completely copied my post and posted it on their own blog, such as the posts at the Birth Balance Blog and Full Circle Midwifery. These posts are not alone, as this article was entirely copied in at least 5 locations. In some cases these posts refer to me and my original post, while some make it look like I wrote the piece entirely for their blog, without reference to the original post at all. While I recognize that the reposting represents some kind of admiration of my work, it is still a violation of copyright, and is not acceptable behavior.
While the NIH Conference on VBAC behind us, the blogosphere continues active discussion of this important issue. I’ve been involved in this discussion a bit over at Science and Sensibility.
Here’s the message I am getting from a lot of folks strongly in favor of VBAC rights and availability.
The choice to VBAC is an informed refusal of a intervention. There should be no “right” required to have it. Hospitals should not be allowed to refuse VBAC attempts, as this is the same as requiring a woman to have an elective surgery.
I hear a general feeling that the risk of uterine rupture is overstated, as is the likelihood of a severe adverse outcome if a rupture occurs.
I hear a general feeling that the short and long term risks of repeat cesarean deliveries are overstated.
I think these are good messages. I agree with women should be be free to refuse repeat cesarean delivery, even in hospitals that do not have 24 hour anesthesia access and 24 hour OB coverage. As long as this refusal is informed, it should be a woman’s right. I also agree that the risks of VBAC are overstated by many, and the risks of repeat cesarean are understated by many.
The problem is liability.
There are times in our medical careers where we see a shift in thought that leads to a completely different way of doing things. This happened with episiotomy in the last few decades. Most recently trained physicians cannot imagine doing routine episiotomy with every delivery, yet it was not so long ago that this was common practice.
Episiotomy was supported in Medline indexed publications as early as the 1920s(1), and many publications followed in support of this procedure. But by as early as the 1940s, publications began to appear that argued that episiotomy was not such a good thing(2). Over the years the mix of publications changed, now the vast majority of recent publications on episiotomy focus on the problems with the procedure, and lament why older physicians are still doing them (3) (4). And over all this time, practice began to change.
It took a long time for this change to occur, and a lot of data had to accumulate and be absorbed by young inquisitive minds before we got to where we are today, with the majority of recently trained OBs and midwives now reserving episiotomy only for rare indicated situations.
Though this change in episiotomy seems behind us, there are many changes that are ahead of us. One of these changes, I believe, is in the way obstetricians handle the timing of cord clamping.