Facts
	The plaintiff mother received prenatal care at defendant ob/gyn practice, predominately from Dr. A, between August 29, 2013 and April 15, 2014. There was no issue with that care.

At 4:16 am on April 14, 2014, the plaintiff was admitted to defendant hospital at 36 weeks, 6 days because of increasing contractions. An epidural was started at 8:06 am. Labor was managed by Dr. B from 8:00 am up to and including delivery of the infant at 5:06 pm. Dr. B was the daytime on-call attending for defendant ob/gyn practice and Dr. A (who was on vacation, but in the office) came to deliver the infant when Dr. B called to inform her that the patient was fully dilated. Dr. A arrived at about 4:50 pm or 16 minutes before delivery.

Labor was reported to be routine until 2:30 pm. At that time, the fetal heart rate monitor (FHR) showed fetal tachycardia to 165 bpm. The patient was 7 cm dilated, 90% effaced, and the infant was at +1 station. Oxytocin was started at 4 MUmin. At 3:25 pm, the patient was fully dilated and the oxytocin was stopped because of long variable decelerations, which had started at 3:10 pm, some of which had a late component. At that time, there was still good beat-to-beat variability. Tachysystole had begun at 3:15 pm.

The infant was at +4 station as of 4:20 pm, and the FHR continued to deteriorate from “bad” Category II strips to Category III strips, with decreasing beat-to-beat variability over that time until 4:36 pm, when variability was absent. At that time, maternal fever also was noted, from 99.7°F to 102.3°F. When Dr. A arrived at about 4:50 pm, she reviewed the FHR monitor and instructed the mother that her infant had to be delivered now. Because the head was so far down (at +5 station), Dr. A believed the infant could be delivered faster vaginally than with a cesarean section. At vaginal delivery at 5:06 pm, meconium and a tight nuchal cord x 1 were present. The mother’s temperature at delivery was 100.6°F.

The infant’s Apgars were 1, 3, and 4. Pediatrics was in the room at the time of delivery and suctioned the meconium but the infant’s heart rate was less than 60 beats per minute (bpm). Tactile stimulation and positive pressure ventilation (PPV) did not improve the heart rate. At 52 seconds, a neonatal airway specialist was called. At 2:27 minutes, the anesthesiologist arrived to assist. At 3:59 minutes, the pediatric resident made an unsuccessful attempt to intubate the infant. Another unsuccessful attempt at intubation was made at 4:17 minutes, by the pediatric attending. At 5 minutes, the neonatal airway specialist arrived and at 5:21 minutes, another unsuccessful attempt at intubation was made. Finally, at 6:10 minutes, Pediatrics successfully intubated the infant.

A cord venous blood gas indicated a pH of 6.905, CO2 of 94.9, PAO

 of 28.1, bicarbonate of 17.3, and a base excess of 16.7. 

The infant’s initial neurological examination showed pupils pinpoint and equal bilaterally, no reaction to light, no tone, no spontaneous movement or eye opening, and no reflexes. He was diagnosed with “severe encephalopathy secondary to perinatal hypoxic – ischemia and DIC.”  Although there were no detectable subclinical seizures on electroencephalogram, the physicians suspected seizure activity on physical examination and, as a result, the infant was treated with phenobarbital. He was placed on hypothermia protocol from birth until April 19, 2014. On April 21, 2014, magnetic resonance imaging was performed and the infant was noted to have an “acute” right thalamic infarct, measuring 1.1 x 1.3 cm. In addition, there was a finding of a posterior fossa subdural hematoma, as well as some arachnoid hemorrhage. Almost every note refers to the fact that the infant was suffering from “severe hypoxic ischemic encephalopathy (HIE).”  
	 

Damages
	Records from pediatric neurology and the infant’s pediatrician indicate that the child met milestones up to age 1 year. The pediatric neurologist found two to three beats of clonus with some possible hypertonicity. At age 1 year, the boy was able to say consonant sounds and “dada” was emerging as specific. However, the plaintiffs hired their own speech pathologist, who said the child might or might not have a speech delay. In October 2014 (age 6 months), the parents applied for early intervention program (EIP) services and an evaluation performed did find “significant delays in gross and fine motor function.” He was also evaluated by a developmental pediatrician, physical therapist, and occupational therapist and found to have low trunk tone centrally and there was head lag when he was pulled to a sitting position. They also found increased tone in his extremities and his hands sometimes would fist and other times were open. Tightness was found, particularly in the child’s lower extremities at the knees and ankles. His deep tendon reflexes were very brisk at 3+, but no ankle clonus was found and no tremors were observed. Two cognitive developmental tests administered to the infant arrived at opposite conclusions. The infant began occupational therapy in October 2014 and continued to receive it.

Experts/Discovery
	The ob/gyn expert believed the case was indefensible as to Dr. B. She believed the infant should have been delivered at 3:36 pm, and if he had been, he would have no issues. She believed a cesarean delivery was warranted at 4:20 pm. The expert did not fault Dr. A for delivering the child vaginally, given the time she arrived on the scene. A crash cesarean delivery performed after Dr. A had a chance to assess the situation, the expert said, would not have amounted to significant time-saving in the infant’s delivery.

The pediatric neurology expert believed the infant would be fine. Although the child may have some discoordination, his comprehension, the neurologist said, was normal. The expert also believed that the child might have some speech difficulty early but that it would improve with time. He believed the child would be enrolled in mainstream classes.

As for the 5- to 6-minute delay in intubating the infant until the pediatric resuscitation team arrived, the neurology expert pointed out that the infant was receiving (PPV), which did provide oxygenation. He did not believe that the time it took for the resuscitation team to arrive or the difficulty the pediatricians had intubating the infant represented a departure from standard of care. He agreed, however, that plaintiff counsel could make an argument that “every second counts.” Intubation would have been better in the long term, but medically, PPV was fine in the short term. He agreed that the infant suffered HIE.

The neonatology expert opined that this case established an incredibly clear, almost textbook case of what would be relatively acute perinatal asphyxia. He gave a lot of credit to the neonatal team and believed that the aggressive treatment they provided was adequate. The expert stated that the resuscitation was appropriate although there was a slight delay in intubation. He stated that the 6-minute delay did not correlate with the degree of abnormalities found on clinical exam.

Dr. B and Dr. A agreed that Dr. B’s assessment of the infant at critical times was lacking. They also agreed that Dr. B probably would not have communicated any issues to Dr. A because she did not appreciate them. The assumption was that she was so intent on delivery she did not appreciate what was occurring on the FHR monitor.

In reviewing the strips, Dr. A testified at deposition there were three decelerations between 10:55 and 10:59 am. Dr. B believed the nursing entry at that time, which reflected fetal bradycardia was incorrect and she disagreed with that assessment. She stated for that for fetal bradycardia, the infant’s heart rate had to remain there for 10 minutes and that did not occur. Dr. B was forced to acknowledge that from 2:08 pm through 5:06 pm, there were decelerations seen on each panel through time of delivery. She testified that did not mean there were recurrent decelerations the entire time but she did admit that there were portions of time that there were recurrent variable decelerations. 

At 3:34 pm, the patient was fully dilated and she started pushing with every contraction at 3:39 pm. Dr. B was asked why she did not administer terbutaline to help with the tachysystole. She testified that she wanted to deliver the baby and did not want to interfere with the patient’s contractions and pushing. Dr. B testified that tachysystole can occur during labor and can be normal. She stated that there was a late deceleration seen at 3:29 pm, which most likely was caused by the tachysystole. Dr. B stated it is “possible” this deceleration was a prolonged deceleration of 9 minutes because the FHR never seemed to fully recover to baseline. She stated this could be viewed as non-reassuring but testified that there was still moderate beat-to-beat variability and some loss of contact, so it was difficult for her to comment on this finding. Dr. B testified that at delivery, the infant was floppy with no spontaneous respirations. 

The testimony of Dr. A was that she did not believe she could have performed a cesarean delivery faster than she was able to deliver the infant vaginally.  To transport the patient to the operating room, get everyone set up, make the incisions, and top off the epidural anesthesia, she said, would have taken approximately 20 minutes, which is roughly the timeframe in which the infant was delivered from her arrival on the scene. Dr. A ultimately said that what is seen towards the end of the strips (fetal tachycardia, decreased beat-to-beat variability, and decelerations) could be consistent with hypoxia. Because there was a loss of contact towards the end on the FHR monitor strips, however, some of the strips were difficult to decipher. Dr. A stated that after delivery and when the infant’s arterial blood gas levels were obtained, what was seen on the FHR monitor strips toward the end could have been consistent with hypoxia. 
	 

The case was settled prior to trial for slightly under $4 million. Dr. B’s “failure” to appreciate the significance of fetal well-being, or lack thereof, as exhibited by non-reassuring FHR monitoring strips and to effectuate early caesarean delivery was too daunting a departure from acceptable practice to risk a trial and a jury’s verdict. While we were able to effectively tiptoe around the land mines of criticism during deposition, no such protections would have been afforded at trial, when both defendants’ criticisms of management were likely to be exposed. Dr. A’s opinions regarding Dr. B’s management of delivery until she arrived also would likely have proved damning. Efforts were made to limit defendants’ exposure during the discovery phase of the case, but once the opportunity presented itself to resolve the case within available insurance coverage rather than risk a jury’s verdict, we took the opportunity to do so.   

Articles

In this case, the question of fetal well-being as demonstrated on the FHR tracing is significant.

The importance of intervention: When was this baby in trouble?

My 12-year-old patient was sitting alone in the exam room when I walked in. Eyes on her phone, she was engrossed in a video of a girl about her age in the middle of a long rant. We listened together to the girl’s tirade against everything from her parents to her school to her boyfriend to pop culture stars. “She seems pretty angry,” I said, to which my patient replied that she knew the girl well and her videos sometimes went on for hours.

In life and in my work, I try to focus on “finding the funny”-the parts of a day that make me laugh. In pediatric gynecology, there are a lot of really great, hilarious moments. A mom reports a “Crayola Seafoam Green” discharge from her child’s vagina, into which the girl had placed a crayon. A laugh-cry moment when a patient sobs to me that her grandmother was given a diagnosis of cancer and “has only 30 or 40 more years to live.” And then there are the nicknames that my patients use to refer to the vulva and vagina. When I first meet them, I try to use their words and hear myself saying 

But some days, the humor is hard to find, and I feel like I want to make a rant video myself. In gynecology, we’re constantly navigating a world that, at best, sends mixed messages to our girls about their worth as human beings, and at worst can feel like a constant assault. In trying to be emotionally present for every patient, we talk easily about sadness or joy. It’s less easy to acknowledge that anger can co-exist with these feelings, maybe because discussing anger means having to discuss its complicated roots. 

My patient with the friend who makes the angry videos has a lot to be angry about herself. I met her in the Emergency Room when she was
	11 years old and came in with heavy vaginal bleeding from a molar pregnancy. There was no fetus, but a molar pregnancy starts like any other, with sperm. She had been raped. Afterwards, I could find no 11-year-old-appropriate words to describe the abnormal pregnancy to her, to reassure her when she asked me the difference between an abortion and the procedure that she had undergone to remove the tissue from inside her uterus, to explain that the abnormal pregnancy tissue can linger in the body even after treatment, and can return and become like a cancer, requiring months of laboratory monitoring. She was transferred into foster care shortly after discharge from the hospital. When the girl missed one of her lab checks, our social worker learned that she had run away with an older boyfriend. For a brief time, she was sought by the police, and she was eventually found and placed in a locked-down care facility. As far as I know, her rapists have never been locked down, have never been in the hospital undergoing a procedure they didn’t understand, and have never felt the prick of a blood draw every week, then every month.

It seems natural and justified to feel angry for my patients who are in difficult situations borne of violence. When the difficult situation is borne of love, my anger feels less natural and justified, my values more suspect, my role less clear. For example, we cared for a 17-year-old woman who has had multiple major surgeries for a severe congenital reproductive tract malformation. Health-wise, she’s currently doing very well. A member of a religious sect in which marriages are arranged, she is nearing the age of marriage. Her parents and the leader of the sect, all loving people devoted to her happiness, recently had a conference call with the gynecology team. The patient was not on the call, but it was done with her knowledge and permission. The parents and the religious leader requested a formal letter describing in detail the woman’s fertility potential and said that an inability to carry a pregnancy would make my patient potentially un-marriageable. Her fertility potential is meager, and I felt frustrated at the circumstances and at what we were being asked to do. I was lucky to have an amazing attending to talk to about my anger in private. That conversation allowed me to examine my values, find a space where my anger was welcomed-and recognize where it was not-and to grow as a physician.

It can become overwhelming. I’m angry at myths about hymens, and the widespread belief that a pelvic exam or using tampons will break one. At misinformation about what the vulva should look like, so my patients feel uncomfortable about their bodies, unsure who to ask if they are normal. At restrictions on birth control access and insurance coverage, so that my patients can’t all use the medications they need for their painful periods, heavy bleeding, acne, cancer prevention-or yes, for contraception. I am angry about the never-ending stories of sexual abuse and sexual pressure, and the meager number of girls who have access to counseling to help them heal. Add to this a health care system that under-prioritizes the female body. For example, there are operative reports for young girls who have had major urinary and bowel surgeries that don’t mention the vagina and uterus. Girls with menses so heavy they necessitate blood transfusion, yet whose previous providers noted nothing abnormal about their menstrual flow, or maybe didn’t ask. And there are preschoolers treated over and over for yeast infections, even though it’s extremely rare for a yeast infection to occur at that age.

In case you missed it: Why I Chose A MIGS Fellowship

It’s confusing and tragic and it hurts, then it feels unreal, then routine, then almost inevitable (or worse, almost normal). In the #MeToo era, acknowledging anger seems healthy and constructive, but it doesn’t end there. We can move from anger to support to empowerment.  

Our patients show us how to travel this arc, and what it means to support women. This can be most apparent in situations that challenge traditional ideas of womanhood. One of my patients, amenorrheic at age 15, was found to carry an XY genotype. She laughed as she said that when she tried to tell her friends about her karyotype, they thought she was transgender and planning to transition, “and they were so supportive!” (They were still supportive after they learned she was not transitioning). Another patient, a 21-year-old married woman with vaginal cancer, could not have intercourse without bleeding and severe pain. At her request, and with her husband present and participating in the conversation, we discussed other ways they could safely be intimate. The mother of a 2-month-old expected to undergo a bone marrow transplant for a rare genetic disorder met with her gynecologist because the chemotherapy required for the transplant had a high risk of causing her ovaries to stop functioning. This mother was entirely alone, having moved to our city to seek care for her baby, and was staying in the Ronald McDonald house. I marveled at the woman’s strength as she tried to peer into a future that she wasn’t certain would exist for her baby, and how, through it all, she was so appreciative that our medical team was discussing this aspect of her daughter’s health. In addition, she had found a network of supportive parents online that she could talk to openly about fertility, who supported and loved her, and made her feel that she didn’t have to make this decision alone.

In light of how these conversations could have gone for my patients, these stories seem like more than expressions of love: they seem like fighting back.

We work in a job where difficult conversations about sex and fertility occur every day, and serve as guides in a world of conflicting messages where we don’t always know the way ourselves. It’s okay to be angry at how our patients struggle, at the systems around us, at ourselves-make a rant video, write an article, shout it in the streets! Then do what our patients do: fight back with love.

Are you a current intern or resident and interested in writing about your experiences? 

 to learn more about becoming a resident blogger.

When an ob/gyn treats young patients exposed to cruelty and confusing messages, it can be tough to overcome anger at the situation.

Fighting back with love

Obesity has become an overwhelming epidemic in the United States and contributes an estimated $147 to nearly $210 billion per year in healthcare costs. It is estimated that over 60% of the US female population is considered overweight, with 45% of US women between ages 15 and 49 considered obese.

This prevalent disorder increases both risk of infertility and complications during pregnancy, and has become a major clinical risk factor for adverse outcomes for both mother and fetus.

 Women with obesity experience increased risks of maternal complications of gestational diabetes, preeclampsia, cesarean delivery, thromboembolism, and postpartum hemorrhage, and fetal complications, such as prematurity, congenital anomalies, macrosomia, birth complications, and stillbirth.

Maternal obesity is also associated with increased risk of fetal structural anomalies, especially cardiac defects, neural tube defects, sacral agenesis, anal atresia, and limb reduction abnormalites.

 Prevalence of cardiac defects in women with body mass index (BMI) > 40 kg/m

 is increased (RR 3.63; 95% CI 1.33- 9.91).


	In addition to the risk of structural anomalies, technical challenges associated with sonographic imaging result in a significantly lower detection rate for cardiac anomalies, as well as an increased risk of missing markers of aneuploidy.

 The percentage of overweight women who have suboptimal fetal echocardiography is 17.4% when compared to 6.4% in normal-weight patients.

Many factors contribute to suboptimal imaging in women with higher BMI. Sonographic visualization of fetal structures is degraded by depth of the body fat layer, with resultant increased depth of insonation, absorption of energy by the adipose tissue, and higher back-scatter from refraction.

 Over 50% of fetal anatomic surveys in women with obesity cannot be completed during the first ultrasound examination.

 Studies of second-
	trimester ultrasound examinations have shown that as BMI increases, there is a steady degradation in scan quality, and rates of poor visualization of fetal heart and spine correlate linearly with the degree of obesity.

 One study found that if a repeat ultrasound is performed at 21 weeks, then visualization of the heart improved; however, in 20% of exams, the fetal heart could not be adequately assessed despite several ultrasounds.


	Images obtained while scanning a patient with obesity are often of poor resolution secondary to backscatter, artifacts, and noise.

 There are several techniques that can result in better sonographic imaging of these patients. The primary goal is to reduce the distance between the transducer and the fetus, and to leverage advanced ultrasound technologies for post-processing.  


	The panniculus limits visualization due to absorption of ultrasound energy by the adipose tissue, as well as increasing depth of insonation. Because the basic tenet of good ultrasound technique is placement of the organ of interest as close as possible to the transducer, scanning at a point away from the thickest portion of the pannus (between the umbilicus and pubic symphysis) may improve image quality.

 Placing patients in alternate positions, such as lateral decubitus, oblique, semi-recumbent or upright may allow the sonographer to scan away from the areas of most depth, yielding better images. The decubitus position causes the pannus to fall away, allowing the practitioner to use the lateral flank as a window, while pointing the transducer medially. The pannus can also be lifted by an assistant or by the patient herself, and scanning can be performed from the infrapanicular crease to minimize the distance to the target of the ultrasound, the fetus.

 Using multiple positions throughout the course of a single visit can result in more optimal views of fetal anatomy and maternal structures. In addition, after the first trimester, it may be necessary to move the fetus into a different position, using a free hand.

 Figures 1 and 2 show examples of the importance of appropriate positioning of the patient during ultrasound. 


	It is also helpful to have the patient maintain a full bladder, which displaces the uterus cephalad, where the adipose tissue of the anterior abdominal wall may be thinner.


	A lower-frequency transducer (e.g. 1 MHz), as opposed to the traditional 2-to 5-MHz abdominal probe, can be combined with beam-forming algorithms to allow for better modeling in overweight patients.

 Because absorption is proportional to ultrasound frequency, lower-frequency transducers allow for less absorption, less attenuation, and more penetration, at the expense of less resolution. Using tissue aberration programs that correct and adjust for the speed changes that occur in adipose tissue also allows for improved resolution and greater depth of penetration. Real-time multiplanar imaging provided by isotropic and new crystal array transducers also be helpful in patients who are obese.


	Because the vaginal probe can be placed closer to the fetal anatomy when used with a transvaginal approach, it is particularly useful in patients with excess adiposity. A transvaginal approach should be considered routine in suboptimal imaging in the first trimester and in scenarios where fetal parts close to the cervix are suboptimally visualized (i.e., intracranial anatomy in a cephalic fetus, or fetal extremities and sacral spine in a breech fetus). The vaginal probe can also be placed directly in the umbilicus, using it as an acoustic window, and has been shown to improve the fetal cardiac exam.


	Use of specialized advanced imaging technologies allows for post-image capture enhancements. Increased signal-to-noise ratios and improved margin definition are easier with post-processing techniques. Use of compound imaging and tissue harmonic imaging has also vastly improved the quality of images that can be obtained from standard ultrasound techniques.

 The principle behind compound imaging is to combine multiple slices of images that have been obtained from different angles to generate an improved composite sonographic image.

 Tissue harmonic sonography, on the other hand, is a gray-scale sonographic technique that markedly improves sonographic contrast resolution, particularly in patients who are difficult to image with conventional techniques.

Ergonomic tips to prevent injury to sonographer/physician


	Taking into account good ergonomic practices is especially important for a practitioner performing ultrasonography on patients who are obese. When performing ultrasound regularly, repetitive injury is common, due to forceful or awkward positions, applying pressure for extended periods of time, and improper positioning. Musculoskeletal injuries are common in sonographers who work in the ob/gyn setting, and it is imperative that they remain aware of hand positions and proper posture and avoid awkward twisting movements while doing scans to avoid injury.

Avoiding bias against patients who are obese


	In our society, obesity is stigmatized, and even though one-third of the adult US population is obese, patients with it are frequently the targets of negative or derogatory comments, prejudice and poor treatment in many settings, including healthcare. There is a growing amount of evidence that supports the notion that physicians and other healthcare workers hold strong implicit bias about patients with obesity,

 and those biases need to be addressed at the systematic and training levels. Because many of our patients have already experienced negative reactions from others, it is even more important to provide them with compassionate care, and to avoid any unconscious bias against patients with obesity, especially because they are more likely to have complications during pregnancy and will need to be able to trust that their physician treats them with respect and dignity. 

Obesity is a growing epidemic in the United States. Patients who are obese are at increased risk of fetal anomalies and overall, adverse outcomes are increased in both mothers who are obese and their fetuses. Pregnant patients who are obese present significant technical challenges for those performing ultrasonography. Providers should leverage a patient position, optimize probe selection, and acquire an understanding of post-processing abilities of their ultrasound machines to maximize image quality and facilitate appropriate counseling of pregnant women who are obese.

 Patients who are obese often require additional ultrasounds to complete anatomical surveys, and have a higher utilization of healthcare resources during and after their pregnancies. The economic impacts of obesity cannot be ignored and working with our patients to improve their health before, during, and after their pregnancies can improve the health of society over the long term.

The authors report no potential conflicts of interest with regard to this article.

Hendler I, Blackwell S, Treadwekk M, Bujold E, Sokol R, Sorokin Y. Does advanced ultrasound equipment improve the adequacy of ultrasound visualization of fetal cardiac structures in the obese gravid woman? Am J Obstet Gynecol. 2004;190:1616-1620.

Hendler I, Blackwell S, Treadwekk M, Bujold E, Sokol R, Sorokin Y. The impact of maternal obesity on midtrimester sonographic visualization of fetal cardiac and craniospinal structures. Int J Obes. 2004;28:1607-1611.

Benacerraf B. The use of obstetrical ultrasound in the obese gravida. Sem Perinatol. 2013;37:345-347.

Maxwell C, Glanc P. Imaging and obesity: a perspective during pregnancy. Am J Roentgenol. 2011;196:311-319.

Brite J, Laughon SK, Troendle J, Mills J. Maternal overweight and obesity and risk of congenital heart defects in offspring. Int J Obes. 2014 Jun;38(6):878-882.

Uhden M, Knippel AJ, Stressig R, Hammer R, Siegmann H, Froelich S, Kozlowski P. Impact of maternal obesity and maternal overweight on the detection rate of fetal heart defects and the image quality of prenatal echocardiography. Ultraschall Med. 2011 Dec; 32(S2):E108-14.

Rosenberg JC, Guzman ER, Vintzileos AM, Knuppel RA. Transumbilical placement of the vaginal probe in obese pregnant women. Obstet Gyncecol. 1995;85:132-134.

Oktar SO, Yucel C, Ozdemir H, Uluturk A, Isik S. Comparison of conventional sonography, real-time compound sonography, tissue harmonic sonography, and  tissue harmonic compound sonography of abdominal and pelvic lesions. Am J Roentg. Nov 2003;181(5):1341-1347.

Phelan SM, Burges DJ, Yeazel MW, Hellerstedt WL, Griffin JM, van Ryn M. Impact of weight bias and stigma on quality of care and outcomes for patients with obesity. Obes Rev. 2015;16:319-326.

Proper positioning, careful choice of probe, and leveraging of post-processing capabilities all can improve ultrasound quality in this patient population.

How to optimize imaging in the obese gravida

History
	A 65-year-old woman with a history of well-controlled vulvar lichen sclerosus presents to your clinic with acutely worsening vulvar pruritus and pain that feel like paper cuts. She has been using topical triamcinolone 0.1% regularly without improvement. Examination reveals the findings seen in Figure 1.

Click here for the diagnosis, treatment plan, and discussion

, which are linear erosions (loss of epithelium) that can be seen in a number of vulvar diseases, including lichen sclerosus, 

 infections, herpes simplex virus infections, lichen simplex chronicus (itch-scratch), Crohn’s disease, or tearing from the genitourinary syndrome of menopause.

 Patients with vulvar fissures often describe them as stinging or burning pain that feels similar to a paper cut.

In this patient’s case, we are drawn away from a 

 flare as the diagnosis given the fact that she was previously well-controlled on topical corticosteroids. Long-term studies have demonstrated that topical corticosteroids are safe for lichen sclerosus and decrease the chance of developing cancer if used regularly.

 However, we know that these drugs can  increase risk of infections, especially 

 Thus whenever patients with lichen sclerosus do not respond or are no longer responding to therapy for lichen sclerosus, you should consider other causes of their worsening symptoms, such as infection or coexisting vulvar conditions.

More test your knowledge: Irregular Vulvar Mass In A Postmenopausal Woman

The first step in evaluation of this patient would be to obtain a sample for a wet preparation with saline and 10% KOH and consider a yeast culture (identify the species if positive).

 The advantage to performing direct microscopy is that you can obtain an immediate diagnosis. However, yeast is missed on 50% of wet mounts. So, if the wet prep is negative, or the patient has not responded to prior antifungal treatments, a yeast culture to identify the species and guide your treatment should be considered. Yeast cultures are most helpful in recurrent or resistant infections. 
	 


	Up to 75% of all women will have at least one episode of vulvovaginal candidiasis with 10% to 20% of women being classified as having complicated infections.

 Complicated infections are defined as those that are recurrent, severe, or that occur in patients with diabetes or who are immunocompromised.

 but other species can also be identified, including 

, which can be resistant to first-line therapies.

 Risk factors for developing this fungal infection include recent antibiotic usage, incontinence, obesity, diabetes mellitus, and immunosuppression (including local topical steroid use).

Most commonly, patients present with vulvar pruritus and may have thick white vaginal discharge.

 On examination you may also see vulvar fissures, excoriations, and erythema. The diagnosis is confirmed via vaginal pH measurement (from the lateral side wall of the vagina) and wet mount. Classic microscopic findings include pseudohyphae (Figure 2). As mentioned above, a yeast culture may be beneficial in cases of recurrent or resistant infections, defined as four or more infections per year, or infections that are unresponsive to treatment.

 We would recommend treating this patient for complicated vulvovaginal candidiasis given her topical corticosteroid use. Treatment can be topical or oral. Topical treatments to the vulva include miconazole nitrate 2% cream twice daily for up to 7 days or nystatin ointment 100,000 units/gram two to three times per day for up to 7 to 14 days.

 Intravaginal antifungal treatment (numerous azole medications are available) should be given along with the topical treatment to the vulva. Oral treatments include fluconazole, 150 mg for every 72 hours for three doses, before starting a maintenance antifungal regimen.

 For recurrent infections, weekly fluconazole can be used for up to 6 months.  

Can you make the diagnosis: Dysuria, Painful Lesions In 26-Year-Old Woman

For additional information, a yeast app is available in the app store (type in ISSVD). This app was developed by the International Society for the Study of Vulvovaginal Disease with an unrestricted educational grant from Prestige, Inc., manufacturers of Monistat. The company had no input into the app content, or development of treatment recommendations.


	This is a chronic inflammatory condition of the skin that is likely autoimmune in nature. Patients typically present with vulvar pruritus, burning or pain with intercourse.

 is characterized by classical skin changes, which include whitening of the skin that can be scattered or diffuse with atrophy and a cigarette paper/cellophane appearance.

 Often the condition manifests in a figure of eight pattern around the vaginal opening and anus.

 There may also be thickened areas and fissuring. Vulvar biopsy confirms the diagnosis although the clinical appearance can be utilized as well.

As mentioned previously, treatment is with topical corticosteroids. For lichen sclerosus, clobetasol 0.05% ointment is used up to twice daily for 1 month followed by daily for 2 months and then the patient is maintained on topical triamcinolone 0.1% ointment daily. An alternative regimen is to treat as above, for 3 months with clobetasol 0.05% ointment, then use clobetasol 0.05% ointment three times weekly long term.


	A decrease in circulating estrogen that comes with menopause results in thinning of vaginal epithelium.

 This increases the likelihood of erosions and secondary infection.

 Patients often present with complaints of dryness, pruritus, and dyspareunia. Erosions or fissuring from friction may be seen.

 The diagnosis is made based on the clinical appearance of the vaginal mucosa and vulvar skin. On wet preparation, you would see parabasal cells (small, round, immature epithelial cells), elevated vaginal pH (greater than 4.5) and loss of lactobacilli.

First-line treatment is the use of lubricants.

 Patients who do not respond to this therapy may benefit from a trial of local estrogen therapy, ospemifene, or prasterone.

Hope K. Haefner, MD, is on the advisory board of Prestige, Inc.

Edwards L. Genital Dermatology Atlas. Philadelphia, PA: Lippincott Williams and Wilkins; 2004

Edwards L.  Vulvar fissures:  causes and therapy. Dermatol Ther. 2004;17(1):111-116.

Dalziel K, Wojnarowska F. Long-term control of vulval lichen sclerosus after treatment with a potent topical steroid cream. J Reprod Med. 1993;38:25-27.

Lee A, Bradford J, Fischer G. Long-term management of adult vulval lichen sclerosus. A prospective cohort study of 507 women. JAMA Dermatol. 2015:1061-1067.

Wilkinson EJ, Stone IK. Atlas of Vulvar Disease. In: 3rd ed. New York: Wolters Kluwer/Lippincott Williams & Wilkins; 2012:139-142.

Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2015. MMWR Recomm Rep. 2015;64(No. RR-3):1-137.

The North American Menopause Society. Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013;20:888–902. quiz 3–quiz 4.

What is your diagnosis when you see vulvar fissures?

Pruritus, pain and fissures in a 65-year-old woman

By now you have likely seen advertisements by the pharmaceutical industry criticizing Trump administration proposals to reduce the high cost of prescription drugs using various strategies that include linking the price that Medicare pays for drugs to that paid by other industrialized countries.

 In my own state, a modest proposal by the Governor to permit importation of Canadian medications has been met by grim commercials claiming this action would open a flood gate of deadly “contaminated” Chinese drugs. Many of these attack ads remind me of those used to try to block the Obama administration’s Affordable Care Act. When an industry attacks both liberal and conservative policy proposals aimed at restraining health care costs, it is worth carefully examining the issues. 

The US pharmaceutical industry is responsible for bringing to market many truly extraordinary drugs that are revolutionizing treatment of common and rare (so-called orphan) diseases but the cost of prescription drugs is bankrupting families and threatening the solvency of both public and private health care financing systems. The first half of this two-part editorial looks at the challenges posed by the high cost of brand-name drugs and the reasons for those numbers. Part two, in a future issue, will review market-based solutions and improved regulatory policies that can make prescription drugs more affordable without stifling innovation. 

In case you missed it: How likely are adolescents to fill antibiotic prescriptions for STIs?

Economic burden of high medication costs 

 was $3.5 trillion or $10,739 per person and consumed 17.9% of our Gross Domestic Product (GDP).

 That is twice as much as the average of the next nine highest-spending nations.

 To place this into context, if we could reduce health care expenditures to 10% of GDP, we would recoup enough money to pay for the country’s entire primary and secondary education system, twice our current defense budget or three times what we spend on public transportation and highways.

 Annual expenditures on pharmaceuticals now account for $500 billion or about 16.7% of total US health care spending and costs for branded drugs are increasing at an unsustainable 15% per year.

 Among the 11 highest income nations, the United States has the highest pharmaceutical spending per capita at $1443 compared with a mean of $749 for all 11 countries, with brand medications accounting for almost all our excess spending.

 In the United States, brand medications represent about 10% of prescriptions but 75% of costs.

 reported that 62% of respondents took at least one prescription drug and 24% took four or more.

 Of the latter, 29% had either not filled prescriptions, skipped doses or taken an over-the-counter drug instead of a prescribed one because of cost and 58% spent more than $100 per month for prescriptions. And although manufacturers of brand and generic drugs are in a high-risk business, their net profit margins are 28% and 18%, respectively, placing them second and fourth in profitability, respectively, among 26 major industrial sectors.

Normally the market for commercial products operates in a predictable manner with price reflecting supply and demand curves and intense competition enhancing the value of products. Moreover, consumers generally have access to accurate, understandable, and readily available information about product quality and price. In efficient markets, rational price equilibria are established among producers, wholesalers, retailers, and consumers. But medications are not a rational market (Figure 1). In contrast to traditional markets, in which consumers are the primary decision-makers, patients have little say over prescription drug purchases. Physicians generally determine which drugs are prescribed bound only by the occasional and appealable payor formulary. But most physicians have 

 knowledge of what a patient will actually pay for a drug.

Next, supply chain intermediaries (i.e., wholesale and retail pharmacies, pharmacy benefit managers, and payers) engage in a complex set of opaque transactions with manufacturers and/or among themselves to set prices. Resultant rebates and discounts permit skimming of profits that together account for 41% of medication costs.

 Pharmacy benefit managers (PBMs) are supposed to negotiate prices and establish formularies to reduce costs for private insurers and self-insured large employers. But many PBMs operate their own mail-order and retail pharmacies and receive rebates from manufacturers that are not passed on to insurers, employers or patients. Worse, PBM payment algorithms are often linked to the dollar value of the drugs provided (i.e., the higher the price, the more the profit). While PBMs now cover 85% of patients with prescription drug insurance coverage, three PBMs have 73% market share, which allows them to extract greater discounts from manufacturers while retaining more of the savings.

Direct-to-consumer (DTC) marketing also drives up the cost of brand drugs. Because of the complexity of pharmacokinetics, drug interactions, etc., most nations do not permit DTC marketing of drugs. In fact, the United States is one of only two nations in the world (New Zealand is the other) that permits DTC drug advertising.

 In 2015, $5.2 billion was spent on DTC advertising of prescription drugs, the majority on television ads and all of it tax deductible as a business expense.

 Another marketing ploy is the common use of manufacturer rebates or co-pay coupons to encourage patients to accept, request, and occasionally demand high-priced specialty drugs rather than cheaper generics. These coupons selectively increase brand drug sales by 60%.

 Pharmaceutical advertisements and drug representative “detailing” in physician offices are designed to influence physician prescribing patterns. Currently, nine out of 10 drug companies spend more on marketing than on research and development.

Have you read - Study: 1 in 7 antibiotic scripts may be unnecessary

Also unique among other nations, US drug makers are free to set the price of their drugs without government constraints. Specialty drugs (like the ones you see commonly advertised on TV for psoriasis and Crohn’s disease) account for 2% of prescriptions but 33% of drug spending.

 Biogen’s Spinraza, an anti-sense oligonucleotide to treat spinal muscular atrophy, was initially priced at $750,000 in the first year and $375,000 annually thereafter.

, a gene therapy for retinal disease caused by homozygosity for RPE65 gene mutations, was initially priced at $850,000 while Novartis’ Kymriah, a chimeric antigen receptor T cell (CAR T) treatment for refractory B-cell precursor acute lymphoblastic leukemia, costs $475,000.

 While it’s hard to contest the benefits of these agents if you or a family member are affected by such serious diseases, their costs appear exorbitant. 

Beyond the factors itemized above, medication prices are also inflated by perverse government regulations, prohibitions against drug importation, the inability of Medicare to negotiate drug prices, brand drug makers’ suppression of generic competition, price gouging by generic drug manufacturers, and conflicts of interest accruing direct payments to physicians by industry. 

Perverse effects of government regulations

The Orphan Drug Act of 1983 was designed to encourage development of treatments for rare diseases (i.e., affecting fewer than 200,000 patients/year).

 Since then, about 600 “orphan’ drugs have been approved with approvals accelerating over the past few years. Benefits to companies whose agents are approved under this pathway include an additional 7 years of exclusivity, expedited processing, reduced clinical trial size, and tax credits for development. Despite these advantages or perhaps because of them, the average orphan drug price is 5.5-fold higher than other agents and by 2020, orphan drugs will account for 21% of brand drug sales or $209 billion. Among the top 100 US drugs, orphan drug costs per year were $140,443 vs. $27,756 for non-orphan drugs.

It is important to bear in mind that many of these orphan drugs are generics that are simply repurposed. Obstetricians will recall that in 2011, the US Food and Drug Administration (FDA) approved exclusive manufacture of 17-hydroxyprogesterone caproate by K-V Pharmaceuticals for 7 years under the Orphan Drug Act and while the compounded version cost $200 per pregnancy, the company initially priced their version at $11,000 per pregnancy.

Yet another well-meaning but perversely applied regulation is the 2006 FDA Unapproved Drug Initiative, designed to bring grandfathered medications (i.e., those that entered the market before the FDA’s 1938 enabling legislation) in line with modern standards. Gynecologists may recall that in 2014, the FDA approved vasopressin for hypotension using this law and Par Pharmaceuticals was given exclusive rights to manufacture this 100-year-old drug. Its price quickly soared from $4 to $138 per vial, a 3,141% increase, triggering acute shortages.

 Other drugs with prices and availability similarly adversely impacted by this Act include epinephrine, ephedrine, colchicine, potassium chloride, and neostigmine. The latter an 80-year-old drug saw its price increase from $3.25 to $80.50 per vial!

Absence of regulation also poses a challenge. Other nations directly negotiate with drug makers to lower costs. In contrast, Medicare makes coverage determinations based on whether a drug is “necessary and reasonable” not on its costs for Parts A & B, which account for about 40% of Medicare drug costs. While Medicare Part D plans can negotiate prices, they use PBMs and have only 20% lower costs.

 Worse yet, because other nations aggressively negotiate drug prices, many US drug makers sell products outside this country at variable cost but charge Americans a premium to cover fixed, variable, and other costs and to generate hefty profits. Allowing drug imports would create a global market instead of compelling US consumers to subsidize other nations’ drug costs. While the Health and Human Services Secretary has had discretion to allow certain imports since 2000, this has never been done. But permitting drug imports is not a panacea because other countries might limit exports to prevent shortages and price increases. Moreover, drug makers could penalize exporting countries (e.g., in 2004, GlaxoSmithKline and Pfizer threatened to limit sales of their drugs to Canadian pharmacies that resold them in the United States).

Suppression of generic competition and generic market distortions

The ability of generic drug manufacturers to compete with brand drug makers can have a dramatic effect on drug prices. On average, the transition to generic status reduces a drug’s cost by 70%.

 However, while generics represent 90% of prescriptions, they account for only 25% of drug costs. Brand drug makers seek to delay the transition to generics by engaging in “product hopping,” the practice of slightly modifying existing drug formulas to obtain new patents and then “ever-greening,” extending exclusivity by removing the original drug from the market. For example, since the 1980s, 

drug makers have tweaked versions of insulin

 that act for either a short or long duration, patenting these innovations along the way such that there are no current generic versions.

 This strategy has led to high prices, large profits, and acute shortages of insulin. 

Brand drug makers can also deny potential generic competitors access to their patented drugs for comparison studies required by the FDA to establish equivalence. Some brand drug makers pay potential generic drug makers to delay production, so called “pay-to-delay” or, as noted, incentivize patients to buy higher-priced brand drugs instead of generics through co-pay coupons. 

But even after a brand drug goes off-patent and generic competition begins, distortions in the market can lead to price gouging. FDA backlogs and high regulatory costs can delay and/or limit other generic drug competitors from entering the market, creating monopolies and drug shortages. The Government Accounting Office (GAO) reports that more than 50% of generic drugs are now produced by a single company.

 Where competition exists, price fixing may occur with the GAO reporting 315 instances of generic drug price increases of more than 100%, and 48 of 1,411 drugs increasing price 500% or more in 1 year. As a result, shortages have occurred among commonly used generic drugs such as heparin, doxycycline, methotrexate, and various cardiac drugs. Forty-five states and Washington, D.C. have filed lawsuits against 18 companies alleging collusion to fix prices on 15 generic medicines.

These market distortions in generic prices have received much media attention. Many readers will remember Martin Shkreli, the CEO of Turing Pharmaceuticals. He 

, a 62-year-old drug used to treat toxoplasmosis in AIDS patients by 5,000%, from $13.50 to $750 per tablet.

 Mylan hiked the price of its EpiPen two-pack from $160 to $600 (with $300 going to a PBM).

 Rodelis Therapeutics bought rights to the tuberculosis drug cycloserine and bumped its price from $500 to $10,800 for 30 capsules.

 While such egregious price increases have received much notoriety, public awareness has not attenuated the practice.

More from Dr. Lockwood: ‘Policing’ pregnant women during the opioid epidemic

 authorized by the Physicians Payment Sunshine Act requires industry to disclose all payments to physicians.

$2.82 billion in general (non-research) payments were made to physicians

 While that figure includes over $1 billion for invention-related royalties and licensing fees, it also includes nearly $500 million in consulting fees, $237 million for food and beverages, and $188 million for travel and lodging. In addition, eight out of 10 patient advocacy groups, which often lobby for a specific drug or device, receive financial support from Pharma which they are not obligated to report.

Industry made 517,077 non-research payments, valued at $80 million to 23,292 (49.7%) ob/gyns between August 1, 2013 and December 31, 2015.

 Subspecialists received larger median payments than generalists ($500 vs. $296); urogynecologists received the largest median dollar amount, maternal-fetal medicine physicians the least. Median payments to ob/gyn subspecialists exceeded payments to orthopedic surgeons, although the latter remain the biggest recipients of overall payments, primarily from royalties or licenses. By contrast, the most common (94%) payments to ob/gyns were for food and beverages, entertainment, and travel.

The extent to which rising drug costs are adversely impacting our economy and threatening the viability of our health care system seems clear. There are many drivers of escalating drug prices, including absence of a true market, high costs of intermediaries, unscrupulous marketing practices, and suppression of generic competition by brand drug makers. Other cost drivers include perverse incentives engendered by flawed government regulations and the inability of Medicare to negotiate drug prices or to permit drug importation. Finally, long-standing symbiotic financial relationships between physicians and drug makers adds yet another layer of incremental costs. While the sheer magnitude of these challenges is daunting, the good news is that there are also many practicable steps that can be taken to enhance medication affordability while preserving the extraordinary level of innovation that the US pharmaceutical industry has achieved. In Part 2 of this editorial, I will describe these solutions. 

American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs https://www.hhs.gov/sites/default/files/AmericanPatientsFirst.pdf  Accessed 4/20/2019

CMS.gov National Health Expenditure Fact Sheet 

https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/nationalhealthexpenddata/nhe-fact-sheet.html

Augustine NR, Madhavan G, Nass SJ (editors) National Academies of Sciences, Engineering, and Medicine. 2018. Making medicines affordable: A national imperative. Washington, DC: The National Academies Press. 

Papanicolas I, Woskie LR, Jha AK. Health care spending in the United States and other high-income countries. 

. 2018 Mar 13;319(10):1024-1039. Erratum in: 

Henry J. Kaiser Family Foundation. Public opinion on prescription drugs and their prices. Published March 1, 2019. 

https://www.kff.org/slideshow/public-opinion-on-prescription-drugs-and-their-prices/

National Public Radio. Drug puts a $750,000 “price tag on life” August 1, 2017 https://www.npr.org/sections/health-shots/2017/08/01/540100976/drug-puts-a-750-000-price-tag-on-life; Accessed 4/20/2019

CNBC A US drugmaker offers to cure rare blindness for $850,000 Jan. 3, 2018 

https://www.cnbc.com/2018/01/03/spark-therapeutics-luxturna-gene-therapy-will-cost-about-850000.html

Fried I, Beam AL, Kohane IS, Palmer NP. Utilization, cost, and outcome of branded vs compounded 17-alpha hydroxyprogesterone caproate in prevention of preterm birth. 

Hakim A, Gupta R, Ross JS. High costs of FDA approval for formerly unapproved marketed drugs. 

Business Insider. Why a lifesaving drug that’s been around since 1923 is still unaffordable.

 https://www.businessinsider.com/why-is-there-no-generic-insulin-for-diabetes-2016-8

The New York Times. Big price increase for tuberculosis drug is rescinded. Sept. 21, 2015. 

https://www.nytimes.com/2015/09/22/business/big-price-increase-for-tb-drug-is-rescinded.html

Policy & Medicine. Open Payments Data 2017: Significant drop in number of payments. 

https://www.policymed.com/2018/07/open-payments-data-2017-shows-significant-drop-in-number-of-payments.html

Muffly TM, Giamberardino WL, Guido J, et al. Industry payments to obstetricians and gynecologists under the Sunshine Act. 

The economic impact of drug costs and how we got here are examined in the first of a two-part series.

Vol 64 No 05

The importance of intervention: When was this baby in trouble?

Fighting back with love

How to optimize imaging in the obese gravida

Pruritus, pain and fissures in a 65-year-old woman

Ensuring medications are more affordable without stifling innovation

Antibiotic prophylaxis and operative vaginal delivery

Barriers to abortion training in ob/gyn residency