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Alternative birthing practices increase risk of infection
All three have been associated with sporadic, serious neonatal infections.
The U.S. prevalence of water births – delivering a baby underwater – is currently unknown, but in the United Kingdom the practice is common. According to a 2015 National Health Service maternity survey, approximately 9% of women who underwent vaginal delivery opted for water birth (Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101[4]:F357-65). Both the Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives endorse this practice for healthy women with uncomplicated term pregnancies. According to a 2009 Cochrane Review, immersion during the first phase of labor reduces the use of epidural/spinal analgesia (Cochrane Database Syst Rev. 2009. doi: 10.1002/14651858.CD000111.pub3). The maternal benefits of delivery under water, though, have not been clearly defined.
Legionella pneumophila is an uncommon pathogen in children, but cases of neonatal Legionnaires’ disease have been reported after water birth. Two affected babies born in Arizona in 2016 were successfully treated and survived (MMWR Morb Mortal Wkly Rep. 2017. doi: 10.15585/mmwr.mm6622a4). A baby born in Texas in 2014 died of sepsis and respiratory failure (Emerg Infect Dis. 2015. doi: 10.3201/eid2101.140846). Canadian investigators have reported fatal disseminated herpes simplex virus infection in an infant after water birth; the mother had herpetic whitlow and a recent blister concerning for HSV on her thigh (J Pediatric Infect Dis Soc. 2017 May 16. doi: 10.1093/jpids/pix035).
Admittedly, each of these cases might have been prevented by adherence to recommended infection control practices, and the absolute risk of infection after water birth is unknown and likely to be small. Still, neither the American Academy of Pediatrics nor the American College of Obstetricians and Gynecologists currently recommend the practice. ACOG suggests that “births occur on land, not in water” and has called for well-designed, prospective studies of the maternal and perinatal benefits and risks associated with immersion during labor and delivery (Obstet Gynecol. 2016;128:1198-9).
Placentophagia – consuming the placenta after birth – has been promoted by celebrity moms, including Katherine Heigl and Kourtney Kardashian. Placenta can be cooked, blended raw into a smoothie, or dehydrated and encapsulated.
Proponents of placentophagia claim health benefits of this practice, including improved mood and energy, and increased breast milk production. There are few published data to support these claims. A recent case report suggests the practice has the potential to harm the baby. In June 2017, Oregon public health authorities described a neonate with recurrent episodes of group B streptococcal (GBS) bacteremia. An identical strain of GBS was cultured from capsules containing the mother’s dehydrated placenta – she had consumed six of the capsules daily beginning a few days after the baby’s birth. According to the Morbidity and Mortality Weekly Report communication, “no standards exist for processing placenta for consumption” and the “placenta encapsulation process does not eradicate infectious pathogens per se. … Placenta capsule ingestion should be avoided”(MMWR Morb Mortal Wkly Rep. 2017;66:677-8. doi: 10.15585/mmwr.mm6625a4).
Finally, the ritual practice of umbilical cord nonseverance or lotus birth deserves a mention. In a lotus birth, the umbilical cord is left uncut, allowing the placenta to remain attached to the baby until the cord dries and naturally separates, generally 3-10 days after delivery. Describing a spiritual connection between the baby and the placenta, proponents claim lotus birth promotes bonding and allows for a gentler transition between intra- and extrauterine life.
A review of PubMed turned up no formal studies of this practice, but case reports describe complications such as neonatal idiopathic hepatitis and neonatal sepsis. The Royal College of Obstetricians and Gynaecologists has issued a warning about lotus births, advising that babies be monitored closely for infection. RCOG spokesperson Dr. Patrick O’Brien said in a 2008 statement, “If left for a period of time after the birth, there is a risk of infection in the placenta which can consequently spread to the baby. The placenta is particularly prone to infection as it contains blood. Within a short time after birth, once the umbilical cord has stopped pulsating, the placenta has no circulation and is essentially dead tissue.”
Interestingly, a quick scan of Etsy, the popular e-commerce website, turned up a number of lotus birth kits for sale. These generally contain a decorative cloth bag as well as an herb mix containing lavender and eucalyptus to promote drying and mask the smell of the decomposing placenta.
In contrast, many pediatricians, me included, are not well informed about these practices and don’t routinely ask expectant moms about their plans. I propose that we can advocate for our patients-to-be by learning about these practices so that we can engage in an honest, respectful discussion about potential risks and benefits. For me, for now, the risks outweigh the benefits.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].
All three have been associated with sporadic, serious neonatal infections.
The U.S. prevalence of water births – delivering a baby underwater – is currently unknown, but in the United Kingdom the practice is common. According to a 2015 National Health Service maternity survey, approximately 9% of women who underwent vaginal delivery opted for water birth (Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101[4]:F357-65). Both the Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives endorse this practice for healthy women with uncomplicated term pregnancies. According to a 2009 Cochrane Review, immersion during the first phase of labor reduces the use of epidural/spinal analgesia (Cochrane Database Syst Rev. 2009. doi: 10.1002/14651858.CD000111.pub3). The maternal benefits of delivery under water, though, have not been clearly defined.
Legionella pneumophila is an uncommon pathogen in children, but cases of neonatal Legionnaires’ disease have been reported after water birth. Two affected babies born in Arizona in 2016 were successfully treated and survived (MMWR Morb Mortal Wkly Rep. 2017. doi: 10.15585/mmwr.mm6622a4). A baby born in Texas in 2014 died of sepsis and respiratory failure (Emerg Infect Dis. 2015. doi: 10.3201/eid2101.140846). Canadian investigators have reported fatal disseminated herpes simplex virus infection in an infant after water birth; the mother had herpetic whitlow and a recent blister concerning for HSV on her thigh (J Pediatric Infect Dis Soc. 2017 May 16. doi: 10.1093/jpids/pix035).
Admittedly, each of these cases might have been prevented by adherence to recommended infection control practices, and the absolute risk of infection after water birth is unknown and likely to be small. Still, neither the American Academy of Pediatrics nor the American College of Obstetricians and Gynecologists currently recommend the practice. ACOG suggests that “births occur on land, not in water” and has called for well-designed, prospective studies of the maternal and perinatal benefits and risks associated with immersion during labor and delivery (Obstet Gynecol. 2016;128:1198-9).
Placentophagia – consuming the placenta after birth – has been promoted by celebrity moms, including Katherine Heigl and Kourtney Kardashian. Placenta can be cooked, blended raw into a smoothie, or dehydrated and encapsulated.
Proponents of placentophagia claim health benefits of this practice, including improved mood and energy, and increased breast milk production. There are few published data to support these claims. A recent case report suggests the practice has the potential to harm the baby. In June 2017, Oregon public health authorities described a neonate with recurrent episodes of group B streptococcal (GBS) bacteremia. An identical strain of GBS was cultured from capsules containing the mother’s dehydrated placenta – she had consumed six of the capsules daily beginning a few days after the baby’s birth. According to the Morbidity and Mortality Weekly Report communication, “no standards exist for processing placenta for consumption” and the “placenta encapsulation process does not eradicate infectious pathogens per se. … Placenta capsule ingestion should be avoided”(MMWR Morb Mortal Wkly Rep. 2017;66:677-8. doi: 10.15585/mmwr.mm6625a4).
Finally, the ritual practice of umbilical cord nonseverance or lotus birth deserves a mention. In a lotus birth, the umbilical cord is left uncut, allowing the placenta to remain attached to the baby until the cord dries and naturally separates, generally 3-10 days after delivery. Describing a spiritual connection between the baby and the placenta, proponents claim lotus birth promotes bonding and allows for a gentler transition between intra- and extrauterine life.
A review of PubMed turned up no formal studies of this practice, but case reports describe complications such as neonatal idiopathic hepatitis and neonatal sepsis. The Royal College of Obstetricians and Gynaecologists has issued a warning about lotus births, advising that babies be monitored closely for infection. RCOG spokesperson Dr. Patrick O’Brien said in a 2008 statement, “If left for a period of time after the birth, there is a risk of infection in the placenta which can consequently spread to the baby. The placenta is particularly prone to infection as it contains blood. Within a short time after birth, once the umbilical cord has stopped pulsating, the placenta has no circulation and is essentially dead tissue.”
Interestingly, a quick scan of Etsy, the popular e-commerce website, turned up a number of lotus birth kits for sale. These generally contain a decorative cloth bag as well as an herb mix containing lavender and eucalyptus to promote drying and mask the smell of the decomposing placenta.
In contrast, many pediatricians, me included, are not well informed about these practices and don’t routinely ask expectant moms about their plans. I propose that we can advocate for our patients-to-be by learning about these practices so that we can engage in an honest, respectful discussion about potential risks and benefits. For me, for now, the risks outweigh the benefits.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].
All three have been associated with sporadic, serious neonatal infections.
The U.S. prevalence of water births – delivering a baby underwater – is currently unknown, but in the United Kingdom the practice is common. According to a 2015 National Health Service maternity survey, approximately 9% of women who underwent vaginal delivery opted for water birth (Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101[4]:F357-65). Both the Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives endorse this practice for healthy women with uncomplicated term pregnancies. According to a 2009 Cochrane Review, immersion during the first phase of labor reduces the use of epidural/spinal analgesia (Cochrane Database Syst Rev. 2009. doi: 10.1002/14651858.CD000111.pub3). The maternal benefits of delivery under water, though, have not been clearly defined.
Legionella pneumophila is an uncommon pathogen in children, but cases of neonatal Legionnaires’ disease have been reported after water birth. Two affected babies born in Arizona in 2016 were successfully treated and survived (MMWR Morb Mortal Wkly Rep. 2017. doi: 10.15585/mmwr.mm6622a4). A baby born in Texas in 2014 died of sepsis and respiratory failure (Emerg Infect Dis. 2015. doi: 10.3201/eid2101.140846). Canadian investigators have reported fatal disseminated herpes simplex virus infection in an infant after water birth; the mother had herpetic whitlow and a recent blister concerning for HSV on her thigh (J Pediatric Infect Dis Soc. 2017 May 16. doi: 10.1093/jpids/pix035).
Admittedly, each of these cases might have been prevented by adherence to recommended infection control practices, and the absolute risk of infection after water birth is unknown and likely to be small. Still, neither the American Academy of Pediatrics nor the American College of Obstetricians and Gynecologists currently recommend the practice. ACOG suggests that “births occur on land, not in water” and has called for well-designed, prospective studies of the maternal and perinatal benefits and risks associated with immersion during labor and delivery (Obstet Gynecol. 2016;128:1198-9).
Placentophagia – consuming the placenta after birth – has been promoted by celebrity moms, including Katherine Heigl and Kourtney Kardashian. Placenta can be cooked, blended raw into a smoothie, or dehydrated and encapsulated.
Proponents of placentophagia claim health benefits of this practice, including improved mood and energy, and increased breast milk production. There are few published data to support these claims. A recent case report suggests the practice has the potential to harm the baby. In June 2017, Oregon public health authorities described a neonate with recurrent episodes of group B streptococcal (GBS) bacteremia. An identical strain of GBS was cultured from capsules containing the mother’s dehydrated placenta – she had consumed six of the capsules daily beginning a few days after the baby’s birth. According to the Morbidity and Mortality Weekly Report communication, “no standards exist for processing placenta for consumption” and the “placenta encapsulation process does not eradicate infectious pathogens per se. … Placenta capsule ingestion should be avoided”(MMWR Morb Mortal Wkly Rep. 2017;66:677-8. doi: 10.15585/mmwr.mm6625a4).
Finally, the ritual practice of umbilical cord nonseverance or lotus birth deserves a mention. In a lotus birth, the umbilical cord is left uncut, allowing the placenta to remain attached to the baby until the cord dries and naturally separates, generally 3-10 days after delivery. Describing a spiritual connection between the baby and the placenta, proponents claim lotus birth promotes bonding and allows for a gentler transition between intra- and extrauterine life.
A review of PubMed turned up no formal studies of this practice, but case reports describe complications such as neonatal idiopathic hepatitis and neonatal sepsis. The Royal College of Obstetricians and Gynaecologists has issued a warning about lotus births, advising that babies be monitored closely for infection. RCOG spokesperson Dr. Patrick O’Brien said in a 2008 statement, “If left for a period of time after the birth, there is a risk of infection in the placenta which can consequently spread to the baby. The placenta is particularly prone to infection as it contains blood. Within a short time after birth, once the umbilical cord has stopped pulsating, the placenta has no circulation and is essentially dead tissue.”
Interestingly, a quick scan of Etsy, the popular e-commerce website, turned up a number of lotus birth kits for sale. These generally contain a decorative cloth bag as well as an herb mix containing lavender and eucalyptus to promote drying and mask the smell of the decomposing placenta.
In contrast, many pediatricians, me included, are not well informed about these practices and don’t routinely ask expectant moms about their plans. I propose that we can advocate for our patients-to-be by learning about these practices so that we can engage in an honest, respectful discussion about potential risks and benefits. For me, for now, the risks outweigh the benefits.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].
Cannabis shows inconsistent benefits for pain, PTSD
Chronic pain and posttraumatic stress disorder are among the top reasons given by patients seeking medical marijuana in states where it is legal, but there is little scientific evidence to support its value for treating either condition, based on the results of a pair of systemic evidence reviews conducted by the U.S. Department of Veterans Affairs.
The findings were published online Aug. 14 in the Annals of Internal Medicine.
In the PTSD study, Maya E. O’Neil, PhD, of the VA Portland (Ore.) Health Care System, and colleagues found no significant evidence to support the effectiveness of cannabis for relieving symptoms (Ann Intern Med. 2017 Aug 14. doi: 10.7326/M17-0477). The researchers reviewed data from two systematic reviews and three primary studies.
One of the larger studies (included in one of the systematic reviews) included 47,000 veterans in VA intensive PTSD programs during 1992-2011. In fact, after controlling for demographic factors and other confounding variables, individuals who continued to use cannabis or started using cannabis showed worse PTSD symptoms than did nonusers after 4 months.
“Findings from [randomized, controlled trials] are needed to help determine whether and to what extent cannabis may improve PTSD symptoms, and further studies also are needed to clarify harms in patients with PTSD,” the researchers noted.
In the review of chronic pain literature, Shannon M. Nugent, PhD, also of the VA Portland (Ore.) Health Care System, and her colleagues examined 27 trials, 11 reviews, and 32 primary studies (Ann Intern Med. 2017 Aug 14. doi: 10.7326/M17-0155).
“Across nine studies, intervention patients were more likely to report at least 30% improvement in pain,” the investigators said. But this finding was specific to tetrahydrocannabinol (THC), the researchers said, and evidence of the ability of cannabis to relieve other types of pain, such as cancer pain and multiple sclerosis pain, was insufficient.
In addition, the researchers found a low strength of evidence association between cannabis use and the development of psychotic symptoms, and a moderate strength of evidence association between cannabis use and impaired cognitive function in the general population. “However, our confidence in the findings is limited by inconsistent findings among included studies, inadequate assessment of exposure, and inadequate adjustment for confounding among the studies” they said.
Although no significant differences were noted in rates of adverse events between cannabis users and nonusers, some data suggested users had an increased risk for short-term adverse events that ranged from dizziness to paranoia and suicide attempts.
Other potential harms associated with cannabis use included decreased lung function, increased risk of complications from infectious diseases, cannabis hyperemesis syndrome, and increased risk of violent behavior.
“Even though we did not find strong, consistent evidence of benefit, clinicians will still need to engage in evidence-based discussions with patients managing chronic pain who are using or requesting to use cannabis,” the researchers wrote.
The researchers had no financial conflicts to disclose. The study was commissioned by the Veterans Health Administration.
“The systematic reviews highlight an alarming lack of high-quality data from which to draw firm conclusions about the efficacy of cannabis for these conditions, for which cannabis is both sanctioned and commonly used,” wrote Sachin Patel, MD, PhD, in an accompanying editorial (Ann Intern Med. 2017 Aug 14. doi: 10.7326/M17-1713).
“Even if future studies reveal a clear lack of substantial benefit of cannabis for pain or PTSD, legislation is unlikely to remove these conditions from the lists of indications for medical cannabis,” he cautioned. “It will be up to front-line practicing physicians to learn about the harms and benefits of cannabis, educate their patients on these topics, and make evidence-based recommendations about using cannabis and related products for various health conditions.
“In parallel, the research community must pursue high-quality studies and disseminate the results to clinicians and the public. In this context, these reviews are must-reads for all physicians, especially those practicing in states where medical cannabis is legal,” Dr. Patel added.
Dr. Patel is affiliated with Vanderbilt Psychiatric Hospital in Nashville, Tenn. He had no relevant financial conflicts to disclose, but reported receiving grants from Lundbeck.
“The systematic reviews highlight an alarming lack of high-quality data from which to draw firm conclusions about the efficacy of cannabis for these conditions, for which cannabis is both sanctioned and commonly used,” wrote Sachin Patel, MD, PhD, in an accompanying editorial (Ann Intern Med. 2017 Aug 14. doi: 10.7326/M17-1713).
“Even if future studies reveal a clear lack of substantial benefit of cannabis for pain or PTSD, legislation is unlikely to remove these conditions from the lists of indications for medical cannabis,” he cautioned. “It will be up to front-line practicing physicians to learn about the harms and benefits of cannabis, educate their patients on these topics, and make evidence-based recommendations about using cannabis and related products for various health conditions.
“In parallel, the research community must pursue high-quality studies and disseminate the results to clinicians and the public. In this context, these reviews are must-reads for all physicians, especially those practicing in states where medical cannabis is legal,” Dr. Patel added.
Dr. Patel is affiliated with Vanderbilt Psychiatric Hospital in Nashville, Tenn. He had no relevant financial conflicts to disclose, but reported receiving grants from Lundbeck.
“The systematic reviews highlight an alarming lack of high-quality data from which to draw firm conclusions about the efficacy of cannabis for these conditions, for which cannabis is both sanctioned and commonly used,” wrote Sachin Patel, MD, PhD, in an accompanying editorial (Ann Intern Med. 2017 Aug 14. doi: 10.7326/M17-1713).
“Even if future studies reveal a clear lack of substantial benefit of cannabis for pain or PTSD, legislation is unlikely to remove these conditions from the lists of indications for medical cannabis,” he cautioned. “It will be up to front-line practicing physicians to learn about the harms and benefits of cannabis, educate their patients on these topics, and make evidence-based recommendations about using cannabis and related products for various health conditions.
“In parallel, the research community must pursue high-quality studies and disseminate the results to clinicians and the public. In this context, these reviews are must-reads for all physicians, especially those practicing in states where medical cannabis is legal,” Dr. Patel added.
Dr. Patel is affiliated with Vanderbilt Psychiatric Hospital in Nashville, Tenn. He had no relevant financial conflicts to disclose, but reported receiving grants from Lundbeck.
Chronic pain and posttraumatic stress disorder are among the top reasons given by patients seeking medical marijuana in states where it is legal, but there is little scientific evidence to support its value for treating either condition, based on the results of a pair of systemic evidence reviews conducted by the U.S. Department of Veterans Affairs.
The findings were published online Aug. 14 in the Annals of Internal Medicine.
In the PTSD study, Maya E. O’Neil, PhD, of the VA Portland (Ore.) Health Care System, and colleagues found no significant evidence to support the effectiveness of cannabis for relieving symptoms (Ann Intern Med. 2017 Aug 14. doi: 10.7326/M17-0477). The researchers reviewed data from two systematic reviews and three primary studies.
One of the larger studies (included in one of the systematic reviews) included 47,000 veterans in VA intensive PTSD programs during 1992-2011. In fact, after controlling for demographic factors and other confounding variables, individuals who continued to use cannabis or started using cannabis showed worse PTSD symptoms than did nonusers after 4 months.
“Findings from [randomized, controlled trials] are needed to help determine whether and to what extent cannabis may improve PTSD symptoms, and further studies also are needed to clarify harms in patients with PTSD,” the researchers noted.
In the review of chronic pain literature, Shannon M. Nugent, PhD, also of the VA Portland (Ore.) Health Care System, and her colleagues examined 27 trials, 11 reviews, and 32 primary studies (Ann Intern Med. 2017 Aug 14. doi: 10.7326/M17-0155).
“Across nine studies, intervention patients were more likely to report at least 30% improvement in pain,” the investigators said. But this finding was specific to tetrahydrocannabinol (THC), the researchers said, and evidence of the ability of cannabis to relieve other types of pain, such as cancer pain and multiple sclerosis pain, was insufficient.
In addition, the researchers found a low strength of evidence association between cannabis use and the development of psychotic symptoms, and a moderate strength of evidence association between cannabis use and impaired cognitive function in the general population. “However, our confidence in the findings is limited by inconsistent findings among included studies, inadequate assessment of exposure, and inadequate adjustment for confounding among the studies” they said.
Although no significant differences were noted in rates of adverse events between cannabis users and nonusers, some data suggested users had an increased risk for short-term adverse events that ranged from dizziness to paranoia and suicide attempts.
Other potential harms associated with cannabis use included decreased lung function, increased risk of complications from infectious diseases, cannabis hyperemesis syndrome, and increased risk of violent behavior.
“Even though we did not find strong, consistent evidence of benefit, clinicians will still need to engage in evidence-based discussions with patients managing chronic pain who are using or requesting to use cannabis,” the researchers wrote.
The researchers had no financial conflicts to disclose. The study was commissioned by the Veterans Health Administration.
Chronic pain and posttraumatic stress disorder are among the top reasons given by patients seeking medical marijuana in states where it is legal, but there is little scientific evidence to support its value for treating either condition, based on the results of a pair of systemic evidence reviews conducted by the U.S. Department of Veterans Affairs.
The findings were published online Aug. 14 in the Annals of Internal Medicine.
In the PTSD study, Maya E. O’Neil, PhD, of the VA Portland (Ore.) Health Care System, and colleagues found no significant evidence to support the effectiveness of cannabis for relieving symptoms (Ann Intern Med. 2017 Aug 14. doi: 10.7326/M17-0477). The researchers reviewed data from two systematic reviews and three primary studies.
One of the larger studies (included in one of the systematic reviews) included 47,000 veterans in VA intensive PTSD programs during 1992-2011. In fact, after controlling for demographic factors and other confounding variables, individuals who continued to use cannabis or started using cannabis showed worse PTSD symptoms than did nonusers after 4 months.
“Findings from [randomized, controlled trials] are needed to help determine whether and to what extent cannabis may improve PTSD symptoms, and further studies also are needed to clarify harms in patients with PTSD,” the researchers noted.
In the review of chronic pain literature, Shannon M. Nugent, PhD, also of the VA Portland (Ore.) Health Care System, and her colleagues examined 27 trials, 11 reviews, and 32 primary studies (Ann Intern Med. 2017 Aug 14. doi: 10.7326/M17-0155).
“Across nine studies, intervention patients were more likely to report at least 30% improvement in pain,” the investigators said. But this finding was specific to tetrahydrocannabinol (THC), the researchers said, and evidence of the ability of cannabis to relieve other types of pain, such as cancer pain and multiple sclerosis pain, was insufficient.
In addition, the researchers found a low strength of evidence association between cannabis use and the development of psychotic symptoms, and a moderate strength of evidence association between cannabis use and impaired cognitive function in the general population. “However, our confidence in the findings is limited by inconsistent findings among included studies, inadequate assessment of exposure, and inadequate adjustment for confounding among the studies” they said.
Although no significant differences were noted in rates of adverse events between cannabis users and nonusers, some data suggested users had an increased risk for short-term adverse events that ranged from dizziness to paranoia and suicide attempts.
Other potential harms associated with cannabis use included decreased lung function, increased risk of complications from infectious diseases, cannabis hyperemesis syndrome, and increased risk of violent behavior.
“Even though we did not find strong, consistent evidence of benefit, clinicians will still need to engage in evidence-based discussions with patients managing chronic pain who are using or requesting to use cannabis,” the researchers wrote.
The researchers had no financial conflicts to disclose. The study was commissioned by the Veterans Health Administration.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point:
Major finding: One study of cannabis use for neuropathic pain showed an approximately 30% improvement in pain, but researchers found no significant impact on relieving other types of chronic pain or PTSD symptoms.
Data source: The data come from a chronic pain review that included 27 trials, 11 systematic reviews, and 32 primary studies; and a PTSD review that included 2 systematic reviews and 3 primary studies.
Disclosures: The researchers had no financial conflicts to disclose. The study was commissioned by the Veterans Health Administration.
Climbing cost of decades-old drugs threatens to break Medicaid bank
Skyrocketing price tags for new drugs to treat rare diseases have stoked outrage nationwide. But hundreds of old, commonly used drugs cost the Medicaid program billions of extra dollars in 2016 vs. 2015, a Kaiser Health News data analysis shows. Eighty of the drugs – some generic and some still carrying brand names – proved more than 2 decades old.
Rising costs for 313 brand-name drugs lifted Medicaid’s spending by as much as $3.2 billion in 2016, the analysis shows. Nine of these brand-name drugs have been on the market since before 1970. In addition, the data reveal that Medicaid outlays for 67 generics and other nonbranded drugs cost taxpayers an extra $258 million last year.
Even after a medicine has gone generic, the branded version often remains on the market. Medicaid recipients might choose to purchase it because they’re brand loyalists or because state laws prevent pharmacists from automatically substituting generics. Drugs driving Medicaid spending increases ranged from common asthma medicines like Ventolin to over-the-counter painkillers such as the generic form of Aleve to generic antidepressants and heartburn medicines.
Among the stark examples:
- Ventolin, originally approved in 1981, treats and prevents spasms that constrict patients’ airways and make it difficult to breathe. When a gram of it went from $2.58 to $2.90 on average, Medicaid paid out an extra $54.5 million for the drug.
- Naproxen sodium, a painkiller originally approved in 1994 as brand-name Aleve, went from costing Medicaid an average of $0.72 to $1.70 a pill, an increase of 136%. Overall, the change cost the program an extra $10 million in 2016.
- Generic metformin hydrochloride, an oral type 2 diabetes drug that’s been around since the 1990s, went from an average 10 cents to 13 cents a pill from 2015 to 2016. Those extra 3 pennies per pill cost Medicaid a combined $8.3 million in 2016. And cost increases for the extended-release, authorized generic version cost the program another $6.5 million.
“People always thought, ‘They’re generics. They’re cheap,’ ” said Matt Salo, who runs the National Association of Medicaid Directors. But with drug prices going up “across the board,” generics are far from immune.
Historically, generics tend to drive costs lower over time, and Medicaid’s overall spending on generics dropped $1.6 billion last year because many generics did get cheaper. But the per-unit cost of dozens of generics doubled or even tripled from 2015 to 2016. Manufacturers of branded drugs tend to lower prices once several comparable generics enter a market.
Medicaid tracks drug sales by “units” and a unit can be a milliliter or a gram, or refer to a tablet, vial, or kit.
Old drugs that became far more expensive included those used to treat ear infections, psychosis, cancer, and other ailments:
- Fluphenazine hydrochloride, an antipsychotic drug approved in 1988 to treat schizophrenia, cost Medicaid an extra $8.5 million in 2016. Medicaid spent an average $1.39 per unit in 2016, an increase of 347% versus the year before.
- Depo-Provera was first approved in 1960 as a cancer drug and is often used now as birth control. It cost Medicaid an extra $4.5 million after its cost more than doubled to $37 per unit in 2016.
- Potassium phosphates – on the market since the 1980s and used for renal failure patients, preemies, and patients undergoing chemotherapy – cost Medicaid an extra $1.8 million in 2016. Its average cost to Medicaid jumped 290%, to $6.70 per unit.
A shortage of potassium phosphates began in 2015 after manufacturer American Regent closed its facility to address quality concerns, according to Erin Fox, PharmD, who directs the Drug Information Center at the University of Utah, Salt Lake City, and tracks shortages for the American Society of Health-System Pharmacists.
When generics enter a market, competition can drive prices lower initially. But, when prices sink, some companies inevitably stop making their drugs.
“One manufacturer is left standing … [so] guess who now has a monopoly?” Mr. Salo said. “Guess who can bring prices as far up as they want?”
According to a Food and Drug Administration analysis, drug prices decline to about half of their original price with two generic competitors on the market and to about a third of the original price with five generics available. But, if there’s only one generic, a drug’s price drops just 6 percentage points.
The increases paid by Medicaid ultimately fall on taxpayers, who pay for the drugs taken by its 68.9 million beneficiaries. And those costs eat “into states’ ability to pay for other stuff that matters to [every] resident,” said economist Rena Conti, PhD, a professor at the University of Chicago who coauthored a National Bureau of Economics paper about generic price hikes in July. The manufacturers’ list prices for the drugs named here also rose in 2016, according to Truven Health Analytics, which means customers outside Medicaid also paid more.
Ms. Conti said that about 30% of generic drugs had price increases of 100% or more the past 5 years.
Medicaid spending per unit doesn’t include rebates, which drug manufacturers return to states after they pay for the drugs upfront. Such rebates are extremely complicated, but generally start at the federally required 23.1% for brand-name drugs, plus supplemental rebates that vary by state, Mr. Salo said. Final rebate amounts are considered proprietary, he noted. “All rebates are completely opaque” … it’s “black-box stuff.”
Dr. Fox said drug prices also could jump when a pharmaceutical product changes ownership, gets new packaging, or just hasn’t had a price increase in a long time.
Recently named FDA Commissioner Scott Gottlieb, MD, has made increasing generic competition a core mission. Plans include publishing lists of off-patent drugs made by one manufacturer and preventing brand-name drugmakers from using anticompetitive tactics to stave off competition.
Doctors, pharmacists, and patients don’t always receive warning when a price hike is about to occur, Dr. Fox said.
“Sometimes, we will get notices. Other times, it’s like a bad surprise,” she said, adding that the amount of wiggle room for alternatives depends on the drug and the patient.
Following some price hikes, doctors can use fewer units of a drug or switch it out entirely, she said.
Ofloxacin otic, long used to treat swimmer’s ear, became so expensive when generic manufacturers exited the market that doctors started using eye drops in patients’ ears, Dr. Fox said.
When old drugs get more expensive, hospitals try to eliminate waste by making smaller infusion bags and keeping really expensive drugs in the pharmacy instead of stocked in readily available shelves and drawers. But that’s not always possible.
“These drugs do have a place in daily therapy. Sometimes they’re life-sustaining and sometimes they’re lifesaving,” said Michael O’Neal, a pharmacist at Vanderbilt University Medical Center, Nashville, Tenn. “In this case, you just need to take it on the chin, and you hope one day for competition.”
KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Skyrocketing price tags for new drugs to treat rare diseases have stoked outrage nationwide. But hundreds of old, commonly used drugs cost the Medicaid program billions of extra dollars in 2016 vs. 2015, a Kaiser Health News data analysis shows. Eighty of the drugs – some generic and some still carrying brand names – proved more than 2 decades old.
Rising costs for 313 brand-name drugs lifted Medicaid’s spending by as much as $3.2 billion in 2016, the analysis shows. Nine of these brand-name drugs have been on the market since before 1970. In addition, the data reveal that Medicaid outlays for 67 generics and other nonbranded drugs cost taxpayers an extra $258 million last year.
Even after a medicine has gone generic, the branded version often remains on the market. Medicaid recipients might choose to purchase it because they’re brand loyalists or because state laws prevent pharmacists from automatically substituting generics. Drugs driving Medicaid spending increases ranged from common asthma medicines like Ventolin to over-the-counter painkillers such as the generic form of Aleve to generic antidepressants and heartburn medicines.
Among the stark examples:
- Ventolin, originally approved in 1981, treats and prevents spasms that constrict patients’ airways and make it difficult to breathe. When a gram of it went from $2.58 to $2.90 on average, Medicaid paid out an extra $54.5 million for the drug.
- Naproxen sodium, a painkiller originally approved in 1994 as brand-name Aleve, went from costing Medicaid an average of $0.72 to $1.70 a pill, an increase of 136%. Overall, the change cost the program an extra $10 million in 2016.
- Generic metformin hydrochloride, an oral type 2 diabetes drug that’s been around since the 1990s, went from an average 10 cents to 13 cents a pill from 2015 to 2016. Those extra 3 pennies per pill cost Medicaid a combined $8.3 million in 2016. And cost increases for the extended-release, authorized generic version cost the program another $6.5 million.
“People always thought, ‘They’re generics. They’re cheap,’ ” said Matt Salo, who runs the National Association of Medicaid Directors. But with drug prices going up “across the board,” generics are far from immune.
Historically, generics tend to drive costs lower over time, and Medicaid’s overall spending on generics dropped $1.6 billion last year because many generics did get cheaper. But the per-unit cost of dozens of generics doubled or even tripled from 2015 to 2016. Manufacturers of branded drugs tend to lower prices once several comparable generics enter a market.
Medicaid tracks drug sales by “units” and a unit can be a milliliter or a gram, or refer to a tablet, vial, or kit.
Old drugs that became far more expensive included those used to treat ear infections, psychosis, cancer, and other ailments:
- Fluphenazine hydrochloride, an antipsychotic drug approved in 1988 to treat schizophrenia, cost Medicaid an extra $8.5 million in 2016. Medicaid spent an average $1.39 per unit in 2016, an increase of 347% versus the year before.
- Depo-Provera was first approved in 1960 as a cancer drug and is often used now as birth control. It cost Medicaid an extra $4.5 million after its cost more than doubled to $37 per unit in 2016.
- Potassium phosphates – on the market since the 1980s and used for renal failure patients, preemies, and patients undergoing chemotherapy – cost Medicaid an extra $1.8 million in 2016. Its average cost to Medicaid jumped 290%, to $6.70 per unit.
A shortage of potassium phosphates began in 2015 after manufacturer American Regent closed its facility to address quality concerns, according to Erin Fox, PharmD, who directs the Drug Information Center at the University of Utah, Salt Lake City, and tracks shortages for the American Society of Health-System Pharmacists.
When generics enter a market, competition can drive prices lower initially. But, when prices sink, some companies inevitably stop making their drugs.
“One manufacturer is left standing … [so] guess who now has a monopoly?” Mr. Salo said. “Guess who can bring prices as far up as they want?”
According to a Food and Drug Administration analysis, drug prices decline to about half of their original price with two generic competitors on the market and to about a third of the original price with five generics available. But, if there’s only one generic, a drug’s price drops just 6 percentage points.
The increases paid by Medicaid ultimately fall on taxpayers, who pay for the drugs taken by its 68.9 million beneficiaries. And those costs eat “into states’ ability to pay for other stuff that matters to [every] resident,” said economist Rena Conti, PhD, a professor at the University of Chicago who coauthored a National Bureau of Economics paper about generic price hikes in July. The manufacturers’ list prices for the drugs named here also rose in 2016, according to Truven Health Analytics, which means customers outside Medicaid also paid more.
Ms. Conti said that about 30% of generic drugs had price increases of 100% or more the past 5 years.
Medicaid spending per unit doesn’t include rebates, which drug manufacturers return to states after they pay for the drugs upfront. Such rebates are extremely complicated, but generally start at the federally required 23.1% for brand-name drugs, plus supplemental rebates that vary by state, Mr. Salo said. Final rebate amounts are considered proprietary, he noted. “All rebates are completely opaque” … it’s “black-box stuff.”
Dr. Fox said drug prices also could jump when a pharmaceutical product changes ownership, gets new packaging, or just hasn’t had a price increase in a long time.
Recently named FDA Commissioner Scott Gottlieb, MD, has made increasing generic competition a core mission. Plans include publishing lists of off-patent drugs made by one manufacturer and preventing brand-name drugmakers from using anticompetitive tactics to stave off competition.
Doctors, pharmacists, and patients don’t always receive warning when a price hike is about to occur, Dr. Fox said.
“Sometimes, we will get notices. Other times, it’s like a bad surprise,” she said, adding that the amount of wiggle room for alternatives depends on the drug and the patient.
Following some price hikes, doctors can use fewer units of a drug or switch it out entirely, she said.
Ofloxacin otic, long used to treat swimmer’s ear, became so expensive when generic manufacturers exited the market that doctors started using eye drops in patients’ ears, Dr. Fox said.
When old drugs get more expensive, hospitals try to eliminate waste by making smaller infusion bags and keeping really expensive drugs in the pharmacy instead of stocked in readily available shelves and drawers. But that’s not always possible.
“These drugs do have a place in daily therapy. Sometimes they’re life-sustaining and sometimes they’re lifesaving,” said Michael O’Neal, a pharmacist at Vanderbilt University Medical Center, Nashville, Tenn. “In this case, you just need to take it on the chin, and you hope one day for competition.”
KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Skyrocketing price tags for new drugs to treat rare diseases have stoked outrage nationwide. But hundreds of old, commonly used drugs cost the Medicaid program billions of extra dollars in 2016 vs. 2015, a Kaiser Health News data analysis shows. Eighty of the drugs – some generic and some still carrying brand names – proved more than 2 decades old.
Rising costs for 313 brand-name drugs lifted Medicaid’s spending by as much as $3.2 billion in 2016, the analysis shows. Nine of these brand-name drugs have been on the market since before 1970. In addition, the data reveal that Medicaid outlays for 67 generics and other nonbranded drugs cost taxpayers an extra $258 million last year.
Even after a medicine has gone generic, the branded version often remains on the market. Medicaid recipients might choose to purchase it because they’re brand loyalists or because state laws prevent pharmacists from automatically substituting generics. Drugs driving Medicaid spending increases ranged from common asthma medicines like Ventolin to over-the-counter painkillers such as the generic form of Aleve to generic antidepressants and heartburn medicines.
Among the stark examples:
- Ventolin, originally approved in 1981, treats and prevents spasms that constrict patients’ airways and make it difficult to breathe. When a gram of it went from $2.58 to $2.90 on average, Medicaid paid out an extra $54.5 million for the drug.
- Naproxen sodium, a painkiller originally approved in 1994 as brand-name Aleve, went from costing Medicaid an average of $0.72 to $1.70 a pill, an increase of 136%. Overall, the change cost the program an extra $10 million in 2016.
- Generic metformin hydrochloride, an oral type 2 diabetes drug that’s been around since the 1990s, went from an average 10 cents to 13 cents a pill from 2015 to 2016. Those extra 3 pennies per pill cost Medicaid a combined $8.3 million in 2016. And cost increases for the extended-release, authorized generic version cost the program another $6.5 million.
“People always thought, ‘They’re generics. They’re cheap,’ ” said Matt Salo, who runs the National Association of Medicaid Directors. But with drug prices going up “across the board,” generics are far from immune.
Historically, generics tend to drive costs lower over time, and Medicaid’s overall spending on generics dropped $1.6 billion last year because many generics did get cheaper. But the per-unit cost of dozens of generics doubled or even tripled from 2015 to 2016. Manufacturers of branded drugs tend to lower prices once several comparable generics enter a market.
Medicaid tracks drug sales by “units” and a unit can be a milliliter or a gram, or refer to a tablet, vial, or kit.
Old drugs that became far more expensive included those used to treat ear infections, psychosis, cancer, and other ailments:
- Fluphenazine hydrochloride, an antipsychotic drug approved in 1988 to treat schizophrenia, cost Medicaid an extra $8.5 million in 2016. Medicaid spent an average $1.39 per unit in 2016, an increase of 347% versus the year before.
- Depo-Provera was first approved in 1960 as a cancer drug and is often used now as birth control. It cost Medicaid an extra $4.5 million after its cost more than doubled to $37 per unit in 2016.
- Potassium phosphates – on the market since the 1980s and used for renal failure patients, preemies, and patients undergoing chemotherapy – cost Medicaid an extra $1.8 million in 2016. Its average cost to Medicaid jumped 290%, to $6.70 per unit.
A shortage of potassium phosphates began in 2015 after manufacturer American Regent closed its facility to address quality concerns, according to Erin Fox, PharmD, who directs the Drug Information Center at the University of Utah, Salt Lake City, and tracks shortages for the American Society of Health-System Pharmacists.
When generics enter a market, competition can drive prices lower initially. But, when prices sink, some companies inevitably stop making their drugs.
“One manufacturer is left standing … [so] guess who now has a monopoly?” Mr. Salo said. “Guess who can bring prices as far up as they want?”
According to a Food and Drug Administration analysis, drug prices decline to about half of their original price with two generic competitors on the market and to about a third of the original price with five generics available. But, if there’s only one generic, a drug’s price drops just 6 percentage points.
The increases paid by Medicaid ultimately fall on taxpayers, who pay for the drugs taken by its 68.9 million beneficiaries. And those costs eat “into states’ ability to pay for other stuff that matters to [every] resident,” said economist Rena Conti, PhD, a professor at the University of Chicago who coauthored a National Bureau of Economics paper about generic price hikes in July. The manufacturers’ list prices for the drugs named here also rose in 2016, according to Truven Health Analytics, which means customers outside Medicaid also paid more.
Ms. Conti said that about 30% of generic drugs had price increases of 100% or more the past 5 years.
Medicaid spending per unit doesn’t include rebates, which drug manufacturers return to states after they pay for the drugs upfront. Such rebates are extremely complicated, but generally start at the federally required 23.1% for brand-name drugs, plus supplemental rebates that vary by state, Mr. Salo said. Final rebate amounts are considered proprietary, he noted. “All rebates are completely opaque” … it’s “black-box stuff.”
Dr. Fox said drug prices also could jump when a pharmaceutical product changes ownership, gets new packaging, or just hasn’t had a price increase in a long time.
Recently named FDA Commissioner Scott Gottlieb, MD, has made increasing generic competition a core mission. Plans include publishing lists of off-patent drugs made by one manufacturer and preventing brand-name drugmakers from using anticompetitive tactics to stave off competition.
Doctors, pharmacists, and patients don’t always receive warning when a price hike is about to occur, Dr. Fox said.
“Sometimes, we will get notices. Other times, it’s like a bad surprise,” she said, adding that the amount of wiggle room for alternatives depends on the drug and the patient.
Following some price hikes, doctors can use fewer units of a drug or switch it out entirely, she said.
Ofloxacin otic, long used to treat swimmer’s ear, became so expensive when generic manufacturers exited the market that doctors started using eye drops in patients’ ears, Dr. Fox said.
When old drugs get more expensive, hospitals try to eliminate waste by making smaller infusion bags and keeping really expensive drugs in the pharmacy instead of stocked in readily available shelves and drawers. But that’s not always possible.
“These drugs do have a place in daily therapy. Sometimes they’re life-sustaining and sometimes they’re lifesaving,” said Michael O’Neal, a pharmacist at Vanderbilt University Medical Center, Nashville, Tenn. “In this case, you just need to take it on the chin, and you hope one day for competition.”
KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
End-of-life advice: More than 500,000 chat on Medicare’s dime
The 90-year-old woman in the San Diego–area nursing home was quite clear, said Karl Steinberg, MD. She didn’t want aggressive measures to prolong her life. If her heart stopped, she didn’t want CPR.
But when Dr. Steinberg, a palliative care physician, relayed those wishes to the woman’s daughter, the younger woman would have none of it.
“She said, ‘I don’t agree with that. My mom is confused,’ ” Steinberg recalled. “I said, ‘Let’s talk about it.’ ”
Instead of arguing, Dr. Steinberg used an increasingly popular tool to resolve the impasse last month. He brought mother and daughter together for an advance-care planning session, an end-of-life consultation that’s now being paid for by Medicare.
In 2016, the first year that health care providers were allowed to bill for the service, nearly 575,000 Medicare beneficiaries took part in the conversations, new federal data obtained by Kaiser Health News show.
Nearly 23,000 providers submitted about $93 million in charges, including more than $43 million covered by the federal program for seniors and the disabled.
Use was much higher than expected, nearly double the 300,000 people that the American Medical Association projected would use the service in the first year.
That’s good news to proponents of the sessions, which focus on understanding and documenting treatment preferences for people nearing the end of their lives. Patients – and often their families – discuss with a doctor or other provider what kind of care they want if they’re unable to make decisions themselves.
“I think it’s great that half a million people talked with their doctors last year. That’s a good thing,” said Paul Malley, president of Aging with Dignity, a Florida nonprofit that promotes end-of-life discussions. “Physician practices are learning. My guess is that it will increase each year.”
Still, only a fraction of eligible Medicare providers – and patients – have used the benefit, which pays about $86 for the first 30-minute office visit and about $75 for additional sessions.
Nationwide, slightly more than 1% of the more than 56 million Medicare beneficiaries enrolled at the end of 2016 received advance-care planning talks, according to calculations by health policy analysts at Duke University, Durham, N.C. But use varied widely among states, from 0.2% of Alaska Medicare recipients to 2.49% of those enrolled in the program in Hawaii.
“There’s tremendous variation by state. That’s the first thing that jumps out,” said Donald Taylor Jr., a Duke professor of public policy.
In part, that’s because many providers, especially primary care doctors, aren’t aware that the Medicare reimbursement agreement, approved in 2015, has taken effect.
“Some physicians don’t know that this is a service,” said Barbie Hays, a Medicare coding and compliance strategist for the American Academy of Family Physicians. “They don’t know how to get paid for it. One of the struggles here is we’re trying to get this message out to our members.”
There also may be lingering controversy over the sessions, which were famously decried as “death panels” during the 2009 debate about the Affordable Care Act. Earlier this year, the issue resurfaced in Congress, where Rep. Steve King (R-Iowa) introduced the Protecting Life Until Natural Death Act, which would halt Medicare reimbursement for advance-care planning appointments.
Mr. King said the move was financially motivated and not in the interest of Americans “who were promised life-sustaining care in their older years.”
Proponents like Dr. Steinberg, however, contend that informed decisions, not cost savings, are the point of the new policy.
“It’s really important to say the reason for this isn’t to save money, although that may be a side benefit, but it’s really about person-centered care,” he said. “It’s about taking the time when people are ill or even when they’re not ill to talk about what their values are. To talk about what constitutes an acceptable versus an unacceptable quality of life.”
That’s just the discussion that the San Diego nursing home resident was able to have with her daughter, Dr. Steinberg said. The 90-year-old was able to say why she didn’t want CPR or to be intubated if she became seriously ill.
“I believe it brought the two of them closer,” Dr. Steinberg said. Even though the daughter didn’t necessarily hear what she wanted to hear. It was like, “You may not agree with your mom, but she’s your mom, and if she doesn’t want somebody beating her chest or ramming a tube down her throat, that’s her decision.”
KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
The 90-year-old woman in the San Diego–area nursing home was quite clear, said Karl Steinberg, MD. She didn’t want aggressive measures to prolong her life. If her heart stopped, she didn’t want CPR.
But when Dr. Steinberg, a palliative care physician, relayed those wishes to the woman’s daughter, the younger woman would have none of it.
“She said, ‘I don’t agree with that. My mom is confused,’ ” Steinberg recalled. “I said, ‘Let’s talk about it.’ ”
Instead of arguing, Dr. Steinberg used an increasingly popular tool to resolve the impasse last month. He brought mother and daughter together for an advance-care planning session, an end-of-life consultation that’s now being paid for by Medicare.
In 2016, the first year that health care providers were allowed to bill for the service, nearly 575,000 Medicare beneficiaries took part in the conversations, new federal data obtained by Kaiser Health News show.
Nearly 23,000 providers submitted about $93 million in charges, including more than $43 million covered by the federal program for seniors and the disabled.
Use was much higher than expected, nearly double the 300,000 people that the American Medical Association projected would use the service in the first year.
That’s good news to proponents of the sessions, which focus on understanding and documenting treatment preferences for people nearing the end of their lives. Patients – and often their families – discuss with a doctor or other provider what kind of care they want if they’re unable to make decisions themselves.
“I think it’s great that half a million people talked with their doctors last year. That’s a good thing,” said Paul Malley, president of Aging with Dignity, a Florida nonprofit that promotes end-of-life discussions. “Physician practices are learning. My guess is that it will increase each year.”
Still, only a fraction of eligible Medicare providers – and patients – have used the benefit, which pays about $86 for the first 30-minute office visit and about $75 for additional sessions.
Nationwide, slightly more than 1% of the more than 56 million Medicare beneficiaries enrolled at the end of 2016 received advance-care planning talks, according to calculations by health policy analysts at Duke University, Durham, N.C. But use varied widely among states, from 0.2% of Alaska Medicare recipients to 2.49% of those enrolled in the program in Hawaii.
“There’s tremendous variation by state. That’s the first thing that jumps out,” said Donald Taylor Jr., a Duke professor of public policy.
In part, that’s because many providers, especially primary care doctors, aren’t aware that the Medicare reimbursement agreement, approved in 2015, has taken effect.
“Some physicians don’t know that this is a service,” said Barbie Hays, a Medicare coding and compliance strategist for the American Academy of Family Physicians. “They don’t know how to get paid for it. One of the struggles here is we’re trying to get this message out to our members.”
There also may be lingering controversy over the sessions, which were famously decried as “death panels” during the 2009 debate about the Affordable Care Act. Earlier this year, the issue resurfaced in Congress, where Rep. Steve King (R-Iowa) introduced the Protecting Life Until Natural Death Act, which would halt Medicare reimbursement for advance-care planning appointments.
Mr. King said the move was financially motivated and not in the interest of Americans “who were promised life-sustaining care in their older years.”
Proponents like Dr. Steinberg, however, contend that informed decisions, not cost savings, are the point of the new policy.
“It’s really important to say the reason for this isn’t to save money, although that may be a side benefit, but it’s really about person-centered care,” he said. “It’s about taking the time when people are ill or even when they’re not ill to talk about what their values are. To talk about what constitutes an acceptable versus an unacceptable quality of life.”
That’s just the discussion that the San Diego nursing home resident was able to have with her daughter, Dr. Steinberg said. The 90-year-old was able to say why she didn’t want CPR or to be intubated if she became seriously ill.
“I believe it brought the two of them closer,” Dr. Steinberg said. Even though the daughter didn’t necessarily hear what she wanted to hear. It was like, “You may not agree with your mom, but she’s your mom, and if she doesn’t want somebody beating her chest or ramming a tube down her throat, that’s her decision.”
KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
The 90-year-old woman in the San Diego–area nursing home was quite clear, said Karl Steinberg, MD. She didn’t want aggressive measures to prolong her life. If her heart stopped, she didn’t want CPR.
But when Dr. Steinberg, a palliative care physician, relayed those wishes to the woman’s daughter, the younger woman would have none of it.
“She said, ‘I don’t agree with that. My mom is confused,’ ” Steinberg recalled. “I said, ‘Let’s talk about it.’ ”
Instead of arguing, Dr. Steinberg used an increasingly popular tool to resolve the impasse last month. He brought mother and daughter together for an advance-care planning session, an end-of-life consultation that’s now being paid for by Medicare.
In 2016, the first year that health care providers were allowed to bill for the service, nearly 575,000 Medicare beneficiaries took part in the conversations, new federal data obtained by Kaiser Health News show.
Nearly 23,000 providers submitted about $93 million in charges, including more than $43 million covered by the federal program for seniors and the disabled.
Use was much higher than expected, nearly double the 300,000 people that the American Medical Association projected would use the service in the first year.
That’s good news to proponents of the sessions, which focus on understanding and documenting treatment preferences for people nearing the end of their lives. Patients – and often their families – discuss with a doctor or other provider what kind of care they want if they’re unable to make decisions themselves.
“I think it’s great that half a million people talked with their doctors last year. That’s a good thing,” said Paul Malley, president of Aging with Dignity, a Florida nonprofit that promotes end-of-life discussions. “Physician practices are learning. My guess is that it will increase each year.”
Still, only a fraction of eligible Medicare providers – and patients – have used the benefit, which pays about $86 for the first 30-minute office visit and about $75 for additional sessions.
Nationwide, slightly more than 1% of the more than 56 million Medicare beneficiaries enrolled at the end of 2016 received advance-care planning talks, according to calculations by health policy analysts at Duke University, Durham, N.C. But use varied widely among states, from 0.2% of Alaska Medicare recipients to 2.49% of those enrolled in the program in Hawaii.
“There’s tremendous variation by state. That’s the first thing that jumps out,” said Donald Taylor Jr., a Duke professor of public policy.
In part, that’s because many providers, especially primary care doctors, aren’t aware that the Medicare reimbursement agreement, approved in 2015, has taken effect.
“Some physicians don’t know that this is a service,” said Barbie Hays, a Medicare coding and compliance strategist for the American Academy of Family Physicians. “They don’t know how to get paid for it. One of the struggles here is we’re trying to get this message out to our members.”
There also may be lingering controversy over the sessions, which were famously decried as “death panels” during the 2009 debate about the Affordable Care Act. Earlier this year, the issue resurfaced in Congress, where Rep. Steve King (R-Iowa) introduced the Protecting Life Until Natural Death Act, which would halt Medicare reimbursement for advance-care planning appointments.
Mr. King said the move was financially motivated and not in the interest of Americans “who were promised life-sustaining care in their older years.”
Proponents like Dr. Steinberg, however, contend that informed decisions, not cost savings, are the point of the new policy.
“It’s really important to say the reason for this isn’t to save money, although that may be a side benefit, but it’s really about person-centered care,” he said. “It’s about taking the time when people are ill or even when they’re not ill to talk about what their values are. To talk about what constitutes an acceptable versus an unacceptable quality of life.”
That’s just the discussion that the San Diego nursing home resident was able to have with her daughter, Dr. Steinberg said. The 90-year-old was able to say why she didn’t want CPR or to be intubated if she became seriously ill.
“I believe it brought the two of them closer,” Dr. Steinberg said. Even though the daughter didn’t necessarily hear what she wanted to hear. It was like, “You may not agree with your mom, but she’s your mom, and if she doesn’t want somebody beating her chest or ramming a tube down her throat, that’s her decision.”
KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Hospice care underused in older patients with de novo AML
Although adults older than 65 newly diagnosed with acute myeloid leukemia (AML) have a generally poor prognosis and short life expectancy, fewer than half were enrolled in hospice, and of those patients who were enrolled, two-thirds entered hospice within the last week of life, results of a retrospective cohort study show.
The findings suggest that there is substantial room for improvement in the care of older patients with AML in their last days of life, said investigators led by Rong Wang, PhD, and colleagues from Yale University in New Haven, Connecticut.
“[We] found that the current end-of-life care for older patients with AML is suboptimal, as reflected by low hospice enrollment and high use of potentially aggressive treatment. Transfer in and out of hospice was associated with the receipt of transfusions. Changes to current hospice services, such as enabling the provision of transfusion support, and improvements in physician-patient communications, may help facilitate better end-of-life care in this patient population,” they wrote (J Clin Oncol. 2017 Aug 7. doi: 10.1200/JCO.2017.72.7149)
Patients aged 65 and over with AML have a median overall survival (OS) of only about 2 months, and the older the patient, the worse the survival, with patients 85 and older having a median OS of just 1 month, the investigators noted.
“Hence, end-of-life care is particularly relevant for this patient population,” they wrote.
To get a better idea of how clinicians prescribe hospice and palliative care for older patients with AML, Dr. Wang and colleagues conducted a population-based, retrospective cohort study of patients with AML who were 66 or older at diagnosis, received a diagnosis from 1999 through 2011, and died before the end of 2012.
They reviewed Medicare claims data on 13,156 patients to see whether patients were receiving aggressive care such as chemotherapy and whether and when they were enrolled in hospice.
The investigators found that the proportion of patients who were enrolled in hospice after an AML diagnosis increased from 31.3% in 1999 to 56.4% in 2012 (P for trend less than .01).
They also discovered, however, that most of the increase was attributable to patients who were enrolled within the last week of life.
When they compared patients who died within 30 days of diagnosis to those who lived longer than 30 days after diagnosis, they found that the longer-lived patients were significantly more likely to have been enrolled in hospice (48.1% vs. 30.7%, P less than .01). Additionally, of those patients who were enrolled in hospice, 51.2% of those who died within 30 days of entering hospice had been enrolled in the last 3 days of life, compared with 24.9% of those who survived for more than a month after entering hospice (P value not shown).
Over the course of the study 1,528 patients (11.6%) had chemotherapy within their last two weeks of life. The proportion of patients undergoing chemotherapy within their last 14 days increased from 7.7% in 1999 to 18.8% in 2012 (P for trend less than .01).
Patients who had end-of-life chemotherapy were significantly more likely to have had an ICU stay in the last month of life (43.0% vs. 28.4%; P less than .01) and were significantly more likely to be enrolled in hospice (22.1% vs. 47.4%, P less than .01) than patients who did not get chemotherapy with the last 14 days of life.
Predictors for end-of-life chemotherapy were male sex, being married, and dying in more recent years. Patients who were older, had state Medicaid buy-in (an optional program for workers with disabilities), or who lived outside the Northeast or major metropolitan areas were less likely to be subjected to chemotherapy in their final days.
Overall, 3,956 patients (30.1%) were admitted to the ICU within 30 days of their deaths. The percentage of ICU admissions just before death increased from 25.2% in 1999 to 31.3% in 2012 (P for trend .01).
Predictors for late-life ICU admission were similar to those for chemotherapy, except that patients with state Medicaid buy-in had 19% greater odds of being admitted to an ICU within 30 days of death (P less than .01).
The study was funded by the National Cancer Institute. Dr. Wang reported no relevant conflicts of interests. Multiple coauthors reported financial relationships with various companies.
Although adults older than 65 newly diagnosed with acute myeloid leukemia (AML) have a generally poor prognosis and short life expectancy, fewer than half were enrolled in hospice, and of those patients who were enrolled, two-thirds entered hospice within the last week of life, results of a retrospective cohort study show.
The findings suggest that there is substantial room for improvement in the care of older patients with AML in their last days of life, said investigators led by Rong Wang, PhD, and colleagues from Yale University in New Haven, Connecticut.
“[We] found that the current end-of-life care for older patients with AML is suboptimal, as reflected by low hospice enrollment and high use of potentially aggressive treatment. Transfer in and out of hospice was associated with the receipt of transfusions. Changes to current hospice services, such as enabling the provision of transfusion support, and improvements in physician-patient communications, may help facilitate better end-of-life care in this patient population,” they wrote (J Clin Oncol. 2017 Aug 7. doi: 10.1200/JCO.2017.72.7149)
Patients aged 65 and over with AML have a median overall survival (OS) of only about 2 months, and the older the patient, the worse the survival, with patients 85 and older having a median OS of just 1 month, the investigators noted.
“Hence, end-of-life care is particularly relevant for this patient population,” they wrote.
To get a better idea of how clinicians prescribe hospice and palliative care for older patients with AML, Dr. Wang and colleagues conducted a population-based, retrospective cohort study of patients with AML who were 66 or older at diagnosis, received a diagnosis from 1999 through 2011, and died before the end of 2012.
They reviewed Medicare claims data on 13,156 patients to see whether patients were receiving aggressive care such as chemotherapy and whether and when they were enrolled in hospice.
The investigators found that the proportion of patients who were enrolled in hospice after an AML diagnosis increased from 31.3% in 1999 to 56.4% in 2012 (P for trend less than .01).
They also discovered, however, that most of the increase was attributable to patients who were enrolled within the last week of life.
When they compared patients who died within 30 days of diagnosis to those who lived longer than 30 days after diagnosis, they found that the longer-lived patients were significantly more likely to have been enrolled in hospice (48.1% vs. 30.7%, P less than .01). Additionally, of those patients who were enrolled in hospice, 51.2% of those who died within 30 days of entering hospice had been enrolled in the last 3 days of life, compared with 24.9% of those who survived for more than a month after entering hospice (P value not shown).
Over the course of the study 1,528 patients (11.6%) had chemotherapy within their last two weeks of life. The proportion of patients undergoing chemotherapy within their last 14 days increased from 7.7% in 1999 to 18.8% in 2012 (P for trend less than .01).
Patients who had end-of-life chemotherapy were significantly more likely to have had an ICU stay in the last month of life (43.0% vs. 28.4%; P less than .01) and were significantly more likely to be enrolled in hospice (22.1% vs. 47.4%, P less than .01) than patients who did not get chemotherapy with the last 14 days of life.
Predictors for end-of-life chemotherapy were male sex, being married, and dying in more recent years. Patients who were older, had state Medicaid buy-in (an optional program for workers with disabilities), or who lived outside the Northeast or major metropolitan areas were less likely to be subjected to chemotherapy in their final days.
Overall, 3,956 patients (30.1%) were admitted to the ICU within 30 days of their deaths. The percentage of ICU admissions just before death increased from 25.2% in 1999 to 31.3% in 2012 (P for trend .01).
Predictors for late-life ICU admission were similar to those for chemotherapy, except that patients with state Medicaid buy-in had 19% greater odds of being admitted to an ICU within 30 days of death (P less than .01).
The study was funded by the National Cancer Institute. Dr. Wang reported no relevant conflicts of interests. Multiple coauthors reported financial relationships with various companies.
Although adults older than 65 newly diagnosed with acute myeloid leukemia (AML) have a generally poor prognosis and short life expectancy, fewer than half were enrolled in hospice, and of those patients who were enrolled, two-thirds entered hospice within the last week of life, results of a retrospective cohort study show.
The findings suggest that there is substantial room for improvement in the care of older patients with AML in their last days of life, said investigators led by Rong Wang, PhD, and colleagues from Yale University in New Haven, Connecticut.
“[We] found that the current end-of-life care for older patients with AML is suboptimal, as reflected by low hospice enrollment and high use of potentially aggressive treatment. Transfer in and out of hospice was associated with the receipt of transfusions. Changes to current hospice services, such as enabling the provision of transfusion support, and improvements in physician-patient communications, may help facilitate better end-of-life care in this patient population,” they wrote (J Clin Oncol. 2017 Aug 7. doi: 10.1200/JCO.2017.72.7149)
Patients aged 65 and over with AML have a median overall survival (OS) of only about 2 months, and the older the patient, the worse the survival, with patients 85 and older having a median OS of just 1 month, the investigators noted.
“Hence, end-of-life care is particularly relevant for this patient population,” they wrote.
To get a better idea of how clinicians prescribe hospice and palliative care for older patients with AML, Dr. Wang and colleagues conducted a population-based, retrospective cohort study of patients with AML who were 66 or older at diagnosis, received a diagnosis from 1999 through 2011, and died before the end of 2012.
They reviewed Medicare claims data on 13,156 patients to see whether patients were receiving aggressive care such as chemotherapy and whether and when they were enrolled in hospice.
The investigators found that the proportion of patients who were enrolled in hospice after an AML diagnosis increased from 31.3% in 1999 to 56.4% in 2012 (P for trend less than .01).
They also discovered, however, that most of the increase was attributable to patients who were enrolled within the last week of life.
When they compared patients who died within 30 days of diagnosis to those who lived longer than 30 days after diagnosis, they found that the longer-lived patients were significantly more likely to have been enrolled in hospice (48.1% vs. 30.7%, P less than .01). Additionally, of those patients who were enrolled in hospice, 51.2% of those who died within 30 days of entering hospice had been enrolled in the last 3 days of life, compared with 24.9% of those who survived for more than a month after entering hospice (P value not shown).
Over the course of the study 1,528 patients (11.6%) had chemotherapy within their last two weeks of life. The proportion of patients undergoing chemotherapy within their last 14 days increased from 7.7% in 1999 to 18.8% in 2012 (P for trend less than .01).
Patients who had end-of-life chemotherapy were significantly more likely to have had an ICU stay in the last month of life (43.0% vs. 28.4%; P less than .01) and were significantly more likely to be enrolled in hospice (22.1% vs. 47.4%, P less than .01) than patients who did not get chemotherapy with the last 14 days of life.
Predictors for end-of-life chemotherapy were male sex, being married, and dying in more recent years. Patients who were older, had state Medicaid buy-in (an optional program for workers with disabilities), or who lived outside the Northeast or major metropolitan areas were less likely to be subjected to chemotherapy in their final days.
Overall, 3,956 patients (30.1%) were admitted to the ICU within 30 days of their deaths. The percentage of ICU admissions just before death increased from 25.2% in 1999 to 31.3% in 2012 (P for trend .01).
Predictors for late-life ICU admission were similar to those for chemotherapy, except that patients with state Medicaid buy-in had 19% greater odds of being admitted to an ICU within 30 days of death (P less than .01).
The study was funded by the National Cancer Institute. Dr. Wang reported no relevant conflicts of interests. Multiple coauthors reported financial relationships with various companies.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: End-of-life care for patients 65 and older with acute myeloid leukemia is suboptimal.
Major finding: Patients who lived more than 30 days after an AML diagnosis were significantly more likely to have been enrolled in hospice than those who died within 30 days of diagnosis.
Data source: Retrospective cohort study of 13,156 patients diagnosed with AML at age 66 or older from 1999 through 2012.
Disclosures: The study was funded by the National Cancer Institute. Dr. Wang reported no relevant conflicts of interests. Multiple coauthors reported financial relationships with various companies.
Folic acid fortification prevents millions of cases of anemia
DENVER – Mandatory food fortification with folic acid not only prevents neural tube defects, it also prevents an estimated 10 million cases of folate-deficiency anemia annually in the United States, James L. Mills, MD, reported at the annual meeting of the Teratology Society.
“We should have people be thinking about the fact that we’re preventing millions of cases of folate-deficiency anemia, not just thousands of cases of neural tube defects. That point does not seem to have reached the public health community. We need to correct the erroneous assumption that a small group are the only ones benefiting by exposing the entire population to folic acid,” said Dr. Mills, senior investigator at the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Bethesda, Md.
Extrapolating from the nationally representative survey to the full U.S. population, Dr. Mills estimated that translates to roughly 10 million cases of folate-deficiency anemia prevented per year as a result of the mandatory fortification of grain introduced in 1998. That represents an enormous financial savings in avoided costs of diagnosis and treatment of this disorder.
The Food Fortification Initiative reports that 86 countries have embraced mandatory food fortification of wheat, maize, and/or rice. More than two dozen reports from around the world describe 40%-60% reductions in neural tube defect rates as a consequence. However, some of the world’s most populous nations are not on board. These include China, India, Russia, and the entire European Union.
Among the arguments raised by opponents of mandatory food fortification is the notion that it exposes the entire population to folic acid while benefiting only a small group of individuals who are spared having a neural tube defect. But the findings regarding prevention of folate-deficiency anemia demonstrate that argument is incorrect, Dr. Mills said.
Increased risks of asthma, cancer, and twinning as a consequence of mandatory food fortification have been proposed but are not supported by evidence. The only well-established adverse event is masking of vitamin B12 deficiency by correction of the anemia. But most reported cases have occurred after exposure to folic acid in milligram per day amounts, whereas the average U.S. exposure in women of childbearing age is just 163 mcg per day, less than half the recommended daily intake for that group. Also, no increase in cases of newly diagnosed vitamin B12 deficiency without anemia occurred in the U.S. after mandatory fortification was introduced, according to Dr. Mills.
Audience member Godfrey P. Oakley Jr., MD, noted that there is randomized trial evidence to indicate that folic acid supplementation has another important benefit: primary prevention of stroke in hypertensive adults. He cited the randomized, double-blind China Stroke Primary Prevention Trial, in which almost 21,000 hypertensive Chinese adults without a history of myocardial infarction or stroke were randomized to a single-pill combination of 10 mg of enalapril and 0.8 mg of folic acid daily or to a tablet containing 10 mg of enalapril alone.
During a median 4.5 years of follow-up, the enalapril/folic acid group had a 24% reduction in the risk of ischemic stroke and a 20% reduction in the composite of cardiovascular death, MI, and stroke (JAMA. 2015 Apr 7;313[13]:1325-35).
This is a potential game-changing finding which cries out for a confirmatory trial, he said. “There’s a lot going for that paper. I don’t know of a research agenda item that’s more important than trying to find out the relationship between folic acid fortification and stroke. I wish somebody would put some money into it,” said Dr. Oakley, research professor of epidemiology at Emory University in Atlanta.
Dr. Mills responded that he has reservations about the quality of the Chinese study, particularly in light of a Chinese government analysis that concluded that 80% of Chinese clinical trials were fraudulent (BMJ. 2016 Oct 5;355:i5396).
“That makes me want to see more data from a source I have a little bit more confidence in,” he added.
Another possible benefit of folic acid supplementation worthy of investigation is its theoretic potential for cancer prevention. “Folic acid provides one-carbon atoms for DNA repair,” Dr. Mills noted.
Dr. Mills reported having no relevant financial disclosures.
DENVER – Mandatory food fortification with folic acid not only prevents neural tube defects, it also prevents an estimated 10 million cases of folate-deficiency anemia annually in the United States, James L. Mills, MD, reported at the annual meeting of the Teratology Society.
“We should have people be thinking about the fact that we’re preventing millions of cases of folate-deficiency anemia, not just thousands of cases of neural tube defects. That point does not seem to have reached the public health community. We need to correct the erroneous assumption that a small group are the only ones benefiting by exposing the entire population to folic acid,” said Dr. Mills, senior investigator at the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Bethesda, Md.
Extrapolating from the nationally representative survey to the full U.S. population, Dr. Mills estimated that translates to roughly 10 million cases of folate-deficiency anemia prevented per year as a result of the mandatory fortification of grain introduced in 1998. That represents an enormous financial savings in avoided costs of diagnosis and treatment of this disorder.
The Food Fortification Initiative reports that 86 countries have embraced mandatory food fortification of wheat, maize, and/or rice. More than two dozen reports from around the world describe 40%-60% reductions in neural tube defect rates as a consequence. However, some of the world’s most populous nations are not on board. These include China, India, Russia, and the entire European Union.
Among the arguments raised by opponents of mandatory food fortification is the notion that it exposes the entire population to folic acid while benefiting only a small group of individuals who are spared having a neural tube defect. But the findings regarding prevention of folate-deficiency anemia demonstrate that argument is incorrect, Dr. Mills said.
Increased risks of asthma, cancer, and twinning as a consequence of mandatory food fortification have been proposed but are not supported by evidence. The only well-established adverse event is masking of vitamin B12 deficiency by correction of the anemia. But most reported cases have occurred after exposure to folic acid in milligram per day amounts, whereas the average U.S. exposure in women of childbearing age is just 163 mcg per day, less than half the recommended daily intake for that group. Also, no increase in cases of newly diagnosed vitamin B12 deficiency without anemia occurred in the U.S. after mandatory fortification was introduced, according to Dr. Mills.
Audience member Godfrey P. Oakley Jr., MD, noted that there is randomized trial evidence to indicate that folic acid supplementation has another important benefit: primary prevention of stroke in hypertensive adults. He cited the randomized, double-blind China Stroke Primary Prevention Trial, in which almost 21,000 hypertensive Chinese adults without a history of myocardial infarction or stroke were randomized to a single-pill combination of 10 mg of enalapril and 0.8 mg of folic acid daily or to a tablet containing 10 mg of enalapril alone.
During a median 4.5 years of follow-up, the enalapril/folic acid group had a 24% reduction in the risk of ischemic stroke and a 20% reduction in the composite of cardiovascular death, MI, and stroke (JAMA. 2015 Apr 7;313[13]:1325-35).
This is a potential game-changing finding which cries out for a confirmatory trial, he said. “There’s a lot going for that paper. I don’t know of a research agenda item that’s more important than trying to find out the relationship between folic acid fortification and stroke. I wish somebody would put some money into it,” said Dr. Oakley, research professor of epidemiology at Emory University in Atlanta.
Dr. Mills responded that he has reservations about the quality of the Chinese study, particularly in light of a Chinese government analysis that concluded that 80% of Chinese clinical trials were fraudulent (BMJ. 2016 Oct 5;355:i5396).
“That makes me want to see more data from a source I have a little bit more confidence in,” he added.
Another possible benefit of folic acid supplementation worthy of investigation is its theoretic potential for cancer prevention. “Folic acid provides one-carbon atoms for DNA repair,” Dr. Mills noted.
Dr. Mills reported having no relevant financial disclosures.
DENVER – Mandatory food fortification with folic acid not only prevents neural tube defects, it also prevents an estimated 10 million cases of folate-deficiency anemia annually in the United States, James L. Mills, MD, reported at the annual meeting of the Teratology Society.
“We should have people be thinking about the fact that we’re preventing millions of cases of folate-deficiency anemia, not just thousands of cases of neural tube defects. That point does not seem to have reached the public health community. We need to correct the erroneous assumption that a small group are the only ones benefiting by exposing the entire population to folic acid,” said Dr. Mills, senior investigator at the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Bethesda, Md.
Extrapolating from the nationally representative survey to the full U.S. population, Dr. Mills estimated that translates to roughly 10 million cases of folate-deficiency anemia prevented per year as a result of the mandatory fortification of grain introduced in 1998. That represents an enormous financial savings in avoided costs of diagnosis and treatment of this disorder.
The Food Fortification Initiative reports that 86 countries have embraced mandatory food fortification of wheat, maize, and/or rice. More than two dozen reports from around the world describe 40%-60% reductions in neural tube defect rates as a consequence. However, some of the world’s most populous nations are not on board. These include China, India, Russia, and the entire European Union.
Among the arguments raised by opponents of mandatory food fortification is the notion that it exposes the entire population to folic acid while benefiting only a small group of individuals who are spared having a neural tube defect. But the findings regarding prevention of folate-deficiency anemia demonstrate that argument is incorrect, Dr. Mills said.
Increased risks of asthma, cancer, and twinning as a consequence of mandatory food fortification have been proposed but are not supported by evidence. The only well-established adverse event is masking of vitamin B12 deficiency by correction of the anemia. But most reported cases have occurred after exposure to folic acid in milligram per day amounts, whereas the average U.S. exposure in women of childbearing age is just 163 mcg per day, less than half the recommended daily intake for that group. Also, no increase in cases of newly diagnosed vitamin B12 deficiency without anemia occurred in the U.S. after mandatory fortification was introduced, according to Dr. Mills.
Audience member Godfrey P. Oakley Jr., MD, noted that there is randomized trial evidence to indicate that folic acid supplementation has another important benefit: primary prevention of stroke in hypertensive adults. He cited the randomized, double-blind China Stroke Primary Prevention Trial, in which almost 21,000 hypertensive Chinese adults without a history of myocardial infarction or stroke were randomized to a single-pill combination of 10 mg of enalapril and 0.8 mg of folic acid daily or to a tablet containing 10 mg of enalapril alone.
During a median 4.5 years of follow-up, the enalapril/folic acid group had a 24% reduction in the risk of ischemic stroke and a 20% reduction in the composite of cardiovascular death, MI, and stroke (JAMA. 2015 Apr 7;313[13]:1325-35).
This is a potential game-changing finding which cries out for a confirmatory trial, he said. “There’s a lot going for that paper. I don’t know of a research agenda item that’s more important than trying to find out the relationship between folic acid fortification and stroke. I wish somebody would put some money into it,” said Dr. Oakley, research professor of epidemiology at Emory University in Atlanta.
Dr. Mills responded that he has reservations about the quality of the Chinese study, particularly in light of a Chinese government analysis that concluded that 80% of Chinese clinical trials were fraudulent (BMJ. 2016 Oct 5;355:i5396).
“That makes me want to see more data from a source I have a little bit more confidence in,” he added.
Another possible benefit of folic acid supplementation worthy of investigation is its theoretic potential for cancer prevention. “Folic acid provides one-carbon atoms for DNA repair,” Dr. Mills noted.
Dr. Mills reported having no relevant financial disclosures.
EXPERT ANALYSIS FROM TERATOLOGY SOCIETY 2017
Air pollution seen acting on stress hormones
Increases in stress hormone levels and other adverse metabolic changes accompany higher exposure to air pollution, Chinese researchers have found, while cutting indoor pollution levels appears to mitigate these effects.
Air pollution has been linked in epidemiological studies to increased risk of cardiovascular and metabolic diseases, but the mechanisms remain poorly understood. The new findings, published online Aug. 14 in Circulation, offer compelling evidence that air pollution may impact the central nervous system, and the hypothalamus-pituitary-adrenal axis especially (Circulation 2017 Aug 14;136:618-27).
The study design required that students spend as much time in their dorms as possible with the windows closed, though they could venture out for classes and exams. Fine particle concentration in the dorms treated by purifiers was 8.6 mcg per cubic meter during the study period, compared with a mean 101.4 outdoors. The researchers determined that the time-weighted average student exposure to fine particle pollutants was reduced by more than half when the dorm air was being purified, though average student exposure was estimated at 24 mcg per cubic meter at best. The World Health Organization considers levels below 10 mcg to be safe.
Students in untreated dorms had significant increases in cortisol, cortisone, epinephrine, norepinephrine, and biomarkers of oxidative stress at 9 days compared to those in treated ones. Glucose, insulin, measures of insulin resistance, amino acids, fatty acids, and lipids differed significantly between treatment assignments, and the untreated dorm groups also saw 2.61% higher systolic blood pressure (95% confidence interval [CI], 0.39-4.79).
Glucocorticoids are known to affect blood pressure, the investigators noted. Serum cortisol and cortisone levels were 1.3 and 1.2 times higher for the students in the sham-treated dorms, with each 10-mcg increase in pollutant exposure associated with a 7.8% increase in cortisol (95% CI, 4.75-10.91) and a nearly 3.8% increase in cortisone (95% CI, 1.84-5.71). Similar exposure-dependent increases were seen for norepinephrine, melatonin, phenylalanine, tyrosine, L-tryptophan and other compounds.
“To the best of our knowledge, this is the first study that used the untargeted metabolomics approach to investigate human global metabolic changes in relation to changes in ambient [air pollution] exposures,” the investigators wrote in their analysis, adding that the findings “provide insights into the potential mechanisms of the adverse health effects that have been found to be associated with [pollution] exposure.”
Mr. Li and Dr. Cai recommended the use of indoor air purification technology as a practical way to reduce harmful exposure, noting that the benefits of long-term use, particularly relating to cardiovascular and metabolic health, remain to be established.
The study was funded with grants from national and regional government agencies in China, and none of its authors declared conflicts of interest.
Although the past decade has seen much advancement in our knowledge of how air pollutants promote cardiovascular diseases, important questions remain.
There is a need to better understand the precise nature and systemic pathways whereby ambient air pollution elicits a multitude of adverse responses in the heart and vasculature anatomically remote from the site of inhalation. Also, what can (and should) an individual do to protect oneself against the hazards of air pollution, given that substantial improvements in air quality throughout many parts of the world are likely decades away?
Li and colleagues have provided some significant insights into both of these issues. Responses to short-term exposure to high levels of pollution include increased blood pressure and insulin resistance, along with alterations in a battery of circulating markers indicative of systemic inflammation, oxidative stress, and platelet activation.
A distinguishing feature of their work is the detailed exploration of health responses using state-of-the-art metabolomic profiling. Although similar outcomes after brief exposure to ozone have been shown, this was the first usage of an untargeted metabolomic approach to evaluate the impact of ambient air pollution. The results confirm and extend the growing body of evidence that air pollution elicits systemic perturbations favoring the development of the metabolic syndrome. The findings also add to the growing body of evidence that simple interventions such as air purifier systems with high-efficiency filters can help protect against adverse health impacts of air pollution. The reduction in estimated exposure afforded by filtration favorably influenced most of the health outcomes (blood pressure, insulin resistance, oxidative stress, inflammation), curtailed pollution-induced activation of the sympathetic nervous system and hypothalamic-pituitary-adrenal axis, and helped mitigate the ensuing metabolomic perturbations.
Robert D Brook, MD, of the University of Michigan in Ann Arbor, and Sanjay Rajagopalan, MD, of Cleveland Hospitals, made these comments in an editorial (Circulation. 2017 Aug 14;136:628-31). Dr. Brook receives research support from RB, Inc. Dr. Rajagopalan had no disclosures.
Although the past decade has seen much advancement in our knowledge of how air pollutants promote cardiovascular diseases, important questions remain.
There is a need to better understand the precise nature and systemic pathways whereby ambient air pollution elicits a multitude of adverse responses in the heart and vasculature anatomically remote from the site of inhalation. Also, what can (and should) an individual do to protect oneself against the hazards of air pollution, given that substantial improvements in air quality throughout many parts of the world are likely decades away?
Li and colleagues have provided some significant insights into both of these issues. Responses to short-term exposure to high levels of pollution include increased blood pressure and insulin resistance, along with alterations in a battery of circulating markers indicative of systemic inflammation, oxidative stress, and platelet activation.
A distinguishing feature of their work is the detailed exploration of health responses using state-of-the-art metabolomic profiling. Although similar outcomes after brief exposure to ozone have been shown, this was the first usage of an untargeted metabolomic approach to evaluate the impact of ambient air pollution. The results confirm and extend the growing body of evidence that air pollution elicits systemic perturbations favoring the development of the metabolic syndrome. The findings also add to the growing body of evidence that simple interventions such as air purifier systems with high-efficiency filters can help protect against adverse health impacts of air pollution. The reduction in estimated exposure afforded by filtration favorably influenced most of the health outcomes (blood pressure, insulin resistance, oxidative stress, inflammation), curtailed pollution-induced activation of the sympathetic nervous system and hypothalamic-pituitary-adrenal axis, and helped mitigate the ensuing metabolomic perturbations.
Robert D Brook, MD, of the University of Michigan in Ann Arbor, and Sanjay Rajagopalan, MD, of Cleveland Hospitals, made these comments in an editorial (Circulation. 2017 Aug 14;136:628-31). Dr. Brook receives research support from RB, Inc. Dr. Rajagopalan had no disclosures.
Although the past decade has seen much advancement in our knowledge of how air pollutants promote cardiovascular diseases, important questions remain.
There is a need to better understand the precise nature and systemic pathways whereby ambient air pollution elicits a multitude of adverse responses in the heart and vasculature anatomically remote from the site of inhalation. Also, what can (and should) an individual do to protect oneself against the hazards of air pollution, given that substantial improvements in air quality throughout many parts of the world are likely decades away?
Li and colleagues have provided some significant insights into both of these issues. Responses to short-term exposure to high levels of pollution include increased blood pressure and insulin resistance, along with alterations in a battery of circulating markers indicative of systemic inflammation, oxidative stress, and platelet activation.
A distinguishing feature of their work is the detailed exploration of health responses using state-of-the-art metabolomic profiling. Although similar outcomes after brief exposure to ozone have been shown, this was the first usage of an untargeted metabolomic approach to evaluate the impact of ambient air pollution. The results confirm and extend the growing body of evidence that air pollution elicits systemic perturbations favoring the development of the metabolic syndrome. The findings also add to the growing body of evidence that simple interventions such as air purifier systems with high-efficiency filters can help protect against adverse health impacts of air pollution. The reduction in estimated exposure afforded by filtration favorably influenced most of the health outcomes (blood pressure, insulin resistance, oxidative stress, inflammation), curtailed pollution-induced activation of the sympathetic nervous system and hypothalamic-pituitary-adrenal axis, and helped mitigate the ensuing metabolomic perturbations.
Robert D Brook, MD, of the University of Michigan in Ann Arbor, and Sanjay Rajagopalan, MD, of Cleveland Hospitals, made these comments in an editorial (Circulation. 2017 Aug 14;136:628-31). Dr. Brook receives research support from RB, Inc. Dr. Rajagopalan had no disclosures.
Increases in stress hormone levels and other adverse metabolic changes accompany higher exposure to air pollution, Chinese researchers have found, while cutting indoor pollution levels appears to mitigate these effects.
Air pollution has been linked in epidemiological studies to increased risk of cardiovascular and metabolic diseases, but the mechanisms remain poorly understood. The new findings, published online Aug. 14 in Circulation, offer compelling evidence that air pollution may impact the central nervous system, and the hypothalamus-pituitary-adrenal axis especially (Circulation 2017 Aug 14;136:618-27).
The study design required that students spend as much time in their dorms as possible with the windows closed, though they could venture out for classes and exams. Fine particle concentration in the dorms treated by purifiers was 8.6 mcg per cubic meter during the study period, compared with a mean 101.4 outdoors. The researchers determined that the time-weighted average student exposure to fine particle pollutants was reduced by more than half when the dorm air was being purified, though average student exposure was estimated at 24 mcg per cubic meter at best. The World Health Organization considers levels below 10 mcg to be safe.
Students in untreated dorms had significant increases in cortisol, cortisone, epinephrine, norepinephrine, and biomarkers of oxidative stress at 9 days compared to those in treated ones. Glucose, insulin, measures of insulin resistance, amino acids, fatty acids, and lipids differed significantly between treatment assignments, and the untreated dorm groups also saw 2.61% higher systolic blood pressure (95% confidence interval [CI], 0.39-4.79).
Glucocorticoids are known to affect blood pressure, the investigators noted. Serum cortisol and cortisone levels were 1.3 and 1.2 times higher for the students in the sham-treated dorms, with each 10-mcg increase in pollutant exposure associated with a 7.8% increase in cortisol (95% CI, 4.75-10.91) and a nearly 3.8% increase in cortisone (95% CI, 1.84-5.71). Similar exposure-dependent increases were seen for norepinephrine, melatonin, phenylalanine, tyrosine, L-tryptophan and other compounds.
“To the best of our knowledge, this is the first study that used the untargeted metabolomics approach to investigate human global metabolic changes in relation to changes in ambient [air pollution] exposures,” the investigators wrote in their analysis, adding that the findings “provide insights into the potential mechanisms of the adverse health effects that have been found to be associated with [pollution] exposure.”
Mr. Li and Dr. Cai recommended the use of indoor air purification technology as a practical way to reduce harmful exposure, noting that the benefits of long-term use, particularly relating to cardiovascular and metabolic health, remain to be established.
The study was funded with grants from national and regional government agencies in China, and none of its authors declared conflicts of interest.
Increases in stress hormone levels and other adverse metabolic changes accompany higher exposure to air pollution, Chinese researchers have found, while cutting indoor pollution levels appears to mitigate these effects.
Air pollution has been linked in epidemiological studies to increased risk of cardiovascular and metabolic diseases, but the mechanisms remain poorly understood. The new findings, published online Aug. 14 in Circulation, offer compelling evidence that air pollution may impact the central nervous system, and the hypothalamus-pituitary-adrenal axis especially (Circulation 2017 Aug 14;136:618-27).
The study design required that students spend as much time in their dorms as possible with the windows closed, though they could venture out for classes and exams. Fine particle concentration in the dorms treated by purifiers was 8.6 mcg per cubic meter during the study period, compared with a mean 101.4 outdoors. The researchers determined that the time-weighted average student exposure to fine particle pollutants was reduced by more than half when the dorm air was being purified, though average student exposure was estimated at 24 mcg per cubic meter at best. The World Health Organization considers levels below 10 mcg to be safe.
Students in untreated dorms had significant increases in cortisol, cortisone, epinephrine, norepinephrine, and biomarkers of oxidative stress at 9 days compared to those in treated ones. Glucose, insulin, measures of insulin resistance, amino acids, fatty acids, and lipids differed significantly between treatment assignments, and the untreated dorm groups also saw 2.61% higher systolic blood pressure (95% confidence interval [CI], 0.39-4.79).
Glucocorticoids are known to affect blood pressure, the investigators noted. Serum cortisol and cortisone levels were 1.3 and 1.2 times higher for the students in the sham-treated dorms, with each 10-mcg increase in pollutant exposure associated with a 7.8% increase in cortisol (95% CI, 4.75-10.91) and a nearly 3.8% increase in cortisone (95% CI, 1.84-5.71). Similar exposure-dependent increases were seen for norepinephrine, melatonin, phenylalanine, tyrosine, L-tryptophan and other compounds.
“To the best of our knowledge, this is the first study that used the untargeted metabolomics approach to investigate human global metabolic changes in relation to changes in ambient [air pollution] exposures,” the investigators wrote in their analysis, adding that the findings “provide insights into the potential mechanisms of the adverse health effects that have been found to be associated with [pollution] exposure.”
Mr. Li and Dr. Cai recommended the use of indoor air purification technology as a practical way to reduce harmful exposure, noting that the benefits of long-term use, particularly relating to cardiovascular and metabolic health, remain to be established.
The study was funded with grants from national and regional government agencies in China, and none of its authors declared conflicts of interest.
FROM CIRCULATION
Key clinical point: Air pollution exposure is associated with increases in stress hormones and a wide array of other biochemical changes.
Major finding: Increases in pollution exposure corresponded to increases in cortisol, cortisone, epinephrine, and norepinephrine.
Data source: A randomized, double-blinded crossover trial on 55 subjects in Shanghai, China.
Disclosures: Chinese national and regional governments supported the study, whose authors declared no conflicts of interest.
Can low-dose aspirin reduce the risk of spontaneous preterm birth?
Antiplatelet agents (mainly low-dose aspirin) have been shown to reduce the risk of preeclampsia in women at risk for the condition. The American College of Obstetricians and Gynecologists currently supports consideration of the use of low-dose aspirin (81 mg/day), initiated between 12 and 28 weeks of gestation, for the prevention of preeclampsia in women at high risk.1
Can antiplatelet agents also reduce the risk of preterm birth? It is a reasonable question, postulate van Vliet and colleagues2: Women with a history of preeclampsia also have an increased risk of spontaneous preterm birth (SPB), and vice versa. Uteroplacental ischemia is present in cases of preeclampsia, and research is showing that uteroplacental ischemia also plays a role in the etiology of spontaneous preterm labor.3,4
Details of the study
To investigate their research question, van Vliet and colleagues performed an additional analysis of the Perinatal Antiplatelet Review of International Studies Individual Participant Data meta-analysis. The original meta-analysis involved the data of 32,217 women at risk for preeclampsia who were randomly assigned to low-dose aspirin-dipyridamole or placebo (no treatment); the study revealed a moderate risk reduction for preeclampsia as well as a significant reduction in preterm birth at less than 34 weeks of gestation in women treated with antiplatelets.2
In the additional analysis, for women with an SPB who began antiplatelet treatment before 20 weeks of gestation, the researchers assessed the time between 20 weeks and spontaneous preterm delivery, iatrogenic preterm delivery, and any preterm delivery. Overall, 9.7% of women (n = 2,670) had an SPB before 37 weeks of gestation, 2.8% (n = 773) had an SPB before 34 weeks of gestation, and 0.5% (n = 151) had an SPB before 28 weeks of gestation. Antiplatelet agents were associated with a significant reduction in the risk of SPB before 37 weeks (relative risk [RR], 0.93; 95% confidence interval [CI], 0.86–0.996) and before 34 weeks (RR, 0.86; 95% CI, 0.76–0.99). The RR of having an SPB at less than 37 weeks of gestation was 0.83 for women with a previous pregnancy and 0.98 for women in their first pregnancy.2
Bottom line
Antiplatelet use resulted in a 7% reduction in SPB risk in women at risk for preeclampsia. Antiplatelet use resulted in a 14% reduction in moderate to very preterm birth risk (<34 weeks’ gestation).
The authors advise that their study “provides clinicians with the best available evidence to counsel women regarding who might benefit from” antiplatelet use during pregnancy and suggest that antiplatelet use may be a promising intervention for women at high risk for SPB, especially in high-risk women with a previous pregnancy.2
Caveats
The researchers found no difference among those receiving and not receiving antiplatelets in the incidence of antepartum hemorrhage (RR, 1.02; 95% CI, 0.90–1.15), placental abruption (RR, 1.13; 95% CI, 0.87–1.48), or neonatal bleeding (RR, 0.93; 95% CI, 0.80–1.09). The incidence of postpartum hemorrhage (PPH) was again found to be borderline significant (RR, 1.06; 95% CI, 1.00–1.13), but it was more frequent. The authors caution that the SPB reduction that they found in their study (as well as the reduced risk for preeclampsia with low-dose aspirin use) be balanced against the potential higher risk for PPH.2
- The American College of Obstetricians and Gynecologists. Practice advisory on low-dose aspirin and prevention of preeclampsia: updated recommendations. https://www.acog.org/About-ACOG/News-Room/Practice-Advisories/Practice-Advisory-Low-Dose-Aspirin-and-Prevention-of-Preeclampsia-Updated-Recommendations. Updated July 11, 2016. Accessed August 14, 2017.
- van Vliet EO, Askie LA, Mol BW, Oudijk MA. Antiplatelet agents and the prevention of spontaneous preterm birth. Obstet Gynecol. 2017;129(2):327–336.
- Arias F, Rodriquez L, Rayne SC, Kraus FT. Maternal placental vasculopathy and infection: two distinct subgroups among patients with preterm labor and preterm ruptured membranes. Am J Obstet Gynecol. 1993;168(2):585–591.
- Kelly R, Holzman C, Senagore P, et al. Placental vascular pathology findings and pathways of preterm delivery. Am J Epidemiol. 2009;170(2):148–158.
Antiplatelet agents (mainly low-dose aspirin) have been shown to reduce the risk of preeclampsia in women at risk for the condition. The American College of Obstetricians and Gynecologists currently supports consideration of the use of low-dose aspirin (81 mg/day), initiated between 12 and 28 weeks of gestation, for the prevention of preeclampsia in women at high risk.1
Can antiplatelet agents also reduce the risk of preterm birth? It is a reasonable question, postulate van Vliet and colleagues2: Women with a history of preeclampsia also have an increased risk of spontaneous preterm birth (SPB), and vice versa. Uteroplacental ischemia is present in cases of preeclampsia, and research is showing that uteroplacental ischemia also plays a role in the etiology of spontaneous preterm labor.3,4
Details of the study
To investigate their research question, van Vliet and colleagues performed an additional analysis of the Perinatal Antiplatelet Review of International Studies Individual Participant Data meta-analysis. The original meta-analysis involved the data of 32,217 women at risk for preeclampsia who were randomly assigned to low-dose aspirin-dipyridamole or placebo (no treatment); the study revealed a moderate risk reduction for preeclampsia as well as a significant reduction in preterm birth at less than 34 weeks of gestation in women treated with antiplatelets.2
In the additional analysis, for women with an SPB who began antiplatelet treatment before 20 weeks of gestation, the researchers assessed the time between 20 weeks and spontaneous preterm delivery, iatrogenic preterm delivery, and any preterm delivery. Overall, 9.7% of women (n = 2,670) had an SPB before 37 weeks of gestation, 2.8% (n = 773) had an SPB before 34 weeks of gestation, and 0.5% (n = 151) had an SPB before 28 weeks of gestation. Antiplatelet agents were associated with a significant reduction in the risk of SPB before 37 weeks (relative risk [RR], 0.93; 95% confidence interval [CI], 0.86–0.996) and before 34 weeks (RR, 0.86; 95% CI, 0.76–0.99). The RR of having an SPB at less than 37 weeks of gestation was 0.83 for women with a previous pregnancy and 0.98 for women in their first pregnancy.2
Bottom line
Antiplatelet use resulted in a 7% reduction in SPB risk in women at risk for preeclampsia. Antiplatelet use resulted in a 14% reduction in moderate to very preterm birth risk (<34 weeks’ gestation).
The authors advise that their study “provides clinicians with the best available evidence to counsel women regarding who might benefit from” antiplatelet use during pregnancy and suggest that antiplatelet use may be a promising intervention for women at high risk for SPB, especially in high-risk women with a previous pregnancy.2
Caveats
The researchers found no difference among those receiving and not receiving antiplatelets in the incidence of antepartum hemorrhage (RR, 1.02; 95% CI, 0.90–1.15), placental abruption (RR, 1.13; 95% CI, 0.87–1.48), or neonatal bleeding (RR, 0.93; 95% CI, 0.80–1.09). The incidence of postpartum hemorrhage (PPH) was again found to be borderline significant (RR, 1.06; 95% CI, 1.00–1.13), but it was more frequent. The authors caution that the SPB reduction that they found in their study (as well as the reduced risk for preeclampsia with low-dose aspirin use) be balanced against the potential higher risk for PPH.2
Antiplatelet agents (mainly low-dose aspirin) have been shown to reduce the risk of preeclampsia in women at risk for the condition. The American College of Obstetricians and Gynecologists currently supports consideration of the use of low-dose aspirin (81 mg/day), initiated between 12 and 28 weeks of gestation, for the prevention of preeclampsia in women at high risk.1
Can antiplatelet agents also reduce the risk of preterm birth? It is a reasonable question, postulate van Vliet and colleagues2: Women with a history of preeclampsia also have an increased risk of spontaneous preterm birth (SPB), and vice versa. Uteroplacental ischemia is present in cases of preeclampsia, and research is showing that uteroplacental ischemia also plays a role in the etiology of spontaneous preterm labor.3,4
Details of the study
To investigate their research question, van Vliet and colleagues performed an additional analysis of the Perinatal Antiplatelet Review of International Studies Individual Participant Data meta-analysis. The original meta-analysis involved the data of 32,217 women at risk for preeclampsia who were randomly assigned to low-dose aspirin-dipyridamole or placebo (no treatment); the study revealed a moderate risk reduction for preeclampsia as well as a significant reduction in preterm birth at less than 34 weeks of gestation in women treated with antiplatelets.2
In the additional analysis, for women with an SPB who began antiplatelet treatment before 20 weeks of gestation, the researchers assessed the time between 20 weeks and spontaneous preterm delivery, iatrogenic preterm delivery, and any preterm delivery. Overall, 9.7% of women (n = 2,670) had an SPB before 37 weeks of gestation, 2.8% (n = 773) had an SPB before 34 weeks of gestation, and 0.5% (n = 151) had an SPB before 28 weeks of gestation. Antiplatelet agents were associated with a significant reduction in the risk of SPB before 37 weeks (relative risk [RR], 0.93; 95% confidence interval [CI], 0.86–0.996) and before 34 weeks (RR, 0.86; 95% CI, 0.76–0.99). The RR of having an SPB at less than 37 weeks of gestation was 0.83 for women with a previous pregnancy and 0.98 for women in their first pregnancy.2
Bottom line
Antiplatelet use resulted in a 7% reduction in SPB risk in women at risk for preeclampsia. Antiplatelet use resulted in a 14% reduction in moderate to very preterm birth risk (<34 weeks’ gestation).
The authors advise that their study “provides clinicians with the best available evidence to counsel women regarding who might benefit from” antiplatelet use during pregnancy and suggest that antiplatelet use may be a promising intervention for women at high risk for SPB, especially in high-risk women with a previous pregnancy.2
Caveats
The researchers found no difference among those receiving and not receiving antiplatelets in the incidence of antepartum hemorrhage (RR, 1.02; 95% CI, 0.90–1.15), placental abruption (RR, 1.13; 95% CI, 0.87–1.48), or neonatal bleeding (RR, 0.93; 95% CI, 0.80–1.09). The incidence of postpartum hemorrhage (PPH) was again found to be borderline significant (RR, 1.06; 95% CI, 1.00–1.13), but it was more frequent. The authors caution that the SPB reduction that they found in their study (as well as the reduced risk for preeclampsia with low-dose aspirin use) be balanced against the potential higher risk for PPH.2
- The American College of Obstetricians and Gynecologists. Practice advisory on low-dose aspirin and prevention of preeclampsia: updated recommendations. https://www.acog.org/About-ACOG/News-Room/Practice-Advisories/Practice-Advisory-Low-Dose-Aspirin-and-Prevention-of-Preeclampsia-Updated-Recommendations. Updated July 11, 2016. Accessed August 14, 2017.
- van Vliet EO, Askie LA, Mol BW, Oudijk MA. Antiplatelet agents and the prevention of spontaneous preterm birth. Obstet Gynecol. 2017;129(2):327–336.
- Arias F, Rodriquez L, Rayne SC, Kraus FT. Maternal placental vasculopathy and infection: two distinct subgroups among patients with preterm labor and preterm ruptured membranes. Am J Obstet Gynecol. 1993;168(2):585–591.
- Kelly R, Holzman C, Senagore P, et al. Placental vascular pathology findings and pathways of preterm delivery. Am J Epidemiol. 2009;170(2):148–158.
- The American College of Obstetricians and Gynecologists. Practice advisory on low-dose aspirin and prevention of preeclampsia: updated recommendations. https://www.acog.org/About-ACOG/News-Room/Practice-Advisories/Practice-Advisory-Low-Dose-Aspirin-and-Prevention-of-Preeclampsia-Updated-Recommendations. Updated July 11, 2016. Accessed August 14, 2017.
- van Vliet EO, Askie LA, Mol BW, Oudijk MA. Antiplatelet agents and the prevention of spontaneous preterm birth. Obstet Gynecol. 2017;129(2):327–336.
- Arias F, Rodriquez L, Rayne SC, Kraus FT. Maternal placental vasculopathy and infection: two distinct subgroups among patients with preterm labor and preterm ruptured membranes. Am J Obstet Gynecol. 1993;168(2):585–591.
- Kelly R, Holzman C, Senagore P, et al. Placental vascular pathology findings and pathways of preterm delivery. Am J Epidemiol. 2009;170(2):148–158.
Marijuana use triples risk of death from hypertension
The risk of death from hypertension is three times greater in adults who use marijuana, compared with nonusers, based on data from a retrospective study of 1,213 adults.
Changes in the legalization of marijuana may promote increased recreational use, but data on the long-term effects of marijuana use on cardiovascular and cerebrovascular mortality are limited, wrote Barbara A. Yankey, PhD, of Georgia State University, Atlanta, and her colleagues.
Data on 686 users and 527 nonusers were combined with the 2011 mortality data from the National Center for Health Statistics (Eur J Prev Cardiol. 2017 Aug 9; doi: 10.1177/2047487317723212).
Overall, marijuana users had a 3.42 times greater risk of death from hypertension than did nonusers (95% confidence interval, 1.20-9.79), and the risk increased by 1.04 for each year of use (95% CI, 1.00-1.07). The average duration of marijuana use was 11.5 years. At the time of study entry, the average age of the participants was 38 years, and the average body mass index was 29 kg/m2; 23% of marijuana users and 21% of nonusers had a prior diagnosis of hypertension.
Of the study participants, 20% used marijuana and smoked cigarettes, 16% used marijuana and were past smokers, 5% were past smokers, and 4% only smoked cigarettes. “In our study, increase in risk for hypertension, [heart disease], or cerebrovascular disease mortality associated with cigarette use was not significant,” the researchers wrote. They attributed this factor to the small sample size and noted that the dangers of cigarette smoking to the cardiovascular system are well established.
The study findings were limited by the relatively small sample size and potentially inaccurate data on the duration of marijuana use, the researchers said.
However, the results suggest that “cardiovascular risk associated with marijuana use may be greater than the cardiovascular risk already established for cigarette smoking,” and longitudinal studies are warranted, they concluded.
The researchers had no financial conflicts to disclose.
The risk of death from hypertension is three times greater in adults who use marijuana, compared with nonusers, based on data from a retrospective study of 1,213 adults.
Changes in the legalization of marijuana may promote increased recreational use, but data on the long-term effects of marijuana use on cardiovascular and cerebrovascular mortality are limited, wrote Barbara A. Yankey, PhD, of Georgia State University, Atlanta, and her colleagues.
Data on 686 users and 527 nonusers were combined with the 2011 mortality data from the National Center for Health Statistics (Eur J Prev Cardiol. 2017 Aug 9; doi: 10.1177/2047487317723212).
Overall, marijuana users had a 3.42 times greater risk of death from hypertension than did nonusers (95% confidence interval, 1.20-9.79), and the risk increased by 1.04 for each year of use (95% CI, 1.00-1.07). The average duration of marijuana use was 11.5 years. At the time of study entry, the average age of the participants was 38 years, and the average body mass index was 29 kg/m2; 23% of marijuana users and 21% of nonusers had a prior diagnosis of hypertension.
Of the study participants, 20% used marijuana and smoked cigarettes, 16% used marijuana and were past smokers, 5% were past smokers, and 4% only smoked cigarettes. “In our study, increase in risk for hypertension, [heart disease], or cerebrovascular disease mortality associated with cigarette use was not significant,” the researchers wrote. They attributed this factor to the small sample size and noted that the dangers of cigarette smoking to the cardiovascular system are well established.
The study findings were limited by the relatively small sample size and potentially inaccurate data on the duration of marijuana use, the researchers said.
However, the results suggest that “cardiovascular risk associated with marijuana use may be greater than the cardiovascular risk already established for cigarette smoking,” and longitudinal studies are warranted, they concluded.
The researchers had no financial conflicts to disclose.
The risk of death from hypertension is three times greater in adults who use marijuana, compared with nonusers, based on data from a retrospective study of 1,213 adults.
Changes in the legalization of marijuana may promote increased recreational use, but data on the long-term effects of marijuana use on cardiovascular and cerebrovascular mortality are limited, wrote Barbara A. Yankey, PhD, of Georgia State University, Atlanta, and her colleagues.
Data on 686 users and 527 nonusers were combined with the 2011 mortality data from the National Center for Health Statistics (Eur J Prev Cardiol. 2017 Aug 9; doi: 10.1177/2047487317723212).
Overall, marijuana users had a 3.42 times greater risk of death from hypertension than did nonusers (95% confidence interval, 1.20-9.79), and the risk increased by 1.04 for each year of use (95% CI, 1.00-1.07). The average duration of marijuana use was 11.5 years. At the time of study entry, the average age of the participants was 38 years, and the average body mass index was 29 kg/m2; 23% of marijuana users and 21% of nonusers had a prior diagnosis of hypertension.
Of the study participants, 20% used marijuana and smoked cigarettes, 16% used marijuana and were past smokers, 5% were past smokers, and 4% only smoked cigarettes. “In our study, increase in risk for hypertension, [heart disease], or cerebrovascular disease mortality associated with cigarette use was not significant,” the researchers wrote. They attributed this factor to the small sample size and noted that the dangers of cigarette smoking to the cardiovascular system are well established.
The study findings were limited by the relatively small sample size and potentially inaccurate data on the duration of marijuana use, the researchers said.
However, the results suggest that “cardiovascular risk associated with marijuana use may be greater than the cardiovascular risk already established for cigarette smoking,” and longitudinal studies are warranted, they concluded.
The researchers had no financial conflicts to disclose.
FROM THE EUROPEAN JOURNAL OF PREVENTIVE CARDIOLOGY
Key clinical point: A history of marijuana use significantly increases the risk of death from hypertension.
Major finding: Marijuana users had a 3.42 times higher risk of death from hypertension and a 1.04 times increased risk of death for each year of use.
Data source: A retrospective study of 1,213 adults aged 20 years and older using data from National Health and Nutrition Examination Survey and the National Center for Health Statistics.
Disclosures: The researchers had no financial conflicts to disclose.
Here’s what’s trending at SHM - Aug. 2017
Awards of Excellence nominations now open
SHM’s prestigious Awards of Excellence recognize exceptional achievements in the field of hospital medicine. Nominate a colleague (or yourself) for exemplary contributions that deserve acknowledgment and respect in the following categories:
- Excellence in Research
- Management Excellence in Hospital Medicine
- Outstanding Service in Hospital Medicine
- Excellence in Teaching
- Clinical Excellence for Physicians
- Clinical Excellence for Nurse Practitioners and Physician Assistants
- Excellence in Humanitarian Services
- Excellence in Teamwork
Awards of Excellence nominations are due on October 6, 2017. Nominate yourself or a colleague today at hospitalmedicine.org/awards.
Academic Hospitalist Academy
The eighth annual Academic Hospitalist Academy (AHA) is filling up quickly! For the second year in a row, it will be held at the beautiful Lakeway Resort and Spa in Austin, Texas, Sept. 25-28, 2017.
The principal goals of the Academy are to develop junior academic hospitalists as the premier teachers and educational leaders at their institutions, help academic hospitalists develop scholarly work and increase scholarly output, and enhance awareness of the value of quality improvement and patient safety work.
Each full day of learning is facilitated by leading clinician-educators, hospitalist-researchers, and clinical administrators in a 1:10 faculty-to-student ratio. Don’t miss out on this unique, hands-on experience. Visit academichospitalist.org to learn more.
Strengthen your skills with our Practice Administrator Mentor Program
New to practice administration? SHM invites you to join the Practice Administrators’ Committee Mentor/Mentee Program.
This structured program is geared toward hospitalist administrators seeking to strengthen their knowledge and skills. The program helps you develop relationships and serves as an outlet for you to pose questions to or share ideas with a seasoned administrator. There are two different ways you can participate. If you are a less experienced administrator looking for a mentor, or if you have more experience and are looking to be paired with a peer to learn from each other, you can choose the buddy system.
Learn more and submit your application at hospitalmedicine.org/pamentor. (The program is free to members only.)
Not a member? Join today at hospitalmedicine.org/join.
Distinguish yourself as a Class of 2018 Fellow in Hospital Medicine
SHM’s Fellows designation is a prestigious way to differentiate yourself in the rapidly growing profession of hospital medicine. There are currently over 2,000 hospitalists who have earned the Fellow in Hospital Medicine (FHM) or Senior Fellow in Hospital Medicine (SFHM) designation by demonstrating the core values of leadership, teamwork, and quality improvement.
If you applied for early decision on or before Sept. 15, you will receive a response on or before Oct. 27, 2017. The regular decision application will remain open through Nov. 30, with a decision on or before Dec. 31, 2017. Apply now and learn how you can join other hospitalists who have earned this exclusive designation and recognition at hospitalmedicine.org/fellows.
HM17 On Demand
Did you miss Hospital Medicine 2017? Are you looking to earn both CME credit and MOC points?
HM17 On Demand is a collection of the most popular tracks from Hospital Medicine 2017 (HM17), SHM’s annual meeting. HM17 is the premier educational event for health care professionals who specialize in hospital medicine.
HM17 On Demand gives you access to over 80 online audio and slide recordings from the hottest tracks, including clinical updates, rapid fire, pediatrics, comanagement, quality, and high-value care. Additionally, you can earn up to 70 AMA PRA Category 1 Credits and up to 30 ABIM MOC credits. HM17 attendees can also earn additional credits on sessions they missed out on.
HM17 On Demand is easily accessed through SHM’s Learning Portal. Visit shmlearningportal.org/hm17-demand to get your copy.
Brett Radler is marketing communications manager at the Society of Hospital Medicine.
Awards of Excellence nominations now open
SHM’s prestigious Awards of Excellence recognize exceptional achievements in the field of hospital medicine. Nominate a colleague (or yourself) for exemplary contributions that deserve acknowledgment and respect in the following categories:
- Excellence in Research
- Management Excellence in Hospital Medicine
- Outstanding Service in Hospital Medicine
- Excellence in Teaching
- Clinical Excellence for Physicians
- Clinical Excellence for Nurse Practitioners and Physician Assistants
- Excellence in Humanitarian Services
- Excellence in Teamwork
Awards of Excellence nominations are due on October 6, 2017. Nominate yourself or a colleague today at hospitalmedicine.org/awards.
Academic Hospitalist Academy
The eighth annual Academic Hospitalist Academy (AHA) is filling up quickly! For the second year in a row, it will be held at the beautiful Lakeway Resort and Spa in Austin, Texas, Sept. 25-28, 2017.
The principal goals of the Academy are to develop junior academic hospitalists as the premier teachers and educational leaders at their institutions, help academic hospitalists develop scholarly work and increase scholarly output, and enhance awareness of the value of quality improvement and patient safety work.
Each full day of learning is facilitated by leading clinician-educators, hospitalist-researchers, and clinical administrators in a 1:10 faculty-to-student ratio. Don’t miss out on this unique, hands-on experience. Visit academichospitalist.org to learn more.
Strengthen your skills with our Practice Administrator Mentor Program
New to practice administration? SHM invites you to join the Practice Administrators’ Committee Mentor/Mentee Program.
This structured program is geared toward hospitalist administrators seeking to strengthen their knowledge and skills. The program helps you develop relationships and serves as an outlet for you to pose questions to or share ideas with a seasoned administrator. There are two different ways you can participate. If you are a less experienced administrator looking for a mentor, or if you have more experience and are looking to be paired with a peer to learn from each other, you can choose the buddy system.
Learn more and submit your application at hospitalmedicine.org/pamentor. (The program is free to members only.)
Not a member? Join today at hospitalmedicine.org/join.
Distinguish yourself as a Class of 2018 Fellow in Hospital Medicine
SHM’s Fellows designation is a prestigious way to differentiate yourself in the rapidly growing profession of hospital medicine. There are currently over 2,000 hospitalists who have earned the Fellow in Hospital Medicine (FHM) or Senior Fellow in Hospital Medicine (SFHM) designation by demonstrating the core values of leadership, teamwork, and quality improvement.
If you applied for early decision on or before Sept. 15, you will receive a response on or before Oct. 27, 2017. The regular decision application will remain open through Nov. 30, with a decision on or before Dec. 31, 2017. Apply now and learn how you can join other hospitalists who have earned this exclusive designation and recognition at hospitalmedicine.org/fellows.
HM17 On Demand
Did you miss Hospital Medicine 2017? Are you looking to earn both CME credit and MOC points?
HM17 On Demand is a collection of the most popular tracks from Hospital Medicine 2017 (HM17), SHM’s annual meeting. HM17 is the premier educational event for health care professionals who specialize in hospital medicine.
HM17 On Demand gives you access to over 80 online audio and slide recordings from the hottest tracks, including clinical updates, rapid fire, pediatrics, comanagement, quality, and high-value care. Additionally, you can earn up to 70 AMA PRA Category 1 Credits and up to 30 ABIM MOC credits. HM17 attendees can also earn additional credits on sessions they missed out on.
HM17 On Demand is easily accessed through SHM’s Learning Portal. Visit shmlearningportal.org/hm17-demand to get your copy.
Brett Radler is marketing communications manager at the Society of Hospital Medicine.
Awards of Excellence nominations now open
SHM’s prestigious Awards of Excellence recognize exceptional achievements in the field of hospital medicine. Nominate a colleague (or yourself) for exemplary contributions that deserve acknowledgment and respect in the following categories:
- Excellence in Research
- Management Excellence in Hospital Medicine
- Outstanding Service in Hospital Medicine
- Excellence in Teaching
- Clinical Excellence for Physicians
- Clinical Excellence for Nurse Practitioners and Physician Assistants
- Excellence in Humanitarian Services
- Excellence in Teamwork
Awards of Excellence nominations are due on October 6, 2017. Nominate yourself or a colleague today at hospitalmedicine.org/awards.
Academic Hospitalist Academy
The eighth annual Academic Hospitalist Academy (AHA) is filling up quickly! For the second year in a row, it will be held at the beautiful Lakeway Resort and Spa in Austin, Texas, Sept. 25-28, 2017.
The principal goals of the Academy are to develop junior academic hospitalists as the premier teachers and educational leaders at their institutions, help academic hospitalists develop scholarly work and increase scholarly output, and enhance awareness of the value of quality improvement and patient safety work.
Each full day of learning is facilitated by leading clinician-educators, hospitalist-researchers, and clinical administrators in a 1:10 faculty-to-student ratio. Don’t miss out on this unique, hands-on experience. Visit academichospitalist.org to learn more.
Strengthen your skills with our Practice Administrator Mentor Program
New to practice administration? SHM invites you to join the Practice Administrators’ Committee Mentor/Mentee Program.
This structured program is geared toward hospitalist administrators seeking to strengthen their knowledge and skills. The program helps you develop relationships and serves as an outlet for you to pose questions to or share ideas with a seasoned administrator. There are two different ways you can participate. If you are a less experienced administrator looking for a mentor, or if you have more experience and are looking to be paired with a peer to learn from each other, you can choose the buddy system.
Learn more and submit your application at hospitalmedicine.org/pamentor. (The program is free to members only.)
Not a member? Join today at hospitalmedicine.org/join.
Distinguish yourself as a Class of 2018 Fellow in Hospital Medicine
SHM’s Fellows designation is a prestigious way to differentiate yourself in the rapidly growing profession of hospital medicine. There are currently over 2,000 hospitalists who have earned the Fellow in Hospital Medicine (FHM) or Senior Fellow in Hospital Medicine (SFHM) designation by demonstrating the core values of leadership, teamwork, and quality improvement.
If you applied for early decision on or before Sept. 15, you will receive a response on or before Oct. 27, 2017. The regular decision application will remain open through Nov. 30, with a decision on or before Dec. 31, 2017. Apply now and learn how you can join other hospitalists who have earned this exclusive designation and recognition at hospitalmedicine.org/fellows.
HM17 On Demand
Did you miss Hospital Medicine 2017? Are you looking to earn both CME credit and MOC points?
HM17 On Demand is a collection of the most popular tracks from Hospital Medicine 2017 (HM17), SHM’s annual meeting. HM17 is the premier educational event for health care professionals who specialize in hospital medicine.
HM17 On Demand gives you access to over 80 online audio and slide recordings from the hottest tracks, including clinical updates, rapid fire, pediatrics, comanagement, quality, and high-value care. Additionally, you can earn up to 70 AMA PRA Category 1 Credits and up to 30 ABIM MOC credits. HM17 attendees can also earn additional credits on sessions they missed out on.
HM17 On Demand is easily accessed through SHM’s Learning Portal. Visit shmlearningportal.org/hm17-demand to get your copy.
Brett Radler is marketing communications manager at the Society of Hospital Medicine.