Rationale:  
ICP has a 60%-70% recurrence rate, and therefore, this patient is at high risk of recurrence. Ursodeoxycholic acid (UDCA) has been shown to reduce pruritus and improve bile acid levels and liver-associated enzymes. There is also evidence that UDCA is safe late in pregnancy and likely improves fetal outcomes. Cholestyramine is not as effective as UCDA at reducing pruritus, reducing bile acid levels, or normalizing aminotransferase. In addition, babies are delivered closer to term with UDCA as opposed to cholestyramine. Hydroxyzine improves pruritus but can aggravate respiratory issues in preterm babies and is not recommended in ICP. Given these findings, UDCA is considered first-line therapy in treatment of ICP. A recent study showed that the perinatal mortality is decreased with delivery of the baby at 36 weeks gestation, or if ICP develops past 36 weeks, delivery with onset of symptoms. Thus, optimal management if her current pregnancy mimics the previous pregnancy if UDCA is given with development of symptoms with planned delivery at approximately 36-37 weeks gestation. 
 
References  
1. Bacq Y, Sentilhes L, Reyes HB, et al. Efficacy of ursodeoxycholic acid in treating intrahepatic cholestasis of pregnancy: a meta-analysis. Gastroenterology. 2012;143(6):1492-501.  
2. Kondrackiene J, Beurers U, Kupcinskas L. Efficacy and safety of ursodeoxycholic acid versus cholestyramine in intrahepatic cholestasis of pregnancy. Gastroenterology. 2005;129(3):894-901. 
3. Puljic A, Kim E, Page J, et al. The risk of fetal death by each additional week of expectant management in intrahepatic cholestasis of pregnancy by gestational age. Am J Obstet Gynecol. 2015;212(5):667e1-5.

Rationale:  
ICP has a 60%-70% recurrence rate, and therefore, this patient is at high risk of recurrence. Ursodeoxycholic acid (UDCA) has been shown to reduce pruritus and improve bile acid levels and liver-associated enzymes. There is also evidence that UDCA is safe late in pregnancy and likely improves fetal outcomes. Cholestyramine is not as effective as UCDA at reducing pruritus, reducing bile acid levels, or normalizing aminotransferase. In addition, babies are delivered closer to term with UDCA as opposed to cholestyramine. Hydroxyzine improves pruritus but can aggravate respiratory issues in preterm babies and is not recommended in ICP. Given these findings, UDCA is considered first-line therapy in treatment of ICP. A recent study showed that the perinatal mortality is decreased with delivery of the baby at 36 weeks gestation, or if ICP develops past 36 weeks, delivery with onset of symptoms. Thus, optimal management if her current pregnancy mimics the previous pregnancy if UDCA is given with development of symptoms with planned delivery at approximately 36-37 weeks gestation. 
 
References  
1. Bacq Y, Sentilhes L, Reyes HB, et al. Efficacy of ursodeoxycholic acid in treating intrahepatic cholestasis of pregnancy: a meta-analysis. Gastroenterology. 2012;143(6):1492-501.  
2. Kondrackiene J, Beurers U, Kupcinskas L. Efficacy and safety of ursodeoxycholic acid versus cholestyramine in intrahepatic cholestasis of pregnancy. Gastroenterology. 2005;129(3):894-901. 
3. Puljic A, Kim E, Page J, et al. The risk of fetal death by each additional week of expectant management in intrahepatic cholestasis of pregnancy by gestational age. Am J Obstet Gynecol. 2015;212(5):667e1-5.

Rationale:  
ICP has a 60%-70% recurrence rate, and therefore, this patient is at high risk of recurrence. Ursodeoxycholic acid (UDCA) has been shown to reduce pruritus and improve bile acid levels and liver-associated enzymes. There is also evidence that UDCA is safe late in pregnancy and likely improves fetal outcomes. Cholestyramine is not as effective as UCDA at reducing pruritus, reducing bile acid levels, or normalizing aminotransferase. In addition, babies are delivered closer to term with UDCA as opposed to cholestyramine. Hydroxyzine improves pruritus but can aggravate respiratory issues in preterm babies and is not recommended in ICP. Given these findings, UDCA is considered first-line therapy in treatment of ICP. A recent study showed that the perinatal mortality is decreased with delivery of the baby at 36 weeks gestation, or if ICP develops past 36 weeks, delivery with onset of symptoms. Thus, optimal management if her current pregnancy mimics the previous pregnancy if UDCA is given with development of symptoms with planned delivery at approximately 36-37 weeks gestation. 
 
References  
1. Bacq Y, Sentilhes L, Reyes HB, et al. Efficacy of ursodeoxycholic acid in treating intrahepatic cholestasis of pregnancy: a meta-analysis. Gastroenterology. 2012;143(6):1492-501.  
2. Kondrackiene J, Beurers U, Kupcinskas L. Efficacy and safety of ursodeoxycholic acid versus cholestyramine in intrahepatic cholestasis of pregnancy. Gastroenterology. 2005;129(3):894-901. 
3. Puljic A, Kim E, Page J, et al. The risk of fetal death by each additional week of expectant management in intrahepatic cholestasis of pregnancy by gestational age. Am J Obstet Gynecol. 2015;212(5):667e1-5.

Determining who is responsible for the increase in health care cost in the United States has seemingly limitless possibilities. There are enough culprits to go around, but a recent analysis points a finger at hospital-based care (Health Aff. 2019 Feb;38[2]:184-9).

The authors of the paper found that, during the period from 2007 to 2014, inpatient hospital care for surgical procedures increased 42% and outpatient hospital care increased 25%. In the same period, physician care increased only 6%. Much of this increase in hospital costs was associated with hospital consolidations and mergers.

We have been led to believe that hospital mergers will cut costs by eliminating duplication of both physical and personnel overhead costs. In fact that doesn’t seem to happen. It appears that hospital mergers were associated with increased per patient costs and is a result of decrease in competition in local health care markets. This observation has been made in the past (Am Econ Rev. 2015 Jan;105:172-203), and was reiterated by the most recent report. If there were decreases in overhead observed in the mergers, they were not passed on to the patients or insurers.

There was a time when community hospitals, large and small, were run by community leaders and local doctors, often under the aegis of religious and social groups. I can remember the medical and community leadership in Utica, N.Y., where I grew up and where I worked in a hospital as a summer intern. Their goal was to provide quality health care. The financial success or failures of the hospitals were the responsibility of the local community, and the profits and losses were kept at a minimum.

Fast forward to the 21st century and health care in general, and hospital care in particular, has become a “cash cow.” Community leadership has been minimized, and where it exists, it is under constant pressure to make a profit. Hospital mergers, arranged under the guise of economy of size, are now controlled by hedge funds and large health care corporations.

The community board of trustees has been replaced by investors, whose main concern is the return on their investments regardless of quality of care or need. If those profits fail to materialize, the hospitals are taken over by another investor group. So much for quality. As the corporations grow, they buy up the competition, particularly small community hospitals leaving many, particularly in rural America, without medical support.

There seems to be little recourse to consumers or insurers to mitigate this process. Investors have a right to a return on their investment, but until we have governmental control of competition, that incentive remains. We can see similar price increases in the pharmaceutical marketplace, where Congress has limited competition to preserve the drug monopoly. Americans will be asked to pay more to maintain a system that is inherently on the road to bankruptcy and fails to provide either quality or fair drug and hospital charges.

But what do we care, we can afford it.

Dr. Goldstein is professor of medicine at Wayne State University and the division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit.

Determining who is responsible for the increase in health care cost in the United States has seemingly limitless possibilities. There are enough culprits to go around, but a recent analysis points a finger at hospital-based care (Health Aff. 2019 Feb;38[2]:184-9).

The authors of the paper found that, during the period from 2007 to 2014, inpatient hospital care for surgical procedures increased 42% and outpatient hospital care increased 25%. In the same period, physician care increased only 6%. Much of this increase in hospital costs was associated with hospital consolidations and mergers.

We have been led to believe that hospital mergers will cut costs by eliminating duplication of both physical and personnel overhead costs. In fact that doesn’t seem to happen. It appears that hospital mergers were associated with increased per patient costs and is a result of decrease in competition in local health care markets. This observation has been made in the past (Am Econ Rev. 2015 Jan;105:172-203), and was reiterated by the most recent report. If there were decreases in overhead observed in the mergers, they were not passed on to the patients or insurers.

There was a time when community hospitals, large and small, were run by community leaders and local doctors, often under the aegis of religious and social groups. I can remember the medical and community leadership in Utica, N.Y., where I grew up and where I worked in a hospital as a summer intern. Their goal was to provide quality health care. The financial success or failures of the hospitals were the responsibility of the local community, and the profits and losses were kept at a minimum.

Fast forward to the 21st century and health care in general, and hospital care in particular, has become a “cash cow.” Community leadership has been minimized, and where it exists, it is under constant pressure to make a profit. Hospital mergers, arranged under the guise of economy of size, are now controlled by hedge funds and large health care corporations.

The community board of trustees has been replaced by investors, whose main concern is the return on their investments regardless of quality of care or need. If those profits fail to materialize, the hospitals are taken over by another investor group. So much for quality. As the corporations grow, they buy up the competition, particularly small community hospitals leaving many, particularly in rural America, without medical support.

There seems to be little recourse to consumers or insurers to mitigate this process. Investors have a right to a return on their investment, but until we have governmental control of competition, that incentive remains. We can see similar price increases in the pharmaceutical marketplace, where Congress has limited competition to preserve the drug monopoly. Americans will be asked to pay more to maintain a system that is inherently on the road to bankruptcy and fails to provide either quality or fair drug and hospital charges.

But what do we care, we can afford it.

Dr. Goldstein is professor of medicine at Wayne State University and the division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit.

Determining who is responsible for the increase in health care cost in the United States has seemingly limitless possibilities. There are enough culprits to go around, but a recent analysis points a finger at hospital-based care (Health Aff. 2019 Feb;38[2]:184-9).

The authors of the paper found that, during the period from 2007 to 2014, inpatient hospital care for surgical procedures increased 42% and outpatient hospital care increased 25%. In the same period, physician care increased only 6%. Much of this increase in hospital costs was associated with hospital consolidations and mergers.

We have been led to believe that hospital mergers will cut costs by eliminating duplication of both physical and personnel overhead costs. In fact that doesn’t seem to happen. It appears that hospital mergers were associated with increased per patient costs and is a result of decrease in competition in local health care markets. This observation has been made in the past (Am Econ Rev. 2015 Jan;105:172-203), and was reiterated by the most recent report. If there were decreases in overhead observed in the mergers, they were not passed on to the patients or insurers.

There was a time when community hospitals, large and small, were run by community leaders and local doctors, often under the aegis of religious and social groups. I can remember the medical and community leadership in Utica, N.Y., where I grew up and where I worked in a hospital as a summer intern. Their goal was to provide quality health care. The financial success or failures of the hospitals were the responsibility of the local community, and the profits and losses were kept at a minimum.

Fast forward to the 21st century and health care in general, and hospital care in particular, has become a “cash cow.” Community leadership has been minimized, and where it exists, it is under constant pressure to make a profit. Hospital mergers, arranged under the guise of economy of size, are now controlled by hedge funds and large health care corporations.

The community board of trustees has been replaced by investors, whose main concern is the return on their investments regardless of quality of care or need. If those profits fail to materialize, the hospitals are taken over by another investor group. So much for quality. As the corporations grow, they buy up the competition, particularly small community hospitals leaving many, particularly in rural America, without medical support.

There seems to be little recourse to consumers or insurers to mitigate this process. Investors have a right to a return on their investment, but until we have governmental control of competition, that incentive remains. We can see similar price increases in the pharmaceutical marketplace, where Congress has limited competition to preserve the drug monopoly. Americans will be asked to pay more to maintain a system that is inherently on the road to bankruptcy and fails to provide either quality or fair drug and hospital charges.

But what do we care, we can afford it.

Dr. Goldstein is professor of medicine at Wayne State University and the division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit.

For more than 2 years, this 36-year-old woman has had a slightly itchy rash that waxes and wanes on her posterior neck. She has consulted several primary care providers and received multiple diagnoses, the most consistent of which has been fungal infection. However, despite use of a variety of antifungal creams (nystatin, clotrimazole, and combination clotrimazole/betamethasone), a 1-month course of oral terbinafine, and OTC tolnaftate, no improvement has occurred.

The patient asserts that she is otherwise in good health, with no joint pain or fever and no history of recent health crises. Family history is free of dermatologic complaints except for psoriasis in her father.

EXAMINATION
A pink plaque with white, fairly adherent scale covers most of the patient’s posterior neck/upper midline back. When a 3-mm section of scaling is peeled away, 2 tiny dots of pinpoint bleeding are immediately noted.

The rest of her scalp is free of any such changes, as are her elbows and knees. But a similar rash is seen in the upper intergluteal area, and 3 of 10 fingernails are mildly pitted.

What’s the diagnosis?

DISCUSSION
Psoriasis vulgaris (common psoriasis) affects around 3% of the white population in this country. That incidence almost doubles in northern Europe and Scandinavia.

Psoriasis is so common that you should expect to see it regularly; the important question is not “Will you see it?” but rather “Will you know it when you see it?” Sometimes the various clinical elements of psoriasis must be sought, and those dots connected, as this case demonstrates effectively.

For one thing, the nape of the neck is commonly affected, especially in women. It is pure speculation, but one imagines that the heat and sweat associated with longer hair might contribute to this predilection.

The pink color, whitish scale, and pinpoint bleeding (termed the Auspitz sign) all corroborate the diagnosis, as does the positive family history and nail pitting. The intergluteal involvement was the icing on the cake; this is seen in only 2 common conditions: psoriasis and seborrhea.

The lesson? Even though psoriasis is supposed to appear on elbows, knees, and other extensor surfaces, sometimes it breaks the rules. The posterior neck was the primary area of involvement in this case, but sometimes psoriasis is completely confined to the scalp or the palms. And, of course, there are different types of psoriasis, some of which bear scant resemblance to psoriasis vulgaris. That’s where biopsies and/or referrals prove to be useful.

It is true that this patient’s rash could have had a fungal origin. When in doubt, however, a punch or shave biopsy would most likely settle the matter, since the histologic picture is usually pathognomic.

TAKE-HOME LEARNING POINTS

• Psoriasis is often be easy to diagnose—but just as often, it takes a bit of detective work.
• This “investigation” consists of looking for and asking about findings that could corroborate the diagnosis.
• The morphology of the neck lesion, as well as the Auspitz sign, nail pitting, intergluteal involvement, and family history in this case all served quite well to establish the diagnosis of psoriasis.
• It is helpful to remember how utterly common psoriasis is, affecting around 10,000,000 Americans.

For more than 2 years, this 36-year-old woman has had a slightly itchy rash that waxes and wanes on her posterior neck. She has consulted several primary care providers and received multiple diagnoses, the most consistent of which has been fungal infection. However, despite use of a variety of antifungal creams (nystatin, clotrimazole, and combination clotrimazole/betamethasone), a 1-month course of oral terbinafine, and OTC tolnaftate, no improvement has occurred.

The patient asserts that she is otherwise in good health, with no joint pain or fever and no history of recent health crises. Family history is free of dermatologic complaints except for psoriasis in her father.

EXAMINATION
A pink plaque with white, fairly adherent scale covers most of the patient’s posterior neck/upper midline back. When a 3-mm section of scaling is peeled away, 2 tiny dots of pinpoint bleeding are immediately noted.

The rest of her scalp is free of any such changes, as are her elbows and knees. But a similar rash is seen in the upper intergluteal area, and 3 of 10 fingernails are mildly pitted.

What’s the diagnosis?

DISCUSSION
Psoriasis vulgaris (common psoriasis) affects around 3% of the white population in this country. That incidence almost doubles in northern Europe and Scandinavia.

Psoriasis is so common that you should expect to see it regularly; the important question is not “Will you see it?” but rather “Will you know it when you see it?” Sometimes the various clinical elements of psoriasis must be sought, and those dots connected, as this case demonstrates effectively.

For one thing, the nape of the neck is commonly affected, especially in women. It is pure speculation, but one imagines that the heat and sweat associated with longer hair might contribute to this predilection.

The pink color, whitish scale, and pinpoint bleeding (termed the Auspitz sign) all corroborate the diagnosis, as does the positive family history and nail pitting. The intergluteal involvement was the icing on the cake; this is seen in only 2 common conditions: psoriasis and seborrhea.

The lesson? Even though psoriasis is supposed to appear on elbows, knees, and other extensor surfaces, sometimes it breaks the rules. The posterior neck was the primary area of involvement in this case, but sometimes psoriasis is completely confined to the scalp or the palms. And, of course, there are different types of psoriasis, some of which bear scant resemblance to psoriasis vulgaris. That’s where biopsies and/or referrals prove to be useful.

It is true that this patient’s rash could have had a fungal origin. When in doubt, however, a punch or shave biopsy would most likely settle the matter, since the histologic picture is usually pathognomic.

TAKE-HOME LEARNING POINTS

• Psoriasis is often be easy to diagnose—but just as often, it takes a bit of detective work.
• This “investigation” consists of looking for and asking about findings that could corroborate the diagnosis.
• The morphology of the neck lesion, as well as the Auspitz sign, nail pitting, intergluteal involvement, and family history in this case all served quite well to establish the diagnosis of psoriasis.
• It is helpful to remember how utterly common psoriasis is, affecting around 10,000,000 Americans.

For more than 2 years, this 36-year-old woman has had a slightly itchy rash that waxes and wanes on her posterior neck. She has consulted several primary care providers and received multiple diagnoses, the most consistent of which has been fungal infection. However, despite use of a variety of antifungal creams (nystatin, clotrimazole, and combination clotrimazole/betamethasone), a 1-month course of oral terbinafine, and OTC tolnaftate, no improvement has occurred.

The patient asserts that she is otherwise in good health, with no joint pain or fever and no history of recent health crises. Family history is free of dermatologic complaints except for psoriasis in her father.

EXAMINATION
A pink plaque with white, fairly adherent scale covers most of the patient’s posterior neck/upper midline back. When a 3-mm section of scaling is peeled away, 2 tiny dots of pinpoint bleeding are immediately noted.

The rest of her scalp is free of any such changes, as are her elbows and knees. But a similar rash is seen in the upper intergluteal area, and 3 of 10 fingernails are mildly pitted.

What’s the diagnosis?

DISCUSSION
Psoriasis vulgaris (common psoriasis) affects around 3% of the white population in this country. That incidence almost doubles in northern Europe and Scandinavia.

Psoriasis is so common that you should expect to see it regularly; the important question is not “Will you see it?” but rather “Will you know it when you see it?” Sometimes the various clinical elements of psoriasis must be sought, and those dots connected, as this case demonstrates effectively.

For one thing, the nape of the neck is commonly affected, especially in women. It is pure speculation, but one imagines that the heat and sweat associated with longer hair might contribute to this predilection.

The pink color, whitish scale, and pinpoint bleeding (termed the Auspitz sign) all corroborate the diagnosis, as does the positive family history and nail pitting. The intergluteal involvement was the icing on the cake; this is seen in only 2 common conditions: psoriasis and seborrhea.

The lesson? Even though psoriasis is supposed to appear on elbows, knees, and other extensor surfaces, sometimes it breaks the rules. The posterior neck was the primary area of involvement in this case, but sometimes psoriasis is completely confined to the scalp or the palms. And, of course, there are different types of psoriasis, some of which bear scant resemblance to psoriasis vulgaris. That’s where biopsies and/or referrals prove to be useful.

It is true that this patient’s rash could have had a fungal origin. When in doubt, however, a punch or shave biopsy would most likely settle the matter, since the histologic picture is usually pathognomic.

TAKE-HOME LEARNING POINTS

• Psoriasis is often be easy to diagnose—but just as often, it takes a bit of detective work.
• This “investigation” consists of looking for and asking about findings that could corroborate the diagnosis.
• The morphology of the neck lesion, as well as the Auspitz sign, nail pitting, intergluteal involvement, and family history in this case all served quite well to establish the diagnosis of psoriasis.
• It is helpful to remember how utterly common psoriasis is, affecting around 10,000,000 Americans.

MIAMI – Eating a Western diet correlated with significantly lower gut microbiome diversity in an observational study of 1,000 healthy men and women.

happy_lark/iStock/Getty Images

The chief culprits were fried foods, sodas, fatty sweets, processed meats, ready-cooked meals, and desserts, reported Valentin Partula, a PhD student at the Université Paris 13 Nord and his associates. The more often individuals reported consuming these, the fewer bacterial species were identified in their stool (P less than .05 for each association), the investigators wrote in a poster presented at the annual Gut Microbiota for Health World Summit.

Studies have linked decreased microbiota diversity with health conditions ranging from inflammatory bowel disease and colorectal cancer to diabetes mellitus. Obesity also is characterized by a less diverse microbiome and is linked to many of the same diseases, but the diversity (richness) of the gut microbiome appears to have more to do with diet than body mass index. However, interventional studies linking diet to microbiome shifts often have been small, narrow in scope, and short in duration, the researchers noted at the meeting sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility.

To help fill these gaps, they administered a 19-item food-frequency questionnaire to 1,000 healthy men and women in France who were 20-69 years old. Each food question had six possible responses, ranging from “at least twice a day” to “never.” For 862 of these men and women, the researchers also analyzed stool samples using 16S rRNA sequencing – a standard test for microbiome diversity. These sequencing results were analyzed in terms of both alpha diversity (the number of species within a sample, and the relative abundance of each) and beta diversity (the degree of dissimilarity among different individuals).

The most significant correlate of low alpha diversity (that is, a less diverse gut microbiome) was frequent consumption of fried foods, followed by sodas or sugary drinks, fatty sweet products, processed meats, ready-cooked meals, and desserts (P less than .05 for each). Conversely, raw fruits and fish each correlated with having a richer microbiome (P less than .05). Consuming eggs and raw and cooked vegetables also correlated with greater diversity, but these associations did not reach statistical significance.

In terms of beta diversity (uniqueness of the microbiome signature), the strongest correlates were fresh fruit, fried products, ready-cooked meals, and cheese. The finding for fresh fruit might be an effect of weighting but needs further study, the researchers said. Taken together, however, the findings “extend and support mechanistic arguments linking Western diet to altered microbiota composition,” they said.

Next, they looked at how specific foods correlated with specific bacterial taxa. Consuming more dairy correlated with a greater abundance of Streptococcus salivarius, which disrupts S. pyogenes biofilms in the pharynx and thus might help prevent bacterial pharyngitis. Eating raw fruits was tied to increases in Eubacterium eligens, a nonpathogenic bacterium whose role in the gut remains unclear. Finally, frequent cheese consumption was linked to lower abundance of Akkermansia muciniphila, a bacterium that is thought to benefit metabolic pathways and immune signaling.

For the same 846 individuals, the researchers performed ¹hydrogen nuclear magnetic resonance metabolomic tests on plasma Carr-Purcell-Meiboom-Gill (CPMG)–pulse sequence and nuclear Overhauser enhancement spectroscopy (NOESY). Increased creatinine was associated with the highest number of bacterial taxa and might reflect effects on kidney function or trimethylamine N-oxide, they wrote. Greater microbiome diversity correlated with higher plasma levels of amino acids, proteins, creatinine, choline, glucose, and citrate. Lower diversity was tied to the presence of lipid-based metabolites, including ketones and esters.

The next step is to confirm the findings in a separate population and establish which of these associations are probably causal, the researchers wrote. “Mechanistic studies elucidating the metabolic capability of the organisms [also] are needed.”

No external funding sources or conflicts of interest were reported.

MIAMI – Eating a Western diet correlated with significantly lower gut microbiome diversity in an observational study of 1,000 healthy men and women.

happy_lark/iStock/Getty Images

The chief culprits were fried foods, sodas, fatty sweets, processed meats, ready-cooked meals, and desserts, reported Valentin Partula, a PhD student at the Université Paris 13 Nord and his associates. The more often individuals reported consuming these, the fewer bacterial species were identified in their stool (P less than .05 for each association), the investigators wrote in a poster presented at the annual Gut Microbiota for Health World Summit.

Studies have linked decreased microbiota diversity with health conditions ranging from inflammatory bowel disease and colorectal cancer to diabetes mellitus. Obesity also is characterized by a less diverse microbiome and is linked to many of the same diseases, but the diversity (richness) of the gut microbiome appears to have more to do with diet than body mass index. However, interventional studies linking diet to microbiome shifts often have been small, narrow in scope, and short in duration, the researchers noted at the meeting sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility.

To help fill these gaps, they administered a 19-item food-frequency questionnaire to 1,000 healthy men and women in France who were 20-69 years old. Each food question had six possible responses, ranging from “at least twice a day” to “never.” For 862 of these men and women, the researchers also analyzed stool samples using 16S rRNA sequencing – a standard test for microbiome diversity. These sequencing results were analyzed in terms of both alpha diversity (the number of species within a sample, and the relative abundance of each) and beta diversity (the degree of dissimilarity among different individuals).

The most significant correlate of low alpha diversity (that is, a less diverse gut microbiome) was frequent consumption of fried foods, followed by sodas or sugary drinks, fatty sweet products, processed meats, ready-cooked meals, and desserts (P less than .05 for each). Conversely, raw fruits and fish each correlated with having a richer microbiome (P less than .05). Consuming eggs and raw and cooked vegetables also correlated with greater diversity, but these associations did not reach statistical significance.

In terms of beta diversity (uniqueness of the microbiome signature), the strongest correlates were fresh fruit, fried products, ready-cooked meals, and cheese. The finding for fresh fruit might be an effect of weighting but needs further study, the researchers said. Taken together, however, the findings “extend and support mechanistic arguments linking Western diet to altered microbiota composition,” they said.

Next, they looked at how specific foods correlated with specific bacterial taxa. Consuming more dairy correlated with a greater abundance of Streptococcus salivarius, which disrupts S. pyogenes biofilms in the pharynx and thus might help prevent bacterial pharyngitis. Eating raw fruits was tied to increases in Eubacterium eligens, a nonpathogenic bacterium whose role in the gut remains unclear. Finally, frequent cheese consumption was linked to lower abundance of Akkermansia muciniphila, a bacterium that is thought to benefit metabolic pathways and immune signaling.

For the same 846 individuals, the researchers performed ¹hydrogen nuclear magnetic resonance metabolomic tests on plasma Carr-Purcell-Meiboom-Gill (CPMG)–pulse sequence and nuclear Overhauser enhancement spectroscopy (NOESY). Increased creatinine was associated with the highest number of bacterial taxa and might reflect effects on kidney function or trimethylamine N-oxide, they wrote. Greater microbiome diversity correlated with higher plasma levels of amino acids, proteins, creatinine, choline, glucose, and citrate. Lower diversity was tied to the presence of lipid-based metabolites, including ketones and esters.

The next step is to confirm the findings in a separate population and establish which of these associations are probably causal, the researchers wrote. “Mechanistic studies elucidating the metabolic capability of the organisms [also] are needed.”

No external funding sources or conflicts of interest were reported.

MIAMI – Eating a Western diet correlated with significantly lower gut microbiome diversity in an observational study of 1,000 healthy men and women.

happy_lark/iStock/Getty Images

The chief culprits were fried foods, sodas, fatty sweets, processed meats, ready-cooked meals, and desserts, reported Valentin Partula, a PhD student at the Université Paris 13 Nord and his associates. The more often individuals reported consuming these, the fewer bacterial species were identified in their stool (P less than .05 for each association), the investigators wrote in a poster presented at the annual Gut Microbiota for Health World Summit.

Studies have linked decreased microbiota diversity with health conditions ranging from inflammatory bowel disease and colorectal cancer to diabetes mellitus. Obesity also is characterized by a less diverse microbiome and is linked to many of the same diseases, but the diversity (richness) of the gut microbiome appears to have more to do with diet than body mass index. However, interventional studies linking diet to microbiome shifts often have been small, narrow in scope, and short in duration, the researchers noted at the meeting sponsored by the American Gastroenterological Association and the European Society for Neurogastroenterology and Motility.

To help fill these gaps, they administered a 19-item food-frequency questionnaire to 1,000 healthy men and women in France who were 20-69 years old. Each food question had six possible responses, ranging from “at least twice a day” to “never.” For 862 of these men and women, the researchers also analyzed stool samples using 16S rRNA sequencing – a standard test for microbiome diversity. These sequencing results were analyzed in terms of both alpha diversity (the number of species within a sample, and the relative abundance of each) and beta diversity (the degree of dissimilarity among different individuals).

The most significant correlate of low alpha diversity (that is, a less diverse gut microbiome) was frequent consumption of fried foods, followed by sodas or sugary drinks, fatty sweet products, processed meats, ready-cooked meals, and desserts (P less than .05 for each). Conversely, raw fruits and fish each correlated with having a richer microbiome (P less than .05). Consuming eggs and raw and cooked vegetables also correlated with greater diversity, but these associations did not reach statistical significance.

In terms of beta diversity (uniqueness of the microbiome signature), the strongest correlates were fresh fruit, fried products, ready-cooked meals, and cheese. The finding for fresh fruit might be an effect of weighting but needs further study, the researchers said. Taken together, however, the findings “extend and support mechanistic arguments linking Western diet to altered microbiota composition,” they said.

Next, they looked at how specific foods correlated with specific bacterial taxa. Consuming more dairy correlated with a greater abundance of Streptococcus salivarius, which disrupts S. pyogenes biofilms in the pharynx and thus might help prevent bacterial pharyngitis. Eating raw fruits was tied to increases in Eubacterium eligens, a nonpathogenic bacterium whose role in the gut remains unclear. Finally, frequent cheese consumption was linked to lower abundance of Akkermansia muciniphila, a bacterium that is thought to benefit metabolic pathways and immune signaling.

For the same 846 individuals, the researchers performed ¹hydrogen nuclear magnetic resonance metabolomic tests on plasma Carr-Purcell-Meiboom-Gill (CPMG)–pulse sequence and nuclear Overhauser enhancement spectroscopy (NOESY). Increased creatinine was associated with the highest number of bacterial taxa and might reflect effects on kidney function or trimethylamine N-oxide, they wrote. Greater microbiome diversity correlated with higher plasma levels of amino acids, proteins, creatinine, choline, glucose, and citrate. Lower diversity was tied to the presence of lipid-based metabolites, including ketones and esters.

The next step is to confirm the findings in a separate population and establish which of these associations are probably causal, the researchers wrote. “Mechanistic studies elucidating the metabolic capability of the organisms [also] are needed.”

No external funding sources or conflicts of interest were reported.

A 56% increase in neonatal herpes simplex virus (HSV) infection over 7 years was determined as part of a retrospective, multistate, longitudinal cohort study using information collected from the MarketScan Medicaid Database, reported Sanjay Mahant, MD, of the University of Toronto, and his associates.

Comprehensive coordinated care – as well as public health strategies targeting disease prevention, early diagnosis, and treatment – are needed to manage the growing number of neonates diagnosed with HSV, Dr. Mahant and his colleagues said.

A total of 900 newborn Medicaid enrollees aged 0-28 days were chosen from 2,107,124 births for inclusion in the study. All patients, who were diagnosed with HSV infection during hospital admission, were born during Jan. 1, 2009–Dec. 31, 2015.

Susceptibility to primary HSV-1 infection among younger women has been attributed to an increase in oral sex practices over the past 2 decades, which is putting adolescents and young adults at greater risk of genital HSV-1 infection (J Infect Dis. 2007;196[12]:1852-9). As a result, more “primary or nonprimary genital HSV-1 infections among childbearing women” are believed to be the likely cause for the increasing numbers of neonatal HSV cases, the authors speculated, citing a recent study (J Infect Dis. 2014 Feb 1;209[3]:315-7).

HSV, a rare infection typically contracted immediately before or after birth, has both high morbidity and mortality rates; transmission rates “after exposure and during delivery increase from 2% in recurrent infection to 25% and 60% in nonprimary and primary infections, respectively,” Dr. Mahant and his colleagues noted.

Over the study period, disease incidence grew from 3.4/10,000 births in 2009 (1/2,941 births) to 5.3/10,000 births in 2015 (1/1,886 births).

Dr. Mahant and his associates noted several limitations in the study that might explain the increase in incidence.

ICD diagnosis codes, which they characterized as imperfect in their ability to correctly identify neonatal HSV infections, may have led researchers to include infants who were not actually infected or (less likely) to have excluded infants who were infected. States participating in the MarketScan Medicaid Database also may have changed over the study period. Incomplete follow-up after hospitalization made it impossible to track infants who had changed insurers, moved to other states, or died during the study. They also cautioned that outcomes may not be transferable to the general population because outcomes were specific to Medicaid enrollees.

The total cost for initial hospitalization and treatments provided during 6 months of follow-up was $60,620,431 ($87,602 median cost per patient) for the cohort of 900 infants. This is significant given that the authors reported a median length of stay of 18 days for initial hospitalization. Of the 846 patients discharged (54, or 6%, died during initial hospitalization), follow-up data was available for 692 (81%). A total of 316 (46%) infants required at least one subsequent visit to the emergency room, and another 112 (16%) experienced at least one hospital readmission.

That Dr. Mahant and his colleagues “observed high health care use and associated payments over the first 6 months, including and after hospitalization for neonatal HSV” suggests that there is a need for comprehensive, coordinated care once neonatal patients receive a diagnosis of HSV.

“Public health strategies that are targeted on disease prevention and early diagnosis and treatment are needed,” they advised.

The authors had no relevant financial disclosures. The study was funded by the National Institutes of Health.

SOURCE: Mahant S et al. Pediatrics. 2019 Mar. doi: 10.1542/peds.2018-3233.

A 56% increase in neonatal herpes simplex virus (HSV) infection over 7 years was determined as part of a retrospective, multistate, longitudinal cohort study using information collected from the MarketScan Medicaid Database, reported Sanjay Mahant, MD, of the University of Toronto, and his associates.

Comprehensive coordinated care – as well as public health strategies targeting disease prevention, early diagnosis, and treatment – are needed to manage the growing number of neonates diagnosed with HSV, Dr. Mahant and his colleagues said.

A total of 900 newborn Medicaid enrollees aged 0-28 days were chosen from 2,107,124 births for inclusion in the study. All patients, who were diagnosed with HSV infection during hospital admission, were born during Jan. 1, 2009–Dec. 31, 2015.

Susceptibility to primary HSV-1 infection among younger women has been attributed to an increase in oral sex practices over the past 2 decades, which is putting adolescents and young adults at greater risk of genital HSV-1 infection (J Infect Dis. 2007;196[12]:1852-9). As a result, more “primary or nonprimary genital HSV-1 infections among childbearing women” are believed to be the likely cause for the increasing numbers of neonatal HSV cases, the authors speculated, citing a recent study (J Infect Dis. 2014 Feb 1;209[3]:315-7).

HSV, a rare infection typically contracted immediately before or after birth, has both high morbidity and mortality rates; transmission rates “after exposure and during delivery increase from 2% in recurrent infection to 25% and 60% in nonprimary and primary infections, respectively,” Dr. Mahant and his colleagues noted.

Over the study period, disease incidence grew from 3.4/10,000 births in 2009 (1/2,941 births) to 5.3/10,000 births in 2015 (1/1,886 births).

Dr. Mahant and his associates noted several limitations in the study that might explain the increase in incidence.

ICD diagnosis codes, which they characterized as imperfect in their ability to correctly identify neonatal HSV infections, may have led researchers to include infants who were not actually infected or (less likely) to have excluded infants who were infected. States participating in the MarketScan Medicaid Database also may have changed over the study period. Incomplete follow-up after hospitalization made it impossible to track infants who had changed insurers, moved to other states, or died during the study. They also cautioned that outcomes may not be transferable to the general population because outcomes were specific to Medicaid enrollees.

The total cost for initial hospitalization and treatments provided during 6 months of follow-up was $60,620,431 ($87,602 median cost per patient) for the cohort of 900 infants. This is significant given that the authors reported a median length of stay of 18 days for initial hospitalization. Of the 846 patients discharged (54, or 6%, died during initial hospitalization), follow-up data was available for 692 (81%). A total of 316 (46%) infants required at least one subsequent visit to the emergency room, and another 112 (16%) experienced at least one hospital readmission.

That Dr. Mahant and his colleagues “observed high health care use and associated payments over the first 6 months, including and after hospitalization for neonatal HSV” suggests that there is a need for comprehensive, coordinated care once neonatal patients receive a diagnosis of HSV.

“Public health strategies that are targeted on disease prevention and early diagnosis and treatment are needed,” they advised.

The authors had no relevant financial disclosures. The study was funded by the National Institutes of Health.

SOURCE: Mahant S et al. Pediatrics. 2019 Mar. doi: 10.1542/peds.2018-3233.

A 56% increase in neonatal herpes simplex virus (HSV) infection over 7 years was determined as part of a retrospective, multistate, longitudinal cohort study using information collected from the MarketScan Medicaid Database, reported Sanjay Mahant, MD, of the University of Toronto, and his associates.

Comprehensive coordinated care – as well as public health strategies targeting disease prevention, early diagnosis, and treatment – are needed to manage the growing number of neonates diagnosed with HSV, Dr. Mahant and his colleagues said.

A total of 900 newborn Medicaid enrollees aged 0-28 days were chosen from 2,107,124 births for inclusion in the study. All patients, who were diagnosed with HSV infection during hospital admission, were born during Jan. 1, 2009–Dec. 31, 2015.

Susceptibility to primary HSV-1 infection among younger women has been attributed to an increase in oral sex practices over the past 2 decades, which is putting adolescents and young adults at greater risk of genital HSV-1 infection (J Infect Dis. 2007;196[12]:1852-9). As a result, more “primary or nonprimary genital HSV-1 infections among childbearing women” are believed to be the likely cause for the increasing numbers of neonatal HSV cases, the authors speculated, citing a recent study (J Infect Dis. 2014 Feb 1;209[3]:315-7).

HSV, a rare infection typically contracted immediately before or after birth, has both high morbidity and mortality rates; transmission rates “after exposure and during delivery increase from 2% in recurrent infection to 25% and 60% in nonprimary and primary infections, respectively,” Dr. Mahant and his colleagues noted.

Over the study period, disease incidence grew from 3.4/10,000 births in 2009 (1/2,941 births) to 5.3/10,000 births in 2015 (1/1,886 births).

Dr. Mahant and his associates noted several limitations in the study that might explain the increase in incidence.

ICD diagnosis codes, which they characterized as imperfect in their ability to correctly identify neonatal HSV infections, may have led researchers to include infants who were not actually infected or (less likely) to have excluded infants who were infected. States participating in the MarketScan Medicaid Database also may have changed over the study period. Incomplete follow-up after hospitalization made it impossible to track infants who had changed insurers, moved to other states, or died during the study. They also cautioned that outcomes may not be transferable to the general population because outcomes were specific to Medicaid enrollees.

The total cost for initial hospitalization and treatments provided during 6 months of follow-up was $60,620,431 ($87,602 median cost per patient) for the cohort of 900 infants. This is significant given that the authors reported a median length of stay of 18 days for initial hospitalization. Of the 846 patients discharged (54, or 6%, died during initial hospitalization), follow-up data was available for 692 (81%). A total of 316 (46%) infants required at least one subsequent visit to the emergency room, and another 112 (16%) experienced at least one hospital readmission.

That Dr. Mahant and his colleagues “observed high health care use and associated payments over the first 6 months, including and after hospitalization for neonatal HSV” suggests that there is a need for comprehensive, coordinated care once neonatal patients receive a diagnosis of HSV.

“Public health strategies that are targeted on disease prevention and early diagnosis and treatment are needed,” they advised.

The authors had no relevant financial disclosures. The study was funded by the National Institutes of Health.

SOURCE: Mahant S et al. Pediatrics. 2019 Mar. doi: 10.1542/peds.2018-3233.

WASHINGTON – At the annual meeting of the American Academy of Dermatology, the current and past presidents of the American Society for Laser Medicine and Surgery (ASLMS) sat down to discuss the Society’s annual meeting, taking place March 27-31, 2019, in Denver.

Vidyard Video

“ASLMS is always an amazing meeting, and it’s a unique meeting,” said past president Mathew Avram, MD, director of the Dermatology Laser & Cosmetic Center at Massachusetts General Hospital, Boston. “At its core, it’s a scientific meeting ... you can take things back to your practice that change the practice of medicine.”

Current ASLMS president Eric Bernstein, MD, of Main Line Center for Laser Surgery, Ardmore, Pa., pointed out that, in addition to doctors and other health care practitioners, other available and accessible attendees include the engineers who build the lasers. And this year, injectables are being incorporated into the program.

MDedge reporter Doug Brunk will be reporting from the meeting.

WASHINGTON – At the annual meeting of the American Academy of Dermatology, the current and past presidents of the American Society for Laser Medicine and Surgery (ASLMS) sat down to discuss the Society’s annual meeting, taking place March 27-31, 2019, in Denver.

Vidyard Video

“ASLMS is always an amazing meeting, and it’s a unique meeting,” said past president Mathew Avram, MD, director of the Dermatology Laser & Cosmetic Center at Massachusetts General Hospital, Boston. “At its core, it’s a scientific meeting ... you can take things back to your practice that change the practice of medicine.”

Current ASLMS president Eric Bernstein, MD, of Main Line Center for Laser Surgery, Ardmore, Pa., pointed out that, in addition to doctors and other health care practitioners, other available and accessible attendees include the engineers who build the lasers. And this year, injectables are being incorporated into the program.

MDedge reporter Doug Brunk will be reporting from the meeting.

WASHINGTON – At the annual meeting of the American Academy of Dermatology, the current and past presidents of the American Society for Laser Medicine and Surgery (ASLMS) sat down to discuss the Society’s annual meeting, taking place March 27-31, 2019, in Denver.

Vidyard Video

“ASLMS is always an amazing meeting, and it’s a unique meeting,” said past president Mathew Avram, MD, director of the Dermatology Laser & Cosmetic Center at Massachusetts General Hospital, Boston. “At its core, it’s a scientific meeting ... you can take things back to your practice that change the practice of medicine.”

Current ASLMS president Eric Bernstein, MD, of Main Line Center for Laser Surgery, Ardmore, Pa., pointed out that, in addition to doctors and other health care practitioners, other available and accessible attendees include the engineers who build the lasers. And this year, injectables are being incorporated into the program.

MDedge reporter Doug Brunk will be reporting from the meeting.

A 38-year-old man is admitted to the hospital with a painful, swollen left leg. This was not the first instance of this kind for him. He had been admitted for the same problem 3 months earlier. During the earlier admission, he was diagnosed with cellulitis and treated with intravenous cefazolin for 4 days, then discharged on cephalexin with resolution of his swelling and pain. Today, his blood pressure is 120/70, pulse is 90, temperature is 38.2°C, his left leg is edematous from the mid-calf to the ankle, and he has erythema and warmth over the calf. His white blood cell count is 13,000, and a diagnosis of cellulitis is made. Which of the following treatments is most likely to shorten his hospital stay?

Concheiro and colleagues did a retrospective study of 122 cases of cellulitis and found tinea pedis in 33% of the cases.⁶ Muller et al. studied the importance of toe web microorganisms and erysipelas and found that the presence of interdigital tinea pedis was correlated with recurrent infection.⁷ Treatment of tinea pedis is an easily modifiable risk factor in patients with recurrent cellulitis.

Pearls: Consider adding a short course of steroids in patients with more severe erysipelas/cellulitis, as it can decrease hospital stay and IV antibiotics.

Look for tinea pedis and treat if present in patients who have erysipelas/cellulitis.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

References

1. Arch Intern Med. 2008 May 26;168(10):1034-46.

2. Scand J Infect Dis 1997;29(4):377-82.

3. Scand J Infect Dis. 1998;30(2):206-7.

4. Isr Med Assoc J. 2018 Mar;20(3):137-40.

5. J Dtsch Dermatol Ges. 2004 Feb;2(2):89-95.

6. Actas Dermosifiliogr. 2009 Dec;100(10):888-94.

7. J Dtsch Dermatol Ges. 2014 Aug;12(8):691-5.

A 38-year-old man is admitted to the hospital with a painful, swollen left leg. This was not the first instance of this kind for him. He had been admitted for the same problem 3 months earlier. During the earlier admission, he was diagnosed with cellulitis and treated with intravenous cefazolin for 4 days, then discharged on cephalexin with resolution of his swelling and pain. Today, his blood pressure is 120/70, pulse is 90, temperature is 38.2°C, his left leg is edematous from the mid-calf to the ankle, and he has erythema and warmth over the calf. His white blood cell count is 13,000, and a diagnosis of cellulitis is made. Which of the following treatments is most likely to shorten his hospital stay?

Concheiro and colleagues did a retrospective study of 122 cases of cellulitis and found tinea pedis in 33% of the cases.⁶ Muller et al. studied the importance of toe web microorganisms and erysipelas and found that the presence of interdigital tinea pedis was correlated with recurrent infection.⁷ Treatment of tinea pedis is an easily modifiable risk factor in patients with recurrent cellulitis.

Pearls: Consider adding a short course of steroids in patients with more severe erysipelas/cellulitis, as it can decrease hospital stay and IV antibiotics.

Look for tinea pedis and treat if present in patients who have erysipelas/cellulitis.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

References

1. Arch Intern Med. 2008 May 26;168(10):1034-46.

2. Scand J Infect Dis 1997;29(4):377-82.

3. Scand J Infect Dis. 1998;30(2):206-7.

4. Isr Med Assoc J. 2018 Mar;20(3):137-40.

5. J Dtsch Dermatol Ges. 2004 Feb;2(2):89-95.

6. Actas Dermosifiliogr. 2009 Dec;100(10):888-94.

7. J Dtsch Dermatol Ges. 2014 Aug;12(8):691-5.

A 38-year-old man is admitted to the hospital with a painful, swollen left leg. This was not the first instance of this kind for him. He had been admitted for the same problem 3 months earlier. During the earlier admission, he was diagnosed with cellulitis and treated with intravenous cefazolin for 4 days, then discharged on cephalexin with resolution of his swelling and pain. Today, his blood pressure is 120/70, pulse is 90, temperature is 38.2°C, his left leg is edematous from the mid-calf to the ankle, and he has erythema and warmth over the calf. His white blood cell count is 13,000, and a diagnosis of cellulitis is made. Which of the following treatments is most likely to shorten his hospital stay?

Concheiro and colleagues did a retrospective study of 122 cases of cellulitis and found tinea pedis in 33% of the cases.⁶ Muller et al. studied the importance of toe web microorganisms and erysipelas and found that the presence of interdigital tinea pedis was correlated with recurrent infection.⁷ Treatment of tinea pedis is an easily modifiable risk factor in patients with recurrent cellulitis.

Pearls: Consider adding a short course of steroids in patients with more severe erysipelas/cellulitis, as it can decrease hospital stay and IV antibiotics.

Look for tinea pedis and treat if present in patients who have erysipelas/cellulitis.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

References

1. Arch Intern Med. 2008 May 26;168(10):1034-46.

2. Scand J Infect Dis 1997;29(4):377-82.

3. Scand J Infect Dis. 1998;30(2):206-7.

4. Isr Med Assoc J. 2018 Mar;20(3):137-40.

5. J Dtsch Dermatol Ges. 2004 Feb;2(2):89-95.

6. Actas Dermosifiliogr. 2009 Dec;100(10):888-94.

7. J Dtsch Dermatol Ges. 2014 Aug;12(8):691-5.

Starting April 1, 2019, intravenous artesunate will become the first-line treatment for malaria in the United States, following the discontinuation of quinidine, the only Food and Drug Administration–approved intravenous drug for severe malaria treatment.

Although artesunate is not approved or commercially available in the United States, it is recommended by the World Health Organization. The Centers for Disease Control and Prevention have made the drug available through an expanded use investigational new drug protocol, an FDA regulatory mechanism. Clinicians can obtain the medication through the CDC’s Malaria Hotline (770-488-7788); artesunate will be stocked at 10 quarantine stations and will be released to hospitals free of charge, according to a CDC announcement.

Clinical trials have illustrated that intravenous artesunate is safe, well tolerated, and can be administered even to infants, children, and pregnant women in the second and third trimester.

About 1,700 cases of malaria are reported in the United States per year, 300 of which are classified as severe. The CDC believes the supply of artesunate obtained will be sufficient to treat all cases of severe malaria in the country, according to a CDC press release.

[email protected]

Starting April 1, 2019, intravenous artesunate will become the first-line treatment for malaria in the United States, following the discontinuation of quinidine, the only Food and Drug Administration–approved intravenous drug for severe malaria treatment.

Although artesunate is not approved or commercially available in the United States, it is recommended by the World Health Organization. The Centers for Disease Control and Prevention have made the drug available through an expanded use investigational new drug protocol, an FDA regulatory mechanism. Clinicians can obtain the medication through the CDC’s Malaria Hotline (770-488-7788); artesunate will be stocked at 10 quarantine stations and will be released to hospitals free of charge, according to a CDC announcement.

Clinical trials have illustrated that intravenous artesunate is safe, well tolerated, and can be administered even to infants, children, and pregnant women in the second and third trimester.

About 1,700 cases of malaria are reported in the United States per year, 300 of which are classified as severe. The CDC believes the supply of artesunate obtained will be sufficient to treat all cases of severe malaria in the country, according to a CDC press release.

[email protected]

Starting April 1, 2019, intravenous artesunate will become the first-line treatment for malaria in the United States, following the discontinuation of quinidine, the only Food and Drug Administration–approved intravenous drug for severe malaria treatment.

Although artesunate is not approved or commercially available in the United States, it is recommended by the World Health Organization. The Centers for Disease Control and Prevention have made the drug available through an expanded use investigational new drug protocol, an FDA regulatory mechanism. Clinicians can obtain the medication through the CDC’s Malaria Hotline (770-488-7788); artesunate will be stocked at 10 quarantine stations and will be released to hospitals free of charge, according to a CDC announcement.

Clinical trials have illustrated that intravenous artesunate is safe, well tolerated, and can be administered even to infants, children, and pregnant women in the second and third trimester.

About 1,700 cases of malaria are reported in the United States per year, 300 of which are classified as severe. The CDC believes the supply of artesunate obtained will be sufficient to treat all cases of severe malaria in the country, according to a CDC press release.

[email protected]

Food and Drug Administration Commissioner Scott Gottlieb, MD, announced in a tweet Wednesday that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices.

“We’re now prioritizing making ALL of this data available,” Dr. Gottlieb tweeted.

A recent Kaiser Health News investigation revealed the scope of a hidden reporting pathway for device makers, with the agency accepting more than 1.1 million such reports since the start of 2016.

Device makers for nearly 20 years were able to quietly seek an “exemption” from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart-surgery patients.

Dr. Gottlieb’s tweet also referenced the challenge in opening the database, saying it “wasn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public.”

The agency made changes to the “alternative summary reporting” program in mid-2017 to require a public report summarizing data filed within the FDA. But nearly two decades of data remained cordoned off from doctors, patients, and device-safety researchers who say they could use it to detect problems.

Dr. Gottlieb’s announcement was welcomed by Madris Tomes, who has testified to FDA device-review panels about the importance of making summary data on patient harm open to the public.

“That’s the best news I’ve heard in years,” said Ms. Tomes, president of Device Events, which makes the FDA device-harm data more user-friendly. “I’m really happy that they’re taking notice and realizing that physicians who couldn’t see this data before were using devices that they wouldn’t have used if they had this data in front of them.”

Since September, KHN has filed Freedom of Information Act requests for parts or all of the “alternative summary reporting” database and for other special “exemption” reports, to little effect. A request to expedite delivery of those records was denied, and the FDA cited the lack of “compelling need” for the public to have the information. Officials noted that it might take up to 2 years to get such records through the FOIA process.

As recently as March 22, though, the agency began publishing previously undisclosed reports of harm, suddenly updating the numbers of breast implant malfunctions or injuries submitted over the years. The new data was presented to an FDA advisory panel, which is reviewing the safety of such devices. The panel, which met March 25 and 26, saw a chart showing hundreds of thousands more accounts of harm or malfunctions than had previously been acknowledged.

Michael Carome, MD, director of Public Citizen’s health research group, said his initial reaction to the news is “better late than never.”

“If [Dr. Gottlieb] follows through with his pledge to make all this data public, then that’s certainly a positive development,” he said. “But this is safety information that should have been made available years ago.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Food and Drug Administration Commissioner Scott Gottlieb, MD, announced in a tweet Wednesday that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices.

“We’re now prioritizing making ALL of this data available,” Dr. Gottlieb tweeted.

A recent Kaiser Health News investigation revealed the scope of a hidden reporting pathway for device makers, with the agency accepting more than 1.1 million such reports since the start of 2016.

Device makers for nearly 20 years were able to quietly seek an “exemption” from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart-surgery patients.

Dr. Gottlieb’s tweet also referenced the challenge in opening the database, saying it “wasn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public.”

The agency made changes to the “alternative summary reporting” program in mid-2017 to require a public report summarizing data filed within the FDA. But nearly two decades of data remained cordoned off from doctors, patients, and device-safety researchers who say they could use it to detect problems.

Dr. Gottlieb’s announcement was welcomed by Madris Tomes, who has testified to FDA device-review panels about the importance of making summary data on patient harm open to the public.

“That’s the best news I’ve heard in years,” said Ms. Tomes, president of Device Events, which makes the FDA device-harm data more user-friendly. “I’m really happy that they’re taking notice and realizing that physicians who couldn’t see this data before were using devices that they wouldn’t have used if they had this data in front of them.”

Since September, KHN has filed Freedom of Information Act requests for parts or all of the “alternative summary reporting” database and for other special “exemption” reports, to little effect. A request to expedite delivery of those records was denied, and the FDA cited the lack of “compelling need” for the public to have the information. Officials noted that it might take up to 2 years to get such records through the FOIA process.

As recently as March 22, though, the agency began publishing previously undisclosed reports of harm, suddenly updating the numbers of breast implant malfunctions or injuries submitted over the years. The new data was presented to an FDA advisory panel, which is reviewing the safety of such devices. The panel, which met March 25 and 26, saw a chart showing hundreds of thousands more accounts of harm or malfunctions than had previously been acknowledged.

Michael Carome, MD, director of Public Citizen’s health research group, said his initial reaction to the news is “better late than never.”

“If [Dr. Gottlieb] follows through with his pledge to make all this data public, then that’s certainly a positive development,” he said. “But this is safety information that should have been made available years ago.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Food and Drug Administration Commissioner Scott Gottlieb, MD, announced in a tweet Wednesday that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices.

“We’re now prioritizing making ALL of this data available,” Dr. Gottlieb tweeted.

A recent Kaiser Health News investigation revealed the scope of a hidden reporting pathway for device makers, with the agency accepting more than 1.1 million such reports since the start of 2016.

Device makers for nearly 20 years were able to quietly seek an “exemption” from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart-surgery patients.

Dr. Gottlieb’s tweet also referenced the challenge in opening the database, saying it “wasn’t easily accessible electronically owing to the system’s age. But it’s imperative that all safety information be available to the public.”

The agency made changes to the “alternative summary reporting” program in mid-2017 to require a public report summarizing data filed within the FDA. But nearly two decades of data remained cordoned off from doctors, patients, and device-safety researchers who say they could use it to detect problems.

Dr. Gottlieb’s announcement was welcomed by Madris Tomes, who has testified to FDA device-review panels about the importance of making summary data on patient harm open to the public.

“That’s the best news I’ve heard in years,” said Ms. Tomes, president of Device Events, which makes the FDA device-harm data more user-friendly. “I’m really happy that they’re taking notice and realizing that physicians who couldn’t see this data before were using devices that they wouldn’t have used if they had this data in front of them.”

Since September, KHN has filed Freedom of Information Act requests for parts or all of the “alternative summary reporting” database and for other special “exemption” reports, to little effect. A request to expedite delivery of those records was denied, and the FDA cited the lack of “compelling need” for the public to have the information. Officials noted that it might take up to 2 years to get such records through the FOIA process.

As recently as March 22, though, the agency began publishing previously undisclosed reports of harm, suddenly updating the numbers of breast implant malfunctions or injuries submitted over the years. The new data was presented to an FDA advisory panel, which is reviewing the safety of such devices. The panel, which met March 25 and 26, saw a chart showing hundreds of thousands more accounts of harm or malfunctions than had previously been acknowledged.

Michael Carome, MD, director of Public Citizen’s health research group, said his initial reaction to the news is “better late than never.”

“If [Dr. Gottlieb] follows through with his pledge to make all this data public, then that’s certainly a positive development,” he said. “But this is safety information that should have been made available years ago.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The Food and Drug Administration approved certolizumab pegol (Cimzia) on March 28 for the treatment of patients with nonradiographic axial spondyloarthritis, with objective evidence of inflammation, making it the first treatment approved by the agency for the condition.

The FDA approved the tumor necrosis factor inhibitor based on results from a randomized clinical trial in 317 adult patients with nonradiographic axial spondyloarthritis (nr-axSpA) who had elevated C-reactive protein levels and/or sacroiliitis (inflammation of the sacroiliac joints) on MRI.

The trial entailed 52 weeks of double-blind therapy with certolizumab at a starting dose of 400 mg on weeks 0, 2, and 4 followed by 200 mg every 2 weeks, or placebo. The Ankylosing Spondylitis Disease Activity Score Major Improvement rate, defined as at least a 2-point improvement from baseline, was 47% in the active treatment arm, compared with 7% on placebo. The Assessment in Ankylosing Spondylitis International Society 40% response rate, a more patient-reported outcome measure, was 57% in the certolizumab group and 16% in controls (Arthritis Rheumatol. 2019 March 8. doi: 10.1002/art.40866).

The overall safety profile observed in the Cimzia treatment group was consistent with the known safety profile of certolizumab.

Cimzia was first approved in 2008 and has FDA-approved indications for adult patients with Crohn’s disease, moderate to severe rheumatoid arthritis, active ankylosing spondylitis and moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

[email protected]

The Food and Drug Administration approved certolizumab pegol (Cimzia) on March 28 for the treatment of patients with nonradiographic axial spondyloarthritis, with objective evidence of inflammation, making it the first treatment approved by the agency for the condition.

The FDA approved the tumor necrosis factor inhibitor based on results from a randomized clinical trial in 317 adult patients with nonradiographic axial spondyloarthritis (nr-axSpA) who had elevated C-reactive protein levels and/or sacroiliitis (inflammation of the sacroiliac joints) on MRI.

The trial entailed 52 weeks of double-blind therapy with certolizumab at a starting dose of 400 mg on weeks 0, 2, and 4 followed by 200 mg every 2 weeks, or placebo. The Ankylosing Spondylitis Disease Activity Score Major Improvement rate, defined as at least a 2-point improvement from baseline, was 47% in the active treatment arm, compared with 7% on placebo. The Assessment in Ankylosing Spondylitis International Society 40% response rate, a more patient-reported outcome measure, was 57% in the certolizumab group and 16% in controls (Arthritis Rheumatol. 2019 March 8. doi: 10.1002/art.40866).

The overall safety profile observed in the Cimzia treatment group was consistent with the known safety profile of certolizumab.

Cimzia was first approved in 2008 and has FDA-approved indications for adult patients with Crohn’s disease, moderate to severe rheumatoid arthritis, active ankylosing spondylitis and moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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The Food and Drug Administration approved certolizumab pegol (Cimzia) on March 28 for the treatment of patients with nonradiographic axial spondyloarthritis, with objective evidence of inflammation, making it the first treatment approved by the agency for the condition.

The FDA approved the tumor necrosis factor inhibitor based on results from a randomized clinical trial in 317 adult patients with nonradiographic axial spondyloarthritis (nr-axSpA) who had elevated C-reactive protein levels and/or sacroiliitis (inflammation of the sacroiliac joints) on MRI.

The trial entailed 52 weeks of double-blind therapy with certolizumab at a starting dose of 400 mg on weeks 0, 2, and 4 followed by 200 mg every 2 weeks, or placebo. The Ankylosing Spondylitis Disease Activity Score Major Improvement rate, defined as at least a 2-point improvement from baseline, was 47% in the active treatment arm, compared with 7% on placebo. The Assessment in Ankylosing Spondylitis International Society 40% response rate, a more patient-reported outcome measure, was 57% in the certolizumab group and 16% in controls (Arthritis Rheumatol. 2019 March 8. doi: 10.1002/art.40866).

The overall safety profile observed in the Cimzia treatment group was consistent with the known safety profile of certolizumab.

Cimzia was first approved in 2008 and has FDA-approved indications for adult patients with Crohn’s disease, moderate to severe rheumatoid arthritis, active ankylosing spondylitis and moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

[email protected]