Micrograph showing MCL

Researchers say they have developed a system for delivering therapy at the site of mantle cell lymphoma (MCL).

The system harnesses nanoparticles coated with “GPS” antibodies that navigate toward cancerous cells, where they offload cyclin D1-blockers in the form of small interfering RNAs (siRNAs).

Experiments showed the system can halt the proliferation of cyclin D1 in both animal models and samples from MCL patients.

Dan Peer, PhD, of Tel Aviv University in Israel, and his colleagues reported these results in PNAS.

“MCL has a genetic hallmark,” Dr Peer noted. “In 85% of cases, the characteristic that defines this aggressive and prototypic B-cell lymphoma is the heightened activity of the gene CCND1, which leads to the extreme overexpression—a 3000- to 15,000-fold increase—of cyclin D1, a protein that controls the proliferation of cells. Downregulation of cyclin D1 using siRNAs is a potential therapeutic approach to this malignancy.”

For this research, Dr Peer and his colleagues designed lipid-based nanoparticles (LNPs) coated with anti-CD38 monoclonal antibodies that were taken up by human MCL cells in the bone marrow of affected mice.

When loaded with siRNAs against cyclin D1, the targeting LNPs induced gene silencing in MCL cells and prolonged the survival of tumor-bearing mice, with no observed adverse effects.

“In MCL, cyclin D1 is the exclusive cause of the overproduction of B lymphocytes, the cells responsible for generating antibodies,” Dr Peer said. “This makes the protein a perfect target for RNA therapy by siRNAs.”

“Normal, healthy cells don’t express the gene, so therapies that destroy the gene will only attack cancer cells. The RNA interference we have developed targets the faulty cyclin D1 within the cancerous cells. And when the cells are inhibited from proliferating, they sense they are being targeted and begin to die off.”

Dr Peer and his colleagues believe this work presents new opportunities for treating MCL and other similar B-cell malignancies.

“This research makes a definite contribution to the revolution of personalized medicine, whereby you tailor the drug based on the genetic profile of patient,” Dr Peer said. “In this case, MCL is a disease with a specific genetic hallmark, so you can sequence the patient to identify the mutation(s) and design RNA blockers to be placed inside a nanovehicle.”

“While the targeting antibodies—the ‘GPS’—can be used to target many different B-cell malignancies, the drug itself is designed to silence this specific disease. However, the delivery system can be used to accommodate any disease with a genetic profile. This could be the future. We are seeing it happen before our very eyes.”

Micrograph showing MCL

Researchers say they have developed a system for delivering therapy at the site of mantle cell lymphoma (MCL).

The system harnesses nanoparticles coated with “GPS” antibodies that navigate toward cancerous cells, where they offload cyclin D1-blockers in the form of small interfering RNAs (siRNAs).

Experiments showed the system can halt the proliferation of cyclin D1 in both animal models and samples from MCL patients.

Dan Peer, PhD, of Tel Aviv University in Israel, and his colleagues reported these results in PNAS.

“MCL has a genetic hallmark,” Dr Peer noted. “In 85% of cases, the characteristic that defines this aggressive and prototypic B-cell lymphoma is the heightened activity of the gene CCND1, which leads to the extreme overexpression—a 3000- to 15,000-fold increase—of cyclin D1, a protein that controls the proliferation of cells. Downregulation of cyclin D1 using siRNAs is a potential therapeutic approach to this malignancy.”

For this research, Dr Peer and his colleagues designed lipid-based nanoparticles (LNPs) coated with anti-CD38 monoclonal antibodies that were taken up by human MCL cells in the bone marrow of affected mice.

When loaded with siRNAs against cyclin D1, the targeting LNPs induced gene silencing in MCL cells and prolonged the survival of tumor-bearing mice, with no observed adverse effects.

“In MCL, cyclin D1 is the exclusive cause of the overproduction of B lymphocytes, the cells responsible for generating antibodies,” Dr Peer said. “This makes the protein a perfect target for RNA therapy by siRNAs.”

“Normal, healthy cells don’t express the gene, so therapies that destroy the gene will only attack cancer cells. The RNA interference we have developed targets the faulty cyclin D1 within the cancerous cells. And when the cells are inhibited from proliferating, they sense they are being targeted and begin to die off.”

Dr Peer and his colleagues believe this work presents new opportunities for treating MCL and other similar B-cell malignancies.

“This research makes a definite contribution to the revolution of personalized medicine, whereby you tailor the drug based on the genetic profile of patient,” Dr Peer said. “In this case, MCL is a disease with a specific genetic hallmark, so you can sequence the patient to identify the mutation(s) and design RNA blockers to be placed inside a nanovehicle.”

“While the targeting antibodies—the ‘GPS’—can be used to target many different B-cell malignancies, the drug itself is designed to silence this specific disease. However, the delivery system can be used to accommodate any disease with a genetic profile. This could be the future. We are seeing it happen before our very eyes.”

Micrograph showing MCL

Researchers say they have developed a system for delivering therapy at the site of mantle cell lymphoma (MCL).

The system harnesses nanoparticles coated with “GPS” antibodies that navigate toward cancerous cells, where they offload cyclin D1-blockers in the form of small interfering RNAs (siRNAs).

Experiments showed the system can halt the proliferation of cyclin D1 in both animal models and samples from MCL patients.

Dan Peer, PhD, of Tel Aviv University in Israel, and his colleagues reported these results in PNAS.

“MCL has a genetic hallmark,” Dr Peer noted. “In 85% of cases, the characteristic that defines this aggressive and prototypic B-cell lymphoma is the heightened activity of the gene CCND1, which leads to the extreme overexpression—a 3000- to 15,000-fold increase—of cyclin D1, a protein that controls the proliferation of cells. Downregulation of cyclin D1 using siRNAs is a potential therapeutic approach to this malignancy.”

For this research, Dr Peer and his colleagues designed lipid-based nanoparticles (LNPs) coated with anti-CD38 monoclonal antibodies that were taken up by human MCL cells in the bone marrow of affected mice.

When loaded with siRNAs against cyclin D1, the targeting LNPs induced gene silencing in MCL cells and prolonged the survival of tumor-bearing mice, with no observed adverse effects.

“In MCL, cyclin D1 is the exclusive cause of the overproduction of B lymphocytes, the cells responsible for generating antibodies,” Dr Peer said. “This makes the protein a perfect target for RNA therapy by siRNAs.”

“Normal, healthy cells don’t express the gene, so therapies that destroy the gene will only attack cancer cells. The RNA interference we have developed targets the faulty cyclin D1 within the cancerous cells. And when the cells are inhibited from proliferating, they sense they are being targeted and begin to die off.”

Dr Peer and his colleagues believe this work presents new opportunities for treating MCL and other similar B-cell malignancies.

“This research makes a definite contribution to the revolution of personalized medicine, whereby you tailor the drug based on the genetic profile of patient,” Dr Peer said. “In this case, MCL is a disease with a specific genetic hallmark, so you can sequence the patient to identify the mutation(s) and design RNA blockers to be placed inside a nanovehicle.”

“While the targeting antibodies—the ‘GPS’—can be used to target many different B-cell malignancies, the drug itself is designed to silence this specific disease. However, the delivery system can be used to accommodate any disease with a genetic profile. This could be the future. We are seeing it happen before our very eyes.”

Radiation therapist preparing

woman for radiation

Photo by Rhoda Baer

A topical paste can reduce fibrosis caused by radiation therapy, according to preclinical research published in The FASEB Journal.

The study addressed a type of fibrosis called radiation dermatitis, in which radiation applied to the skin causes the buildup of fibrotic tissue and skin thickening.

To test their topical paste, researchers mimicked the development of radiation dermatitis in mice.

They exposed the mice’s skin to a single dose of 40 Gy, an amount of radiation similar to what patients undergoing anticancer radiation typically receive over 5 weeks.

Some of the irradiated animals were wild-type mice, while others were genetically engineered to lack the A2A receptor (A2AR). The researchers had previously shown that occupancy of A2AR induces collagen production.

The wild-type mice went on to receive placebo or daily treatment with ZM241385, a paste made with the research team’s patented A2AR blocker. The paste contains 2.5 milligrams of active ingredient per milliliter of 3% carboxymethyl cellulose, a gum “binder.”

A month after exposure, wild-type mice that received placebo had a nearly 2-fold increase in the amount of collagen and skin thickness. These mice also experienced epithelial hyperplasia.

On the other hand, mice treated with ZM241385 accumulated only 10% more skin-thickening collagen. ZM241385 treatment reduced the number of myofibroblasts, collagen fibrils, proliferating keratinocytes, and angiogenesis when compared to placebo. And the paste prevented epithelial hyperplasia.

Like ZM241385-treated mice, A2AR knockout mice did not have the excessive collagen production and skin thickening observed in placebo-treated wild-type mice. The knockout mice also exhibited reductions in myofibroblast content, angiogenesis, and epithelial hyperplasia.

The researchers noted that radiation-induced changes in the dermis and epidermis were accompanied by an infiltrate of T cells, which was prevented in both ZM241385-treated and A2AR knockout mice.

“Our latest study is the first to demonstrate that blocking or deleting the A2A receptor can be useful in reducing radiation-induced scarring in skin,” said study author Bruce Cronstein, MD, of New York University School of Medicine in New York, New York.

“The study also suggests that adenosine A2A receptor antagonists may have broad applications as drug therapies for preventing fibrosis and scarring, not just in the liver but also in the skin.”

If further experiments prove successful, Dr Cronstein said, clinicians treating early stage cancers with radiation could eventually prescribe an A2AR inhibitor paste to prevent fibrosis. He said his team next plans to study the mechanism underlying A2AR’s role in fibrosis.

Radiation therapist preparing

woman for radiation

Photo by Rhoda Baer

A topical paste can reduce fibrosis caused by radiation therapy, according to preclinical research published in The FASEB Journal.

The study addressed a type of fibrosis called radiation dermatitis, in which radiation applied to the skin causes the buildup of fibrotic tissue and skin thickening.

To test their topical paste, researchers mimicked the development of radiation dermatitis in mice.

They exposed the mice’s skin to a single dose of 40 Gy, an amount of radiation similar to what patients undergoing anticancer radiation typically receive over 5 weeks.

Some of the irradiated animals were wild-type mice, while others were genetically engineered to lack the A2A receptor (A2AR). The researchers had previously shown that occupancy of A2AR induces collagen production.

The wild-type mice went on to receive placebo or daily treatment with ZM241385, a paste made with the research team’s patented A2AR blocker. The paste contains 2.5 milligrams of active ingredient per milliliter of 3% carboxymethyl cellulose, a gum “binder.”

A month after exposure, wild-type mice that received placebo had a nearly 2-fold increase in the amount of collagen and skin thickness. These mice also experienced epithelial hyperplasia.

On the other hand, mice treated with ZM241385 accumulated only 10% more skin-thickening collagen. ZM241385 treatment reduced the number of myofibroblasts, collagen fibrils, proliferating keratinocytes, and angiogenesis when compared to placebo. And the paste prevented epithelial hyperplasia.

Like ZM241385-treated mice, A2AR knockout mice did not have the excessive collagen production and skin thickening observed in placebo-treated wild-type mice. The knockout mice also exhibited reductions in myofibroblast content, angiogenesis, and epithelial hyperplasia.

The researchers noted that radiation-induced changes in the dermis and epidermis were accompanied by an infiltrate of T cells, which was prevented in both ZM241385-treated and A2AR knockout mice.

“Our latest study is the first to demonstrate that blocking or deleting the A2A receptor can be useful in reducing radiation-induced scarring in skin,” said study author Bruce Cronstein, MD, of New York University School of Medicine in New York, New York.

“The study also suggests that adenosine A2A receptor antagonists may have broad applications as drug therapies for preventing fibrosis and scarring, not just in the liver but also in the skin.”

If further experiments prove successful, Dr Cronstein said, clinicians treating early stage cancers with radiation could eventually prescribe an A2AR inhibitor paste to prevent fibrosis. He said his team next plans to study the mechanism underlying A2AR’s role in fibrosis.

Radiation therapist preparing

woman for radiation

Photo by Rhoda Baer

A topical paste can reduce fibrosis caused by radiation therapy, according to preclinical research published in The FASEB Journal.

The study addressed a type of fibrosis called radiation dermatitis, in which radiation applied to the skin causes the buildup of fibrotic tissue and skin thickening.

To test their topical paste, researchers mimicked the development of radiation dermatitis in mice.

They exposed the mice’s skin to a single dose of 40 Gy, an amount of radiation similar to what patients undergoing anticancer radiation typically receive over 5 weeks.

Some of the irradiated animals were wild-type mice, while others were genetically engineered to lack the A2A receptor (A2AR). The researchers had previously shown that occupancy of A2AR induces collagen production.

The wild-type mice went on to receive placebo or daily treatment with ZM241385, a paste made with the research team’s patented A2AR blocker. The paste contains 2.5 milligrams of active ingredient per milliliter of 3% carboxymethyl cellulose, a gum “binder.”

A month after exposure, wild-type mice that received placebo had a nearly 2-fold increase in the amount of collagen and skin thickness. These mice also experienced epithelial hyperplasia.

On the other hand, mice treated with ZM241385 accumulated only 10% more skin-thickening collagen. ZM241385 treatment reduced the number of myofibroblasts, collagen fibrils, proliferating keratinocytes, and angiogenesis when compared to placebo. And the paste prevented epithelial hyperplasia.

Like ZM241385-treated mice, A2AR knockout mice did not have the excessive collagen production and skin thickening observed in placebo-treated wild-type mice. The knockout mice also exhibited reductions in myofibroblast content, angiogenesis, and epithelial hyperplasia.

The researchers noted that radiation-induced changes in the dermis and epidermis were accompanied by an infiltrate of T cells, which was prevented in both ZM241385-treated and A2AR knockout mice.

“Our latest study is the first to demonstrate that blocking or deleting the A2A receptor can be useful in reducing radiation-induced scarring in skin,” said study author Bruce Cronstein, MD, of New York University School of Medicine in New York, New York.

“The study also suggests that adenosine A2A receptor antagonists may have broad applications as drug therapies for preventing fibrosis and scarring, not just in the liver but also in the skin.”

If further experiments prove successful, Dr Cronstein said, clinicians treating early stage cancers with radiation could eventually prescribe an A2AR inhibitor paste to prevent fibrosis. He said his team next plans to study the mechanism underlying A2AR’s role in fibrosis.

Drosophila melanogaster

Photo by Andre Karwath

New research has revealed a mechanism that allows cancer cells to respond and grow rapidly when blood sugar levels rise.

This may help to explain why people who develop conditions in which they have chronically high blood sugar levels, such as obesity, also have an increased risk of developing certain cancers.

Susumu Hirabayashi, PhD, of Imperial College London in the UK, and Ross Cagan, PhD, of Mount Sinai Hospital in New York, New York, described the mechanism in eLife.

In a study published 2 years ago, the pair engineered fruit flies (Drosophila melanogaster) to activate the genes Ras and Src, which are activated in a range of malignancies.

The researchers activated Ras and Src in the flies’ developing eye tissue. Flies that were fed a normal diet grew small, benign tumors. But when flies were fed a high-sugar diet, they developed large, malignant tumors.

In flies fed a high-sugar diet, the normal cells became insulin-resistant, but the tumor cells didn’t. The tumor cells actually became more sensitive to insulin because they turned on a metabolic switch that triggered them to produce extra receptors for insulin. But this study did not explain how the tumor cells turned on this metabolic switch.

Now, after studying the same flies in more detail, Drs Hirabayashi and Cagan have found the tumor cells detect glucose availability indirectly, through a protein called salt-inducible kinase (SIK). When glucose levels are high, SIK sends a signal along the Hippo signaling pathway.

The Hippo signaling pathway is known to play a role in controlling cell growth. When it’s turned on, it keeps cell growth under control, but if it’s turned off, the cell can continue growing and may ultimately develop into a tumor.

Drs Hirabayashi and Cagan found that SIK acts like a sugar sensor, turning the Hippo signaling pathway off in response to raised glucose levels. This allows the tumor cells to continue to grow.

“Ras and Src co-activated tumors use SIK to sense that there’s lots of glucose available outside of their cells and to tell the cells to take advantage of that,” Dr Hirabayashi said. “Together, Ras and Src co-activated tumors use SIK to efficiently respond to glucose availability and ensure the tumors grow in nutrient-rich conditions such as obesity. We still don’t know if tumors caused by other genes respond to sugar in the same way.”

“Our results suggest that if we can develop drugs to target SIK, and stop it from alerting cancer cells in this way, then we may be able to stop cancer cells from thriving in an insulin-resistant environment and break the connection between obesity and cancer.”

Drosophila melanogaster

Photo by Andre Karwath

New research has revealed a mechanism that allows cancer cells to respond and grow rapidly when blood sugar levels rise.

This may help to explain why people who develop conditions in which they have chronically high blood sugar levels, such as obesity, also have an increased risk of developing certain cancers.

Susumu Hirabayashi, PhD, of Imperial College London in the UK, and Ross Cagan, PhD, of Mount Sinai Hospital in New York, New York, described the mechanism in eLife.

In a study published 2 years ago, the pair engineered fruit flies (Drosophila melanogaster) to activate the genes Ras and Src, which are activated in a range of malignancies.

The researchers activated Ras and Src in the flies’ developing eye tissue. Flies that were fed a normal diet grew small, benign tumors. But when flies were fed a high-sugar diet, they developed large, malignant tumors.

In flies fed a high-sugar diet, the normal cells became insulin-resistant, but the tumor cells didn’t. The tumor cells actually became more sensitive to insulin because they turned on a metabolic switch that triggered them to produce extra receptors for insulin. But this study did not explain how the tumor cells turned on this metabolic switch.

Now, after studying the same flies in more detail, Drs Hirabayashi and Cagan have found the tumor cells detect glucose availability indirectly, through a protein called salt-inducible kinase (SIK). When glucose levels are high, SIK sends a signal along the Hippo signaling pathway.

The Hippo signaling pathway is known to play a role in controlling cell growth. When it’s turned on, it keeps cell growth under control, but if it’s turned off, the cell can continue growing and may ultimately develop into a tumor.

Drs Hirabayashi and Cagan found that SIK acts like a sugar sensor, turning the Hippo signaling pathway off in response to raised glucose levels. This allows the tumor cells to continue to grow.

“Ras and Src co-activated tumors use SIK to sense that there’s lots of glucose available outside of their cells and to tell the cells to take advantage of that,” Dr Hirabayashi said. “Together, Ras and Src co-activated tumors use SIK to efficiently respond to glucose availability and ensure the tumors grow in nutrient-rich conditions such as obesity. We still don’t know if tumors caused by other genes respond to sugar in the same way.”

“Our results suggest that if we can develop drugs to target SIK, and stop it from alerting cancer cells in this way, then we may be able to stop cancer cells from thriving in an insulin-resistant environment and break the connection between obesity and cancer.”

Drosophila melanogaster

Photo by Andre Karwath

New research has revealed a mechanism that allows cancer cells to respond and grow rapidly when blood sugar levels rise.

This may help to explain why people who develop conditions in which they have chronically high blood sugar levels, such as obesity, also have an increased risk of developing certain cancers.

Susumu Hirabayashi, PhD, of Imperial College London in the UK, and Ross Cagan, PhD, of Mount Sinai Hospital in New York, New York, described the mechanism in eLife.

In a study published 2 years ago, the pair engineered fruit flies (Drosophila melanogaster) to activate the genes Ras and Src, which are activated in a range of malignancies.

The researchers activated Ras and Src in the flies’ developing eye tissue. Flies that were fed a normal diet grew small, benign tumors. But when flies were fed a high-sugar diet, they developed large, malignant tumors.

In flies fed a high-sugar diet, the normal cells became insulin-resistant, but the tumor cells didn’t. The tumor cells actually became more sensitive to insulin because they turned on a metabolic switch that triggered them to produce extra receptors for insulin. But this study did not explain how the tumor cells turned on this metabolic switch.

Now, after studying the same flies in more detail, Drs Hirabayashi and Cagan have found the tumor cells detect glucose availability indirectly, through a protein called salt-inducible kinase (SIK). When glucose levels are high, SIK sends a signal along the Hippo signaling pathway.

The Hippo signaling pathway is known to play a role in controlling cell growth. When it’s turned on, it keeps cell growth under control, but if it’s turned off, the cell can continue growing and may ultimately develop into a tumor.

Drs Hirabayashi and Cagan found that SIK acts like a sugar sensor, turning the Hippo signaling pathway off in response to raised glucose levels. This allows the tumor cells to continue to grow.

“Ras and Src co-activated tumors use SIK to sense that there’s lots of glucose available outside of their cells and to tell the cells to take advantage of that,” Dr Hirabayashi said. “Together, Ras and Src co-activated tumors use SIK to efficiently respond to glucose availability and ensure the tumors grow in nutrient-rich conditions such as obesity. We still don’t know if tumors caused by other genes respond to sugar in the same way.”

“Our results suggest that if we can develop drugs to target SIK, and stop it from alerting cancer cells in this way, then we may be able to stop cancer cells from thriving in an insulin-resistant environment and break the connection between obesity and cancer.”

To improve patient care and outcomes, leading dermatologists offered their recommendations on dermal fillers. Consideration must be given to:
 

• Belotero Balance
  Merz North America, Inc
  
  “In my experience, this is the only filler available in the US market that can be used to treat very fine, “etched-in” lines without creating ridges or bumps.”
  — Mark G. Rubin, MD, Beverly Hills, California
  
  Recommended by Gary Goldenberg, MD, New York, New York

• Juvéderm Voluma XC
  Allergan, Inc
  
  “This is a longer-lasting dermal filler great for adding structural support and lift in the zygoma, chin, and jawline.”
  —Anthony M. Rossi, MD, New York, New York
  
  Recommended by Gary Goldenberg, MD, New York, New York

• Radiesse
  Merz North America, Inc
  
  Recommended by Gary Goldenberg, MD, New York, New York

• Restylane Lyft and Restylane Silk
  Galderma Laboratories, LP
  
  Recommended by Gary Goldenberg, MD, New York, New York

• Sculptra Aesthetic
  Galderma Laboratories, LP
  
  Recommended by Gary Goldenberg, MD, New York, New York
   

Cutis invites readers to send us their recommendations. Antiperspirants, shampoos, and conditioners will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on dermal fillers. Consideration must be given to:
 

• Belotero Balance
  Merz North America, Inc
  
  “In my experience, this is the only filler available in the US market that can be used to treat very fine, “etched-in” lines without creating ridges or bumps.”
  — Mark G. Rubin, MD, Beverly Hills, California
  
  Recommended by Gary Goldenberg, MD, New York, New York

• Juvéderm Voluma XC
  Allergan, Inc
  
  “This is a longer-lasting dermal filler great for adding structural support and lift in the zygoma, chin, and jawline.”
  —Anthony M. Rossi, MD, New York, New York
  
  Recommended by Gary Goldenberg, MD, New York, New York

• Radiesse
  Merz North America, Inc
  
  Recommended by Gary Goldenberg, MD, New York, New York

• Restylane Lyft and Restylane Silk
  Galderma Laboratories, LP
  
  Recommended by Gary Goldenberg, MD, New York, New York

• Sculptra Aesthetic
  Galderma Laboratories, LP
  
  Recommended by Gary Goldenberg, MD, New York, New York
   

Cutis invites readers to send us their recommendations. Antiperspirants, shampoos, and conditioners will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on dermal fillers. Consideration must be given to:
 

• Belotero Balance
  Merz North America, Inc
  
  “In my experience, this is the only filler available in the US market that can be used to treat very fine, “etched-in” lines without creating ridges or bumps.”
  — Mark G. Rubin, MD, Beverly Hills, California
  
  Recommended by Gary Goldenberg, MD, New York, New York

• Juvéderm Voluma XC
  Allergan, Inc
  
  “This is a longer-lasting dermal filler great for adding structural support and lift in the zygoma, chin, and jawline.”
  —Anthony M. Rossi, MD, New York, New York
  
  Recommended by Gary Goldenberg, MD, New York, New York

• Radiesse
  Merz North America, Inc
  
  Recommended by Gary Goldenberg, MD, New York, New York

• Restylane Lyft and Restylane Silk
  Galderma Laboratories, LP
  
  Recommended by Gary Goldenberg, MD, New York, New York

• Sculptra Aesthetic
  Galderma Laboratories, LP
  
  Recommended by Gary Goldenberg, MD, New York, New York
   

Cutis invites readers to send us their recommendations. Antiperspirants, shampoos, and conditioners will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to the Editorial Office.

Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc. and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc. endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

YES

The recent 2-year bipartisan budget deal signed by President Obama and sent up by Congress brought the hammer down on hospitals so quickly that they did not see it coming. It is highly unusual for Congress to keep anything secreted from the American Hospital Association (AHA) lobby. The AHA spent $4.6 million in the first quarter of 2015 for an annual estimated expenditure of about $18 million. This does not include dollars spent by local and state hospital associations. The SVS is clearly dwarfed by these powerful interests. Our society spent less than $100,000 in that same quarter on advocating for over 4,000 members, the majority of whom are United States residents and most of whom depend solely on the SVS to look out for them.

As a result of the budget deal, Medicare will not pay most hospital-owned physician practices higher rates than those of independently owned practices. The reimbursement changes will apply to those hospital-owned physician practices acquired or opened since the date the law was signed and also located farther than 250 yards from a hospital’s main campus. It does grandfather in facilities prior to the signing that were being reimbursed with hospital outpatient department (HOPD) rates. The savings will prevent an increase in premiums for about 15 million Medicare beneficiaries. The AHA expressed its outrage while the AARP celebrated. So did independent physicians who have been protesting all along that costs were rising because of excessive payments to hospitals for essentially the same services.

Margot Sanger-Katz, in a column for “The Upshot” in the New York Times, wrote that it had been estimated that correcting this payment differential would save Medicare $30 billion over 10 years, more than Medicare could save if it raised the Medicare eligibility age to 67!¹ She also pointed out that the Medicare Payment Advisory Committee (MedPAC), an independent group that advises Congress, thinks “that the pay differences should be narrowed, but only for a select set of medical services in which it’s really clear that there’s no difference between the care offered by a hospital and a physician office.”

The rush to buy physician practices is being done for many reasons but the disparate payment schedule favoring hospital-owned practices for many of the same services is one reason. The hospital brings in a lot more revenue through its hired physicians providing the same service in their offices that are now under the banner of the health system. The hospitals cite several justifications for the “surcharge” on care provided by employed physicians in hospital facilities, some of which may be valid. Regulatory requirements, sicker inpatients, increased cost due to training programs, and being required to support money-losing services such as burn care are some reasons. But, independent physicians say they provide the same or better quality care at a lower cost without resources such as legal, accounting, self-insurance against professional liability, and robust lobbying firms.

Hospitals have also contended that vertical integration by buying physician practices should lead to lower health care costs by squeezing efficiencies within the system. There have been conflicting reports on whether physician hospital integration leads to lower health care expenditures.² The public debate has caught the attention of government regulators. In the recent case of Saint Lukes-Saltzer, the question before the Federal Trade Commission (the agency responsible for federal antitrust action) was: Did total medical expenditures increase or decrease for patients cared for by physician practices acquired by St. Luke’s? Indeed, the conclusions were that not only did overall costs not go down but evidence showed that the merger may have resulted in increased costs.

On appeal, the Ninth Circuit Court ruled that any future efficiency must be “substantial, verifiable and specific” to the merger. Ciliberto and Dranove looked at hospital prices after physician hospital affiliations in California and found no evidence of increase in prices.³ Baker and coauthors analyzed privately insured patients between 2001 and 2007 and the effect of physician hospital integration on hospital prices, admission volumes, and spending.⁴ They reported higher hospital prices and spending in hospitals with the tightest vertically integrated relationship with physicians. In one of the few studies of the issue, Capps and colleagues reviewed 7 years of administrative data from multiple insurers across the United States to estimate postintegration costs. From 2007 to 2013, they found that there was a 57% increase in the share of spending by physicians whose practices are owned by hospitals. In addition, this led to an increase in physician prices of 14% post integration.⁵ The larger the market share of inpatients by a hospital the larger the price increase. The authors estimate that about 25% of the price increases are precisely due to “exploitation of reimbursement rules” by charging the facility fees for their employed physicians. If these “surcharges” led to decreased utilization as one measure of increased efficiency and therefore reduced overall health care costs, it would be acceptable. But, Capps et al. found no such evidence and speculate that this scenario could lead to higher expenditures.

In a recent study, total expenditures for over 4 million patients by private physician groups or integrated groups covered by health maintenance organizations (HMOs) in California between 2009 and 2012 were analyzed.⁶ Mean annual expenditures were highest for large multihospital systems followed by hospital-owned physician groups and, lastly, physician-owned groups. The expenditures for multihospital systems were 19.8% higher and for local hospital-employed physician groups 10% higher compared to physician-owned organizations.

Why should prices increase after tighter physician hospital integration on a large scale? Market power. Once health systems have a large enough number of physicians in their panel, hospitals could charge insurers higher prices to access their specialists. Similarly, by employing a large number of physicians in a particular specialty, which then attracts a large pool of patients with a particular illness, they could dominate the other health systems in the region. One action specifically forbidden by anti-kickback laws is compensating physicians based on the number of referrals they make to the hospital. But, there are enough loopholes that allow hospitals to indirectly tie compensation to “productivity.” This may change with bundled payments or compensation tied to “value,” although there will always be incentives for work volume to some degree.

A further roadblock for basing merger decisions entirely on possible efficiencies is how the courts will see these activities in terms of antitrust actions. Most arguments using efficiency as the basis for merging physician groups with hospitals are vague and in general courts have not superseded antitrust actions with economic efficiency arguments.

What should be genuine reasons for hospitals employing and aligning with physicians? Addressing uneven quality of care, access and, of course, ever spiraling costs. If the object was to share responsibility for attacking these problems, health care systems and physicians would be cut a lot of slack. But, some health care systems want to not only survive the existing chaos but also dominate their local market.

I guess health care is really no different from Wall Street corporations in its focus on short-term gains versus long-term benefits. Until broader incentives change, health systems will continue to look to survive and gain market share and power. Competition, in isolation, drives tactics where the only objective may be to increase market share. However, it appears that the FTC will be busy wielding the Sherman Act of the antitrust law to keep a check on health systems to ensure consumers, payers, physicians, and the country at large are all on a fair playing field.⁷

Dr. Satiani is professor of clinical surgery, division of vascular diseases & surgery, department of surgery, associate director, FAME; director, Faculty Leadership Institute, and medical director, Vascular Labs, at Ohio State University College of Medicine, Columbus. He is also an associate medical editor for Vascular Specialist.

References

1.www.nytimes.com/2015/02/07/upshot/medicare-proposal-would-even-out-doctors-pay.html?_r=1&abt=0002&abg=1.

2. Journal of Health Economics 2006; 25: 1-28.

3. Journal of Health Economics 2006; 25: 29-38.

4. Health Affairs 2014; 33(5): 756-63.

5. www.ipr.northwestern.edu/publications/docs/workingpapers/2015/IPR-WP-15-02.pdf

6. JAMA. 2014; 312(16):1663-9.

7. Plastic & Reconstructive Surgery. 2006; 117(3): 1012-22.

NO

The days of hanging one’s shingle on a door and starting a self-employed practice are rapidly fading. While some fondly remember the practice of medicine as it was in Norman Rockwell’s classic “Before the Shot,” the realities of a current practice couldn’t be more different. Reusable syringes, analog weighing stations, an unaccompanied minor, and lack of regard for universal precautions are just a few examples from that painting that have long since disappeared. However, the humor in this painting comes from the young boy scrutinizing the doctor’s credentials, implying a sense of distrust and fear as he stands there with his buttocks partially exposed waiting for the vaccination.

This scrutiny of physician performance and results is more relevant today than ever before. Perhaps if we were to update the painting today, it would depict the boy furiously tapping away at his tablet searching through ProPublica to see what the doctor’s complication rate with the intended procedure truly is.

This is just one of the many pressures physicians are facing today. Navigating the publicly reported complication data is but one tiny portion of the regulatory red tape physicians face in taking care of their patients. If you add in the need to negotiate and contact with insurers, manage an office staff, acquire and maintain an electronic medical record (EMR) while ensuring that your EMR is properly secured against potential cyber threats and compliant with meaningful use regulations, audit your billing and coding, keep up to date with upcoming changes to bundled payments, mail out and track Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), as well as an endless list of other requirements, it is no wonder physicians are less willing to take these challenges on as solo practitioners. In fact, based on Medscape’s 2014 Employed Doctors Report, which compiled responses from over 4,600 physicians, the top three reasons for being an employed physician were not having to deal with the business of running an office (58%), not having to deal with insurers and billing (45%), and guaranteed income/even cash flow (42%).¹

Multiple sources continue to confirm the trend that more physicians are moving to an employed practice.^2-4 In the last decade, the rate of hospital employment has increased from 11% to 64%.¹ There are many factors that have pushed physicians away from self-employment. Some of these are related to physicians’ personal choices, and many are from external pressures. As various parts of the Affordable Care Act come into play, there will continue to be increasing regulatory demands. These have the potential of increasing overhead costs, and, coupled with decreasing reimbursement, will inevitably make staying profitable more challenging in a self-employed model.

There are two other very telling trends that foretell the inevitable decline of self-employed physicians. Fewer and fewer new graduates are reporting that they are self employed. In the most recent surveys, twice as many physicians under the age of 40 are employed than self-employed.¹ Furthermore, 92% of residents surveyed in their final year would prefer employment with a salary, and only 2% would consider solo practice.⁵ Of these graduating residents, 36% specifically were considering hospital employment, which is nearly a 10-fold increase from a decade ago. The second factor affecting new hires is their confidence that they have the necessary skills to manage a self-employed model. During the same decade, there was only a small increase in graduating residents who felt very prepared to deal with the business side of medicine (10% vs. 2%).⁵ This lack of knowledge will undoubtedly make it difficult for those who would consider self-employment to feel comfortable in that practice model. Some have speculated that there is soon to be a “push back” from the physicians and specifically from specialists who don’t have as much to gain in large group practices. With so few graduates considering solo and small group practice, and the overwhelming majority not feeling very prepared to manage the business of medicine, who can help lead this trend reversal?

Not only are fewer new graduates choosing self-employment, but fewer opportunities for self-employment are available as more physician groups are being bought by hospitals or other large group practices. Specifically with vascular surgery, there is a significant overhead cost requirement. Advantages to joining a large group practice include better ability to negotiate cost savings with the frequent capital requirements for new equipment, updates and maintenance of the electronic records, and professional liability. In fact, one study in California shows that as the proportion of physicians employed by the health system increased, supply chain expenses and inventory costs improved.⁶ Furthermore, hospitals have administrators who are hired to negotiate with insurers regarding reimbursement and respond to audits and other regulatory changes. As mentioned above, the top two reasons for avoiding self-employment are precisely these. This will no doubt draw even more physicians and specifically vascular surgeons into employed models.

Dr. Haurani is assistant professor of surgery in the division of vascular diseases and surgery, Ohio State University Medical Center, Columbus.

References

1. www.medscape.com/features/slideshow/public/employed-doctors#1

2. JAMA Surg. 2013;148:323-8.

3.Perspect Vasc Surg Endovasc Ther. 2013;25:46-52.

4 Tenn Med. 2012;105:38-39.

5.www.merritthawkins.com/uploadedFiles/MerrittHawkings/Surveys/2014_MerrittHawkins_FYMR_Survey.pdf.

6. Health Care Manage Rev. 2015 Jul 23. [Epub ahead of print] www.ncbi.nlm.nih.gov/pubmed/26207654

YES

The recent 2-year bipartisan budget deal signed by President Obama and sent up by Congress brought the hammer down on hospitals so quickly that they did not see it coming. It is highly unusual for Congress to keep anything secreted from the American Hospital Association (AHA) lobby. The AHA spent $4.6 million in the first quarter of 2015 for an annual estimated expenditure of about $18 million. This does not include dollars spent by local and state hospital associations. The SVS is clearly dwarfed by these powerful interests. Our society spent less than $100,000 in that same quarter on advocating for over 4,000 members, the majority of whom are United States residents and most of whom depend solely on the SVS to look out for them.

As a result of the budget deal, Medicare will not pay most hospital-owned physician practices higher rates than those of independently owned practices. The reimbursement changes will apply to those hospital-owned physician practices acquired or opened since the date the law was signed and also located farther than 250 yards from a hospital’s main campus. It does grandfather in facilities prior to the signing that were being reimbursed with hospital outpatient department (HOPD) rates. The savings will prevent an increase in premiums for about 15 million Medicare beneficiaries. The AHA expressed its outrage while the AARP celebrated. So did independent physicians who have been protesting all along that costs were rising because of excessive payments to hospitals for essentially the same services.

Margot Sanger-Katz, in a column for “The Upshot” in the New York Times, wrote that it had been estimated that correcting this payment differential would save Medicare $30 billion over 10 years, more than Medicare could save if it raised the Medicare eligibility age to 67!¹ She also pointed out that the Medicare Payment Advisory Committee (MedPAC), an independent group that advises Congress, thinks “that the pay differences should be narrowed, but only for a select set of medical services in which it’s really clear that there’s no difference between the care offered by a hospital and a physician office.”

The rush to buy physician practices is being done for many reasons but the disparate payment schedule favoring hospital-owned practices for many of the same services is one reason. The hospital brings in a lot more revenue through its hired physicians providing the same service in their offices that are now under the banner of the health system. The hospitals cite several justifications for the “surcharge” on care provided by employed physicians in hospital facilities, some of which may be valid. Regulatory requirements, sicker inpatients, increased cost due to training programs, and being required to support money-losing services such as burn care are some reasons. But, independent physicians say they provide the same or better quality care at a lower cost without resources such as legal, accounting, self-insurance against professional liability, and robust lobbying firms.

Hospitals have also contended that vertical integration by buying physician practices should lead to lower health care costs by squeezing efficiencies within the system. There have been conflicting reports on whether physician hospital integration leads to lower health care expenditures.² The public debate has caught the attention of government regulators. In the recent case of Saint Lukes-Saltzer, the question before the Federal Trade Commission (the agency responsible for federal antitrust action) was: Did total medical expenditures increase or decrease for patients cared for by physician practices acquired by St. Luke’s? Indeed, the conclusions were that not only did overall costs not go down but evidence showed that the merger may have resulted in increased costs.

On appeal, the Ninth Circuit Court ruled that any future efficiency must be “substantial, verifiable and specific” to the merger. Ciliberto and Dranove looked at hospital prices after physician hospital affiliations in California and found no evidence of increase in prices.³ Baker and coauthors analyzed privately insured patients between 2001 and 2007 and the effect of physician hospital integration on hospital prices, admission volumes, and spending.⁴ They reported higher hospital prices and spending in hospitals with the tightest vertically integrated relationship with physicians. In one of the few studies of the issue, Capps and colleagues reviewed 7 years of administrative data from multiple insurers across the United States to estimate postintegration costs. From 2007 to 2013, they found that there was a 57% increase in the share of spending by physicians whose practices are owned by hospitals. In addition, this led to an increase in physician prices of 14% post integration.⁵ The larger the market share of inpatients by a hospital the larger the price increase. The authors estimate that about 25% of the price increases are precisely due to “exploitation of reimbursement rules” by charging the facility fees for their employed physicians. If these “surcharges” led to decreased utilization as one measure of increased efficiency and therefore reduced overall health care costs, it would be acceptable. But, Capps et al. found no such evidence and speculate that this scenario could lead to higher expenditures.

In a recent study, total expenditures for over 4 million patients by private physician groups or integrated groups covered by health maintenance organizations (HMOs) in California between 2009 and 2012 were analyzed.⁶ Mean annual expenditures were highest for large multihospital systems followed by hospital-owned physician groups and, lastly, physician-owned groups. The expenditures for multihospital systems were 19.8% higher and for local hospital-employed physician groups 10% higher compared to physician-owned organizations.

Why should prices increase after tighter physician hospital integration on a large scale? Market power. Once health systems have a large enough number of physicians in their panel, hospitals could charge insurers higher prices to access their specialists. Similarly, by employing a large number of physicians in a particular specialty, which then attracts a large pool of patients with a particular illness, they could dominate the other health systems in the region. One action specifically forbidden by anti-kickback laws is compensating physicians based on the number of referrals they make to the hospital. But, there are enough loopholes that allow hospitals to indirectly tie compensation to “productivity.” This may change with bundled payments or compensation tied to “value,” although there will always be incentives for work volume to some degree.

A further roadblock for basing merger decisions entirely on possible efficiencies is how the courts will see these activities in terms of antitrust actions. Most arguments using efficiency as the basis for merging physician groups with hospitals are vague and in general courts have not superseded antitrust actions with economic efficiency arguments.

What should be genuine reasons for hospitals employing and aligning with physicians? Addressing uneven quality of care, access and, of course, ever spiraling costs. If the object was to share responsibility for attacking these problems, health care systems and physicians would be cut a lot of slack. But, some health care systems want to not only survive the existing chaos but also dominate their local market.

I guess health care is really no different from Wall Street corporations in its focus on short-term gains versus long-term benefits. Until broader incentives change, health systems will continue to look to survive and gain market share and power. Competition, in isolation, drives tactics where the only objective may be to increase market share. However, it appears that the FTC will be busy wielding the Sherman Act of the antitrust law to keep a check on health systems to ensure consumers, payers, physicians, and the country at large are all on a fair playing field.⁷

Dr. Satiani is professor of clinical surgery, division of vascular diseases & surgery, department of surgery, associate director, FAME; director, Faculty Leadership Institute, and medical director, Vascular Labs, at Ohio State University College of Medicine, Columbus. He is also an associate medical editor for Vascular Specialist.

References

1.www.nytimes.com/2015/02/07/upshot/medicare-proposal-would-even-out-doctors-pay.html?_r=1&abt=0002&abg=1.

2. Journal of Health Economics 2006; 25: 1-28.

3. Journal of Health Economics 2006; 25: 29-38.

4. Health Affairs 2014; 33(5): 756-63.

5. www.ipr.northwestern.edu/publications/docs/workingpapers/2015/IPR-WP-15-02.pdf

6. JAMA. 2014; 312(16):1663-9.

7. Plastic & Reconstructive Surgery. 2006; 117(3): 1012-22.

NO

The days of hanging one’s shingle on a door and starting a self-employed practice are rapidly fading. While some fondly remember the practice of medicine as it was in Norman Rockwell’s classic “Before the Shot,” the realities of a current practice couldn’t be more different. Reusable syringes, analog weighing stations, an unaccompanied minor, and lack of regard for universal precautions are just a few examples from that painting that have long since disappeared. However, the humor in this painting comes from the young boy scrutinizing the doctor’s credentials, implying a sense of distrust and fear as he stands there with his buttocks partially exposed waiting for the vaccination.

This scrutiny of physician performance and results is more relevant today than ever before. Perhaps if we were to update the painting today, it would depict the boy furiously tapping away at his tablet searching through ProPublica to see what the doctor’s complication rate with the intended procedure truly is.

This is just one of the many pressures physicians are facing today. Navigating the publicly reported complication data is but one tiny portion of the regulatory red tape physicians face in taking care of their patients. If you add in the need to negotiate and contact with insurers, manage an office staff, acquire and maintain an electronic medical record (EMR) while ensuring that your EMR is properly secured against potential cyber threats and compliant with meaningful use regulations, audit your billing and coding, keep up to date with upcoming changes to bundled payments, mail out and track Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), as well as an endless list of other requirements, it is no wonder physicians are less willing to take these challenges on as solo practitioners. In fact, based on Medscape’s 2014 Employed Doctors Report, which compiled responses from over 4,600 physicians, the top three reasons for being an employed physician were not having to deal with the business of running an office (58%), not having to deal with insurers and billing (45%), and guaranteed income/even cash flow (42%).¹

Multiple sources continue to confirm the trend that more physicians are moving to an employed practice.^2-4 In the last decade, the rate of hospital employment has increased from 11% to 64%.¹ There are many factors that have pushed physicians away from self-employment. Some of these are related to physicians’ personal choices, and many are from external pressures. As various parts of the Affordable Care Act come into play, there will continue to be increasing regulatory demands. These have the potential of increasing overhead costs, and, coupled with decreasing reimbursement, will inevitably make staying profitable more challenging in a self-employed model.

There are two other very telling trends that foretell the inevitable decline of self-employed physicians. Fewer and fewer new graduates are reporting that they are self employed. In the most recent surveys, twice as many physicians under the age of 40 are employed than self-employed.¹ Furthermore, 92% of residents surveyed in their final year would prefer employment with a salary, and only 2% would consider solo practice.⁵ Of these graduating residents, 36% specifically were considering hospital employment, which is nearly a 10-fold increase from a decade ago. The second factor affecting new hires is their confidence that they have the necessary skills to manage a self-employed model. During the same decade, there was only a small increase in graduating residents who felt very prepared to deal with the business side of medicine (10% vs. 2%).⁵ This lack of knowledge will undoubtedly make it difficult for those who would consider self-employment to feel comfortable in that practice model. Some have speculated that there is soon to be a “push back” from the physicians and specifically from specialists who don’t have as much to gain in large group practices. With so few graduates considering solo and small group practice, and the overwhelming majority not feeling very prepared to manage the business of medicine, who can help lead this trend reversal?

Not only are fewer new graduates choosing self-employment, but fewer opportunities for self-employment are available as more physician groups are being bought by hospitals or other large group practices. Specifically with vascular surgery, there is a significant overhead cost requirement. Advantages to joining a large group practice include better ability to negotiate cost savings with the frequent capital requirements for new equipment, updates and maintenance of the electronic records, and professional liability. In fact, one study in California shows that as the proportion of physicians employed by the health system increased, supply chain expenses and inventory costs improved.⁶ Furthermore, hospitals have administrators who are hired to negotiate with insurers regarding reimbursement and respond to audits and other regulatory changes. As mentioned above, the top two reasons for avoiding self-employment are precisely these. This will no doubt draw even more physicians and specifically vascular surgeons into employed models.

Dr. Haurani is assistant professor of surgery in the division of vascular diseases and surgery, Ohio State University Medical Center, Columbus.

References

1. www.medscape.com/features/slideshow/public/employed-doctors#1

2. JAMA Surg. 2013;148:323-8.

3.Perspect Vasc Surg Endovasc Ther. 2013;25:46-52.

4 Tenn Med. 2012;105:38-39.

5.www.merritthawkins.com/uploadedFiles/MerrittHawkings/Surveys/2014_MerrittHawkins_FYMR_Survey.pdf.

6. Health Care Manage Rev. 2015 Jul 23. [Epub ahead of print] www.ncbi.nlm.nih.gov/pubmed/26207654

YES

The recent 2-year bipartisan budget deal signed by President Obama and sent up by Congress brought the hammer down on hospitals so quickly that they did not see it coming. It is highly unusual for Congress to keep anything secreted from the American Hospital Association (AHA) lobby. The AHA spent $4.6 million in the first quarter of 2015 for an annual estimated expenditure of about $18 million. This does not include dollars spent by local and state hospital associations. The SVS is clearly dwarfed by these powerful interests. Our society spent less than $100,000 in that same quarter on advocating for over 4,000 members, the majority of whom are United States residents and most of whom depend solely on the SVS to look out for them.

As a result of the budget deal, Medicare will not pay most hospital-owned physician practices higher rates than those of independently owned practices. The reimbursement changes will apply to those hospital-owned physician practices acquired or opened since the date the law was signed and also located farther than 250 yards from a hospital’s main campus. It does grandfather in facilities prior to the signing that were being reimbursed with hospital outpatient department (HOPD) rates. The savings will prevent an increase in premiums for about 15 million Medicare beneficiaries. The AHA expressed its outrage while the AARP celebrated. So did independent physicians who have been protesting all along that costs were rising because of excessive payments to hospitals for essentially the same services.

Margot Sanger-Katz, in a column for “The Upshot” in the New York Times, wrote that it had been estimated that correcting this payment differential would save Medicare $30 billion over 10 years, more than Medicare could save if it raised the Medicare eligibility age to 67!¹ She also pointed out that the Medicare Payment Advisory Committee (MedPAC), an independent group that advises Congress, thinks “that the pay differences should be narrowed, but only for a select set of medical services in which it’s really clear that there’s no difference between the care offered by a hospital and a physician office.”

The rush to buy physician practices is being done for many reasons but the disparate payment schedule favoring hospital-owned practices for many of the same services is one reason. The hospital brings in a lot more revenue through its hired physicians providing the same service in their offices that are now under the banner of the health system. The hospitals cite several justifications for the “surcharge” on care provided by employed physicians in hospital facilities, some of which may be valid. Regulatory requirements, sicker inpatients, increased cost due to training programs, and being required to support money-losing services such as burn care are some reasons. But, independent physicians say they provide the same or better quality care at a lower cost without resources such as legal, accounting, self-insurance against professional liability, and robust lobbying firms.

Hospitals have also contended that vertical integration by buying physician practices should lead to lower health care costs by squeezing efficiencies within the system. There have been conflicting reports on whether physician hospital integration leads to lower health care expenditures.² The public debate has caught the attention of government regulators. In the recent case of Saint Lukes-Saltzer, the question before the Federal Trade Commission (the agency responsible for federal antitrust action) was: Did total medical expenditures increase or decrease for patients cared for by physician practices acquired by St. Luke’s? Indeed, the conclusions were that not only did overall costs not go down but evidence showed that the merger may have resulted in increased costs.

On appeal, the Ninth Circuit Court ruled that any future efficiency must be “substantial, verifiable and specific” to the merger. Ciliberto and Dranove looked at hospital prices after physician hospital affiliations in California and found no evidence of increase in prices.³ Baker and coauthors analyzed privately insured patients between 2001 and 2007 and the effect of physician hospital integration on hospital prices, admission volumes, and spending.⁴ They reported higher hospital prices and spending in hospitals with the tightest vertically integrated relationship with physicians. In one of the few studies of the issue, Capps and colleagues reviewed 7 years of administrative data from multiple insurers across the United States to estimate postintegration costs. From 2007 to 2013, they found that there was a 57% increase in the share of spending by physicians whose practices are owned by hospitals. In addition, this led to an increase in physician prices of 14% post integration.⁵ The larger the market share of inpatients by a hospital the larger the price increase. The authors estimate that about 25% of the price increases are precisely due to “exploitation of reimbursement rules” by charging the facility fees for their employed physicians. If these “surcharges” led to decreased utilization as one measure of increased efficiency and therefore reduced overall health care costs, it would be acceptable. But, Capps et al. found no such evidence and speculate that this scenario could lead to higher expenditures.

In a recent study, total expenditures for over 4 million patients by private physician groups or integrated groups covered by health maintenance organizations (HMOs) in California between 2009 and 2012 were analyzed.⁶ Mean annual expenditures were highest for large multihospital systems followed by hospital-owned physician groups and, lastly, physician-owned groups. The expenditures for multihospital systems were 19.8% higher and for local hospital-employed physician groups 10% higher compared to physician-owned organizations.

Why should prices increase after tighter physician hospital integration on a large scale? Market power. Once health systems have a large enough number of physicians in their panel, hospitals could charge insurers higher prices to access their specialists. Similarly, by employing a large number of physicians in a particular specialty, which then attracts a large pool of patients with a particular illness, they could dominate the other health systems in the region. One action specifically forbidden by anti-kickback laws is compensating physicians based on the number of referrals they make to the hospital. But, there are enough loopholes that allow hospitals to indirectly tie compensation to “productivity.” This may change with bundled payments or compensation tied to “value,” although there will always be incentives for work volume to some degree.

A further roadblock for basing merger decisions entirely on possible efficiencies is how the courts will see these activities in terms of antitrust actions. Most arguments using efficiency as the basis for merging physician groups with hospitals are vague and in general courts have not superseded antitrust actions with economic efficiency arguments.

What should be genuine reasons for hospitals employing and aligning with physicians? Addressing uneven quality of care, access and, of course, ever spiraling costs. If the object was to share responsibility for attacking these problems, health care systems and physicians would be cut a lot of slack. But, some health care systems want to not only survive the existing chaos but also dominate their local market.

I guess health care is really no different from Wall Street corporations in its focus on short-term gains versus long-term benefits. Until broader incentives change, health systems will continue to look to survive and gain market share and power. Competition, in isolation, drives tactics where the only objective may be to increase market share. However, it appears that the FTC will be busy wielding the Sherman Act of the antitrust law to keep a check on health systems to ensure consumers, payers, physicians, and the country at large are all on a fair playing field.⁷

Dr. Satiani is professor of clinical surgery, division of vascular diseases & surgery, department of surgery, associate director, FAME; director, Faculty Leadership Institute, and medical director, Vascular Labs, at Ohio State University College of Medicine, Columbus. He is also an associate medical editor for Vascular Specialist.

References

1.www.nytimes.com/2015/02/07/upshot/medicare-proposal-would-even-out-doctors-pay.html?_r=1&abt=0002&abg=1.

2. Journal of Health Economics 2006; 25: 1-28.

3. Journal of Health Economics 2006; 25: 29-38.

4. Health Affairs 2014; 33(5): 756-63.

5. www.ipr.northwestern.edu/publications/docs/workingpapers/2015/IPR-WP-15-02.pdf

6. JAMA. 2014; 312(16):1663-9.

7. Plastic & Reconstructive Surgery. 2006; 117(3): 1012-22.

NO

The days of hanging one’s shingle on a door and starting a self-employed practice are rapidly fading. While some fondly remember the practice of medicine as it was in Norman Rockwell’s classic “Before the Shot,” the realities of a current practice couldn’t be more different. Reusable syringes, analog weighing stations, an unaccompanied minor, and lack of regard for universal precautions are just a few examples from that painting that have long since disappeared. However, the humor in this painting comes from the young boy scrutinizing the doctor’s credentials, implying a sense of distrust and fear as he stands there with his buttocks partially exposed waiting for the vaccination.

This scrutiny of physician performance and results is more relevant today than ever before. Perhaps if we were to update the painting today, it would depict the boy furiously tapping away at his tablet searching through ProPublica to see what the doctor’s complication rate with the intended procedure truly is.

This is just one of the many pressures physicians are facing today. Navigating the publicly reported complication data is but one tiny portion of the regulatory red tape physicians face in taking care of their patients. If you add in the need to negotiate and contact with insurers, manage an office staff, acquire and maintain an electronic medical record (EMR) while ensuring that your EMR is properly secured against potential cyber threats and compliant with meaningful use regulations, audit your billing and coding, keep up to date with upcoming changes to bundled payments, mail out and track Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), as well as an endless list of other requirements, it is no wonder physicians are less willing to take these challenges on as solo practitioners. In fact, based on Medscape’s 2014 Employed Doctors Report, which compiled responses from over 4,600 physicians, the top three reasons for being an employed physician were not having to deal with the business of running an office (58%), not having to deal with insurers and billing (45%), and guaranteed income/even cash flow (42%).¹

Multiple sources continue to confirm the trend that more physicians are moving to an employed practice.^2-4 In the last decade, the rate of hospital employment has increased from 11% to 64%.¹ There are many factors that have pushed physicians away from self-employment. Some of these are related to physicians’ personal choices, and many are from external pressures. As various parts of the Affordable Care Act come into play, there will continue to be increasing regulatory demands. These have the potential of increasing overhead costs, and, coupled with decreasing reimbursement, will inevitably make staying profitable more challenging in a self-employed model.

There are two other very telling trends that foretell the inevitable decline of self-employed physicians. Fewer and fewer new graduates are reporting that they are self employed. In the most recent surveys, twice as many physicians under the age of 40 are employed than self-employed.¹ Furthermore, 92% of residents surveyed in their final year would prefer employment with a salary, and only 2% would consider solo practice.⁵ Of these graduating residents, 36% specifically were considering hospital employment, which is nearly a 10-fold increase from a decade ago. The second factor affecting new hires is their confidence that they have the necessary skills to manage a self-employed model. During the same decade, there was only a small increase in graduating residents who felt very prepared to deal with the business side of medicine (10% vs. 2%).⁵ This lack of knowledge will undoubtedly make it difficult for those who would consider self-employment to feel comfortable in that practice model. Some have speculated that there is soon to be a “push back” from the physicians and specifically from specialists who don’t have as much to gain in large group practices. With so few graduates considering solo and small group practice, and the overwhelming majority not feeling very prepared to manage the business of medicine, who can help lead this trend reversal?

Not only are fewer new graduates choosing self-employment, but fewer opportunities for self-employment are available as more physician groups are being bought by hospitals or other large group practices. Specifically with vascular surgery, there is a significant overhead cost requirement. Advantages to joining a large group practice include better ability to negotiate cost savings with the frequent capital requirements for new equipment, updates and maintenance of the electronic records, and professional liability. In fact, one study in California shows that as the proportion of physicians employed by the health system increased, supply chain expenses and inventory costs improved.⁶ Furthermore, hospitals have administrators who are hired to negotiate with insurers regarding reimbursement and respond to audits and other regulatory changes. As mentioned above, the top two reasons for avoiding self-employment are precisely these. This will no doubt draw even more physicians and specifically vascular surgeons into employed models.

Dr. Haurani is assistant professor of surgery in the division of vascular diseases and surgery, Ohio State University Medical Center, Columbus.

References

1. www.medscape.com/features/slideshow/public/employed-doctors#1

2. JAMA Surg. 2013;148:323-8.

3.Perspect Vasc Surg Endovasc Ther. 2013;25:46-52.

4 Tenn Med. 2012;105:38-39.

5.www.merritthawkins.com/uploadedFiles/MerrittHawkings/Surveys/2014_MerrittHawkins_FYMR_Survey.pdf.

6. Health Care Manage Rev. 2015 Jul 23. [Epub ahead of print] www.ncbi.nlm.nih.gov/pubmed/26207654

ORLANDO – Cold temperature days were associated with a 28% increase in the risk of MI and a 15% increase in stroke over an 18-year period in Ontario, Hong Chen, Ph.D., reported at the American Heart Association scientific sessions.

The relationship between air temperature and cardiovascular events mapped out as a U-shaped pattern, with the lowest-risk trough occurring on days when the temperature averaged 54º F. However, the U-shape was skewed such that the increased risk achieved significance on the cold but not hot days, according to Dr. Chen of Public Health Ontario and the University of Toronto.

©roboriginal/thinkstockphotos.com

He and his coinvestigators looked at the relationship between daily temperature and cardiovascular risk because the epidemiologic data in this area was sparse even though there are intriguing animal studies suggesting that extreme cold weather can induce a prothrombotic inflammatory reaction and hypercoagulable state.

The investigators matched daily temperature and cardiovascular hospital admission data for all 14 health districts in the sprawling province of Ontario for the period 1996-2013. During the study period, there were 443,447 hospitalizations for acute MI, 355,837 for stroke, 237,979 for ischemic stroke, and 1.4 million admissions coded as ischemic heart disease.

In a multivariate analysis controlling for influenza activity, air pollution levels, relative humidity, and day of the week, the adjusted rate of admissions for MI was 28% greater on the coldest 1% of days than on days where the temperature averaged the optimal 54º F. The coldest days were also associated with a 12% increase in the risk of admission for ischemic heart disease, a 15% increase in stroke, and a 19% increase in ischemic stroke.

Dr. Chen and his coworkers also examined their mountain of data to see how selected comorbid conditions might affect temperature-related risk. They found that the risk of admission for ischemic heart disease on cold days was greatest among individuals with a history of conduction disorders, while the risk of cold-related stroke was highest in Ontarians with preexisting arrhythmias.

Dr. Chen reported having no financial conflicts of interest regarding this public health study.

[email protected]

ORLANDO – Cold temperature days were associated with a 28% increase in the risk of MI and a 15% increase in stroke over an 18-year period in Ontario, Hong Chen, Ph.D., reported at the American Heart Association scientific sessions.

The relationship between air temperature and cardiovascular events mapped out as a U-shaped pattern, with the lowest-risk trough occurring on days when the temperature averaged 54º F. However, the U-shape was skewed such that the increased risk achieved significance on the cold but not hot days, according to Dr. Chen of Public Health Ontario and the University of Toronto.

©roboriginal/thinkstockphotos.com

He and his coinvestigators looked at the relationship between daily temperature and cardiovascular risk because the epidemiologic data in this area was sparse even though there are intriguing animal studies suggesting that extreme cold weather can induce a prothrombotic inflammatory reaction and hypercoagulable state.

The investigators matched daily temperature and cardiovascular hospital admission data for all 14 health districts in the sprawling province of Ontario for the period 1996-2013. During the study period, there were 443,447 hospitalizations for acute MI, 355,837 for stroke, 237,979 for ischemic stroke, and 1.4 million admissions coded as ischemic heart disease.

In a multivariate analysis controlling for influenza activity, air pollution levels, relative humidity, and day of the week, the adjusted rate of admissions for MI was 28% greater on the coldest 1% of days than on days where the temperature averaged the optimal 54º F. The coldest days were also associated with a 12% increase in the risk of admission for ischemic heart disease, a 15% increase in stroke, and a 19% increase in ischemic stroke.

Dr. Chen and his coworkers also examined their mountain of data to see how selected comorbid conditions might affect temperature-related risk. They found that the risk of admission for ischemic heart disease on cold days was greatest among individuals with a history of conduction disorders, while the risk of cold-related stroke was highest in Ontarians with preexisting arrhythmias.

Dr. Chen reported having no financial conflicts of interest regarding this public health study.

[email protected]

ORLANDO – Cold temperature days were associated with a 28% increase in the risk of MI and a 15% increase in stroke over an 18-year period in Ontario, Hong Chen, Ph.D., reported at the American Heart Association scientific sessions.

The relationship between air temperature and cardiovascular events mapped out as a U-shaped pattern, with the lowest-risk trough occurring on days when the temperature averaged 54º F. However, the U-shape was skewed such that the increased risk achieved significance on the cold but not hot days, according to Dr. Chen of Public Health Ontario and the University of Toronto.

©roboriginal/thinkstockphotos.com

He and his coinvestigators looked at the relationship between daily temperature and cardiovascular risk because the epidemiologic data in this area was sparse even though there are intriguing animal studies suggesting that extreme cold weather can induce a prothrombotic inflammatory reaction and hypercoagulable state.

The investigators matched daily temperature and cardiovascular hospital admission data for all 14 health districts in the sprawling province of Ontario for the period 1996-2013. During the study period, there were 443,447 hospitalizations for acute MI, 355,837 for stroke, 237,979 for ischemic stroke, and 1.4 million admissions coded as ischemic heart disease.

In a multivariate analysis controlling for influenza activity, air pollution levels, relative humidity, and day of the week, the adjusted rate of admissions for MI was 28% greater on the coldest 1% of days than on days where the temperature averaged the optimal 54º F. The coldest days were also associated with a 12% increase in the risk of admission for ischemic heart disease, a 15% increase in stroke, and a 19% increase in ischemic stroke.

Dr. Chen and his coworkers also examined their mountain of data to see how selected comorbid conditions might affect temperature-related risk. They found that the risk of admission for ischemic heart disease on cold days was greatest among individuals with a history of conduction disorders, while the risk of cold-related stroke was highest in Ontarians with preexisting arrhythmias.

Dr. Chen reported having no financial conflicts of interest regarding this public health study.

[email protected]

SAN FRANCISCO – Etanercept during pregnancy more than doubled the risk of major congenital malformations in a study by the Organization of Teratology Information Specialists.

The group keeps a prospective registry on exposures to biologics during pregnancy. It is finishing up its adalimumab (Humira) investigation and hasn’t found much to worry about, and continues to gather data on abatacept (Orencia), tocilizumab (Actemra), tofacitinib (Xeljanz), apremilast (Otezla), and certolizumab pegol (Cimzia).

Etanercept (Enbrel), however, seems to be a different story; major malformations turned up in the group’s recently completed investigation. Even so, Organization of Teratology Information Specialists (OTIS) investigator Dr. Christina D. Chambers, Ph.D., of the University of California, San Diego, was careful to note at the annual meeting of the American College of Rheumatology that “etanercept is not meeting the criteria for causality. There’s no pattern” in major defects and “no biological plausibility” because the drug doesn’t seem to cross the placenta when the fetus is most vulnerable to adverse outcomes.

“It is difficult to draw the conclusion that this drug is causing harm. With true teratogens, you tend to see reduced birth weights and an increased risk of spontaneous abortion, which is not the case with etanercept. We are seeing only this one finding that kind of stands alone, and everything else looks pretty good,” she said.

The etanercept study investigated pregnancy outcomes in 370 women exposed to the drug while pregnant, mostly women with rheumatoid arthritis, but also women with psoriasis and ankylosing spondylitis. Their outcomes were compared with 164 pregnant women with the same diseases but no etanercept exposure – the disease control group – and 296 healthy pregnant women.

Women in all three groups were about 33 years old on average, and about 80% were white. The women were enrolled toward the end of their first trimester. Disease severity, comorbidities, and use of vitamins, alcohol, and tobacco were similar between etanercept and disease control women. About 40% of the etanercept and disease control women, but just one in the healthy pregnancy group, were exposed to systemic corticosteroids while pregnant.

There were 33 major structural defects in children born to women taking etanercept versus 7 in the disease control group. That translated to a more than doubling of risk with etanercept (odds ratio, 2.37; 95% confidence interval, 1.02-5.52), and a more than doubling of risk versus the 10 major structural defects in children born to healthy control women (OR, 2.91; 95% CI, 1.37-6.76).

A subanalysis excluded chromosomal anomalies, but “did not [change] our conclusions,” Dr. Chambers said.

Major structural defects generally refer to problems that need a surgical fix, including spina bifida, atrial septal defects, cleft palates, hypospadias, polydactyly, and craniosynostosis.

Minor defects that don’t need surgery, like a missing earlobe, occurred in six children exposed to etanercept and showed two different patterns that involved “three specific minor malformations” not seen in either of the control groups, Dr. Chambers said. She did not elaborate on what those patterns were, but noted that the parents usually had them, too, “suggesting a genetic component as opposed to a drug effect.”

Children in the three study groups had no statistically significant differences in 1-year malignancy rates, serious infections, and hospitalizations, even when exposed to etanercept in the third trimester.

Children exposed to etanercept, however, were more likely to be born preterm and more likely to be small for gestational age in weight, length, and head circumference. They were also more likely than disease control children to screen positive for developmental issues at 1 year, but none of those differences were statistically significant.

Dr. Chambers disclosed funding from 14 companies, including Amgen, the maker of etanercept, and Janssen, Pfizer, Roche, Sanofi/Genzyme, GlaxoSmithKline, and AbbVie, the maker of adalimumab.

[email protected]

SAN FRANCISCO – Etanercept during pregnancy more than doubled the risk of major congenital malformations in a study by the Organization of Teratology Information Specialists.

The group keeps a prospective registry on exposures to biologics during pregnancy. It is finishing up its adalimumab (Humira) investigation and hasn’t found much to worry about, and continues to gather data on abatacept (Orencia), tocilizumab (Actemra), tofacitinib (Xeljanz), apremilast (Otezla), and certolizumab pegol (Cimzia).

Etanercept (Enbrel), however, seems to be a different story; major malformations turned up in the group’s recently completed investigation. Even so, Organization of Teratology Information Specialists (OTIS) investigator Dr. Christina D. Chambers, Ph.D., of the University of California, San Diego, was careful to note at the annual meeting of the American College of Rheumatology that “etanercept is not meeting the criteria for causality. There’s no pattern” in major defects and “no biological plausibility” because the drug doesn’t seem to cross the placenta when the fetus is most vulnerable to adverse outcomes.

“It is difficult to draw the conclusion that this drug is causing harm. With true teratogens, you tend to see reduced birth weights and an increased risk of spontaneous abortion, which is not the case with etanercept. We are seeing only this one finding that kind of stands alone, and everything else looks pretty good,” she said.

The etanercept study investigated pregnancy outcomes in 370 women exposed to the drug while pregnant, mostly women with rheumatoid arthritis, but also women with psoriasis and ankylosing spondylitis. Their outcomes were compared with 164 pregnant women with the same diseases but no etanercept exposure – the disease control group – and 296 healthy pregnant women.

Women in all three groups were about 33 years old on average, and about 80% were white. The women were enrolled toward the end of their first trimester. Disease severity, comorbidities, and use of vitamins, alcohol, and tobacco were similar between etanercept and disease control women. About 40% of the etanercept and disease control women, but just one in the healthy pregnancy group, were exposed to systemic corticosteroids while pregnant.

There were 33 major structural defects in children born to women taking etanercept versus 7 in the disease control group. That translated to a more than doubling of risk with etanercept (odds ratio, 2.37; 95% confidence interval, 1.02-5.52), and a more than doubling of risk versus the 10 major structural defects in children born to healthy control women (OR, 2.91; 95% CI, 1.37-6.76).

A subanalysis excluded chromosomal anomalies, but “did not [change] our conclusions,” Dr. Chambers said.

Major structural defects generally refer to problems that need a surgical fix, including spina bifida, atrial septal defects, cleft palates, hypospadias, polydactyly, and craniosynostosis.

Minor defects that don’t need surgery, like a missing earlobe, occurred in six children exposed to etanercept and showed two different patterns that involved “three specific minor malformations” not seen in either of the control groups, Dr. Chambers said. She did not elaborate on what those patterns were, but noted that the parents usually had them, too, “suggesting a genetic component as opposed to a drug effect.”

Children in the three study groups had no statistically significant differences in 1-year malignancy rates, serious infections, and hospitalizations, even when exposed to etanercept in the third trimester.

Children exposed to etanercept, however, were more likely to be born preterm and more likely to be small for gestational age in weight, length, and head circumference. They were also more likely than disease control children to screen positive for developmental issues at 1 year, but none of those differences were statistically significant.

Dr. Chambers disclosed funding from 14 companies, including Amgen, the maker of etanercept, and Janssen, Pfizer, Roche, Sanofi/Genzyme, GlaxoSmithKline, and AbbVie, the maker of adalimumab.

[email protected]

SAN FRANCISCO – Etanercept during pregnancy more than doubled the risk of major congenital malformations in a study by the Organization of Teratology Information Specialists.

The group keeps a prospective registry on exposures to biologics during pregnancy. It is finishing up its adalimumab (Humira) investigation and hasn’t found much to worry about, and continues to gather data on abatacept (Orencia), tocilizumab (Actemra), tofacitinib (Xeljanz), apremilast (Otezla), and certolizumab pegol (Cimzia).

Etanercept (Enbrel), however, seems to be a different story; major malformations turned up in the group’s recently completed investigation. Even so, Organization of Teratology Information Specialists (OTIS) investigator Dr. Christina D. Chambers, Ph.D., of the University of California, San Diego, was careful to note at the annual meeting of the American College of Rheumatology that “etanercept is not meeting the criteria for causality. There’s no pattern” in major defects and “no biological plausibility” because the drug doesn’t seem to cross the placenta when the fetus is most vulnerable to adverse outcomes.

“It is difficult to draw the conclusion that this drug is causing harm. With true teratogens, you tend to see reduced birth weights and an increased risk of spontaneous abortion, which is not the case with etanercept. We are seeing only this one finding that kind of stands alone, and everything else looks pretty good,” she said.

The etanercept study investigated pregnancy outcomes in 370 women exposed to the drug while pregnant, mostly women with rheumatoid arthritis, but also women with psoriasis and ankylosing spondylitis. Their outcomes were compared with 164 pregnant women with the same diseases but no etanercept exposure – the disease control group – and 296 healthy pregnant women.

Women in all three groups were about 33 years old on average, and about 80% were white. The women were enrolled toward the end of their first trimester. Disease severity, comorbidities, and use of vitamins, alcohol, and tobacco were similar between etanercept and disease control women. About 40% of the etanercept and disease control women, but just one in the healthy pregnancy group, were exposed to systemic corticosteroids while pregnant.

There were 33 major structural defects in children born to women taking etanercept versus 7 in the disease control group. That translated to a more than doubling of risk with etanercept (odds ratio, 2.37; 95% confidence interval, 1.02-5.52), and a more than doubling of risk versus the 10 major structural defects in children born to healthy control women (OR, 2.91; 95% CI, 1.37-6.76).

A subanalysis excluded chromosomal anomalies, but “did not [change] our conclusions,” Dr. Chambers said.

Major structural defects generally refer to problems that need a surgical fix, including spina bifida, atrial septal defects, cleft palates, hypospadias, polydactyly, and craniosynostosis.

Minor defects that don’t need surgery, like a missing earlobe, occurred in six children exposed to etanercept and showed two different patterns that involved “three specific minor malformations” not seen in either of the control groups, Dr. Chambers said. She did not elaborate on what those patterns were, but noted that the parents usually had them, too, “suggesting a genetic component as opposed to a drug effect.”

Children in the three study groups had no statistically significant differences in 1-year malignancy rates, serious infections, and hospitalizations, even when exposed to etanercept in the third trimester.

Children exposed to etanercept, however, were more likely to be born preterm and more likely to be small for gestational age in weight, length, and head circumference. They were also more likely than disease control children to screen positive for developmental issues at 1 year, but none of those differences were statistically significant.

Dr. Chambers disclosed funding from 14 companies, including Amgen, the maker of etanercept, and Janssen, Pfizer, Roche, Sanofi/Genzyme, GlaxoSmithKline, and AbbVie, the maker of adalimumab.

[email protected]

Q2: ANSWER: B

Critique

Cyclic vomiting syndrome (CVS) is characterized by typical vomiting episodes regarding onset and duration, which usually occur three or more times per year. Typically, there is absence of nausea and vomiting between episodes. CVS affects both genders; however, there does appear to be a hormonal influence in women, with 57% of women with CVS reporting an association with menses. Tricyclic antidepressants have been shown to be effective as a prophylactic agent in several small studies with amitriptyline being the most commonly studied medication. Namin and colleagues investigated 31 adult patients who fit the Rome II criteria for CVS. Twenty-seven patients were treated with amitriptyline and completed scales for anxiety, depression, and symptoms. Eighty-four percent suffered from an anxiety disorder, and 78% revealed depression. The patients were started on a low dose of amitriptyline and titrated up to a goal of 1 mg/kg per day. After an average of 16.8 months, the Visual Analog Scale revealed a significant mean improvement (P less than .05) in severity of their symptoms by 6.1. Additionally, there was 78% improvement in vomiting, 75.3% improvement in pain, and 69.3% improvement in nausea.

Choice A: Domperidone has not been found to be beneficial in CVS.

Choice C: Metoclopramide does not decrease symptom recurrence in CVS.

Choice D: Selective serotonin reuptake inhibitors have not been shown in clinical trials to decrease CVS recurrence.

Choice E: Proton pump inhibitors can help as an adjunct to suppress gastric secretion. However, they do not decrease the frequency of CVS episodes.

References

1. Namin F., et al. Clinical, psychiatric, and manometric profile of cyclic vomiting syndrome in adults and response to tricyclic therapy. Neurogastroenterol Motil. 2007;19:196-202.

Q2: ANSWER: B

Critique

Cyclic vomiting syndrome (CVS) is characterized by typical vomiting episodes regarding onset and duration, which usually occur three or more times per year. Typically, there is absence of nausea and vomiting between episodes. CVS affects both genders; however, there does appear to be a hormonal influence in women, with 57% of women with CVS reporting an association with menses. Tricyclic antidepressants have been shown to be effective as a prophylactic agent in several small studies with amitriptyline being the most commonly studied medication. Namin and colleagues investigated 31 adult patients who fit the Rome II criteria for CVS. Twenty-seven patients were treated with amitriptyline and completed scales for anxiety, depression, and symptoms. Eighty-four percent suffered from an anxiety disorder, and 78% revealed depression. The patients were started on a low dose of amitriptyline and titrated up to a goal of 1 mg/kg per day. After an average of 16.8 months, the Visual Analog Scale revealed a significant mean improvement (P less than .05) in severity of their symptoms by 6.1. Additionally, there was 78% improvement in vomiting, 75.3% improvement in pain, and 69.3% improvement in nausea.

Choice A: Domperidone has not been found to be beneficial in CVS.

Choice C: Metoclopramide does not decrease symptom recurrence in CVS.

Choice D: Selective serotonin reuptake inhibitors have not been shown in clinical trials to decrease CVS recurrence.

Choice E: Proton pump inhibitors can help as an adjunct to suppress gastric secretion. However, they do not decrease the frequency of CVS episodes.

References

1. Namin F., et al. Clinical, psychiatric, and manometric profile of cyclic vomiting syndrome in adults and response to tricyclic therapy. Neurogastroenterol Motil. 2007;19:196-202.

Q2: ANSWER: B

Critique

Cyclic vomiting syndrome (CVS) is characterized by typical vomiting episodes regarding onset and duration, which usually occur three or more times per year. Typically, there is absence of nausea and vomiting between episodes. CVS affects both genders; however, there does appear to be a hormonal influence in women, with 57% of women with CVS reporting an association with menses. Tricyclic antidepressants have been shown to be effective as a prophylactic agent in several small studies with amitriptyline being the most commonly studied medication. Namin and colleagues investigated 31 adult patients who fit the Rome II criteria for CVS. Twenty-seven patients were treated with amitriptyline and completed scales for anxiety, depression, and symptoms. Eighty-four percent suffered from an anxiety disorder, and 78% revealed depression. The patients were started on a low dose of amitriptyline and titrated up to a goal of 1 mg/kg per day. After an average of 16.8 months, the Visual Analog Scale revealed a significant mean improvement (P less than .05) in severity of their symptoms by 6.1. Additionally, there was 78% improvement in vomiting, 75.3% improvement in pain, and 69.3% improvement in nausea.

Choice A: Domperidone has not been found to be beneficial in CVS.

Choice C: Metoclopramide does not decrease symptom recurrence in CVS.

Choice D: Selective serotonin reuptake inhibitors have not been shown in clinical trials to decrease CVS recurrence.

Choice E: Proton pump inhibitors can help as an adjunct to suppress gastric secretion. However, they do not decrease the frequency of CVS episodes.

References

1. Namin F., et al. Clinical, psychiatric, and manometric profile of cyclic vomiting syndrome in adults and response to tricyclic therapy. Neurogastroenterol Motil. 2007;19:196-202.