Federal Practitioner

The American Cancer Society has updated its screening guidelines for lung cancer, the leading cause of cancer-specific deaths in the United States and the largest driver of potential years of life lost from cancer.

The 2023 screening guidance, aimed principally at reducing lung cancer mortality in asymptomatic but high-risk, tobacco-exposed individuals, expands the age eligibility and lowers both the former smoking history and the years since quitting threshold for screening with low-dose CT (LDCT).

It is based on the most recent evidence on the efficacy and effectiveness of screening and lung cancer risk in persons who formerly smoked, wrote the ACS’s Guideline Development Group led by Robert A. Smith, PhD, senior vice president of early cancer detection science. The new guidelines, which replace the 2013 statement, appear in CA: A Cancer Journal for Physicians.

The primary evidence source for the update was a systematic review of LDCT lung cancer screening conducted for the U.S. Preventive Services Task Force and published in 2021.

The new guideline continues a trend of expanding eligibility for lung cancer screening, which has had low uptake, to prevent more deaths. “Recent studies have shown that extending the age for persons who smoked and formerly smoked, eliminating the ‘years since quitting’ requirement, and lowering the pack-per-year recommendation could make a real difference in saving lives,” Dr. Smith said. “The relative risk of developing lung cancer in people who have smoked most of their life compared to people who never smoked is very high – about 70 times the risk.” Although lung cancer is the third most common malignancy in the United States, it accounts for more deaths than colorectal, breast, prostate, and cervical cancers combined.

The recommendation for annual LDCT for at-risk persons remains unchanged from 2013.

Among the 2023 eligibility changes:

• Age: Expanded to 50-80 years from 55-74 years.
• Smoking status: Changed to current or previous smoker from current smoker or smoker who quit within past 15 years (number of years since quitting no longer a criterion to start or stop screening). Dr. Smith noted that both the 2013 guidelines and other groups’ updated recommendations retained the eligibility cutoff of 15 years since smoking cessation. “But had their risk declined to a level that just did not justify continuing screening?” he asked. “There wasn’t an answer to that question, so we needed to look carefully at the absolute risk of lung cancer in persons who formerly smoked compared with people who currently smoked and people who never smoked.”
• Smoking history: Reduced to 20 or more pack-years (average of 20 cigarettes a day) versus 30 or more pack-years.
• Exclusions: Expanded to health conditions that may increase harm or hinder further evaluation, surgery, or treatment; comorbidities limiting life expectancy to fewer than 5 years; unwillingness to accept treatment for screen‐detected cancer, which was changed from 2013’s life‐limiting comorbid conditions, metallic implants or devices in the chest or back, home oxygen supplementation.

In addition, decision-making should be a shared process with a health professional providing the patient with information on the benefits, limitations, and harms of LDCT screening, as well as prescreening advice on smoking cessation and the offer of assistive counseling and pharmocotherapy.

“Overall, lung cancer screening remains one of the least used early cancer detection modalities in clinical practice. The new guidance opens up lung cancer screening to all former smokers regardless of time of cessation,” said internist William E. Golden, MD, MACP, a professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock. “This may promote greater uptake in concert with greater availability of low-radiation CT scanning.”

While agreeing the expanded criteria will enfranchise nearly 5 million current and former U.S. smokers for screening and may reduce deaths, internist Aarati D. Didwania, MD, MMSCI, MACP, a professor of medicine and medical education at Northwestern University, Chicago, warned that increasing actual uptake may be an uphill battle. “The practical part of the equation is seeing that the scans get done. There is often a lag between a recommendation of a yearly test and getting insurance coverage for it, and many disadvantaged people face barriers.” Then there’s the knowledge gap. “Patients and doctors have to know what the new guidelines are and who has access,” she said.

Reaching the target population in rural areas is particularly challenging with the greater distances to imaging centers. Another barrier is that most electronic health records do not identify eligible patients based on smoking and pack‐year history.

In Dr. Didwania’s view, professional medical societies have an important role to play in educating their members, and through them, patients. “Disseminating information about the new recommendations is the first step and would be incredibly helpful.”
 

A brief history of lung cancer screening

1950s: By mid-20th century, the causal association between tobacco exposure and lung cancer became clear and by the late 1950s attempts were made to develop a lung cancer screening strategy for high‐risk individuals, commonly with the combination of sputum cytology and chest x-ray.

1970s: The ACS recommended annual testing for current or former smokers with chest x-ray (and sometimes sputum cytology).

1980: The ACS withdrew the above recommendation for regular radiographic screening after randomized controlled trials failed to yield convincing evidence that such screening saved lives.

2013: After the National Lung Screening Trial found three annual LDCT screenings were associated with a 20% relative mortality reduction, compared with annual chest x-ray, the ACS issued a recommendation for annual screening with LDCT: in persons 55-74 years with a pack‐year history of 30 or more who currently smoke or formerly smoked but had not exceeded 15 years since quitting and had no life-limiting morbidity.
 

Future mortality

Although tobacco controls are expected to reduce age‐adjusted lung cancer mortality in the United States by 79% from 2015 to 2065, 4.4 million lung cancer deaths are projected to occur in this period, the authors stated. “A large fraction of these deaths can be prevented if we embrace the urgent challenge to improve our ability to identify the population at risk and apply our knowledge to achieve high rates of participation in regular [lung cancer screening].”

The study was funded by the American Cancer Society Guideline Development Group and the National Comprehensive Cancer Network. The authors disclosed no relevant competing interests. Dr. Golden and Dr. Didwania had no relevant conflicts of interest to declare with regard to their comments.

The American Cancer Society has updated its screening guidelines for lung cancer, the leading cause of cancer-specific deaths in the United States and the largest driver of potential years of life lost from cancer.

The 2023 screening guidance, aimed principally at reducing lung cancer mortality in asymptomatic but high-risk, tobacco-exposed individuals, expands the age eligibility and lowers both the former smoking history and the years since quitting threshold for screening with low-dose CT (LDCT).

It is based on the most recent evidence on the efficacy and effectiveness of screening and lung cancer risk in persons who formerly smoked, wrote the ACS’s Guideline Development Group led by Robert A. Smith, PhD, senior vice president of early cancer detection science. The new guidelines, which replace the 2013 statement, appear in CA: A Cancer Journal for Physicians.

The primary evidence source for the update was a systematic review of LDCT lung cancer screening conducted for the U.S. Preventive Services Task Force and published in 2021.

The new guideline continues a trend of expanding eligibility for lung cancer screening, which has had low uptake, to prevent more deaths. “Recent studies have shown that extending the age for persons who smoked and formerly smoked, eliminating the ‘years since quitting’ requirement, and lowering the pack-per-year recommendation could make a real difference in saving lives,” Dr. Smith said. “The relative risk of developing lung cancer in people who have smoked most of their life compared to people who never smoked is very high – about 70 times the risk.” Although lung cancer is the third most common malignancy in the United States, it accounts for more deaths than colorectal, breast, prostate, and cervical cancers combined.

The recommendation for annual LDCT for at-risk persons remains unchanged from 2013.

Among the 2023 eligibility changes:

• Age: Expanded to 50-80 years from 55-74 years.
• Smoking status: Changed to current or previous smoker from current smoker or smoker who quit within past 15 years (number of years since quitting no longer a criterion to start or stop screening). Dr. Smith noted that both the 2013 guidelines and other groups’ updated recommendations retained the eligibility cutoff of 15 years since smoking cessation. “But had their risk declined to a level that just did not justify continuing screening?” he asked. “There wasn’t an answer to that question, so we needed to look carefully at the absolute risk of lung cancer in persons who formerly smoked compared with people who currently smoked and people who never smoked.”
• Smoking history: Reduced to 20 or more pack-years (average of 20 cigarettes a day) versus 30 or more pack-years.
• Exclusions: Expanded to health conditions that may increase harm or hinder further evaluation, surgery, or treatment; comorbidities limiting life expectancy to fewer than 5 years; unwillingness to accept treatment for screen‐detected cancer, which was changed from 2013’s life‐limiting comorbid conditions, metallic implants or devices in the chest or back, home oxygen supplementation.

In addition, decision-making should be a shared process with a health professional providing the patient with information on the benefits, limitations, and harms of LDCT screening, as well as prescreening advice on smoking cessation and the offer of assistive counseling and pharmocotherapy.

“Overall, lung cancer screening remains one of the least used early cancer detection modalities in clinical practice. The new guidance opens up lung cancer screening to all former smokers regardless of time of cessation,” said internist William E. Golden, MD, MACP, a professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock. “This may promote greater uptake in concert with greater availability of low-radiation CT scanning.”

While agreeing the expanded criteria will enfranchise nearly 5 million current and former U.S. smokers for screening and may reduce deaths, internist Aarati D. Didwania, MD, MMSCI, MACP, a professor of medicine and medical education at Northwestern University, Chicago, warned that increasing actual uptake may be an uphill battle. “The practical part of the equation is seeing that the scans get done. There is often a lag between a recommendation of a yearly test and getting insurance coverage for it, and many disadvantaged people face barriers.” Then there’s the knowledge gap. “Patients and doctors have to know what the new guidelines are and who has access,” she said.

Reaching the target population in rural areas is particularly challenging with the greater distances to imaging centers. Another barrier is that most electronic health records do not identify eligible patients based on smoking and pack‐year history.

In Dr. Didwania’s view, professional medical societies have an important role to play in educating their members, and through them, patients. “Disseminating information about the new recommendations is the first step and would be incredibly helpful.”
 

A brief history of lung cancer screening

1950s: By mid-20th century, the causal association between tobacco exposure and lung cancer became clear and by the late 1950s attempts were made to develop a lung cancer screening strategy for high‐risk individuals, commonly with the combination of sputum cytology and chest x-ray.

1970s: The ACS recommended annual testing for current or former smokers with chest x-ray (and sometimes sputum cytology).

1980: The ACS withdrew the above recommendation for regular radiographic screening after randomized controlled trials failed to yield convincing evidence that such screening saved lives.

2013: After the National Lung Screening Trial found three annual LDCT screenings were associated with a 20% relative mortality reduction, compared with annual chest x-ray, the ACS issued a recommendation for annual screening with LDCT: in persons 55-74 years with a pack‐year history of 30 or more who currently smoke or formerly smoked but had not exceeded 15 years since quitting and had no life-limiting morbidity.
 

Future mortality

Although tobacco controls are expected to reduce age‐adjusted lung cancer mortality in the United States by 79% from 2015 to 2065, 4.4 million lung cancer deaths are projected to occur in this period, the authors stated. “A large fraction of these deaths can be prevented if we embrace the urgent challenge to improve our ability to identify the population at risk and apply our knowledge to achieve high rates of participation in regular [lung cancer screening].”

The study was funded by the American Cancer Society Guideline Development Group and the National Comprehensive Cancer Network. The authors disclosed no relevant competing interests. Dr. Golden and Dr. Didwania had no relevant conflicts of interest to declare with regard to their comments.

The American Cancer Society has updated its screening guidelines for lung cancer, the leading cause of cancer-specific deaths in the United States and the largest driver of potential years of life lost from cancer.

The 2023 screening guidance, aimed principally at reducing lung cancer mortality in asymptomatic but high-risk, tobacco-exposed individuals, expands the age eligibility and lowers both the former smoking history and the years since quitting threshold for screening with low-dose CT (LDCT).

It is based on the most recent evidence on the efficacy and effectiveness of screening and lung cancer risk in persons who formerly smoked, wrote the ACS’s Guideline Development Group led by Robert A. Smith, PhD, senior vice president of early cancer detection science. The new guidelines, which replace the 2013 statement, appear in CA: A Cancer Journal for Physicians.

The primary evidence source for the update was a systematic review of LDCT lung cancer screening conducted for the U.S. Preventive Services Task Force and published in 2021.

The new guideline continues a trend of expanding eligibility for lung cancer screening, which has had low uptake, to prevent more deaths. “Recent studies have shown that extending the age for persons who smoked and formerly smoked, eliminating the ‘years since quitting’ requirement, and lowering the pack-per-year recommendation could make a real difference in saving lives,” Dr. Smith said. “The relative risk of developing lung cancer in people who have smoked most of their life compared to people who never smoked is very high – about 70 times the risk.” Although lung cancer is the third most common malignancy in the United States, it accounts for more deaths than colorectal, breast, prostate, and cervical cancers combined.

The recommendation for annual LDCT for at-risk persons remains unchanged from 2013.

Among the 2023 eligibility changes:

• Age: Expanded to 50-80 years from 55-74 years.
• Smoking status: Changed to current or previous smoker from current smoker or smoker who quit within past 15 years (number of years since quitting no longer a criterion to start or stop screening). Dr. Smith noted that both the 2013 guidelines and other groups’ updated recommendations retained the eligibility cutoff of 15 years since smoking cessation. “But had their risk declined to a level that just did not justify continuing screening?” he asked. “There wasn’t an answer to that question, so we needed to look carefully at the absolute risk of lung cancer in persons who formerly smoked compared with people who currently smoked and people who never smoked.”
• Smoking history: Reduced to 20 or more pack-years (average of 20 cigarettes a day) versus 30 or more pack-years.
• Exclusions: Expanded to health conditions that may increase harm or hinder further evaluation, surgery, or treatment; comorbidities limiting life expectancy to fewer than 5 years; unwillingness to accept treatment for screen‐detected cancer, which was changed from 2013’s life‐limiting comorbid conditions, metallic implants or devices in the chest or back, home oxygen supplementation.

In addition, decision-making should be a shared process with a health professional providing the patient with information on the benefits, limitations, and harms of LDCT screening, as well as prescreening advice on smoking cessation and the offer of assistive counseling and pharmocotherapy.

“Overall, lung cancer screening remains one of the least used early cancer detection modalities in clinical practice. The new guidance opens up lung cancer screening to all former smokers regardless of time of cessation,” said internist William E. Golden, MD, MACP, a professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock. “This may promote greater uptake in concert with greater availability of low-radiation CT scanning.”

While agreeing the expanded criteria will enfranchise nearly 5 million current and former U.S. smokers for screening and may reduce deaths, internist Aarati D. Didwania, MD, MMSCI, MACP, a professor of medicine and medical education at Northwestern University, Chicago, warned that increasing actual uptake may be an uphill battle. “The practical part of the equation is seeing that the scans get done. There is often a lag between a recommendation of a yearly test and getting insurance coverage for it, and many disadvantaged people face barriers.” Then there’s the knowledge gap. “Patients and doctors have to know what the new guidelines are and who has access,” she said.

Reaching the target population in rural areas is particularly challenging with the greater distances to imaging centers. Another barrier is that most electronic health records do not identify eligible patients based on smoking and pack‐year history.

In Dr. Didwania’s view, professional medical societies have an important role to play in educating their members, and through them, patients. “Disseminating information about the new recommendations is the first step and would be incredibly helpful.”
 

A brief history of lung cancer screening

1950s: By mid-20th century, the causal association between tobacco exposure and lung cancer became clear and by the late 1950s attempts were made to develop a lung cancer screening strategy for high‐risk individuals, commonly with the combination of sputum cytology and chest x-ray.

1970s: The ACS recommended annual testing for current or former smokers with chest x-ray (and sometimes sputum cytology).

1980: The ACS withdrew the above recommendation for regular radiographic screening after randomized controlled trials failed to yield convincing evidence that such screening saved lives.

2013: After the National Lung Screening Trial found three annual LDCT screenings were associated with a 20% relative mortality reduction, compared with annual chest x-ray, the ACS issued a recommendation for annual screening with LDCT: in persons 55-74 years with a pack‐year history of 30 or more who currently smoke or formerly smoked but had not exceeded 15 years since quitting and had no life-limiting morbidity.
 

Future mortality

Although tobacco controls are expected to reduce age‐adjusted lung cancer mortality in the United States by 79% from 2015 to 2065, 4.4 million lung cancer deaths are projected to occur in this period, the authors stated. “A large fraction of these deaths can be prevented if we embrace the urgent challenge to improve our ability to identify the population at risk and apply our knowledge to achieve high rates of participation in regular [lung cancer screening].”

The study was funded by the American Cancer Society Guideline Development Group and the National Comprehensive Cancer Network. The authors disclosed no relevant competing interests. Dr. Golden and Dr. Didwania had no relevant conflicts of interest to declare with regard to their comments.

TOPLINE:

Among patients with colorectal cancer (CRC), those with complicated diabetes were at higher risk of poor survival than their peers without diabetes, while those with uncomplicated diabetes had insignificantly worse cancer outcomes.

METHODOLOGY:

• This population-based retrospective cohort study used 2007-2015 data from the Taiwan Cancer Registry, which is linked to national insurance and death registry data.
• The analysis included 59,202 adults with stage I-III CRC who underwent potentially curative surgery: 44,944 without diabetes, 8,864 with uncomplicated diabetes, and 5,394 with complicated diabetes.
• The association between diabetes severity and CRC survival, overall survival (OS), disease-free survival (DFS), time to recurrence, and cancer-specific survival (CSS) was examined.
•  

TAKEAWAY:

• Patients with uncomplicated diabetes had insignificantly worse OS (hazard ratio, 1.05), DFS (HR, 1.08), and CSS (HR, 0.98), compared with peers who did not have diabetes.
• Patients with complicated diabetes were at significantly higher risk of poor OS (HR, 1.85), DFS (HR, 1.75), and CSS (HR, 1.41), compared with those without diabetes.
• Patients with diabetes were also at higher risk for CRC recurrence than those without diabetes.
• Except for recurrence risk, the impact of complicated diabetes on CRC survival – that is, OS, DFS, and CSS – was more pronounced among women and those with early-stage cancer.

IN PRACTICE:

“These findings indicate that preventing diabetes complications may help improve survival in patients with CRC, especially [in] female patients and those in the early stages of the disease. Thus, a multidisciplinary approach is recommended for patients with CRC,” the authors conclude.

SOURCE:

The study, with first author Hsin-Yin Hsu, MD, National Taiwan University, Taipei, was published online in the journal Cancer.

LIMITATIONS:

Only patients from Taiwan were included, which limits generalizability, because CRC prognosis may vary in accordance with race or cancer treatment strategy – factors that may differ among countries. Data on glucose levels and diabetes duration were unavailable, potentially leading to misclassification of diabetes status.

DISCLOSURES:

Funding was provided by the Ministry of Science and Technology and the Ministry of Health and Welfare. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

Among patients with colorectal cancer (CRC), those with complicated diabetes were at higher risk of poor survival than their peers without diabetes, while those with uncomplicated diabetes had insignificantly worse cancer outcomes.

METHODOLOGY:

• This population-based retrospective cohort study used 2007-2015 data from the Taiwan Cancer Registry, which is linked to national insurance and death registry data.
• The analysis included 59,202 adults with stage I-III CRC who underwent potentially curative surgery: 44,944 without diabetes, 8,864 with uncomplicated diabetes, and 5,394 with complicated diabetes.
• The association between diabetes severity and CRC survival, overall survival (OS), disease-free survival (DFS), time to recurrence, and cancer-specific survival (CSS) was examined.
•  

TAKEAWAY:

• Patients with uncomplicated diabetes had insignificantly worse OS (hazard ratio, 1.05), DFS (HR, 1.08), and CSS (HR, 0.98), compared with peers who did not have diabetes.
• Patients with complicated diabetes were at significantly higher risk of poor OS (HR, 1.85), DFS (HR, 1.75), and CSS (HR, 1.41), compared with those without diabetes.
• Patients with diabetes were also at higher risk for CRC recurrence than those without diabetes.
• Except for recurrence risk, the impact of complicated diabetes on CRC survival – that is, OS, DFS, and CSS – was more pronounced among women and those with early-stage cancer.

IN PRACTICE:

“These findings indicate that preventing diabetes complications may help improve survival in patients with CRC, especially [in] female patients and those in the early stages of the disease. Thus, a multidisciplinary approach is recommended for patients with CRC,” the authors conclude.

SOURCE:

The study, with first author Hsin-Yin Hsu, MD, National Taiwan University, Taipei, was published online in the journal Cancer.

LIMITATIONS:

Only patients from Taiwan were included, which limits generalizability, because CRC prognosis may vary in accordance with race or cancer treatment strategy – factors that may differ among countries. Data on glucose levels and diabetes duration were unavailable, potentially leading to misclassification of diabetes status.

DISCLOSURES:

Funding was provided by the Ministry of Science and Technology and the Ministry of Health and Welfare. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

Among patients with colorectal cancer (CRC), those with complicated diabetes were at higher risk of poor survival than their peers without diabetes, while those with uncomplicated diabetes had insignificantly worse cancer outcomes.

METHODOLOGY:

• This population-based retrospective cohort study used 2007-2015 data from the Taiwan Cancer Registry, which is linked to national insurance and death registry data.
• The analysis included 59,202 adults with stage I-III CRC who underwent potentially curative surgery: 44,944 without diabetes, 8,864 with uncomplicated diabetes, and 5,394 with complicated diabetes.
• The association between diabetes severity and CRC survival, overall survival (OS), disease-free survival (DFS), time to recurrence, and cancer-specific survival (CSS) was examined.
•  

TAKEAWAY:

• Patients with uncomplicated diabetes had insignificantly worse OS (hazard ratio, 1.05), DFS (HR, 1.08), and CSS (HR, 0.98), compared with peers who did not have diabetes.
• Patients with complicated diabetes were at significantly higher risk of poor OS (HR, 1.85), DFS (HR, 1.75), and CSS (HR, 1.41), compared with those without diabetes.
• Patients with diabetes were also at higher risk for CRC recurrence than those without diabetes.
• Except for recurrence risk, the impact of complicated diabetes on CRC survival – that is, OS, DFS, and CSS – was more pronounced among women and those with early-stage cancer.

IN PRACTICE:

“These findings indicate that preventing diabetes complications may help improve survival in patients with CRC, especially [in] female patients and those in the early stages of the disease. Thus, a multidisciplinary approach is recommended for patients with CRC,” the authors conclude.

SOURCE:

The study, with first author Hsin-Yin Hsu, MD, National Taiwan University, Taipei, was published online in the journal Cancer.

LIMITATIONS:

Only patients from Taiwan were included, which limits generalizability, because CRC prognosis may vary in accordance with race or cancer treatment strategy – factors that may differ among countries. Data on glucose levels and diabetes duration were unavailable, potentially leading to misclassification of diabetes status.

DISCLOSURES:

Funding was provided by the Ministry of Science and Technology and the Ministry of Health and Welfare. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Community oncologists across the United States are concerned about a recent lawsuit in Philadelphia between the Jefferson Health hospital system and the largest independent oncology and hematology practice in southeastern Pennsylvania, Alliance Cancer Specialists.

The outcome, some community oncologists say, could set a new precedent in how far large health care organizations will go to take their patients or drive them out of business.
 

The case

On Sept. 5, Alliance sued Jefferson Health after Jefferson canceled the inpatient oncology/hematology privileges of five Alliance oncologists at three Jefferson Health-Northeast hospitals, primarily alleging that Jefferson was attempting to monopolize cancer care in the area.

Jefferson – one of the largest health care systems in the Philadelphia area that includes the NCI-designated Sidney Kimmel Cancer Center – made the move because it had entered into an exclusive agreement with its own medical group to provide inpatient and outpatient oncology/hematology services at the hospitals.

In its court filings, Jefferson said it entered into the exclusive agreement because doing so was in “the best interest of patients, as it would ensure better integration and availability of care and help ensure that Jefferson consistently provides high-quality medical care in accordance with evidence-based standards.”

Tensions had been building between Alliance and Jefferson for years, ever since, according to Alliance, the community practice declined a buyout offer from Jefferson almost a decade ago.

But the revocation of privileges ultimately tipped the scales for Alliance, sparking the lawsuit.

“For us, that crossed a line,” said Moshe Chasky, MD, one of the five Alliance oncologists and a plaintiff in the suit.

Dr. Chasky and his colleagues had provided care at the hospitals for years, with about 10-15 patients admitted at any one time. The quality of their care is not in dispute. Dr. Chasky, for instance, routinely makes Philadelphia Magazine’s Top Doc List.

Under the new arrangement, the five Alliance oncologists have to hand over care of their admitted patients to Jefferson oncologists or send their patients to another hospital farther away where they do have admitting privileges.

“Without having admitting privileges,” community oncologists “can’t look a patient in the eye and say, ‘No matter what, I’ve got you,’ ” explained Nicolas Ferreyros, managing director of policy, advocacy, and communications at the Community Oncology Alliance, a DC-based lobbying group for independent oncologists.

“A doctor doesn’t want to tell a patient that ‘once you go in the hospital, I have to hand you off.’ ” It undermines their practice, Mr. Ferreyros said.

The situation has caught the attention of other community oncologists who are worried that hospitals canceling admitting privileges might become a new tactic in what they characterize as an ongoing effort to elbow-out independent practitioners and corner the oncology market.

Dr. Chasky said he is getting “calls every day from independent oncologists throughout the country” who “are very concerned. People are watching this for sure.”   

Alliance attorney Daniel Frier said that there is nothing unusual about hospitals entering into exclusive contracts with hospital-based practices.

But Mr. Frier said he’s never heard of a hospital entering into an exclusive contract and then terminating the privileges of community oncologists.  

“There’s no direct precedent” for the move, he said.

Jefferson Health did not respond to requests for comment. 
 

The ruling

U.S. District Court Judge Kai Scott, who ruled on Alliance’s motion to block the contract and preserve its oncologists’ admitting privileges, ultimately sided with Jefferson and allowed the contract to go forward.

Judge Scott wrote that, “while the court understands the plaintiffs’ concerns and desires to maintain the continuity of care for their own patients,” the court “is not persuaded that either of the two threshold elements for a temporary restraining order or preliminary injunction are met” – first, that Jefferson’s actions violate antitrust laws and second that the plaintiffs “will suffer immediate, irreparable harm” from having their admitting privileges rescinded.

Alliance argued that Jefferson’s contract violated federal antitrust laws and would allow Jefferson to monopolize the local oncology market.

However, Judge Scott called Alliance’s antitrust argument “lifeless” under the strict requirements for antitrust violations, explaining that, among other reasons, a monopoly is unlikely given that Jefferson competes with several high-profile oncology programs in the Philadelphia area, including the Fox Chase Cancer Center.

Judge Scott also expressed doubt that the Jefferson’s actions would cause irreparable harm to Alliance’s business. Alliance employs more than thirty oncologists affiliated with over a dozen hospitals in the greater Philadelphia area, and the inpatient services provided at Jefferson Health-Northeast did not represent a major part of its business. 

Despite her ruling, Judge Scott did voice skepticism about some of Jefferson’s arguments.

“The court notes that the Jefferson defendants have briefly argued that Jefferson will be better able to ensure that its own patients receive fully integrated and coordinated care” under the exclusive provider agreement, but “it is unclear how the cooperation of ACS [Alliance Cancer Specialists] and JNE [Jefferson Health-Northeast] hospitalists really caused any problems for the coordinated care of” patients in the many years that they worked together.

It also “does not seem to necessarily serve the community to quickly sever the artery between the services that ACS provides and the services that JNE provides,” Judge Scott wrote.

She added that she would consider another motion from Alliance if the practice makes stronger arguments illustrating antitrust violations and demonstrating irreparable harm.

Currently, Dr. Chasky and Mr. Frier are considering their next steps in the case. The oncologists said they can appeal the judge’s decision or file a new complaint.

Meanwhile, Dr. Chasky and his four colleagues requested and were granted internal medicine privileges at Jefferson Health-Northeast, but given the considerable overlap between oncology and internal medicine, the line between what they can and cannot do remains unclear.

“It’s a mess,” he said.
 

A familiar story

Large health care entities have increasingly worked to push out or swallow up smaller, independent practices for years.

“What Dr. Chasky and his practice are going through is a little bit more of an aggressive version of what’s going on in the rest of the country,” said Michael Diaz, MD, a community oncologist at Florida Cancer Specialists, the largest independent medical oncology/hematology group in the United States. “The larger institutional hospitals try to make it a closed system so they can keep everything in-house and refer to their own physicians.”

The incentive, Dr. Diaz said, is the financial windfall that Section 340B of the 1992 Public Health Service Act generates for hospital-based oncology services at nonprofit hospitals, such as the Jefferson Health-Northeast facilities.

The 340B program allows nonprofit hospitals to buy primarily outpatient oncology drugs at steep discounts, sometimes 50% or more, and be reimbursed at full price.

When launched in 1992, the program was meant to help a handful of safety-net hospitals cover the cost of charity care, and now approximately more than half of U.S. hospitals participate in the program, particularly after requirements were loosened by the Affordable Care Act. But there’s little transparency on how the money is spent.

Critics say the incentives have created a feeding frenzy among 340B hospitals to either acquire outpatient oncology practices or take their business because of the particularly high margins on oncology drugs. There are similar incentives for hospital-based infusion centers.

In its lawsuit, Alliance alleged that such incentives are what motivated Jefferson’s recent actions.

“It’s all about the money at the end of the day,” said Christian Thomas, MD, a community oncologist with New England Cancer Specialists, Scarborough, Maine, who, like Dr. Diaz, said he’s seen the dynamic play out repeatedly in his career. 

The American Hospital Association has been a vigorous defender of 340B in the courts and elsewhere, but the Association’s communications staff had little to say when this news organization reached out about the Jefferson-Alliance situation, except that they do not comment on “specific hospital circumstance.”
 

Reverberations around the country

Many community oncologists are keeping close tabs on the Jefferson-Alliance situation.

“Our group has been watching Jefferson closely because our [local] hospital is following the same playbook, but they have not yet gone after our privileges,” said Scott Herbert, MD, a community oncologist with the independent Nexus Health system, Sante Fe, N.M.

Dr. Herbert was referring to what has happened since he and his colleagues declined to renew an exclusive provider agreement early this year with St. Vincent Regional Medical Center, a nonprofit hospital in Sante Fe. The agreement allowed the hospital to take advantage of the 340B program because Nexus oncologists acted on its behalf.

St. Vincent’s owner, Christus Health, did not respond to inquiries from this news organization.

Nexus let the contract lapse because its oncologists wanted to provide services at a second, newer hospital in Santa Fe where some of their patients had begun seeking treatment.

The nonprofit hospital in Sante Fe is now building its own oncology practice. Similar to Dr. Chasky’s experience in Philadelphia, Dr. Herbert said his group has seen referrals from the hospital dry up and existing patients rechanneled to the hospital’s oncologists.  

“We found over 109 patients in January and February that were referred to one of our docs that got rerouted to one of their docs,” he said.

Dr. Herbert has sent cease-and-desist letters, but “after we saw what Jefferson did, my group said, ‘You better back off of the hospital, or it’s going to take our privileges.’ ”

The Jefferson situation “is sending a message,” he said. “Frankly, we’ve been terrified” at the thought of losing privileges there. “It’s the busiest hospital in our area.”
 

The future of community oncology

Despite the challenges, Mr. Ferreyros at the Community Oncology Alliance remains optimistic about the future of independent oncology.

Under the competitive pressures, a lot of independent oncology practices have folded in recent years, but the ones that remain are strong. Payers are also increasingly noticing that community oncology practices are less expensive than hospital-based practices for comparable care, he said.

Relationships with hospitals aren’t always adversarial, either. “A lot of practices have collaborative agreements with local hospitals” that work out well, Mr. Ferreyros said, adding that sometimes hospitals even hand over oncology care to local independents after finding that starting and maintaining an oncology service is harder than they imagined.

“The last two decades have been difficult,” but the remaining community oncology practices “are going strong,” he said, and “we’ve never seen more engagement on our issues,” particularly around the issue of cost savings.

A version of this article first appeared on Medscape.com.

Community oncologists across the United States are concerned about a recent lawsuit in Philadelphia between the Jefferson Health hospital system and the largest independent oncology and hematology practice in southeastern Pennsylvania, Alliance Cancer Specialists.

The outcome, some community oncologists say, could set a new precedent in how far large health care organizations will go to take their patients or drive them out of business.
 

The case

On Sept. 5, Alliance sued Jefferson Health after Jefferson canceled the inpatient oncology/hematology privileges of five Alliance oncologists at three Jefferson Health-Northeast hospitals, primarily alleging that Jefferson was attempting to monopolize cancer care in the area.

Jefferson – one of the largest health care systems in the Philadelphia area that includes the NCI-designated Sidney Kimmel Cancer Center – made the move because it had entered into an exclusive agreement with its own medical group to provide inpatient and outpatient oncology/hematology services at the hospitals.

In its court filings, Jefferson said it entered into the exclusive agreement because doing so was in “the best interest of patients, as it would ensure better integration and availability of care and help ensure that Jefferson consistently provides high-quality medical care in accordance with evidence-based standards.”

Tensions had been building between Alliance and Jefferson for years, ever since, according to Alliance, the community practice declined a buyout offer from Jefferson almost a decade ago.

But the revocation of privileges ultimately tipped the scales for Alliance, sparking the lawsuit.

“For us, that crossed a line,” said Moshe Chasky, MD, one of the five Alliance oncologists and a plaintiff in the suit.

Dr. Chasky and his colleagues had provided care at the hospitals for years, with about 10-15 patients admitted at any one time. The quality of their care is not in dispute. Dr. Chasky, for instance, routinely makes Philadelphia Magazine’s Top Doc List.

Under the new arrangement, the five Alliance oncologists have to hand over care of their admitted patients to Jefferson oncologists or send their patients to another hospital farther away where they do have admitting privileges.

“Without having admitting privileges,” community oncologists “can’t look a patient in the eye and say, ‘No matter what, I’ve got you,’ ” explained Nicolas Ferreyros, managing director of policy, advocacy, and communications at the Community Oncology Alliance, a DC-based lobbying group for independent oncologists.

“A doctor doesn’t want to tell a patient that ‘once you go in the hospital, I have to hand you off.’ ” It undermines their practice, Mr. Ferreyros said.

The situation has caught the attention of other community oncologists who are worried that hospitals canceling admitting privileges might become a new tactic in what they characterize as an ongoing effort to elbow-out independent practitioners and corner the oncology market.

Dr. Chasky said he is getting “calls every day from independent oncologists throughout the country” who “are very concerned. People are watching this for sure.”   

Alliance attorney Daniel Frier said that there is nothing unusual about hospitals entering into exclusive contracts with hospital-based practices.

But Mr. Frier said he’s never heard of a hospital entering into an exclusive contract and then terminating the privileges of community oncologists.  

“There’s no direct precedent” for the move, he said.

Jefferson Health did not respond to requests for comment. 
 

The ruling

U.S. District Court Judge Kai Scott, who ruled on Alliance’s motion to block the contract and preserve its oncologists’ admitting privileges, ultimately sided with Jefferson and allowed the contract to go forward.

Judge Scott wrote that, “while the court understands the plaintiffs’ concerns and desires to maintain the continuity of care for their own patients,” the court “is not persuaded that either of the two threshold elements for a temporary restraining order or preliminary injunction are met” – first, that Jefferson’s actions violate antitrust laws and second that the plaintiffs “will suffer immediate, irreparable harm” from having their admitting privileges rescinded.

Alliance argued that Jefferson’s contract violated federal antitrust laws and would allow Jefferson to monopolize the local oncology market.

However, Judge Scott called Alliance’s antitrust argument “lifeless” under the strict requirements for antitrust violations, explaining that, among other reasons, a monopoly is unlikely given that Jefferson competes with several high-profile oncology programs in the Philadelphia area, including the Fox Chase Cancer Center.

Judge Scott also expressed doubt that the Jefferson’s actions would cause irreparable harm to Alliance’s business. Alliance employs more than thirty oncologists affiliated with over a dozen hospitals in the greater Philadelphia area, and the inpatient services provided at Jefferson Health-Northeast did not represent a major part of its business. 

Despite her ruling, Judge Scott did voice skepticism about some of Jefferson’s arguments.

“The court notes that the Jefferson defendants have briefly argued that Jefferson will be better able to ensure that its own patients receive fully integrated and coordinated care” under the exclusive provider agreement, but “it is unclear how the cooperation of ACS [Alliance Cancer Specialists] and JNE [Jefferson Health-Northeast] hospitalists really caused any problems for the coordinated care of” patients in the many years that they worked together.

It also “does not seem to necessarily serve the community to quickly sever the artery between the services that ACS provides and the services that JNE provides,” Judge Scott wrote.

She added that she would consider another motion from Alliance if the practice makes stronger arguments illustrating antitrust violations and demonstrating irreparable harm.

Currently, Dr. Chasky and Mr. Frier are considering their next steps in the case. The oncologists said they can appeal the judge’s decision or file a new complaint.

Meanwhile, Dr. Chasky and his four colleagues requested and were granted internal medicine privileges at Jefferson Health-Northeast, but given the considerable overlap between oncology and internal medicine, the line between what they can and cannot do remains unclear.

“It’s a mess,” he said.
 

A familiar story

Large health care entities have increasingly worked to push out or swallow up smaller, independent practices for years.

“What Dr. Chasky and his practice are going through is a little bit more of an aggressive version of what’s going on in the rest of the country,” said Michael Diaz, MD, a community oncologist at Florida Cancer Specialists, the largest independent medical oncology/hematology group in the United States. “The larger institutional hospitals try to make it a closed system so they can keep everything in-house and refer to their own physicians.”

The incentive, Dr. Diaz said, is the financial windfall that Section 340B of the 1992 Public Health Service Act generates for hospital-based oncology services at nonprofit hospitals, such as the Jefferson Health-Northeast facilities.

The 340B program allows nonprofit hospitals to buy primarily outpatient oncology drugs at steep discounts, sometimes 50% or more, and be reimbursed at full price.

When launched in 1992, the program was meant to help a handful of safety-net hospitals cover the cost of charity care, and now approximately more than half of U.S. hospitals participate in the program, particularly after requirements were loosened by the Affordable Care Act. But there’s little transparency on how the money is spent.

Critics say the incentives have created a feeding frenzy among 340B hospitals to either acquire outpatient oncology practices or take their business because of the particularly high margins on oncology drugs. There are similar incentives for hospital-based infusion centers.

In its lawsuit, Alliance alleged that such incentives are what motivated Jefferson’s recent actions.

“It’s all about the money at the end of the day,” said Christian Thomas, MD, a community oncologist with New England Cancer Specialists, Scarborough, Maine, who, like Dr. Diaz, said he’s seen the dynamic play out repeatedly in his career. 

The American Hospital Association has been a vigorous defender of 340B in the courts and elsewhere, but the Association’s communications staff had little to say when this news organization reached out about the Jefferson-Alliance situation, except that they do not comment on “specific hospital circumstance.”
 

Reverberations around the country

Many community oncologists are keeping close tabs on the Jefferson-Alliance situation.

“Our group has been watching Jefferson closely because our [local] hospital is following the same playbook, but they have not yet gone after our privileges,” said Scott Herbert, MD, a community oncologist with the independent Nexus Health system, Sante Fe, N.M.

Dr. Herbert was referring to what has happened since he and his colleagues declined to renew an exclusive provider agreement early this year with St. Vincent Regional Medical Center, a nonprofit hospital in Sante Fe. The agreement allowed the hospital to take advantage of the 340B program because Nexus oncologists acted on its behalf.

St. Vincent’s owner, Christus Health, did not respond to inquiries from this news organization.

Nexus let the contract lapse because its oncologists wanted to provide services at a second, newer hospital in Santa Fe where some of their patients had begun seeking treatment.

The nonprofit hospital in Sante Fe is now building its own oncology practice. Similar to Dr. Chasky’s experience in Philadelphia, Dr. Herbert said his group has seen referrals from the hospital dry up and existing patients rechanneled to the hospital’s oncologists.  

“We found over 109 patients in January and February that were referred to one of our docs that got rerouted to one of their docs,” he said.

Dr. Herbert has sent cease-and-desist letters, but “after we saw what Jefferson did, my group said, ‘You better back off of the hospital, or it’s going to take our privileges.’ ”

The Jefferson situation “is sending a message,” he said. “Frankly, we’ve been terrified” at the thought of losing privileges there. “It’s the busiest hospital in our area.”
 

The future of community oncology

Despite the challenges, Mr. Ferreyros at the Community Oncology Alliance remains optimistic about the future of independent oncology.

Under the competitive pressures, a lot of independent oncology practices have folded in recent years, but the ones that remain are strong. Payers are also increasingly noticing that community oncology practices are less expensive than hospital-based practices for comparable care, he said.

Relationships with hospitals aren’t always adversarial, either. “A lot of practices have collaborative agreements with local hospitals” that work out well, Mr. Ferreyros said, adding that sometimes hospitals even hand over oncology care to local independents after finding that starting and maintaining an oncology service is harder than they imagined.

“The last two decades have been difficult,” but the remaining community oncology practices “are going strong,” he said, and “we’ve never seen more engagement on our issues,” particularly around the issue of cost savings.

A version of this article first appeared on Medscape.com.

Community oncologists across the United States are concerned about a recent lawsuit in Philadelphia between the Jefferson Health hospital system and the largest independent oncology and hematology practice in southeastern Pennsylvania, Alliance Cancer Specialists.

The outcome, some community oncologists say, could set a new precedent in how far large health care organizations will go to take their patients or drive them out of business.
 

The case

On Sept. 5, Alliance sued Jefferson Health after Jefferson canceled the inpatient oncology/hematology privileges of five Alliance oncologists at three Jefferson Health-Northeast hospitals, primarily alleging that Jefferson was attempting to monopolize cancer care in the area.

Jefferson – one of the largest health care systems in the Philadelphia area that includes the NCI-designated Sidney Kimmel Cancer Center – made the move because it had entered into an exclusive agreement with its own medical group to provide inpatient and outpatient oncology/hematology services at the hospitals.

In its court filings, Jefferson said it entered into the exclusive agreement because doing so was in “the best interest of patients, as it would ensure better integration and availability of care and help ensure that Jefferson consistently provides high-quality medical care in accordance with evidence-based standards.”

Tensions had been building between Alliance and Jefferson for years, ever since, according to Alliance, the community practice declined a buyout offer from Jefferson almost a decade ago.

But the revocation of privileges ultimately tipped the scales for Alliance, sparking the lawsuit.

“For us, that crossed a line,” said Moshe Chasky, MD, one of the five Alliance oncologists and a plaintiff in the suit.

Dr. Chasky and his colleagues had provided care at the hospitals for years, with about 10-15 patients admitted at any one time. The quality of their care is not in dispute. Dr. Chasky, for instance, routinely makes Philadelphia Magazine’s Top Doc List.

Under the new arrangement, the five Alliance oncologists have to hand over care of their admitted patients to Jefferson oncologists or send their patients to another hospital farther away where they do have admitting privileges.

“Without having admitting privileges,” community oncologists “can’t look a patient in the eye and say, ‘No matter what, I’ve got you,’ ” explained Nicolas Ferreyros, managing director of policy, advocacy, and communications at the Community Oncology Alliance, a DC-based lobbying group for independent oncologists.

“A doctor doesn’t want to tell a patient that ‘once you go in the hospital, I have to hand you off.’ ” It undermines their practice, Mr. Ferreyros said.

The situation has caught the attention of other community oncologists who are worried that hospitals canceling admitting privileges might become a new tactic in what they characterize as an ongoing effort to elbow-out independent practitioners and corner the oncology market.

Dr. Chasky said he is getting “calls every day from independent oncologists throughout the country” who “are very concerned. People are watching this for sure.”   

Alliance attorney Daniel Frier said that there is nothing unusual about hospitals entering into exclusive contracts with hospital-based practices.

But Mr. Frier said he’s never heard of a hospital entering into an exclusive contract and then terminating the privileges of community oncologists.  

“There’s no direct precedent” for the move, he said.

Jefferson Health did not respond to requests for comment. 
 

The ruling

U.S. District Court Judge Kai Scott, who ruled on Alliance’s motion to block the contract and preserve its oncologists’ admitting privileges, ultimately sided with Jefferson and allowed the contract to go forward.

Judge Scott wrote that, “while the court understands the plaintiffs’ concerns and desires to maintain the continuity of care for their own patients,” the court “is not persuaded that either of the two threshold elements for a temporary restraining order or preliminary injunction are met” – first, that Jefferson’s actions violate antitrust laws and second that the plaintiffs “will suffer immediate, irreparable harm” from having their admitting privileges rescinded.

Alliance argued that Jefferson’s contract violated federal antitrust laws and would allow Jefferson to monopolize the local oncology market.

However, Judge Scott called Alliance’s antitrust argument “lifeless” under the strict requirements for antitrust violations, explaining that, among other reasons, a monopoly is unlikely given that Jefferson competes with several high-profile oncology programs in the Philadelphia area, including the Fox Chase Cancer Center.

Judge Scott also expressed doubt that the Jefferson’s actions would cause irreparable harm to Alliance’s business. Alliance employs more than thirty oncologists affiliated with over a dozen hospitals in the greater Philadelphia area, and the inpatient services provided at Jefferson Health-Northeast did not represent a major part of its business. 

Despite her ruling, Judge Scott did voice skepticism about some of Jefferson’s arguments.

“The court notes that the Jefferson defendants have briefly argued that Jefferson will be better able to ensure that its own patients receive fully integrated and coordinated care” under the exclusive provider agreement, but “it is unclear how the cooperation of ACS [Alliance Cancer Specialists] and JNE [Jefferson Health-Northeast] hospitalists really caused any problems for the coordinated care of” patients in the many years that they worked together.

It also “does not seem to necessarily serve the community to quickly sever the artery between the services that ACS provides and the services that JNE provides,” Judge Scott wrote.

She added that she would consider another motion from Alliance if the practice makes stronger arguments illustrating antitrust violations and demonstrating irreparable harm.

Currently, Dr. Chasky and Mr. Frier are considering their next steps in the case. The oncologists said they can appeal the judge’s decision or file a new complaint.

Meanwhile, Dr. Chasky and his four colleagues requested and were granted internal medicine privileges at Jefferson Health-Northeast, but given the considerable overlap between oncology and internal medicine, the line between what they can and cannot do remains unclear.

“It’s a mess,” he said.
 

A familiar story

Large health care entities have increasingly worked to push out or swallow up smaller, independent practices for years.

“What Dr. Chasky and his practice are going through is a little bit more of an aggressive version of what’s going on in the rest of the country,” said Michael Diaz, MD, a community oncologist at Florida Cancer Specialists, the largest independent medical oncology/hematology group in the United States. “The larger institutional hospitals try to make it a closed system so they can keep everything in-house and refer to their own physicians.”

The incentive, Dr. Diaz said, is the financial windfall that Section 340B of the 1992 Public Health Service Act generates for hospital-based oncology services at nonprofit hospitals, such as the Jefferson Health-Northeast facilities.

The 340B program allows nonprofit hospitals to buy primarily outpatient oncology drugs at steep discounts, sometimes 50% or more, and be reimbursed at full price.

When launched in 1992, the program was meant to help a handful of safety-net hospitals cover the cost of charity care, and now approximately more than half of U.S. hospitals participate in the program, particularly after requirements were loosened by the Affordable Care Act. But there’s little transparency on how the money is spent.

Critics say the incentives have created a feeding frenzy among 340B hospitals to either acquire outpatient oncology practices or take their business because of the particularly high margins on oncology drugs. There are similar incentives for hospital-based infusion centers.

In its lawsuit, Alliance alleged that such incentives are what motivated Jefferson’s recent actions.

“It’s all about the money at the end of the day,” said Christian Thomas, MD, a community oncologist with New England Cancer Specialists, Scarborough, Maine, who, like Dr. Diaz, said he’s seen the dynamic play out repeatedly in his career. 

The American Hospital Association has been a vigorous defender of 340B in the courts and elsewhere, but the Association’s communications staff had little to say when this news organization reached out about the Jefferson-Alliance situation, except that they do not comment on “specific hospital circumstance.”
 

Reverberations around the country

Many community oncologists are keeping close tabs on the Jefferson-Alliance situation.

“Our group has been watching Jefferson closely because our [local] hospital is following the same playbook, but they have not yet gone after our privileges,” said Scott Herbert, MD, a community oncologist with the independent Nexus Health system, Sante Fe, N.M.

Dr. Herbert was referring to what has happened since he and his colleagues declined to renew an exclusive provider agreement early this year with St. Vincent Regional Medical Center, a nonprofit hospital in Sante Fe. The agreement allowed the hospital to take advantage of the 340B program because Nexus oncologists acted on its behalf.

St. Vincent’s owner, Christus Health, did not respond to inquiries from this news organization.

Nexus let the contract lapse because its oncologists wanted to provide services at a second, newer hospital in Santa Fe where some of their patients had begun seeking treatment.

The nonprofit hospital in Sante Fe is now building its own oncology practice. Similar to Dr. Chasky’s experience in Philadelphia, Dr. Herbert said his group has seen referrals from the hospital dry up and existing patients rechanneled to the hospital’s oncologists.  

“We found over 109 patients in January and February that were referred to one of our docs that got rerouted to one of their docs,” he said.

Dr. Herbert has sent cease-and-desist letters, but “after we saw what Jefferson did, my group said, ‘You better back off of the hospital, or it’s going to take our privileges.’ ”

The Jefferson situation “is sending a message,” he said. “Frankly, we’ve been terrified” at the thought of losing privileges there. “It’s the busiest hospital in our area.”
 

The future of community oncology

Despite the challenges, Mr. Ferreyros at the Community Oncology Alliance remains optimistic about the future of independent oncology.

Under the competitive pressures, a lot of independent oncology practices have folded in recent years, but the ones that remain are strong. Payers are also increasingly noticing that community oncology practices are less expensive than hospital-based practices for comparable care, he said.

Relationships with hospitals aren’t always adversarial, either. “A lot of practices have collaborative agreements with local hospitals” that work out well, Mr. Ferreyros said, adding that sometimes hospitals even hand over oncology care to local independents after finding that starting and maintaining an oncology service is harder than they imagined.

“The last two decades have been difficult,” but the remaining community oncology practices “are going strong,” he said, and “we’ve never seen more engagement on our issues,” particularly around the issue of cost savings.

A version of this article first appeared on Medscape.com.

A new artificial intelligence (AI) model can detect the deadliest skin cancer with 100% accuracy, highlighting the rapid improvement of AI in medicine, say researchers from the United Kingdom. AI detected more than 99% of all skin cancers.

The researchers tested the AI by integrating it into a clinical diagnosis process – anticipating a future in which AI helps doctors catch skin cancer faster and triage patients.

Skin cancer is the most common cancer in the United States;  one in five 5 Americans develop skin cancer by age 70. With melanoma, the deadliest skin cancer, the 5-year survival rate is better than 99% if caught early, though only about three-quarters of melanomas are caught at this stage.

Amid rising skin cancer rates come concerns that the number of dermatologists in the workforce isn’t keeping pace. That may be why the average wait time for a dermatology appointment is trending up – in 2022, it reached 34.5 days.

The study, which was presented at the European Academy of Dermatology and Venereology Congress recently and has not yet been published, involved 6,900 patients in the United Kingdom with suspected skin cancer. The patients had been referred by their primary care physicians. The researchers took images of the suspicious areas and uploaded them to the AI software. The AI’s assessment was then shared with a dermatologist.

“Note that the diagnosis issued by the AI was not hidden from the dermatologist doing the second assessment,” said lead researcher Kashini Andrew, MBBS, a dermatologist and specialist registrar at University Hospitals Birmingham NHS Foundation Trust.

Dr. Andrew acknowledged that this may have influenced the dermatologist’s opinion. But that’s the vision of how doctors could use this tool.

The AI caught 59 of 59 melanomas and 189 of 190 total skin cancers (99.5%). (The one case that the AI missed was caught by the dermatologist.) It also flagged 541 of 585 precancerous lesions (92.5%). This represented a big improvement from a 2021 version of the model, which detected 86% of melanomas, 84% of all skin cancers, and 54% of precancerous lesions.

Over the 10-month period of the study, the system saved more than 1,000 face-to-face consultations, freeing dermatologists’ time to catch more cancers and serve more patients.

Limitations

The patients in the study were from “one hospital in a single region of the UK,” and the sample was not large enough to allow broad statements to be made about the use of AI in dermatology, Dr. Andrew said.

But it can open the conversation. Roxana Daneshjou, MD, PhD, a dermatologist at Stanford (Calif.) University who has studied the pros and cons of AI in medicine, had some concerns. For one thing, doctors can gather more in-depth information during an in-person exam than AI can glean from a photo, Dr. Daneshjou noted. They can examine skin texture, gather patient history, and take photos with special lighting and magnification.

Christopher Smith

And the AI needs to get better at ruling out malignancy, Dr. Daneshjou said. In this study, the AI identified 75% of benign lesions, a decline from the earlier version. The researchers noted in the abstract that this is a potential trade-off for increased sensitivity.

“[Unnecessary] biopsies can clog up the health care system, cost money, and cause stress and scarring,” said Dr. Daneshjou. “You don’t want to increase the burden of that.”

Still, if AI software such as the kind used in the study proves just as accurate in larger, more diverse sample sizes, then it could be a powerful tool for triage, Dr. Daneshjou said. “If AI gets particularly good at finding malignancy and also ruling it out, that would be a win.”

A version of this article appeared on Medscape.com.

A new artificial intelligence (AI) model can detect the deadliest skin cancer with 100% accuracy, highlighting the rapid improvement of AI in medicine, say researchers from the United Kingdom. AI detected more than 99% of all skin cancers.

The researchers tested the AI by integrating it into a clinical diagnosis process – anticipating a future in which AI helps doctors catch skin cancer faster and triage patients.

Skin cancer is the most common cancer in the United States;  one in five 5 Americans develop skin cancer by age 70. With melanoma, the deadliest skin cancer, the 5-year survival rate is better than 99% if caught early, though only about three-quarters of melanomas are caught at this stage.

Amid rising skin cancer rates come concerns that the number of dermatologists in the workforce isn’t keeping pace. That may be why the average wait time for a dermatology appointment is trending up – in 2022, it reached 34.5 days.

The study, which was presented at the European Academy of Dermatology and Venereology Congress recently and has not yet been published, involved 6,900 patients in the United Kingdom with suspected skin cancer. The patients had been referred by their primary care physicians. The researchers took images of the suspicious areas and uploaded them to the AI software. The AI’s assessment was then shared with a dermatologist.

“Note that the diagnosis issued by the AI was not hidden from the dermatologist doing the second assessment,” said lead researcher Kashini Andrew, MBBS, a dermatologist and specialist registrar at University Hospitals Birmingham NHS Foundation Trust.

Dr. Andrew acknowledged that this may have influenced the dermatologist’s opinion. But that’s the vision of how doctors could use this tool.

The AI caught 59 of 59 melanomas and 189 of 190 total skin cancers (99.5%). (The one case that the AI missed was caught by the dermatologist.) It also flagged 541 of 585 precancerous lesions (92.5%). This represented a big improvement from a 2021 version of the model, which detected 86% of melanomas, 84% of all skin cancers, and 54% of precancerous lesions.

Over the 10-month period of the study, the system saved more than 1,000 face-to-face consultations, freeing dermatologists’ time to catch more cancers and serve more patients.

Limitations

The patients in the study were from “one hospital in a single region of the UK,” and the sample was not large enough to allow broad statements to be made about the use of AI in dermatology, Dr. Andrew said.

But it can open the conversation. Roxana Daneshjou, MD, PhD, a dermatologist at Stanford (Calif.) University who has studied the pros and cons of AI in medicine, had some concerns. For one thing, doctors can gather more in-depth information during an in-person exam than AI can glean from a photo, Dr. Daneshjou noted. They can examine skin texture, gather patient history, and take photos with special lighting and magnification.

Christopher Smith

And the AI needs to get better at ruling out malignancy, Dr. Daneshjou said. In this study, the AI identified 75% of benign lesions, a decline from the earlier version. The researchers noted in the abstract that this is a potential trade-off for increased sensitivity.

“[Unnecessary] biopsies can clog up the health care system, cost money, and cause stress and scarring,” said Dr. Daneshjou. “You don’t want to increase the burden of that.”

Still, if AI software such as the kind used in the study proves just as accurate in larger, more diverse sample sizes, then it could be a powerful tool for triage, Dr. Daneshjou said. “If AI gets particularly good at finding malignancy and also ruling it out, that would be a win.”

A version of this article appeared on Medscape.com.

A new artificial intelligence (AI) model can detect the deadliest skin cancer with 100% accuracy, highlighting the rapid improvement of AI in medicine, say researchers from the United Kingdom. AI detected more than 99% of all skin cancers.

The researchers tested the AI by integrating it into a clinical diagnosis process – anticipating a future in which AI helps doctors catch skin cancer faster and triage patients.

Skin cancer is the most common cancer in the United States;  one in five 5 Americans develop skin cancer by age 70. With melanoma, the deadliest skin cancer, the 5-year survival rate is better than 99% if caught early, though only about three-quarters of melanomas are caught at this stage.

Amid rising skin cancer rates come concerns that the number of dermatologists in the workforce isn’t keeping pace. That may be why the average wait time for a dermatology appointment is trending up – in 2022, it reached 34.5 days.

The study, which was presented at the European Academy of Dermatology and Venereology Congress recently and has not yet been published, involved 6,900 patients in the United Kingdom with suspected skin cancer. The patients had been referred by their primary care physicians. The researchers took images of the suspicious areas and uploaded them to the AI software. The AI’s assessment was then shared with a dermatologist.

“Note that the diagnosis issued by the AI was not hidden from the dermatologist doing the second assessment,” said lead researcher Kashini Andrew, MBBS, a dermatologist and specialist registrar at University Hospitals Birmingham NHS Foundation Trust.

Dr. Andrew acknowledged that this may have influenced the dermatologist’s opinion. But that’s the vision of how doctors could use this tool.

The AI caught 59 of 59 melanomas and 189 of 190 total skin cancers (99.5%). (The one case that the AI missed was caught by the dermatologist.) It also flagged 541 of 585 precancerous lesions (92.5%). This represented a big improvement from a 2021 version of the model, which detected 86% of melanomas, 84% of all skin cancers, and 54% of precancerous lesions.

Over the 10-month period of the study, the system saved more than 1,000 face-to-face consultations, freeing dermatologists’ time to catch more cancers and serve more patients.

Limitations

The patients in the study were from “one hospital in a single region of the UK,” and the sample was not large enough to allow broad statements to be made about the use of AI in dermatology, Dr. Andrew said.

But it can open the conversation. Roxana Daneshjou, MD, PhD, a dermatologist at Stanford (Calif.) University who has studied the pros and cons of AI in medicine, had some concerns. For one thing, doctors can gather more in-depth information during an in-person exam than AI can glean from a photo, Dr. Daneshjou noted. They can examine skin texture, gather patient history, and take photos with special lighting and magnification.

Christopher Smith

And the AI needs to get better at ruling out malignancy, Dr. Daneshjou said. In this study, the AI identified 75% of benign lesions, a decline from the earlier version. The researchers noted in the abstract that this is a potential trade-off for increased sensitivity.

“[Unnecessary] biopsies can clog up the health care system, cost money, and cause stress and scarring,” said Dr. Daneshjou. “You don’t want to increase the burden of that.”

Still, if AI software such as the kind used in the study proves just as accurate in larger, more diverse sample sizes, then it could be a powerful tool for triage, Dr. Daneshjou said. “If AI gets particularly good at finding malignancy and also ruling it out, that would be a win.”

A version of this article appeared on Medscape.com.

TOPLINE:

Ketamine was no more effective than placebo in reducing depressive symptoms in surgical patients with major depressive disorder (MDD), results of a new study suggest, contradicting prior research. Although symptoms improved in both study groups, investigators say participants’ expectations of an improvement from ketamine may be driving that result.

METHODOLOGY:

• The randomized, placebo-controlled trial included 40 patients who had previously been diagnosed with MDD and who were scheduled for elective noncardiac, nonintracranial surgery.
• Participants completed pre- and postsurgery depression screenings with the Patient Health Questionnaire–8 (inclusion score was ≥ 12) and the Montgomery-Åsberg Depression Rating Scale (MADRS).
• Patients received an infusion of 0.5 mg/kg of saline (placebo group; n = 20) or ketamine (n = 20) during surgery, along with general anesthesia.
• At the end of a 14-day follow-up, patients were asked to guess whether they had received ketamine or placebo.

TAKEAWAY:

• MADRS scores dropped by around half 1 day after treatment, indicating an improvement in depressive symptoms in both the group that received ketamine (mean decrease from 25 to 12.6 points) and the group that received placebo (mean decrease from 30 to 15.3 points). There was no significant difference between the two.
• Participants in the ketamine and placebo groups also reported high rates of clinical response (60% and 50%, respectively) and remission (50% and 35%, respectively), again with no significant difference based on treatment with ketamine or placebo.
• Only 36.8% of participants accurately guessed their treatment group. Those who guessed they had received ketamine had higher MADRS scores than those who guessed they had received placebo or said they didn’t know (10.1 vs. 19.2 vs. 23.0).
• The ketamine group had a significantly shorter hospital stay (1.9 days) than the placebo group (4 days) (P = .02).

IN PRACTICE:

“Our primary findings differ from those of previous antidepressant trials with ketamine conducted without adequate masking, which find robust effects of ketamine,” the authors wrote, adding that “regardless of the intervention being tested, participant expectations of a positive outcome – also known as hope – may drive large decreases in depression symptoms seen in antidepressant trials.”

SOURCE:

Boris D. Heifets, MD, PhD, led the study, which was published online in Nature Mental Health. The study was funded by the Society for Neuroscience in Anesthesiology and Critical Care, the National Institutes of Health, and the Stanford School of Medicine Research Office.

LIMITATIONS:

The investigators did not measure participants’ treatment expectations prior to randomization and could not determine what effect participant expectancy bias may have had on the results. In addition, there was no assessment of the blind for anesthesiologists who administered the ketamine or placebo to patients.

DISCLOSURES:

Dr. Heifets is on the scientific advisory boards of Osmind and Journey Clinical and is a consultant to Clairvoyant Therapeutics and Vine Ventures.

A version of this article first appeared on Medscape.com.

TOPLINE:

Ketamine was no more effective than placebo in reducing depressive symptoms in surgical patients with major depressive disorder (MDD), results of a new study suggest, contradicting prior research. Although symptoms improved in both study groups, investigators say participants’ expectations of an improvement from ketamine may be driving that result.

METHODOLOGY:

• The randomized, placebo-controlled trial included 40 patients who had previously been diagnosed with MDD and who were scheduled for elective noncardiac, nonintracranial surgery.
• Participants completed pre- and postsurgery depression screenings with the Patient Health Questionnaire–8 (inclusion score was ≥ 12) and the Montgomery-Åsberg Depression Rating Scale (MADRS).
• Patients received an infusion of 0.5 mg/kg of saline (placebo group; n = 20) or ketamine (n = 20) during surgery, along with general anesthesia.
• At the end of a 14-day follow-up, patients were asked to guess whether they had received ketamine or placebo.

TAKEAWAY:

• MADRS scores dropped by around half 1 day after treatment, indicating an improvement in depressive symptoms in both the group that received ketamine (mean decrease from 25 to 12.6 points) and the group that received placebo (mean decrease from 30 to 15.3 points). There was no significant difference between the two.
• Participants in the ketamine and placebo groups also reported high rates of clinical response (60% and 50%, respectively) and remission (50% and 35%, respectively), again with no significant difference based on treatment with ketamine or placebo.
• Only 36.8% of participants accurately guessed their treatment group. Those who guessed they had received ketamine had higher MADRS scores than those who guessed they had received placebo or said they didn’t know (10.1 vs. 19.2 vs. 23.0).
• The ketamine group had a significantly shorter hospital stay (1.9 days) than the placebo group (4 days) (P = .02).

IN PRACTICE:

“Our primary findings differ from those of previous antidepressant trials with ketamine conducted without adequate masking, which find robust effects of ketamine,” the authors wrote, adding that “regardless of the intervention being tested, participant expectations of a positive outcome – also known as hope – may drive large decreases in depression symptoms seen in antidepressant trials.”

SOURCE:

Boris D. Heifets, MD, PhD, led the study, which was published online in Nature Mental Health. The study was funded by the Society for Neuroscience in Anesthesiology and Critical Care, the National Institutes of Health, and the Stanford School of Medicine Research Office.

LIMITATIONS:

The investigators did not measure participants’ treatment expectations prior to randomization and could not determine what effect participant expectancy bias may have had on the results. In addition, there was no assessment of the blind for anesthesiologists who administered the ketamine or placebo to patients.

DISCLOSURES:

Dr. Heifets is on the scientific advisory boards of Osmind and Journey Clinical and is a consultant to Clairvoyant Therapeutics and Vine Ventures.

A version of this article first appeared on Medscape.com.

TOPLINE:

Ketamine was no more effective than placebo in reducing depressive symptoms in surgical patients with major depressive disorder (MDD), results of a new study suggest, contradicting prior research. Although symptoms improved in both study groups, investigators say participants’ expectations of an improvement from ketamine may be driving that result.

METHODOLOGY:

• The randomized, placebo-controlled trial included 40 patients who had previously been diagnosed with MDD and who were scheduled for elective noncardiac, nonintracranial surgery.
• Participants completed pre- and postsurgery depression screenings with the Patient Health Questionnaire–8 (inclusion score was ≥ 12) and the Montgomery-Åsberg Depression Rating Scale (MADRS).
• Patients received an infusion of 0.5 mg/kg of saline (placebo group; n = 20) or ketamine (n = 20) during surgery, along with general anesthesia.
• At the end of a 14-day follow-up, patients were asked to guess whether they had received ketamine or placebo.

TAKEAWAY:

• MADRS scores dropped by around half 1 day after treatment, indicating an improvement in depressive symptoms in both the group that received ketamine (mean decrease from 25 to 12.6 points) and the group that received placebo (mean decrease from 30 to 15.3 points). There was no significant difference between the two.
• Participants in the ketamine and placebo groups also reported high rates of clinical response (60% and 50%, respectively) and remission (50% and 35%, respectively), again with no significant difference based on treatment with ketamine or placebo.
• Only 36.8% of participants accurately guessed their treatment group. Those who guessed they had received ketamine had higher MADRS scores than those who guessed they had received placebo or said they didn’t know (10.1 vs. 19.2 vs. 23.0).
• The ketamine group had a significantly shorter hospital stay (1.9 days) than the placebo group (4 days) (P = .02).

IN PRACTICE:

“Our primary findings differ from those of previous antidepressant trials with ketamine conducted without adequate masking, which find robust effects of ketamine,” the authors wrote, adding that “regardless of the intervention being tested, participant expectations of a positive outcome – also known as hope – may drive large decreases in depression symptoms seen in antidepressant trials.”

SOURCE:

Boris D. Heifets, MD, PhD, led the study, which was published online in Nature Mental Health. The study was funded by the Society for Neuroscience in Anesthesiology and Critical Care, the National Institutes of Health, and the Stanford School of Medicine Research Office.

LIMITATIONS:

The investigators did not measure participants’ treatment expectations prior to randomization and could not determine what effect participant expectancy bias may have had on the results. In addition, there was no assessment of the blind for anesthesiologists who administered the ketamine or placebo to patients.

DISCLOSURES:

Dr. Heifets is on the scientific advisory boards of Osmind and Journey Clinical and is a consultant to Clairvoyant Therapeutics and Vine Ventures.

A version of this article first appeared on Medscape.com.

Studies have shown links between statin use and type 2 diabetes (T2D) for more than a decade. A U.S. Food and Drug Administration label change for the drugs warned in 2012 about reports of increased risks of high blood glucose and glycosylated hemoglobin (A1c) levels. However, in the same warning, the FDA said it “continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.”

Indeed, although the warning triggered much discussion at the time and a number of meta-analyses and other observational studies in more recent years, that conclusion seems to hold among clinicians and society guidelines.

For example, in a recent practice pointer on the risk of diabetes with statins published in the BMJ, Ishak Mansi, MD, of the Orlando VA Health Care System, and colleagues write, “This potential adverse effect of diabetes with statin use should not be a barrier to starting statin treatment when indicated.”

They also called for further research to answer such questions as, “Is statin-associated diabetes reversible upon statin discontinuation? Would intermittent use minimize this risk while maintaining cardiovascular benefits?”

An earlier study among individuals at high risk for diabetes found significantly higher rates of incident diabetes at 10 years among patients on placebo, metformin, or lifestyle intervention who also initiated statin therapy. Jill Crandall, MD, Albert Einstein College of Medicine, New York, and colleagues conclude, “For individual patients, a potential modest increase in diabetes risk clearly needs to be balanced against the consistent and highly significant reductions in myocardial infarction, stroke, and cardiovascular death associated with statin treatment.”

In the same vein, a recent review by Byron Hoogwerf, MD, Emeritus, department of endocrinology, diabetes, and metabolism, Cleveland Clinic, is titled, “Statins may increase diabetes, but benefit still outweighs risk.”
 

Rosuvastatin versus Atorvastatin

The latest study in this arena is an analysis of the LODESTAR randomized controlled trial of 4,400 patients with coronary artery disease in 12 hospitals in Korea which compares the risks associated with individual statins.

Senior author Myeong-Ki Hong, MD, PhD, Yonsei University College of Medicine, Severance Cardiovascular Hospital, Seoul, South Korea, said in an interview that the study was prompted by the “limited” studies evaluating clinical outcomes, including diabetes risk, according to statin type.

Dr. Hong and colleagues compared the risk of developing diabetes among those taking rosuvastatin (mean daily dose, 17.1 mg) or atorvastatin (mean daily dose 36 mg) for 3 years. While both statins effectively prevented myocardial infarction, stroke, and death, those taking rosuvastatin had a higher incidence of new-onset T2D requiring initiation of antidiabetic drugs (7.2% vs. 5.3%; hazard ratio, 1.39) and cataract surgery (2.5% vs. 1.5%; HR, 1.66).

Overall, the HR of new-onset T2D was 1.29 (95% confidence interval, 1.01-1.63; P = .04).

“The percentages of new-onset diabetes and cataract are in line with previous studies regarding statin therapy in patients with atherosclerotic cardiovascular disease,” Dr. Hong said. “Additional research specifically focusing on these outcomes is required, with more frequent measurement of glucose and A1c levels to detect new-onset diabetes and regular ophthalmologic examinations to detect cataracts.”

“However,” he added, “when using rosuvastatin over atorvastatin, we ... emphasize the importance of meticulous monitoring and appropriate lifestyle interventions to mitigate the risk of new-onset diabetes or cataracts.”

Steven Nissen, MD, chief academic officer of Cleveland Clinic’s Heart and Vascular Institute, was not convinced, and said the study “does not provide useful insights into the use of these drugs.”

The investigators used whatever dose they wanted, “and the authors report only the median dose after 3 years,” he said in an interview. “Because there was a slightly greater reduction in low-density lipoprotein (LDL) cholesterol with rosuvastatin, the relative dose was actually higher.”

“We know that new-onset diabetes with statins is dose-dependent,” he said. “The P-values for diabetes incidence were marginal (very close to P = .05). Accordingly, the diabetes data are unconvincing. ... The similar efficacy is not surprising given the open-label dosing with relatively similar effects on lipids.”

Seth Shay Martin, MD, MHS, director of the Advanced Lipid Disorders Program and Digital Health Lab, Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins Medicine, Baltimore, also commented on the results. The findings are “in line with existing knowledge and current guidelines,” he said. “Therefore, the study should not influence prescribing.”

“Although the study suggests that rosuvastatin was associated with a higher risk of new-onset diabetes mellitus requiring antidiabetics and cataract surgery, compared with atorvastatin, these findings should be interpreted with caution given the open-label nature of the study and require further investigation,” he said.

“The mean daily doses of statins were somewhat below target for secondary prevention,” he noted. “Ideally, patients with coronary artery disease (CAD) take 20-40 mg daily of rosuvastatin or 40-80 mg daily of atorvastatin.”

“Furthermore, the LDL cholesterol levels were not optimized in the patients,” he said. “The mean LDL-C was 1.8-1.9 mmol/L, which is equivalent to 70-73 mg/dL. In the current treatment era, we generally treat to LDL-C levels less than 70 mg/dL and often less than 55 mg/dL in CAD patients.”

“The cataracts finding is particularly odd,” he added. “There was historic concern for cataracts with statin therapy, initially because of studies in beagle dogs. However, high-quality evidence from statin trials has not shown a risk for cataracts.” 

So which statin has the lowest risk of triggering new-onset diabetes? As Dr. Hong noted, the literature is sparse when it comes to comparing the risk among specific statins. Some studies suggest that the risk may depend on the individual and their specific risk factors, as well as the dose and intensity of the prescribed statin.

One recent study suggests that while the overall chance of developing diabetes is small, when looking at risk by years of exposure, atorvastatin, rosuvastatin, and lovastatin carried the largest risk, whereas the risk was lower with pravastatin and simvastatin.

Risks also seemed lower with fluvastatin and pitavastatin, but there were too few study patients taking those drugs long-term to include in the subanalysis.

With input from the latest guidelines from the American Heart Association and the American Diabetes Association, as well as findings from a clinical guide on statin-associated diabetes, Dr. Hoogwerf suggests in his review that shared decision-making before starting statin therapy of any type include the following considerations/discussion points:

• For all patients: Screening to determine baseline glycemic status; nonstatin therapies to lower cholesterol; and variables associated with an increased risk of diabetes, including antihypertensive drugs.
• For patients without T2D: The possibility of developing T2D, types and doses of statins, and the fact that statin benefits “generally far outweigh” risks of developing diabetes.
• For patients with T2D: Possible small adverse effects on glycemic control; statin benefits in reducing risk for atherosclerotic cardiovascular disease, which “significantly outweigh” the small increase in A1c; and mitigation of adverse glycemic effects of statins with glucose-lowering therapies.

It’s worth noting that the AHA and ADA guidelines, among others, also emphasize that such discussions should include the importance of weight loss, regular exercise, and adhering to a healthy lifestyle to mitigate risks of both diabetes and heart disease, with or without statins.

Dr. Hong, Dr. Nissen, and Dr. Martin report no relevant financial relationships. Dr. Hoogwerf has disclosed ownership interest in Eli Lilly and consulting for MannKind and Zealand Pharmaceuticals.

A version of this article appeared on Medscape.com.

Studies have shown links between statin use and type 2 diabetes (T2D) for more than a decade. A U.S. Food and Drug Administration label change for the drugs warned in 2012 about reports of increased risks of high blood glucose and glycosylated hemoglobin (A1c) levels. However, in the same warning, the FDA said it “continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.”

Indeed, although the warning triggered much discussion at the time and a number of meta-analyses and other observational studies in more recent years, that conclusion seems to hold among clinicians and society guidelines.

For example, in a recent practice pointer on the risk of diabetes with statins published in the BMJ, Ishak Mansi, MD, of the Orlando VA Health Care System, and colleagues write, “This potential adverse effect of diabetes with statin use should not be a barrier to starting statin treatment when indicated.”

They also called for further research to answer such questions as, “Is statin-associated diabetes reversible upon statin discontinuation? Would intermittent use minimize this risk while maintaining cardiovascular benefits?”

An earlier study among individuals at high risk for diabetes found significantly higher rates of incident diabetes at 10 years among patients on placebo, metformin, or lifestyle intervention who also initiated statin therapy. Jill Crandall, MD, Albert Einstein College of Medicine, New York, and colleagues conclude, “For individual patients, a potential modest increase in diabetes risk clearly needs to be balanced against the consistent and highly significant reductions in myocardial infarction, stroke, and cardiovascular death associated with statin treatment.”

In the same vein, a recent review by Byron Hoogwerf, MD, Emeritus, department of endocrinology, diabetes, and metabolism, Cleveland Clinic, is titled, “Statins may increase diabetes, but benefit still outweighs risk.”
 

Rosuvastatin versus Atorvastatin

The latest study in this arena is an analysis of the LODESTAR randomized controlled trial of 4,400 patients with coronary artery disease in 12 hospitals in Korea which compares the risks associated with individual statins.

Senior author Myeong-Ki Hong, MD, PhD, Yonsei University College of Medicine, Severance Cardiovascular Hospital, Seoul, South Korea, said in an interview that the study was prompted by the “limited” studies evaluating clinical outcomes, including diabetes risk, according to statin type.

Dr. Hong and colleagues compared the risk of developing diabetes among those taking rosuvastatin (mean daily dose, 17.1 mg) or atorvastatin (mean daily dose 36 mg) for 3 years. While both statins effectively prevented myocardial infarction, stroke, and death, those taking rosuvastatin had a higher incidence of new-onset T2D requiring initiation of antidiabetic drugs (7.2% vs. 5.3%; hazard ratio, 1.39) and cataract surgery (2.5% vs. 1.5%; HR, 1.66).

Overall, the HR of new-onset T2D was 1.29 (95% confidence interval, 1.01-1.63; P = .04).

“The percentages of new-onset diabetes and cataract are in line with previous studies regarding statin therapy in patients with atherosclerotic cardiovascular disease,” Dr. Hong said. “Additional research specifically focusing on these outcomes is required, with more frequent measurement of glucose and A1c levels to detect new-onset diabetes and regular ophthalmologic examinations to detect cataracts.”

“However,” he added, “when using rosuvastatin over atorvastatin, we ... emphasize the importance of meticulous monitoring and appropriate lifestyle interventions to mitigate the risk of new-onset diabetes or cataracts.”

Steven Nissen, MD, chief academic officer of Cleveland Clinic’s Heart and Vascular Institute, was not convinced, and said the study “does not provide useful insights into the use of these drugs.”

The investigators used whatever dose they wanted, “and the authors report only the median dose after 3 years,” he said in an interview. “Because there was a slightly greater reduction in low-density lipoprotein (LDL) cholesterol with rosuvastatin, the relative dose was actually higher.”

“We know that new-onset diabetes with statins is dose-dependent,” he said. “The P-values for diabetes incidence were marginal (very close to P = .05). Accordingly, the diabetes data are unconvincing. ... The similar efficacy is not surprising given the open-label dosing with relatively similar effects on lipids.”

Seth Shay Martin, MD, MHS, director of the Advanced Lipid Disorders Program and Digital Health Lab, Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins Medicine, Baltimore, also commented on the results. The findings are “in line with existing knowledge and current guidelines,” he said. “Therefore, the study should not influence prescribing.”

“Although the study suggests that rosuvastatin was associated with a higher risk of new-onset diabetes mellitus requiring antidiabetics and cataract surgery, compared with atorvastatin, these findings should be interpreted with caution given the open-label nature of the study and require further investigation,” he said.

“The mean daily doses of statins were somewhat below target for secondary prevention,” he noted. “Ideally, patients with coronary artery disease (CAD) take 20-40 mg daily of rosuvastatin or 40-80 mg daily of atorvastatin.”

“Furthermore, the LDL cholesterol levels were not optimized in the patients,” he said. “The mean LDL-C was 1.8-1.9 mmol/L, which is equivalent to 70-73 mg/dL. In the current treatment era, we generally treat to LDL-C levels less than 70 mg/dL and often less than 55 mg/dL in CAD patients.”

“The cataracts finding is particularly odd,” he added. “There was historic concern for cataracts with statin therapy, initially because of studies in beagle dogs. However, high-quality evidence from statin trials has not shown a risk for cataracts.” 

So which statin has the lowest risk of triggering new-onset diabetes? As Dr. Hong noted, the literature is sparse when it comes to comparing the risk among specific statins. Some studies suggest that the risk may depend on the individual and their specific risk factors, as well as the dose and intensity of the prescribed statin.

One recent study suggests that while the overall chance of developing diabetes is small, when looking at risk by years of exposure, atorvastatin, rosuvastatin, and lovastatin carried the largest risk, whereas the risk was lower with pravastatin and simvastatin.

Risks also seemed lower with fluvastatin and pitavastatin, but there were too few study patients taking those drugs long-term to include in the subanalysis.

With input from the latest guidelines from the American Heart Association and the American Diabetes Association, as well as findings from a clinical guide on statin-associated diabetes, Dr. Hoogwerf suggests in his review that shared decision-making before starting statin therapy of any type include the following considerations/discussion points:

• For all patients: Screening to determine baseline glycemic status; nonstatin therapies to lower cholesterol; and variables associated with an increased risk of diabetes, including antihypertensive drugs.
• For patients without T2D: The possibility of developing T2D, types and doses of statins, and the fact that statin benefits “generally far outweigh” risks of developing diabetes.
• For patients with T2D: Possible small adverse effects on glycemic control; statin benefits in reducing risk for atherosclerotic cardiovascular disease, which “significantly outweigh” the small increase in A1c; and mitigation of adverse glycemic effects of statins with glucose-lowering therapies.

It’s worth noting that the AHA and ADA guidelines, among others, also emphasize that such discussions should include the importance of weight loss, regular exercise, and adhering to a healthy lifestyle to mitigate risks of both diabetes and heart disease, with or without statins.

Dr. Hong, Dr. Nissen, and Dr. Martin report no relevant financial relationships. Dr. Hoogwerf has disclosed ownership interest in Eli Lilly and consulting for MannKind and Zealand Pharmaceuticals.

A version of this article appeared on Medscape.com.

Studies have shown links between statin use and type 2 diabetes (T2D) for more than a decade. A U.S. Food and Drug Administration label change for the drugs warned in 2012 about reports of increased risks of high blood glucose and glycosylated hemoglobin (A1c) levels. However, in the same warning, the FDA said it “continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.”

Indeed, although the warning triggered much discussion at the time and a number of meta-analyses and other observational studies in more recent years, that conclusion seems to hold among clinicians and society guidelines.

For example, in a recent practice pointer on the risk of diabetes with statins published in the BMJ, Ishak Mansi, MD, of the Orlando VA Health Care System, and colleagues write, “This potential adverse effect of diabetes with statin use should not be a barrier to starting statin treatment when indicated.”

They also called for further research to answer such questions as, “Is statin-associated diabetes reversible upon statin discontinuation? Would intermittent use minimize this risk while maintaining cardiovascular benefits?”

An earlier study among individuals at high risk for diabetes found significantly higher rates of incident diabetes at 10 years among patients on placebo, metformin, or lifestyle intervention who also initiated statin therapy. Jill Crandall, MD, Albert Einstein College of Medicine, New York, and colleagues conclude, “For individual patients, a potential modest increase in diabetes risk clearly needs to be balanced against the consistent and highly significant reductions in myocardial infarction, stroke, and cardiovascular death associated with statin treatment.”

In the same vein, a recent review by Byron Hoogwerf, MD, Emeritus, department of endocrinology, diabetes, and metabolism, Cleveland Clinic, is titled, “Statins may increase diabetes, but benefit still outweighs risk.”
 

Rosuvastatin versus Atorvastatin

The latest study in this arena is an analysis of the LODESTAR randomized controlled trial of 4,400 patients with coronary artery disease in 12 hospitals in Korea which compares the risks associated with individual statins.

Senior author Myeong-Ki Hong, MD, PhD, Yonsei University College of Medicine, Severance Cardiovascular Hospital, Seoul, South Korea, said in an interview that the study was prompted by the “limited” studies evaluating clinical outcomes, including diabetes risk, according to statin type.

Dr. Hong and colleagues compared the risk of developing diabetes among those taking rosuvastatin (mean daily dose, 17.1 mg) or atorvastatin (mean daily dose 36 mg) for 3 years. While both statins effectively prevented myocardial infarction, stroke, and death, those taking rosuvastatin had a higher incidence of new-onset T2D requiring initiation of antidiabetic drugs (7.2% vs. 5.3%; hazard ratio, 1.39) and cataract surgery (2.5% vs. 1.5%; HR, 1.66).

Overall, the HR of new-onset T2D was 1.29 (95% confidence interval, 1.01-1.63; P = .04).

“The percentages of new-onset diabetes and cataract are in line with previous studies regarding statin therapy in patients with atherosclerotic cardiovascular disease,” Dr. Hong said. “Additional research specifically focusing on these outcomes is required, with more frequent measurement of glucose and A1c levels to detect new-onset diabetes and regular ophthalmologic examinations to detect cataracts.”

“However,” he added, “when using rosuvastatin over atorvastatin, we ... emphasize the importance of meticulous monitoring and appropriate lifestyle interventions to mitigate the risk of new-onset diabetes or cataracts.”

Steven Nissen, MD, chief academic officer of Cleveland Clinic’s Heart and Vascular Institute, was not convinced, and said the study “does not provide useful insights into the use of these drugs.”

The investigators used whatever dose they wanted, “and the authors report only the median dose after 3 years,” he said in an interview. “Because there was a slightly greater reduction in low-density lipoprotein (LDL) cholesterol with rosuvastatin, the relative dose was actually higher.”

“We know that new-onset diabetes with statins is dose-dependent,” he said. “The P-values for diabetes incidence were marginal (very close to P = .05). Accordingly, the diabetes data are unconvincing. ... The similar efficacy is not surprising given the open-label dosing with relatively similar effects on lipids.”

Seth Shay Martin, MD, MHS, director of the Advanced Lipid Disorders Program and Digital Health Lab, Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins Medicine, Baltimore, also commented on the results. The findings are “in line with existing knowledge and current guidelines,” he said. “Therefore, the study should not influence prescribing.”

“Although the study suggests that rosuvastatin was associated with a higher risk of new-onset diabetes mellitus requiring antidiabetics and cataract surgery, compared with atorvastatin, these findings should be interpreted with caution given the open-label nature of the study and require further investigation,” he said.

“The mean daily doses of statins were somewhat below target for secondary prevention,” he noted. “Ideally, patients with coronary artery disease (CAD) take 20-40 mg daily of rosuvastatin or 40-80 mg daily of atorvastatin.”

“Furthermore, the LDL cholesterol levels were not optimized in the patients,” he said. “The mean LDL-C was 1.8-1.9 mmol/L, which is equivalent to 70-73 mg/dL. In the current treatment era, we generally treat to LDL-C levels less than 70 mg/dL and often less than 55 mg/dL in CAD patients.”

“The cataracts finding is particularly odd,” he added. “There was historic concern for cataracts with statin therapy, initially because of studies in beagle dogs. However, high-quality evidence from statin trials has not shown a risk for cataracts.” 

So which statin has the lowest risk of triggering new-onset diabetes? As Dr. Hong noted, the literature is sparse when it comes to comparing the risk among specific statins. Some studies suggest that the risk may depend on the individual and their specific risk factors, as well as the dose and intensity of the prescribed statin.

One recent study suggests that while the overall chance of developing diabetes is small, when looking at risk by years of exposure, atorvastatin, rosuvastatin, and lovastatin carried the largest risk, whereas the risk was lower with pravastatin and simvastatin.

Risks also seemed lower with fluvastatin and pitavastatin, but there were too few study patients taking those drugs long-term to include in the subanalysis.

With input from the latest guidelines from the American Heart Association and the American Diabetes Association, as well as findings from a clinical guide on statin-associated diabetes, Dr. Hoogwerf suggests in his review that shared decision-making before starting statin therapy of any type include the following considerations/discussion points:

• For all patients: Screening to determine baseline glycemic status; nonstatin therapies to lower cholesterol; and variables associated with an increased risk of diabetes, including antihypertensive drugs.
• For patients without T2D: The possibility of developing T2D, types and doses of statins, and the fact that statin benefits “generally far outweigh” risks of developing diabetes.
• For patients with T2D: Possible small adverse effects on glycemic control; statin benefits in reducing risk for atherosclerotic cardiovascular disease, which “significantly outweigh” the small increase in A1c; and mitigation of adverse glycemic effects of statins with glucose-lowering therapies.

It’s worth noting that the AHA and ADA guidelines, among others, also emphasize that such discussions should include the importance of weight loss, regular exercise, and adhering to a healthy lifestyle to mitigate risks of both diabetes and heart disease, with or without statins.

Dr. Hong, Dr. Nissen, and Dr. Martin report no relevant financial relationships. Dr. Hoogwerf has disclosed ownership interest in Eli Lilly and consulting for MannKind and Zealand Pharmaceuticals.

A version of this article appeared on Medscape.com.

CARLSBAD, CALIF. – In the opinion of Swati Kannan, MD, deciding whether or not to establish a presence on social media starts with a gut-check about your intentions.

“Why use it?” Dr. Kannan, a dermatologist and Mohs surgeon at the University of California, San Diego, asked attendees at the annual symposium of the California Society of Dermatology & Dermatologic Surgery. “Isn’t being an MD or DO enough? Not anymore. Social media allows you to reach a much larger audience. You’re able to market yourself and market dermatology. It establishes us as the authority in dermatology [topics], showcases our expertise and knowledge, and differentiates us from other nondermatology providers.”

Dr. Swati Kannan

Her favorite part about using Instagram and other social media platforms, she said, is connecting with other dermatologists and other specialists. “I’ve learned a lot from communicating with other dermatologists on different platforms, not just for social media but for changing how I practice as well.”

Dr. Kannan offered the following tips and considerations for building and maintaining a presence on social media:

Know the demographics of your practice and your target audience. In general, individuals in their 20s have a presence on many platforms, mainly TikTok for entertainment. Those in their 30s and 40s mainly use Facebook, Instagram, and YouTube, and those in their 40s-60s primarily use Facebook and YouTube. “Men tend to use YouTube, Twitter (X), Reddit, and LinkedIn, while women prefer more photo or video content platforms like Instagram, TikTok, and Facebook,” she said. In addition, knowing your target audience will help select which social media platforms to be active on.

Think about your goal. Is it a side hustle? Is it to raise awareness of various dermatologic conditions? Is it to grow your business? “Knowing this goal will help you determine how much time you’re going to commit to it.”

Do you have the time? To be effective, being active on social media can take 10-15 hours a week, especially for beginners, “so it’s like another job,” she said.

Devise a social media strategy. “Ideally, pick one to three social media platforms that you are going to be active on,” Dr. Kannan advised. “I’m active on Instagram and YouTube, and I cross-post on TikTok and Facebook. That means when I’m making content, it’s geared toward the audience on Instagram. If it hits a few people on TikTok, that’s fine, too, but the TikTok audience is not my target.”

Stick to a posting schedule. Ideally, post three to five times per week.

Create a content strategy. This includes a variety of photos, diagrams, videos, “and you want to use relevant hashtags,” she said.

Find your niche and style. This comes with time. If you specialize in a specific dermatologic condition such as psoriasis, hair loss, or vitiligo, emphasize that in your content.

Find your voice. This also comes with time. But be a professional version of yourself.

Have a plan for how to handle complaints or bad comments. “Avoid posting content that would make you a target,” she advised. “When I get a rude comment, I delete it. If the comment is racist or sexist, I will report it.”

Learn how to review the stats on your accounts. This will provide information on which posts or videos are being well received, which can serve as the basis of creating content that’s similar going forward.

Follow certain social media strategists. This can help grow followers and learn how to find trending audio or music to accompany your content. On Instagram, for example, Dr. Kannan follows @creators and @instagramforbusiness. On YouTube, she follows the Think Media channel.

Avoid posting content that would make you a target. Limit photos about partying/alcohol consumption or anything considered unprofessional. “If you can’t say it or do it in front of a patient, then you shouldn’t post it on your professional social media page,” she said.

Protect yourself. Don’t provide individual medical advice. “All of my home pages contain the statement, ‘this page is not for medical advice,’” Dr. Kannan said. “Get photo and video consent from all patients, even if you’re posting a zoomed-in version of their face. Deidentify patients as much as possible, and watermark your before and after photos and videos so that they’re not easily used by others.”

Be consistent and patient as you engage on social media platforms. Being a good digital citizen includes networking with other creators by liking and commenting on their posts, and responding to and liking comments that people make to your posts. “Remember: it’s not just about the number of followers, but also about engagement,” she said.

Dr. Kannan reported having no relevant disclosures.

CARLSBAD, CALIF. – In the opinion of Swati Kannan, MD, deciding whether or not to establish a presence on social media starts with a gut-check about your intentions.

“Why use it?” Dr. Kannan, a dermatologist and Mohs surgeon at the University of California, San Diego, asked attendees at the annual symposium of the California Society of Dermatology & Dermatologic Surgery. “Isn’t being an MD or DO enough? Not anymore. Social media allows you to reach a much larger audience. You’re able to market yourself and market dermatology. It establishes us as the authority in dermatology [topics], showcases our expertise and knowledge, and differentiates us from other nondermatology providers.”

Dr. Swati Kannan

Her favorite part about using Instagram and other social media platforms, she said, is connecting with other dermatologists and other specialists. “I’ve learned a lot from communicating with other dermatologists on different platforms, not just for social media but for changing how I practice as well.”

Dr. Kannan offered the following tips and considerations for building and maintaining a presence on social media:

Know the demographics of your practice and your target audience. In general, individuals in their 20s have a presence on many platforms, mainly TikTok for entertainment. Those in their 30s and 40s mainly use Facebook, Instagram, and YouTube, and those in their 40s-60s primarily use Facebook and YouTube. “Men tend to use YouTube, Twitter (X), Reddit, and LinkedIn, while women prefer more photo or video content platforms like Instagram, TikTok, and Facebook,” she said. In addition, knowing your target audience will help select which social media platforms to be active on.

Think about your goal. Is it a side hustle? Is it to raise awareness of various dermatologic conditions? Is it to grow your business? “Knowing this goal will help you determine how much time you’re going to commit to it.”

Do you have the time? To be effective, being active on social media can take 10-15 hours a week, especially for beginners, “so it’s like another job,” she said.

Devise a social media strategy. “Ideally, pick one to three social media platforms that you are going to be active on,” Dr. Kannan advised. “I’m active on Instagram and YouTube, and I cross-post on TikTok and Facebook. That means when I’m making content, it’s geared toward the audience on Instagram. If it hits a few people on TikTok, that’s fine, too, but the TikTok audience is not my target.”

Stick to a posting schedule. Ideally, post three to five times per week.

Create a content strategy. This includes a variety of photos, diagrams, videos, “and you want to use relevant hashtags,” she said.

Find your niche and style. This comes with time. If you specialize in a specific dermatologic condition such as psoriasis, hair loss, or vitiligo, emphasize that in your content.

Find your voice. This also comes with time. But be a professional version of yourself.

Have a plan for how to handle complaints or bad comments. “Avoid posting content that would make you a target,” she advised. “When I get a rude comment, I delete it. If the comment is racist or sexist, I will report it.”

Learn how to review the stats on your accounts. This will provide information on which posts or videos are being well received, which can serve as the basis of creating content that’s similar going forward.

Follow certain social media strategists. This can help grow followers and learn how to find trending audio or music to accompany your content. On Instagram, for example, Dr. Kannan follows @creators and @instagramforbusiness. On YouTube, she follows the Think Media channel.

Avoid posting content that would make you a target. Limit photos about partying/alcohol consumption or anything considered unprofessional. “If you can’t say it or do it in front of a patient, then you shouldn’t post it on your professional social media page,” she said.

Protect yourself. Don’t provide individual medical advice. “All of my home pages contain the statement, ‘this page is not for medical advice,’” Dr. Kannan said. “Get photo and video consent from all patients, even if you’re posting a zoomed-in version of their face. Deidentify patients as much as possible, and watermark your before and after photos and videos so that they’re not easily used by others.”

Be consistent and patient as you engage on social media platforms. Being a good digital citizen includes networking with other creators by liking and commenting on their posts, and responding to and liking comments that people make to your posts. “Remember: it’s not just about the number of followers, but also about engagement,” she said.

Dr. Kannan reported having no relevant disclosures.

CARLSBAD, CALIF. – In the opinion of Swati Kannan, MD, deciding whether or not to establish a presence on social media starts with a gut-check about your intentions.

“Why use it?” Dr. Kannan, a dermatologist and Mohs surgeon at the University of California, San Diego, asked attendees at the annual symposium of the California Society of Dermatology & Dermatologic Surgery. “Isn’t being an MD or DO enough? Not anymore. Social media allows you to reach a much larger audience. You’re able to market yourself and market dermatology. It establishes us as the authority in dermatology [topics], showcases our expertise and knowledge, and differentiates us from other nondermatology providers.”

Dr. Swati Kannan

Her favorite part about using Instagram and other social media platforms, she said, is connecting with other dermatologists and other specialists. “I’ve learned a lot from communicating with other dermatologists on different platforms, not just for social media but for changing how I practice as well.”

Dr. Kannan offered the following tips and considerations for building and maintaining a presence on social media:

Know the demographics of your practice and your target audience. In general, individuals in their 20s have a presence on many platforms, mainly TikTok for entertainment. Those in their 30s and 40s mainly use Facebook, Instagram, and YouTube, and those in their 40s-60s primarily use Facebook and YouTube. “Men tend to use YouTube, Twitter (X), Reddit, and LinkedIn, while women prefer more photo or video content platforms like Instagram, TikTok, and Facebook,” she said. In addition, knowing your target audience will help select which social media platforms to be active on.

Think about your goal. Is it a side hustle? Is it to raise awareness of various dermatologic conditions? Is it to grow your business? “Knowing this goal will help you determine how much time you’re going to commit to it.”

Do you have the time? To be effective, being active on social media can take 10-15 hours a week, especially for beginners, “so it’s like another job,” she said.

Devise a social media strategy. “Ideally, pick one to three social media platforms that you are going to be active on,” Dr. Kannan advised. “I’m active on Instagram and YouTube, and I cross-post on TikTok and Facebook. That means when I’m making content, it’s geared toward the audience on Instagram. If it hits a few people on TikTok, that’s fine, too, but the TikTok audience is not my target.”

Stick to a posting schedule. Ideally, post three to five times per week.

Create a content strategy. This includes a variety of photos, diagrams, videos, “and you want to use relevant hashtags,” she said.

Find your niche and style. This comes with time. If you specialize in a specific dermatologic condition such as psoriasis, hair loss, or vitiligo, emphasize that in your content.

Find your voice. This also comes with time. But be a professional version of yourself.

Have a plan for how to handle complaints or bad comments. “Avoid posting content that would make you a target,” she advised. “When I get a rude comment, I delete it. If the comment is racist or sexist, I will report it.”

Learn how to review the stats on your accounts. This will provide information on which posts or videos are being well received, which can serve as the basis of creating content that’s similar going forward.

Follow certain social media strategists. This can help grow followers and learn how to find trending audio or music to accompany your content. On Instagram, for example, Dr. Kannan follows @creators and @instagramforbusiness. On YouTube, she follows the Think Media channel.

Avoid posting content that would make you a target. Limit photos about partying/alcohol consumption or anything considered unprofessional. “If you can’t say it or do it in front of a patient, then you shouldn’t post it on your professional social media page,” she said.

Protect yourself. Don’t provide individual medical advice. “All of my home pages contain the statement, ‘this page is not for medical advice,’” Dr. Kannan said. “Get photo and video consent from all patients, even if you’re posting a zoomed-in version of their face. Deidentify patients as much as possible, and watermark your before and after photos and videos so that they’re not easily used by others.”

Be consistent and patient as you engage on social media platforms. Being a good digital citizen includes networking with other creators by liking and commenting on their posts, and responding to and liking comments that people make to your posts. “Remember: it’s not just about the number of followers, but also about engagement,” she said.

Dr. Kannan reported having no relevant disclosures.

I, like every pediatrician I know, believe that breast milk is the best nutrition for human newborns. Its balance of nutritive elements and its role in preventing of a wide range of illnesses are so great that we are still learning the extent of their magnitude. It just makes sense that a mother’s milk is most well suited for her baby.

I am a bit less unambiguous about breastfeeding. By that I mean the process of providing breast milk to an infant directly from its mother’s breast. Before you yank my AAP membership card, let me make it clear that I think every woman should consider breastfeeding her infant. But we must accept that in a few situations, even with help from caring and enlightened health care providers and family members, breastfeeding doesn’t work as well as we would have hoped. Fortunately, there are alternatives.

My reservations about the process are few, and until recently I have had an unwaveringly positive attitude toward the safety of breast milk. The cause of my little bit of uncertainty arrived in a recent study by two researchers at the Dana Farber Institute in Boston, in which the investigators examining the health histories of more than 150,000 women found that those who were breastfed incurred a 23% greater risk of developing colorectal cancer when they reached adulthood. A younger cohort within that larger group had a dramatic 40% increased risk of developing high-risk cancer before reaching age 55.

The population the investigators studied came from the large Nurses’ Health Study II, a well-known repository of longitudinal health data. The researchers reported that they included biometric data and a large collection of lifestyle factors including smoking, alcohol intake, and diet in their calculations. However, breastfeeding continued to register the highest association. Interestingly, the investigators found that women who were breastfed for 9 months or longer had twice the risk of colorectal cancer as those who breastfed for from 4 to 8 months.

The study population was all women and predominantly white. However, in the general population it is the non-Hispanic white population that is experiencing the greatest increase in incidence. Of course, the study could not answer whether this association with breastfeeding also existed in minority populations.

The researchers suspect that what they are seeing is a reflection of the Westernization of the American lifestyle. One of the researchers is interested in the gut biome of infants and plans to further the investigation in that direction. Could some substance from the environment be concentrating in breast milk? Or is something missing in breast milk? She points out that, while formulas are generally fortified with vitamin D, breast milk is not.

As concerning as the results of this study may sound, the authors are very careful to urge mothers to continue to breastfeed and choose it as their first choice for feeding their babies. I have been pleasantly surprised that this study has not gotten widespread media attention because bad news travels fast. I have chosen to share it with you because at some point you may begin getting questions from concerned parents.

While apparently well done, this study is just the beginning. Like any good research, it poses more questions than it answers. For us as pediatricians it means we should continue to recommend breast milk as the first food. But, we must stay alert as further research looks deeper into this association.

We should also take advantage of our special access to young parents, a demographic that less frequently sees a physician for preventive care. For whatever reason colorectal cancer is occurring at younger ages. When we have the opportunity we should be reminding 40-year-olds not to wait until age 50 to screen for colorectal cancer, particularly if they have a family history of the disease.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I, like every pediatrician I know, believe that breast milk is the best nutrition for human newborns. Its balance of nutritive elements and its role in preventing of a wide range of illnesses are so great that we are still learning the extent of their magnitude. It just makes sense that a mother’s milk is most well suited for her baby.

I am a bit less unambiguous about breastfeeding. By that I mean the process of providing breast milk to an infant directly from its mother’s breast. Before you yank my AAP membership card, let me make it clear that I think every woman should consider breastfeeding her infant. But we must accept that in a few situations, even with help from caring and enlightened health care providers and family members, breastfeeding doesn’t work as well as we would have hoped. Fortunately, there are alternatives.

My reservations about the process are few, and until recently I have had an unwaveringly positive attitude toward the safety of breast milk. The cause of my little bit of uncertainty arrived in a recent study by two researchers at the Dana Farber Institute in Boston, in which the investigators examining the health histories of more than 150,000 women found that those who were breastfed incurred a 23% greater risk of developing colorectal cancer when they reached adulthood. A younger cohort within that larger group had a dramatic 40% increased risk of developing high-risk cancer before reaching age 55.

The population the investigators studied came from the large Nurses’ Health Study II, a well-known repository of longitudinal health data. The researchers reported that they included biometric data and a large collection of lifestyle factors including smoking, alcohol intake, and diet in their calculations. However, breastfeeding continued to register the highest association. Interestingly, the investigators found that women who were breastfed for 9 months or longer had twice the risk of colorectal cancer as those who breastfed for from 4 to 8 months.

The study population was all women and predominantly white. However, in the general population it is the non-Hispanic white population that is experiencing the greatest increase in incidence. Of course, the study could not answer whether this association with breastfeeding also existed in minority populations.

The researchers suspect that what they are seeing is a reflection of the Westernization of the American lifestyle. One of the researchers is interested in the gut biome of infants and plans to further the investigation in that direction. Could some substance from the environment be concentrating in breast milk? Or is something missing in breast milk? She points out that, while formulas are generally fortified with vitamin D, breast milk is not.

As concerning as the results of this study may sound, the authors are very careful to urge mothers to continue to breastfeed and choose it as their first choice for feeding their babies. I have been pleasantly surprised that this study has not gotten widespread media attention because bad news travels fast. I have chosen to share it with you because at some point you may begin getting questions from concerned parents.

While apparently well done, this study is just the beginning. Like any good research, it poses more questions than it answers. For us as pediatricians it means we should continue to recommend breast milk as the first food. But, we must stay alert as further research looks deeper into this association.

We should also take advantage of our special access to young parents, a demographic that less frequently sees a physician for preventive care. For whatever reason colorectal cancer is occurring at younger ages. When we have the opportunity we should be reminding 40-year-olds not to wait until age 50 to screen for colorectal cancer, particularly if they have a family history of the disease.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I, like every pediatrician I know, believe that breast milk is the best nutrition for human newborns. Its balance of nutritive elements and its role in preventing of a wide range of illnesses are so great that we are still learning the extent of their magnitude. It just makes sense that a mother’s milk is most well suited for her baby.

I am a bit less unambiguous about breastfeeding. By that I mean the process of providing breast milk to an infant directly from its mother’s breast. Before you yank my AAP membership card, let me make it clear that I think every woman should consider breastfeeding her infant. But we must accept that in a few situations, even with help from caring and enlightened health care providers and family members, breastfeeding doesn’t work as well as we would have hoped. Fortunately, there are alternatives.

My reservations about the process are few, and until recently I have had an unwaveringly positive attitude toward the safety of breast milk. The cause of my little bit of uncertainty arrived in a recent study by two researchers at the Dana Farber Institute in Boston, in which the investigators examining the health histories of more than 150,000 women found that those who were breastfed incurred a 23% greater risk of developing colorectal cancer when they reached adulthood. A younger cohort within that larger group had a dramatic 40% increased risk of developing high-risk cancer before reaching age 55.

The population the investigators studied came from the large Nurses’ Health Study II, a well-known repository of longitudinal health data. The researchers reported that they included biometric data and a large collection of lifestyle factors including smoking, alcohol intake, and diet in their calculations. However, breastfeeding continued to register the highest association. Interestingly, the investigators found that women who were breastfed for 9 months or longer had twice the risk of colorectal cancer as those who breastfed for from 4 to 8 months.

The study population was all women and predominantly white. However, in the general population it is the non-Hispanic white population that is experiencing the greatest increase in incidence. Of course, the study could not answer whether this association with breastfeeding also existed in minority populations.

The researchers suspect that what they are seeing is a reflection of the Westernization of the American lifestyle. One of the researchers is interested in the gut biome of infants and plans to further the investigation in that direction. Could some substance from the environment be concentrating in breast milk? Or is something missing in breast milk? She points out that, while formulas are generally fortified with vitamin D, breast milk is not.

As concerning as the results of this study may sound, the authors are very careful to urge mothers to continue to breastfeed and choose it as their first choice for feeding their babies. I have been pleasantly surprised that this study has not gotten widespread media attention because bad news travels fast. I have chosen to share it with you because at some point you may begin getting questions from concerned parents.

While apparently well done, this study is just the beginning. Like any good research, it poses more questions than it answers. For us as pediatricians it means we should continue to recommend breast milk as the first food. But, we must stay alert as further research looks deeper into this association.

We should also take advantage of our special access to young parents, a demographic that less frequently sees a physician for preventive care. For whatever reason colorectal cancer is occurring at younger ages. When we have the opportunity we should be reminding 40-year-olds not to wait until age 50 to screen for colorectal cancer, particularly if they have a family history of the disease.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Ultraprocessed foods (UPFs) make up nearly three-quarters of the entire U.S. food supply and about 60% of Americans’ daily caloric intake. A significant body of research has tied consumption of these foods – awash in added sugar, salt, fat, artificial colors, or preservatives – to cancer, diabetes, and heart disease.
 

Now, a growing number of studies also link them to poor brain health, including an increased risk of dementia, depression, and anxiety, and some experts are calling for public health policies aimed at reducing UPF consumption.

But what’s the science behind the link between UPFs and brain health and what does it mean for clinicians and their patients?
 

Under srutiny

A mainstay of diets in countries around the world, UPFs have come under increasing scrutiny because of their link to major diseases. The ingredients in UPFs add little or no nutritional value. Their primary function is to increase a product’s shelf life and palatability. Some recent evidence suggests these foods may be as addictive as tobacco. In addition, two pooled analysis studies using the Yale Food Addiction Scale showed that 14% of adults and 12% of children in the United States may have a UPF addiction.

The most widely used measure of what is, and what is not, a UPF was developed in 2009 by researchers in Brazil. The NOVA food classification system assigns food and beverages to one of four groups:

• Unprocessed and minimally processed foods, such as fruits, vegetables, milk, and meat.
• Processed culinary ingredients, including white sugar, butter, and oils derived from seeds, nuts, and fruits.
• Processed foods, such as tomato paste, bacon, canned tuna, and wine.
• Ultraprocessed foods, such as soda, ice cream, breakfast cereal, and prepackaged meals.

Those sounding the alarm about the potential harmful effects of UPFs are particularly concerned about their consumption by young people. The National Health and Nutrition Examination Survey showed that from 1999 to 2018, highly processed foods accounted for the majority of energy intake in those aged 2-19 years.

One of the most commonly used additives in UPFs, the artificial sweetener aspartame, garnered headlines this summer when the World Health Organization classified it as a likely carcinogen in humans. Aspartame is used in thousands of products, from soda to chewing gum to chewable vitamins.

The U.S. Food and Drug Administration strongly disagreed with the WHO’s position and is sticking by its recommended daily limit of 50 mg/kg of body weight – equivalent to 75 packets of the sweetener Equal – as safe for human consumption.

“Aspartame is one of the most studied food additives in the human food supply,” FDA officials said in a statement, adding that the agency found “significant shortcomings” in the studies the WHO used to justify the new classification. “FDA scientists do not have safety concerns when aspartame is used under the approved conditions.”

Increased attention to consumption of UPFs in general and aspartame particularly in recent years has yielded several studies pointing to the foods’ association with compromised brain health.
 

Link to depression, dementia

A recent report on UPF consumption and mental well-being among nearly 300,000 people across 70 countries showed that 53% of those who consumed UPFs several times a day were distressed or were struggling with their mental well-being, compared with 18% of those who rarely or never consumed UPFs.

Part of the Global Mind Project run by the nonprofit Sapien Labs in Arlington, Va., the report also showed that individuals with the highest rates of UPF consumption reported higher levels of confusion, slowed thinking, unwanted or obsessive thoughts, irritability, and feelings of sadness.

“There seems to be a much broader effect than just depression symptoms,” Tara Thiagarajan, PhD, founder and chief scientist of Sapien Labs and coauthor of the report, said in an interview.

The report, which has not been peer reviewed, comes on the heels of several other studies, including one from the Nurses Health Study II that showed that participants who consumed more than eight servings of UPFs daily had about a 50% higher depression risk, compared with those who consumed half that much.

“We found that UPFs in general, and artificial sweeteners and beverages in particular, were associated with increased risk,” said lead investigator Andrew T. Chan, MD, MPH, professor of medicine at Harvard Medical School and chief of the clinical and translational epidemiology unit, Massachusetts General Hospital, both in Boston.

“This was an interesting finding that correlates with data from animal studies that artificial sweeteners may trigger the transmission of particular signaling molecules in the brain that are important for mood,” he told this news organization.

Cognition may also be affected. An analysis of more than 72,000 people in the UK Biobank showed that those who consumed a high levels of UPFs were 50% more likely to develop dementia than those who consumed fewer processed foods. For every 10% increase in UPF consumption, the odds of developing any kind of dementia increased by 25%.

Another study of nearly 11,000 people showed that higher UPF consumption was associated with a significantly faster decline in executive and global cognitive function.
 

Epigenetic changes

While these and other studies suggest a link between UPF consumption and brain health, they are designed to demonstrate correlation. To date, no human study has proven that eating highly processed foods directly causes a decline in mental health or cognition.

Animal studies could provide that causal link. Earlier this year, researchers at Florida State University in Tallahassee reported learning and memory deficits in two groups of male mice that completed a maze test after being fed water mixed with aspartame for about 20% of their adult lives, compared with a group of mice that drank water only. Animals that ingested aspartame could finish the test, but it took them longer, and they needed help.

The amount of aspartame used in the study was just 7% and 15% of the FDA’s recommended maximum intake of aspartame (equivalent to two to four 8-ounce diet sodas daily).

Most intriguing was that offspring of the mice in the aspartame groups demonstrated the same levels of cognitive decline and anxiety as their fathers, even though they had never ingested the artificial sweetener. Researchers theorize that in addition to changes in brain gene expression, aspartame also caused epigenetic changes in germ cells.

“Epigenetic changes in germ cells due to environmental exposures are both good and bad,” lead investigator Pradeep G. Bhide, PhD, professor of developmental neuroscience and director of the Center for Brain Repair at FSU, told this news organization. “They are bad because the next generation is affected. But they’re good because as long as the exposure no longer occurs, 2 or 3 generations later, that’s gone.”

The mice, which lacked taste receptors for aspartame, were the same age and weight in all three groups. Because the only difference was exposure to the artificial sweetener, Dr. Bhide says it suggests a causal link.

“Extrapolation of data from well-controlled laboratory experiments in mice to humans is always risky,” Dr. Bhide said. “The extrapolations give us insights into what could happen rather than what will happen.”
 

Potential mechanisms

Although scientists can’t say for certain how UPFs affect brain health, there are several theories. UPFs may influence an inflammatory immune response, which has been linked to depression and dementia. Consumption of highly processed foods may also disrupt the gut microbiome, Dr. Chan said, which, in turn, may increase depression risk.

“This is an important potential mechanism linking ultraprocessed food to depression since there is emerging evidence that microbes in the gut have been linked with mood through their role in metabolizing and producing proteins that have activity in the brain,” he said.

In addition, with UPFs that contain aspartame, there could be a more direct link to brain function. In the gastrointestinal track, the sweetener is quickly broken down into methanol, aspartic acid, and phenylalanine. All three enter the bloodstream, cross the blood-brain barrier, and are neuroactive.

“Phenylalanine is a precursor for neurotransmitters in the brain, and aspartic acid activates the glutamate excitatory neurotransmitter receptor,” Dr. Bhide said. “The effects we’ve seen could be due to these metabolites that have a direct effect on the brain function.”
 

Time to act?

Some researchers are building a case for classifying UPFs as addictive substances. Others are calling for additional research on UPF safety that is conducted outside the food industry.

There has also been some discussion of placing warning labels on UPFs. However, there is disagreement about what information should be included and how consumers might interpret it. The question of which food products are UPFs and which are not also isn’t settled. The NOVA system may be widely used, but it still has its detractors who believe it misclassifies some healthy foods as ultraprocessed.

Dr. Chan and other experts say the research conducted thus far requires additional corroboration to inform appropriate public health interventions. That would likely take the form of a large, randomized trial with one group of participants eating a healthy diet and the other consuming large amounts of UPFs.

“This type of study is extremely challenging given the number of people that would have to be willing to participate and be willing to eat a very specific diet over a long period of time,” Dr. Chan said. “I am also not sure it would be ethical to assign people to such a diet, given what we already know about the potential health effects of UPFs.”

Dr. Thiagarajan and others have called on funding agencies to direct more grant monies toward studies of UPFs to better understand their effect on brain health.

“Given the magnitude of the problem and given that there is a fair bit of evidence that points to a potential causal link, then we damn well better put money into this and get to the bottom of it,” she said.

Others are looking to the FDA to increase the agency’s scrutiny of food additives. While some additives such as artificial sweeteners have a place in diets of people with diabetes or obesity, Dr. Bhide suggests it may be wise for healthy individuals to reduce their daily intake of UPFs.

“Our data raise this to a different level because of the transgenerational transmission, which has never been shown before,” he said. “We are saying that the FDA should look in preclinical models at germ cells and maybe transgenerational transmission before approving any food additive.”

A version of this article first appeared on Medscape.com.

Ultraprocessed foods (UPFs) make up nearly three-quarters of the entire U.S. food supply and about 60% of Americans’ daily caloric intake. A significant body of research has tied consumption of these foods – awash in added sugar, salt, fat, artificial colors, or preservatives – to cancer, diabetes, and heart disease.
 

Now, a growing number of studies also link them to poor brain health, including an increased risk of dementia, depression, and anxiety, and some experts are calling for public health policies aimed at reducing UPF consumption.

But what’s the science behind the link between UPFs and brain health and what does it mean for clinicians and their patients?
 

Under srutiny

A mainstay of diets in countries around the world, UPFs have come under increasing scrutiny because of their link to major diseases. The ingredients in UPFs add little or no nutritional value. Their primary function is to increase a product’s shelf life and palatability. Some recent evidence suggests these foods may be as addictive as tobacco. In addition, two pooled analysis studies using the Yale Food Addiction Scale showed that 14% of adults and 12% of children in the United States may have a UPF addiction.

The most widely used measure of what is, and what is not, a UPF was developed in 2009 by researchers in Brazil. The NOVA food classification system assigns food and beverages to one of four groups:

• Unprocessed and minimally processed foods, such as fruits, vegetables, milk, and meat.
• Processed culinary ingredients, including white sugar, butter, and oils derived from seeds, nuts, and fruits.
• Processed foods, such as tomato paste, bacon, canned tuna, and wine.
• Ultraprocessed foods, such as soda, ice cream, breakfast cereal, and prepackaged meals.