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B-cell level may affect COVID booster efficacy in MS
Patients with multiple sclerosis (MS) treated with the B-cell-depleting medication rituximab who have not yet been vaccinated against COVID-19 should get the initial vaccination as soon as possible but wait to get a booster shot until B-cell levels increase, new research suggests.
In a prospective cohort study, 90% of patients taking rituximab whose B-cell level was at least 40 cells/mcL had a sufficient antibody response to the Pfizer vaccine, whereas among those with lower levels, the antibody response was significantly lower.
Results also showed a wide variation in the length of time needed for adequate B-cell restoration. Some patients needed a year or longer for levels to become adequate.
The findings led the hospital where the study was conducted to suspend rituximab therapy until patients could be vaccinated. The findings also prompted researchers to call for new guidelines on vaccine scheduling that are based on B-cell levels and not on the current criteria of length of time since last treatment.
“It’s meaningless to just go by some recommendation covering time since the last treatment,” study investigator Joachim Burman, MD, PhD, a consultant neurologist at Uppsala University Hospital and an associate professor at Uppsala University, both in Sweden, told this news organization.
“It’s misleading and potentially harmful for patients,” Dr. Burman said.
The findings were published online in JAMA Network Open.
Finding the cutoff
Drugs such as rituximab target CD20, a protein found on the surface of B cells, resulting in B-cell depletion.
Rituximab is the most common MS therapy used in Sweden. The drug is approved in the United States to treat rheumatoid arthritis and some forms of cancer, but it is not approved for treatment of MS.
Prior research showed that antibody response to COVID-19 vaccines was lower in patients receiving B-cell therapy than in the general population. That was not altogether surprising, given the fact that studies have found a similarly weakened antibody response to other vaccines.
But before now, there was no known B-cell threshold sufficient to mount an acceptable antibody response following COVID vaccination.
Researchers enrolled 67 patients in the study. Of those patients, 60 had received rituximab treatment, and seven had not.
Approximately 6 months after the last rituximab dose, the B-cell count was lower than 10/mcL for 40% of patients. In that group, rituximab treatment duration was the only factor significantly associated with slower B-cell mobilization (median duration, 4.0 years, vs. 2.1; P = .002).
Close monitoring needed
Six weeks after vaccination with tozinameran, the mRNA vaccine manufactured by Pfizer, 28% of patients failed to generate a sufficient antibody response. Among those patients, the median B-cell count was 22/mcL, versus 51/mcL for the remainder of the cohort (P < .001).
A cutoff value of 40/mcL rendered adequate levels of anti-spike immunoglobulin G antibodies in 90% of patients and a strong response in anti-RBD antibodies in 72%.
Study participants did register an adequate T-cell response to the vaccine, suggesting at least some level of protection.
Because MS patients are at increased risk for serious illness from SARS-CoV-2 infection, the investigators recommend that patients with MS receive their initial COVID vaccines as soon as possible – but that they should hold off on receiving a booster until their B-cell counts reach 40/mcL.
Regarding when a clinician should re-vaccinate, “the results from our study strongly suggest that you should not do that right away or just follow some generic guideline,” Dr. Burman said.
“You should closely monitor the B-cell values, and re-vaccinate once those B- cells hit the level of 40 cells/mcL” he added.
Dr. Burman said he would expect that their findings would hold with the other mRNA vaccine and with any other B-cell therapy.
Too soon for B-cell measures?
Commenting for this news organization, Robert J. Fox, MD, staff neurologist at the Mellen Center for MS and vice-chair for research at the Neurological Institute at Cleveland Clinic, Ohio, said the B-cell threshold identified in the study is much higher than what is typically seen in patients who undergo treatment with ocrelizumab, an anti-CD20 B-cell therapy approved in the United States for treating MS.
“Decisions about treatment interval need to balance efficacy in treating MS with safety, including response to vaccines,” said Dr. Fox, who was not involved with the research.
“Given the unknown efficacy of these extended intervals, I don’t think we’re at the point of making management recommendations based upon B-cell counts,” he added.
And yet, Uppsala University Hospital, where the study was conducted, and other centers in Sweden decided to do just that. They suspended administering rituximab to patients with MS until the patients were vaccinated. For patients newly diagnosed with MS, therapy was initiated using another disease-modifying treatment, and for those who were due for a rituximab infusion, that treatment was delayed.
Only one patient experienced a mild MS relapse during the rituximab suspension, and that case went into remission within a week, Dr. Burman reported.
“Ever since the Bar-Or report showing that the humeral response to vaccines is markedly diminished in MS patients treated with anti-CD20 therapies, clinicians have been struggling to balance those safety concerns related to anti-CD20 monoclonal antibody treatments and the clinical benefit of this treatment class,” Dr. Fox said.
“Given the uncharted waters of the COVID pandemic, clinicians made judgments and decisions as best they could, given the paucity of data,” he noted.
“At this point, we don’t know which decisions were right or wrong, but I certainly don’t think we should judge clinicians for making decisions the best they could.”
The study was funded by the Engkvist Foundation, the Marianne and Marcus Wallenberg Foundation, and the Swedish Society for Medical Research. Dr. Burman reported no relevant financial relationships. Dr. Fox has received consulting fees from Genentech/Roche, Biogen, and other companies that promote MS therapies.
A version of this article first appeared on Medscape.com.
Patients with multiple sclerosis (MS) treated with the B-cell-depleting medication rituximab who have not yet been vaccinated against COVID-19 should get the initial vaccination as soon as possible but wait to get a booster shot until B-cell levels increase, new research suggests.
In a prospective cohort study, 90% of patients taking rituximab whose B-cell level was at least 40 cells/mcL had a sufficient antibody response to the Pfizer vaccine, whereas among those with lower levels, the antibody response was significantly lower.
Results also showed a wide variation in the length of time needed for adequate B-cell restoration. Some patients needed a year or longer for levels to become adequate.
The findings led the hospital where the study was conducted to suspend rituximab therapy until patients could be vaccinated. The findings also prompted researchers to call for new guidelines on vaccine scheduling that are based on B-cell levels and not on the current criteria of length of time since last treatment.
“It’s meaningless to just go by some recommendation covering time since the last treatment,” study investigator Joachim Burman, MD, PhD, a consultant neurologist at Uppsala University Hospital and an associate professor at Uppsala University, both in Sweden, told this news organization.
“It’s misleading and potentially harmful for patients,” Dr. Burman said.
The findings were published online in JAMA Network Open.
Finding the cutoff
Drugs such as rituximab target CD20, a protein found on the surface of B cells, resulting in B-cell depletion.
Rituximab is the most common MS therapy used in Sweden. The drug is approved in the United States to treat rheumatoid arthritis and some forms of cancer, but it is not approved for treatment of MS.
Prior research showed that antibody response to COVID-19 vaccines was lower in patients receiving B-cell therapy than in the general population. That was not altogether surprising, given the fact that studies have found a similarly weakened antibody response to other vaccines.
But before now, there was no known B-cell threshold sufficient to mount an acceptable antibody response following COVID vaccination.
Researchers enrolled 67 patients in the study. Of those patients, 60 had received rituximab treatment, and seven had not.
Approximately 6 months after the last rituximab dose, the B-cell count was lower than 10/mcL for 40% of patients. In that group, rituximab treatment duration was the only factor significantly associated with slower B-cell mobilization (median duration, 4.0 years, vs. 2.1; P = .002).
Close monitoring needed
Six weeks after vaccination with tozinameran, the mRNA vaccine manufactured by Pfizer, 28% of patients failed to generate a sufficient antibody response. Among those patients, the median B-cell count was 22/mcL, versus 51/mcL for the remainder of the cohort (P < .001).
A cutoff value of 40/mcL rendered adequate levels of anti-spike immunoglobulin G antibodies in 90% of patients and a strong response in anti-RBD antibodies in 72%.
Study participants did register an adequate T-cell response to the vaccine, suggesting at least some level of protection.
Because MS patients are at increased risk for serious illness from SARS-CoV-2 infection, the investigators recommend that patients with MS receive their initial COVID vaccines as soon as possible – but that they should hold off on receiving a booster until their B-cell counts reach 40/mcL.
Regarding when a clinician should re-vaccinate, “the results from our study strongly suggest that you should not do that right away or just follow some generic guideline,” Dr. Burman said.
“You should closely monitor the B-cell values, and re-vaccinate once those B- cells hit the level of 40 cells/mcL” he added.
Dr. Burman said he would expect that their findings would hold with the other mRNA vaccine and with any other B-cell therapy.
Too soon for B-cell measures?
Commenting for this news organization, Robert J. Fox, MD, staff neurologist at the Mellen Center for MS and vice-chair for research at the Neurological Institute at Cleveland Clinic, Ohio, said the B-cell threshold identified in the study is much higher than what is typically seen in patients who undergo treatment with ocrelizumab, an anti-CD20 B-cell therapy approved in the United States for treating MS.
“Decisions about treatment interval need to balance efficacy in treating MS with safety, including response to vaccines,” said Dr. Fox, who was not involved with the research.
“Given the unknown efficacy of these extended intervals, I don’t think we’re at the point of making management recommendations based upon B-cell counts,” he added.
And yet, Uppsala University Hospital, where the study was conducted, and other centers in Sweden decided to do just that. They suspended administering rituximab to patients with MS until the patients were vaccinated. For patients newly diagnosed with MS, therapy was initiated using another disease-modifying treatment, and for those who were due for a rituximab infusion, that treatment was delayed.
Only one patient experienced a mild MS relapse during the rituximab suspension, and that case went into remission within a week, Dr. Burman reported.
“Ever since the Bar-Or report showing that the humeral response to vaccines is markedly diminished in MS patients treated with anti-CD20 therapies, clinicians have been struggling to balance those safety concerns related to anti-CD20 monoclonal antibody treatments and the clinical benefit of this treatment class,” Dr. Fox said.
“Given the uncharted waters of the COVID pandemic, clinicians made judgments and decisions as best they could, given the paucity of data,” he noted.
“At this point, we don’t know which decisions were right or wrong, but I certainly don’t think we should judge clinicians for making decisions the best they could.”
The study was funded by the Engkvist Foundation, the Marianne and Marcus Wallenberg Foundation, and the Swedish Society for Medical Research. Dr. Burman reported no relevant financial relationships. Dr. Fox has received consulting fees from Genentech/Roche, Biogen, and other companies that promote MS therapies.
A version of this article first appeared on Medscape.com.
Patients with multiple sclerosis (MS) treated with the B-cell-depleting medication rituximab who have not yet been vaccinated against COVID-19 should get the initial vaccination as soon as possible but wait to get a booster shot until B-cell levels increase, new research suggests.
In a prospective cohort study, 90% of patients taking rituximab whose B-cell level was at least 40 cells/mcL had a sufficient antibody response to the Pfizer vaccine, whereas among those with lower levels, the antibody response was significantly lower.
Results also showed a wide variation in the length of time needed for adequate B-cell restoration. Some patients needed a year or longer for levels to become adequate.
The findings led the hospital where the study was conducted to suspend rituximab therapy until patients could be vaccinated. The findings also prompted researchers to call for new guidelines on vaccine scheduling that are based on B-cell levels and not on the current criteria of length of time since last treatment.
“It’s meaningless to just go by some recommendation covering time since the last treatment,” study investigator Joachim Burman, MD, PhD, a consultant neurologist at Uppsala University Hospital and an associate professor at Uppsala University, both in Sweden, told this news organization.
“It’s misleading and potentially harmful for patients,” Dr. Burman said.
The findings were published online in JAMA Network Open.
Finding the cutoff
Drugs such as rituximab target CD20, a protein found on the surface of B cells, resulting in B-cell depletion.
Rituximab is the most common MS therapy used in Sweden. The drug is approved in the United States to treat rheumatoid arthritis and some forms of cancer, but it is not approved for treatment of MS.
Prior research showed that antibody response to COVID-19 vaccines was lower in patients receiving B-cell therapy than in the general population. That was not altogether surprising, given the fact that studies have found a similarly weakened antibody response to other vaccines.
But before now, there was no known B-cell threshold sufficient to mount an acceptable antibody response following COVID vaccination.
Researchers enrolled 67 patients in the study. Of those patients, 60 had received rituximab treatment, and seven had not.
Approximately 6 months after the last rituximab dose, the B-cell count was lower than 10/mcL for 40% of patients. In that group, rituximab treatment duration was the only factor significantly associated with slower B-cell mobilization (median duration, 4.0 years, vs. 2.1; P = .002).
Close monitoring needed
Six weeks after vaccination with tozinameran, the mRNA vaccine manufactured by Pfizer, 28% of patients failed to generate a sufficient antibody response. Among those patients, the median B-cell count was 22/mcL, versus 51/mcL for the remainder of the cohort (P < .001).
A cutoff value of 40/mcL rendered adequate levels of anti-spike immunoglobulin G antibodies in 90% of patients and a strong response in anti-RBD antibodies in 72%.
Study participants did register an adequate T-cell response to the vaccine, suggesting at least some level of protection.
Because MS patients are at increased risk for serious illness from SARS-CoV-2 infection, the investigators recommend that patients with MS receive their initial COVID vaccines as soon as possible – but that they should hold off on receiving a booster until their B-cell counts reach 40/mcL.
Regarding when a clinician should re-vaccinate, “the results from our study strongly suggest that you should not do that right away or just follow some generic guideline,” Dr. Burman said.
“You should closely monitor the B-cell values, and re-vaccinate once those B- cells hit the level of 40 cells/mcL” he added.
Dr. Burman said he would expect that their findings would hold with the other mRNA vaccine and with any other B-cell therapy.
Too soon for B-cell measures?
Commenting for this news organization, Robert J. Fox, MD, staff neurologist at the Mellen Center for MS and vice-chair for research at the Neurological Institute at Cleveland Clinic, Ohio, said the B-cell threshold identified in the study is much higher than what is typically seen in patients who undergo treatment with ocrelizumab, an anti-CD20 B-cell therapy approved in the United States for treating MS.
“Decisions about treatment interval need to balance efficacy in treating MS with safety, including response to vaccines,” said Dr. Fox, who was not involved with the research.
“Given the unknown efficacy of these extended intervals, I don’t think we’re at the point of making management recommendations based upon B-cell counts,” he added.
And yet, Uppsala University Hospital, where the study was conducted, and other centers in Sweden decided to do just that. They suspended administering rituximab to patients with MS until the patients were vaccinated. For patients newly diagnosed with MS, therapy was initiated using another disease-modifying treatment, and for those who were due for a rituximab infusion, that treatment was delayed.
Only one patient experienced a mild MS relapse during the rituximab suspension, and that case went into remission within a week, Dr. Burman reported.
“Ever since the Bar-Or report showing that the humeral response to vaccines is markedly diminished in MS patients treated with anti-CD20 therapies, clinicians have been struggling to balance those safety concerns related to anti-CD20 monoclonal antibody treatments and the clinical benefit of this treatment class,” Dr. Fox said.
“Given the uncharted waters of the COVID pandemic, clinicians made judgments and decisions as best they could, given the paucity of data,” he noted.
“At this point, we don’t know which decisions were right or wrong, but I certainly don’t think we should judge clinicians for making decisions the best they could.”
The study was funded by the Engkvist Foundation, the Marianne and Marcus Wallenberg Foundation, and the Swedish Society for Medical Research. Dr. Burman reported no relevant financial relationships. Dr. Fox has received consulting fees from Genentech/Roche, Biogen, and other companies that promote MS therapies.
A version of this article first appeared on Medscape.com.
ECDC gives guidance on prevention and treatment of monkeypox
In a new risk-assessment document, the European Centre for Disease Prevention and Control summarizes what we currently know about monkeypox and recommends that European countries focus on the identification and management of the disease as well as contract tracing and prompt reporting of new cases of the virus.
Recent developments
From May 15 to May 23, in eight European Union member states (Belgium, France, Germany, Italy, the Netherlands, Portugal, Spain, and Sweden) a total of 85 cases of monkeypox were reported; they were acquired through autochthonous transmission. Current diagnosed cases of monkeypox have mainly been recorded in men who have sexual relations with other men, suggesting that transmission may occur during sexual intercourse, through infectious material coming into contact with mucosa or damaged skin, or via large respiratory droplets during prolonged face-to-face contact.
Andrea Ammon, MD, director of the ECDC, stated that “most current cases have presented with mild symptoms of the disease, and for the general population, the chance of diffusion is very low. However, the likelihood of a further spread of the virus through close contact, for example during sexual activities among people with multiple sexual partners, is considerably increased.”
Stella Kyriakides, European commissioner for health and food safety, added, “I am worried about the increase of cases of monkeypox in the EU and worldwide. We are currently monitoring the situation and, although, at the moment, the probability of it spreading to the general population is low, the situation is evolving. We should all remain alert, making sure that contact tracing and a sufficient diagnostic capacity are in place and guarantee that vaccines and antiviral drugs are available, as well as sufficient personal protective equipment [PPE] for health care professionals.”
Routes of transmission
Monkeypox is not easily spread among people. Person-to-person transmission occurs through close contact with infectious material, coming from skin lesions of an infected person, through air droplets in the case of prolonged face-to-face contact, and through fomites. So far, diagnosed cases suggest that transmission can occur through sexual intercourse.
The incubation period is 5-21 days, and patients are symptomatic for 2-4 weeks.
According to the ECDC, the likelihood of this infection spreading is increased among people who have more than one sexual partner. Although most current cases present with mild symptoms, monkeypox can cause severe disease in some groups (such as young children, pregnant women, and immunosuppressed people). However, the probability of severe disease cannot yet be estimated precisely.
The overall risk is considered moderate for people who have multiple sexual partners and low for the general population.
Clinical course
The disease initially presents with fever, myalgia, fatigue, and headache. Within 3 days of the onset of the prodromal symptoms, a centrifugal maculopapular rash appears on the site of primary infection and rapidly spreads to other parts of the body. The palms of the hands and bottoms of the feet are involved in cases where the rash has spread, which is a characteristic of the disease. Usually within 12 days, the lesions progress, simultaneously changing from macules to papules, blisters, pustules, and scabs before falling off. The lesions may have a central depression and be extremely itchy.
If the patient scratches them, a secondary bacterial infection may take hold (for which treatment with oral antihistamines is indicated). Lesions may also be present in the oral or ocular mucous membrane. Either before or at the same time as onset of the rash, patients may experience swelling of the lymph nodes, which usually is not seen with smallpox or chickenpox.
The onset of the rash is considered the start of the infectious period; however, people with prodromal symptoms may also transmit the virus.
Most cases in people present with mild or moderate symptoms. Complications seen in endemic countries include encephalitis, secondary bacterial skin infections, dehydration, conjunctivitis, keratitis, and pneumonia. The death rate ranges from 0% to 11% in endemic areas, with fatalities from the disease mostly occurring in younger children.
There is not a lot of information available on the disease in immunosuppressed individuals. In the 2017 Nigerian epidemic, patients with a concomitant HIV infection presented with more severe disease, with a greater number of skin lesions and genital ulcers, compared with HIV-negative individuals. No deaths were reported among seropositive patients. The main sequelae from the disease are usually disfiguring scars and permanent corneal lesions.
Treatment
No smallpox vaccines are authorized for use against monkeypox, however the third-generation smallpox vaccine Imvanex (Modified Vaccinia Ankara) has been authorized by the European Medicines Agency (EMA) for the EU market against smallpox and has demonstrated to provide protection in primates.
Old-generation smallpox vaccines have significant side effects, are no longer authorized, and should no longer be used. It is also important to note the lack of safety data for the use of Imvanex in immunocompromised people.
For this reason, National Immunization Technical Advisory Groups have been asked to develop specific guidelines for vaccination in close contacts of patients with monkeypox. The use of a smallpox vaccine for preexposure prophylaxis cannot be considered now, when taking into account the risk-benefit ratio.
In regard to treatment, tecovirimat is the only antiviral drug with an EMA-authorized indication for orthopoxvirus infection.
Brincidofovir is not authorized in the EU but has been authorized by the US Food and Drug Administration. However, availability on the European market is limited somewhat by the number of doses.
According to the ECDC, health care authorities should provide information about which groups should have priority access to treatment.
The use of antivirals for postexposure prophylaxis should be investigated further. Cidofovir is active in vitro for smallpox but has a pronounced nephrotoxicity profile that makes it unsuitable for first-line treatment.
The ECDC document also proposes an interim case definition for epidemiologic reporting. Further indications will also be provided for the management of monkeypox cases and close contacts. Those infected should remain in isolation until the scabs have fallen off and should, above all, avoid close contact with at-risk or immunosuppressed people as well as pets.
Most infected people can remain at home with supportive care.
Prevention
Close contacts for cases of monkeypox should monitor the development of their symptoms until 21 days have passed from their most recent exposure to the virus.
Health care workers should wear appropriate PPE (gloves, water-resistant gowns, FFP2 masks) during screening for suspected cases or when working with confirmed cases. Laboratory staff should also take precautions to avoid exposure in the workplace.
Close contacts of an infected person should not donate blood, organs, or bone marrow for at least 21 days from the last day of exposure.
Finally, the ECDC recommends increasing proactive communication of the risks to increase awareness and provide updates and indications to individuals who are at a greater risk, as well as to the general public. These messages should highlight that monkeypox is spread through close person-to-person contact, especially within the family unit, and also potentially through sexual intercourse. A balance, however, should be maintained between informing the individuals who are at greater risk and communicating that the virus is not easily spread and that the risk for the general population is low.
Human-to-animal transmission
A potential risk for human-to-animal transmission exists in Europe; therefore, a close collaboration is required between human and veterinary health care authorities, working together to manage domestic animals exposed to the virus and to prevent transmission of the disease to wildlife. To date, the European Food Safety Authority is not aware of any reports of animal infections (domestic or wild) within the EU.
There are still many unknown factors about this outbreak. The ECDC continues to closely monitor any developments and will update the risk assessment as soon as new data and information become available.
If human-to-animal transmission occurs and the virus spreads among animal populations, there is a risk that the disease could become an endemic in Europe. Therefore, human and veterinary health care authorities should work together closely to manage cases of domestic animals exposed to the virus and prevent transmission of the disease to wildlife.
A version of this article appeared on Medscape.com. This article was translated from Univadis Italy.
In a new risk-assessment document, the European Centre for Disease Prevention and Control summarizes what we currently know about monkeypox and recommends that European countries focus on the identification and management of the disease as well as contract tracing and prompt reporting of new cases of the virus.
Recent developments
From May 15 to May 23, in eight European Union member states (Belgium, France, Germany, Italy, the Netherlands, Portugal, Spain, and Sweden) a total of 85 cases of monkeypox were reported; they were acquired through autochthonous transmission. Current diagnosed cases of monkeypox have mainly been recorded in men who have sexual relations with other men, suggesting that transmission may occur during sexual intercourse, through infectious material coming into contact with mucosa or damaged skin, or via large respiratory droplets during prolonged face-to-face contact.
Andrea Ammon, MD, director of the ECDC, stated that “most current cases have presented with mild symptoms of the disease, and for the general population, the chance of diffusion is very low. However, the likelihood of a further spread of the virus through close contact, for example during sexual activities among people with multiple sexual partners, is considerably increased.”
Stella Kyriakides, European commissioner for health and food safety, added, “I am worried about the increase of cases of monkeypox in the EU and worldwide. We are currently monitoring the situation and, although, at the moment, the probability of it spreading to the general population is low, the situation is evolving. We should all remain alert, making sure that contact tracing and a sufficient diagnostic capacity are in place and guarantee that vaccines and antiviral drugs are available, as well as sufficient personal protective equipment [PPE] for health care professionals.”
Routes of transmission
Monkeypox is not easily spread among people. Person-to-person transmission occurs through close contact with infectious material, coming from skin lesions of an infected person, through air droplets in the case of prolonged face-to-face contact, and through fomites. So far, diagnosed cases suggest that transmission can occur through sexual intercourse.
The incubation period is 5-21 days, and patients are symptomatic for 2-4 weeks.
According to the ECDC, the likelihood of this infection spreading is increased among people who have more than one sexual partner. Although most current cases present with mild symptoms, monkeypox can cause severe disease in some groups (such as young children, pregnant women, and immunosuppressed people). However, the probability of severe disease cannot yet be estimated precisely.
The overall risk is considered moderate for people who have multiple sexual partners and low for the general population.
Clinical course
The disease initially presents with fever, myalgia, fatigue, and headache. Within 3 days of the onset of the prodromal symptoms, a centrifugal maculopapular rash appears on the site of primary infection and rapidly spreads to other parts of the body. The palms of the hands and bottoms of the feet are involved in cases where the rash has spread, which is a characteristic of the disease. Usually within 12 days, the lesions progress, simultaneously changing from macules to papules, blisters, pustules, and scabs before falling off. The lesions may have a central depression and be extremely itchy.
If the patient scratches them, a secondary bacterial infection may take hold (for which treatment with oral antihistamines is indicated). Lesions may also be present in the oral or ocular mucous membrane. Either before or at the same time as onset of the rash, patients may experience swelling of the lymph nodes, which usually is not seen with smallpox or chickenpox.
The onset of the rash is considered the start of the infectious period; however, people with prodromal symptoms may also transmit the virus.
Most cases in people present with mild or moderate symptoms. Complications seen in endemic countries include encephalitis, secondary bacterial skin infections, dehydration, conjunctivitis, keratitis, and pneumonia. The death rate ranges from 0% to 11% in endemic areas, with fatalities from the disease mostly occurring in younger children.
There is not a lot of information available on the disease in immunosuppressed individuals. In the 2017 Nigerian epidemic, patients with a concomitant HIV infection presented with more severe disease, with a greater number of skin lesions and genital ulcers, compared with HIV-negative individuals. No deaths were reported among seropositive patients. The main sequelae from the disease are usually disfiguring scars and permanent corneal lesions.
Treatment
No smallpox vaccines are authorized for use against monkeypox, however the third-generation smallpox vaccine Imvanex (Modified Vaccinia Ankara) has been authorized by the European Medicines Agency (EMA) for the EU market against smallpox and has demonstrated to provide protection in primates.
Old-generation smallpox vaccines have significant side effects, are no longer authorized, and should no longer be used. It is also important to note the lack of safety data for the use of Imvanex in immunocompromised people.
For this reason, National Immunization Technical Advisory Groups have been asked to develop specific guidelines for vaccination in close contacts of patients with monkeypox. The use of a smallpox vaccine for preexposure prophylaxis cannot be considered now, when taking into account the risk-benefit ratio.
In regard to treatment, tecovirimat is the only antiviral drug with an EMA-authorized indication for orthopoxvirus infection.
Brincidofovir is not authorized in the EU but has been authorized by the US Food and Drug Administration. However, availability on the European market is limited somewhat by the number of doses.
According to the ECDC, health care authorities should provide information about which groups should have priority access to treatment.
The use of antivirals for postexposure prophylaxis should be investigated further. Cidofovir is active in vitro for smallpox but has a pronounced nephrotoxicity profile that makes it unsuitable for first-line treatment.
The ECDC document also proposes an interim case definition for epidemiologic reporting. Further indications will also be provided for the management of monkeypox cases and close contacts. Those infected should remain in isolation until the scabs have fallen off and should, above all, avoid close contact with at-risk or immunosuppressed people as well as pets.
Most infected people can remain at home with supportive care.
Prevention
Close contacts for cases of monkeypox should monitor the development of their symptoms until 21 days have passed from their most recent exposure to the virus.
Health care workers should wear appropriate PPE (gloves, water-resistant gowns, FFP2 masks) during screening for suspected cases or when working with confirmed cases. Laboratory staff should also take precautions to avoid exposure in the workplace.
Close contacts of an infected person should not donate blood, organs, or bone marrow for at least 21 days from the last day of exposure.
Finally, the ECDC recommends increasing proactive communication of the risks to increase awareness and provide updates and indications to individuals who are at a greater risk, as well as to the general public. These messages should highlight that monkeypox is spread through close person-to-person contact, especially within the family unit, and also potentially through sexual intercourse. A balance, however, should be maintained between informing the individuals who are at greater risk and communicating that the virus is not easily spread and that the risk for the general population is low.
Human-to-animal transmission
A potential risk for human-to-animal transmission exists in Europe; therefore, a close collaboration is required between human and veterinary health care authorities, working together to manage domestic animals exposed to the virus and to prevent transmission of the disease to wildlife. To date, the European Food Safety Authority is not aware of any reports of animal infections (domestic or wild) within the EU.
There are still many unknown factors about this outbreak. The ECDC continues to closely monitor any developments and will update the risk assessment as soon as new data and information become available.
If human-to-animal transmission occurs and the virus spreads among animal populations, there is a risk that the disease could become an endemic in Europe. Therefore, human and veterinary health care authorities should work together closely to manage cases of domestic animals exposed to the virus and prevent transmission of the disease to wildlife.
A version of this article appeared on Medscape.com. This article was translated from Univadis Italy.
In a new risk-assessment document, the European Centre for Disease Prevention and Control summarizes what we currently know about monkeypox and recommends that European countries focus on the identification and management of the disease as well as contract tracing and prompt reporting of new cases of the virus.
Recent developments
From May 15 to May 23, in eight European Union member states (Belgium, France, Germany, Italy, the Netherlands, Portugal, Spain, and Sweden) a total of 85 cases of monkeypox were reported; they were acquired through autochthonous transmission. Current diagnosed cases of monkeypox have mainly been recorded in men who have sexual relations with other men, suggesting that transmission may occur during sexual intercourse, through infectious material coming into contact with mucosa or damaged skin, or via large respiratory droplets during prolonged face-to-face contact.
Andrea Ammon, MD, director of the ECDC, stated that “most current cases have presented with mild symptoms of the disease, and for the general population, the chance of diffusion is very low. However, the likelihood of a further spread of the virus through close contact, for example during sexual activities among people with multiple sexual partners, is considerably increased.”
Stella Kyriakides, European commissioner for health and food safety, added, “I am worried about the increase of cases of monkeypox in the EU and worldwide. We are currently monitoring the situation and, although, at the moment, the probability of it spreading to the general population is low, the situation is evolving. We should all remain alert, making sure that contact tracing and a sufficient diagnostic capacity are in place and guarantee that vaccines and antiviral drugs are available, as well as sufficient personal protective equipment [PPE] for health care professionals.”
Routes of transmission
Monkeypox is not easily spread among people. Person-to-person transmission occurs through close contact with infectious material, coming from skin lesions of an infected person, through air droplets in the case of prolonged face-to-face contact, and through fomites. So far, diagnosed cases suggest that transmission can occur through sexual intercourse.
The incubation period is 5-21 days, and patients are symptomatic for 2-4 weeks.
According to the ECDC, the likelihood of this infection spreading is increased among people who have more than one sexual partner. Although most current cases present with mild symptoms, monkeypox can cause severe disease in some groups (such as young children, pregnant women, and immunosuppressed people). However, the probability of severe disease cannot yet be estimated precisely.
The overall risk is considered moderate for people who have multiple sexual partners and low for the general population.
Clinical course
The disease initially presents with fever, myalgia, fatigue, and headache. Within 3 days of the onset of the prodromal symptoms, a centrifugal maculopapular rash appears on the site of primary infection and rapidly spreads to other parts of the body. The palms of the hands and bottoms of the feet are involved in cases where the rash has spread, which is a characteristic of the disease. Usually within 12 days, the lesions progress, simultaneously changing from macules to papules, blisters, pustules, and scabs before falling off. The lesions may have a central depression and be extremely itchy.
If the patient scratches them, a secondary bacterial infection may take hold (for which treatment with oral antihistamines is indicated). Lesions may also be present in the oral or ocular mucous membrane. Either before or at the same time as onset of the rash, patients may experience swelling of the lymph nodes, which usually is not seen with smallpox or chickenpox.
The onset of the rash is considered the start of the infectious period; however, people with prodromal symptoms may also transmit the virus.
Most cases in people present with mild or moderate symptoms. Complications seen in endemic countries include encephalitis, secondary bacterial skin infections, dehydration, conjunctivitis, keratitis, and pneumonia. The death rate ranges from 0% to 11% in endemic areas, with fatalities from the disease mostly occurring in younger children.
There is not a lot of information available on the disease in immunosuppressed individuals. In the 2017 Nigerian epidemic, patients with a concomitant HIV infection presented with more severe disease, with a greater number of skin lesions and genital ulcers, compared with HIV-negative individuals. No deaths were reported among seropositive patients. The main sequelae from the disease are usually disfiguring scars and permanent corneal lesions.
Treatment
No smallpox vaccines are authorized for use against monkeypox, however the third-generation smallpox vaccine Imvanex (Modified Vaccinia Ankara) has been authorized by the European Medicines Agency (EMA) for the EU market against smallpox and has demonstrated to provide protection in primates.
Old-generation smallpox vaccines have significant side effects, are no longer authorized, and should no longer be used. It is also important to note the lack of safety data for the use of Imvanex in immunocompromised people.
For this reason, National Immunization Technical Advisory Groups have been asked to develop specific guidelines for vaccination in close contacts of patients with monkeypox. The use of a smallpox vaccine for preexposure prophylaxis cannot be considered now, when taking into account the risk-benefit ratio.
In regard to treatment, tecovirimat is the only antiviral drug with an EMA-authorized indication for orthopoxvirus infection.
Brincidofovir is not authorized in the EU but has been authorized by the US Food and Drug Administration. However, availability on the European market is limited somewhat by the number of doses.
According to the ECDC, health care authorities should provide information about which groups should have priority access to treatment.
The use of antivirals for postexposure prophylaxis should be investigated further. Cidofovir is active in vitro for smallpox but has a pronounced nephrotoxicity profile that makes it unsuitable for first-line treatment.
The ECDC document also proposes an interim case definition for epidemiologic reporting. Further indications will also be provided for the management of monkeypox cases and close contacts. Those infected should remain in isolation until the scabs have fallen off and should, above all, avoid close contact with at-risk or immunosuppressed people as well as pets.
Most infected people can remain at home with supportive care.
Prevention
Close contacts for cases of monkeypox should monitor the development of their symptoms until 21 days have passed from their most recent exposure to the virus.
Health care workers should wear appropriate PPE (gloves, water-resistant gowns, FFP2 masks) during screening for suspected cases or when working with confirmed cases. Laboratory staff should also take precautions to avoid exposure in the workplace.
Close contacts of an infected person should not donate blood, organs, or bone marrow for at least 21 days from the last day of exposure.
Finally, the ECDC recommends increasing proactive communication of the risks to increase awareness and provide updates and indications to individuals who are at a greater risk, as well as to the general public. These messages should highlight that monkeypox is spread through close person-to-person contact, especially within the family unit, and also potentially through sexual intercourse. A balance, however, should be maintained between informing the individuals who are at greater risk and communicating that the virus is not easily spread and that the risk for the general population is low.
Human-to-animal transmission
A potential risk for human-to-animal transmission exists in Europe; therefore, a close collaboration is required between human and veterinary health care authorities, working together to manage domestic animals exposed to the virus and to prevent transmission of the disease to wildlife. To date, the European Food Safety Authority is not aware of any reports of animal infections (domestic or wild) within the EU.
There are still many unknown factors about this outbreak. The ECDC continues to closely monitor any developments and will update the risk assessment as soon as new data and information become available.
If human-to-animal transmission occurs and the virus spreads among animal populations, there is a risk that the disease could become an endemic in Europe. Therefore, human and veterinary health care authorities should work together closely to manage cases of domestic animals exposed to the virus and prevent transmission of the disease to wildlife.
A version of this article appeared on Medscape.com. This article was translated from Univadis Italy.
Oncologists flock to Chicago for ASCO, after 2 years online
And it appears many are eager to attend the American Society of Clinical Oncology annual meeting in person now that they can.
By early May, ASCO already had 30,000 registrations, of which 80% were in person – there were 27,000 hotel reservations.
“That’s almost identical to where we were in terms of numbers in 2019 at the same point in time,” Julie Gralow, MD, chief medical officer at ASCO, said in an interview.
These figures, which are from May 11, are likely to increase. In past years, there has been an upswing in registrations right before the meeting starts.
The annual meeting begins on Friday, June 3, and runs until Tuesday, June 7. It will be held in Chicago, yet again, in the vast McCormick Place, sections of which were transformed into field hospital wards when the pandemic hit in 2020.
But the meeting will also continue to be transmitted virtually, as it has been for the past 2 years, for those not attending in person.
“I do think that the hybrid model will move forward,” Dr. Gralow said. “We can get a lot of attendees, especially from very distant places, who can’t travel, or can’t easily travel, and we have learned how to make that experience better for them as well.”
Attendees can also change their minds if, for example, rising numbers of COVID cases as the meeting nears put them off traveling. “We are allowing people to change to virtual. So I think there may be a little bit of that, depending on what happens to COVID in different parts of the world,” Dr. Gralow commented.
For those who do attend, the organization is “doing the best that we can to keep people safe,” said Dr. Gralow, who was previously a professor of global health and is now a breast medical oncologist and clinical trialist.
To attend in person, ASCO is mandating proof of vaccination (which in the United States means two doses of the COVID vaccine). “If you prove in advance that you are vaccinated, we will send you your badge, so you don’t have to stand in line,” she added.
“As far as masks go, we are saying right now that we are complying with Chicago’s rules, which mean there is no mandatory indoor masking,” she continued. “We are recommending masking because this is a group of physicians who treat immunocompromised patients. So we are recommending that.”
This stance has gotten some push-back on Twitter from both physicians and patient advocates, with some surprised that masking is not mandatory.
“I know that ‘mask-optional’ meetings mean most will omit masks; I literally just saw this at my last meeting as one of the few masked MDs,” commented radiation oncologist Fumiko Ladd Chino, MD. She appealed to the organizers with a plea: “There’s still time to change #ASCO22 policies. We’re in it for patient health.”
Patient advocate Manju George, MVSc, PhD, a rectal cancer survivor, was also campaigning for a change in policy by setting up a letter that others could sign, adding that “ASCO leadership is being flooded with pleads from concerned HCPs.”
When asked whether it was considering a change in mask policy, ASCO replied: “As far as health and safety go, the protocols we’ve put in place meet or exceed current [World Health Organization, [Centers for Disease Control and Prevention, and city of Chicago guidelines. ASCO is also closely coordinating with both the city and the convention center and we are actively monitoring local conditions.”
“To protect the health and safety of all meeting attendees, our protocols require attendees to be fully vaccinated and self-test negative for COVID-19 within 48 hours prior to their arrival at the meeting. In addition, we expect all attendees to be masked when indoors and are encouraging regular self-testing. We fully expect members of our community to do their part to help keep everyone safe, and we’re making it easy for attendees to comply with our policies by providing medical-grade masks as well as both rapid antigen and [polymerase chain reaction] COVID-19 tests,” the organization said.
There will also be a notification system so attendees can select how they identify for closeness, with red meaning stand back, no hugs, no handshakes; yellow signifying something more intermediate; and green signaling the person is okay with contact with a handshake or a hug. This system has already been used during smaller ASCO subspecialty meetings earlier this year, and feedback from delegates was positive, Dr. Gralow commented.
Advancing equitable care
The theme of the 2022 meeting, chosen by ASCO President Everett Vokes, MD, is advancing equitable cancer care through innovation.
It builds on the theme of equity from 2021, chosen by previous president Lori Pierce, MD, which was “Equity: Every Patient. Every Day. Everywhere.”
Some of this relates to disparities in equity, commented Dr. Gralow. This is the focus of a premeeting press briefing on May 26 that will highlight a few abstracts that focus on disparities and what can be done to address them. One study (abstract 6511) focuses on telemedicine, which was increasingly used during the pandemic, but the results show not all U.S. patient populations could access the specialty care they needed in this way.
De-escalation of therapy
De-escalation of therapy is another theme running through the meeting.
“There are some cancers where we have achieved such good outcomes that it is time to look at de-escalating therapy because we know that we are probably way overtreating a component of those patients. ... So we are looking at whether we can find subpopulations where we can back off on therapy,” commented Dr. Gralow.
One example is the LUMINA trial in breast cancer (abstract LBA501), which looked at omitting radiotherapy after surgery. “In standard practice we have already been doing this, not based on solid data, but based on an accumulation of retrospective analyses and similar evidence,” commented Dr. Gralow. This trial tested the approach prospectively, lowered the age range of patients, and better defined which patients were likely to benefit.
Another example is the DYNAMIC trial in colorectal cancer (abstract LBA-100), which looks at omitting chemotherapy based on levels of circulating tumor DNA after surgery. These patients had stage 2 disease and generally do very well with surgery and adjuvant chemotherapy, Dr. Gralow stated. This trial aims to find the subset of patients who could do just as well without the chemotherapy; it may also identify those patients at the other end of the scale, who perhaps need a bit more treatment, she added.
Spotlight on innovation
The focus on innovation includes exploring drugs developed outside the United States. One example is nimotuzumab, which is already approved in China for use in nasopharyngeal cancer but is also being explored in other cancer types. At ASCO, data will be presented in patients with KRAS wild-type pancreatic cancer (abstract 4011). This study, like the other trials with nimotuzumab, was conducted in China.
This brings up an important point about the data the Food and Drug Administration requires for new drug approvals, commented Dr. Gralow.
She noted that the FDA recently rejected an application for sintilimab, a drug also developed in China, on the basis that all trial data submitted for approval were from China. The agency said it would like to see multiregional clinical trials and trials that reflect the U.S. cancer population.
Advice for attendees
A large trial in a rare cancer promises to establish a new standard of care, where previously a number of different regimens have been used in various parts of the world, and even at different hospitals within the same country. These are the results from an international trial in children and adolescents/young adults with Ewing’s sarcoma (abstract LBA-02). “I have been told by experts in the field that these results will change practice ... [and] will have a global impact,” commented Dr. Gralow.
In addition to the scientific sessions that will see new data, there are a number of educational sessions that will tackle tricky issues that clinicians sometimes face. “Microaggressions, Bias, and Equity in the Workplace” will be discussed in one session, while another promises, “Strategies to Address Moral Distress in Clinicians: What Should We Do When We Don’t Know What to Do?”
There is also a special session featuring the “Cancer Groundshot: Addressing the Global and National Inequities in Cancer Care.” This is a move spearheaded by Bishal Gyawali, MD, PhD, from Brigham and Women’s Hospital, Boston, who was reacting to the lofty goals of the presidential Cancer Moonshot, including the aim of “ending cancer as we know it.” In a blog post in 2016 he suggested “forget the moon; let’s get back to blood and flesh reality on the ground ... [and] research that can be immediately applied to every global community.” He recounts the journey from ‘Blog Post to ASCO Session’ in a recent commentary.
Dr. Gyawali also has some advice for those attending the ASCO annual meeting: Reach out to people you respect, trust that connections will happen, scrutinize the data, listen critically for jargon, and perhaps most importantly, have fun.
“There’s more to life than your job,” he wrote. “Don’t stress. Think about the bigger picture. Think about your patients. And remember, life is beautiful, even when it feels like it isn’t.”
A version of this article first appeared on Medscape.com.
And it appears many are eager to attend the American Society of Clinical Oncology annual meeting in person now that they can.
By early May, ASCO already had 30,000 registrations, of which 80% were in person – there were 27,000 hotel reservations.
“That’s almost identical to where we were in terms of numbers in 2019 at the same point in time,” Julie Gralow, MD, chief medical officer at ASCO, said in an interview.
These figures, which are from May 11, are likely to increase. In past years, there has been an upswing in registrations right before the meeting starts.
The annual meeting begins on Friday, June 3, and runs until Tuesday, June 7. It will be held in Chicago, yet again, in the vast McCormick Place, sections of which were transformed into field hospital wards when the pandemic hit in 2020.
But the meeting will also continue to be transmitted virtually, as it has been for the past 2 years, for those not attending in person.
“I do think that the hybrid model will move forward,” Dr. Gralow said. “We can get a lot of attendees, especially from very distant places, who can’t travel, or can’t easily travel, and we have learned how to make that experience better for them as well.”
Attendees can also change their minds if, for example, rising numbers of COVID cases as the meeting nears put them off traveling. “We are allowing people to change to virtual. So I think there may be a little bit of that, depending on what happens to COVID in different parts of the world,” Dr. Gralow commented.
For those who do attend, the organization is “doing the best that we can to keep people safe,” said Dr. Gralow, who was previously a professor of global health and is now a breast medical oncologist and clinical trialist.
To attend in person, ASCO is mandating proof of vaccination (which in the United States means two doses of the COVID vaccine). “If you prove in advance that you are vaccinated, we will send you your badge, so you don’t have to stand in line,” she added.
“As far as masks go, we are saying right now that we are complying with Chicago’s rules, which mean there is no mandatory indoor masking,” she continued. “We are recommending masking because this is a group of physicians who treat immunocompromised patients. So we are recommending that.”
This stance has gotten some push-back on Twitter from both physicians and patient advocates, with some surprised that masking is not mandatory.
“I know that ‘mask-optional’ meetings mean most will omit masks; I literally just saw this at my last meeting as one of the few masked MDs,” commented radiation oncologist Fumiko Ladd Chino, MD. She appealed to the organizers with a plea: “There’s still time to change #ASCO22 policies. We’re in it for patient health.”
Patient advocate Manju George, MVSc, PhD, a rectal cancer survivor, was also campaigning for a change in policy by setting up a letter that others could sign, adding that “ASCO leadership is being flooded with pleads from concerned HCPs.”
When asked whether it was considering a change in mask policy, ASCO replied: “As far as health and safety go, the protocols we’ve put in place meet or exceed current [World Health Organization, [Centers for Disease Control and Prevention, and city of Chicago guidelines. ASCO is also closely coordinating with both the city and the convention center and we are actively monitoring local conditions.”
“To protect the health and safety of all meeting attendees, our protocols require attendees to be fully vaccinated and self-test negative for COVID-19 within 48 hours prior to their arrival at the meeting. In addition, we expect all attendees to be masked when indoors and are encouraging regular self-testing. We fully expect members of our community to do their part to help keep everyone safe, and we’re making it easy for attendees to comply with our policies by providing medical-grade masks as well as both rapid antigen and [polymerase chain reaction] COVID-19 tests,” the organization said.
There will also be a notification system so attendees can select how they identify for closeness, with red meaning stand back, no hugs, no handshakes; yellow signifying something more intermediate; and green signaling the person is okay with contact with a handshake or a hug. This system has already been used during smaller ASCO subspecialty meetings earlier this year, and feedback from delegates was positive, Dr. Gralow commented.
Advancing equitable care
The theme of the 2022 meeting, chosen by ASCO President Everett Vokes, MD, is advancing equitable cancer care through innovation.
It builds on the theme of equity from 2021, chosen by previous president Lori Pierce, MD, which was “Equity: Every Patient. Every Day. Everywhere.”
Some of this relates to disparities in equity, commented Dr. Gralow. This is the focus of a premeeting press briefing on May 26 that will highlight a few abstracts that focus on disparities and what can be done to address them. One study (abstract 6511) focuses on telemedicine, which was increasingly used during the pandemic, but the results show not all U.S. patient populations could access the specialty care they needed in this way.
De-escalation of therapy
De-escalation of therapy is another theme running through the meeting.
“There are some cancers where we have achieved such good outcomes that it is time to look at de-escalating therapy because we know that we are probably way overtreating a component of those patients. ... So we are looking at whether we can find subpopulations where we can back off on therapy,” commented Dr. Gralow.
One example is the LUMINA trial in breast cancer (abstract LBA501), which looked at omitting radiotherapy after surgery. “In standard practice we have already been doing this, not based on solid data, but based on an accumulation of retrospective analyses and similar evidence,” commented Dr. Gralow. This trial tested the approach prospectively, lowered the age range of patients, and better defined which patients were likely to benefit.
Another example is the DYNAMIC trial in colorectal cancer (abstract LBA-100), which looks at omitting chemotherapy based on levels of circulating tumor DNA after surgery. These patients had stage 2 disease and generally do very well with surgery and adjuvant chemotherapy, Dr. Gralow stated. This trial aims to find the subset of patients who could do just as well without the chemotherapy; it may also identify those patients at the other end of the scale, who perhaps need a bit more treatment, she added.
Spotlight on innovation
The focus on innovation includes exploring drugs developed outside the United States. One example is nimotuzumab, which is already approved in China for use in nasopharyngeal cancer but is also being explored in other cancer types. At ASCO, data will be presented in patients with KRAS wild-type pancreatic cancer (abstract 4011). This study, like the other trials with nimotuzumab, was conducted in China.
This brings up an important point about the data the Food and Drug Administration requires for new drug approvals, commented Dr. Gralow.
She noted that the FDA recently rejected an application for sintilimab, a drug also developed in China, on the basis that all trial data submitted for approval were from China. The agency said it would like to see multiregional clinical trials and trials that reflect the U.S. cancer population.
Advice for attendees
A large trial in a rare cancer promises to establish a new standard of care, where previously a number of different regimens have been used in various parts of the world, and even at different hospitals within the same country. These are the results from an international trial in children and adolescents/young adults with Ewing’s sarcoma (abstract LBA-02). “I have been told by experts in the field that these results will change practice ... [and] will have a global impact,” commented Dr. Gralow.
In addition to the scientific sessions that will see new data, there are a number of educational sessions that will tackle tricky issues that clinicians sometimes face. “Microaggressions, Bias, and Equity in the Workplace” will be discussed in one session, while another promises, “Strategies to Address Moral Distress in Clinicians: What Should We Do When We Don’t Know What to Do?”
There is also a special session featuring the “Cancer Groundshot: Addressing the Global and National Inequities in Cancer Care.” This is a move spearheaded by Bishal Gyawali, MD, PhD, from Brigham and Women’s Hospital, Boston, who was reacting to the lofty goals of the presidential Cancer Moonshot, including the aim of “ending cancer as we know it.” In a blog post in 2016 he suggested “forget the moon; let’s get back to blood and flesh reality on the ground ... [and] research that can be immediately applied to every global community.” He recounts the journey from ‘Blog Post to ASCO Session’ in a recent commentary.
Dr. Gyawali also has some advice for those attending the ASCO annual meeting: Reach out to people you respect, trust that connections will happen, scrutinize the data, listen critically for jargon, and perhaps most importantly, have fun.
“There’s more to life than your job,” he wrote. “Don’t stress. Think about the bigger picture. Think about your patients. And remember, life is beautiful, even when it feels like it isn’t.”
A version of this article first appeared on Medscape.com.
And it appears many are eager to attend the American Society of Clinical Oncology annual meeting in person now that they can.
By early May, ASCO already had 30,000 registrations, of which 80% were in person – there were 27,000 hotel reservations.
“That’s almost identical to where we were in terms of numbers in 2019 at the same point in time,” Julie Gralow, MD, chief medical officer at ASCO, said in an interview.
These figures, which are from May 11, are likely to increase. In past years, there has been an upswing in registrations right before the meeting starts.
The annual meeting begins on Friday, June 3, and runs until Tuesday, June 7. It will be held in Chicago, yet again, in the vast McCormick Place, sections of which were transformed into field hospital wards when the pandemic hit in 2020.
But the meeting will also continue to be transmitted virtually, as it has been for the past 2 years, for those not attending in person.
“I do think that the hybrid model will move forward,” Dr. Gralow said. “We can get a lot of attendees, especially from very distant places, who can’t travel, or can’t easily travel, and we have learned how to make that experience better for them as well.”
Attendees can also change their minds if, for example, rising numbers of COVID cases as the meeting nears put them off traveling. “We are allowing people to change to virtual. So I think there may be a little bit of that, depending on what happens to COVID in different parts of the world,” Dr. Gralow commented.
For those who do attend, the organization is “doing the best that we can to keep people safe,” said Dr. Gralow, who was previously a professor of global health and is now a breast medical oncologist and clinical trialist.
To attend in person, ASCO is mandating proof of vaccination (which in the United States means two doses of the COVID vaccine). “If you prove in advance that you are vaccinated, we will send you your badge, so you don’t have to stand in line,” she added.
“As far as masks go, we are saying right now that we are complying with Chicago’s rules, which mean there is no mandatory indoor masking,” she continued. “We are recommending masking because this is a group of physicians who treat immunocompromised patients. So we are recommending that.”
This stance has gotten some push-back on Twitter from both physicians and patient advocates, with some surprised that masking is not mandatory.
“I know that ‘mask-optional’ meetings mean most will omit masks; I literally just saw this at my last meeting as one of the few masked MDs,” commented radiation oncologist Fumiko Ladd Chino, MD. She appealed to the organizers with a plea: “There’s still time to change #ASCO22 policies. We’re in it for patient health.”
Patient advocate Manju George, MVSc, PhD, a rectal cancer survivor, was also campaigning for a change in policy by setting up a letter that others could sign, adding that “ASCO leadership is being flooded with pleads from concerned HCPs.”
When asked whether it was considering a change in mask policy, ASCO replied: “As far as health and safety go, the protocols we’ve put in place meet or exceed current [World Health Organization, [Centers for Disease Control and Prevention, and city of Chicago guidelines. ASCO is also closely coordinating with both the city and the convention center and we are actively monitoring local conditions.”
“To protect the health and safety of all meeting attendees, our protocols require attendees to be fully vaccinated and self-test negative for COVID-19 within 48 hours prior to their arrival at the meeting. In addition, we expect all attendees to be masked when indoors and are encouraging regular self-testing. We fully expect members of our community to do their part to help keep everyone safe, and we’re making it easy for attendees to comply with our policies by providing medical-grade masks as well as both rapid antigen and [polymerase chain reaction] COVID-19 tests,” the organization said.
There will also be a notification system so attendees can select how they identify for closeness, with red meaning stand back, no hugs, no handshakes; yellow signifying something more intermediate; and green signaling the person is okay with contact with a handshake or a hug. This system has already been used during smaller ASCO subspecialty meetings earlier this year, and feedback from delegates was positive, Dr. Gralow commented.
Advancing equitable care
The theme of the 2022 meeting, chosen by ASCO President Everett Vokes, MD, is advancing equitable cancer care through innovation.
It builds on the theme of equity from 2021, chosen by previous president Lori Pierce, MD, which was “Equity: Every Patient. Every Day. Everywhere.”
Some of this relates to disparities in equity, commented Dr. Gralow. This is the focus of a premeeting press briefing on May 26 that will highlight a few abstracts that focus on disparities and what can be done to address them. One study (abstract 6511) focuses on telemedicine, which was increasingly used during the pandemic, but the results show not all U.S. patient populations could access the specialty care they needed in this way.
De-escalation of therapy
De-escalation of therapy is another theme running through the meeting.
“There are some cancers where we have achieved such good outcomes that it is time to look at de-escalating therapy because we know that we are probably way overtreating a component of those patients. ... So we are looking at whether we can find subpopulations where we can back off on therapy,” commented Dr. Gralow.
One example is the LUMINA trial in breast cancer (abstract LBA501), which looked at omitting radiotherapy after surgery. “In standard practice we have already been doing this, not based on solid data, but based on an accumulation of retrospective analyses and similar evidence,” commented Dr. Gralow. This trial tested the approach prospectively, lowered the age range of patients, and better defined which patients were likely to benefit.
Another example is the DYNAMIC trial in colorectal cancer (abstract LBA-100), which looks at omitting chemotherapy based on levels of circulating tumor DNA after surgery. These patients had stage 2 disease and generally do very well with surgery and adjuvant chemotherapy, Dr. Gralow stated. This trial aims to find the subset of patients who could do just as well without the chemotherapy; it may also identify those patients at the other end of the scale, who perhaps need a bit more treatment, she added.
Spotlight on innovation
The focus on innovation includes exploring drugs developed outside the United States. One example is nimotuzumab, which is already approved in China for use in nasopharyngeal cancer but is also being explored in other cancer types. At ASCO, data will be presented in patients with KRAS wild-type pancreatic cancer (abstract 4011). This study, like the other trials with nimotuzumab, was conducted in China.
This brings up an important point about the data the Food and Drug Administration requires for new drug approvals, commented Dr. Gralow.
She noted that the FDA recently rejected an application for sintilimab, a drug also developed in China, on the basis that all trial data submitted for approval were from China. The agency said it would like to see multiregional clinical trials and trials that reflect the U.S. cancer population.
Advice for attendees
A large trial in a rare cancer promises to establish a new standard of care, where previously a number of different regimens have been used in various parts of the world, and even at different hospitals within the same country. These are the results from an international trial in children and adolescents/young adults with Ewing’s sarcoma (abstract LBA-02). “I have been told by experts in the field that these results will change practice ... [and] will have a global impact,” commented Dr. Gralow.
In addition to the scientific sessions that will see new data, there are a number of educational sessions that will tackle tricky issues that clinicians sometimes face. “Microaggressions, Bias, and Equity in the Workplace” will be discussed in one session, while another promises, “Strategies to Address Moral Distress in Clinicians: What Should We Do When We Don’t Know What to Do?”
There is also a special session featuring the “Cancer Groundshot: Addressing the Global and National Inequities in Cancer Care.” This is a move spearheaded by Bishal Gyawali, MD, PhD, from Brigham and Women’s Hospital, Boston, who was reacting to the lofty goals of the presidential Cancer Moonshot, including the aim of “ending cancer as we know it.” In a blog post in 2016 he suggested “forget the moon; let’s get back to blood and flesh reality on the ground ... [and] research that can be immediately applied to every global community.” He recounts the journey from ‘Blog Post to ASCO Session’ in a recent commentary.
Dr. Gyawali also has some advice for those attending the ASCO annual meeting: Reach out to people you respect, trust that connections will happen, scrutinize the data, listen critically for jargon, and perhaps most importantly, have fun.
“There’s more to life than your job,” he wrote. “Don’t stress. Think about the bigger picture. Think about your patients. And remember, life is beautiful, even when it feels like it isn’t.”
A version of this article first appeared on Medscape.com.
Telemedicine in cancer care: Not all patients can access
CHICAGO – for patients with cancer, but uptake of telemedicine was plagued by inequities, a retrospective study suggests.
Before March 2020, only a very small percentage of patients with cancer used telemedicine services.
By November 2021, nearly 16% of patients initiating cancer treatment were using this approach.
However, certain groups were less likely to use telemedicine, in particular, patients who were Black, uninsured, did not live in cities, and were less affluent, noted lead author Jenny S. Guadamuz, PhD, a quantitative scientist at Flatiron Health and a postdoctoral research associate at the University of Southern California, Los Angeles.
The results are concerning because they suggest that telemedicine expansion could widen cancer care disparities, Dr. Guadamuz said. Previous studies found racial disparities in care access and outcomes early on in the pandemic.
“These findings are critically important considering recent efforts to make coverage of telemedicine services permanent, instead of tied to the [Health and Human Services] public health emergency declaration,” she said. “There are also efforts to increase reimbursement rates for telemedicine services by Medicare, several Medicaid programs, and private insurers.”
This study was highlighted at a press briefing held in advance of the American Society of Clinical Oncology annual meeting, where it will be presented at a poster session (abstract 6511).
ASCO President Everett E. Vokes, MD, said telemedicine is “an important tool to communicate with patients” but that it is important to consider the “digital divide.”
He also emphasized the need “to expand and learn to use telehealth not in a crisis but as part of our regular care moving forward.” In July 2021, as telemedicine services were expanding, ASCO released practice recommendations specific to telehealth and oncology.
“Telemedicine can improve access to timely cancer care, but, as this study points out, telemedicine must be available equitably, so that every patient can access the care they need and deserve,” he said in a press statement.
Study details
For the study, Dr. Guadamuz and colleagues assessed telemedicine uptake by nearly 27,000 patients in a Flatiron electronic health record–derived deidentified database of patients who initiated treatment for any of 21 common cancers at about 280 community oncology clinics between March 2020 and November 2021.
They found that Black patients were significantly less likely than were White patients to use telemedicine (13.2% vs. 15.6%; odds ratio [OR], 0.82), as were patients without documented insurance, compared with those who were well insured (11.6% vs. 16.4%; OR, 0.68).
Those in rural and suburban areas were less likely than were those in urban areas to use telemedicine (9.7% and 13.0% vs. 17.7%; ORs, 0.50 and 0.69, respectively), and those in less affluent vs. more affluent areas were also less likely to use telemedicine (10.6% vs. 23.6%, OR, 0.39).
Dr. Guadamuz noted that the differences remained statistically significant after adjustment for clinical characteristics and that racial inequities were seen across cancer types and over time.
Future work should assess other potential characteristics associated with telemedicine inequities, evaluate whether health care delivered via telemedicine is of similar quality as in-person services, and determine the types of practice that are providing telemedicine more equitably to their patients, she concluded.
A version of this article first appeared on Medscape.com.
CHICAGO – for patients with cancer, but uptake of telemedicine was plagued by inequities, a retrospective study suggests.
Before March 2020, only a very small percentage of patients with cancer used telemedicine services.
By November 2021, nearly 16% of patients initiating cancer treatment were using this approach.
However, certain groups were less likely to use telemedicine, in particular, patients who were Black, uninsured, did not live in cities, and were less affluent, noted lead author Jenny S. Guadamuz, PhD, a quantitative scientist at Flatiron Health and a postdoctoral research associate at the University of Southern California, Los Angeles.
The results are concerning because they suggest that telemedicine expansion could widen cancer care disparities, Dr. Guadamuz said. Previous studies found racial disparities in care access and outcomes early on in the pandemic.
“These findings are critically important considering recent efforts to make coverage of telemedicine services permanent, instead of tied to the [Health and Human Services] public health emergency declaration,” she said. “There are also efforts to increase reimbursement rates for telemedicine services by Medicare, several Medicaid programs, and private insurers.”
This study was highlighted at a press briefing held in advance of the American Society of Clinical Oncology annual meeting, where it will be presented at a poster session (abstract 6511).
ASCO President Everett E. Vokes, MD, said telemedicine is “an important tool to communicate with patients” but that it is important to consider the “digital divide.”
He also emphasized the need “to expand and learn to use telehealth not in a crisis but as part of our regular care moving forward.” In July 2021, as telemedicine services were expanding, ASCO released practice recommendations specific to telehealth and oncology.
“Telemedicine can improve access to timely cancer care, but, as this study points out, telemedicine must be available equitably, so that every patient can access the care they need and deserve,” he said in a press statement.
Study details
For the study, Dr. Guadamuz and colleagues assessed telemedicine uptake by nearly 27,000 patients in a Flatiron electronic health record–derived deidentified database of patients who initiated treatment for any of 21 common cancers at about 280 community oncology clinics between March 2020 and November 2021.
They found that Black patients were significantly less likely than were White patients to use telemedicine (13.2% vs. 15.6%; odds ratio [OR], 0.82), as were patients without documented insurance, compared with those who were well insured (11.6% vs. 16.4%; OR, 0.68).
Those in rural and suburban areas were less likely than were those in urban areas to use telemedicine (9.7% and 13.0% vs. 17.7%; ORs, 0.50 and 0.69, respectively), and those in less affluent vs. more affluent areas were also less likely to use telemedicine (10.6% vs. 23.6%, OR, 0.39).
Dr. Guadamuz noted that the differences remained statistically significant after adjustment for clinical characteristics and that racial inequities were seen across cancer types and over time.
Future work should assess other potential characteristics associated with telemedicine inequities, evaluate whether health care delivered via telemedicine is of similar quality as in-person services, and determine the types of practice that are providing telemedicine more equitably to their patients, she concluded.
A version of this article first appeared on Medscape.com.
CHICAGO – for patients with cancer, but uptake of telemedicine was plagued by inequities, a retrospective study suggests.
Before March 2020, only a very small percentage of patients with cancer used telemedicine services.
By November 2021, nearly 16% of patients initiating cancer treatment were using this approach.
However, certain groups were less likely to use telemedicine, in particular, patients who were Black, uninsured, did not live in cities, and were less affluent, noted lead author Jenny S. Guadamuz, PhD, a quantitative scientist at Flatiron Health and a postdoctoral research associate at the University of Southern California, Los Angeles.
The results are concerning because they suggest that telemedicine expansion could widen cancer care disparities, Dr. Guadamuz said. Previous studies found racial disparities in care access and outcomes early on in the pandemic.
“These findings are critically important considering recent efforts to make coverage of telemedicine services permanent, instead of tied to the [Health and Human Services] public health emergency declaration,” she said. “There are also efforts to increase reimbursement rates for telemedicine services by Medicare, several Medicaid programs, and private insurers.”
This study was highlighted at a press briefing held in advance of the American Society of Clinical Oncology annual meeting, where it will be presented at a poster session (abstract 6511).
ASCO President Everett E. Vokes, MD, said telemedicine is “an important tool to communicate with patients” but that it is important to consider the “digital divide.”
He also emphasized the need “to expand and learn to use telehealth not in a crisis but as part of our regular care moving forward.” In July 2021, as telemedicine services were expanding, ASCO released practice recommendations specific to telehealth and oncology.
“Telemedicine can improve access to timely cancer care, but, as this study points out, telemedicine must be available equitably, so that every patient can access the care they need and deserve,” he said in a press statement.
Study details
For the study, Dr. Guadamuz and colleagues assessed telemedicine uptake by nearly 27,000 patients in a Flatiron electronic health record–derived deidentified database of patients who initiated treatment for any of 21 common cancers at about 280 community oncology clinics between March 2020 and November 2021.
They found that Black patients were significantly less likely than were White patients to use telemedicine (13.2% vs. 15.6%; odds ratio [OR], 0.82), as were patients without documented insurance, compared with those who were well insured (11.6% vs. 16.4%; OR, 0.68).
Those in rural and suburban areas were less likely than were those in urban areas to use telemedicine (9.7% and 13.0% vs. 17.7%; ORs, 0.50 and 0.69, respectively), and those in less affluent vs. more affluent areas were also less likely to use telemedicine (10.6% vs. 23.6%, OR, 0.39).
Dr. Guadamuz noted that the differences remained statistically significant after adjustment for clinical characteristics and that racial inequities were seen across cancer types and over time.
Future work should assess other potential characteristics associated with telemedicine inequities, evaluate whether health care delivered via telemedicine is of similar quality as in-person services, and determine the types of practice that are providing telemedicine more equitably to their patients, she concluded.
A version of this article first appeared on Medscape.com.
AT ASCO 2022
Increased social services spending ups cancer survival of Blacks
Five-year overall survival increased among non-Hispanic Black patients by 2.02% in conjunction with a 10% increase in spending. In addition, there was a decrease in racial disparities in survival between non-Hispanic Black patients and White patients for many types of cancers.
However, public welfare spending had no real impact on the overall 5-year survival for the entire cohort (0.25 % per 10% increase in spending; P = .78) or for non-Hispanic White patients (0.52% per 10% increase in spending, P = .58).
“We know from prior research that outcomes are worse for minorities,” said lead author Justin Michael Barnes, MD, from the department of radiation oncology at Washington University in St. Louis, Mo. “It’s thought that some of the differences are related to impaired access to health care for minorities, which is related to social determinants of health. This includes socioeconomic factors, educational attainment, place of residence, as well as environmental stressors.
“Our data show that greater state welfare expenditures were associated with greater 5-year survival among Black patients and decreased Black–White disparities,” said Dr. Barnes. “I think these data are thought provoking, but they certainly aren’t the end. I see these data as a proof-of-concept project.”
Dr. Barnes reported the findings at a press conference held in advance of the annual meeting of the American Society of Clinical Oncology, during which the study will be presented (Abstract 6509).
Improved 5-year survival in Black patients
For the study, Dr. Barnes and colleagues evaluated the association of 5-year overall survival and public welfare spending in 2,925,550 individuals aged 18 years and older who were diagnosed with cancer during the period 2007-2016. The cohort was drawn from the Surveillance, Epidemiology, and End Results Program. In addition, annual state spending data were obtained from the U.S. Census Bureau. The team examined survival outcomes by race and ethnicity as well as by cancer site. The investigators accounted for factors such as age, sex, metropolitan residence, state, county-level income and education, insurance status, cancer site, stage at diagnosis, and year of diagnosis.
Much of public welfare spending was related to Medicaid but also included programs that provide subsidy assistance for individuals, such as Supplemental Security Income.
As compared with White patients, the 5-year overall survival rate was 10.8% lower among non-Hispanic Black patients. But there was a 4.46% (P for interaction <.001) narrowing of the 5-year overall survival disparity in non-Hispanic Black patients in comparison with White patients per 10% increase in spending, or a 42% closure of the 10.8% disparity.
Regarding specific cancer types, increased public welfare spending was associated with a narrowing of the 5-year overall survival disparity between Black patients and non-Hispanic White patients for the following cancers: breast (a 6.15% survival increase for Black patients led to a 39% closing of the disparity), cervix (a 11.9% survival increase led to a 46% closing of the disparity), colorectum (a 4.42% survival increase led to a 48% closing of the disparity), head and neck (a 9.41% survival increase led to a 38% closing of the disparity), liver (a 7.02% survival increase led to a 49% closing of the disparity), ovary (an 8.95% survival increase led to a 41% closing of the disparity), bladder (an 8.18% survival increase led to a 44% closing of the disparity), and uterus (a 14.1% survival increase led to a 40% closing of the disparity).
“Some type of public welfare seems to be helping improve oncologic outcomes for some of our most socioeconomically at-risk patients, but we don’t know the specifics,” Dr. Barnes concluded. “Additional work is needed to identify the most influential public health expenditures. If we can do this, we can more rigorously evaluate state-level policies and their association with cancer outcomes.”
Public welfare improves outcomes
Weighing in on the data, Sarah P. Cate, MD, director, Special Surveillance and Breast Program, Mount Sinai Health System, New York, noted that racial disparities have been identified in many areas of health care and with respect to many diseases. “In the world of oncology, time to diagnosis and treatment significantly impacts overall survival,” she told this news organization. “Many studies are currently underway to investigate why certain ethnic groups have worse cancer outcomes.”
This study is important, she noted, in that it “highlights a discrete source of correcting these disparities in a large group of patients. Obviously there are multiple barriers to care, but increased public welfare spending in oncology should decrease some of these disparities.”
Julie R. Gralow, MD, ASCO’s chief medical officer and executive vice president, commented that it is known that state public welfare spending can mitigate structural racism and at least partially address social determinants of health, such as financial stability, education, place of residence, and insurance status. “This research found that states that increased their public health spending improved overall survival in Black patients with a variety of solid tumors and also resulted in a decrease in racial disparities in survival,” she said. “This important data provides clear support for the benefits of investment in public welfare spending at the state level, including Medicaid expansion.”
The study did not receive funding. Dr. Barnes and Dr. Cate have disclosed no relevant financial relationships. Dr. Gralow has relationships with Genentech, AstraZeneca Hexal, Puma BioTechnology, Roche, Novartis, Seagen, and Genomic Health.
A version of this article first appeared on Medscape.com.
Five-year overall survival increased among non-Hispanic Black patients by 2.02% in conjunction with a 10% increase in spending. In addition, there was a decrease in racial disparities in survival between non-Hispanic Black patients and White patients for many types of cancers.
However, public welfare spending had no real impact on the overall 5-year survival for the entire cohort (0.25 % per 10% increase in spending; P = .78) or for non-Hispanic White patients (0.52% per 10% increase in spending, P = .58).
“We know from prior research that outcomes are worse for minorities,” said lead author Justin Michael Barnes, MD, from the department of radiation oncology at Washington University in St. Louis, Mo. “It’s thought that some of the differences are related to impaired access to health care for minorities, which is related to social determinants of health. This includes socioeconomic factors, educational attainment, place of residence, as well as environmental stressors.
“Our data show that greater state welfare expenditures were associated with greater 5-year survival among Black patients and decreased Black–White disparities,” said Dr. Barnes. “I think these data are thought provoking, but they certainly aren’t the end. I see these data as a proof-of-concept project.”
Dr. Barnes reported the findings at a press conference held in advance of the annual meeting of the American Society of Clinical Oncology, during which the study will be presented (Abstract 6509).
Improved 5-year survival in Black patients
For the study, Dr. Barnes and colleagues evaluated the association of 5-year overall survival and public welfare spending in 2,925,550 individuals aged 18 years and older who were diagnosed with cancer during the period 2007-2016. The cohort was drawn from the Surveillance, Epidemiology, and End Results Program. In addition, annual state spending data were obtained from the U.S. Census Bureau. The team examined survival outcomes by race and ethnicity as well as by cancer site. The investigators accounted for factors such as age, sex, metropolitan residence, state, county-level income and education, insurance status, cancer site, stage at diagnosis, and year of diagnosis.
Much of public welfare spending was related to Medicaid but also included programs that provide subsidy assistance for individuals, such as Supplemental Security Income.
As compared with White patients, the 5-year overall survival rate was 10.8% lower among non-Hispanic Black patients. But there was a 4.46% (P for interaction <.001) narrowing of the 5-year overall survival disparity in non-Hispanic Black patients in comparison with White patients per 10% increase in spending, or a 42% closure of the 10.8% disparity.
Regarding specific cancer types, increased public welfare spending was associated with a narrowing of the 5-year overall survival disparity between Black patients and non-Hispanic White patients for the following cancers: breast (a 6.15% survival increase for Black patients led to a 39% closing of the disparity), cervix (a 11.9% survival increase led to a 46% closing of the disparity), colorectum (a 4.42% survival increase led to a 48% closing of the disparity), head and neck (a 9.41% survival increase led to a 38% closing of the disparity), liver (a 7.02% survival increase led to a 49% closing of the disparity), ovary (an 8.95% survival increase led to a 41% closing of the disparity), bladder (an 8.18% survival increase led to a 44% closing of the disparity), and uterus (a 14.1% survival increase led to a 40% closing of the disparity).
“Some type of public welfare seems to be helping improve oncologic outcomes for some of our most socioeconomically at-risk patients, but we don’t know the specifics,” Dr. Barnes concluded. “Additional work is needed to identify the most influential public health expenditures. If we can do this, we can more rigorously evaluate state-level policies and their association with cancer outcomes.”
Public welfare improves outcomes
Weighing in on the data, Sarah P. Cate, MD, director, Special Surveillance and Breast Program, Mount Sinai Health System, New York, noted that racial disparities have been identified in many areas of health care and with respect to many diseases. “In the world of oncology, time to diagnosis and treatment significantly impacts overall survival,” she told this news organization. “Many studies are currently underway to investigate why certain ethnic groups have worse cancer outcomes.”
This study is important, she noted, in that it “highlights a discrete source of correcting these disparities in a large group of patients. Obviously there are multiple barriers to care, but increased public welfare spending in oncology should decrease some of these disparities.”
Julie R. Gralow, MD, ASCO’s chief medical officer and executive vice president, commented that it is known that state public welfare spending can mitigate structural racism and at least partially address social determinants of health, such as financial stability, education, place of residence, and insurance status. “This research found that states that increased their public health spending improved overall survival in Black patients with a variety of solid tumors and also resulted in a decrease in racial disparities in survival,” she said. “This important data provides clear support for the benefits of investment in public welfare spending at the state level, including Medicaid expansion.”
The study did not receive funding. Dr. Barnes and Dr. Cate have disclosed no relevant financial relationships. Dr. Gralow has relationships with Genentech, AstraZeneca Hexal, Puma BioTechnology, Roche, Novartis, Seagen, and Genomic Health.
A version of this article first appeared on Medscape.com.
Five-year overall survival increased among non-Hispanic Black patients by 2.02% in conjunction with a 10% increase in spending. In addition, there was a decrease in racial disparities in survival between non-Hispanic Black patients and White patients for many types of cancers.
However, public welfare spending had no real impact on the overall 5-year survival for the entire cohort (0.25 % per 10% increase in spending; P = .78) or for non-Hispanic White patients (0.52% per 10% increase in spending, P = .58).
“We know from prior research that outcomes are worse for minorities,” said lead author Justin Michael Barnes, MD, from the department of radiation oncology at Washington University in St. Louis, Mo. “It’s thought that some of the differences are related to impaired access to health care for minorities, which is related to social determinants of health. This includes socioeconomic factors, educational attainment, place of residence, as well as environmental stressors.
“Our data show that greater state welfare expenditures were associated with greater 5-year survival among Black patients and decreased Black–White disparities,” said Dr. Barnes. “I think these data are thought provoking, but they certainly aren’t the end. I see these data as a proof-of-concept project.”
Dr. Barnes reported the findings at a press conference held in advance of the annual meeting of the American Society of Clinical Oncology, during which the study will be presented (Abstract 6509).
Improved 5-year survival in Black patients
For the study, Dr. Barnes and colleagues evaluated the association of 5-year overall survival and public welfare spending in 2,925,550 individuals aged 18 years and older who were diagnosed with cancer during the period 2007-2016. The cohort was drawn from the Surveillance, Epidemiology, and End Results Program. In addition, annual state spending data were obtained from the U.S. Census Bureau. The team examined survival outcomes by race and ethnicity as well as by cancer site. The investigators accounted for factors such as age, sex, metropolitan residence, state, county-level income and education, insurance status, cancer site, stage at diagnosis, and year of diagnosis.
Much of public welfare spending was related to Medicaid but also included programs that provide subsidy assistance for individuals, such as Supplemental Security Income.
As compared with White patients, the 5-year overall survival rate was 10.8% lower among non-Hispanic Black patients. But there was a 4.46% (P for interaction <.001) narrowing of the 5-year overall survival disparity in non-Hispanic Black patients in comparison with White patients per 10% increase in spending, or a 42% closure of the 10.8% disparity.
Regarding specific cancer types, increased public welfare spending was associated with a narrowing of the 5-year overall survival disparity between Black patients and non-Hispanic White patients for the following cancers: breast (a 6.15% survival increase for Black patients led to a 39% closing of the disparity), cervix (a 11.9% survival increase led to a 46% closing of the disparity), colorectum (a 4.42% survival increase led to a 48% closing of the disparity), head and neck (a 9.41% survival increase led to a 38% closing of the disparity), liver (a 7.02% survival increase led to a 49% closing of the disparity), ovary (an 8.95% survival increase led to a 41% closing of the disparity), bladder (an 8.18% survival increase led to a 44% closing of the disparity), and uterus (a 14.1% survival increase led to a 40% closing of the disparity).
“Some type of public welfare seems to be helping improve oncologic outcomes for some of our most socioeconomically at-risk patients, but we don’t know the specifics,” Dr. Barnes concluded. “Additional work is needed to identify the most influential public health expenditures. If we can do this, we can more rigorously evaluate state-level policies and their association with cancer outcomes.”
Public welfare improves outcomes
Weighing in on the data, Sarah P. Cate, MD, director, Special Surveillance and Breast Program, Mount Sinai Health System, New York, noted that racial disparities have been identified in many areas of health care and with respect to many diseases. “In the world of oncology, time to diagnosis and treatment significantly impacts overall survival,” she told this news organization. “Many studies are currently underway to investigate why certain ethnic groups have worse cancer outcomes.”
This study is important, she noted, in that it “highlights a discrete source of correcting these disparities in a large group of patients. Obviously there are multiple barriers to care, but increased public welfare spending in oncology should decrease some of these disparities.”
Julie R. Gralow, MD, ASCO’s chief medical officer and executive vice president, commented that it is known that state public welfare spending can mitigate structural racism and at least partially address social determinants of health, such as financial stability, education, place of residence, and insurance status. “This research found that states that increased their public health spending improved overall survival in Black patients with a variety of solid tumors and also resulted in a decrease in racial disparities in survival,” she said. “This important data provides clear support for the benefits of investment in public welfare spending at the state level, including Medicaid expansion.”
The study did not receive funding. Dr. Barnes and Dr. Cate have disclosed no relevant financial relationships. Dr. Gralow has relationships with Genentech, AstraZeneca Hexal, Puma BioTechnology, Roche, Novartis, Seagen, and Genomic Health.
A version of this article first appeared on Medscape.com.
FROM ASCO 2022
Surgeons, who see it up close, offer ways to stop gun violence
Their strategies can work regardless of where you stand on the Second Amendment of the Constitution, said Patricia Turner, MD. “Our proposals are embraced by both gun owners and non–gun owners alike, and we are unique in that regard.”
These “implementable solutions” could prevent the next massacre, Dr. Turner, executive director of the American College of Surgeons, said during a news briefing the group sponsored on June 2.
“Our future – indeed all of our futures – depend on our ability to find durable, actionable steps that we can implement tomorrow to save lives,” she said.
Firsthand perspective
“Sadly I’m here today as a trauma surgeon who has cared for two of the largest mass shootings in modern U.S. history,” said Ronald Stewart, MD, chair of the department of surgery at University Hospital in San Antonio, Texas.
Dr. Stewart treated victims of the 2017 Sutherland Springs First Baptist Church shooting – where 27 people died, including the shooter – and the recent Uvalde school shooting, both in Texas.
“The injuries inflicted by high-velocity weapons used at both of these attacks are horrific. A high-capacity, magazine-fed automatic rifle such as the AR-15 causes extremely destructive tissue wounds,” he said.
One of the group’s proposals is to increase the regulation of high-velocity weapons, including AR-15s.
“These wounds are horribly lethal at close range, and sadly, most victims do not survive long enough to make it to a trauma center,” Dr. Stewart said.
On a positive note, “all of our current [Uvalde] patients are improving, which really brings us joy in this dark time,” he said. “But all of them have a long road to deal with recovery with both the physical and emotional impact of their injuries.”
Jeffrey Kerby, MD, agreed.
“Trauma surgeons see the short-term physical effects of these injuries and watch patients struggle with the long-term impact of these wounds,” said Dr. Kerby, director of trauma and acute care surgery at the University of Alabama at Birmingham.
Surgeons feel ‘profound impact’ of shootings
“Firearm violence has a profound impact on surgeons, and we are the undisputed subject matter experts in treating the tragic results,” said Patrick Bailey, MD, medical director for advocacy at the American College of Surgeons.
“This impacts surgeons as well,” said Dr. Kerby, chair of the Committee on Trauma for the surgeons’ group. “We are human, and we can’t help but share in the grief, the pain, and the suffering that our patients endure.
“As a pediatric surgeon ... I have too often witnessed the impact of firearm violence, and obviously, the devastation extends beyond the victims to their families,” he said. “To put it succinctly, in our culture, parents are not supposed to be put in a position of burying their children.”
A public health crisis
“It’s important to recognize that we’ve been talking about a public health approach,” said Eileen Bulger, MD, acting chief of the trauma division at the University of Washington in Seattle. That strategy is important for engaging both firearm owners and communities that have a higher risk for firearm violence, she said.
A committee of the American College of Surgeons developed specific recommendations in 2018, which are still valid today. The group brought together surgeons from across the U.S. including “passionate firearm owners and experts in firearm safety,” Dr. Bulger said.
The committee, for example, agreed on 10 specific recommendations “that we believe are bipartisan and could have an immediate impact in saving lives.”
“I’m a lifelong gun owner,” Dr. Bailey said, emphasizing that the team’s process included participation and perspective from other surgeons “who, like me, are also gun owners, but gun owners who also seek to reduce the impact of firearm violence in our country.”
The recommendations address these areas:
- Gun ownership
- Firearm registration
- Licensure
- Education and training
- Ownership responsibilities
- Mandatory reporting and risk reduction
- Safety innovation and technology
- Research
- The culture of violence
- Social isolation and mental health
For example, “we currently have certain classes of weapons with significant offensive capability,” Dr. Bulger said, “that are appropriately restricted and regulated under the National Firearms Act as Class 3 weapons.”
This group includes fully automatic machine guns, explosive devices, and short-barrel shotguns.
“We recommend a formal reassessment of the firearms designated within each of these national firearms classifications,” Dr. Bulger said.
For example, high-capacity, magazine-fed semiautomatic rifles, such as the AR-15, should be considered for reclassification as NFA Class 3 firearms, or they should get a new designation with tighter regulation.
The ACS endorses formal firearm safety training for all new gun owners. Also, owners who do not provide reasonably safe firearm storage should be held responsible for events related to the discharge of their firearms, Dr. Bulger said. And people who are deemed an imminent threat to themselves or others through firearm ownership should be temporarily or permanently restricted, with due process.
Research and reporting reforms
The ACS is also calling for research on firearm injuries and firearm injury prevention to be federally funded, Dr. Bulger said. The research should be done in a nonpartisan manner, she said.
“We have concerns that the manner and tone in which information is released to the public may lead to copycat mass killers,” she said. “The ACS recommends that law enforcement officials and the press take steps to eliminate the notoriety of the shooter, for example.”
Dr. Bulger also addressed the mental health angle. “We encourage recognition of mental health warning signs and social isolation by teachers, counselors, peers, and parents.” When identified, immediate referral to professionals is needed.
In addition to these recommendations, another team from the American College of Surgeons has published an overview of ways to address the inequities that contribute to violence. “We advocate for federal funding to support the development of hospital-based and community programs for violence intervention and prevention,” Dr. Bulger said.
Dr. Bailey said that as a gun owner himself, he thinks other gun owners would support these recommendations.
“I do not believe that the steps recommended ... pose undue burden on the rights of individual gun owners,” he said.
The time is now
Most firearm injuries are not from mass shooting events, Dr. Kerby said.
“My own trauma center has seen a 40% increase in the number of firearm injuries just in the last 2 years,” he added, “and these numbers continue to grow.”
A version of this article first appeared on WebMD.com.
Their strategies can work regardless of where you stand on the Second Amendment of the Constitution, said Patricia Turner, MD. “Our proposals are embraced by both gun owners and non–gun owners alike, and we are unique in that regard.”
These “implementable solutions” could prevent the next massacre, Dr. Turner, executive director of the American College of Surgeons, said during a news briefing the group sponsored on June 2.
“Our future – indeed all of our futures – depend on our ability to find durable, actionable steps that we can implement tomorrow to save lives,” she said.
Firsthand perspective
“Sadly I’m here today as a trauma surgeon who has cared for two of the largest mass shootings in modern U.S. history,” said Ronald Stewart, MD, chair of the department of surgery at University Hospital in San Antonio, Texas.
Dr. Stewart treated victims of the 2017 Sutherland Springs First Baptist Church shooting – where 27 people died, including the shooter – and the recent Uvalde school shooting, both in Texas.
“The injuries inflicted by high-velocity weapons used at both of these attacks are horrific. A high-capacity, magazine-fed automatic rifle such as the AR-15 causes extremely destructive tissue wounds,” he said.
One of the group’s proposals is to increase the regulation of high-velocity weapons, including AR-15s.
“These wounds are horribly lethal at close range, and sadly, most victims do not survive long enough to make it to a trauma center,” Dr. Stewart said.
On a positive note, “all of our current [Uvalde] patients are improving, which really brings us joy in this dark time,” he said. “But all of them have a long road to deal with recovery with both the physical and emotional impact of their injuries.”
Jeffrey Kerby, MD, agreed.
“Trauma surgeons see the short-term physical effects of these injuries and watch patients struggle with the long-term impact of these wounds,” said Dr. Kerby, director of trauma and acute care surgery at the University of Alabama at Birmingham.
Surgeons feel ‘profound impact’ of shootings
“Firearm violence has a profound impact on surgeons, and we are the undisputed subject matter experts in treating the tragic results,” said Patrick Bailey, MD, medical director for advocacy at the American College of Surgeons.
“This impacts surgeons as well,” said Dr. Kerby, chair of the Committee on Trauma for the surgeons’ group. “We are human, and we can’t help but share in the grief, the pain, and the suffering that our patients endure.
“As a pediatric surgeon ... I have too often witnessed the impact of firearm violence, and obviously, the devastation extends beyond the victims to their families,” he said. “To put it succinctly, in our culture, parents are not supposed to be put in a position of burying their children.”
A public health crisis
“It’s important to recognize that we’ve been talking about a public health approach,” said Eileen Bulger, MD, acting chief of the trauma division at the University of Washington in Seattle. That strategy is important for engaging both firearm owners and communities that have a higher risk for firearm violence, she said.
A committee of the American College of Surgeons developed specific recommendations in 2018, which are still valid today. The group brought together surgeons from across the U.S. including “passionate firearm owners and experts in firearm safety,” Dr. Bulger said.
The committee, for example, agreed on 10 specific recommendations “that we believe are bipartisan and could have an immediate impact in saving lives.”
“I’m a lifelong gun owner,” Dr. Bailey said, emphasizing that the team’s process included participation and perspective from other surgeons “who, like me, are also gun owners, but gun owners who also seek to reduce the impact of firearm violence in our country.”
The recommendations address these areas:
- Gun ownership
- Firearm registration
- Licensure
- Education and training
- Ownership responsibilities
- Mandatory reporting and risk reduction
- Safety innovation and technology
- Research
- The culture of violence
- Social isolation and mental health
For example, “we currently have certain classes of weapons with significant offensive capability,” Dr. Bulger said, “that are appropriately restricted and regulated under the National Firearms Act as Class 3 weapons.”
This group includes fully automatic machine guns, explosive devices, and short-barrel shotguns.
“We recommend a formal reassessment of the firearms designated within each of these national firearms classifications,” Dr. Bulger said.
For example, high-capacity, magazine-fed semiautomatic rifles, such as the AR-15, should be considered for reclassification as NFA Class 3 firearms, or they should get a new designation with tighter regulation.
The ACS endorses formal firearm safety training for all new gun owners. Also, owners who do not provide reasonably safe firearm storage should be held responsible for events related to the discharge of their firearms, Dr. Bulger said. And people who are deemed an imminent threat to themselves or others through firearm ownership should be temporarily or permanently restricted, with due process.
Research and reporting reforms
The ACS is also calling for research on firearm injuries and firearm injury prevention to be federally funded, Dr. Bulger said. The research should be done in a nonpartisan manner, she said.
“We have concerns that the manner and tone in which information is released to the public may lead to copycat mass killers,” she said. “The ACS recommends that law enforcement officials and the press take steps to eliminate the notoriety of the shooter, for example.”
Dr. Bulger also addressed the mental health angle. “We encourage recognition of mental health warning signs and social isolation by teachers, counselors, peers, and parents.” When identified, immediate referral to professionals is needed.
In addition to these recommendations, another team from the American College of Surgeons has published an overview of ways to address the inequities that contribute to violence. “We advocate for federal funding to support the development of hospital-based and community programs for violence intervention and prevention,” Dr. Bulger said.
Dr. Bailey said that as a gun owner himself, he thinks other gun owners would support these recommendations.
“I do not believe that the steps recommended ... pose undue burden on the rights of individual gun owners,” he said.
The time is now
Most firearm injuries are not from mass shooting events, Dr. Kerby said.
“My own trauma center has seen a 40% increase in the number of firearm injuries just in the last 2 years,” he added, “and these numbers continue to grow.”
A version of this article first appeared on WebMD.com.
Their strategies can work regardless of where you stand on the Second Amendment of the Constitution, said Patricia Turner, MD. “Our proposals are embraced by both gun owners and non–gun owners alike, and we are unique in that regard.”
These “implementable solutions” could prevent the next massacre, Dr. Turner, executive director of the American College of Surgeons, said during a news briefing the group sponsored on June 2.
“Our future – indeed all of our futures – depend on our ability to find durable, actionable steps that we can implement tomorrow to save lives,” she said.
Firsthand perspective
“Sadly I’m here today as a trauma surgeon who has cared for two of the largest mass shootings in modern U.S. history,” said Ronald Stewart, MD, chair of the department of surgery at University Hospital in San Antonio, Texas.
Dr. Stewart treated victims of the 2017 Sutherland Springs First Baptist Church shooting – where 27 people died, including the shooter – and the recent Uvalde school shooting, both in Texas.
“The injuries inflicted by high-velocity weapons used at both of these attacks are horrific. A high-capacity, magazine-fed automatic rifle such as the AR-15 causes extremely destructive tissue wounds,” he said.
One of the group’s proposals is to increase the regulation of high-velocity weapons, including AR-15s.
“These wounds are horribly lethal at close range, and sadly, most victims do not survive long enough to make it to a trauma center,” Dr. Stewart said.
On a positive note, “all of our current [Uvalde] patients are improving, which really brings us joy in this dark time,” he said. “But all of them have a long road to deal with recovery with both the physical and emotional impact of their injuries.”
Jeffrey Kerby, MD, agreed.
“Trauma surgeons see the short-term physical effects of these injuries and watch patients struggle with the long-term impact of these wounds,” said Dr. Kerby, director of trauma and acute care surgery at the University of Alabama at Birmingham.
Surgeons feel ‘profound impact’ of shootings
“Firearm violence has a profound impact on surgeons, and we are the undisputed subject matter experts in treating the tragic results,” said Patrick Bailey, MD, medical director for advocacy at the American College of Surgeons.
“This impacts surgeons as well,” said Dr. Kerby, chair of the Committee on Trauma for the surgeons’ group. “We are human, and we can’t help but share in the grief, the pain, and the suffering that our patients endure.
“As a pediatric surgeon ... I have too often witnessed the impact of firearm violence, and obviously, the devastation extends beyond the victims to their families,” he said. “To put it succinctly, in our culture, parents are not supposed to be put in a position of burying their children.”
A public health crisis
“It’s important to recognize that we’ve been talking about a public health approach,” said Eileen Bulger, MD, acting chief of the trauma division at the University of Washington in Seattle. That strategy is important for engaging both firearm owners and communities that have a higher risk for firearm violence, she said.
A committee of the American College of Surgeons developed specific recommendations in 2018, which are still valid today. The group brought together surgeons from across the U.S. including “passionate firearm owners and experts in firearm safety,” Dr. Bulger said.
The committee, for example, agreed on 10 specific recommendations “that we believe are bipartisan and could have an immediate impact in saving lives.”
“I’m a lifelong gun owner,” Dr. Bailey said, emphasizing that the team’s process included participation and perspective from other surgeons “who, like me, are also gun owners, but gun owners who also seek to reduce the impact of firearm violence in our country.”
The recommendations address these areas:
- Gun ownership
- Firearm registration
- Licensure
- Education and training
- Ownership responsibilities
- Mandatory reporting and risk reduction
- Safety innovation and technology
- Research
- The culture of violence
- Social isolation and mental health
For example, “we currently have certain classes of weapons with significant offensive capability,” Dr. Bulger said, “that are appropriately restricted and regulated under the National Firearms Act as Class 3 weapons.”
This group includes fully automatic machine guns, explosive devices, and short-barrel shotguns.
“We recommend a formal reassessment of the firearms designated within each of these national firearms classifications,” Dr. Bulger said.
For example, high-capacity, magazine-fed semiautomatic rifles, such as the AR-15, should be considered for reclassification as NFA Class 3 firearms, or they should get a new designation with tighter regulation.
The ACS endorses formal firearm safety training for all new gun owners. Also, owners who do not provide reasonably safe firearm storage should be held responsible for events related to the discharge of their firearms, Dr. Bulger said. And people who are deemed an imminent threat to themselves or others through firearm ownership should be temporarily or permanently restricted, with due process.
Research and reporting reforms
The ACS is also calling for research on firearm injuries and firearm injury prevention to be federally funded, Dr. Bulger said. The research should be done in a nonpartisan manner, she said.
“We have concerns that the manner and tone in which information is released to the public may lead to copycat mass killers,” she said. “The ACS recommends that law enforcement officials and the press take steps to eliminate the notoriety of the shooter, for example.”
Dr. Bulger also addressed the mental health angle. “We encourage recognition of mental health warning signs and social isolation by teachers, counselors, peers, and parents.” When identified, immediate referral to professionals is needed.
In addition to these recommendations, another team from the American College of Surgeons has published an overview of ways to address the inequities that contribute to violence. “We advocate for federal funding to support the development of hospital-based and community programs for violence intervention and prevention,” Dr. Bulger said.
Dr. Bailey said that as a gun owner himself, he thinks other gun owners would support these recommendations.
“I do not believe that the steps recommended ... pose undue burden on the rights of individual gun owners,” he said.
The time is now
Most firearm injuries are not from mass shooting events, Dr. Kerby said.
“My own trauma center has seen a 40% increase in the number of firearm injuries just in the last 2 years,” he added, “and these numbers continue to grow.”
A version of this article first appeared on WebMD.com.
Woman who faked cancer gets 5 years in prison
A California woman who pretended to have cancer and received more than $100,000 in charitable donations from hundreds of people has been sentenced to 5 years in prison.
Amanda Christine Riley pleaded guilty to one count of wire fraud for soliciting donations from people through various social media sites to help pay for cancer treatments that she never received or needed, according to the U.S. Department of Justice.
In total, the government identified 349 individuals and entities who made contributions totaling $105,513. Ms. Riley was sentenced to 60 months in prison on May 3.
Ms. Riley is hardly the first person to fake a cancer diagnosis for money. In fact, the phenomenon of faking illness online now occurs so often that researchers have given it a name: “Munchausen by internet.” However, few appear to be penalized with prison time.
In this case, the scam began in 2012, when Ms. Riley falsely claimed to have been diagnosed with Hodgkin’s lymphoma. She used Facebook, Instagram, Twitter, and a blog to document her imaginary condition and “aggressively” solicit donations to cover her supposed medical expenses, the DOJ said.
Instead, Ms. Riley used the donations to pay living expenses.
According to the DOJ, Ms. Riley went to “great lengths to maintain her deception.” She shaved her head to appear to be undergoing chemotherapy, faked her medical records, forged physicians’ letters and medical certifications, and convinced family members to back up her false claims.
Ms. Riley’s scheme continued for 7 years, until 2019, when her deception was uncovered by an investigation of the Internal Revenue Service and the San Jose Police Department.
Ms. Riley was charged in July 2020 and pleaded guilty in October 2021.
In addition to serving 5 years in prison, Ms. Riley must pay back the $105,513 and undergo 3 years of supervision after her release.
A version of this article first appeared on Medscape.com.
A California woman who pretended to have cancer and received more than $100,000 in charitable donations from hundreds of people has been sentenced to 5 years in prison.
Amanda Christine Riley pleaded guilty to one count of wire fraud for soliciting donations from people through various social media sites to help pay for cancer treatments that she never received or needed, according to the U.S. Department of Justice.
In total, the government identified 349 individuals and entities who made contributions totaling $105,513. Ms. Riley was sentenced to 60 months in prison on May 3.
Ms. Riley is hardly the first person to fake a cancer diagnosis for money. In fact, the phenomenon of faking illness online now occurs so often that researchers have given it a name: “Munchausen by internet.” However, few appear to be penalized with prison time.
In this case, the scam began in 2012, when Ms. Riley falsely claimed to have been diagnosed with Hodgkin’s lymphoma. She used Facebook, Instagram, Twitter, and a blog to document her imaginary condition and “aggressively” solicit donations to cover her supposed medical expenses, the DOJ said.
Instead, Ms. Riley used the donations to pay living expenses.
According to the DOJ, Ms. Riley went to “great lengths to maintain her deception.” She shaved her head to appear to be undergoing chemotherapy, faked her medical records, forged physicians’ letters and medical certifications, and convinced family members to back up her false claims.
Ms. Riley’s scheme continued for 7 years, until 2019, when her deception was uncovered by an investigation of the Internal Revenue Service and the San Jose Police Department.
Ms. Riley was charged in July 2020 and pleaded guilty in October 2021.
In addition to serving 5 years in prison, Ms. Riley must pay back the $105,513 and undergo 3 years of supervision after her release.
A version of this article first appeared on Medscape.com.
A California woman who pretended to have cancer and received more than $100,000 in charitable donations from hundreds of people has been sentenced to 5 years in prison.
Amanda Christine Riley pleaded guilty to one count of wire fraud for soliciting donations from people through various social media sites to help pay for cancer treatments that she never received or needed, according to the U.S. Department of Justice.
In total, the government identified 349 individuals and entities who made contributions totaling $105,513. Ms. Riley was sentenced to 60 months in prison on May 3.
Ms. Riley is hardly the first person to fake a cancer diagnosis for money. In fact, the phenomenon of faking illness online now occurs so often that researchers have given it a name: “Munchausen by internet.” However, few appear to be penalized with prison time.
In this case, the scam began in 2012, when Ms. Riley falsely claimed to have been diagnosed with Hodgkin’s lymphoma. She used Facebook, Instagram, Twitter, and a blog to document her imaginary condition and “aggressively” solicit donations to cover her supposed medical expenses, the DOJ said.
Instead, Ms. Riley used the donations to pay living expenses.
According to the DOJ, Ms. Riley went to “great lengths to maintain her deception.” She shaved her head to appear to be undergoing chemotherapy, faked her medical records, forged physicians’ letters and medical certifications, and convinced family members to back up her false claims.
Ms. Riley’s scheme continued for 7 years, until 2019, when her deception was uncovered by an investigation of the Internal Revenue Service and the San Jose Police Department.
Ms. Riley was charged in July 2020 and pleaded guilty in October 2021.
In addition to serving 5 years in prison, Ms. Riley must pay back the $105,513 and undergo 3 years of supervision after her release.
A version of this article first appeared on Medscape.com.
Dogs can be protective, even against Crohn’s disease
Sorry, cat people and only children: Having a dog as a toddler and growing up in a large family are two things linked to a significantly lower chance of getting Crohn’s disease later in life, according to a new study.
Children who lived with a dog between the ages of 2 years and 4 years were 37% less likely to have Crohn’s disease, the study says. And those who lived with at least three other family members during the first year of life were 64% less likely to have this form of inflammatory bowel disease (IBD).
“In this study, we’re interested in environmental exposures and which ones are associated with Crohn’s disease onset,” Williams Turpin, PhD, said in a media interview May 23 at the annual Digestive Disease Week® (DDW).
Dr. Turpin and colleagues looked at other things in the environment – including living on a farm, drinking unpasteurized milk or well water, and growing up with a cat – but they did not have a significant link to a higher risk.
Two other things were associated with a slight increase in risk: having a sibling with Crohn’s disease and living with a bird at time of the study. But the number of bird owners was small; only a few people in the study had a pet bird when they enrolled.
The link to living with a dog as a toddler “was more robust,” said Dr. Turpin, a project manager at Mount Sinai Hospital in Toronto.
The study included 4,289 healthy first-degree relatives of people diagnosed with Crohn’s disease. They provided urine, blood, and stool samples and did surveys about environmental exposures at different stages of life.
Investigators followed them an average of 5.6 years, during which time 86 people got Crohn’s disease.
Gut instinct
Living with a dog early in life likely means more exposure to different microbes, boosting the strength of a person’s immune system against later challenges. This theory was supported in the study comparing the gut microbiome in people who did and not have a dog in the home early in life.
Dr. Turpin and colleagues genetically sequenced the gut microbiome of the people in the study and found differences in bacteria between groups.
“Our study also shows that just by living with a dog, it impacts your gut microbiome composition, which may have an impact on the immune response later in life,” Dr. Turpin said.
The researchers also looked at the health of the gut by measuring certain factors in the urine. One factor was higher in people who did not live with a dog at any point.
Mediated by the microbiome?
Living with a dog between the ages of 2 and 4 years and a large family size (more than three people) in the first year were significantly associated with a lower risk of Crohn’s disease onset.
It is unknown if the results apply to other populations; the researchers studied first-degree relatives of people with Crohn’s disease.
“The study needs to be replicated and validated,” Dr. Turpin said.
Future research could evaluate people who never had a dog and look for changes in their microbiome after they get one.
‘Well-crafted’ study
“It’s a really interesting study from a good group. It’s novel in terms of getting at what really drives environmental risk factors,” said Brigid Boland, MD, a gastroenterologist at UC San Diego Health, who was not affiliated with the study.
Autoimmune diseases are really complicated, in part because the risk of getting an autoimmune disease is low, and you’re going back in time to look at what put people at risk.
“The study was well crafted in choosing siblings and family members of people with IBD,” Dr. Boland said, agreeing with Dr. Turpin that more research is needed to understand this.
A version of this article first appeared on WebMD.com.
Sorry, cat people and only children: Having a dog as a toddler and growing up in a large family are two things linked to a significantly lower chance of getting Crohn’s disease later in life, according to a new study.
Children who lived with a dog between the ages of 2 years and 4 years were 37% less likely to have Crohn’s disease, the study says. And those who lived with at least three other family members during the first year of life were 64% less likely to have this form of inflammatory bowel disease (IBD).
“In this study, we’re interested in environmental exposures and which ones are associated with Crohn’s disease onset,” Williams Turpin, PhD, said in a media interview May 23 at the annual Digestive Disease Week® (DDW).
Dr. Turpin and colleagues looked at other things in the environment – including living on a farm, drinking unpasteurized milk or well water, and growing up with a cat – but they did not have a significant link to a higher risk.
Two other things were associated with a slight increase in risk: having a sibling with Crohn’s disease and living with a bird at time of the study. But the number of bird owners was small; only a few people in the study had a pet bird when they enrolled.
The link to living with a dog as a toddler “was more robust,” said Dr. Turpin, a project manager at Mount Sinai Hospital in Toronto.
The study included 4,289 healthy first-degree relatives of people diagnosed with Crohn’s disease. They provided urine, blood, and stool samples and did surveys about environmental exposures at different stages of life.
Investigators followed them an average of 5.6 years, during which time 86 people got Crohn’s disease.
Gut instinct
Living with a dog early in life likely means more exposure to different microbes, boosting the strength of a person’s immune system against later challenges. This theory was supported in the study comparing the gut microbiome in people who did and not have a dog in the home early in life.
Dr. Turpin and colleagues genetically sequenced the gut microbiome of the people in the study and found differences in bacteria between groups.
“Our study also shows that just by living with a dog, it impacts your gut microbiome composition, which may have an impact on the immune response later in life,” Dr. Turpin said.
The researchers also looked at the health of the gut by measuring certain factors in the urine. One factor was higher in people who did not live with a dog at any point.
Mediated by the microbiome?
Living with a dog between the ages of 2 and 4 years and a large family size (more than three people) in the first year were significantly associated with a lower risk of Crohn’s disease onset.
It is unknown if the results apply to other populations; the researchers studied first-degree relatives of people with Crohn’s disease.
“The study needs to be replicated and validated,” Dr. Turpin said.
Future research could evaluate people who never had a dog and look for changes in their microbiome after they get one.
‘Well-crafted’ study
“It’s a really interesting study from a good group. It’s novel in terms of getting at what really drives environmental risk factors,” said Brigid Boland, MD, a gastroenterologist at UC San Diego Health, who was not affiliated with the study.
Autoimmune diseases are really complicated, in part because the risk of getting an autoimmune disease is low, and you’re going back in time to look at what put people at risk.
“The study was well crafted in choosing siblings and family members of people with IBD,” Dr. Boland said, agreeing with Dr. Turpin that more research is needed to understand this.
A version of this article first appeared on WebMD.com.
Sorry, cat people and only children: Having a dog as a toddler and growing up in a large family are two things linked to a significantly lower chance of getting Crohn’s disease later in life, according to a new study.
Children who lived with a dog between the ages of 2 years and 4 years were 37% less likely to have Crohn’s disease, the study says. And those who lived with at least three other family members during the first year of life were 64% less likely to have this form of inflammatory bowel disease (IBD).
“In this study, we’re interested in environmental exposures and which ones are associated with Crohn’s disease onset,” Williams Turpin, PhD, said in a media interview May 23 at the annual Digestive Disease Week® (DDW).
Dr. Turpin and colleagues looked at other things in the environment – including living on a farm, drinking unpasteurized milk or well water, and growing up with a cat – but they did not have a significant link to a higher risk.
Two other things were associated with a slight increase in risk: having a sibling with Crohn’s disease and living with a bird at time of the study. But the number of bird owners was small; only a few people in the study had a pet bird when they enrolled.
The link to living with a dog as a toddler “was more robust,” said Dr. Turpin, a project manager at Mount Sinai Hospital in Toronto.
The study included 4,289 healthy first-degree relatives of people diagnosed with Crohn’s disease. They provided urine, blood, and stool samples and did surveys about environmental exposures at different stages of life.
Investigators followed them an average of 5.6 years, during which time 86 people got Crohn’s disease.
Gut instinct
Living with a dog early in life likely means more exposure to different microbes, boosting the strength of a person’s immune system against later challenges. This theory was supported in the study comparing the gut microbiome in people who did and not have a dog in the home early in life.
Dr. Turpin and colleagues genetically sequenced the gut microbiome of the people in the study and found differences in bacteria between groups.
“Our study also shows that just by living with a dog, it impacts your gut microbiome composition, which may have an impact on the immune response later in life,” Dr. Turpin said.
The researchers also looked at the health of the gut by measuring certain factors in the urine. One factor was higher in people who did not live with a dog at any point.
Mediated by the microbiome?
Living with a dog between the ages of 2 and 4 years and a large family size (more than three people) in the first year were significantly associated with a lower risk of Crohn’s disease onset.
It is unknown if the results apply to other populations; the researchers studied first-degree relatives of people with Crohn’s disease.
“The study needs to be replicated and validated,” Dr. Turpin said.
Future research could evaluate people who never had a dog and look for changes in their microbiome after they get one.
‘Well-crafted’ study
“It’s a really interesting study from a good group. It’s novel in terms of getting at what really drives environmental risk factors,” said Brigid Boland, MD, a gastroenterologist at UC San Diego Health, who was not affiliated with the study.
Autoimmune diseases are really complicated, in part because the risk of getting an autoimmune disease is low, and you’re going back in time to look at what put people at risk.
“The study was well crafted in choosing siblings and family members of people with IBD,” Dr. Boland said, agreeing with Dr. Turpin that more research is needed to understand this.
A version of this article first appeared on WebMD.com.
FROM DDW 2022
Pfizer asks FDA to authorize COVID vaccine for children younger than 5
The FDA has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, which clears the way for approval and distribution in June.
Pfizer announced June 1 that it completed the application for a three-dose vaccine for kids between 6 months and 5 years old, and the FDA said it received the emergency use application.
Children in this age group – the last to be eligible for COVID-19 vaccines – could begin getting shots as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.
Meanwhile, COVID-19 cases are still high – an average of 100,000 cases a day – but death numbers are about 90% lower than they were when President Joe Biden first took office, Dr. Jha said.
The FDA’s advisory group, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet June 14 and June 15 to discuss data submitted by both Pfizer and Moderna.
If the FDA gives them the green light, the CDC will then weigh in.
“We know that many, many parents are eager to vaccinate their youngest kids, and it’s important to do this right,” Dr. Jha said at a White House press briefing on June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”
States can place their orders as early as June 3, Dr. Jha said, and there will initially be 10 million doses available. If the FDA gives emergency use authorization for the vaccines, the government will begin shipping doses to thousands of sites across the country.
“The good news is we have plenty of supply of Pfizer and Moderna vaccines,” Dr. Jha said. “We’ve asked states to distribute to their highest priority sites, serving the highest risk and hardest to reach areas.”
Pfizer’s clinical trials found that three doses of the vaccine for children 6 months to under 5 years were safe and effective and proved to be 80% effective against Omicron.
The FDA announced its meeting information with a conversation about the Moderna vaccine for ages 6-17 scheduled for June 14 and a conversation about the Pfizer and Moderna vaccines for young children scheduled for June 15.
Moderna applied for FDA authorization of its two-dose vaccine for children under age 6 on April 28. The company said the vaccine was 51% effective against infections with symptoms for children ages 6 months to 2 years and 37% effective for ages 2-5.
Pfizer’s 3-microgram dose is one-tenth of its adult dose. Moderna’s 25-microgram dose is one-quarter of its adult dose.
A version of this article first appeared on Medscape.com.
The FDA has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, which clears the way for approval and distribution in June.
Pfizer announced June 1 that it completed the application for a three-dose vaccine for kids between 6 months and 5 years old, and the FDA said it received the emergency use application.
Children in this age group – the last to be eligible for COVID-19 vaccines – could begin getting shots as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.
Meanwhile, COVID-19 cases are still high – an average of 100,000 cases a day – but death numbers are about 90% lower than they were when President Joe Biden first took office, Dr. Jha said.
The FDA’s advisory group, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet June 14 and June 15 to discuss data submitted by both Pfizer and Moderna.
If the FDA gives them the green light, the CDC will then weigh in.
“We know that many, many parents are eager to vaccinate their youngest kids, and it’s important to do this right,” Dr. Jha said at a White House press briefing on June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”
States can place their orders as early as June 3, Dr. Jha said, and there will initially be 10 million doses available. If the FDA gives emergency use authorization for the vaccines, the government will begin shipping doses to thousands of sites across the country.
“The good news is we have plenty of supply of Pfizer and Moderna vaccines,” Dr. Jha said. “We’ve asked states to distribute to their highest priority sites, serving the highest risk and hardest to reach areas.”
Pfizer’s clinical trials found that three doses of the vaccine for children 6 months to under 5 years were safe and effective and proved to be 80% effective against Omicron.
The FDA announced its meeting information with a conversation about the Moderna vaccine for ages 6-17 scheduled for June 14 and a conversation about the Pfizer and Moderna vaccines for young children scheduled for June 15.
Moderna applied for FDA authorization of its two-dose vaccine for children under age 6 on April 28. The company said the vaccine was 51% effective against infections with symptoms for children ages 6 months to 2 years and 37% effective for ages 2-5.
Pfizer’s 3-microgram dose is one-tenth of its adult dose. Moderna’s 25-microgram dose is one-quarter of its adult dose.
A version of this article first appeared on Medscape.com.
The FDA has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, which clears the way for approval and distribution in June.
Pfizer announced June 1 that it completed the application for a three-dose vaccine for kids between 6 months and 5 years old, and the FDA said it received the emergency use application.
Children in this age group – the last to be eligible for COVID-19 vaccines – could begin getting shots as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.
Meanwhile, COVID-19 cases are still high – an average of 100,000 cases a day – but death numbers are about 90% lower than they were when President Joe Biden first took office, Dr. Jha said.
The FDA’s advisory group, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet June 14 and June 15 to discuss data submitted by both Pfizer and Moderna.
If the FDA gives them the green light, the CDC will then weigh in.
“We know that many, many parents are eager to vaccinate their youngest kids, and it’s important to do this right,” Dr. Jha said at a White House press briefing on June 2. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”
States can place their orders as early as June 3, Dr. Jha said, and there will initially be 10 million doses available. If the FDA gives emergency use authorization for the vaccines, the government will begin shipping doses to thousands of sites across the country.
“The good news is we have plenty of supply of Pfizer and Moderna vaccines,” Dr. Jha said. “We’ve asked states to distribute to their highest priority sites, serving the highest risk and hardest to reach areas.”
Pfizer’s clinical trials found that three doses of the vaccine for children 6 months to under 5 years were safe and effective and proved to be 80% effective against Omicron.
The FDA announced its meeting information with a conversation about the Moderna vaccine for ages 6-17 scheduled for June 14 and a conversation about the Pfizer and Moderna vaccines for young children scheduled for June 15.
Moderna applied for FDA authorization of its two-dose vaccine for children under age 6 on April 28. The company said the vaccine was 51% effective against infections with symptoms for children ages 6 months to 2 years and 37% effective for ages 2-5.
Pfizer’s 3-microgram dose is one-tenth of its adult dose. Moderna’s 25-microgram dose is one-quarter of its adult dose.
A version of this article first appeared on Medscape.com.
White children more likely to get imaging in EDs: Study
Non-Hispanic White children were more likely to receive diagnostic imaging at children’s hospitals’ emergency departments across the United States than were Hispanic children and non-Hispanic Black children, according to a large study published in JAMA Network Open.
Researchers found that, the more the percentage of children from minority groups cared for by a hospital increased, the wider the imaging gap between those children and non-Hispanic White children.
The cross-sectional study, led by Margaret E. Samuels-Kalow, MD, MPhil, MSHP, with the department of emergency medicine, Massachusetts General Hospital and Harvard Medical School in Boston, included 38 children’s hospitals and more than 12 million ED visits.
“These findings emphasize the urgent need for interventions at the hospital level to improve equity in imaging in pediatric emergency medicine,” the authors write.
Patients included in the study were younger than 18 and visited an ED from January 2016 through December 2019. Data were pulled from the Pediatric Health Information System.
Of the more than 12 million visits in this study, 3.5 million (28.7%) involved at least one diagnostic imaging test.
Diagnostic imaging was performed in 1.5 million visits (34.2%) for non-Hispanic White children; 790,961 (24.6%) for non-Hispanic Black children; and 907,222 (26.1%) for Hispanic children (P < .001).
Non-Hispanic Black children were consistently less likely to get diagnostic imaging than non-Hispanic White counterparts at every hospital in the study, no matter the imaging modality: radiography, ultrasonography, computed tomography, or magnetic resonance imaging.
Hispanic patients were generally less likely to get imaging than non-Hispanic White patients, though results were less consistent for ultrasound and MRI.
In a sensitivity analysis, when looking at imaging from patients’ first visit across the study cohort, non-Hispanic Black children were significantly less likely to get imaging than non-Hispanic White children (adjusted odds ratio, 0.77; 95% confidence interval, 0.74-0.79).
“This remained significant even after adjustment for a priori specified confounders including hospital propensity to image,” the authors write.
Authors acknowledge that it is possible that some of the differences may be attributable to the patient mix regarding severity of cases or indications for imaging by hospital, but they note that all models were adjusted for diagnosis-related group and other potential confounders.
This study did not assess whether one group is being overtested. Researchers also note that higher rates of imaging do not necessarily indicate higher quality of care.
However, the authors note, previous research has suggested overtesting of non-Hispanic White patients for head CT and chest pain, as well as patterns of overtreatment of non-Hispanic White patients who have bronchiolitis or viral upper respiratory tract infections.
Medell Briggs-Malonson, MD, MPH, chief of health equity, diversity and inclusion for the University of California, Los Angeles, Hospital and Clinic System, who was not part of the study, said in an interview “this all rings true.”
“This is not the first study we have had in either the pediatric or adult populations that shows disparate levels of care as well as health outcomes. Now we are starting to be able to measure it,” she said.
This study is further evidence of medical racism, she says, and highlights that it’s not the hospital choice or the insurance type affecting the numbers, she said.
“When you control for those factors, it looks to be it’s only due to race and that’s because of the very deep levels of implicit bias as well as explicit bias that we still have in our health systems and even in our providers,” said Dr. Briggs-Malonson, who is also an associate professor of emergency medicine at UCLA. “It’s incredibly important to identify and immediately address.”
What can be done?
Changing these patterns starts with knowing the numbers, the authors write.
“Hospitals should measure their own differences in imaging rates and increase awareness of existing areas of differential treatment as a starting point for improvement,” Dr. Samuels-Kalow and coauthors say.
Dr. Briggs-Malonson added that guidelines are very clear about when children should get imaging. Adhering to evidence-based guidelines can help avoid variations in care from external factors.
“If children are not receiving the absolute best comprehensive evaluation in the emergency department that they deserve, we can miss many different illnesses, which can lead to worse outcomes,” she noted.
As for what might motivate lack of imaging, Dr. Briggs-Malonson pointed to longstanding trends of providers thinking complaints raised by minority patients may not be as severe as they report. Conversely, in caring for White patients there may be a feeling that more tests and imaging may be better out of more fear of missing something, she said.
At UCLA, she says, dashboards have been developed to track statistics on care by age, race, ethnicity, language, insurance type, etc., though not specifically in pediatric imaging, to assess and address any care inequities.
Summer L. Kaplan, MD, MS, director of emergency radiology at Children’s Hospital of Philadelphia, who also was not part of the study, said the finding of racial disparities in pediatric ED imaging provides evidence that gaps still exist in providing the best care to all children and families seeking emergency care.
“However, it is important to recognize that more imaging does not equal better care,” she said. “More imaging may be associated with unnecessary, low-value tests that may add radiation and other risks but do not improve care.”
She said higher rates of imaging may occur when patients present early in the course of a disease, when the differential diagnosis remains broad.
If families have delayed seeking care because of time constraints, transportation problems, cost of care, or mistrust of the health system, children may present later in the course of a disease and require less imaging for a diagnosis, she explained.
“This paper offers a valuable look at the inequities that exist in pediatric emergency imaging use, and further research will be essential to understand and address the causes of these differences,” Dr. Kaplan said.
A coauthor reported compensation as a member of a Medical Review Committee for Highmark. Other coauthors reported grants from the U.S. Agency for Healthcare Research and Quality outside the submitted work. Dr. Briggs-Malonson and Dr. Kaplan reported no relevant financial relationships.
Non-Hispanic White children were more likely to receive diagnostic imaging at children’s hospitals’ emergency departments across the United States than were Hispanic children and non-Hispanic Black children, according to a large study published in JAMA Network Open.
Researchers found that, the more the percentage of children from minority groups cared for by a hospital increased, the wider the imaging gap between those children and non-Hispanic White children.
The cross-sectional study, led by Margaret E. Samuels-Kalow, MD, MPhil, MSHP, with the department of emergency medicine, Massachusetts General Hospital and Harvard Medical School in Boston, included 38 children’s hospitals and more than 12 million ED visits.
“These findings emphasize the urgent need for interventions at the hospital level to improve equity in imaging in pediatric emergency medicine,” the authors write.
Patients included in the study were younger than 18 and visited an ED from January 2016 through December 2019. Data were pulled from the Pediatric Health Information System.
Of the more than 12 million visits in this study, 3.5 million (28.7%) involved at least one diagnostic imaging test.
Diagnostic imaging was performed in 1.5 million visits (34.2%) for non-Hispanic White children; 790,961 (24.6%) for non-Hispanic Black children; and 907,222 (26.1%) for Hispanic children (P < .001).
Non-Hispanic Black children were consistently less likely to get diagnostic imaging than non-Hispanic White counterparts at every hospital in the study, no matter the imaging modality: radiography, ultrasonography, computed tomography, or magnetic resonance imaging.
Hispanic patients were generally less likely to get imaging than non-Hispanic White patients, though results were less consistent for ultrasound and MRI.
In a sensitivity analysis, when looking at imaging from patients’ first visit across the study cohort, non-Hispanic Black children were significantly less likely to get imaging than non-Hispanic White children (adjusted odds ratio, 0.77; 95% confidence interval, 0.74-0.79).
“This remained significant even after adjustment for a priori specified confounders including hospital propensity to image,” the authors write.
Authors acknowledge that it is possible that some of the differences may be attributable to the patient mix regarding severity of cases or indications for imaging by hospital, but they note that all models were adjusted for diagnosis-related group and other potential confounders.
This study did not assess whether one group is being overtested. Researchers also note that higher rates of imaging do not necessarily indicate higher quality of care.
However, the authors note, previous research has suggested overtesting of non-Hispanic White patients for head CT and chest pain, as well as patterns of overtreatment of non-Hispanic White patients who have bronchiolitis or viral upper respiratory tract infections.
Medell Briggs-Malonson, MD, MPH, chief of health equity, diversity and inclusion for the University of California, Los Angeles, Hospital and Clinic System, who was not part of the study, said in an interview “this all rings true.”
“This is not the first study we have had in either the pediatric or adult populations that shows disparate levels of care as well as health outcomes. Now we are starting to be able to measure it,” she said.
This study is further evidence of medical racism, she says, and highlights that it’s not the hospital choice or the insurance type affecting the numbers, she said.
“When you control for those factors, it looks to be it’s only due to race and that’s because of the very deep levels of implicit bias as well as explicit bias that we still have in our health systems and even in our providers,” said Dr. Briggs-Malonson, who is also an associate professor of emergency medicine at UCLA. “It’s incredibly important to identify and immediately address.”
What can be done?
Changing these patterns starts with knowing the numbers, the authors write.
“Hospitals should measure their own differences in imaging rates and increase awareness of existing areas of differential treatment as a starting point for improvement,” Dr. Samuels-Kalow and coauthors say.
Dr. Briggs-Malonson added that guidelines are very clear about when children should get imaging. Adhering to evidence-based guidelines can help avoid variations in care from external factors.
“If children are not receiving the absolute best comprehensive evaluation in the emergency department that they deserve, we can miss many different illnesses, which can lead to worse outcomes,” she noted.
As for what might motivate lack of imaging, Dr. Briggs-Malonson pointed to longstanding trends of providers thinking complaints raised by minority patients may not be as severe as they report. Conversely, in caring for White patients there may be a feeling that more tests and imaging may be better out of more fear of missing something, she said.
At UCLA, she says, dashboards have been developed to track statistics on care by age, race, ethnicity, language, insurance type, etc., though not specifically in pediatric imaging, to assess and address any care inequities.
Summer L. Kaplan, MD, MS, director of emergency radiology at Children’s Hospital of Philadelphia, who also was not part of the study, said the finding of racial disparities in pediatric ED imaging provides evidence that gaps still exist in providing the best care to all children and families seeking emergency care.
“However, it is important to recognize that more imaging does not equal better care,” she said. “More imaging may be associated with unnecessary, low-value tests that may add radiation and other risks but do not improve care.”
She said higher rates of imaging may occur when patients present early in the course of a disease, when the differential diagnosis remains broad.
If families have delayed seeking care because of time constraints, transportation problems, cost of care, or mistrust of the health system, children may present later in the course of a disease and require less imaging for a diagnosis, she explained.
“This paper offers a valuable look at the inequities that exist in pediatric emergency imaging use, and further research will be essential to understand and address the causes of these differences,” Dr. Kaplan said.
A coauthor reported compensation as a member of a Medical Review Committee for Highmark. Other coauthors reported grants from the U.S. Agency for Healthcare Research and Quality outside the submitted work. Dr. Briggs-Malonson and Dr. Kaplan reported no relevant financial relationships.
Non-Hispanic White children were more likely to receive diagnostic imaging at children’s hospitals’ emergency departments across the United States than were Hispanic children and non-Hispanic Black children, according to a large study published in JAMA Network Open.
Researchers found that, the more the percentage of children from minority groups cared for by a hospital increased, the wider the imaging gap between those children and non-Hispanic White children.
The cross-sectional study, led by Margaret E. Samuels-Kalow, MD, MPhil, MSHP, with the department of emergency medicine, Massachusetts General Hospital and Harvard Medical School in Boston, included 38 children’s hospitals and more than 12 million ED visits.
“These findings emphasize the urgent need for interventions at the hospital level to improve equity in imaging in pediatric emergency medicine,” the authors write.
Patients included in the study were younger than 18 and visited an ED from January 2016 through December 2019. Data were pulled from the Pediatric Health Information System.
Of the more than 12 million visits in this study, 3.5 million (28.7%) involved at least one diagnostic imaging test.
Diagnostic imaging was performed in 1.5 million visits (34.2%) for non-Hispanic White children; 790,961 (24.6%) for non-Hispanic Black children; and 907,222 (26.1%) for Hispanic children (P < .001).
Non-Hispanic Black children were consistently less likely to get diagnostic imaging than non-Hispanic White counterparts at every hospital in the study, no matter the imaging modality: radiography, ultrasonography, computed tomography, or magnetic resonance imaging.
Hispanic patients were generally less likely to get imaging than non-Hispanic White patients, though results were less consistent for ultrasound and MRI.
In a sensitivity analysis, when looking at imaging from patients’ first visit across the study cohort, non-Hispanic Black children were significantly less likely to get imaging than non-Hispanic White children (adjusted odds ratio, 0.77; 95% confidence interval, 0.74-0.79).
“This remained significant even after adjustment for a priori specified confounders including hospital propensity to image,” the authors write.
Authors acknowledge that it is possible that some of the differences may be attributable to the patient mix regarding severity of cases or indications for imaging by hospital, but they note that all models were adjusted for diagnosis-related group and other potential confounders.
This study did not assess whether one group is being overtested. Researchers also note that higher rates of imaging do not necessarily indicate higher quality of care.
However, the authors note, previous research has suggested overtesting of non-Hispanic White patients for head CT and chest pain, as well as patterns of overtreatment of non-Hispanic White patients who have bronchiolitis or viral upper respiratory tract infections.
Medell Briggs-Malonson, MD, MPH, chief of health equity, diversity and inclusion for the University of California, Los Angeles, Hospital and Clinic System, who was not part of the study, said in an interview “this all rings true.”
“This is not the first study we have had in either the pediatric or adult populations that shows disparate levels of care as well as health outcomes. Now we are starting to be able to measure it,” she said.
This study is further evidence of medical racism, she says, and highlights that it’s not the hospital choice or the insurance type affecting the numbers, she said.
“When you control for those factors, it looks to be it’s only due to race and that’s because of the very deep levels of implicit bias as well as explicit bias that we still have in our health systems and even in our providers,” said Dr. Briggs-Malonson, who is also an associate professor of emergency medicine at UCLA. “It’s incredibly important to identify and immediately address.”
What can be done?
Changing these patterns starts with knowing the numbers, the authors write.
“Hospitals should measure their own differences in imaging rates and increase awareness of existing areas of differential treatment as a starting point for improvement,” Dr. Samuels-Kalow and coauthors say.
Dr. Briggs-Malonson added that guidelines are very clear about when children should get imaging. Adhering to evidence-based guidelines can help avoid variations in care from external factors.
“If children are not receiving the absolute best comprehensive evaluation in the emergency department that they deserve, we can miss many different illnesses, which can lead to worse outcomes,” she noted.
As for what might motivate lack of imaging, Dr. Briggs-Malonson pointed to longstanding trends of providers thinking complaints raised by minority patients may not be as severe as they report. Conversely, in caring for White patients there may be a feeling that more tests and imaging may be better out of more fear of missing something, she said.
At UCLA, she says, dashboards have been developed to track statistics on care by age, race, ethnicity, language, insurance type, etc., though not specifically in pediatric imaging, to assess and address any care inequities.
Summer L. Kaplan, MD, MS, director of emergency radiology at Children’s Hospital of Philadelphia, who also was not part of the study, said the finding of racial disparities in pediatric ED imaging provides evidence that gaps still exist in providing the best care to all children and families seeking emergency care.
“However, it is important to recognize that more imaging does not equal better care,” she said. “More imaging may be associated with unnecessary, low-value tests that may add radiation and other risks but do not improve care.”
She said higher rates of imaging may occur when patients present early in the course of a disease, when the differential diagnosis remains broad.
If families have delayed seeking care because of time constraints, transportation problems, cost of care, or mistrust of the health system, children may present later in the course of a disease and require less imaging for a diagnosis, she explained.
“This paper offers a valuable look at the inequities that exist in pediatric emergency imaging use, and further research will be essential to understand and address the causes of these differences,” Dr. Kaplan said.
A coauthor reported compensation as a member of a Medical Review Committee for Highmark. Other coauthors reported grants from the U.S. Agency for Healthcare Research and Quality outside the submitted work. Dr. Briggs-Malonson and Dr. Kaplan reported no relevant financial relationships.
FROM JAMA NETWORK OPEN