Case

Ms. F. is a 68-year-old woman who presented to the hospital with sepsis, developed delirium, and stopped eating. Her clinicians recommended a PEG tube. Although she was inconsistently oriented to self, time, and place, she reiterated the same decision across multiple discussions: She did not want the PEG tube. Her replies to what would happen if she didn’t have the procedure and continued not to eat were consistent, too: “I’ll wither away.”

Ms. F. had impaired cognition. Do these impairments mean her clinicians should over-rule her choice? What evidence indicates whether she lacks decision-making capacity? This case of a patient refusing a potentially life-saving procedure amplifies the importance of asking these questions and integrating capacity assessments into clinical care. In this article, we will describe what capacity is, when and how to assess it, and the alternatives when a patient does not have capacity.
 

The ethical background

Before starting a medical treatment or procedure, a physician must obtain the patient’s informed consent. This is a core ethic of medicine. Informed consent describes the voluntary decision made by a competent patient following the disclosure of necessary information. Informed consent is key to achieving a balance between promoting patient self-determination and protecting vulnerable patients from harm. In most clinical encounters, informed consent unfolds effortlessly. However, in the care of patients who are acutely ill, particularly those in hospitals, fulfilling the ethic can be challenging.

It is important to have skills to recognize and address these challenges. One of the most common challenges to practicing the ethic of informed consent is the impact of illness on a person’s decision-making capacity. A patient who retains capacity ought to make his or her decisions and does not need someone else (a friend or a family member) to help with the decision.

Incapacity is unfortunately common among the acutely ill medical inpatient population, which typically skews older with more comorbidities.¹ Impairments frequently are overlooked for a variety of reasons,^2-6 including that many hospitalized patients do not challenge their doctors’ decisions. Doctors may be reluctant to assess capacity because the assessment may medically, legally, or ethically complicate the patient’s care.

Two common terms describe the outcome of an assessment of a patient’s decision-making abilities: competency and capacity. Competency describes a legal principle. It is granted or withdrawn by judicial review. The consequences of a judge rescinding competency are severe: A patient would need a guardian to make choices on his or her behalf.

Capacity, on the other hand, is a clinical concept. A physician assesses whether the patient can make a specific decision in a specific context. The difference between the two terms – competency and capacity – delineates what are the consequences of the assessment and which authority, a judge or a physician, has the right to withdraw a person’s decision-making authority.

The judge offers a global assessment that can lead to a guardianship. The physician’s decision is temporal and situational. Patients can lack capacity when they are ill and recover it when they are healed. Capacity is specific to each medical decision that the patient makes and so a person can lack capacity to make some decisions but not others.
 

Ethical framework to make assessment

Capacity is described by four decisional abilities: 1) communicate a choice, 2) understand relevant information, 3) appreciation, and 4) reasoning.⁷

Communication of a choice may be verbal or nonverbal, but the patient must be able to indicate the treatment choice clearly and consistently. Understanding describes knowing essential information a physician has conveyed. This is assessed by having the patients say back what they were told, such as: “Can you tell me in your own words what is a PEG tube?”

The components of appreciation are: the diagnosis or disorder and the benefits and risks of the proposed intervention as it relates to the diagnosis or disorder. Patients who appreciate their disorder have insight into their condition: “I’m not eating because I have an infection.” This can be assessed with a question such as: “Can you tell me in your own words what are the risks or downsides to you?” This prompt assesses the patient’s appreciation of risk. Reframing the question to ask, “Can you tell me about the upsides of this intervention?” will assess the patient’s appreciation of benefit.

Reasoning assesses the thought process and rationale for a person’s decision. It has two components – comparative and consequential reasoning. The first compares the different choices presented about the proposed intervention: “How does having a PEG tube compare to not having it?” The second asks about the consequences of each choice: “What might happen to a person who has the PEG tube?”

The capacity assessment evaluates a patient's performance on these decision-making abilities. This informs the clinician’s judgment of whether the patient has the capacity to make a decision. A patient who has capacity makes the choice, regardless of the physician’s preference or recommendation.

The physician’s duty is to decide which decision-making abilities to assess. Choice and understanding are essential. In riskier or more consequential decisions, a physician may raise the rigor of the assessment to include appreciation and reasoning.⁸ It is common practice for physicians to raise the standard for when to evaluate and how extensive their evaluation is when the decision is life-altering, as with a PEG tube versus a more routine, non–life-altering decision such as drawing blood for a routine wellness visit.

A simple scoring rubric determines the patient’s ability to answer each question along a range from adequate = 2, marginal = 1, to inadequate = 0. The extremes or adequate or inadequate are straightforward. Judgment is needed when performance is marginal. In the case of repeated marginal answers, a physician must strongly consider whether the patient lacks capacity to make the decision in question.⁹

Who receives a capacity assessment and when?

A good doctor is a good teacher. A doctor should therefore check that patients understand what is happening with their health. Assessing understanding is simply good medicine; for example, a good teacher ought to be asking an unimpaired patient without impaired cognition, “Can you say back to me the key points of what I explained?” With this approach, every patient is effectively “screened” for a capacity impairment.

Certain patients ought to trigger a more thorough examination of decisional abilities. Across multiple articles, the strongest factors associated with incapacity are older age and diminished cognitive function (often detected by MMSE scores below the low 20s).^1,7,10 Other factors that may amplify these deficits and thus should raise clinician concern would be patients with brain diseases such as Alzheimer’s or Parkinson’s, persons with lower education levels, or those who already have someone who helps them make decisions. To be sure, many older adults, even those with cognitive impairments, retain capacity, but extra protection should be in place to ensure their well-being.
 

Consequences of incapacity

If a careful assessment shows a patient has sound decision-making abilities, the patient is free to make the choice. On the other hand, a person does not have the capacity to make the decision at hand if he or she cannot communicate a choice or understand relevant information. Whether appreciation or reasoning ought to be assessed depends on the complexity and the significance of the decision. An assessment of decisional ability is not the end of the decision-making process. The goal is to maximize the patient’s autonomy.

Capacity can change over time. Factors that may inhibit capacity, such as medications, time of day, and even illness acuity, need to be accounted for and, if possible, addressed. The decision ought to be delayed, if possible, to a time when the patient has better chances of having capacity. If it is unlikely that patients’ status will change in the time frame needed to make the choice and they are found to not have capacity, then the decision making can be aided by advance directives or substitute decision makers such as family members or legal guardians.
 

Revisiting the case

Ms. F., who was delirious, retained notable decisional abilities. She understood the procedure of receiving the PEG tube and how the risk of continuing to not eat and not receive the PEG would result in dying by starvation. She appreciated her own diagnosis and how the proposed intervention could alter her condition. She appreciated how not having a PEG would lead to her death. Her choice to refuse the procedure was consistent. Ms. F. showed she retained capacity to make this decision. It was the physician’s duty to respect her autonomy and so to respect her refusal of the PEG.

Dr. Ney is a physician resident, department of psychiatry and human behavior, Thomas Jefferson University Hospital, Philadelphia. He has no conflicts to disclose. Dr. Karlawish is a professor in the departments of medicine, medical ethics and health policy, and neurology, University of Pennsylvania, Philadelphia. He is a site investigator for clinical trials sponsored by Biogen, Eisai, and Lilly.

References

1. Raymont V et al. Prevalence of mental incapacity in medical inpatients and associated risk factors: Cross-sectional study. Lancet. 2004;364(9443):1421-7. doi: 10.1016/S0140-6736(04)17224-3.

2. Hanson M and Pitt D. Informed consent for surgery: risk discussion and documentation. Can J Surg. 2017;60(1):69-70. doi: 10.1503/cjs.004816.

3. Dahlberg J et al. Lack of informed consent for surgical procedures by elderly patients with inability to consent: A retrospective chart review from an academic medical center in Norway. Patient Saf Surg. 2019;13:24. doi: 10.1186/s13037-019-0205-5.

4. Sessums LL et al. Does this patient have medical decision-making capacity? JAMA. 2011;306(4):420-7. doi: 10.1001/jama.2011.1023.

5. Terranova C et al. Ethical and medicolegal implications of capacity of patients in geriatric surgery. Med Sci Law. 2013;53(3):166-71. doi: 10.1177/0025802412473963.

6. John S et al. Assessing patients decision-making capacity in the hospital setting: A literature review. Aust J Rural Health. 2020;28(2):141-8. doi: 10.1111/ajr.12592.

7. Kim SYH et al. Do clinicians follow a risk-sensitive model of capacity-determination? An experimental video survey. Psychosomatics. 2006;47(4):325-9. doi: 10.1176/appi.psy.47.4.325.

8. Appelbaum PS. Assessment of patients’ competence to consent to treatment. N Engl J Med. 2007;357(18):1834-40. doi: 10.1056/NEJMcp074045.

9. Karlawish J. Measuring decision-making capacity in cognitively impaired individuals. Neurosignals. 2008;16(1):91-8. doi: 10.1159/000109763.

10. Christensen K et al. Decision-making capacity for informed consent in the older population. Bull Am Acad Psychiatry Law. 1995;23(3):353-65.

Case

Ms. F. is a 68-year-old woman who presented to the hospital with sepsis, developed delirium, and stopped eating. Her clinicians recommended a PEG tube. Although she was inconsistently oriented to self, time, and place, she reiterated the same decision across multiple discussions: She did not want the PEG tube. Her replies to what would happen if she didn’t have the procedure and continued not to eat were consistent, too: “I’ll wither away.”

Ms. F. had impaired cognition. Do these impairments mean her clinicians should over-rule her choice? What evidence indicates whether she lacks decision-making capacity? This case of a patient refusing a potentially life-saving procedure amplifies the importance of asking these questions and integrating capacity assessments into clinical care. In this article, we will describe what capacity is, when and how to assess it, and the alternatives when a patient does not have capacity.
 

The ethical background

Before starting a medical treatment or procedure, a physician must obtain the patient’s informed consent. This is a core ethic of medicine. Informed consent describes the voluntary decision made by a competent patient following the disclosure of necessary information. Informed consent is key to achieving a balance between promoting patient self-determination and protecting vulnerable patients from harm. In most clinical encounters, informed consent unfolds effortlessly. However, in the care of patients who are acutely ill, particularly those in hospitals, fulfilling the ethic can be challenging.

It is important to have skills to recognize and address these challenges. One of the most common challenges to practicing the ethic of informed consent is the impact of illness on a person’s decision-making capacity. A patient who retains capacity ought to make his or her decisions and does not need someone else (a friend or a family member) to help with the decision.

Incapacity is unfortunately common among the acutely ill medical inpatient population, which typically skews older with more comorbidities.¹ Impairments frequently are overlooked for a variety of reasons,^2-6 including that many hospitalized patients do not challenge their doctors’ decisions. Doctors may be reluctant to assess capacity because the assessment may medically, legally, or ethically complicate the patient’s care.

Two common terms describe the outcome of an assessment of a patient’s decision-making abilities: competency and capacity. Competency describes a legal principle. It is granted or withdrawn by judicial review. The consequences of a judge rescinding competency are severe: A patient would need a guardian to make choices on his or her behalf.

Capacity, on the other hand, is a clinical concept. A physician assesses whether the patient can make a specific decision in a specific context. The difference between the two terms – competency and capacity – delineates what are the consequences of the assessment and which authority, a judge or a physician, has the right to withdraw a person’s decision-making authority.

The judge offers a global assessment that can lead to a guardianship. The physician’s decision is temporal and situational. Patients can lack capacity when they are ill and recover it when they are healed. Capacity is specific to each medical decision that the patient makes and so a person can lack capacity to make some decisions but not others.
 

Ethical framework to make assessment

Capacity is described by four decisional abilities: 1) communicate a choice, 2) understand relevant information, 3) appreciation, and 4) reasoning.⁷

Communication of a choice may be verbal or nonverbal, but the patient must be able to indicate the treatment choice clearly and consistently. Understanding describes knowing essential information a physician has conveyed. This is assessed by having the patients say back what they were told, such as: “Can you tell me in your own words what is a PEG tube?”

The components of appreciation are: the diagnosis or disorder and the benefits and risks of the proposed intervention as it relates to the diagnosis or disorder. Patients who appreciate their disorder have insight into their condition: “I’m not eating because I have an infection.” This can be assessed with a question such as: “Can you tell me in your own words what are the risks or downsides to you?” This prompt assesses the patient’s appreciation of risk. Reframing the question to ask, “Can you tell me about the upsides of this intervention?” will assess the patient’s appreciation of benefit.

Reasoning assesses the thought process and rationale for a person’s decision. It has two components – comparative and consequential reasoning. The first compares the different choices presented about the proposed intervention: “How does having a PEG tube compare to not having it?” The second asks about the consequences of each choice: “What might happen to a person who has the PEG tube?”

The capacity assessment evaluates a patient's performance on these decision-making abilities. This informs the clinician’s judgment of whether the patient has the capacity to make a decision. A patient who has capacity makes the choice, regardless of the physician’s preference or recommendation.

The physician’s duty is to decide which decision-making abilities to assess. Choice and understanding are essential. In riskier or more consequential decisions, a physician may raise the rigor of the assessment to include appreciation and reasoning.⁸ It is common practice for physicians to raise the standard for when to evaluate and how extensive their evaluation is when the decision is life-altering, as with a PEG tube versus a more routine, non–life-altering decision such as drawing blood for a routine wellness visit.

A simple scoring rubric determines the patient’s ability to answer each question along a range from adequate = 2, marginal = 1, to inadequate = 0. The extremes or adequate or inadequate are straightforward. Judgment is needed when performance is marginal. In the case of repeated marginal answers, a physician must strongly consider whether the patient lacks capacity to make the decision in question.⁹

Who receives a capacity assessment and when?

A good doctor is a good teacher. A doctor should therefore check that patients understand what is happening with their health. Assessing understanding is simply good medicine; for example, a good teacher ought to be asking an unimpaired patient without impaired cognition, “Can you say back to me the key points of what I explained?” With this approach, every patient is effectively “screened” for a capacity impairment.

Certain patients ought to trigger a more thorough examination of decisional abilities. Across multiple articles, the strongest factors associated with incapacity are older age and diminished cognitive function (often detected by MMSE scores below the low 20s).^1,7,10 Other factors that may amplify these deficits and thus should raise clinician concern would be patients with brain diseases such as Alzheimer’s or Parkinson’s, persons with lower education levels, or those who already have someone who helps them make decisions. To be sure, many older adults, even those with cognitive impairments, retain capacity, but extra protection should be in place to ensure their well-being.
 

Consequences of incapacity

If a careful assessment shows a patient has sound decision-making abilities, the patient is free to make the choice. On the other hand, a person does not have the capacity to make the decision at hand if he or she cannot communicate a choice or understand relevant information. Whether appreciation or reasoning ought to be assessed depends on the complexity and the significance of the decision. An assessment of decisional ability is not the end of the decision-making process. The goal is to maximize the patient’s autonomy.

Capacity can change over time. Factors that may inhibit capacity, such as medications, time of day, and even illness acuity, need to be accounted for and, if possible, addressed. The decision ought to be delayed, if possible, to a time when the patient has better chances of having capacity. If it is unlikely that patients’ status will change in the time frame needed to make the choice and they are found to not have capacity, then the decision making can be aided by advance directives or substitute decision makers such as family members or legal guardians.
 

Revisiting the case

Ms. F., who was delirious, retained notable decisional abilities. She understood the procedure of receiving the PEG tube and how the risk of continuing to not eat and not receive the PEG would result in dying by starvation. She appreciated her own diagnosis and how the proposed intervention could alter her condition. She appreciated how not having a PEG would lead to her death. Her choice to refuse the procedure was consistent. Ms. F. showed she retained capacity to make this decision. It was the physician’s duty to respect her autonomy and so to respect her refusal of the PEG.

Dr. Ney is a physician resident, department of psychiatry and human behavior, Thomas Jefferson University Hospital, Philadelphia. He has no conflicts to disclose. Dr. Karlawish is a professor in the departments of medicine, medical ethics and health policy, and neurology, University of Pennsylvania, Philadelphia. He is a site investigator for clinical trials sponsored by Biogen, Eisai, and Lilly.

References

1. Raymont V et al. Prevalence of mental incapacity in medical inpatients and associated risk factors: Cross-sectional study. Lancet. 2004;364(9443):1421-7. doi: 10.1016/S0140-6736(04)17224-3.

2. Hanson M and Pitt D. Informed consent for surgery: risk discussion and documentation. Can J Surg. 2017;60(1):69-70. doi: 10.1503/cjs.004816.

3. Dahlberg J et al. Lack of informed consent for surgical procedures by elderly patients with inability to consent: A retrospective chart review from an academic medical center in Norway. Patient Saf Surg. 2019;13:24. doi: 10.1186/s13037-019-0205-5.

4. Sessums LL et al. Does this patient have medical decision-making capacity? JAMA. 2011;306(4):420-7. doi: 10.1001/jama.2011.1023.

5. Terranova C et al. Ethical and medicolegal implications of capacity of patients in geriatric surgery. Med Sci Law. 2013;53(3):166-71. doi: 10.1177/0025802412473963.

6. John S et al. Assessing patients decision-making capacity in the hospital setting: A literature review. Aust J Rural Health. 2020;28(2):141-8. doi: 10.1111/ajr.12592.

7. Kim SYH et al. Do clinicians follow a risk-sensitive model of capacity-determination? An experimental video survey. Psychosomatics. 2006;47(4):325-9. doi: 10.1176/appi.psy.47.4.325.

8. Appelbaum PS. Assessment of patients’ competence to consent to treatment. N Engl J Med. 2007;357(18):1834-40. doi: 10.1056/NEJMcp074045.

9. Karlawish J. Measuring decision-making capacity in cognitively impaired individuals. Neurosignals. 2008;16(1):91-8. doi: 10.1159/000109763.

10. Christensen K et al. Decision-making capacity for informed consent in the older population. Bull Am Acad Psychiatry Law. 1995;23(3):353-65.

Case

Ms. F. is a 68-year-old woman who presented to the hospital with sepsis, developed delirium, and stopped eating. Her clinicians recommended a PEG tube. Although she was inconsistently oriented to self, time, and place, she reiterated the same decision across multiple discussions: She did not want the PEG tube. Her replies to what would happen if she didn’t have the procedure and continued not to eat were consistent, too: “I’ll wither away.”

Ms. F. had impaired cognition. Do these impairments mean her clinicians should over-rule her choice? What evidence indicates whether she lacks decision-making capacity? This case of a patient refusing a potentially life-saving procedure amplifies the importance of asking these questions and integrating capacity assessments into clinical care. In this article, we will describe what capacity is, when and how to assess it, and the alternatives when a patient does not have capacity.
 

The ethical background

Before starting a medical treatment or procedure, a physician must obtain the patient’s informed consent. This is a core ethic of medicine. Informed consent describes the voluntary decision made by a competent patient following the disclosure of necessary information. Informed consent is key to achieving a balance between promoting patient self-determination and protecting vulnerable patients from harm. In most clinical encounters, informed consent unfolds effortlessly. However, in the care of patients who are acutely ill, particularly those in hospitals, fulfilling the ethic can be challenging.

It is important to have skills to recognize and address these challenges. One of the most common challenges to practicing the ethic of informed consent is the impact of illness on a person’s decision-making capacity. A patient who retains capacity ought to make his or her decisions and does not need someone else (a friend or a family member) to help with the decision.

Incapacity is unfortunately common among the acutely ill medical inpatient population, which typically skews older with more comorbidities.¹ Impairments frequently are overlooked for a variety of reasons,^2-6 including that many hospitalized patients do not challenge their doctors’ decisions. Doctors may be reluctant to assess capacity because the assessment may medically, legally, or ethically complicate the patient’s care.

Two common terms describe the outcome of an assessment of a patient’s decision-making abilities: competency and capacity. Competency describes a legal principle. It is granted or withdrawn by judicial review. The consequences of a judge rescinding competency are severe: A patient would need a guardian to make choices on his or her behalf.

Capacity, on the other hand, is a clinical concept. A physician assesses whether the patient can make a specific decision in a specific context. The difference between the two terms – competency and capacity – delineates what are the consequences of the assessment and which authority, a judge or a physician, has the right to withdraw a person’s decision-making authority.

The judge offers a global assessment that can lead to a guardianship. The physician’s decision is temporal and situational. Patients can lack capacity when they are ill and recover it when they are healed. Capacity is specific to each medical decision that the patient makes and so a person can lack capacity to make some decisions but not others.
 

Ethical framework to make assessment

Capacity is described by four decisional abilities: 1) communicate a choice, 2) understand relevant information, 3) appreciation, and 4) reasoning.⁷

Communication of a choice may be verbal or nonverbal, but the patient must be able to indicate the treatment choice clearly and consistently. Understanding describes knowing essential information a physician has conveyed. This is assessed by having the patients say back what they were told, such as: “Can you tell me in your own words what is a PEG tube?”

The components of appreciation are: the diagnosis or disorder and the benefits and risks of the proposed intervention as it relates to the diagnosis or disorder. Patients who appreciate their disorder have insight into their condition: “I’m not eating because I have an infection.” This can be assessed with a question such as: “Can you tell me in your own words what are the risks or downsides to you?” This prompt assesses the patient’s appreciation of risk. Reframing the question to ask, “Can you tell me about the upsides of this intervention?” will assess the patient’s appreciation of benefit.

Reasoning assesses the thought process and rationale for a person’s decision. It has two components – comparative and consequential reasoning. The first compares the different choices presented about the proposed intervention: “How does having a PEG tube compare to not having it?” The second asks about the consequences of each choice: “What might happen to a person who has the PEG tube?”

The capacity assessment evaluates a patient's performance on these decision-making abilities. This informs the clinician’s judgment of whether the patient has the capacity to make a decision. A patient who has capacity makes the choice, regardless of the physician’s preference or recommendation.

The physician’s duty is to decide which decision-making abilities to assess. Choice and understanding are essential. In riskier or more consequential decisions, a physician may raise the rigor of the assessment to include appreciation and reasoning.⁸ It is common practice for physicians to raise the standard for when to evaluate and how extensive their evaluation is when the decision is life-altering, as with a PEG tube versus a more routine, non–life-altering decision such as drawing blood for a routine wellness visit.

A simple scoring rubric determines the patient’s ability to answer each question along a range from adequate = 2, marginal = 1, to inadequate = 0. The extremes or adequate or inadequate are straightforward. Judgment is needed when performance is marginal. In the case of repeated marginal answers, a physician must strongly consider whether the patient lacks capacity to make the decision in question.⁹

Who receives a capacity assessment and when?

A good doctor is a good teacher. A doctor should therefore check that patients understand what is happening with their health. Assessing understanding is simply good medicine; for example, a good teacher ought to be asking an unimpaired patient without impaired cognition, “Can you say back to me the key points of what I explained?” With this approach, every patient is effectively “screened” for a capacity impairment.

Certain patients ought to trigger a more thorough examination of decisional abilities. Across multiple articles, the strongest factors associated with incapacity are older age and diminished cognitive function (often detected by MMSE scores below the low 20s).^1,7,10 Other factors that may amplify these deficits and thus should raise clinician concern would be patients with brain diseases such as Alzheimer’s or Parkinson’s, persons with lower education levels, or those who already have someone who helps them make decisions. To be sure, many older adults, even those with cognitive impairments, retain capacity, but extra protection should be in place to ensure their well-being.
 

Consequences of incapacity

If a careful assessment shows a patient has sound decision-making abilities, the patient is free to make the choice. On the other hand, a person does not have the capacity to make the decision at hand if he or she cannot communicate a choice or understand relevant information. Whether appreciation or reasoning ought to be assessed depends on the complexity and the significance of the decision. An assessment of decisional ability is not the end of the decision-making process. The goal is to maximize the patient’s autonomy.

Capacity can change over time. Factors that may inhibit capacity, such as medications, time of day, and even illness acuity, need to be accounted for and, if possible, addressed. The decision ought to be delayed, if possible, to a time when the patient has better chances of having capacity. If it is unlikely that patients’ status will change in the time frame needed to make the choice and they are found to not have capacity, then the decision making can be aided by advance directives or substitute decision makers such as family members or legal guardians.
 

Revisiting the case

Ms. F., who was delirious, retained notable decisional abilities. She understood the procedure of receiving the PEG tube and how the risk of continuing to not eat and not receive the PEG would result in dying by starvation. She appreciated her own diagnosis and how the proposed intervention could alter her condition. She appreciated how not having a PEG would lead to her death. Her choice to refuse the procedure was consistent. Ms. F. showed she retained capacity to make this decision. It was the physician’s duty to respect her autonomy and so to respect her refusal of the PEG.

Dr. Ney is a physician resident, department of psychiatry and human behavior, Thomas Jefferson University Hospital, Philadelphia. He has no conflicts to disclose. Dr. Karlawish is a professor in the departments of medicine, medical ethics and health policy, and neurology, University of Pennsylvania, Philadelphia. He is a site investigator for clinical trials sponsored by Biogen, Eisai, and Lilly.

References

1. Raymont V et al. Prevalence of mental incapacity in medical inpatients and associated risk factors: Cross-sectional study. Lancet. 2004;364(9443):1421-7. doi: 10.1016/S0140-6736(04)17224-3.

2. Hanson M and Pitt D. Informed consent for surgery: risk discussion and documentation. Can J Surg. 2017;60(1):69-70. doi: 10.1503/cjs.004816.

3. Dahlberg J et al. Lack of informed consent for surgical procedures by elderly patients with inability to consent: A retrospective chart review from an academic medical center in Norway. Patient Saf Surg. 2019;13:24. doi: 10.1186/s13037-019-0205-5.

4. Sessums LL et al. Does this patient have medical decision-making capacity? JAMA. 2011;306(4):420-7. doi: 10.1001/jama.2011.1023.

5. Terranova C et al. Ethical and medicolegal implications of capacity of patients in geriatric surgery. Med Sci Law. 2013;53(3):166-71. doi: 10.1177/0025802412473963.

6. John S et al. Assessing patients decision-making capacity in the hospital setting: A literature review. Aust J Rural Health. 2020;28(2):141-8. doi: 10.1111/ajr.12592.

7. Kim SYH et al. Do clinicians follow a risk-sensitive model of capacity-determination? An experimental video survey. Psychosomatics. 2006;47(4):325-9. doi: 10.1176/appi.psy.47.4.325.

8. Appelbaum PS. Assessment of patients’ competence to consent to treatment. N Engl J Med. 2007;357(18):1834-40. doi: 10.1056/NEJMcp074045.

9. Karlawish J. Measuring decision-making capacity in cognitively impaired individuals. Neurosignals. 2008;16(1):91-8. doi: 10.1159/000109763.

10. Christensen K et al. Decision-making capacity for informed consent in the older population. Bull Am Acad Psychiatry Law. 1995;23(3):353-65.

A dolutegravir-based treatment regimen holds its own as a first choice of antiretroviral therapy (ART) for pregnant individuals, based on data from more than 1,200 patients.

“Dolutegravir is increasingly used in pregnancy in the United States,” Kunjal Patel, DSc, one of the investigators, said in an interview. “While its effectiveness and safety in pregnancy have been compared to efavirenz in previous studies, including three randomized trials, efavirenz isn’t really used in the United States and Europe for treatment of HIV; it is mainly used in Africa,” she said. Therefore, it was important to compare dolutegravir use in pregnancy to the other antiretroviral regimens that are listed as being preferred for use in pregnancy in the U.S., including atazanavir/ritonavir, darunavir/ritonavir, and raltegravir, and others often used in the U.S. and Europe, she said.

In the study published in the New England Journal of Medicine, Dr. Patel, of Harvard T.H. Chan School of Public Health, Boston, and colleagues analyzed data from kids enrolled in the Surveillance and Monitoring for ART Toxicities Dynamic (SMARTT) cohort. This group is part of an ongoing research project focused on evaluating ART toxicities during pregnancy in children who were exposed to HIV perinatally but not infected. It included pregnancies from 2007 until January 2020 that involved use of the ARTs listed.

The study population of 1,257 pregnancies with observed birth outcomes included 120 individuals with an initial ART of dolutegravir (DTG), 464 started on atazanavir–ritonavir (ATV/r), 185 on darunavir–ritonavir (DRV/r), 243 on oral rilpivirine (RPV), 86 on raltegravir (RAL), and 159 on elvitegravir–cobicistat (EVG/c). In approximately half of the pregnancies (51%), ART was started before conception, and the initial ART was changed in 27%.

The primary outcomes were viral suppression at delivery, and adverse birth outcomes, including preterm and very preterm birth, low and very low birth weight, and neonatal death within 14 days.

The median age of the patients at conception was 29 years, and 66% were non-Hispanic Black, representative of persons with HIV of childbearing age in the United States, the researchers noted. Overall, 96.7% of the patients who received dolutegravir showed viral suppression at delivery, compared to 90.1% for darunavir–ritonavir, 89.8% for elvitegravir–cobicistat, 89.2% for raltegravir, and 84.0% for atazanavir–ritonavir.

“We expected that dolutegravir to be similar with regards to viral suppression at delivery compared to raltegravir so were surprised that we observed less viral suppression with raltegravir compared to dolutegravir,” Dr. Patel said in an interview. “Our results may be due to the higher pill burden and lower barrier to resistance with RAL compared to dolutegravir, but we did not assess adherence or resistance in our study,” she noted.

Across ART regimens, the observed risks of preterm birth ranged from 13.6% to 17.6%, risks of low birth weight ranged from 11.9% to 16.7%, and risks of being small for gestational age ranged from 9.1% to 12.5%. For the composite of any adverse birth outcome and any severe adverse birth outcome, the observed risks ranged from 22.6% to 27.9% and 0% to 4.2%, respectively.

A total of 20 very preterm births, including 15 infants with very low birth weight, occurred across patients receiving all ART regimens, and no neonatal deaths occurred. The researchers found no apparent patterns of differences in the observed risk of adverse birth outcomes across all groups related to the timing of ART initiation in pregnancy, but the risks were greater among those who began the drugs during pregnancy compared to those who began before conception.

“Our results confirm the recommendation of DTG as “preferred” in U.S. perinatal guidelines, and provide evidence suggesting ATV/r and RAL provides lower HIV viral suppression at delivery compared to DTG, and support DRV/r as a reasonable alternative when DTG use is not feasible,” Dr. Patel said in an interview.

“With regards to next steps, we are interested in comparing the effectiveness and safety of dolutegravir-based regimens that include tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF) in our U.S. setting,” she said.

The study findings were limited by several factors including the lack of data on predictors of preterm birth and low birth weight, such as previous preterm birth and prepregnancy body mass index, the researchers noted.

However, the results indicate that other common ARTs provide less HIV viral suppression at delivery than dolutegravir, with similar adverse birth outcomes; the results also support darunavir–ritonavir as a reasonable alternative when dolutegravir use is not feasible, as it showed the next highest level of viral suppression after dolutegravir, the researchers concluded.
 

Findings fill a key research gap

The current study is important given the limited data on effectiveness and outcomes in pregnancy with the use of contemporary HIV regimens in the United States, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.

“Pregnancy is still among exclusion criteria for most drug studies,” said Dr. Badell, who was not involved in the current study. “Dolutegravir-based ART is first line in the U.S. today because of its effectiveness, lower side effects, and higher barrier to resistance; therefore understanding the benefits and birth outcomes in pregnancy is critical,” she explained.

Dr. Badell said she was not surprised by the study findings. “However it is very reassuring to see in a large observational study comparing the dolutegravir regimens to other contemporary regimens in pregnancy, such a high level of viral suppression and no increased risk of adverse perinatal outcomes,” she said.

The study findings will impact clinical practice by reaffirming patient counseling regarding the use of dolutegravir in pregnancy, said Dr. Badell. “The use of ART in pregnancy is complex given the number of drug choices, whether the patient was on ART prior to pregnancy or initiated during pregnancy, and the various factors other than ART that affect perinatal outcomes, such as preterm birth and congenital anomalies, she explained.

The finding that the risk of adverse outcomes was higher for those who initiated ART during pregnancy vs. those who were already on ARTs when they became pregnant contradicts some previous research, said Dr. Badell. But this is “reassuring, as we highly recommend ART with viral suppression prior to pregnancy or to start as early as possible in pregnancy.”

Adverse birth outcomes can be affected by many variables such as age, substance abuse, prior adverse birth outcome and other factors, and larger studies that control for these variables will allow better evaluation of the effect of the ART drugs, Dr. Badell added.

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, along with the Office of the Director, National Institutes of Health; National Institute of Dental and Craniofacial Research; National Institute of Allergy and Infectious Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; National Institute of Mental Health; National Institute on Drug Abuse; National Cancer Institute; National Institute on Alcohol Abuse and Alcoholism; and National Heart, Lung, and Blood Institute through cooperative agreements with the Harvard T.H. Chan School of Public Health and the Tulane University School of Medicine.

The researchers and Dr. Badell had no financial conflicts to disclose.

A dolutegravir-based treatment regimen holds its own as a first choice of antiretroviral therapy (ART) for pregnant individuals, based on data from more than 1,200 patients.

“Dolutegravir is increasingly used in pregnancy in the United States,” Kunjal Patel, DSc, one of the investigators, said in an interview. “While its effectiveness and safety in pregnancy have been compared to efavirenz in previous studies, including three randomized trials, efavirenz isn’t really used in the United States and Europe for treatment of HIV; it is mainly used in Africa,” she said. Therefore, it was important to compare dolutegravir use in pregnancy to the other antiretroviral regimens that are listed as being preferred for use in pregnancy in the U.S., including atazanavir/ritonavir, darunavir/ritonavir, and raltegravir, and others often used in the U.S. and Europe, she said.

In the study published in the New England Journal of Medicine, Dr. Patel, of Harvard T.H. Chan School of Public Health, Boston, and colleagues analyzed data from kids enrolled in the Surveillance and Monitoring for ART Toxicities Dynamic (SMARTT) cohort. This group is part of an ongoing research project focused on evaluating ART toxicities during pregnancy in children who were exposed to HIV perinatally but not infected. It included pregnancies from 2007 until January 2020 that involved use of the ARTs listed.

The study population of 1,257 pregnancies with observed birth outcomes included 120 individuals with an initial ART of dolutegravir (DTG), 464 started on atazanavir–ritonavir (ATV/r), 185 on darunavir–ritonavir (DRV/r), 243 on oral rilpivirine (RPV), 86 on raltegravir (RAL), and 159 on elvitegravir–cobicistat (EVG/c). In approximately half of the pregnancies (51%), ART was started before conception, and the initial ART was changed in 27%.

The primary outcomes were viral suppression at delivery, and adverse birth outcomes, including preterm and very preterm birth, low and very low birth weight, and neonatal death within 14 days.

The median age of the patients at conception was 29 years, and 66% were non-Hispanic Black, representative of persons with HIV of childbearing age in the United States, the researchers noted. Overall, 96.7% of the patients who received dolutegravir showed viral suppression at delivery, compared to 90.1% for darunavir–ritonavir, 89.8% for elvitegravir–cobicistat, 89.2% for raltegravir, and 84.0% for atazanavir–ritonavir.

“We expected that dolutegravir to be similar with regards to viral suppression at delivery compared to raltegravir so were surprised that we observed less viral suppression with raltegravir compared to dolutegravir,” Dr. Patel said in an interview. “Our results may be due to the higher pill burden and lower barrier to resistance with RAL compared to dolutegravir, but we did not assess adherence or resistance in our study,” she noted.

Across ART regimens, the observed risks of preterm birth ranged from 13.6% to 17.6%, risks of low birth weight ranged from 11.9% to 16.7%, and risks of being small for gestational age ranged from 9.1% to 12.5%. For the composite of any adverse birth outcome and any severe adverse birth outcome, the observed risks ranged from 22.6% to 27.9% and 0% to 4.2%, respectively.

A total of 20 very preterm births, including 15 infants with very low birth weight, occurred across patients receiving all ART regimens, and no neonatal deaths occurred. The researchers found no apparent patterns of differences in the observed risk of adverse birth outcomes across all groups related to the timing of ART initiation in pregnancy, but the risks were greater among those who began the drugs during pregnancy compared to those who began before conception.

“Our results confirm the recommendation of DTG as “preferred” in U.S. perinatal guidelines, and provide evidence suggesting ATV/r and RAL provides lower HIV viral suppression at delivery compared to DTG, and support DRV/r as a reasonable alternative when DTG use is not feasible,” Dr. Patel said in an interview.

“With regards to next steps, we are interested in comparing the effectiveness and safety of dolutegravir-based regimens that include tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF) in our U.S. setting,” she said.

The study findings were limited by several factors including the lack of data on predictors of preterm birth and low birth weight, such as previous preterm birth and prepregnancy body mass index, the researchers noted.

However, the results indicate that other common ARTs provide less HIV viral suppression at delivery than dolutegravir, with similar adverse birth outcomes; the results also support darunavir–ritonavir as a reasonable alternative when dolutegravir use is not feasible, as it showed the next highest level of viral suppression after dolutegravir, the researchers concluded.
 

Findings fill a key research gap

The current study is important given the limited data on effectiveness and outcomes in pregnancy with the use of contemporary HIV regimens in the United States, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.

“Pregnancy is still among exclusion criteria for most drug studies,” said Dr. Badell, who was not involved in the current study. “Dolutegravir-based ART is first line in the U.S. today because of its effectiveness, lower side effects, and higher barrier to resistance; therefore understanding the benefits and birth outcomes in pregnancy is critical,” she explained.

Dr. Badell said she was not surprised by the study findings. “However it is very reassuring to see in a large observational study comparing the dolutegravir regimens to other contemporary regimens in pregnancy, such a high level of viral suppression and no increased risk of adverse perinatal outcomes,” she said.

The study findings will impact clinical practice by reaffirming patient counseling regarding the use of dolutegravir in pregnancy, said Dr. Badell. “The use of ART in pregnancy is complex given the number of drug choices, whether the patient was on ART prior to pregnancy or initiated during pregnancy, and the various factors other than ART that affect perinatal outcomes, such as preterm birth and congenital anomalies, she explained.

The finding that the risk of adverse outcomes was higher for those who initiated ART during pregnancy vs. those who were already on ARTs when they became pregnant contradicts some previous research, said Dr. Badell. But this is “reassuring, as we highly recommend ART with viral suppression prior to pregnancy or to start as early as possible in pregnancy.”

Adverse birth outcomes can be affected by many variables such as age, substance abuse, prior adverse birth outcome and other factors, and larger studies that control for these variables will allow better evaluation of the effect of the ART drugs, Dr. Badell added.

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, along with the Office of the Director, National Institutes of Health; National Institute of Dental and Craniofacial Research; National Institute of Allergy and Infectious Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; National Institute of Mental Health; National Institute on Drug Abuse; National Cancer Institute; National Institute on Alcohol Abuse and Alcoholism; and National Heart, Lung, and Blood Institute through cooperative agreements with the Harvard T.H. Chan School of Public Health and the Tulane University School of Medicine.

The researchers and Dr. Badell had no financial conflicts to disclose.

A dolutegravir-based treatment regimen holds its own as a first choice of antiretroviral therapy (ART) for pregnant individuals, based on data from more than 1,200 patients.

“Dolutegravir is increasingly used in pregnancy in the United States,” Kunjal Patel, DSc, one of the investigators, said in an interview. “While its effectiveness and safety in pregnancy have been compared to efavirenz in previous studies, including three randomized trials, efavirenz isn’t really used in the United States and Europe for treatment of HIV; it is mainly used in Africa,” she said. Therefore, it was important to compare dolutegravir use in pregnancy to the other antiretroviral regimens that are listed as being preferred for use in pregnancy in the U.S., including atazanavir/ritonavir, darunavir/ritonavir, and raltegravir, and others often used in the U.S. and Europe, she said.

In the study published in the New England Journal of Medicine, Dr. Patel, of Harvard T.H. Chan School of Public Health, Boston, and colleagues analyzed data from kids enrolled in the Surveillance and Monitoring for ART Toxicities Dynamic (SMARTT) cohort. This group is part of an ongoing research project focused on evaluating ART toxicities during pregnancy in children who were exposed to HIV perinatally but not infected. It included pregnancies from 2007 until January 2020 that involved use of the ARTs listed.

The study population of 1,257 pregnancies with observed birth outcomes included 120 individuals with an initial ART of dolutegravir (DTG), 464 started on atazanavir–ritonavir (ATV/r), 185 on darunavir–ritonavir (DRV/r), 243 on oral rilpivirine (RPV), 86 on raltegravir (RAL), and 159 on elvitegravir–cobicistat (EVG/c). In approximately half of the pregnancies (51%), ART was started before conception, and the initial ART was changed in 27%.

The primary outcomes were viral suppression at delivery, and adverse birth outcomes, including preterm and very preterm birth, low and very low birth weight, and neonatal death within 14 days.

The median age of the patients at conception was 29 years, and 66% were non-Hispanic Black, representative of persons with HIV of childbearing age in the United States, the researchers noted. Overall, 96.7% of the patients who received dolutegravir showed viral suppression at delivery, compared to 90.1% for darunavir–ritonavir, 89.8% for elvitegravir–cobicistat, 89.2% for raltegravir, and 84.0% for atazanavir–ritonavir.

“We expected that dolutegravir to be similar with regards to viral suppression at delivery compared to raltegravir so were surprised that we observed less viral suppression with raltegravir compared to dolutegravir,” Dr. Patel said in an interview. “Our results may be due to the higher pill burden and lower barrier to resistance with RAL compared to dolutegravir, but we did not assess adherence or resistance in our study,” she noted.

Across ART regimens, the observed risks of preterm birth ranged from 13.6% to 17.6%, risks of low birth weight ranged from 11.9% to 16.7%, and risks of being small for gestational age ranged from 9.1% to 12.5%. For the composite of any adverse birth outcome and any severe adverse birth outcome, the observed risks ranged from 22.6% to 27.9% and 0% to 4.2%, respectively.

A total of 20 very preterm births, including 15 infants with very low birth weight, occurred across patients receiving all ART regimens, and no neonatal deaths occurred. The researchers found no apparent patterns of differences in the observed risk of adverse birth outcomes across all groups related to the timing of ART initiation in pregnancy, but the risks were greater among those who began the drugs during pregnancy compared to those who began before conception.

“Our results confirm the recommendation of DTG as “preferred” in U.S. perinatal guidelines, and provide evidence suggesting ATV/r and RAL provides lower HIV viral suppression at delivery compared to DTG, and support DRV/r as a reasonable alternative when DTG use is not feasible,” Dr. Patel said in an interview.

“With regards to next steps, we are interested in comparing the effectiveness and safety of dolutegravir-based regimens that include tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF) in our U.S. setting,” she said.

The study findings were limited by several factors including the lack of data on predictors of preterm birth and low birth weight, such as previous preterm birth and prepregnancy body mass index, the researchers noted.

However, the results indicate that other common ARTs provide less HIV viral suppression at delivery than dolutegravir, with similar adverse birth outcomes; the results also support darunavir–ritonavir as a reasonable alternative when dolutegravir use is not feasible, as it showed the next highest level of viral suppression after dolutegravir, the researchers concluded.
 

Findings fill a key research gap

The current study is important given the limited data on effectiveness and outcomes in pregnancy with the use of contemporary HIV regimens in the United States, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.

“Pregnancy is still among exclusion criteria for most drug studies,” said Dr. Badell, who was not involved in the current study. “Dolutegravir-based ART is first line in the U.S. today because of its effectiveness, lower side effects, and higher barrier to resistance; therefore understanding the benefits and birth outcomes in pregnancy is critical,” she explained.

Dr. Badell said she was not surprised by the study findings. “However it is very reassuring to see in a large observational study comparing the dolutegravir regimens to other contemporary regimens in pregnancy, such a high level of viral suppression and no increased risk of adverse perinatal outcomes,” she said.

The study findings will impact clinical practice by reaffirming patient counseling regarding the use of dolutegravir in pregnancy, said Dr. Badell. “The use of ART in pregnancy is complex given the number of drug choices, whether the patient was on ART prior to pregnancy or initiated during pregnancy, and the various factors other than ART that affect perinatal outcomes, such as preterm birth and congenital anomalies, she explained.

The finding that the risk of adverse outcomes was higher for those who initiated ART during pregnancy vs. those who were already on ARTs when they became pregnant contradicts some previous research, said Dr. Badell. But this is “reassuring, as we highly recommend ART with viral suppression prior to pregnancy or to start as early as possible in pregnancy.”

Adverse birth outcomes can be affected by many variables such as age, substance abuse, prior adverse birth outcome and other factors, and larger studies that control for these variables will allow better evaluation of the effect of the ART drugs, Dr. Badell added.

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, along with the Office of the Director, National Institutes of Health; National Institute of Dental and Craniofacial Research; National Institute of Allergy and Infectious Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; National Institute of Mental Health; National Institute on Drug Abuse; National Cancer Institute; National Institute on Alcohol Abuse and Alcoholism; and National Heart, Lung, and Blood Institute through cooperative agreements with the Harvard T.H. Chan School of Public Health and the Tulane University School of Medicine.

The researchers and Dr. Badell had no financial conflicts to disclose.

Purpose

To assess promoters and obstacles of enrollment in a decentralized clinical research study, where veterans with cancer-related depressive symptoms are electronically prescribed a 10-session digitally administered Cognitive-Behavioral Stress Management (CBSM) program, called Attune.

Background

The US Department of Veterans Affairs (VA) National TeleOncology (NTO) Program has served 5688 veterans since inception, 3100 of which reside in rural areas (55%). Previous studies demonstrate clinically significant levels of psychosocial distress in up to 52% of patients with cancer. It is unknown if veterans with cancer experiencing psychosocial distress will benefit from a CBSM app. Traditional research studies often underrepresent rural cancer patients, so the VA-Attune clinical trial was designed for implementation in a decentralized fashion for NTO VA facilities serving a more predominant rural population.

Methods

We manually screened veteran appointments to identify potentially eligible veterans. NTO providers were notified if their patients were potentially eligible, providers asked patients if they wanted more information. Research staff then contacted veterans by telephone to confirm eligibility. Consent and HIPAA authorization were mailed to interested veterans and the consent process occurred via telephone. Descriptive statistics were used to summarize the patient population screened and consented.

Results

Between January and May 2022, there were 467 veterans screened and 15 veterans enrolled (mean [SD] age, 67.2 [8.28] years; 12 men and 3 women). 15 veterans received the electronic prescription of the Attune App and providers viewed the CBSM App as feasible. Promotors of implementation included convenience of a virtual format and use of the veteran’s mobile device to deliver the digital CBSM. Barriers identified by veterans were not having an appropriate mobile device, inadequate knowledge on using a mobile device, and insufficient time to commit to regularly using the Attune app.

Conclusions/Implications

This VA-Attune study demonstrated that clinical trials can be implemented in the VA in a decentralized fashion, enrolling rural and urban veterans. We identified significant barriers to enrollment and engagement despite our approach of remote consent. The VA-Attune research study continues to enroll veterans nationally, highlighting best practices and opportunities to improve the implementation of decentralized cancer clinical trials in the VA.

Purpose

To assess promoters and obstacles of enrollment in a decentralized clinical research study, where veterans with cancer-related depressive symptoms are electronically prescribed a 10-session digitally administered Cognitive-Behavioral Stress Management (CBSM) program, called Attune.

Background

The US Department of Veterans Affairs (VA) National TeleOncology (NTO) Program has served 5688 veterans since inception, 3100 of which reside in rural areas (55%). Previous studies demonstrate clinically significant levels of psychosocial distress in up to 52% of patients with cancer. It is unknown if veterans with cancer experiencing psychosocial distress will benefit from a CBSM app. Traditional research studies often underrepresent rural cancer patients, so the VA-Attune clinical trial was designed for implementation in a decentralized fashion for NTO VA facilities serving a more predominant rural population.

Methods

We manually screened veteran appointments to identify potentially eligible veterans. NTO providers were notified if their patients were potentially eligible, providers asked patients if they wanted more information. Research staff then contacted veterans by telephone to confirm eligibility. Consent and HIPAA authorization were mailed to interested veterans and the consent process occurred via telephone. Descriptive statistics were used to summarize the patient population screened and consented.

Results

Between January and May 2022, there were 467 veterans screened and 15 veterans enrolled (mean [SD] age, 67.2 [8.28] years; 12 men and 3 women). 15 veterans received the electronic prescription of the Attune App and providers viewed the CBSM App as feasible. Promotors of implementation included convenience of a virtual format and use of the veteran’s mobile device to deliver the digital CBSM. Barriers identified by veterans were not having an appropriate mobile device, inadequate knowledge on using a mobile device, and insufficient time to commit to regularly using the Attune app.

Conclusions/Implications

This VA-Attune study demonstrated that clinical trials can be implemented in the VA in a decentralized fashion, enrolling rural and urban veterans. We identified significant barriers to enrollment and engagement despite our approach of remote consent. The VA-Attune research study continues to enroll veterans nationally, highlighting best practices and opportunities to improve the implementation of decentralized cancer clinical trials in the VA.

Purpose

To assess promoters and obstacles of enrollment in a decentralized clinical research study, where veterans with cancer-related depressive symptoms are electronically prescribed a 10-session digitally administered Cognitive-Behavioral Stress Management (CBSM) program, called Attune.

Background

The US Department of Veterans Affairs (VA) National TeleOncology (NTO) Program has served 5688 veterans since inception, 3100 of which reside in rural areas (55%). Previous studies demonstrate clinically significant levels of psychosocial distress in up to 52% of patients with cancer. It is unknown if veterans with cancer experiencing psychosocial distress will benefit from a CBSM app. Traditional research studies often underrepresent rural cancer patients, so the VA-Attune clinical trial was designed for implementation in a decentralized fashion for NTO VA facilities serving a more predominant rural population.

Methods

We manually screened veteran appointments to identify potentially eligible veterans. NTO providers were notified if their patients were potentially eligible, providers asked patients if they wanted more information. Research staff then contacted veterans by telephone to confirm eligibility. Consent and HIPAA authorization were mailed to interested veterans and the consent process occurred via telephone. Descriptive statistics were used to summarize the patient population screened and consented.

Results

Between January and May 2022, there were 467 veterans screened and 15 veterans enrolled (mean [SD] age, 67.2 [8.28] years; 12 men and 3 women). 15 veterans received the electronic prescription of the Attune App and providers viewed the CBSM App as feasible. Promotors of implementation included convenience of a virtual format and use of the veteran’s mobile device to deliver the digital CBSM. Barriers identified by veterans were not having an appropriate mobile device, inadequate knowledge on using a mobile device, and insufficient time to commit to regularly using the Attune app.

Conclusions/Implications

This VA-Attune study demonstrated that clinical trials can be implemented in the VA in a decentralized fashion, enrolling rural and urban veterans. We identified significant barriers to enrollment and engagement despite our approach of remote consent. The VA-Attune research study continues to enroll veterans nationally, highlighting best practices and opportunities to improve the implementation of decentralized cancer clinical trials in the VA.

When a mass shooting happens, another often follows in close succession. That’s not just a feeling – it’s a fact.

The devastating shooting on May 24 in Uvalde, Tex., which killed 19 children, two teachers, and injured 17 others, occurred 10 days after a supermarket shooting in Buffalo, N.Y., which resulted in 10 deaths. In 2021, a shooting at a massage parlor in Atlanta, which left eight dead, came less than a week before a shooting at a supermarket in Boulder, Colo., that killed 10. And a 2019 shooting in Dayton, Ohio, on Aug. 4 that killed nine people took place only a day after a Walmart shooting in El Paso, Tex., which claimed 22 lives.
 

Contagion theory

Researchers argue that the clustering of mass shootings suggests that this type of violence spreads like a virus and should be treated as one.

This theory – called the “contagion effect” – has been examined at length in cases of suicide, especially among teens and young adults. Studies have demonstrated that the majority of adolescents who attempt suicide have previously been exposed to the suicidal behavior of a peer.

In many cases, mass shootings are also suicides, with shooters taking their own lives at the time of the shooting or not long after.

“They have literally and figuratively given up on their life as they know it.” said Joel Dvoskin, PhD, a clinical and forensic psychologist at the University of Arizona, Tucson, and former acting commissioner of mental health for New York state.

According to contagion theory, mass shootings – and the round-the-clock media coverage they generate – lead to even more killings.

A team of researchers at Arizona State University led by Sherry Towers, PhD, analyzed mass shooting data in 2015 to find out whether those events followed a similar pattern. Dr. Towers spent much of her career modeling the spread of infectious diseases, such as influenza, Ebola, and Zika.

Dr. Towers and colleagues discovered that a mass killing tended to give rise to more killings in its immediate aftermath. According to her evaluation of USA Today’s mass shooting database, a second incident was most likely to occur within 13 days of the initial event.
 

What defines a mass shooting?

The FBI defines a mass shooting as any incident in which four or more people die by gunfire. That definition, however, is not universally accepted. The lack of a standard definition complicates the work of researchers who study contagion theory.

Mother Jones magazine created an open-source database of mass killings that employs a similar definition but that includes only incidents that involve a person shooting indiscriminately in a public place.

With this narrower definition, shootings involving organized crime, robberies, and domestic violence – which make up the vast majority of shootings in which multiple fatalities occur in this country – are excluded. Events such as those that occurred in Sandy Hook or the killings in Highland Park, Ill.,  this past July would be included.

The Gun Violence Archive categorizes mass shootings as any incident in which four or more people are shot but not necessarily killed, while Everytown for Gun Safety tallies mass shootings that take at least four lives.

James Meindl, PhD, a professor of behavioral analysis at the University of Memphis who studies mass shootings, said parsing the differences between what happened in Uvalde and what happens during a shooting involving organized crime or domestic violence is crucial when thinking about intervention and prevention.

“If you want to intervene, you have to know why the person engaged in this behavior in the first place,” Dr. Meindl said. “The factors that led a person to commit gang violence, the factors in domestic violence, the factors in indiscriminate mass shootings – those are all very different factors that would call for very different interventions.”
 

So, should mass shootings be treated like an infectious disease?

Rather than using contagion theory, Dr. Meindl said he prefers to view mass shootings through the lens of “generalized imitation,” a psychological concept involving the learned ability to mimic behaviors observed either in person or through the media. Behaviors “are not diseases that can spread on contact.”

Gary Slutkin, MD, is an epidemiologist who pivoted from studying the spread of diseases such as tuberculosis, HIV, and cholera to trying to understand the epidemic of gun violence.

“The more you’re exposed [to violence], the more likely you are to repeat it, just like the more you’re exposed to COVID, the more likely you are to get it and give it to somebody else,” Dr. Slutkin said. And just as people have varying degrees of susceptibility to COVID-19 and other infectious diseases, he argued that some are more susceptible to committing a mass shooting, depending on their level of isolation, personal “grievances, and their need for belonging or credit.”

To Dr. Slutkin, mass shootings, and other forms of violence, should be treated with the standard methods that public health officials would use to stop the spread of a contagious disease: detection and interdiction that would put a stop to potential events. The nonprofit organization that he founded, Cure Violence Global, employs “violence interrupters” to reach out to and engage with community members who might be at risk of being a victim of violence or of committing an act of violence, much as a public health worker would approach epidemic control.

Research conducted on the effects of this method of reducing rates of violence suggests the approach works. In 2017, New York City saw a 63% reduction in gun injuries, according to a study from the John Jay College of Criminal Justice. And after evaluating the effects of this approach in Chicago in 2014, researchers from the University of Illinois and the University of Chicago determined that there was a 19% reduction in shootings in the city.

“The results of stopping an epidemic come really fast,” Dr. Slutkin said. “But getting people to switch gears to the right kind of treatment happens really slowly.”

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

When a mass shooting happens, another often follows in close succession. That’s not just a feeling – it’s a fact.

The devastating shooting on May 24 in Uvalde, Tex., which killed 19 children, two teachers, and injured 17 others, occurred 10 days after a supermarket shooting in Buffalo, N.Y., which resulted in 10 deaths. In 2021, a shooting at a massage parlor in Atlanta, which left eight dead, came less than a week before a shooting at a supermarket in Boulder, Colo., that killed 10. And a 2019 shooting in Dayton, Ohio, on Aug. 4 that killed nine people took place only a day after a Walmart shooting in El Paso, Tex., which claimed 22 lives.
 

Contagion theory

Researchers argue that the clustering of mass shootings suggests that this type of violence spreads like a virus and should be treated as one.

This theory – called the “contagion effect” – has been examined at length in cases of suicide, especially among teens and young adults. Studies have demonstrated that the majority of adolescents who attempt suicide have previously been exposed to the suicidal behavior of a peer.

In many cases, mass shootings are also suicides, with shooters taking their own lives at the time of the shooting or not long after.

“They have literally and figuratively given up on their life as they know it.” said Joel Dvoskin, PhD, a clinical and forensic psychologist at the University of Arizona, Tucson, and former acting commissioner of mental health for New York state.

According to contagion theory, mass shootings – and the round-the-clock media coverage they generate – lead to even more killings.

A team of researchers at Arizona State University led by Sherry Towers, PhD, analyzed mass shooting data in 2015 to find out whether those events followed a similar pattern. Dr. Towers spent much of her career modeling the spread of infectious diseases, such as influenza, Ebola, and Zika.

Dr. Towers and colleagues discovered that a mass killing tended to give rise to more killings in its immediate aftermath. According to her evaluation of USA Today’s mass shooting database, a second incident was most likely to occur within 13 days of the initial event.
 

What defines a mass shooting?

The FBI defines a mass shooting as any incident in which four or more people die by gunfire. That definition, however, is not universally accepted. The lack of a standard definition complicates the work of researchers who study contagion theory.

Mother Jones magazine created an open-source database of mass killings that employs a similar definition but that includes only incidents that involve a person shooting indiscriminately in a public place.

With this narrower definition, shootings involving organized crime, robberies, and domestic violence – which make up the vast majority of shootings in which multiple fatalities occur in this country – are excluded. Events such as those that occurred in Sandy Hook or the killings in Highland Park, Ill.,  this past July would be included.

The Gun Violence Archive categorizes mass shootings as any incident in which four or more people are shot but not necessarily killed, while Everytown for Gun Safety tallies mass shootings that take at least four lives.

James Meindl, PhD, a professor of behavioral analysis at the University of Memphis who studies mass shootings, said parsing the differences between what happened in Uvalde and what happens during a shooting involving organized crime or domestic violence is crucial when thinking about intervention and prevention.

“If you want to intervene, you have to know why the person engaged in this behavior in the first place,” Dr. Meindl said. “The factors that led a person to commit gang violence, the factors in domestic violence, the factors in indiscriminate mass shootings – those are all very different factors that would call for very different interventions.”
 

So, should mass shootings be treated like an infectious disease?

Rather than using contagion theory, Dr. Meindl said he prefers to view mass shootings through the lens of “generalized imitation,” a psychological concept involving the learned ability to mimic behaviors observed either in person or through the media. Behaviors “are not diseases that can spread on contact.”

Gary Slutkin, MD, is an epidemiologist who pivoted from studying the spread of diseases such as tuberculosis, HIV, and cholera to trying to understand the epidemic of gun violence.

“The more you’re exposed [to violence], the more likely you are to repeat it, just like the more you’re exposed to COVID, the more likely you are to get it and give it to somebody else,” Dr. Slutkin said. And just as people have varying degrees of susceptibility to COVID-19 and other infectious diseases, he argued that some are more susceptible to committing a mass shooting, depending on their level of isolation, personal “grievances, and their need for belonging or credit.”

To Dr. Slutkin, mass shootings, and other forms of violence, should be treated with the standard methods that public health officials would use to stop the spread of a contagious disease: detection and interdiction that would put a stop to potential events. The nonprofit organization that he founded, Cure Violence Global, employs “violence interrupters” to reach out to and engage with community members who might be at risk of being a victim of violence or of committing an act of violence, much as a public health worker would approach epidemic control.

Research conducted on the effects of this method of reducing rates of violence suggests the approach works. In 2017, New York City saw a 63% reduction in gun injuries, according to a study from the John Jay College of Criminal Justice. And after evaluating the effects of this approach in Chicago in 2014, researchers from the University of Illinois and the University of Chicago determined that there was a 19% reduction in shootings in the city.

“The results of stopping an epidemic come really fast,” Dr. Slutkin said. “But getting people to switch gears to the right kind of treatment happens really slowly.”

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

When a mass shooting happens, another often follows in close succession. That’s not just a feeling – it’s a fact.

The devastating shooting on May 24 in Uvalde, Tex., which killed 19 children, two teachers, and injured 17 others, occurred 10 days after a supermarket shooting in Buffalo, N.Y., which resulted in 10 deaths. In 2021, a shooting at a massage parlor in Atlanta, which left eight dead, came less than a week before a shooting at a supermarket in Boulder, Colo., that killed 10. And a 2019 shooting in Dayton, Ohio, on Aug. 4 that killed nine people took place only a day after a Walmart shooting in El Paso, Tex., which claimed 22 lives.
 

Contagion theory

Researchers argue that the clustering of mass shootings suggests that this type of violence spreads like a virus and should be treated as one.

This theory – called the “contagion effect” – has been examined at length in cases of suicide, especially among teens and young adults. Studies have demonstrated that the majority of adolescents who attempt suicide have previously been exposed to the suicidal behavior of a peer.

In many cases, mass shootings are also suicides, with shooters taking their own lives at the time of the shooting or not long after.

“They have literally and figuratively given up on their life as they know it.” said Joel Dvoskin, PhD, a clinical and forensic psychologist at the University of Arizona, Tucson, and former acting commissioner of mental health for New York state.

According to contagion theory, mass shootings – and the round-the-clock media coverage they generate – lead to even more killings.

A team of researchers at Arizona State University led by Sherry Towers, PhD, analyzed mass shooting data in 2015 to find out whether those events followed a similar pattern. Dr. Towers spent much of her career modeling the spread of infectious diseases, such as influenza, Ebola, and Zika.

Dr. Towers and colleagues discovered that a mass killing tended to give rise to more killings in its immediate aftermath. According to her evaluation of USA Today’s mass shooting database, a second incident was most likely to occur within 13 days of the initial event.
 

What defines a mass shooting?

The FBI defines a mass shooting as any incident in which four or more people die by gunfire. That definition, however, is not universally accepted. The lack of a standard definition complicates the work of researchers who study contagion theory.

Mother Jones magazine created an open-source database of mass killings that employs a similar definition but that includes only incidents that involve a person shooting indiscriminately in a public place.

With this narrower definition, shootings involving organized crime, robberies, and domestic violence – which make up the vast majority of shootings in which multiple fatalities occur in this country – are excluded. Events such as those that occurred in Sandy Hook or the killings in Highland Park, Ill.,  this past July would be included.

The Gun Violence Archive categorizes mass shootings as any incident in which four or more people are shot but not necessarily killed, while Everytown for Gun Safety tallies mass shootings that take at least four lives.

James Meindl, PhD, a professor of behavioral analysis at the University of Memphis who studies mass shootings, said parsing the differences between what happened in Uvalde and what happens during a shooting involving organized crime or domestic violence is crucial when thinking about intervention and prevention.

“If you want to intervene, you have to know why the person engaged in this behavior in the first place,” Dr. Meindl said. “The factors that led a person to commit gang violence, the factors in domestic violence, the factors in indiscriminate mass shootings – those are all very different factors that would call for very different interventions.”
 

So, should mass shootings be treated like an infectious disease?

Rather than using contagion theory, Dr. Meindl said he prefers to view mass shootings through the lens of “generalized imitation,” a psychological concept involving the learned ability to mimic behaviors observed either in person or through the media. Behaviors “are not diseases that can spread on contact.”

Gary Slutkin, MD, is an epidemiologist who pivoted from studying the spread of diseases such as tuberculosis, HIV, and cholera to trying to understand the epidemic of gun violence.

“The more you’re exposed [to violence], the more likely you are to repeat it, just like the more you’re exposed to COVID, the more likely you are to get it and give it to somebody else,” Dr. Slutkin said. And just as people have varying degrees of susceptibility to COVID-19 and other infectious diseases, he argued that some are more susceptible to committing a mass shooting, depending on their level of isolation, personal “grievances, and their need for belonging or credit.”

To Dr. Slutkin, mass shootings, and other forms of violence, should be treated with the standard methods that public health officials would use to stop the spread of a contagious disease: detection and interdiction that would put a stop to potential events. The nonprofit organization that he founded, Cure Violence Global, employs “violence interrupters” to reach out to and engage with community members who might be at risk of being a victim of violence or of committing an act of violence, much as a public health worker would approach epidemic control.

Research conducted on the effects of this method of reducing rates of violence suggests the approach works. In 2017, New York City saw a 63% reduction in gun injuries, according to a study from the John Jay College of Criminal Justice. And after evaluating the effects of this approach in Chicago in 2014, researchers from the University of Illinois and the University of Chicago determined that there was a 19% reduction in shootings in the city.

“The results of stopping an epidemic come really fast,” Dr. Slutkin said. “But getting people to switch gears to the right kind of treatment happens really slowly.”

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

After malaria, human schistosomiasis is the parasitic disease with the highest morbidity and mortality worldwide. An estimated 236 million people are infected. Most are in sub-Saharan Africa. Complications lead to the deaths of 300,000 people each year. Pilot studies point to a high rate of underdiagnosis, whether in the sub-Saharan immigrant population residing in Spain or among individuals affected by outbreaks of autochthonous transmission (as happened in the 2003 case of four Spanish farmers who bathed in an artificial irrigation pool in Almería). If not diagnosed and treated in a timely manner, schistosomiasis can cause serious genitourinary and hepatosplenic complications.

The “Consensus Document for the Management of Schistosomiasis in Primary Care” was recently published in the journal Atención Primaria [Primary Care]. Its aim is to establish clear recommendations so that primary care clinicians will be able to diagnose, manage, and treat this disease. The document was prepared by professionals who belong to the following five scientific societies: the Spanish Society of Family and Community Medicine, the Spanish Society of General Practitioners and Family Doctors, the Spanish Society of Primary Care Physicians, the Spanish Society for Pediatric Infectious Diseases, and the Spanish Society of Tropical Medicine and International Health (SEMTSI).

Agustín Benito Llanes, PhD, is the director of Spain’s National Center for Tropical Medicine (Carlos III Institute of Health) and the president of the SEMTSI. He told Univadis Spain, “The consensus document is invaluable for the management of cases imported by migrant populations coming from endemic areas and in the prevention of possible outbreaks in our country, especially urinary schistosomiasis.” He went on to explain, “This diagnostic strategy, which is also recommended by the European Centre for Disease Prevention and Control (ECDC), must be viewed in the context of the general management of patients with imported eosinophilia – eosinophilia being a condition that indicates that the individual may have a disease caused by a parasitic worm. I do know that primary care has been greatly affected and impacted by the pandemic, but new e-consultation and telemedicine models are making it possible for hospital specialists and primary care specialists to quickly get in touch with each other and work closely together. This technology can play a critical role in the shared care of patients with these types of diseases.”

The document recommends that serologic screening for schistosomiasis be considered for the following patients: asymptomatic individuals who have come from endemic regions and were exposed to freshwater sources; those who present with symptoms consistent with those of the disease; and patients for whom clinical exams or lab tests suggest acute schistosomiasis (eosinophilia is usually a sign). Screening for chronic schistosomiasis is indicated if the necessary resources for diagnosis and treatment are not available. The following considerations support screening asymptomatic individuals: the high prevalence of parasitic infection among migrants from endemic regions and among people who have traveled to those places; and the possibility of preventing serious complications and secondary transmissions.

The working group recommends that all at-risk individuals undergo screening, no matter how long it’s been since they were last in an endemic zone. This is because the parasites can live for over a decade. If primary care physicians don’t have access to diagnostic tests or to treatments, patients should be referred to specialists with experience in tropical diseases. A definitive diagnosis is made through the detection of blood fluke eggs in urine, stool, or body tissues. Through such detection, the species responsible for infection can be identified.
 

Primary care difficulties

To prevent and control the disease, the European health authorities recommend serologic screening of at-risk population groups. Because primary care is usually the first point of contact with the health care system for these infected patients, primary care physicians must know the main characteristics of schistosomiasis and be provided with the necessary means for its diagnosis and treatment. Yet physicians in health care centers face significant limitations when it comes to identifying and treating these patients.

Joaquín Salas, MD, director of the Tropical Medicine Unit at Poniente Hospital in El Ejido (Almería) and the document’s first author, explained these difficulties. “In Spain, we currently have the problem where the care of migrant patients varies greatly between the different autonomous communities – and even within an autonomous community, depending on geographical areas. This variability is caused, in large part, by the number of migrants that they serve. In places that have a large sub-Saharan migrant population, there are health centers that have gotten to a point where they’re able to request serologic testing for schistosomiasis. Unfortunately, in many instances, this testing is still only available to specialists. The objective of documents like ours is to make not only physicians but also managers aware of the importance of diagnosing and treating this disease as early as possible. Raising awareness is complicated, to a large extent, by the lack of knowledge about this disease – something that’s seen with many other ‘neglected diseases’ which primarily affect the poorest people in poor countries.”

Dr. Llanes explained that an autonomous community can individually approve serologic screenings and incorporate them into its primary care programs, regardless of whether they can be approved at the state level. He pointed out that this is what happened with Chagas disease. “To prevent vertical transmission, a protocol for pregnant women was implemented by several communities; it’s about to be approved on a national level.”

But there’s another obstacle to treating schistosomiasis. At the moment, the recommended antiparasitic treatments (e.g., praziquantel) are considered foreign medications. This makes it difficult for primary care physicians and specialists to have access to them. Even so, Dr. Salas believes “that in some places, pharmacy units facilitate things in such a way that physicians who prescribe those treatments are able to obtain them quite quickly and with less red tape. Be that as it may, ideally, the medication would be available in our country’s pharmacies, and it could be prescribed without these kinds of bureaucratic obstacles. The same thing happened with ivermectin, which is used, among other things, to treat strongyloidiasis, and which, for a few months now, has been on the market without restrictions. We hope the same will happen soon with praziquantel.”
 

Increasing risk

Although schistosomiasis is not endemic to Spain, various factors are contributing to an increase in the number of cases within its borders. Dr. Salas said that “without a doubt, climate change and global warming are influencing the expansion of vectors – mosquitoes, ticks, snails – that can transmit, to places like Europe, diseases referred to as ‘tropical.’ In the case of schistosomiasis, it’s been shown that Bulinus snails, intermediate hosts for Schistosoma, have adapted perfectly to Almería here in Spain and to the French island of Corsica, where winters are more and more temperate. But not only is this adaptation due to climate change, those same snails have acquired specific capabilities that allow them to better tolerate temperatures lower than those they initially had in the areas where they’re from in sub-Saharan Africa. To sum up, the colonization of new territories is due as much to a change in the climate – temperatures gradually rising – as to adaptations of the vectors themselves.”

Dr. Llanes noted that “the case involving the farmers in Almería shows that the vectors in Europe can, in fact, transmit the disease, basically because Schistosoma haematobium, human, can develop hybrids with schistosomes of cattle origin, Schistosoma bovis – hybrids that can be transmitted through European snails. This is what happened with the outbreak in Corsica, its vector being the freshwater snail Planorbarius metidjensis – as I said, shown to be implicated in Corsica’s significant outbreak, to which subsequent cases are still being traced. Obviously, the effects of climate change – temperatures rising and extreme meteorological phenomena increasing – on the infections transmitted by vectors are of the utmost importance and, together with the process of globalization, are what makes us consider these types of conditions to be emerging diseases or emerging infections.”

This article was translated from Univadis Spain. A version appeared on Medscape.com.

After malaria, human schistosomiasis is the parasitic disease with the highest morbidity and mortality worldwide. An estimated 236 million people are infected. Most are in sub-Saharan Africa. Complications lead to the deaths of 300,000 people each year. Pilot studies point to a high rate of underdiagnosis, whether in the sub-Saharan immigrant population residing in Spain or among individuals affected by outbreaks of autochthonous transmission (as happened in the 2003 case of four Spanish farmers who bathed in an artificial irrigation pool in Almería). If not diagnosed and treated in a timely manner, schistosomiasis can cause serious genitourinary and hepatosplenic complications.

The “Consensus Document for the Management of Schistosomiasis in Primary Care” was recently published in the journal Atención Primaria [Primary Care]. Its aim is to establish clear recommendations so that primary care clinicians will be able to diagnose, manage, and treat this disease. The document was prepared by professionals who belong to the following five scientific societies: the Spanish Society of Family and Community Medicine, the Spanish Society of General Practitioners and Family Doctors, the Spanish Society of Primary Care Physicians, the Spanish Society for Pediatric Infectious Diseases, and the Spanish Society of Tropical Medicine and International Health (SEMTSI).

Agustín Benito Llanes, PhD, is the director of Spain’s National Center for Tropical Medicine (Carlos III Institute of Health) and the president of the SEMTSI. He told Univadis Spain, “The consensus document is invaluable for the management of cases imported by migrant populations coming from endemic areas and in the prevention of possible outbreaks in our country, especially urinary schistosomiasis.” He went on to explain, “This diagnostic strategy, which is also recommended by the European Centre for Disease Prevention and Control (ECDC), must be viewed in the context of the general management of patients with imported eosinophilia – eosinophilia being a condition that indicates that the individual may have a disease caused by a parasitic worm. I do know that primary care has been greatly affected and impacted by the pandemic, but new e-consultation and telemedicine models are making it possible for hospital specialists and primary care specialists to quickly get in touch with each other and work closely together. This technology can play a critical role in the shared care of patients with these types of diseases.”

The document recommends that serologic screening for schistosomiasis be considered for the following patients: asymptomatic individuals who have come from endemic regions and were exposed to freshwater sources; those who present with symptoms consistent with those of the disease; and patients for whom clinical exams or lab tests suggest acute schistosomiasis (eosinophilia is usually a sign). Screening for chronic schistosomiasis is indicated if the necessary resources for diagnosis and treatment are not available. The following considerations support screening asymptomatic individuals: the high prevalence of parasitic infection among migrants from endemic regions and among people who have traveled to those places; and the possibility of preventing serious complications and secondary transmissions.

The working group recommends that all at-risk individuals undergo screening, no matter how long it’s been since they were last in an endemic zone. This is because the parasites can live for over a decade. If primary care physicians don’t have access to diagnostic tests or to treatments, patients should be referred to specialists with experience in tropical diseases. A definitive diagnosis is made through the detection of blood fluke eggs in urine, stool, or body tissues. Through such detection, the species responsible for infection can be identified.
 

Primary care difficulties

To prevent and control the disease, the European health authorities recommend serologic screening of at-risk population groups. Because primary care is usually the first point of contact with the health care system for these infected patients, primary care physicians must know the main characteristics of schistosomiasis and be provided with the necessary means for its diagnosis and treatment. Yet physicians in health care centers face significant limitations when it comes to identifying and treating these patients.

Joaquín Salas, MD, director of the Tropical Medicine Unit at Poniente Hospital in El Ejido (Almería) and the document’s first author, explained these difficulties. “In Spain, we currently have the problem where the care of migrant patients varies greatly between the different autonomous communities – and even within an autonomous community, depending on geographical areas. This variability is caused, in large part, by the number of migrants that they serve. In places that have a large sub-Saharan migrant population, there are health centers that have gotten to a point where they’re able to request serologic testing for schistosomiasis. Unfortunately, in many instances, this testing is still only available to specialists. The objective of documents like ours is to make not only physicians but also managers aware of the importance of diagnosing and treating this disease as early as possible. Raising awareness is complicated, to a large extent, by the lack of knowledge about this disease – something that’s seen with many other ‘neglected diseases’ which primarily affect the poorest people in poor countries.”

Dr. Llanes explained that an autonomous community can individually approve serologic screenings and incorporate them into its primary care programs, regardless of whether they can be approved at the state level. He pointed out that this is what happened with Chagas disease. “To prevent vertical transmission, a protocol for pregnant women was implemented by several communities; it’s about to be approved on a national level.”

But there’s another obstacle to treating schistosomiasis. At the moment, the recommended antiparasitic treatments (e.g., praziquantel) are considered foreign medications. This makes it difficult for primary care physicians and specialists to have access to them. Even so, Dr. Salas believes “that in some places, pharmacy units facilitate things in such a way that physicians who prescribe those treatments are able to obtain them quite quickly and with less red tape. Be that as it may, ideally, the medication would be available in our country’s pharmacies, and it could be prescribed without these kinds of bureaucratic obstacles. The same thing happened with ivermectin, which is used, among other things, to treat strongyloidiasis, and which, for a few months now, has been on the market without restrictions. We hope the same will happen soon with praziquantel.”
 

Increasing risk

Although schistosomiasis is not endemic to Spain, various factors are contributing to an increase in the number of cases within its borders. Dr. Salas said that “without a doubt, climate change and global warming are influencing the expansion of vectors – mosquitoes, ticks, snails – that can transmit, to places like Europe, diseases referred to as ‘tropical.’ In the case of schistosomiasis, it’s been shown that Bulinus snails, intermediate hosts for Schistosoma, have adapted perfectly to Almería here in Spain and to the French island of Corsica, where winters are more and more temperate. But not only is this adaptation due to climate change, those same snails have acquired specific capabilities that allow them to better tolerate temperatures lower than those they initially had in the areas where they’re from in sub-Saharan Africa. To sum up, the colonization of new territories is due as much to a change in the climate – temperatures gradually rising – as to adaptations of the vectors themselves.”

Dr. Llanes noted that “the case involving the farmers in Almería shows that the vectors in Europe can, in fact, transmit the disease, basically because Schistosoma haematobium, human, can develop hybrids with schistosomes of cattle origin, Schistosoma bovis – hybrids that can be transmitted through European snails. This is what happened with the outbreak in Corsica, its vector being the freshwater snail Planorbarius metidjensis – as I said, shown to be implicated in Corsica’s significant outbreak, to which subsequent cases are still being traced. Obviously, the effects of climate change – temperatures rising and extreme meteorological phenomena increasing – on the infections transmitted by vectors are of the utmost importance and, together with the process of globalization, are what makes us consider these types of conditions to be emerging diseases or emerging infections.”

This article was translated from Univadis Spain. A version appeared on Medscape.com.

After malaria, human schistosomiasis is the parasitic disease with the highest morbidity and mortality worldwide. An estimated 236 million people are infected. Most are in sub-Saharan Africa. Complications lead to the deaths of 300,000 people each year. Pilot studies point to a high rate of underdiagnosis, whether in the sub-Saharan immigrant population residing in Spain or among individuals affected by outbreaks of autochthonous transmission (as happened in the 2003 case of four Spanish farmers who bathed in an artificial irrigation pool in Almería). If not diagnosed and treated in a timely manner, schistosomiasis can cause serious genitourinary and hepatosplenic complications.

The “Consensus Document for the Management of Schistosomiasis in Primary Care” was recently published in the journal Atención Primaria [Primary Care]. Its aim is to establish clear recommendations so that primary care clinicians will be able to diagnose, manage, and treat this disease. The document was prepared by professionals who belong to the following five scientific societies: the Spanish Society of Family and Community Medicine, the Spanish Society of General Practitioners and Family Doctors, the Spanish Society of Primary Care Physicians, the Spanish Society for Pediatric Infectious Diseases, and the Spanish Society of Tropical Medicine and International Health (SEMTSI).

Agustín Benito Llanes, PhD, is the director of Spain’s National Center for Tropical Medicine (Carlos III Institute of Health) and the president of the SEMTSI. He told Univadis Spain, “The consensus document is invaluable for the management of cases imported by migrant populations coming from endemic areas and in the prevention of possible outbreaks in our country, especially urinary schistosomiasis.” He went on to explain, “This diagnostic strategy, which is also recommended by the European Centre for Disease Prevention and Control (ECDC), must be viewed in the context of the general management of patients with imported eosinophilia – eosinophilia being a condition that indicates that the individual may have a disease caused by a parasitic worm. I do know that primary care has been greatly affected and impacted by the pandemic, but new e-consultation and telemedicine models are making it possible for hospital specialists and primary care specialists to quickly get in touch with each other and work closely together. This technology can play a critical role in the shared care of patients with these types of diseases.”

The document recommends that serologic screening for schistosomiasis be considered for the following patients: asymptomatic individuals who have come from endemic regions and were exposed to freshwater sources; those who present with symptoms consistent with those of the disease; and patients for whom clinical exams or lab tests suggest acute schistosomiasis (eosinophilia is usually a sign). Screening for chronic schistosomiasis is indicated if the necessary resources for diagnosis and treatment are not available. The following considerations support screening asymptomatic individuals: the high prevalence of parasitic infection among migrants from endemic regions and among people who have traveled to those places; and the possibility of preventing serious complications and secondary transmissions.

The working group recommends that all at-risk individuals undergo screening, no matter how long it’s been since they were last in an endemic zone. This is because the parasites can live for over a decade. If primary care physicians don’t have access to diagnostic tests or to treatments, patients should be referred to specialists with experience in tropical diseases. A definitive diagnosis is made through the detection of blood fluke eggs in urine, stool, or body tissues. Through such detection, the species responsible for infection can be identified.
 

Primary care difficulties

To prevent and control the disease, the European health authorities recommend serologic screening of at-risk population groups. Because primary care is usually the first point of contact with the health care system for these infected patients, primary care physicians must know the main characteristics of schistosomiasis and be provided with the necessary means for its diagnosis and treatment. Yet physicians in health care centers face significant limitations when it comes to identifying and treating these patients.

Joaquín Salas, MD, director of the Tropical Medicine Unit at Poniente Hospital in El Ejido (Almería) and the document’s first author, explained these difficulties. “In Spain, we currently have the problem where the care of migrant patients varies greatly between the different autonomous communities – and even within an autonomous community, depending on geographical areas. This variability is caused, in large part, by the number of migrants that they serve. In places that have a large sub-Saharan migrant population, there are health centers that have gotten to a point where they’re able to request serologic testing for schistosomiasis. Unfortunately, in many instances, this testing is still only available to specialists. The objective of documents like ours is to make not only physicians but also managers aware of the importance of diagnosing and treating this disease as early as possible. Raising awareness is complicated, to a large extent, by the lack of knowledge about this disease – something that’s seen with many other ‘neglected diseases’ which primarily affect the poorest people in poor countries.”

Dr. Llanes explained that an autonomous community can individually approve serologic screenings and incorporate them into its primary care programs, regardless of whether they can be approved at the state level. He pointed out that this is what happened with Chagas disease. “To prevent vertical transmission, a protocol for pregnant women was implemented by several communities; it’s about to be approved on a national level.”

But there’s another obstacle to treating schistosomiasis. At the moment, the recommended antiparasitic treatments (e.g., praziquantel) are considered foreign medications. This makes it difficult for primary care physicians and specialists to have access to them. Even so, Dr. Salas believes “that in some places, pharmacy units facilitate things in such a way that physicians who prescribe those treatments are able to obtain them quite quickly and with less red tape. Be that as it may, ideally, the medication would be available in our country’s pharmacies, and it could be prescribed without these kinds of bureaucratic obstacles. The same thing happened with ivermectin, which is used, among other things, to treat strongyloidiasis, and which, for a few months now, has been on the market without restrictions. We hope the same will happen soon with praziquantel.”
 

Increasing risk

Although schistosomiasis is not endemic to Spain, various factors are contributing to an increase in the number of cases within its borders. Dr. Salas said that “without a doubt, climate change and global warming are influencing the expansion of vectors – mosquitoes, ticks, snails – that can transmit, to places like Europe, diseases referred to as ‘tropical.’ In the case of schistosomiasis, it’s been shown that Bulinus snails, intermediate hosts for Schistosoma, have adapted perfectly to Almería here in Spain and to the French island of Corsica, where winters are more and more temperate. But not only is this adaptation due to climate change, those same snails have acquired specific capabilities that allow them to better tolerate temperatures lower than those they initially had in the areas where they’re from in sub-Saharan Africa. To sum up, the colonization of new territories is due as much to a change in the climate – temperatures gradually rising – as to adaptations of the vectors themselves.”

Dr. Llanes noted that “the case involving the farmers in Almería shows that the vectors in Europe can, in fact, transmit the disease, basically because Schistosoma haematobium, human, can develop hybrids with schistosomes of cattle origin, Schistosoma bovis – hybrids that can be transmitted through European snails. This is what happened with the outbreak in Corsica, its vector being the freshwater snail Planorbarius metidjensis – as I said, shown to be implicated in Corsica’s significant outbreak, to which subsequent cases are still being traced. Obviously, the effects of climate change – temperatures rising and extreme meteorological phenomena increasing – on the infections transmitted by vectors are of the utmost importance and, together with the process of globalization, are what makes us consider these types of conditions to be emerging diseases or emerging infections.”

This article was translated from Univadis Spain. A version appeared on Medscape.com.

Prompted by the “unprecedented” increase in the occurrence of infective endocarditis (IE) cases among people who inject drugs, the American Heart Association has issued a scientific statement devoted solely to this challenging patient population.

The statement provides a more in-depth focus on the management of IE among this unique population than what has been provided in prior AHA IE-related documents.

The statement stresses that managing IE in people who inject drugs is complex and requires a unique multidisciplinary approach that includes consultation with an addiction specialist.

The statement was published online in Circulation.
 

Poor long-term prognosis

In the United States from 2002 to 2016, the proportion of patients hospitalized with IE related to injection drug use doubled from 8% to about 16%.

The long-term prognosis for this population is “currently dismal for this relatively young group of individuals,” writing group Chair Daniel C. DeSimone, MD, with the Mayo Clinic in Rochester, Minn., notes in a news release.

To improve prognosis, the writing group advises a multidisciplinary team care approach that includes cardiologists, cardiac surgeons, and infectious diseases specialists as well as addiction medicine or addiction psychiatry specialists, pharmacists, social workers, and nurse specialists.

Nurse specialists can coordinate care from the initial IE hospitalization to outpatient and community care to support substance use disorder.

“Clinical teams must recognize that substance use disorder is a treatable chronic, relapsing medical illness and many people are able to enter sustained remission, particularly when they receive effective treatments,” the writing group emphasizes.

Although not all patients with injection drug–related IE have opioid addiction, for those who do, the “best practice” is to offer buprenorphine or methadone “as soon as possible” after the patient presents to the hospital, they advise.
 

Antimicrobial therapy

The writing group says it’s “reasonable” to offer people with injection drug–related IE standard treatment for IE, which is 6 weeks of intravenous antibiotics. They recognize, however, that this regimen is often not feasible in this patient population and say there is growing evidence that partial intravenous therapy followed by oral antibiotic treatment to complete a total of 6 weeks is a possible option.

They also highlight the “critical” importance of preventive measures in people who inject drugs who are successfully treated for an initial bout of IE because they remain at “extremely” high risk for subsequent bouts of IE, regardless of whether injection drug use is continued.

The writing group also stresses that people with IE who inject drugs should be considered for heart valve repair or replacement surgery regardless of current drug use if they have indications for valve surgery.

“There’s no evidence that indications for valve surgery are different for people who inject drugs compared to those who don’t, however, some treatment centers don’t offer surgery, especially if the patient currently injects drugs or has had a previous valve surgery,” Dr. DeSimone says in the release.

“Those who develop infective endocarditis require complex care delivered by professionals who look beyond stigma and bias to provide optimal and equitable care,” Dr. DeSimone adds.

The writing group acknowledges that while addiction medicine and addiction psychiatry expertise are critical to managing IE in injection drug users, these specific resources are currently not widely available.

They call on health care systems to attract individuals with addiction training and support addiction medicine consultative services, particularly in centers where drug use–related IE is common and expected to continue to increase.

This AHA scientific statement was prepared by the volunteer writing group on behalf of the AHA Rheumatic Fever, Endocarditis and Kawasaki Disease Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiovascular and Stroke Nursing; the Council on Clinical Cardiology; and the Council on Peripheral Vascular Disease.

This research had no commercial funding. Dr. DeSimone has no relevant disclosures.

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

Prompted by the “unprecedented” increase in the occurrence of infective endocarditis (IE) cases among people who inject drugs, the American Heart Association has issued a scientific statement devoted solely to this challenging patient population.

The statement provides a more in-depth focus on the management of IE among this unique population than what has been provided in prior AHA IE-related documents.

The statement stresses that managing IE in people who inject drugs is complex and requires a unique multidisciplinary approach that includes consultation with an addiction specialist.

The statement was published online in Circulation.
 

Poor long-term prognosis

In the United States from 2002 to 2016, the proportion of patients hospitalized with IE related to injection drug use doubled from 8% to about 16%.

The long-term prognosis for this population is “currently dismal for this relatively young group of individuals,” writing group Chair Daniel C. DeSimone, MD, with the Mayo Clinic in Rochester, Minn., notes in a news release.

To improve prognosis, the writing group advises a multidisciplinary team care approach that includes cardiologists, cardiac surgeons, and infectious diseases specialists as well as addiction medicine or addiction psychiatry specialists, pharmacists, social workers, and nurse specialists.

Nurse specialists can coordinate care from the initial IE hospitalization to outpatient and community care to support substance use disorder.

“Clinical teams must recognize that substance use disorder is a treatable chronic, relapsing medical illness and many people are able to enter sustained remission, particularly when they receive effective treatments,” the writing group emphasizes.

Although not all patients with injection drug–related IE have opioid addiction, for those who do, the “best practice” is to offer buprenorphine or methadone “as soon as possible” after the patient presents to the hospital, they advise.
 

Antimicrobial therapy

The writing group says it’s “reasonable” to offer people with injection drug–related IE standard treatment for IE, which is 6 weeks of intravenous antibiotics. They recognize, however, that this regimen is often not feasible in this patient population and say there is growing evidence that partial intravenous therapy followed by oral antibiotic treatment to complete a total of 6 weeks is a possible option.

They also highlight the “critical” importance of preventive measures in people who inject drugs who are successfully treated for an initial bout of IE because they remain at “extremely” high risk for subsequent bouts of IE, regardless of whether injection drug use is continued.

The writing group also stresses that people with IE who inject drugs should be considered for heart valve repair or replacement surgery regardless of current drug use if they have indications for valve surgery.

“There’s no evidence that indications for valve surgery are different for people who inject drugs compared to those who don’t, however, some treatment centers don’t offer surgery, especially if the patient currently injects drugs or has had a previous valve surgery,” Dr. DeSimone says in the release.

“Those who develop infective endocarditis require complex care delivered by professionals who look beyond stigma and bias to provide optimal and equitable care,” Dr. DeSimone adds.

The writing group acknowledges that while addiction medicine and addiction psychiatry expertise are critical to managing IE in injection drug users, these specific resources are currently not widely available.

They call on health care systems to attract individuals with addiction training and support addiction medicine consultative services, particularly in centers where drug use–related IE is common and expected to continue to increase.

This AHA scientific statement was prepared by the volunteer writing group on behalf of the AHA Rheumatic Fever, Endocarditis and Kawasaki Disease Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiovascular and Stroke Nursing; the Council on Clinical Cardiology; and the Council on Peripheral Vascular Disease.

This research had no commercial funding. Dr. DeSimone has no relevant disclosures.

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

Prompted by the “unprecedented” increase in the occurrence of infective endocarditis (IE) cases among people who inject drugs, the American Heart Association has issued a scientific statement devoted solely to this challenging patient population.

The statement provides a more in-depth focus on the management of IE among this unique population than what has been provided in prior AHA IE-related documents.

The statement stresses that managing IE in people who inject drugs is complex and requires a unique multidisciplinary approach that includes consultation with an addiction specialist.

The statement was published online in Circulation.
 

Poor long-term prognosis

In the United States from 2002 to 2016, the proportion of patients hospitalized with IE related to injection drug use doubled from 8% to about 16%.

The long-term prognosis for this population is “currently dismal for this relatively young group of individuals,” writing group Chair Daniel C. DeSimone, MD, with the Mayo Clinic in Rochester, Minn., notes in a news release.

To improve prognosis, the writing group advises a multidisciplinary team care approach that includes cardiologists, cardiac surgeons, and infectious diseases specialists as well as addiction medicine or addiction psychiatry specialists, pharmacists, social workers, and nurse specialists.

Nurse specialists can coordinate care from the initial IE hospitalization to outpatient and community care to support substance use disorder.

“Clinical teams must recognize that substance use disorder is a treatable chronic, relapsing medical illness and many people are able to enter sustained remission, particularly when they receive effective treatments,” the writing group emphasizes.

Although not all patients with injection drug–related IE have opioid addiction, for those who do, the “best practice” is to offer buprenorphine or methadone “as soon as possible” after the patient presents to the hospital, they advise.
 

Antimicrobial therapy

The writing group says it’s “reasonable” to offer people with injection drug–related IE standard treatment for IE, which is 6 weeks of intravenous antibiotics. They recognize, however, that this regimen is often not feasible in this patient population and say there is growing evidence that partial intravenous therapy followed by oral antibiotic treatment to complete a total of 6 weeks is a possible option.

They also highlight the “critical” importance of preventive measures in people who inject drugs who are successfully treated for an initial bout of IE because they remain at “extremely” high risk for subsequent bouts of IE, regardless of whether injection drug use is continued.

The writing group also stresses that people with IE who inject drugs should be considered for heart valve repair or replacement surgery regardless of current drug use if they have indications for valve surgery.

“There’s no evidence that indications for valve surgery are different for people who inject drugs compared to those who don’t, however, some treatment centers don’t offer surgery, especially if the patient currently injects drugs or has had a previous valve surgery,” Dr. DeSimone says in the release.

“Those who develop infective endocarditis require complex care delivered by professionals who look beyond stigma and bias to provide optimal and equitable care,” Dr. DeSimone adds.

The writing group acknowledges that while addiction medicine and addiction psychiatry expertise are critical to managing IE in injection drug users, these specific resources are currently not widely available.

They call on health care systems to attract individuals with addiction training and support addiction medicine consultative services, particularly in centers where drug use–related IE is common and expected to continue to increase.

This AHA scientific statement was prepared by the volunteer writing group on behalf of the AHA Rheumatic Fever, Endocarditis and Kawasaki Disease Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiovascular and Stroke Nursing; the Council on Clinical Cardiology; and the Council on Peripheral Vascular Disease.

This research had no commercial funding. Dr. DeSimone has no relevant disclosures.

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

The unfortunate death of Lori McClintock, wife of northern California congressman Tom McClintock, shortly after consuming the herbal remedy white mulberry leaf on Dec. 15, 2021, gives us the opportunity to discuss how to better protect the American public from nutritional supplements with claims to aid health. Mulberry leaf has been purported to lower blood glucose levels, cholesterol, and inflammation as well as promote weight loss.

Many people desire to improve their health with concoctions purported to be “natural” or “from nature” instead of seeing a doctor and taking a medication or other therapy that is evidenced-based and backed by approval from the Food and Drug Administration. With the burgeoning prevalence of obesity and type 2 diabetes in this country (and worldwide) and the lack of a magic bullet that can stop the progression of these life-threatening diseases, many Americans turn to herbal and nutritional supplements that claim to promote weight loss and improve health.

Passed in 1994, the Dietary Supplement Health and Education Act (DSHEA) has allowed manufacturers of herbal and nutritional supplements to be “off the radar” of government regulators, unless their products have been shown to do harm – which is the government’s burden to prove.

A dietary supplement is defined as a product containing one or more vitamin, mineral, herb, or other botanical; amino acid; or other substance that would increase the total dietary intake of that product.

DSHEA exempted dietary supplements from the rigorous safety and efficacy testing that medications must undergo for various disease states, which is regulated by the FDA.
 

People with obesity may fall prey to dietary supplements’ claims

Persons suffering from obesity and its metabolic sequelae may be susceptible to the claims of dietary supplements because:

• The stigma associated with obesity, including the lack of understanding that obesity is a disease not under a person’s control, may make those with the disease wish to remedy it on their own out of shame and peer pressure.
• Clinicians and doctors traditionally have not been trained in obesity medicine so they aren’t comfortable treating obesity.
• It’s only fairly recently that obesity was recognized as a disease, so many insurance companies still don’t reimburse for obesity treatments, including the agents that can suppress appetite and result in weight loss.

For all of these reasons and more, only 2% or less of the millions of Americans suffering from obesity are treated with an antiobesity agent each year.

This has paved the way for the dietary supplement industry to prey on a desperate population, in much the same way that fad diets continue to attract multitudes of Americans. These supplements, however, carry much more risk than fad diets.

The solution, of course, is better regulation of the supplement industry, but it’s also improvement of how obesity is treated by the medical community.
 

How can clinicians and the community help?

Government, academic, community, clinical, and lay persons are more frequently recognizing obesity as a disease. Stigma will slowly come to a halt, as it has for other diseases such as depression and addiction to alcohol and drugs. Medications that have undergone rigorous testing for safety and efficacy eventually will be prescribed more and covered by healthcare insurance. Clinicians, and specifically physicians, are the most trusted persons in terms of giving medical advice. We need to ask patients whether they are taking supplements and be vocal about their lack of protection against harm, as allowed by DSHEA.

It would not be overkill to add prompts to the medical record to ask patients not only about smoking, alcohol, and drug use but also about supplements of all kinds. Some medical records do use these prompts but they are not as ubiquitous as those for smoking, alcohol, and drug use.

The supplement industry is powerful, but so is the medical industry when it comes to lobbying for change. It is ironic that Lori McClintock was the wife of a congressman. Perhaps the silver lining is future work toward legislation advocating for an end to these tragic deaths from poorly regulated supplements. Alignment with government in pushing for stricter regulations could save lives in the future.

Dr. Apovian is a faculty member, department of medicine, division of endocrinology, diabetes, and hypertension; and codirector, Center for Weight Management and Wellness, Boston. She disclosed ties with Abbott, Allergan, Altimmune, Bariatrix Nutrition, Cowen and Company, Curavit, Rhythm Pharma, Jazz, Nutrisystem, Roman, Novo Nordisk, EnteroMedics, Gelesis Srl, Zafgen, Xeno, L-Nutra, Tivity, and Real Appeal.



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

The unfortunate death of Lori McClintock, wife of northern California congressman Tom McClintock, shortly after consuming the herbal remedy white mulberry leaf on Dec. 15, 2021, gives us the opportunity to discuss how to better protect the American public from nutritional supplements with claims to aid health. Mulberry leaf has been purported to lower blood glucose levels, cholesterol, and inflammation as well as promote weight loss.

Many people desire to improve their health with concoctions purported to be “natural” or “from nature” instead of seeing a doctor and taking a medication or other therapy that is evidenced-based and backed by approval from the Food and Drug Administration. With the burgeoning prevalence of obesity and type 2 diabetes in this country (and worldwide) and the lack of a magic bullet that can stop the progression of these life-threatening diseases, many Americans turn to herbal and nutritional supplements that claim to promote weight loss and improve health.

Passed in 1994, the Dietary Supplement Health and Education Act (DSHEA) has allowed manufacturers of herbal and nutritional supplements to be “off the radar” of government regulators, unless their products have been shown to do harm – which is the government’s burden to prove.

A dietary supplement is defined as a product containing one or more vitamin, mineral, herb, or other botanical; amino acid; or other substance that would increase the total dietary intake of that product.

DSHEA exempted dietary supplements from the rigorous safety and efficacy testing that medications must undergo for various disease states, which is regulated by the FDA.
 

People with obesity may fall prey to dietary supplements’ claims

Persons suffering from obesity and its metabolic sequelae may be susceptible to the claims of dietary supplements because:

• The stigma associated with obesity, including the lack of understanding that obesity is a disease not under a person’s control, may make those with the disease wish to remedy it on their own out of shame and peer pressure.
• Clinicians and doctors traditionally have not been trained in obesity medicine so they aren’t comfortable treating obesity.
• It’s only fairly recently that obesity was recognized as a disease, so many insurance companies still don’t reimburse for obesity treatments, including the agents that can suppress appetite and result in weight loss.

For all of these reasons and more, only 2% or less of the millions of Americans suffering from obesity are treated with an antiobesity agent each year.

This has paved the way for the dietary supplement industry to prey on a desperate population, in much the same way that fad diets continue to attract multitudes of Americans. These supplements, however, carry much more risk than fad diets.

The solution, of course, is better regulation of the supplement industry, but it’s also improvement of how obesity is treated by the medical community.
 

How can clinicians and the community help?

Government, academic, community, clinical, and lay persons are more frequently recognizing obesity as a disease. Stigma will slowly come to a halt, as it has for other diseases such as depression and addiction to alcohol and drugs. Medications that have undergone rigorous testing for safety and efficacy eventually will be prescribed more and covered by healthcare insurance. Clinicians, and specifically physicians, are the most trusted persons in terms of giving medical advice. We need to ask patients whether they are taking supplements and be vocal about their lack of protection against harm, as allowed by DSHEA.

It would not be overkill to add prompts to the medical record to ask patients not only about smoking, alcohol, and drug use but also about supplements of all kinds. Some medical records do use these prompts but they are not as ubiquitous as those for smoking, alcohol, and drug use.

The supplement industry is powerful, but so is the medical industry when it comes to lobbying for change. It is ironic that Lori McClintock was the wife of a congressman. Perhaps the silver lining is future work toward legislation advocating for an end to these tragic deaths from poorly regulated supplements. Alignment with government in pushing for stricter regulations could save lives in the future.

Dr. Apovian is a faculty member, department of medicine, division of endocrinology, diabetes, and hypertension; and codirector, Center for Weight Management and Wellness, Boston. She disclosed ties with Abbott, Allergan, Altimmune, Bariatrix Nutrition, Cowen and Company, Curavit, Rhythm Pharma, Jazz, Nutrisystem, Roman, Novo Nordisk, EnteroMedics, Gelesis Srl, Zafgen, Xeno, L-Nutra, Tivity, and Real Appeal.



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

The unfortunate death of Lori McClintock, wife of northern California congressman Tom McClintock, shortly after consuming the herbal remedy white mulberry leaf on Dec. 15, 2021, gives us the opportunity to discuss how to better protect the American public from nutritional supplements with claims to aid health. Mulberry leaf has been purported to lower blood glucose levels, cholesterol, and inflammation as well as promote weight loss.

Many people desire to improve their health with concoctions purported to be “natural” or “from nature” instead of seeing a doctor and taking a medication or other therapy that is evidenced-based and backed by approval from the Food and Drug Administration. With the burgeoning prevalence of obesity and type 2 diabetes in this country (and worldwide) and the lack of a magic bullet that can stop the progression of these life-threatening diseases, many Americans turn to herbal and nutritional supplements that claim to promote weight loss and improve health.

Passed in 1994, the Dietary Supplement Health and Education Act (DSHEA) has allowed manufacturers of herbal and nutritional supplements to be “off the radar” of government regulators, unless their products have been shown to do harm – which is the government’s burden to prove.

A dietary supplement is defined as a product containing one or more vitamin, mineral, herb, or other botanical; amino acid; or other substance that would increase the total dietary intake of that product.

DSHEA exempted dietary supplements from the rigorous safety and efficacy testing that medications must undergo for various disease states, which is regulated by the FDA.
 

People with obesity may fall prey to dietary supplements’ claims

Persons suffering from obesity and its metabolic sequelae may be susceptible to the claims of dietary supplements because:

• The stigma associated with obesity, including the lack of understanding that obesity is a disease not under a person’s control, may make those with the disease wish to remedy it on their own out of shame and peer pressure.
• Clinicians and doctors traditionally have not been trained in obesity medicine so they aren’t comfortable treating obesity.
• It’s only fairly recently that obesity was recognized as a disease, so many insurance companies still don’t reimburse for obesity treatments, including the agents that can suppress appetite and result in weight loss.

For all of these reasons and more, only 2% or less of the millions of Americans suffering from obesity are treated with an antiobesity agent each year.

This has paved the way for the dietary supplement industry to prey on a desperate population, in much the same way that fad diets continue to attract multitudes of Americans. These supplements, however, carry much more risk than fad diets.

The solution, of course, is better regulation of the supplement industry, but it’s also improvement of how obesity is treated by the medical community.
 

How can clinicians and the community help?

Government, academic, community, clinical, and lay persons are more frequently recognizing obesity as a disease. Stigma will slowly come to a halt, as it has for other diseases such as depression and addiction to alcohol and drugs. Medications that have undergone rigorous testing for safety and efficacy eventually will be prescribed more and covered by healthcare insurance. Clinicians, and specifically physicians, are the most trusted persons in terms of giving medical advice. We need to ask patients whether they are taking supplements and be vocal about their lack of protection against harm, as allowed by DSHEA.

It would not be overkill to add prompts to the medical record to ask patients not only about smoking, alcohol, and drug use but also about supplements of all kinds. Some medical records do use these prompts but they are not as ubiquitous as those for smoking, alcohol, and drug use.

The supplement industry is powerful, but so is the medical industry when it comes to lobbying for change. It is ironic that Lori McClintock was the wife of a congressman. Perhaps the silver lining is future work toward legislation advocating for an end to these tragic deaths from poorly regulated supplements. Alignment with government in pushing for stricter regulations could save lives in the future.

Dr. Apovian is a faculty member, department of medicine, division of endocrinology, diabetes, and hypertension; and codirector, Center for Weight Management and Wellness, Boston. She disclosed ties with Abbott, Allergan, Altimmune, Bariatrix Nutrition, Cowen and Company, Curavit, Rhythm Pharma, Jazz, Nutrisystem, Roman, Novo Nordisk, EnteroMedics, Gelesis Srl, Zafgen, Xeno, L-Nutra, Tivity, and Real Appeal.



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

Monkeypox, COVID, and polio: These three very different diseases have been dominating news cycles recently, but they share at least one common characteristic: some people can become infected – and in turn infect others – while showing no symptoms.

In 1883, the famous bacteriologist Friedrich Loeffler (1852-1915) recognized that an individual’s asymptomatic carriage of bacteria could lead to diphtheria in others. Now, as then, asymptomatically infected people present a conundrum: How do you fight the spread of a disease when you can’t identify some of the people who are spreading it?

“Typhoid Mary” is perhaps the quintessential example of asymptomatic transmission of infections leading to illness and death. At the turn of the 20th century, young Mary Mallon emigrated from Ireland to New York, where she soon became a cook for wealthy Manhattan families.

George Soper, a sanitary engineer, was hired by a stricken family to investigate. After epidemiologic study, he suspected that Mary was a carrier of Salmonella typhi, the bacterial cause of typhoid fever. He persuaded the New York Department of Health to test her – against her will – for infection. After her stool was found to test positive for Salmonella, Mary was forcibly moved to North Brother Island, where she remained largely isolated from others for the next 2 years. In 1910, she was released by a new commissioner after promising not to work as a cook.

However, working under an assumed name, Mary resumed cooking at the Sloane Hospital for Women in Manhattan. Over the next 3 months, at least 25 staff members became ill. Having been found out, Mary was again exiled to the island, where she spent the rest of her life. She died in 1938 after having infected at least 122 people, five of whom died.
 

COVID

Asymptomatic infections are primary drivers of COVID. Earlier in the pandemic, a meta-analysis suggested a 40% rate of asymptomatic infections, although some early reports arrived at lower estimates. A 2021 JAMA Network Open modeling study indicated a 60% rate.

Those rates are changing with the Omicron variants, of which even more cases are asymptomatic. Is this from a mutation in the virus? Some suggest that it is most likely attributable to prior vaccination resulting in boosted immunity and infections being milder. Of concern is that, although people may be asymptomatic, they still have the same viral load in their nose and can readily transmit infection.

Vincent Racaniello, PhD, a professor of virology at Columbia University in New York, told this news organization that “SARS-CoV-2 COVID is so effective at transmitting because it does this asymptomatic transmission. And so you’re out and about; you have no idea that you’re infected. You’re effectively doing what we call community transmission.”

This distinguishes SARS-CoV-2 from SARS-CoV-1. SARS-CoV-1 – which caused the SARS epidemic in 2002–2004 – had very little asymptomatic shedding. With COVID, on the other hand, “A lot of people are infected but never transmit,” Dr. Racaniello added. “I think 80% of transmissions are done by 20% of infected people because those are the ones who are shedding the most virus.”
 

Polio

The August case of paralytic polio in Rockland County, N.Y., is “the first case of polio reported in the United States in nearly 10 years, and only the second instance of community transmission identified in the U.S. since 1979,” a spokesperson for the Centers for Disease Control and Prevention said in an email. “Although no additional cases of polio have been reported at this time, recent wastewater findings elevate concerns that poliovirus is present in these communities, posing a risk to those who are unvaccinated.”

Poliovirus has now been found in the wastewater of New York City and three surrounding counties: Rockland, Orange, and Sullivan.

Unlike COVID, which is spread through air and respiratory secretions, polio has primarily fecal-oral transmission, meaning it is spread by people ingesting food or water contaminated with stool.

According to the World Health Organization, up to 90% of infections are unrecognized because the person has no to minimal symptoms. Symptoms are nonspecific in the remainder. Only a small proportion of those infected go on to develop paralysis.

Paul Offit, MD, a virologist and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told this news organization that before widespread immunization, polio “caused 25,000 – 30,000 children every year to be paralyzed and 1,500 to die. Roughly 1 of every 200 children who was infected was paralyzed. We had the inactivated vaccine followed by the oral polio vaccine (OPV). The price that we paid for the OPV was that rarely it could revert to the so-called neurovirulent type, a paralytic type.”

Use of the OPV was discontinued in 2000 in the United States but is still widely used worldwide because it is inexpensive and easier to administer than injections. It appeared that we were close to completely eradicating polio, as we had smallpox, but then vaccine-derived polio virus (VDPV) started cropping up in Africa, the Middle East, and Asia. They are mainly from the type 2 virus, as is the New York case. There have been three other cases of VDPV in the United States since 2000.

Now, Dr. Offit estimates that only 1 in 2,000 of those infected become paralyzed. This is why the CDC and epidemiologists are so concerned about the Rockland patient – that one case of paralysis could represent a large pool of people who are infected with polio and are asymptomatic, continuing to shed infectious virus into the sewage.

The CDC confirmed that it began conducting wastewater testing for polio in August 2022. In their interviews for this article, Dr. Offit and Dr. Racaniello were both critical of this, stressing that it is essential to do wastewater testing nationally, since asymptomatic polio can be expected to crop up from international travelers who have received OPV.

Many countries conduct that kind of wastewater surveillance. Dr. Racaniello was particularly critical of the CDC. “We’ve been telling CDC for years, at least a decade, Why don’t you check the wastewater?,” Dr. Racaniello said, “It’s been known for many years that we should be looking to monitor the circulation of these viruses. So we are using paralysis as a sentinel to say that this virus is in the wastewater, which is just not acceptable!”

Apparently there was some concern that the public would not understand. Dr. Offit viewed it as one more piece of necessary education: “You shouldn’t be alarmed about this as long as you’re vaccinated. If you’re not vaccinated, realize that this is a risk you’re taking.”
 

Monkeypox

Monkeypox cases have been skyrocketing in the United States in recent weeks. More than 18,000 cases have been reported since the first case in Boston on May 19, 2022.

“Monkeypox was such a rare zoonotic disease, and the disease always historically was introduced through animal contact,” Stuart Isaacs, MD, a pox virologist at the University of Pennsylvania, said in an interview. “And then the infected person would have potential spread within the household as the most common human-to-human spread, The sexual transmission is driving a lot of this infection and potentially allowing this to efficiently spread from person to person.”

A recent study from Belgium, available only as a preprint, created concerns about potential asymptomatic transmission of monkeypox Three men had undergone testing for anogenital chlamydia and gonorrhea but showed no clinical signs of monkeypox. The same samples were later tested by polymerase chain reaction (PCR), and their viral load in anorectal swabs was similar to or slightly lower than that of symptomatic patients. While no cultures were done, the patients seroconverted by later antibody testing, confirming infection.

Via email, a CDC spokesperson noted, “At this time, CDC does not have enough data to support transmission from aerosolized virus for the ongoing monkeypox outbreak, or to assess the risks for transmission from asymptomatic people. The data supports the main source of transmission currently as close contact with someone who is infected with monkeypox.”

Dr. Isaacs agreed, saying studies of smallpox, a related orthopox virus, also suggested this.

In the United Kingdom, the Institute of Tropical Medicine is offering PCR testing for monkeypox to all patients who come for gonorrhea/chlamydia screening. Dr. Racaniello said, “I think that would be great to get a sense of who is infected. Then you could look at the results and say what fraction of people go on to develop lesions, and they give you a sense of the asymptomatic rate, which we don’t know at this point.”

Unfortunately, to be tested for monkeypox in the United States requires that the patient have a lesion. “This is part of the dropped ball of public health in the U.S.,” Dr. Racaniello said. “We’re not thinking about this. .... We need to be doing [infectivity] experiments. So then the question is, how much infectious virus do you need to transmit?”
 

Conclusion

We’ve seen that asymptomatic carriage of bacteria and viruses occurs readily with typhoid, COVID, diphtheria, and polio (among many other organisms, such as methicillin-resistant Staphylococcus aureus or group A strep) and is far less likely with monkeypox.

Two common denominators emerged from these interviews. The first and biggest hurdle is identifying asymptomatic carriers, which is hampered by the politicization of the CDC and funding cuts to public health. “It used to be the CDC was all about public health, and now it’s administrators, unfortunately,” said Dr. Racaniello, citing science writer Laurie Garrett, author of the influential 1994 book, “The Coming Plague”.

We don’t conduct proper surveillance, he pointed out. Wastewater surveillance has been neglected for more than a decade. It has been used for SARS-CoV-2 but is only now being initiated for polio and monkeypox. Norovirus testing would also be especially helpful in reducing foodborne outbreaks, Dr. Racaniello suggested.

The second common denominator is the need to increase the availability and uptake of vaccines. As Dr. Racaniello said about COVID, “The virus is here to stay. It’s never going to go away. It’s in humans. It’s in a lot of animals. So we’re stuck with it. We’re going to have outbreaks every year. So what do you do? Get vaccinated.” And he added, “Vaccination is the most important strategy to go on with our lives.”

Dr. Isaacs was a bit more tempered, not wanting to oversell the vaccine. He said, “The vaccine is just part of the toolkit,” which includes education, testing, isolation, and reducing risk, all of which decrease the transmission cycles.

Speaking of how antivaccine advocates had specifically targeted the Hasidic community in New York State’s Rockland County, Dr. Offit noted, “I don’t think it’s a knowledge deficit as much as a trust deficit.” He said officials should identify people in communities such as these who are trusted and have them become the influencers.

The final major hurdle to controlling these outbreaks remains global disparities in care. Monkeypox has been endemic in Nigeria for decades. It was only when it spread to Europe and America that it received attention. Polio has been actively circulating in Africa and the Middle East but is only getting attention because of the New York case.

Africa was unable to afford COVID vaccines until recently. While many in the United States are on their fourth booster, as of December 2021, more than 80% of people in Africa had not yet received a single dose, according to an article by Munyaradzi Makoni in The Lancet Respiratory Medicine.

Echoing Dr. Peter Hotez’s long-standing plea for “vaccine diplomacy,” Dr. Racaniello concluded, “My philosophy has always been we should give [vaccines] to them. I mean, we spend trillions on guns. Can’t we spend a few hundred million on vaccines? We should give away everything in terms of medicine to countries that need it, and people would like us a lot better than they do now. I think it would be such a great way of getting countries to like us. … So what if it costs a billion dollars a year? It’s a drop in the bucket for us.”

Given globalization, an infectious outbreak anywhere is a risk to all.

Dr. Racaniello and Dr. Offit report no relevant financial relationships. Dr. Isaacs receives royalties from UpToDate.

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

Monkeypox, COVID, and polio: These three very different diseases have been dominating news cycles recently, but they share at least one common characteristic: some people can become infected – and in turn infect others – while showing no symptoms.

In 1883, the famous bacteriologist Friedrich Loeffler (1852-1915) recognized that an individual’s asymptomatic carriage of bacteria could lead to diphtheria in others. Now, as then, asymptomatically infected people present a conundrum: How do you fight the spread of a disease when you can’t identify some of the people who are spreading it?

“Typhoid Mary” is perhaps the quintessential example of asymptomatic transmission of infections leading to illness and death. At the turn of the 20th century, young Mary Mallon emigrated from Ireland to New York, where she soon became a cook for wealthy Manhattan families.

George Soper, a sanitary engineer, was hired by a stricken family to investigate. After epidemiologic study, he suspected that Mary was a carrier of Salmonella typhi, the bacterial cause of typhoid fever. He persuaded the New York Department of Health to test her – against her will – for infection. After her stool was found to test positive for Salmonella, Mary was forcibly moved to North Brother Island, where she remained largely isolated from others for the next 2 years. In 1910, she was released by a new commissioner after promising not to work as a cook.

However, working under an assumed name, Mary resumed cooking at the Sloane Hospital for Women in Manhattan. Over the next 3 months, at least 25 staff members became ill. Having been found out, Mary was again exiled to the island, where she spent the rest of her life. She died in 1938 after having infected at least 122 people, five of whom died.
 

COVID

Asymptomatic infections are primary drivers of COVID. Earlier in the pandemic, a meta-analysis suggested a 40% rate of asymptomatic infections, although some early reports arrived at lower estimates. A 2021 JAMA Network Open modeling study indicated a 60% rate.

Those rates are changing with the Omicron variants, of which even more cases are asymptomatic. Is this from a mutation in the virus? Some suggest that it is most likely attributable to prior vaccination resulting in boosted immunity and infections being milder. Of concern is that, although people may be asymptomatic, they still have the same viral load in their nose and can readily transmit infection.

Vincent Racaniello, PhD, a professor of virology at Columbia University in New York, told this news organization that “SARS-CoV-2 COVID is so effective at transmitting because it does this asymptomatic transmission. And so you’re out and about; you have no idea that you’re infected. You’re effectively doing what we call community transmission.”

This distinguishes SARS-CoV-2 from SARS-CoV-1. SARS-CoV-1 – which caused the SARS epidemic in 2002–2004 – had very little asymptomatic shedding. With COVID, on the other hand, “A lot of people are infected but never transmit,” Dr. Racaniello added. “I think 80% of transmissions are done by 20% of infected people because those are the ones who are shedding the most virus.”
 

Polio

The August case of paralytic polio in Rockland County, N.Y., is “the first case of polio reported in the United States in nearly 10 years, and only the second instance of community transmission identified in the U.S. since 1979,” a spokesperson for the Centers for Disease Control and Prevention said in an email. “Although no additional cases of polio have been reported at this time, recent wastewater findings elevate concerns that poliovirus is present in these communities, posing a risk to those who are unvaccinated.”

Poliovirus has now been found in the wastewater of New York City and three surrounding counties: Rockland, Orange, and Sullivan.

Unlike COVID, which is spread through air and respiratory secretions, polio has primarily fecal-oral transmission, meaning it is spread by people ingesting food or water contaminated with stool.

According to the World Health Organization, up to 90% of infections are unrecognized because the person has no to minimal symptoms. Symptoms are nonspecific in the remainder. Only a small proportion of those infected go on to develop paralysis.

Paul Offit, MD, a virologist and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told this news organization that before widespread immunization, polio “caused 25,000 – 30,000 children every year to be paralyzed and 1,500 to die. Roughly 1 of every 200 children who was infected was paralyzed. We had the inactivated vaccine followed by the oral polio vaccine (OPV). The price that we paid for the OPV was that rarely it could revert to the so-called neurovirulent type, a paralytic type.”

Use of the OPV was discontinued in 2000 in the United States but is still widely used worldwide because it is inexpensive and easier to administer than injections. It appeared that we were close to completely eradicating polio, as we had smallpox, but then vaccine-derived polio virus (VDPV) started cropping up in Africa, the Middle East, and Asia. They are mainly from the type 2 virus, as is the New York case. There have been three other cases of VDPV in the United States since 2000.

Now, Dr. Offit estimates that only 1 in 2,000 of those infected become paralyzed. This is why the CDC and epidemiologists are so concerned about the Rockland patient – that one case of paralysis could represent a large pool of people who are infected with polio and are asymptomatic, continuing to shed infectious virus into the sewage.

The CDC confirmed that it began conducting wastewater testing for polio in August 2022. In their interviews for this article, Dr. Offit and Dr. Racaniello were both critical of this, stressing that it is essential to do wastewater testing nationally, since asymptomatic polio can be expected to crop up from international travelers who have received OPV.

Many countries conduct that kind of wastewater surveillance. Dr. Racaniello was particularly critical of the CDC. “We’ve been telling CDC for years, at least a decade, Why don’t you check the wastewater?,” Dr. Racaniello said, “It’s been known for many years that we should be looking to monitor the circulation of these viruses. So we are using paralysis as a sentinel to say that this virus is in the wastewater, which is just not acceptable!”

Apparently there was some concern that the public would not understand. Dr. Offit viewed it as one more piece of necessary education: “You shouldn’t be alarmed about this as long as you’re vaccinated. If you’re not vaccinated, realize that this is a risk you’re taking.”
 

Monkeypox

Monkeypox cases have been skyrocketing in the United States in recent weeks. More than 18,000 cases have been reported since the first case in Boston on May 19, 2022.

“Monkeypox was such a rare zoonotic disease, and the disease always historically was introduced through animal contact,” Stuart Isaacs, MD, a pox virologist at the University of Pennsylvania, said in an interview. “And then the infected person would have potential spread within the household as the most common human-to-human spread, The sexual transmission is driving a lot of this infection and potentially allowing this to efficiently spread from person to person.”

A recent study from Belgium, available only as a preprint, created concerns about potential asymptomatic transmission of monkeypox Three men had undergone testing for anogenital chlamydia and gonorrhea but showed no clinical signs of monkeypox. The same samples were later tested by polymerase chain reaction (PCR), and their viral load in anorectal swabs was similar to or slightly lower than that of symptomatic patients. While no cultures were done, the patients seroconverted by later antibody testing, confirming infection.

Via email, a CDC spokesperson noted, “At this time, CDC does not have enough data to support transmission from aerosolized virus for the ongoing monkeypox outbreak, or to assess the risks for transmission from asymptomatic people. The data supports the main source of transmission currently as close contact with someone who is infected with monkeypox.”

Dr. Isaacs agreed, saying studies of smallpox, a related orthopox virus, also suggested this.

In the United Kingdom, the Institute of Tropical Medicine is offering PCR testing for monkeypox to all patients who come for gonorrhea/chlamydia screening. Dr. Racaniello said, “I think that would be great to get a sense of who is infected. Then you could look at the results and say what fraction of people go on to develop lesions, and they give you a sense of the asymptomatic rate, which we don’t know at this point.”

Unfortunately, to be tested for monkeypox in the United States requires that the patient have a lesion. “This is part of the dropped ball of public health in the U.S.,” Dr. Racaniello said. “We’re not thinking about this. .... We need to be doing [infectivity] experiments. So then the question is, how much infectious virus do you need to transmit?”
 

Conclusion

We’ve seen that asymptomatic carriage of bacteria and viruses occurs readily with typhoid, COVID, diphtheria, and polio (among many other organisms, such as methicillin-resistant Staphylococcus aureus or group A strep) and is far less likely with monkeypox.

Two common denominators emerged from these interviews. The first and biggest hurdle is identifying asymptomatic carriers, which is hampered by the politicization of the CDC and funding cuts to public health. “It used to be the CDC was all about public health, and now it’s administrators, unfortunately,” said Dr. Racaniello, citing science writer Laurie Garrett, author of the influential 1994 book, “The Coming Plague”.

We don’t conduct proper surveillance, he pointed out. Wastewater surveillance has been neglected for more than a decade. It has been used for SARS-CoV-2 but is only now being initiated for polio and monkeypox. Norovirus testing would also be especially helpful in reducing foodborne outbreaks, Dr. Racaniello suggested.

The second common denominator is the need to increase the availability and uptake of vaccines. As Dr. Racaniello said about COVID, “The virus is here to stay. It’s never going to go away. It’s in humans. It’s in a lot of animals. So we’re stuck with it. We’re going to have outbreaks every year. So what do you do? Get vaccinated.” And he added, “Vaccination is the most important strategy to go on with our lives.”

Dr. Isaacs was a bit more tempered, not wanting to oversell the vaccine. He said, “The vaccine is just part of the toolkit,” which includes education, testing, isolation, and reducing risk, all of which decrease the transmission cycles.

Speaking of how antivaccine advocates had specifically targeted the Hasidic community in New York State’s Rockland County, Dr. Offit noted, “I don’t think it’s a knowledge deficit as much as a trust deficit.” He said officials should identify people in communities such as these who are trusted and have them become the influencers.

The final major hurdle to controlling these outbreaks remains global disparities in care. Monkeypox has been endemic in Nigeria for decades. It was only when it spread to Europe and America that it received attention. Polio has been actively circulating in Africa and the Middle East but is only getting attention because of the New York case.

Africa was unable to afford COVID vaccines until recently. While many in the United States are on their fourth booster, as of December 2021, more than 80% of people in Africa had not yet received a single dose, according to an article by Munyaradzi Makoni in The Lancet Respiratory Medicine.

Echoing Dr. Peter Hotez’s long-standing plea for “vaccine diplomacy,” Dr. Racaniello concluded, “My philosophy has always been we should give [vaccines] to them. I mean, we spend trillions on guns. Can’t we spend a few hundred million on vaccines? We should give away everything in terms of medicine to countries that need it, and people would like us a lot better than they do now. I think it would be such a great way of getting countries to like us. … So what if it costs a billion dollars a year? It’s a drop in the bucket for us.”

Given globalization, an infectious outbreak anywhere is a risk to all.

Dr. Racaniello and Dr. Offit report no relevant financial relationships. Dr. Isaacs receives royalties from UpToDate.

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

Monkeypox, COVID, and polio: These three very different diseases have been dominating news cycles recently, but they share at least one common characteristic: some people can become infected – and in turn infect others – while showing no symptoms.

In 1883, the famous bacteriologist Friedrich Loeffler (1852-1915) recognized that an individual’s asymptomatic carriage of bacteria could lead to diphtheria in others. Now, as then, asymptomatically infected people present a conundrum: How do you fight the spread of a disease when you can’t identify some of the people who are spreading it?

“Typhoid Mary” is perhaps the quintessential example of asymptomatic transmission of infections leading to illness and death. At the turn of the 20th century, young Mary Mallon emigrated from Ireland to New York, where she soon became a cook for wealthy Manhattan families.

George Soper, a sanitary engineer, was hired by a stricken family to investigate. After epidemiologic study, he suspected that Mary was a carrier of Salmonella typhi, the bacterial cause of typhoid fever. He persuaded the New York Department of Health to test her – against her will – for infection. After her stool was found to test positive for Salmonella, Mary was forcibly moved to North Brother Island, where she remained largely isolated from others for the next 2 years. In 1910, she was released by a new commissioner after promising not to work as a cook.

However, working under an assumed name, Mary resumed cooking at the Sloane Hospital for Women in Manhattan. Over the next 3 months, at least 25 staff members became ill. Having been found out, Mary was again exiled to the island, where she spent the rest of her life. She died in 1938 after having infected at least 122 people, five of whom died.
 

COVID

Asymptomatic infections are primary drivers of COVID. Earlier in the pandemic, a meta-analysis suggested a 40% rate of asymptomatic infections, although some early reports arrived at lower estimates. A 2021 JAMA Network Open modeling study indicated a 60% rate.

Those rates are changing with the Omicron variants, of which even more cases are asymptomatic. Is this from a mutation in the virus? Some suggest that it is most likely attributable to prior vaccination resulting in boosted immunity and infections being milder. Of concern is that, although people may be asymptomatic, they still have the same viral load in their nose and can readily transmit infection.

Vincent Racaniello, PhD, a professor of virology at Columbia University in New York, told this news organization that “SARS-CoV-2 COVID is so effective at transmitting because it does this asymptomatic transmission. And so you’re out and about; you have no idea that you’re infected. You’re effectively doing what we call community transmission.”

This distinguishes SARS-CoV-2 from SARS-CoV-1. SARS-CoV-1 – which caused the SARS epidemic in 2002–2004 – had very little asymptomatic shedding. With COVID, on the other hand, “A lot of people are infected but never transmit,” Dr. Racaniello added. “I think 80% of transmissions are done by 20% of infected people because those are the ones who are shedding the most virus.”
 

Polio

The August case of paralytic polio in Rockland County, N.Y., is “the first case of polio reported in the United States in nearly 10 years, and only the second instance of community transmission identified in the U.S. since 1979,” a spokesperson for the Centers for Disease Control and Prevention said in an email. “Although no additional cases of polio have been reported at this time, recent wastewater findings elevate concerns that poliovirus is present in these communities, posing a risk to those who are unvaccinated.”

Poliovirus has now been found in the wastewater of New York City and three surrounding counties: Rockland, Orange, and Sullivan.

Unlike COVID, which is spread through air and respiratory secretions, polio has primarily fecal-oral transmission, meaning it is spread by people ingesting food or water contaminated with stool.

According to the World Health Organization, up to 90% of infections are unrecognized because the person has no to minimal symptoms. Symptoms are nonspecific in the remainder. Only a small proportion of those infected go on to develop paralysis.

Paul Offit, MD, a virologist and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told this news organization that before widespread immunization, polio “caused 25,000 – 30,000 children every year to be paralyzed and 1,500 to die. Roughly 1 of every 200 children who was infected was paralyzed. We had the inactivated vaccine followed by the oral polio vaccine (OPV). The price that we paid for the OPV was that rarely it could revert to the so-called neurovirulent type, a paralytic type.”

Use of the OPV was discontinued in 2000 in the United States but is still widely used worldwide because it is inexpensive and easier to administer than injections. It appeared that we were close to completely eradicating polio, as we had smallpox, but then vaccine-derived polio virus (VDPV) started cropping up in Africa, the Middle East, and Asia. They are mainly from the type 2 virus, as is the New York case. There have been three other cases of VDPV in the United States since 2000.

Now, Dr. Offit estimates that only 1 in 2,000 of those infected become paralyzed. This is why the CDC and epidemiologists are so concerned about the Rockland patient – that one case of paralysis could represent a large pool of people who are infected with polio and are asymptomatic, continuing to shed infectious virus into the sewage.

The CDC confirmed that it began conducting wastewater testing for polio in August 2022. In their interviews for this article, Dr. Offit and Dr. Racaniello were both critical of this, stressing that it is essential to do wastewater testing nationally, since asymptomatic polio can be expected to crop up from international travelers who have received OPV.

Many countries conduct that kind of wastewater surveillance. Dr. Racaniello was particularly critical of the CDC. “We’ve been telling CDC for years, at least a decade, Why don’t you check the wastewater?,” Dr. Racaniello said, “It’s been known for many years that we should be looking to monitor the circulation of these viruses. So we are using paralysis as a sentinel to say that this virus is in the wastewater, which is just not acceptable!”

Apparently there was some concern that the public would not understand. Dr. Offit viewed it as one more piece of necessary education: “You shouldn’t be alarmed about this as long as you’re vaccinated. If you’re not vaccinated, realize that this is a risk you’re taking.”
 

Monkeypox

Monkeypox cases have been skyrocketing in the United States in recent weeks. More than 18,000 cases have been reported since the first case in Boston on May 19, 2022.

“Monkeypox was such a rare zoonotic disease, and the disease always historically was introduced through animal contact,” Stuart Isaacs, MD, a pox virologist at the University of Pennsylvania, said in an interview. “And then the infected person would have potential spread within the household as the most common human-to-human spread, The sexual transmission is driving a lot of this infection and potentially allowing this to efficiently spread from person to person.”

A recent study from Belgium, available only as a preprint, created concerns about potential asymptomatic transmission of monkeypox Three men had undergone testing for anogenital chlamydia and gonorrhea but showed no clinical signs of monkeypox. The same samples were later tested by polymerase chain reaction (PCR), and their viral load in anorectal swabs was similar to or slightly lower than that of symptomatic patients. While no cultures were done, the patients seroconverted by later antibody testing, confirming infection.

Via email, a CDC spokesperson noted, “At this time, CDC does not have enough data to support transmission from aerosolized virus for the ongoing monkeypox outbreak, or to assess the risks for transmission from asymptomatic people. The data supports the main source of transmission currently as close contact with someone who is infected with monkeypox.”

Dr. Isaacs agreed, saying studies of smallpox, a related orthopox virus, also suggested this.

In the United Kingdom, the Institute of Tropical Medicine is offering PCR testing for monkeypox to all patients who come for gonorrhea/chlamydia screening. Dr. Racaniello said, “I think that would be great to get a sense of who is infected. Then you could look at the results and say what fraction of people go on to develop lesions, and they give you a sense of the asymptomatic rate, which we don’t know at this point.”

Unfortunately, to be tested for monkeypox in the United States requires that the patient have a lesion. “This is part of the dropped ball of public health in the U.S.,” Dr. Racaniello said. “We’re not thinking about this. .... We need to be doing [infectivity] experiments. So then the question is, how much infectious virus do you need to transmit?”
 

Conclusion

We’ve seen that asymptomatic carriage of bacteria and viruses occurs readily with typhoid, COVID, diphtheria, and polio (among many other organisms, such as methicillin-resistant Staphylococcus aureus or group A strep) and is far less likely with monkeypox.

Two common denominators emerged from these interviews. The first and biggest hurdle is identifying asymptomatic carriers, which is hampered by the politicization of the CDC and funding cuts to public health. “It used to be the CDC was all about public health, and now it’s administrators, unfortunately,” said Dr. Racaniello, citing science writer Laurie Garrett, author of the influential 1994 book, “The Coming Plague”.

We don’t conduct proper surveillance, he pointed out. Wastewater surveillance has been neglected for more than a decade. It has been used for SARS-CoV-2 but is only now being initiated for polio and monkeypox. Norovirus testing would also be especially helpful in reducing foodborne outbreaks, Dr. Racaniello suggested.

The second common denominator is the need to increase the availability and uptake of vaccines. As Dr. Racaniello said about COVID, “The virus is here to stay. It’s never going to go away. It’s in humans. It’s in a lot of animals. So we’re stuck with it. We’re going to have outbreaks every year. So what do you do? Get vaccinated.” And he added, “Vaccination is the most important strategy to go on with our lives.”

Dr. Isaacs was a bit more tempered, not wanting to oversell the vaccine. He said, “The vaccine is just part of the toolkit,” which includes education, testing, isolation, and reducing risk, all of which decrease the transmission cycles.

Speaking of how antivaccine advocates had specifically targeted the Hasidic community in New York State’s Rockland County, Dr. Offit noted, “I don’t think it’s a knowledge deficit as much as a trust deficit.” He said officials should identify people in communities such as these who are trusted and have them become the influencers.

The final major hurdle to controlling these outbreaks remains global disparities in care. Monkeypox has been endemic in Nigeria for decades. It was only when it spread to Europe and America that it received attention. Polio has been actively circulating in Africa and the Middle East but is only getting attention because of the New York case.

Africa was unable to afford COVID vaccines until recently. While many in the United States are on their fourth booster, as of December 2021, more than 80% of people in Africa had not yet received a single dose, according to an article by Munyaradzi Makoni in The Lancet Respiratory Medicine.

Echoing Dr. Peter Hotez’s long-standing plea for “vaccine diplomacy,” Dr. Racaniello concluded, “My philosophy has always been we should give [vaccines] to them. I mean, we spend trillions on guns. Can’t we spend a few hundred million on vaccines? We should give away everything in terms of medicine to countries that need it, and people would like us a lot better than they do now. I think it would be such a great way of getting countries to like us. … So what if it costs a billion dollars a year? It’s a drop in the bucket for us.”

Given globalization, an infectious outbreak anywhere is a risk to all.

Dr. Racaniello and Dr. Offit report no relevant financial relationships. Dr. Isaacs receives royalties from UpToDate.

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

Cannabis companies in the United States and Canada have developed corporate social responsibility (CSR) practices that mirror those of the tobacco industry, according to recent data.

A qualitative study of cannabis companies’ CSR practices over 10 years found, for example, that dispensary Trulieve provided $15,000 for internships and $20,000 for scholarships to prepare Black students for careers in the cannabis industry. The tobacco industry has used similar initiatives to foster good will and market its products to minority populations.

“The main message from this paper is that this is an industry selling a product with health impacts,” said study author Tanner Wakefield, an associate specialist at the Center for Tobacco Control Research and Education at the University of California, San Francisco. “We have seen how the tobacco industry in the past has used corporate social responsibility practices to insulate itself politically, engender public good will, and encourage consumption of tobacco products with harmful health effects.”

The study was published in JAMA Network Open.
 

A double agenda

The investigators identified 9 of the 10 largest publicly traded cannabis companies in the United States and Canada and examined the CSR activities that they conducted between Jan. 1, 2012, and Dec. 31, 2021. The investigators also conducted a systematic review of corporate websites and Nexis Uni articles that identified 153 news stories, press releases, and web pages that communicated about cannabis companies’ charitable and philanthropic activities.

Investigators identified themes in CSR activities by categorizing the language and informational patterns in the evidence they collected. They divided CSR practices into five categories, consisting of campaigns supposedly mitigating the harmful effects of past cannabis prohibition; initiatives characterized as promoting or increasing diversity, equity, and inclusion; charitable contributions; researching therapeutic cannabis uses and increasing medical access; and efforts claiming to address harms related to cannabis legalization.

The investigators observed that Green Thumb Industries and Cresco Labs set up “business incubators” and licensing assistance programs targeted toward members of racial and ethnic minority populations and communities most affected by cannabis prohibition. Canopy Growth Corporation supported research into whether medical cannabis could alleviate sleep disorders or treat mental health conditions. The company also collaborated with Canadian Students for Sensible Drug Policy and Parent Action on Drugs to create materials for preventing cannabis abuse among youth.

“I think we need to remember that this is an industry selling a product,” said Mr. Wakefield. “And just because there is merit to addressing certain issues or harms, that doesn’t mean we should forget that they are businesses seeking to make a profit. While CSR activities may have some potential benefits or apparent legitimacy, we have to remember that CSR is also a form of marketing and political influence.”

The investigators concluded that these CSR activities were similar to CSR strategies that the tobacco industry previously had used to encourage consumption, target marginalized communities, influence regulation, and advance corporate interests.

“A similarity to the tobacco industry is that they would provide funding or assistance to nonprofit groups that are not necessarily tied to cannabis or tobacco,” said Mr. Wakefield. For example, the investigators noted that cannabis companies contributed funding for breast cancer research and for veterans.

Moreover, the investigators observed “similarities in terms of focus and orientation toward special interest populations,” said Mr. Wakefield. Those special populations included the LGBTQ communities, and activities included sponsoring or participating in pride celebrations and releasing limited-edition pride products.

Overall, the cannabis industry engages in CSR activities that appear to mitigate the harmful effects of its products and operations, said Mr. Wakefield.
 

‘Incomplete information’

Jason W. Busse, DC, PhD, associate director of the Michael G. DeGroote Centre for Medicinal Cannabis Research at McMaster University, Hamilton, Ont., described the study as rigorous, but with limitations acknowledged by the authors.

“Understanding how these companies are promoting themselves and justifying themselves as good corporate citizens is important,” said Dr. Busse. “The investigators have undertaken a comprehensive study and identified CSR activities that cannabis companies are engaging in. We know from past experiences with tobacco companies that these activities may be used in part to encourage less regulation and increase market access.”

One constraint of the study is that the investigators used documents that were in the public domain, as opposed to internal company information. “The investigators were limited to the information that they were able to access,” said Dr. Busse. “Unless you use the Freedom of Information Act to compel companies to release internal documents, you don’t have that information. They haven’t done that, and it is almost a certainty that the authors had to work with incomplete information.”

The investigators suggest a need for oversight of the cannabis industry’s CSR practices, and Dr. Busse agreed with this assessment. “While engagement in social responsibility activities by cannabis corporations may have positive results, there should be independent assessment of outcomes. For example, sponsoring research may be problematic if such support comes with strings attached, such as suppressing or modifying unfavorable findings.”

The study was supported by the National Institutes of Health. Dr. Wakefield and Dr. Busse reported no relevant financial relationships.

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

Cannabis companies in the United States and Canada have developed corporate social responsibility (CSR) practices that mirror those of the tobacco industry, according to recent data.

A qualitative study of cannabis companies’ CSR practices over 10 years found, for example, that dispensary Trulieve provided $15,000 for internships and $20,000 for scholarships to prepare Black students for careers in the cannabis industry. The tobacco industry has used similar initiatives to foster good will and market its products to minority populations.

“The main message from this paper is that this is an industry selling a product with health impacts,” said study author Tanner Wakefield, an associate specialist at the Center for Tobacco Control Research and Education at the University of California, San Francisco. “We have seen how the tobacco industry in the past has used corporate social responsibility practices to insulate itself politically, engender public good will, and encourage consumption of tobacco products with harmful health effects.”

The study was published in JAMA Network Open.
 

A double agenda

The investigators identified 9 of the 10 largest publicly traded cannabis companies in the United States and Canada and examined the CSR activities that they conducted between Jan. 1, 2012, and Dec. 31, 2021. The investigators also conducted a systematic review of corporate websites and Nexis Uni articles that identified 153 news stories, press releases, and web pages that communicated about cannabis companies’ charitable and philanthropic activities.

Investigators identified themes in CSR activities by categorizing the language and informational patterns in the evidence they collected. They divided CSR practices into five categories, consisting of campaigns supposedly mitigating the harmful effects of past cannabis prohibition; initiatives characterized as promoting or increasing diversity, equity, and inclusion; charitable contributions; researching therapeutic cannabis uses and increasing medical access; and efforts claiming to address harms related to cannabis legalization.

The investigators observed that Green Thumb Industries and Cresco Labs set up “business incubators” and licensing assistance programs targeted toward members of racial and ethnic minority populations and communities most affected by cannabis prohibition. Canopy Growth Corporation supported research into whether medical cannabis could alleviate sleep disorders or treat mental health conditions. The company also collaborated with Canadian Students for Sensible Drug Policy and Parent Action on Drugs to create materials for preventing cannabis abuse among youth.

“I think we need to remember that this is an industry selling a product,” said Mr. Wakefield. “And just because there is merit to addressing certain issues or harms, that doesn’t mean we should forget that they are businesses seeking to make a profit. While CSR activities may have some potential benefits or apparent legitimacy, we have to remember that CSR is also a form of marketing and political influence.”

The investigators concluded that these CSR activities were similar to CSR strategies that the tobacco industry previously had used to encourage consumption, target marginalized communities, influence regulation, and advance corporate interests.

“A similarity to the tobacco industry is that they would provide funding or assistance to nonprofit groups that are not necessarily tied to cannabis or tobacco,” said Mr. Wakefield. For example, the investigators noted that cannabis companies contributed funding for breast cancer research and for veterans.

Moreover, the investigators observed “similarities in terms of focus and orientation toward special interest populations,” said Mr. Wakefield. Those special populations included the LGBTQ communities, and activities included sponsoring or participating in pride celebrations and releasing limited-edition pride products.

Overall, the cannabis industry engages in CSR activities that appear to mitigate the harmful effects of its products and operations, said Mr. Wakefield.
 

‘Incomplete information’

Jason W. Busse, DC, PhD, associate director of the Michael G. DeGroote Centre for Medicinal Cannabis Research at McMaster University, Hamilton, Ont., described the study as rigorous, but with limitations acknowledged by the authors.

“Understanding how these companies are promoting themselves and justifying themselves as good corporate citizens is important,” said Dr. Busse. “The investigators have undertaken a comprehensive study and identified CSR activities that cannabis companies are engaging in. We know from past experiences with tobacco companies that these activities may be used in part to encourage less regulation and increase market access.”

One constraint of the study is that the investigators used documents that were in the public domain, as opposed to internal company information. “The investigators were limited to the information that they were able to access,” said Dr. Busse. “Unless you use the Freedom of Information Act to compel companies to release internal documents, you don’t have that information. They haven’t done that, and it is almost a certainty that the authors had to work with incomplete information.”

The investigators suggest a need for oversight of the cannabis industry’s CSR practices, and Dr. Busse agreed with this assessment. “While engagement in social responsibility activities by cannabis corporations may have positive results, there should be independent assessment of outcomes. For example, sponsoring research may be problematic if such support comes with strings attached, such as suppressing or modifying unfavorable findings.”

The study was supported by the National Institutes of Health. Dr. Wakefield and Dr. Busse reported no relevant financial relationships.

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

Cannabis companies in the United States and Canada have developed corporate social responsibility (CSR) practices that mirror those of the tobacco industry, according to recent data.

A qualitative study of cannabis companies’ CSR practices over 10 years found, for example, that dispensary Trulieve provided $15,000 for internships and $20,000 for scholarships to prepare Black students for careers in the cannabis industry. The tobacco industry has used similar initiatives to foster good will and market its products to minority populations.

“The main message from this paper is that this is an industry selling a product with health impacts,” said study author Tanner Wakefield, an associate specialist at the Center for Tobacco Control Research and Education at the University of California, San Francisco. “We have seen how the tobacco industry in the past has used corporate social responsibility practices to insulate itself politically, engender public good will, and encourage consumption of tobacco products with harmful health effects.”

The study was published in JAMA Network Open.
 

A double agenda

The investigators identified 9 of the 10 largest publicly traded cannabis companies in the United States and Canada and examined the CSR activities that they conducted between Jan. 1, 2012, and Dec. 31, 2021. The investigators also conducted a systematic review of corporate websites and Nexis Uni articles that identified 153 news stories, press releases, and web pages that communicated about cannabis companies’ charitable and philanthropic activities.

Investigators identified themes in CSR activities by categorizing the language and informational patterns in the evidence they collected. They divided CSR practices into five categories, consisting of campaigns supposedly mitigating the harmful effects of past cannabis prohibition; initiatives characterized as promoting or increasing diversity, equity, and inclusion; charitable contributions; researching therapeutic cannabis uses and increasing medical access; and efforts claiming to address harms related to cannabis legalization.

The investigators observed that Green Thumb Industries and Cresco Labs set up “business incubators” and licensing assistance programs targeted toward members of racial and ethnic minority populations and communities most affected by cannabis prohibition. Canopy Growth Corporation supported research into whether medical cannabis could alleviate sleep disorders or treat mental health conditions. The company also collaborated with Canadian Students for Sensible Drug Policy and Parent Action on Drugs to create materials for preventing cannabis abuse among youth.

“I think we need to remember that this is an industry selling a product,” said Mr. Wakefield. “And just because there is merit to addressing certain issues or harms, that doesn’t mean we should forget that they are businesses seeking to make a profit. While CSR activities may have some potential benefits or apparent legitimacy, we have to remember that CSR is also a form of marketing and political influence.”

The investigators concluded that these CSR activities were similar to CSR strategies that the tobacco industry previously had used to encourage consumption, target marginalized communities, influence regulation, and advance corporate interests.

“A similarity to the tobacco industry is that they would provide funding or assistance to nonprofit groups that are not necessarily tied to cannabis or tobacco,” said Mr. Wakefield. For example, the investigators noted that cannabis companies contributed funding for breast cancer research and for veterans.

Moreover, the investigators observed “similarities in terms of focus and orientation toward special interest populations,” said Mr. Wakefield. Those special populations included the LGBTQ communities, and activities included sponsoring or participating in pride celebrations and releasing limited-edition pride products.

Overall, the cannabis industry engages in CSR activities that appear to mitigate the harmful effects of its products and operations, said Mr. Wakefield.
 

‘Incomplete information’

Jason W. Busse, DC, PhD, associate director of the Michael G. DeGroote Centre for Medicinal Cannabis Research at McMaster University, Hamilton, Ont., described the study as rigorous, but with limitations acknowledged by the authors.

“Understanding how these companies are promoting themselves and justifying themselves as good corporate citizens is important,” said Dr. Busse. “The investigators have undertaken a comprehensive study and identified CSR activities that cannabis companies are engaging in. We know from past experiences with tobacco companies that these activities may be used in part to encourage less regulation and increase market access.”

One constraint of the study is that the investigators used documents that were in the public domain, as opposed to internal company information. “The investigators were limited to the information that they were able to access,” said Dr. Busse. “Unless you use the Freedom of Information Act to compel companies to release internal documents, you don’t have that information. They haven’t done that, and it is almost a certainty that the authors had to work with incomplete information.”

The investigators suggest a need for oversight of the cannabis industry’s CSR practices, and Dr. Busse agreed with this assessment. “While engagement in social responsibility activities by cannabis corporations may have positive results, there should be independent assessment of outcomes. For example, sponsoring research may be problematic if such support comes with strings attached, such as suppressing or modifying unfavorable findings.”

The study was supported by the National Institutes of Health. Dr. Wakefield and Dr. Busse reported no relevant financial relationships.

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

Background

Palliative Care (PC) addresses quality of life and patient satisfaction with care. Recognized as a board-certified subspeciality in 2006, the utilization and implementation of PC has been evolving. Stage IV esophageal cancer has a 5-year survival rate of 15% to 20%, making it a good candidate for PC. This study aims to look at trends in PC interventions and facility type.

Methods

This study looked at 8808 patients with stage IV esophageal cancer who received PC interventions from 2004 to 2018 in the National Cancer Database (NCDB). The NCDB codes 4 different kinds of PC: surgical, radiation, chemotherapy/hormone therapy, and pain management. All PC interventions function to “alleviate symptoms, but no attempt to diagnose, stage, or treat the primary tumor is made.” Data was grouped into 5-year time increments: 2004- 2008 (time 1), 2009-2013 (time 2), 2014-2018 (time 3). Exclusion criteria was concurrent tumors and missing data. Cross tabulation analysis was performed using Pearson chi-square and ANOVA tests.

Results

For all PC interventions, 9.0% were surgical, 42.5% radiation, 41.1% chemotherapy, and 7.4% pain management. Surgical interventions decreased over time, indicated by interventions administered at times 1 (n = 360), 2 (n = 228), and 3 (n = 200). Radiation PC utilization remained nearly constant (n = 1157, n = 1147, n = 1397) over the same time increments. Chemotherapy/hormone therapy and pain management increased over time, indicated by interventions administered at times 1 (n = 713), 2 (n = 1053), and 3 (n = 1795) and times 1 (n = 129) 2 (n = 224), and 3 (n = 291), respectively. For surgical PC, facility type shifted from academic institutions, occurring 45% of all cases in time 1 to 30% by time 3. Radiation PC remained constant with a slight predominance of comprehensive cancer community facilities. Chemotherapy/hormone therapy PC facility type also remained constant, with a slight preference for comprehensive cancer community facilities. Pain management shifted from a predominance of academic/research facilities in time 1 (38.0%) to comprehensive cancer community facilities by time 3 (38.1%).

Conclusions

Radiation, chemotherapy/hormone therapy, and pain management have been growing in utilization, while there has been a downtrend in surgical PC. All PC interventions (besides surgery) have been increasing across all facility locations, with PC predominantly being implemented in community cancer programs.

Background

Palliative Care (PC) addresses quality of life and patient satisfaction with care. Recognized as a board-certified subspeciality in 2006, the utilization and implementation of PC has been evolving. Stage IV esophageal cancer has a 5-year survival rate of 15% to 20%, making it a good candidate for PC. This study aims to look at trends in PC interventions and facility type.

Methods

This study looked at 8808 patients with stage IV esophageal cancer who received PC interventions from 2004 to 2018 in the National Cancer Database (NCDB). The NCDB codes 4 different kinds of PC: surgical, radiation, chemotherapy/hormone therapy, and pain management. All PC interventions function to “alleviate symptoms, but no attempt to diagnose, stage, or treat the primary tumor is made.” Data was grouped into 5-year time increments: 2004- 2008 (time 1), 2009-2013 (time 2), 2014-2018 (time 3). Exclusion criteria was concurrent tumors and missing data. Cross tabulation analysis was performed using Pearson chi-square and ANOVA tests.

Results

For all PC interventions, 9.0% were surgical, 42.5% radiation, 41.1% chemotherapy, and 7.4% pain management. Surgical interventions decreased over time, indicated by interventions administered at times 1 (n = 360), 2 (n = 228), and 3 (n = 200). Radiation PC utilization remained nearly constant (n = 1157, n = 1147, n = 1397) over the same time increments. Chemotherapy/hormone therapy and pain management increased over time, indicated by interventions administered at times 1 (n = 713), 2 (n = 1053), and 3 (n = 1795) and times 1 (n = 129) 2 (n = 224), and 3 (n = 291), respectively. For surgical PC, facility type shifted from academic institutions, occurring 45% of all cases in time 1 to 30% by time 3. Radiation PC remained constant with a slight predominance of comprehensive cancer community facilities. Chemotherapy/hormone therapy PC facility type also remained constant, with a slight preference for comprehensive cancer community facilities. Pain management shifted from a predominance of academic/research facilities in time 1 (38.0%) to comprehensive cancer community facilities by time 3 (38.1%).

Conclusions

Radiation, chemotherapy/hormone therapy, and pain management have been growing in utilization, while there has been a downtrend in surgical PC. All PC interventions (besides surgery) have been increasing across all facility locations, with PC predominantly being implemented in community cancer programs.

Background

Palliative Care (PC) addresses quality of life and patient satisfaction with care. Recognized as a board-certified subspeciality in 2006, the utilization and implementation of PC has been evolving. Stage IV esophageal cancer has a 5-year survival rate of 15% to 20%, making it a good candidate for PC. This study aims to look at trends in PC interventions and facility type.

Methods

This study looked at 8808 patients with stage IV esophageal cancer who received PC interventions from 2004 to 2018 in the National Cancer Database (NCDB). The NCDB codes 4 different kinds of PC: surgical, radiation, chemotherapy/hormone therapy, and pain management. All PC interventions function to “alleviate symptoms, but no attempt to diagnose, stage, or treat the primary tumor is made.” Data was grouped into 5-year time increments: 2004- 2008 (time 1), 2009-2013 (time 2), 2014-2018 (time 3). Exclusion criteria was concurrent tumors and missing data. Cross tabulation analysis was performed using Pearson chi-square and ANOVA tests.

Results

For all PC interventions, 9.0% were surgical, 42.5% radiation, 41.1% chemotherapy, and 7.4% pain management. Surgical interventions decreased over time, indicated by interventions administered at times 1 (n = 360), 2 (n = 228), and 3 (n = 200). Radiation PC utilization remained nearly constant (n = 1157, n = 1147, n = 1397) over the same time increments. Chemotherapy/hormone therapy and pain management increased over time, indicated by interventions administered at times 1 (n = 713), 2 (n = 1053), and 3 (n = 1795) and times 1 (n = 129) 2 (n = 224), and 3 (n = 291), respectively. For surgical PC, facility type shifted from academic institutions, occurring 45% of all cases in time 1 to 30% by time 3. Radiation PC remained constant with a slight predominance of comprehensive cancer community facilities. Chemotherapy/hormone therapy PC facility type also remained constant, with a slight preference for comprehensive cancer community facilities. Pain management shifted from a predominance of academic/research facilities in time 1 (38.0%) to comprehensive cancer community facilities by time 3 (38.1%).

Conclusions

Radiation, chemotherapy/hormone therapy, and pain management have been growing in utilization, while there has been a downtrend in surgical PC. All PC interventions (besides surgery) have been increasing across all facility locations, with PC predominantly being implemented in community cancer programs.