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Seven legal risks of promoting unproven COVID-19 treatments
The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.
Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.
The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.
Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. This can have serious legal consequences.
The crux of the issue
This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.
On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:
“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”
What are the legal consequences?
Medical malpractice
The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.
The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.
By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.
In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.
In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
Professional licensing action
Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.
This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.
In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.
The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.
The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.
Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.
Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.
In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
Peer review and affected privileges
Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.
The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
Criminal charges
Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.
Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
Breach of contract
Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.
Reputation/credibility damage and the attendant consequences
In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.
Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.
In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
Violation of the COVID-19 Consumer Protection Act of 2020
For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.
The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.
Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”
After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.
In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
Conclusion
It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.
Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.
The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.
Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.
The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.
Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. This can have serious legal consequences.
The crux of the issue
This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.
On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:
“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”
What are the legal consequences?
Medical malpractice
The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.
The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.
By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.
In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.
In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
Professional licensing action
Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.
This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.
In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.
The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.
The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.
Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.
Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.
In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
Peer review and affected privileges
Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.
The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
Criminal charges
Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.
Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
Breach of contract
Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.
Reputation/credibility damage and the attendant consequences
In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.
Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.
In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
Violation of the COVID-19 Consumer Protection Act of 2020
For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.
The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.
Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”
After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.
In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
Conclusion
It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.
Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.
The emergence of COVID-19 has given the medical world a bewildering array of prevention and treatment protocols. Some physicians are advocating treatments that have not been validated by sound scientific studies. This has already led to licensing issues and other disciplinary actions being taken against physicians, pharmacies, and other health care providers across the country.
Medical professionals try their very best to give sound advice to patients. A medical license does not, however, confer immunity from being misled.
The supporting “science” for alternative prevention and treatments may look legitimate, but these claims are often based on anecdotal evidence. Some studies involve small populations, some are meta-analyses of several small or single-case studies, and others are not properly designed, interpreted, or executed in line with U.S. research and requirements. Yet others have been conducted only in nonhuman analogues, such as frogs or mice.
Many people are refusing a vaccine that has been proven to be relatively safe and effective in numerous repeated and validated studies in the best medical centers across the globe – all in favor of less validated alternatives. This can have serious legal consequences.
The crux of the issue
This is not a question of a physician’s first amendment rights. Nor is it a question of advocating for a scientifically valid minority medical opinion. The point of this article is that promoting unproven products, preventives, treatments, and cures can have dire consequences for licensed medical professionals.
On July 29, 2021, the Federation of State Medical Boards’ Board of Directors released a statement in response to a dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians and other health care professionals on social media platforms, online, and in the media. The statement reads as follows:
“Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded, and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession, and puts all patients at risk.”
What are the legal consequences?
Medical malpractice
The first consequence to consider is professional liability or medical malpractice. This applies if a patient claims harm as a result of the health care practitioner’s recommendation of an unproven treatment, product, or protocol. For example, strongly discouraging vaccination can result in a wrongful death claim if the patient follows the doctor’s advice, chooses not to vaccinate, contracts COVID-19, and does not recover. Recommending or providing unproven approaches and unapproved treatments is arguably a violation of the standard of care.
The standard of care is grounded in evidence-based medicine: It is commonly defined as the degree of care and skill that would be used by the average physician, who is practicing in his or her relevant specialty, under the same or similar circumstances, given the generally accepted medical knowledge at the time in question.
By way of example, one can see why inhaling peroxide, drinking bleach, or even taking Food and Drug Administration–approved medications that have little or no proven efficacy in treating or preventing COVID-19 is not what the average physician would advocate for under the same or similar circumstances, considering available and commonly accepted medical knowledge. Recommending or providing such treatments can be a breach of the standard of care and can form the basis of a medical malpractice action if, in fact, compensable harm has occurred.
In addition, recommending unproven and unapproved COVID-19 preventives and treatments without appropriate informed consent from patients is arguably also a breach of the standard of care. The claim would be that the patient has not been appropriately informed of the all the known benefits, risks, costs, and other legally required information such as proven efficacy and reasonably available alternatives.
In any event, physicians can rest assured that if a patient is harmed as a result of any of these situations, they’ll probably be answering to someone in the legal system.
Professional licensing action
Regardless of whether there is a medical malpractice action, there is still the potential for a patient complaint to be filed with the state licensing authority on the basis of the same facts and grounds. This can result in an investigation or an administrative complaint against the license of the health care provider.
This is not a mere potential risk. Licensing investigations are underway across the country. Disciplinary licensing actions have already taken place. For example, a Washington Medical Commission panel suspended the license of a physician assistant (PA) on Oct. 12, 2021, after an allegation that his treatment of COVID-19 patients fell below the standard of care. The PA allegedly began a public campaign promoting ivermectin as a curative agent for COVID-19 and prescribed it without adequate examination to at least one person, with no evidence from reliable clinical studies that establish its efficacy in preventing or treating COVID-19.
In licensing claims, alleged violations of failing to comply with the standard of care are usually asserted. These claims may also cite violations of other state statutes that encompass such concepts as negligence; breach of the duty of due care; incompetence; lack of good moral character; and lack of ability to serve the public in a fair, honest, and open manner. A licensing complaint may include alleged violations of statutes that address prescribing protocols, reckless endangerment, failure to supervise, and other issues.
The filing of an administrative complaint is a different animal from a medical malpractice action – they are not even in the same system or branch of government. The focus is not just about what happened to the one patient who complained; it is about protection of the public.
The states’ power to put a clinician on probation, condition, limit, suspend, or revoke the clinician’s license, as well as issue other sanctions such as physician monitoring and fines), is profound. The discipline imposed can upend a clinician’s career and potentially end it entirely.
Administrative discipline determinations are usually available to the public and are required to be reported to all employers (current and future). These discipline determinations are also sent to the National Practitioner Data Bank, other professional clearinghouse organizations (such as the Federation of State Medical Boards), state offices, professional liability insurers, payers with whom the clinician contracts, accreditation and certification organizations, and the clinician’s patients.
Discipline determinations must be promptly reported to licensing agencies in other states where the clinician holds a license, and often results in “sister state” actions because discipline was issued against the clinician in another state. It must be disclosed every time a clinician applies for hospital privileges or new employment. It can result in de-participation from health care insurance programs and can affect board certification, recertification, or accreditation for care programs in which the clinician participates.
In sum, licensing actions can be much worse than medical malpractice judgments and can have longer-term consequences.
Peer review and affected privileges
Recommending, promoting, and providing unapproved or unproven treatments, cures, or preventives to patients may violate hospital/health system, practice group, or surgical center bylaws. This can trigger the peer review process, which serves to improve patient safety and the quality of care.
The peer review process may be commenced because of a concern about the clinician’s compliance with the standard of care; potential patient safety issues; ethical issues; and the clinician’s stability, credibility, or professional competence. Any hospital disciplinary penalty is generally reported to state licensing authorities, which can trigger a licensing investigation. If clinical privileges are affected for a period of more than 30 days, the organization must report the situation to the National Practitioner Data Bank.
Criminal charges
Depending on the facts, a physician or other health care professional could be charged with reckless endangerment, criminal negligence, or manslaughter. If the clinician was assisting someone else who profited from that clinician’s actions, then we can look to a variety of potential federal and state fraud charges as well.
Conviction of a fraud-related felony may also lead to federal health care program and Centers for Medicare & Medicaid Services (CMS) exclusion for several years, and then CMS preclusion that can be imposed for years beyond the conclusion of the statutorily required exclusion.
Breach of contract
Some practice groups or other organizational employers have provisions in employment contracts that treat discipline for this type of conduct as a breach of contract. Because of this, the clinician committing breach may be subject to liquidated damages clauses, forfeiture of monies (such as bonuses or other incentives or rewards), termination of employment, forced withdrawal from ownership status, and being sued for breach of contract to recover damages.
Reputation/credibility damage and the attendant consequences
In regard to hospitals and health care system practice groups, another risk is the loss of referrals and revenue. Local media may air or publish exposés. Such stories may widely publicize the media’s version of the facts – true or not. This can cause immediate reputation and credibility damage within the community and may adversely affect a clinician’s patient base. Any information that is publicly broadcast might attract the attention of licensing and law enforcement authorities and taint potential jurors.
Hospitals and health care systems may pull privileges; post on websites; make official statements about the termination of affiliation; or denounce the clinician’s behavior, conduct, and beliefs as being inconsistent with quality care and patient safety. This causes further damage to a physician’s reputation and credibility.
In a group practice, accusations of this sort, licensing discipline, medical malpractice liability, investigations, loss of privileges, and the other sequelae of this conduct can force the withdrawal of the clinician as a member or shareholder in multiprovider groups. Adverse effects on the financial bottom line, patient referrals, and patient volume and bad press are often the basis for voting a clinician out.
Violation of the COVID-19 Consumer Protection Act of 2020
For the duration of the COVID-19 public health emergency, the FTC COVID-19 Consumer Protection Act makes it unlawful for any person, partnership, or corporation (as those terms are defined broadly in the act) to engage in a deceptive act or practice in or affecting commerce associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19.
The first enforcement action authorized by this act took place in April 2021 against a chiropractor who promised vitamin treatments and cures for COVID-19. The act provides that such a violation shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under the FTC Act.
Under the act, the FTC is authorized to prescribe “rules that define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce.” Deceptive practices are defined as involving a material representation, omission, or practice that is “likely to mislead a consumer acting reasonably in the circumstances.” An act or practice is unfair if it “causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition.”
After an investigation, the FTC may initiate an enforcement action using either an administrative or judicial process if it has “reason to believe” that the law has been violated. Violations of some laws may result in injunctive relief or civil monetary penalties, which are adjusted annually for inflation.
In addition, many states have deceptive and unfair trade laws that can be enforced in regard to the recommendation, sale, or provision of unproven or unapproved COVID-19 treatments, cures, and preventives as well.
Conclusion
It is difficult even for intelligent, well-intentioned physicians to know precisely what to believe and what to advocate for in the middle of a pandemic. It seems as though new reports and recommendations for preventing and treating COVID-19 are surfacing on a weekly basis. By far, the safest approach for any medical clinician to take is to advocate for positions that are generally accepted in the medical and scientific community at the time advice is given.
Mr. Whitelaw disclosed no relevant financial relationships. Ms. Janeway disclosed various associations with the Michigan Association for Healthcare Quality and the Greater Houston Society for Healthcare Risk Management. A version of this article first appeared on Medscape.com.
Cardiologist positive for Omicron after London conference
Elad Maor, MD, an interventional cardiologist at Sheba Medical Centre near Tel Aviv, posted on Twitter on Nov. 30: “What a mess! Came back from a conference in London. With a mask and 3 Pfizer vaccines I managed to get Omicron.”
Dr. Maor traveled to London on November 19 to attend the PCR London Valves 2021 conference held at the ExCeL Centre Nov. 21-23. He stayed four nights at a hotel in north London and took public transport to and from the ExCeL Centre in East London each day of the meeting. He returned to Israel on the evening of Nov. 23.
Dr. Maor, 45, who has received three doses of the Pfizer COVID-19 vaccine, had two PCR tests in the United Kingdom – on November 20 and 21 in line with travel requirements – and another PCR test upon arriving back in Israel in the early hours of Nov. 24. All three tests were negative.
He began experiencing symptoms within days and tested positive on Nov. 27. His symptoms have been mild so far, and he said he was feeling “better” at the time of his tweet on Nov. 30.
Dr. Maor believes he was infected during his trip to London. “The only reasonable explanation is that I got infected on the last day of the meeting – maybe at the airport, maybe at the meeting,” he told The Guardian newspaper.
Although his wife accompanied him to London, neither she nor any of his 3 children have experienced symptoms or tested positive for COVID-19. But Dr. Maor believes he has passed the infection to a 69-year-old colleague in Israel who has since tested positive for the Omicron variant. The colleague, who has also received three vaccine doses, is understood to have mild symptoms at present.
The case suggests that the Omicron variant of COVID-19 may have been circulating in the United Kingdom earlier than previously thought.
Implications for in-person conferences
It will also inevitably lead to questions about the safety of face-to-face conferences, which are only just starting to get underway again.
The PCR Valves 2021 meeting had more than 1,250 on-site attendees as well as 2,400 or more joining online, according to figures on its website. Dr. Maor said he did not have any issues with the conference organizers, who required proof of vaccination before entry. But he posted a photograph on his Twitter account of a crowded auditorium with many delegates not wearing masks.
The conference subsequently posted an announcement on its website alerting delegates that one of the attendees had tested positive for COVID-19 after returning to their home country. It reads: “Since the reported case comes less than a week after the end of PCR London Valves, we want to inform you so that you may decide the best course of action, for yourself, if any.” It does not mention that the case was the Omicron variant.
Patrick Jolly, strategic and market development director of the conference, commented: “As you may imagine, the health, safety and well-being of everyone who visited PCR London Valves was our number-one priority. All protocols mandated by the U.K. government were put in place. Anyone entering the congress center had to present a valid health pass and were requested to wear a mask. Hydro-alcoholic gel and masks were made readily available for all participants and disposal bins for used protective equipment were provided.”
Mr. Jolly also noted: “To date – more than 9 days after the end of PCR London Valves – we have had no report of any other case of participants testing positive who attended PCR London Valves.”
He said the EuroPCR organization believes that medical conferences are safe to be held in person.
“With the above sanitary requirements and protocols, and no complacency in their enforcement, we believe strongly that medical conferences can take place, as the benefits of in-person medical conferences are obvious for the concerned medical communities,” Mr. Jolly added.
But what about other meetings happening imminently and planning in-person attendance?
Eileen Murray, executive director of the American Epilepsy Society (AES), whose annual 5-day meeting starts today at Chicago’s McCormick Place Convention Center, said in an interview that the health, safety, and well-being of everyone attending is a priority.
“Vaccinations are required, with no exceptions, to anyone attending the in-person event,” Ms. Murray said. “AES is using the CLEAR HealthPass to verify identity and vaccination status for our attendees. No one who cannot verify identity and vaccination requirement will be permitted to attend the in-person event.”
She noted that masks will also be required except in limited circumstances when actively eating or drinking, or for a faculty member when actively presenting at a lecture or panel. “Anyone not adhering to the mask policy will be asked to leave the meeting and will be denied readmission to the meeting with no refund,” she said.
“These guidelines were developed in accordance with the latest public health guidance and AES will continue to follow that guidance as any updates are made with the emergence of the Omicron variant,” Ms. Murray added.
Also commenting on this issue, a spokesperson for the American Heart Association, which has its large annual international stroke meeting planned for in-person attendance in New Orleans in February, said: “As we have throughout the pandemic, the American Heart Association is closely monitoring conditions and following the guidance of the CDC as well as state and local health departments related to all in-person meetings.”
“Our upcoming International Stroke Conference, February 9-11, is planned as an in-person and digital experience which allows us the ultimate flexibility to address changing pandemic conditions. The health, safety, and well-being of our volunteers, members, and attendees from around the world remains our number-one priority,” the AHA spokesperson added.
But some COVID-19 experts are taking a more cautious view.
Rowland Kao, PhD, an expert in infectious disease dynamics at the University of Edinburgh, United Kingdom, expressed concern about such large in-person conferences.
“We know that the Omicron variant appears to be spreading rapidly, with a recent preprint also telling us that the reinfection rate appears to be higher in South Africa. Should this be borne out, then the evidence would support that our reliance on a combination of vaccine-induced and natural immunity may be compromised by the Omicron variant,” he commented.
“We already know that extended contact indoors provides an additional risk, and so large meetings of this type have the potential to create extended risks. Until we know the extent to which Omicron causes severe illness, we should be extra cautious about these high-risk settings,” Dr. Kao commented.
A version of this article first appeared on Medscape.com.
Elad Maor, MD, an interventional cardiologist at Sheba Medical Centre near Tel Aviv, posted on Twitter on Nov. 30: “What a mess! Came back from a conference in London. With a mask and 3 Pfizer vaccines I managed to get Omicron.”
Dr. Maor traveled to London on November 19 to attend the PCR London Valves 2021 conference held at the ExCeL Centre Nov. 21-23. He stayed four nights at a hotel in north London and took public transport to and from the ExCeL Centre in East London each day of the meeting. He returned to Israel on the evening of Nov. 23.
Dr. Maor, 45, who has received three doses of the Pfizer COVID-19 vaccine, had two PCR tests in the United Kingdom – on November 20 and 21 in line with travel requirements – and another PCR test upon arriving back in Israel in the early hours of Nov. 24. All three tests were negative.
He began experiencing symptoms within days and tested positive on Nov. 27. His symptoms have been mild so far, and he said he was feeling “better” at the time of his tweet on Nov. 30.
Dr. Maor believes he was infected during his trip to London. “The only reasonable explanation is that I got infected on the last day of the meeting – maybe at the airport, maybe at the meeting,” he told The Guardian newspaper.
Although his wife accompanied him to London, neither she nor any of his 3 children have experienced symptoms or tested positive for COVID-19. But Dr. Maor believes he has passed the infection to a 69-year-old colleague in Israel who has since tested positive for the Omicron variant. The colleague, who has also received three vaccine doses, is understood to have mild symptoms at present.
The case suggests that the Omicron variant of COVID-19 may have been circulating in the United Kingdom earlier than previously thought.
Implications for in-person conferences
It will also inevitably lead to questions about the safety of face-to-face conferences, which are only just starting to get underway again.
The PCR Valves 2021 meeting had more than 1,250 on-site attendees as well as 2,400 or more joining online, according to figures on its website. Dr. Maor said he did not have any issues with the conference organizers, who required proof of vaccination before entry. But he posted a photograph on his Twitter account of a crowded auditorium with many delegates not wearing masks.
The conference subsequently posted an announcement on its website alerting delegates that one of the attendees had tested positive for COVID-19 after returning to their home country. It reads: “Since the reported case comes less than a week after the end of PCR London Valves, we want to inform you so that you may decide the best course of action, for yourself, if any.” It does not mention that the case was the Omicron variant.
Patrick Jolly, strategic and market development director of the conference, commented: “As you may imagine, the health, safety and well-being of everyone who visited PCR London Valves was our number-one priority. All protocols mandated by the U.K. government were put in place. Anyone entering the congress center had to present a valid health pass and were requested to wear a mask. Hydro-alcoholic gel and masks were made readily available for all participants and disposal bins for used protective equipment were provided.”
Mr. Jolly also noted: “To date – more than 9 days after the end of PCR London Valves – we have had no report of any other case of participants testing positive who attended PCR London Valves.”
He said the EuroPCR organization believes that medical conferences are safe to be held in person.
“With the above sanitary requirements and protocols, and no complacency in their enforcement, we believe strongly that medical conferences can take place, as the benefits of in-person medical conferences are obvious for the concerned medical communities,” Mr. Jolly added.
But what about other meetings happening imminently and planning in-person attendance?
Eileen Murray, executive director of the American Epilepsy Society (AES), whose annual 5-day meeting starts today at Chicago’s McCormick Place Convention Center, said in an interview that the health, safety, and well-being of everyone attending is a priority.
“Vaccinations are required, with no exceptions, to anyone attending the in-person event,” Ms. Murray said. “AES is using the CLEAR HealthPass to verify identity and vaccination status for our attendees. No one who cannot verify identity and vaccination requirement will be permitted to attend the in-person event.”
She noted that masks will also be required except in limited circumstances when actively eating or drinking, or for a faculty member when actively presenting at a lecture or panel. “Anyone not adhering to the mask policy will be asked to leave the meeting and will be denied readmission to the meeting with no refund,” she said.
“These guidelines were developed in accordance with the latest public health guidance and AES will continue to follow that guidance as any updates are made with the emergence of the Omicron variant,” Ms. Murray added.
Also commenting on this issue, a spokesperson for the American Heart Association, which has its large annual international stroke meeting planned for in-person attendance in New Orleans in February, said: “As we have throughout the pandemic, the American Heart Association is closely monitoring conditions and following the guidance of the CDC as well as state and local health departments related to all in-person meetings.”
“Our upcoming International Stroke Conference, February 9-11, is planned as an in-person and digital experience which allows us the ultimate flexibility to address changing pandemic conditions. The health, safety, and well-being of our volunteers, members, and attendees from around the world remains our number-one priority,” the AHA spokesperson added.
But some COVID-19 experts are taking a more cautious view.
Rowland Kao, PhD, an expert in infectious disease dynamics at the University of Edinburgh, United Kingdom, expressed concern about such large in-person conferences.
“We know that the Omicron variant appears to be spreading rapidly, with a recent preprint also telling us that the reinfection rate appears to be higher in South Africa. Should this be borne out, then the evidence would support that our reliance on a combination of vaccine-induced and natural immunity may be compromised by the Omicron variant,” he commented.
“We already know that extended contact indoors provides an additional risk, and so large meetings of this type have the potential to create extended risks. Until we know the extent to which Omicron causes severe illness, we should be extra cautious about these high-risk settings,” Dr. Kao commented.
A version of this article first appeared on Medscape.com.
Elad Maor, MD, an interventional cardiologist at Sheba Medical Centre near Tel Aviv, posted on Twitter on Nov. 30: “What a mess! Came back from a conference in London. With a mask and 3 Pfizer vaccines I managed to get Omicron.”
Dr. Maor traveled to London on November 19 to attend the PCR London Valves 2021 conference held at the ExCeL Centre Nov. 21-23. He stayed four nights at a hotel in north London and took public transport to and from the ExCeL Centre in East London each day of the meeting. He returned to Israel on the evening of Nov. 23.
Dr. Maor, 45, who has received three doses of the Pfizer COVID-19 vaccine, had two PCR tests in the United Kingdom – on November 20 and 21 in line with travel requirements – and another PCR test upon arriving back in Israel in the early hours of Nov. 24. All three tests were negative.
He began experiencing symptoms within days and tested positive on Nov. 27. His symptoms have been mild so far, and he said he was feeling “better” at the time of his tweet on Nov. 30.
Dr. Maor believes he was infected during his trip to London. “The only reasonable explanation is that I got infected on the last day of the meeting – maybe at the airport, maybe at the meeting,” he told The Guardian newspaper.
Although his wife accompanied him to London, neither she nor any of his 3 children have experienced symptoms or tested positive for COVID-19. But Dr. Maor believes he has passed the infection to a 69-year-old colleague in Israel who has since tested positive for the Omicron variant. The colleague, who has also received three vaccine doses, is understood to have mild symptoms at present.
The case suggests that the Omicron variant of COVID-19 may have been circulating in the United Kingdom earlier than previously thought.
Implications for in-person conferences
It will also inevitably lead to questions about the safety of face-to-face conferences, which are only just starting to get underway again.
The PCR Valves 2021 meeting had more than 1,250 on-site attendees as well as 2,400 or more joining online, according to figures on its website. Dr. Maor said he did not have any issues with the conference organizers, who required proof of vaccination before entry. But he posted a photograph on his Twitter account of a crowded auditorium with many delegates not wearing masks.
The conference subsequently posted an announcement on its website alerting delegates that one of the attendees had tested positive for COVID-19 after returning to their home country. It reads: “Since the reported case comes less than a week after the end of PCR London Valves, we want to inform you so that you may decide the best course of action, for yourself, if any.” It does not mention that the case was the Omicron variant.
Patrick Jolly, strategic and market development director of the conference, commented: “As you may imagine, the health, safety and well-being of everyone who visited PCR London Valves was our number-one priority. All protocols mandated by the U.K. government were put in place. Anyone entering the congress center had to present a valid health pass and were requested to wear a mask. Hydro-alcoholic gel and masks were made readily available for all participants and disposal bins for used protective equipment were provided.”
Mr. Jolly also noted: “To date – more than 9 days after the end of PCR London Valves – we have had no report of any other case of participants testing positive who attended PCR London Valves.”
He said the EuroPCR organization believes that medical conferences are safe to be held in person.
“With the above sanitary requirements and protocols, and no complacency in their enforcement, we believe strongly that medical conferences can take place, as the benefits of in-person medical conferences are obvious for the concerned medical communities,” Mr. Jolly added.
But what about other meetings happening imminently and planning in-person attendance?
Eileen Murray, executive director of the American Epilepsy Society (AES), whose annual 5-day meeting starts today at Chicago’s McCormick Place Convention Center, said in an interview that the health, safety, and well-being of everyone attending is a priority.
“Vaccinations are required, with no exceptions, to anyone attending the in-person event,” Ms. Murray said. “AES is using the CLEAR HealthPass to verify identity and vaccination status for our attendees. No one who cannot verify identity and vaccination requirement will be permitted to attend the in-person event.”
She noted that masks will also be required except in limited circumstances when actively eating or drinking, or for a faculty member when actively presenting at a lecture or panel. “Anyone not adhering to the mask policy will be asked to leave the meeting and will be denied readmission to the meeting with no refund,” she said.
“These guidelines were developed in accordance with the latest public health guidance and AES will continue to follow that guidance as any updates are made with the emergence of the Omicron variant,” Ms. Murray added.
Also commenting on this issue, a spokesperson for the American Heart Association, which has its large annual international stroke meeting planned for in-person attendance in New Orleans in February, said: “As we have throughout the pandemic, the American Heart Association is closely monitoring conditions and following the guidance of the CDC as well as state and local health departments related to all in-person meetings.”
“Our upcoming International Stroke Conference, February 9-11, is planned as an in-person and digital experience which allows us the ultimate flexibility to address changing pandemic conditions. The health, safety, and well-being of our volunteers, members, and attendees from around the world remains our number-one priority,” the AHA spokesperson added.
But some COVID-19 experts are taking a more cautious view.
Rowland Kao, PhD, an expert in infectious disease dynamics at the University of Edinburgh, United Kingdom, expressed concern about such large in-person conferences.
“We know that the Omicron variant appears to be spreading rapidly, with a recent preprint also telling us that the reinfection rate appears to be higher in South Africa. Should this be borne out, then the evidence would support that our reliance on a combination of vaccine-induced and natural immunity may be compromised by the Omicron variant,” he commented.
“We already know that extended contact indoors provides an additional risk, and so large meetings of this type have the potential to create extended risks. Until we know the extent to which Omicron causes severe illness, we should be extra cautious about these high-risk settings,” Dr. Kao commented.
A version of this article first appeared on Medscape.com.
Hospitals refused to give patients ivermectin. Lockdowns and political pressure followed.
Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.
And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.
These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.
“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”
Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.
Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.
Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.
Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.
In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.
“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.
Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.
The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.
“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”
An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.
That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.
“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.
“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.
A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.
Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.
Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.
The report did not offer any conclusions or allegations of wrongdoing.
Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.
“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.
“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.
The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.
Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.
“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”
He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.
Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.
“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.
Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.
“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.
And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.
These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.
“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”
Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.
Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.
Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.
Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.
In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.
“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.
Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.
The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.
“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”
An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.
That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.
“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.
“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.
A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.
Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.
Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.
The report did not offer any conclusions or allegations of wrongdoing.
Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.
“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.
“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.
The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.
Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.
“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”
He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.
Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.
“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.
Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.
“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Officials of another Montana hospital accused public officials of threatening and harassing their health care workers for refusing to treat a politically connected COVID-19 patient with that antiparasitic drug or hydroxychloroquine, another drug unauthorized by the Food and Drug Administration to treat COVID.
And in neighboring Idaho, a medical resident said police had to be called to a hospital after a COVID patient’s relative verbally abused her and threatened physical violence because she would not prescribe ivermectin or hydroxychloroquine, “drugs that are not beneficial in the treatment of COVID-19,” she wrote.
These three conflicts, which occurred from September to November, underline the pressure on health care workers to provide unauthorized COVID treatments, particularly in parts of the country where vaccination rates are low, government skepticism is high, and conservative leaders have championed the treatments.
“You’re going to have this from time to time, but it’s not the norm,” said Rich Rasmussen, president and CEO of the Montana Hospital Association. “The vast majority of patients are completely compliant and have good, robust conversations with their medical care team. But you’re going to have these outliers.”
Even before the pandemic, the health care and social assistance industry — which includes residential care facilities and child daycare, among other services — led all U.S. industries in nonfatal workplace violence, according to the Bureau of Labor Statistics. COVID has made the problem worse, leading to hospital security upgrades, staff training, and calls for increased federal regulation.
Ivermectin and other unauthorized covid treatments have become a major source of dispute in recent months. Lawsuits over hospitals’ refusals to provide ivermectin to patients have been filed in Texas, Florida, Illinois, and elsewhere. The ivermectin harassment extends beyond U.S. borders to providers and public health officials worldwide, in such countries as Australia, Brazil, and the United Kingdom. Even so, reports of threats of violence and harassment like those recently seen in the Northern Rocky Mountains region have been relatively rare.
Ivermectin is approved to treat parasites in animals, and low doses of the drug are approved to treat worms, head lice, and certain skin conditions in humans. But the FDA has not authorized the drug to treat COVID. The agency says that clinical trials are ongoing but that the current data does not show it is an effective COVID treatment and taking higher-than-approved levels can lead to overdose.
Likewise, hydroxychloroquine can cause serious health problems and the drug does not help speed recovery or decrease the chance of dying of COVID, according to the FDA.
In Missoula, Montana, the Community Medical Center was placed on lockdown, and police were called on Nov. 17 after a woman reportedly threatened violence over how her relative was being treated, according to a Police Department statement. Nobody was arrested.
“The family member was upset the patient was not treated with ivermectin,” Lt. Eddie McLean said Nov. 30.
Hospital spokesperson Megan Condra confirmed Dec. 1 that the patient’s relative demanded ivermectin, but she said the patient was not there for COVID, though she declined to disclose the patient’s medical issue. The main entrance of the hospital was locked to control who entered the building, Ms. Condra added, but the hospital’s formal lockdown procedures were not implemented.
The scare was reminiscent of one that happened in Idaho in September. Dr. Ashley Carvalho, who is completing her medical residency training in Boise, wrote in an op-ed in the Idaho Capital Sun that she was verbally abused and threatened with both physical violence and a lawsuit by a patient’s relative after she refused to prescribe ivermectin or hydroxychloroquine.
“My patient was struggling to breathe, but the family refused to allow me to provide care,” Dr. Carvalho wrote. “A call to the police was the only solution.”
An 82-year-old woman who was active in Montana Republican politics was admitted to St. Peter’s Health, the hospital in Helena, with COVID in October. According to a November report by a special counsel appointed by state lawmakers, a family friend contacted Chief Deputy Attorney General Kris Hansen, a former Republican state senator, with multiple complaints: Hospital officials had not delivered a power-of-attorney document left by relatives for the patient to sign, she was denied her preferred medical treatment, she was cut off from her family, and the family worried hospital officials might prevent her from leaving. The patient later died.
That complaint led to the involvement of Republican Attorney General Austin Knudsen, who texted a lobbyist for the Montana Hospital Association who is also on St. Peter’s board of directors. An image of the exchange was included in the report.
“I’m about to send law enforcement in and file unlawful restraint charges,” Mr. Knudsen wrote to Mark Taylor, who responded that he would make inquiries.
“This has been going on since yesterday and I was hoping the hospital would do the right thing. But my patience is wearing thin,” the attorney general added.
A Montana Highway Patrol trooper was sent to the hospital to take the statement of the patient’s family members. Ms. Hansen also participated in a conference call with multiple health care providers in which she talked about the “legal ramifications” of withholding documents and the patient’s preferred treatment, which included ivermectin and hydroxychloroquine.
Public Service Commissioner Jennifer Fielder, a former Republican state senator, left a three-minute voicemail on a hospital line saying the patient’s friends in the Senate would not be too happy to learn of the care St. Peter’s was providing, according to the special counsel’s report.
Ms. Fielder and the patient’s daughter also cited a “right to try” law that Montana legislators passed in 2015 that allows terminally ill patients to seek experimental treatments. But a legal analysis written for the Montana Medical Association says that while the law does not require a provider to prescribe a particular medication if a patient demands it, it could give a provider legal immunity if the provider decides to prescribe the treatment, according to the Montana State News Bureau.
The report did not offer any conclusions or allegations of wrongdoing.
Hospital officials said before and after the report’s release that their health care providers were threatened and harassed when they refused to administer certain treatments for COVID.
“We stand by our assertion that the involvement of public officials in clinical care is inappropriate; that individuals leveraged their official positions in an attempt to influence clinical care; and that some of the exchanges that took place were threatening or harassing,” spokesperson Katie Gallagher said in a statement.
“Further, we reviewed all medical and legal records related to this patient’s care and verified that our teams provided care in accordance with clinical best practice, hospital policy, and patient rights,” Ms. Gallagher added.
The attorney general’s office did not respond to a request for comment but told the Montana Free Press in a statement that nobody at the state agency threatened anyone.
Mr. Rasmussen, the head of the Montana Hospital Association, said St. Peter’s officials have not reached out to the group for assistance. He downplayed the attorney general’s intervention in Helena, saying it often happens that people who know medical leaders or trustees will advocate on behalf of a relative or friend.
“Is this situation different? Certainly, because it’s from the attorney general,” Mr. Rasmussen said. “But I think the AG was responding to a constituent. Others would reach out to whoever they know on the hospital board.”
He added that hospitals have procedures in place that allow family members of patients to take their complaints to a supervisor or other hospital leader without resorting to threats.
Hospitals in the region that have watched the allegations of threats and harassment unfold declined to comment on their procedures to handle such conflicts.
“We respect the independent medical judgment of our providers who practice medicine consistent with approved, authorized treatment and recognized clinical standards,” said Bozeman Health spokesperson Lauren Brendel.
Tanner Gooch, a spokesperson for SCL Health Montana, which operates hospitals in Billings, Butte, and Miles City, said SCL does not endorse ivermectin or other COVID treatments that haven’t been approved by the FDA but doesn’t ban them, either.
“Ultimately, the treatment decisions are at the discretion of the provider,” Mr. Gooch said. “To our knowledge, no COVID-19 patients have been treated with ivermectin at our hospitals.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
No serious CV risks for elderly after Pfizer COVID-19 vaccine
A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.
The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.
“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.
The study was published as a research letter online Nov. 22 in JAMA.
The Pfizer-BioNTech mRNA vaccine was the first SARS-CoV-2 vaccine authorized in France and has been widely used in older people. The phase 3 trials of the vaccine showed no increase in cardiovascular events, but older people were underrepresented in the trials.
As of April 30, 2021, nearly 3.9 million French adults aged 75 or older had received at least one dose of the Pfizer COVID-19 vaccine and 3.2 million had received two doses.
Using the French National Health Data System linked to the national COVID-19 vaccination database, Dr. Jabagi and her colleagues identified all unvaccinated or vaccinated adults aged 75 and older who were hospitalized between Dec. 15, 2020, and April 30, 2021, for acute MI, hemorrhagic or ischemic stroke, or PE.
During the 4.5-month study period, 11,113 elderly were hospitalized for acute MI, 17,014 for ischemic stroke, 4,804 for hemorrhagic stroke, and 7,221 for PE. Of these, 58.6%, 54.0%, 42.7%, and 55.3%, respectively, had received at least one dose of vaccine.
In the 14 days following receipt of either dose, no significant increased risk was found for any outcome, the investigators report.
The relative incidence (RI) for MI after the first and second dose was 0.97 (95% CI, 0.88-1.06) and 1.04 (95% CI, 0.93-1.16), respectively.
For ischemic stroke, the RI was 0.90 after the first dose (95% CI, 0.84-0.98) and 0.92 (95% CI, 0.84-1.02) after the second; for hemorrhagic stroke, the RI was 0.90 (95% CI, 0.78-1.04) and 0.97 (95% CI, 0.81-1.15), respectively.
For PE, the RI was 0.85 (95% CI, 0.75-0.96) after the first dose and 1.10 (95% CI, 0.95-1.26) after the second dose.
There was also no significant increase for any of the cardiovascular events when the exposure risk window was subdivided into 1 to 7 days and 8 to 14 days.
“Evaluating the short-term risk of hospitalization for severe cardiovascular events after the BNT162b2 mRNA vaccine in older people was a priority, especially after signals for hypertension and cardiovascular, thromboembolic, and hemorrhagic events have been issued from spontaneous notification data,” Dr. Jabagi said in an interview.
“The results of this nationwide study provide further solid evidence regarding the lack of increase of serious cardiovascular adverse events in older people in the 14 days following both doses of the vaccine,” Dr. Jabagi said.
The French study supports a recent U.S. study of more than 6 million people demonstrating that serious health risks were no more common in the first 3 weeks after Pfizer/BioNTech or Moderna COVID-19 vaccination compared with 22 to 42 days later.
As previously reported by this news organization, mRNA vaccination was not associated with greater risks for Guillain-Barré syndrome, myocarditis/pericarditis, stroke, or 20 other serious outcomes.
The current study had no specific funding. Dr. Jabagi and colleagues have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.
The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.
“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.
The study was published as a research letter online Nov. 22 in JAMA.
The Pfizer-BioNTech mRNA vaccine was the first SARS-CoV-2 vaccine authorized in France and has been widely used in older people. The phase 3 trials of the vaccine showed no increase in cardiovascular events, but older people were underrepresented in the trials.
As of April 30, 2021, nearly 3.9 million French adults aged 75 or older had received at least one dose of the Pfizer COVID-19 vaccine and 3.2 million had received two doses.
Using the French National Health Data System linked to the national COVID-19 vaccination database, Dr. Jabagi and her colleagues identified all unvaccinated or vaccinated adults aged 75 and older who were hospitalized between Dec. 15, 2020, and April 30, 2021, for acute MI, hemorrhagic or ischemic stroke, or PE.
During the 4.5-month study period, 11,113 elderly were hospitalized for acute MI, 17,014 for ischemic stroke, 4,804 for hemorrhagic stroke, and 7,221 for PE. Of these, 58.6%, 54.0%, 42.7%, and 55.3%, respectively, had received at least one dose of vaccine.
In the 14 days following receipt of either dose, no significant increased risk was found for any outcome, the investigators report.
The relative incidence (RI) for MI after the first and second dose was 0.97 (95% CI, 0.88-1.06) and 1.04 (95% CI, 0.93-1.16), respectively.
For ischemic stroke, the RI was 0.90 after the first dose (95% CI, 0.84-0.98) and 0.92 (95% CI, 0.84-1.02) after the second; for hemorrhagic stroke, the RI was 0.90 (95% CI, 0.78-1.04) and 0.97 (95% CI, 0.81-1.15), respectively.
For PE, the RI was 0.85 (95% CI, 0.75-0.96) after the first dose and 1.10 (95% CI, 0.95-1.26) after the second dose.
There was also no significant increase for any of the cardiovascular events when the exposure risk window was subdivided into 1 to 7 days and 8 to 14 days.
“Evaluating the short-term risk of hospitalization for severe cardiovascular events after the BNT162b2 mRNA vaccine in older people was a priority, especially after signals for hypertension and cardiovascular, thromboembolic, and hemorrhagic events have been issued from spontaneous notification data,” Dr. Jabagi said in an interview.
“The results of this nationwide study provide further solid evidence regarding the lack of increase of serious cardiovascular adverse events in older people in the 14 days following both doses of the vaccine,” Dr. Jabagi said.
The French study supports a recent U.S. study of more than 6 million people demonstrating that serious health risks were no more common in the first 3 weeks after Pfizer/BioNTech or Moderna COVID-19 vaccination compared with 22 to 42 days later.
As previously reported by this news organization, mRNA vaccination was not associated with greater risks for Guillain-Barré syndrome, myocarditis/pericarditis, stroke, or 20 other serious outcomes.
The current study had no specific funding. Dr. Jabagi and colleagues have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.
The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.
“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.
The study was published as a research letter online Nov. 22 in JAMA.
The Pfizer-BioNTech mRNA vaccine was the first SARS-CoV-2 vaccine authorized in France and has been widely used in older people. The phase 3 trials of the vaccine showed no increase in cardiovascular events, but older people were underrepresented in the trials.
As of April 30, 2021, nearly 3.9 million French adults aged 75 or older had received at least one dose of the Pfizer COVID-19 vaccine and 3.2 million had received two doses.
Using the French National Health Data System linked to the national COVID-19 vaccination database, Dr. Jabagi and her colleagues identified all unvaccinated or vaccinated adults aged 75 and older who were hospitalized between Dec. 15, 2020, and April 30, 2021, for acute MI, hemorrhagic or ischemic stroke, or PE.
During the 4.5-month study period, 11,113 elderly were hospitalized for acute MI, 17,014 for ischemic stroke, 4,804 for hemorrhagic stroke, and 7,221 for PE. Of these, 58.6%, 54.0%, 42.7%, and 55.3%, respectively, had received at least one dose of vaccine.
In the 14 days following receipt of either dose, no significant increased risk was found for any outcome, the investigators report.
The relative incidence (RI) for MI after the first and second dose was 0.97 (95% CI, 0.88-1.06) and 1.04 (95% CI, 0.93-1.16), respectively.
For ischemic stroke, the RI was 0.90 after the first dose (95% CI, 0.84-0.98) and 0.92 (95% CI, 0.84-1.02) after the second; for hemorrhagic stroke, the RI was 0.90 (95% CI, 0.78-1.04) and 0.97 (95% CI, 0.81-1.15), respectively.
For PE, the RI was 0.85 (95% CI, 0.75-0.96) after the first dose and 1.10 (95% CI, 0.95-1.26) after the second dose.
There was also no significant increase for any of the cardiovascular events when the exposure risk window was subdivided into 1 to 7 days and 8 to 14 days.
“Evaluating the short-term risk of hospitalization for severe cardiovascular events after the BNT162b2 mRNA vaccine in older people was a priority, especially after signals for hypertension and cardiovascular, thromboembolic, and hemorrhagic events have been issued from spontaneous notification data,” Dr. Jabagi said in an interview.
“The results of this nationwide study provide further solid evidence regarding the lack of increase of serious cardiovascular adverse events in older people in the 14 days following both doses of the vaccine,” Dr. Jabagi said.
The French study supports a recent U.S. study of more than 6 million people demonstrating that serious health risks were no more common in the first 3 weeks after Pfizer/BioNTech or Moderna COVID-19 vaccination compared with 22 to 42 days later.
As previously reported by this news organization, mRNA vaccination was not associated with greater risks for Guillain-Barré syndrome, myocarditis/pericarditis, stroke, or 20 other serious outcomes.
The current study had no specific funding. Dr. Jabagi and colleagues have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
It feels like COVID is closing in
Like so many of you, I have weathered COVID-19 for the last almost 2 years. We’ve dealt with anxiety in our patients and ourselves, ever conflicting directives over masks, and uncertainty and hope over vaccinations.
In the beginning, it seemed elsewhere. Wuhan, China, the state of Washington, New York City.
In the beginning, I awoke with rising anxiety every morning at 4 a.m.
Now, it is part of life. We know how to do this.
I work in a D.C. hospital that takes care of COVID-19 patients. I don’t intubate or come into direct contact with patients’ secretions.
I felt lucky.
Last summer, I felt relief, after being fully vaccinated. We thought we were almost over it. But the numbers abroad and in the United States keep rising.
We have developed protocols. We test every patient for COVID-19 before admitting them to psychiatry, which is now routine. COVID-19–positive patients with suicidal ideation go to our medicine-psychiatric unit. We are single-room occupancy. No visitors.
Now, it feels like COVID is closing in. Lots of my patients on consultation-liaison psychiatry had COVID-19 or do now. The number of patients with long COVID is increasing. My elderly mother-in-law picked it up from a hospital. My young, healthy adult son got it but is now doing relatively OK. We will see if his ADHD worsens.
I received contact tracing recently for going into a patient room with contact precautions. I had put on the gown and gloves, but did I wear my goggles? I keep them on my forehead but could not remember if I had slipped them over my eyes.
I get tested weekly. My nose runs inside my mask. I sneeze. Is this COVID?
Of course, I am vaccinated with a booster shot. But breakthrough infections occur.
I am lucky, I keep reminding myself. I have a job and income and good PPE.
So, we are learning how to manage this disease. But it still closes in. My brain screams: “I do not want to catch this disease. I do not want to get sick. I do not want to get long COVID.”
“Calm down, Cam,” I tell myself. “You can do this!” I have learned how to do all the PPE, including tying the plastic ties along the backs of the plastic gowns.
All psychiatry meetings are virtual now. I cannot do virtual with enthusiasm. I say I will, but then do not log on. I miss the camaraderie.
All appointments are mainly telehealth. That has its pros and cons.
So bottom line – I will keep keeping on.
But I really want others to get vaccinated and wear masks. More than that, how can we as a psychiatric community get us through this pandemic?
Here are a few suggestions, some of which I have made before:
- Focus on what we can control, especially exercise and sleep. Walk during times when the sun is shining. Rake the gorgeous autumn yellow and orange leaves.
- Give small (or large) gifts of kindness to others. Give to food banks, provide large tips to those who bring you takeout, help out at an animal shelter.
- Talk through established media about self-care and therapy for anxiety and depression.
- Clean out your closets. Give clothes to Afghan refugees.
- Read good books about trying times – such as World War II and the long wars in Afghanistan and Iraq.
- Take care of veterans and the elderly and homeless.
- Take care of yourself and your family.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center. She has no conflicts of interest.
Like so many of you, I have weathered COVID-19 for the last almost 2 years. We’ve dealt with anxiety in our patients and ourselves, ever conflicting directives over masks, and uncertainty and hope over vaccinations.
In the beginning, it seemed elsewhere. Wuhan, China, the state of Washington, New York City.
In the beginning, I awoke with rising anxiety every morning at 4 a.m.
Now, it is part of life. We know how to do this.
I work in a D.C. hospital that takes care of COVID-19 patients. I don’t intubate or come into direct contact with patients’ secretions.
I felt lucky.
Last summer, I felt relief, after being fully vaccinated. We thought we were almost over it. But the numbers abroad and in the United States keep rising.
We have developed protocols. We test every patient for COVID-19 before admitting them to psychiatry, which is now routine. COVID-19–positive patients with suicidal ideation go to our medicine-psychiatric unit. We are single-room occupancy. No visitors.
Now, it feels like COVID is closing in. Lots of my patients on consultation-liaison psychiatry had COVID-19 or do now. The number of patients with long COVID is increasing. My elderly mother-in-law picked it up from a hospital. My young, healthy adult son got it but is now doing relatively OK. We will see if his ADHD worsens.
I received contact tracing recently for going into a patient room with contact precautions. I had put on the gown and gloves, but did I wear my goggles? I keep them on my forehead but could not remember if I had slipped them over my eyes.
I get tested weekly. My nose runs inside my mask. I sneeze. Is this COVID?
Of course, I am vaccinated with a booster shot. But breakthrough infections occur.
I am lucky, I keep reminding myself. I have a job and income and good PPE.
So, we are learning how to manage this disease. But it still closes in. My brain screams: “I do not want to catch this disease. I do not want to get sick. I do not want to get long COVID.”
“Calm down, Cam,” I tell myself. “You can do this!” I have learned how to do all the PPE, including tying the plastic ties along the backs of the plastic gowns.
All psychiatry meetings are virtual now. I cannot do virtual with enthusiasm. I say I will, but then do not log on. I miss the camaraderie.
All appointments are mainly telehealth. That has its pros and cons.
So bottom line – I will keep keeping on.
But I really want others to get vaccinated and wear masks. More than that, how can we as a psychiatric community get us through this pandemic?
Here are a few suggestions, some of which I have made before:
- Focus on what we can control, especially exercise and sleep. Walk during times when the sun is shining. Rake the gorgeous autumn yellow and orange leaves.
- Give small (or large) gifts of kindness to others. Give to food banks, provide large tips to those who bring you takeout, help out at an animal shelter.
- Talk through established media about self-care and therapy for anxiety and depression.
- Clean out your closets. Give clothes to Afghan refugees.
- Read good books about trying times – such as World War II and the long wars in Afghanistan and Iraq.
- Take care of veterans and the elderly and homeless.
- Take care of yourself and your family.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center. She has no conflicts of interest.
Like so many of you, I have weathered COVID-19 for the last almost 2 years. We’ve dealt with anxiety in our patients and ourselves, ever conflicting directives over masks, and uncertainty and hope over vaccinations.
In the beginning, it seemed elsewhere. Wuhan, China, the state of Washington, New York City.
In the beginning, I awoke with rising anxiety every morning at 4 a.m.
Now, it is part of life. We know how to do this.
I work in a D.C. hospital that takes care of COVID-19 patients. I don’t intubate or come into direct contact with patients’ secretions.
I felt lucky.
Last summer, I felt relief, after being fully vaccinated. We thought we were almost over it. But the numbers abroad and in the United States keep rising.
We have developed protocols. We test every patient for COVID-19 before admitting them to psychiatry, which is now routine. COVID-19–positive patients with suicidal ideation go to our medicine-psychiatric unit. We are single-room occupancy. No visitors.
Now, it feels like COVID is closing in. Lots of my patients on consultation-liaison psychiatry had COVID-19 or do now. The number of patients with long COVID is increasing. My elderly mother-in-law picked it up from a hospital. My young, healthy adult son got it but is now doing relatively OK. We will see if his ADHD worsens.
I received contact tracing recently for going into a patient room with contact precautions. I had put on the gown and gloves, but did I wear my goggles? I keep them on my forehead but could not remember if I had slipped them over my eyes.
I get tested weekly. My nose runs inside my mask. I sneeze. Is this COVID?
Of course, I am vaccinated with a booster shot. But breakthrough infections occur.
I am lucky, I keep reminding myself. I have a job and income and good PPE.
So, we are learning how to manage this disease. But it still closes in. My brain screams: “I do not want to catch this disease. I do not want to get sick. I do not want to get long COVID.”
“Calm down, Cam,” I tell myself. “You can do this!” I have learned how to do all the PPE, including tying the plastic ties along the backs of the plastic gowns.
All psychiatry meetings are virtual now. I cannot do virtual with enthusiasm. I say I will, but then do not log on. I miss the camaraderie.
All appointments are mainly telehealth. That has its pros and cons.
So bottom line – I will keep keeping on.
But I really want others to get vaccinated and wear masks. More than that, how can we as a psychiatric community get us through this pandemic?
Here are a few suggestions, some of which I have made before:
- Focus on what we can control, especially exercise and sleep. Walk during times when the sun is shining. Rake the gorgeous autumn yellow and orange leaves.
- Give small (or large) gifts of kindness to others. Give to food banks, provide large tips to those who bring you takeout, help out at an animal shelter.
- Talk through established media about self-care and therapy for anxiety and depression.
- Clean out your closets. Give clothes to Afghan refugees.
- Read good books about trying times – such as World War II and the long wars in Afghanistan and Iraq.
- Take care of veterans and the elderly and homeless.
- Take care of yourself and your family.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center. She has no conflicts of interest.
COVID-19 and the immunocompromised physician
Working feverishly to complete the myriad patient notes accumulated throughout a hectic day, my phone vibrated – alerting me to a number that, over the past several years, has wrought uncertainty, grief, and overwhelming relief. Answering hesitantly, I listened to my physician’s pharmacist inform me of unexpected and alarming news.
Since COVID-19 was first identified more than 1 year ago, more than 770,000 people have died in the United States. In the wake of those losses, countless grieve while attempting to navigate a future without their loved ones. Meanwhile, scientists worked feverishly to combat a pandemic relentless in contagion. As health care professionals, we work tirelessly against the sharpened scythe of death, toiling day after day without an identifiable end. All the while, advocacy has prevailed as the need for personal protective equipment, improved ventilation systems, sanitization measures, and other mitigation measures, such as mask wearing and social distancing, echoed swiftly across the nation and around the world.
But, as the months have progressed, and life has seemingly transitioned toward a parallel version of reality, subsections of communities have grown restless. Several nontherapeutic, ineffective, and falsely touted regimens have been promoted. Amid the chaos of misinformation, most medical professionals have sought support from respected journals and infectious disease experts to filter out jargon and piece together scientifically sound protocols. Although many lives have prevailed by way of those advancements, mixed messages about interventions have emerged – and in many quarters across the country, anger, resistance, and outright refusal have prevailed.
Yet, we – the medical community – have forged ever onward as the cases continued and the death toll steadily climbed. In many cases, physicians who are years removed from critical care training have been thrust into COVID units, while residents have shifted toward working outside of their chosen specialty. Outpatient offices have closed, salaries have been cut, and furloughs have loomed as days fade into months. Beset with exhaustion and uncertainty, sacrifice has become a common thread that intrinsically united us against an unrelenting foe.
Most people continued navigating the many changes and made concerted efforts to mimic our prepandemic lives. Working from home in makeshift offices, dusting off math skills to assist children through the doldrums of distance learning, and mastering various audiovisual platforms, we reinforced social bonds and forged new connections echoing the hallmark resilience reminiscent of our shared distant ancestry.
As of this writing, thanks to our work – and that of scientists and policy makers – about 69% of Americans have received at least one dose of vaccine, and vaccines are widely available to children 5 and older. But it has been disheartening to watch misinformation about vaccine research and development propagated by political figures, social media, and lay people.
Processing the phone call
While listening to my physician’s pharmacist, I slowed my breaths in an effort to find calm. Years of navigating the American health care industry had left me both equipped and ill-prepared for the unexpected. I listened intently to the pharmacist’s words while staring blankly at a computer screen – uncertain of what had felt so assured not 10 minutes earlier.
That’s when I got the news. The intravenous medication that aided in my stabilization had suffered a critical shortage because of its successful use in the treatment of patients with COVID-19 pneumonia – patients who, in a majority of cases, had likely refused the vaccines. As result, the medication that had enabled my return to work, active engagement in nonwork pursuits, and most importantly, equipped my body to thrive despite the damage it had suffered, suddenly vanished.
Gently placing my phone on the desk, my heart beat rapidly as tears steadily streamed down my face. Staring blankly ahead, my hands gradually balled into fists as I let out a sound of fear, agony, and uncertainty. Screaming at everything and nothing, nausea swelled as panic flooded my body. In that moment, I ruminated on the conversation with the pharmacist. There had been no discussion, no option for me to maintain accessibility to this valuable medicine. Consequently, I felt helpless. Although the same medication, albeit a different mechanism of delivery, was promptly chosen as an adequate substitute, there was no guarantee of it bestowing the same degree of efficacy. So I was terrified, envisioning the progress made over several years as plummeting into an abyss of pain and despair. What are those of us who have chosen medicine as our profession but are immunocompromised expected to make of this?
Over the next several weeks, I diligently adhered to the new regimen and focused on positive mentation. Nevertheless, day by day, the symptoms worsened; eventually, I became bed ridden. I tried to gather what little composure remained to reschedule patients and justify the resounding guilt of perceived failure. I remember the sweet and gentle look of my child as I once again could not summon the strength to play pretend. This felt overwhelming. Would I ever go back to work? Would I see my child grow? No amount of pleading or screaming would change the fact that a medical system chose to roll the dice on my health. In a haze of discomfort and betrayal, I wondered how a physician or medical facility could justify removing medication from someone reliant upon it. How do we choose the appropriate allocation of resources when the consequences are potentially catastrophic?
Searching for context
When a country is founded on the mission of rising as a leading world power built upon the concepts of freedom, basic human rights, and individuality while supporting an infrastructure of capitalism, power, and control, crises – particularly those related to public health – can fan deep divisions. Here in the United States, we have seen misinterpretation, misunderstanding, and bitter indignation fuel the flames of provocation as protests of mask mandates, distance learning, and social distancing were touted as violating the very core upon which the country was established. Frustration, palpable among health care professionals, grew ever greater as the importance of vaccination in quelling virus mutations and decreasing morbidity and mortality were openly disparaged and ignored.
Not only have we watched people refuse the vaccines, but some are ignoring other mitigation measures. So the question becomes: How are we, as health care professionals trying to maintain a therapeutic alliance with those who reject lifesaving practices, expected to process this? Sitting in appointments and attempting interventions without judgment feels impractical and nearly impossible – particularly when the behaviors of these patients have the potential of violating our own health and well-being. How do we remain altruistic in our endeavors when those who seek our care seem callously indifferent to our lives – and to those of our families?
Measuring the value of life
Within the fevered haze of this past year, many stories highlighting grim realities have captured the media spotlight. From individuals unable to have emergency evaluations because of facilities being inundated by COVID-19 patients to individuals prematurely discharged, hospital bed shortages, and financial pressures from insurance companies. In reciting the phrase “Primum non noncere,” we physicians are committing to providing fair and competent medical treatment. At times, urgent decisions are necessary but are always made in the best interest of the patient(s). Ultimately, I am left debating how these agonizing weeks served any meaningful purpose. Moreover, when choosing the many over the few, what are the determinant factors? I am left asking: What is the value of a life?
Philosophically, this ethical dilemma is captured succinctly via the “trolley problem,” formulated in 1967 by Philippa Foot, MD. This is how Dr. Foot’s formulation unfolds: Close your eyes, and imagine you are inside a trolley careening unhindered down the rumbling tracks. Straight ahead you see five people bound to the tracks in imminent danger of being struck, and on the other side, one person is tied to the tracks. Do you continue the same course – thereby condemning five innocent people to death – or do you make the active decision to switch tracks, therefore consigning the one to their fate? Envision the people what do they look like? How old are they? If the one were a small child or a close friend, would that alter your decision? How does one make such a harrowing choice knowing the irreversible consequences? Depending on your action, this quandary falls within two primary schools of thought: Utilitarianism, which posits that the best action is the greatest good for the greatest number of people, and deontologicalism, which suggests that action is inherently right or wrong regardless of the consequences. Therefore, the decision to save the five is not favored.
However simplistic those scenarios may read, such principles when viewed through different lenses, they form the basis of medical ethics. In effect, every acute decision, every aspect of treatment is predicated upon the principles of nonmaleficence, beneficence, utility, distributive justice, and autonomy. Yet, the manner in which they are applied is highly contingent upon myriad variables. For example, sociopolitical factors, including population size (rural versus urban), economics (impoverished versus wealthy), as well as demographic factors (age, ethnicity, gender, sexuality) can highly influence and sometimes unknowingly influence interpretation and allocation of health care resources. This dilemma does not yield easily applicable and universal solutions. Nevertheless, it is paramount to evaluate policies effectively and tediously, particularly those with detrimental ramifications. Likewise, remaining flexible in our willingness to explore alternative solutions and encourage open discord among those with opposing viewpoints is key to instituting individual or institutional change that values the one as it values the many.
After several weeks of acute illness and a variety of short-acting interventions, I received approval to resume intravenous therapy. While the saga has ultimately reached a satisfactory conclusion, I am left with stupefied disbelief toward the people who took a gamble on my health. I am facing a battle between understanding the obligation of medicine to provide ethical and reasonable care without hesitation or judgment versus embittered resentment when faced with those who openly campaign against lifesaving interventions, such as the COVID-19 vaccine. For me, each day and the one that follows is riddled with complicated emotion. Every time I prematurely cease activity out of discomfort and weariness, I worry about my increasingly foreboding workload. In those moments, in that place of questions without answers, I remember that someone somewhere ultimately decided to switch the trolley’s track.
Dr. Thomas is a board-certified adult psychiatrist with interests in chronic illness, women’s behavioral health, and minority mental health. She currently practices in North Kingstown and East Providence, R.I. Dr. Thomas has no conflicts of interest.
Working feverishly to complete the myriad patient notes accumulated throughout a hectic day, my phone vibrated – alerting me to a number that, over the past several years, has wrought uncertainty, grief, and overwhelming relief. Answering hesitantly, I listened to my physician’s pharmacist inform me of unexpected and alarming news.
Since COVID-19 was first identified more than 1 year ago, more than 770,000 people have died in the United States. In the wake of those losses, countless grieve while attempting to navigate a future without their loved ones. Meanwhile, scientists worked feverishly to combat a pandemic relentless in contagion. As health care professionals, we work tirelessly against the sharpened scythe of death, toiling day after day without an identifiable end. All the while, advocacy has prevailed as the need for personal protective equipment, improved ventilation systems, sanitization measures, and other mitigation measures, such as mask wearing and social distancing, echoed swiftly across the nation and around the world.
But, as the months have progressed, and life has seemingly transitioned toward a parallel version of reality, subsections of communities have grown restless. Several nontherapeutic, ineffective, and falsely touted regimens have been promoted. Amid the chaos of misinformation, most medical professionals have sought support from respected journals and infectious disease experts to filter out jargon and piece together scientifically sound protocols. Although many lives have prevailed by way of those advancements, mixed messages about interventions have emerged – and in many quarters across the country, anger, resistance, and outright refusal have prevailed.
Yet, we – the medical community – have forged ever onward as the cases continued and the death toll steadily climbed. In many cases, physicians who are years removed from critical care training have been thrust into COVID units, while residents have shifted toward working outside of their chosen specialty. Outpatient offices have closed, salaries have been cut, and furloughs have loomed as days fade into months. Beset with exhaustion and uncertainty, sacrifice has become a common thread that intrinsically united us against an unrelenting foe.
Most people continued navigating the many changes and made concerted efforts to mimic our prepandemic lives. Working from home in makeshift offices, dusting off math skills to assist children through the doldrums of distance learning, and mastering various audiovisual platforms, we reinforced social bonds and forged new connections echoing the hallmark resilience reminiscent of our shared distant ancestry.
As of this writing, thanks to our work – and that of scientists and policy makers – about 69% of Americans have received at least one dose of vaccine, and vaccines are widely available to children 5 and older. But it has been disheartening to watch misinformation about vaccine research and development propagated by political figures, social media, and lay people.
Processing the phone call
While listening to my physician’s pharmacist, I slowed my breaths in an effort to find calm. Years of navigating the American health care industry had left me both equipped and ill-prepared for the unexpected. I listened intently to the pharmacist’s words while staring blankly at a computer screen – uncertain of what had felt so assured not 10 minutes earlier.
That’s when I got the news. The intravenous medication that aided in my stabilization had suffered a critical shortage because of its successful use in the treatment of patients with COVID-19 pneumonia – patients who, in a majority of cases, had likely refused the vaccines. As result, the medication that had enabled my return to work, active engagement in nonwork pursuits, and most importantly, equipped my body to thrive despite the damage it had suffered, suddenly vanished.
Gently placing my phone on the desk, my heart beat rapidly as tears steadily streamed down my face. Staring blankly ahead, my hands gradually balled into fists as I let out a sound of fear, agony, and uncertainty. Screaming at everything and nothing, nausea swelled as panic flooded my body. In that moment, I ruminated on the conversation with the pharmacist. There had been no discussion, no option for me to maintain accessibility to this valuable medicine. Consequently, I felt helpless. Although the same medication, albeit a different mechanism of delivery, was promptly chosen as an adequate substitute, there was no guarantee of it bestowing the same degree of efficacy. So I was terrified, envisioning the progress made over several years as plummeting into an abyss of pain and despair. What are those of us who have chosen medicine as our profession but are immunocompromised expected to make of this?
Over the next several weeks, I diligently adhered to the new regimen and focused on positive mentation. Nevertheless, day by day, the symptoms worsened; eventually, I became bed ridden. I tried to gather what little composure remained to reschedule patients and justify the resounding guilt of perceived failure. I remember the sweet and gentle look of my child as I once again could not summon the strength to play pretend. This felt overwhelming. Would I ever go back to work? Would I see my child grow? No amount of pleading or screaming would change the fact that a medical system chose to roll the dice on my health. In a haze of discomfort and betrayal, I wondered how a physician or medical facility could justify removing medication from someone reliant upon it. How do we choose the appropriate allocation of resources when the consequences are potentially catastrophic?
Searching for context
When a country is founded on the mission of rising as a leading world power built upon the concepts of freedom, basic human rights, and individuality while supporting an infrastructure of capitalism, power, and control, crises – particularly those related to public health – can fan deep divisions. Here in the United States, we have seen misinterpretation, misunderstanding, and bitter indignation fuel the flames of provocation as protests of mask mandates, distance learning, and social distancing were touted as violating the very core upon which the country was established. Frustration, palpable among health care professionals, grew ever greater as the importance of vaccination in quelling virus mutations and decreasing morbidity and mortality were openly disparaged and ignored.
Not only have we watched people refuse the vaccines, but some are ignoring other mitigation measures. So the question becomes: How are we, as health care professionals trying to maintain a therapeutic alliance with those who reject lifesaving practices, expected to process this? Sitting in appointments and attempting interventions without judgment feels impractical and nearly impossible – particularly when the behaviors of these patients have the potential of violating our own health and well-being. How do we remain altruistic in our endeavors when those who seek our care seem callously indifferent to our lives – and to those of our families?
Measuring the value of life
Within the fevered haze of this past year, many stories highlighting grim realities have captured the media spotlight. From individuals unable to have emergency evaluations because of facilities being inundated by COVID-19 patients to individuals prematurely discharged, hospital bed shortages, and financial pressures from insurance companies. In reciting the phrase “Primum non noncere,” we physicians are committing to providing fair and competent medical treatment. At times, urgent decisions are necessary but are always made in the best interest of the patient(s). Ultimately, I am left debating how these agonizing weeks served any meaningful purpose. Moreover, when choosing the many over the few, what are the determinant factors? I am left asking: What is the value of a life?
Philosophically, this ethical dilemma is captured succinctly via the “trolley problem,” formulated in 1967 by Philippa Foot, MD. This is how Dr. Foot’s formulation unfolds: Close your eyes, and imagine you are inside a trolley careening unhindered down the rumbling tracks. Straight ahead you see five people bound to the tracks in imminent danger of being struck, and on the other side, one person is tied to the tracks. Do you continue the same course – thereby condemning five innocent people to death – or do you make the active decision to switch tracks, therefore consigning the one to their fate? Envision the people what do they look like? How old are they? If the one were a small child or a close friend, would that alter your decision? How does one make such a harrowing choice knowing the irreversible consequences? Depending on your action, this quandary falls within two primary schools of thought: Utilitarianism, which posits that the best action is the greatest good for the greatest number of people, and deontologicalism, which suggests that action is inherently right or wrong regardless of the consequences. Therefore, the decision to save the five is not favored.
However simplistic those scenarios may read, such principles when viewed through different lenses, they form the basis of medical ethics. In effect, every acute decision, every aspect of treatment is predicated upon the principles of nonmaleficence, beneficence, utility, distributive justice, and autonomy. Yet, the manner in which they are applied is highly contingent upon myriad variables. For example, sociopolitical factors, including population size (rural versus urban), economics (impoverished versus wealthy), as well as demographic factors (age, ethnicity, gender, sexuality) can highly influence and sometimes unknowingly influence interpretation and allocation of health care resources. This dilemma does not yield easily applicable and universal solutions. Nevertheless, it is paramount to evaluate policies effectively and tediously, particularly those with detrimental ramifications. Likewise, remaining flexible in our willingness to explore alternative solutions and encourage open discord among those with opposing viewpoints is key to instituting individual or institutional change that values the one as it values the many.
After several weeks of acute illness and a variety of short-acting interventions, I received approval to resume intravenous therapy. While the saga has ultimately reached a satisfactory conclusion, I am left with stupefied disbelief toward the people who took a gamble on my health. I am facing a battle between understanding the obligation of medicine to provide ethical and reasonable care without hesitation or judgment versus embittered resentment when faced with those who openly campaign against lifesaving interventions, such as the COVID-19 vaccine. For me, each day and the one that follows is riddled with complicated emotion. Every time I prematurely cease activity out of discomfort and weariness, I worry about my increasingly foreboding workload. In those moments, in that place of questions without answers, I remember that someone somewhere ultimately decided to switch the trolley’s track.
Dr. Thomas is a board-certified adult psychiatrist with interests in chronic illness, women’s behavioral health, and minority mental health. She currently practices in North Kingstown and East Providence, R.I. Dr. Thomas has no conflicts of interest.
Working feverishly to complete the myriad patient notes accumulated throughout a hectic day, my phone vibrated – alerting me to a number that, over the past several years, has wrought uncertainty, grief, and overwhelming relief. Answering hesitantly, I listened to my physician’s pharmacist inform me of unexpected and alarming news.
Since COVID-19 was first identified more than 1 year ago, more than 770,000 people have died in the United States. In the wake of those losses, countless grieve while attempting to navigate a future without their loved ones. Meanwhile, scientists worked feverishly to combat a pandemic relentless in contagion. As health care professionals, we work tirelessly against the sharpened scythe of death, toiling day after day without an identifiable end. All the while, advocacy has prevailed as the need for personal protective equipment, improved ventilation systems, sanitization measures, and other mitigation measures, such as mask wearing and social distancing, echoed swiftly across the nation and around the world.
But, as the months have progressed, and life has seemingly transitioned toward a parallel version of reality, subsections of communities have grown restless. Several nontherapeutic, ineffective, and falsely touted regimens have been promoted. Amid the chaos of misinformation, most medical professionals have sought support from respected journals and infectious disease experts to filter out jargon and piece together scientifically sound protocols. Although many lives have prevailed by way of those advancements, mixed messages about interventions have emerged – and in many quarters across the country, anger, resistance, and outright refusal have prevailed.
Yet, we – the medical community – have forged ever onward as the cases continued and the death toll steadily climbed. In many cases, physicians who are years removed from critical care training have been thrust into COVID units, while residents have shifted toward working outside of their chosen specialty. Outpatient offices have closed, salaries have been cut, and furloughs have loomed as days fade into months. Beset with exhaustion and uncertainty, sacrifice has become a common thread that intrinsically united us against an unrelenting foe.
Most people continued navigating the many changes and made concerted efforts to mimic our prepandemic lives. Working from home in makeshift offices, dusting off math skills to assist children through the doldrums of distance learning, and mastering various audiovisual platforms, we reinforced social bonds and forged new connections echoing the hallmark resilience reminiscent of our shared distant ancestry.
As of this writing, thanks to our work – and that of scientists and policy makers – about 69% of Americans have received at least one dose of vaccine, and vaccines are widely available to children 5 and older. But it has been disheartening to watch misinformation about vaccine research and development propagated by political figures, social media, and lay people.
Processing the phone call
While listening to my physician’s pharmacist, I slowed my breaths in an effort to find calm. Years of navigating the American health care industry had left me both equipped and ill-prepared for the unexpected. I listened intently to the pharmacist’s words while staring blankly at a computer screen – uncertain of what had felt so assured not 10 minutes earlier.
That’s when I got the news. The intravenous medication that aided in my stabilization had suffered a critical shortage because of its successful use in the treatment of patients with COVID-19 pneumonia – patients who, in a majority of cases, had likely refused the vaccines. As result, the medication that had enabled my return to work, active engagement in nonwork pursuits, and most importantly, equipped my body to thrive despite the damage it had suffered, suddenly vanished.
Gently placing my phone on the desk, my heart beat rapidly as tears steadily streamed down my face. Staring blankly ahead, my hands gradually balled into fists as I let out a sound of fear, agony, and uncertainty. Screaming at everything and nothing, nausea swelled as panic flooded my body. In that moment, I ruminated on the conversation with the pharmacist. There had been no discussion, no option for me to maintain accessibility to this valuable medicine. Consequently, I felt helpless. Although the same medication, albeit a different mechanism of delivery, was promptly chosen as an adequate substitute, there was no guarantee of it bestowing the same degree of efficacy. So I was terrified, envisioning the progress made over several years as plummeting into an abyss of pain and despair. What are those of us who have chosen medicine as our profession but are immunocompromised expected to make of this?
Over the next several weeks, I diligently adhered to the new regimen and focused on positive mentation. Nevertheless, day by day, the symptoms worsened; eventually, I became bed ridden. I tried to gather what little composure remained to reschedule patients and justify the resounding guilt of perceived failure. I remember the sweet and gentle look of my child as I once again could not summon the strength to play pretend. This felt overwhelming. Would I ever go back to work? Would I see my child grow? No amount of pleading or screaming would change the fact that a medical system chose to roll the dice on my health. In a haze of discomfort and betrayal, I wondered how a physician or medical facility could justify removing medication from someone reliant upon it. How do we choose the appropriate allocation of resources when the consequences are potentially catastrophic?
Searching for context
When a country is founded on the mission of rising as a leading world power built upon the concepts of freedom, basic human rights, and individuality while supporting an infrastructure of capitalism, power, and control, crises – particularly those related to public health – can fan deep divisions. Here in the United States, we have seen misinterpretation, misunderstanding, and bitter indignation fuel the flames of provocation as protests of mask mandates, distance learning, and social distancing were touted as violating the very core upon which the country was established. Frustration, palpable among health care professionals, grew ever greater as the importance of vaccination in quelling virus mutations and decreasing morbidity and mortality were openly disparaged and ignored.
Not only have we watched people refuse the vaccines, but some are ignoring other mitigation measures. So the question becomes: How are we, as health care professionals trying to maintain a therapeutic alliance with those who reject lifesaving practices, expected to process this? Sitting in appointments and attempting interventions without judgment feels impractical and nearly impossible – particularly when the behaviors of these patients have the potential of violating our own health and well-being. How do we remain altruistic in our endeavors when those who seek our care seem callously indifferent to our lives – and to those of our families?
Measuring the value of life
Within the fevered haze of this past year, many stories highlighting grim realities have captured the media spotlight. From individuals unable to have emergency evaluations because of facilities being inundated by COVID-19 patients to individuals prematurely discharged, hospital bed shortages, and financial pressures from insurance companies. In reciting the phrase “Primum non noncere,” we physicians are committing to providing fair and competent medical treatment. At times, urgent decisions are necessary but are always made in the best interest of the patient(s). Ultimately, I am left debating how these agonizing weeks served any meaningful purpose. Moreover, when choosing the many over the few, what are the determinant factors? I am left asking: What is the value of a life?
Philosophically, this ethical dilemma is captured succinctly via the “trolley problem,” formulated in 1967 by Philippa Foot, MD. This is how Dr. Foot’s formulation unfolds: Close your eyes, and imagine you are inside a trolley careening unhindered down the rumbling tracks. Straight ahead you see five people bound to the tracks in imminent danger of being struck, and on the other side, one person is tied to the tracks. Do you continue the same course – thereby condemning five innocent people to death – or do you make the active decision to switch tracks, therefore consigning the one to their fate? Envision the people what do they look like? How old are they? If the one were a small child or a close friend, would that alter your decision? How does one make such a harrowing choice knowing the irreversible consequences? Depending on your action, this quandary falls within two primary schools of thought: Utilitarianism, which posits that the best action is the greatest good for the greatest number of people, and deontologicalism, which suggests that action is inherently right or wrong regardless of the consequences. Therefore, the decision to save the five is not favored.
However simplistic those scenarios may read, such principles when viewed through different lenses, they form the basis of medical ethics. In effect, every acute decision, every aspect of treatment is predicated upon the principles of nonmaleficence, beneficence, utility, distributive justice, and autonomy. Yet, the manner in which they are applied is highly contingent upon myriad variables. For example, sociopolitical factors, including population size (rural versus urban), economics (impoverished versus wealthy), as well as demographic factors (age, ethnicity, gender, sexuality) can highly influence and sometimes unknowingly influence interpretation and allocation of health care resources. This dilemma does not yield easily applicable and universal solutions. Nevertheless, it is paramount to evaluate policies effectively and tediously, particularly those with detrimental ramifications. Likewise, remaining flexible in our willingness to explore alternative solutions and encourage open discord among those with opposing viewpoints is key to instituting individual or institutional change that values the one as it values the many.
After several weeks of acute illness and a variety of short-acting interventions, I received approval to resume intravenous therapy. While the saga has ultimately reached a satisfactory conclusion, I am left with stupefied disbelief toward the people who took a gamble on my health. I am facing a battle between understanding the obligation of medicine to provide ethical and reasonable care without hesitation or judgment versus embittered resentment when faced with those who openly campaign against lifesaving interventions, such as the COVID-19 vaccine. For me, each day and the one that follows is riddled with complicated emotion. Every time I prematurely cease activity out of discomfort and weariness, I worry about my increasingly foreboding workload. In those moments, in that place of questions without answers, I remember that someone somewhere ultimately decided to switch the trolley’s track.
Dr. Thomas is a board-certified adult psychiatrist with interests in chronic illness, women’s behavioral health, and minority mental health. She currently practices in North Kingstown and East Providence, R.I. Dr. Thomas has no conflicts of interest.
COVID-19 antibody drug likely works against Omicron, companies say
The companies said Dec. 2 that they tested the drug, called sotrovimab, against individual mutations found in the Omicron variant, according to The Wall Street Journal. The preliminary findings haven’t yet been peer-reviewed, and the drug will need to be tested against the whole spike protein on the virus to confirm results.
GlaxoSmithKline and Vir have previously tested sotrovimab against mutations on other variants, the newspaper reported. When the Omicron variant was identified, the companies looked at earlier research to find the tests they had done against mutations that are also found in Omicron.
Sotrovimab targets a spot on the spike protein that is found in other coronaviruses and is thought to be less likely to mutate, according to the newspaper. Omicron has at least two mutations that overlap with the drug’s target site, but researchers at the companies don’t think the mutations will affect the treatment’s ability to bind to the spike protein.
GlaxoSmithKline expects to see results from testing the drug against the full mutated spike protein in the next 2 to 3 weeks, the Journal reported.
Sotrovimab has been authorized in about a dozen countries, including the United States, which paid about $1 billion for hundreds of thousands of doses.
Other companies have also been testing their antibody treatments against the Omicron variant.
Regeneron announced Nov. 30 that its drug could be less effective, and it said further analyses will determine how much less effective by using the actual Omicron genetic sequence, according to Reuters.
Outside scientists have also said the antibody drug from Eli Lilly & Co. isn’t as effective against Omicron. The company told Reuters that it is still testing the treatment against the variant.
Another experimental antibody therapy developed by Adagio Therapeutics appears to work well against the new variant, the Journal reported, but the treatment is in late-stage clinical trials and isn’t yet authorized.
Antiviral drugs could also help prevent hospitalization and may be less vulnerable to new variants because they target a different part of the virus, the newspaper reported. Merck and Pfizer have developed antiviral pills, which still require FDA approval.
In addition, Gilead believes its approved IV therapy, called remdesivir, will continue to be effective against the variant, Reuters reported.
The FDA said Nov. 30 that it is looking at the effect that authorized COVID-19 vaccines can have on Omicron and expects to have more information in coming weeks, Reuters reported.
A version of this article first appeared on WebMD.com.
The companies said Dec. 2 that they tested the drug, called sotrovimab, against individual mutations found in the Omicron variant, according to The Wall Street Journal. The preliminary findings haven’t yet been peer-reviewed, and the drug will need to be tested against the whole spike protein on the virus to confirm results.
GlaxoSmithKline and Vir have previously tested sotrovimab against mutations on other variants, the newspaper reported. When the Omicron variant was identified, the companies looked at earlier research to find the tests they had done against mutations that are also found in Omicron.
Sotrovimab targets a spot on the spike protein that is found in other coronaviruses and is thought to be less likely to mutate, according to the newspaper. Omicron has at least two mutations that overlap with the drug’s target site, but researchers at the companies don’t think the mutations will affect the treatment’s ability to bind to the spike protein.
GlaxoSmithKline expects to see results from testing the drug against the full mutated spike protein in the next 2 to 3 weeks, the Journal reported.
Sotrovimab has been authorized in about a dozen countries, including the United States, which paid about $1 billion for hundreds of thousands of doses.
Other companies have also been testing their antibody treatments against the Omicron variant.
Regeneron announced Nov. 30 that its drug could be less effective, and it said further analyses will determine how much less effective by using the actual Omicron genetic sequence, according to Reuters.
Outside scientists have also said the antibody drug from Eli Lilly & Co. isn’t as effective against Omicron. The company told Reuters that it is still testing the treatment against the variant.
Another experimental antibody therapy developed by Adagio Therapeutics appears to work well against the new variant, the Journal reported, but the treatment is in late-stage clinical trials and isn’t yet authorized.
Antiviral drugs could also help prevent hospitalization and may be less vulnerable to new variants because they target a different part of the virus, the newspaper reported. Merck and Pfizer have developed antiviral pills, which still require FDA approval.
In addition, Gilead believes its approved IV therapy, called remdesivir, will continue to be effective against the variant, Reuters reported.
The FDA said Nov. 30 that it is looking at the effect that authorized COVID-19 vaccines can have on Omicron and expects to have more information in coming weeks, Reuters reported.
A version of this article first appeared on WebMD.com.
The companies said Dec. 2 that they tested the drug, called sotrovimab, against individual mutations found in the Omicron variant, according to The Wall Street Journal. The preliminary findings haven’t yet been peer-reviewed, and the drug will need to be tested against the whole spike protein on the virus to confirm results.
GlaxoSmithKline and Vir have previously tested sotrovimab against mutations on other variants, the newspaper reported. When the Omicron variant was identified, the companies looked at earlier research to find the tests they had done against mutations that are also found in Omicron.
Sotrovimab targets a spot on the spike protein that is found in other coronaviruses and is thought to be less likely to mutate, according to the newspaper. Omicron has at least two mutations that overlap with the drug’s target site, but researchers at the companies don’t think the mutations will affect the treatment’s ability to bind to the spike protein.
GlaxoSmithKline expects to see results from testing the drug against the full mutated spike protein in the next 2 to 3 weeks, the Journal reported.
Sotrovimab has been authorized in about a dozen countries, including the United States, which paid about $1 billion for hundreds of thousands of doses.
Other companies have also been testing their antibody treatments against the Omicron variant.
Regeneron announced Nov. 30 that its drug could be less effective, and it said further analyses will determine how much less effective by using the actual Omicron genetic sequence, according to Reuters.
Outside scientists have also said the antibody drug from Eli Lilly & Co. isn’t as effective against Omicron. The company told Reuters that it is still testing the treatment against the variant.
Another experimental antibody therapy developed by Adagio Therapeutics appears to work well against the new variant, the Journal reported, but the treatment is in late-stage clinical trials and isn’t yet authorized.
Antiviral drugs could also help prevent hospitalization and may be less vulnerable to new variants because they target a different part of the virus, the newspaper reported. Merck and Pfizer have developed antiviral pills, which still require FDA approval.
In addition, Gilead believes its approved IV therapy, called remdesivir, will continue to be effective against the variant, Reuters reported.
The FDA said Nov. 30 that it is looking at the effect that authorized COVID-19 vaccines can have on Omicron and expects to have more information in coming weeks, Reuters reported.
A version of this article first appeared on WebMD.com.
Celiac disease and COVID-19: Reassuring data on outcomes
according to a new study.
Patients with CD are a “population of interest” in terms of the clinical outcomes of COVID-19, Emad Mansoor, MD, Digestive Health Institute, University Hospitals of Cleveland, and colleagues said.
There is emerging evidence that chronic disorders may have an impact on COVID-19 outcomes. But until now, the consequences of COVID-19 in patients with CD have been unclear.
The study was published online Nov. 11, 2021, in Gut.
To investigate, Dr. Mansoor and colleagues used the TriNetX EHR database to identify 599 patients with CD and confirmed COVID-19 and 810,972 patients without CD but with confirmed COVID-19 from 51 health care organizations in the United States.
After propensity-score matching, the CD and non-CD cohorts were “relatively balanced”; there were 598 patients in each group.
Before propensity-score matching, COVID-19 patients with CD were significantly more likely to be hospitalized than peers without CD (18.2% vs. 11.3%; odds ratio, 1.74; 95% confidence interval, 1.41-2.14; P < .0001).
After matching, however, this association became insignificant (OR, 0.96; 95% CI, 0.71-1.11; P = .0906).
Before matching, patients with CD were also more apt to develop blood clots (5.3% vs. 2.1%; OR, 2.69; 95% CI, 1.88-3.83; P < .0001) but not after matching (OR, 0.938; 95% CI, 0.57-1.54; P = .800).
The same pattern was observed for the two other outcomes of interest: mortality and need for care in the ICU.
Overall, there were no significant differences among any of the measured outcomes between CD and non-CD patients with COVID-19 after propensity-score matching, Dr. Mansoor and colleagues reported.
“This is the largest study characterizing CD patients with COVID-19 to date to systematically investigate outcomes of CD patients with COVID-19,” Dr. Mansoor and colleagues wrote.
They also say that their findings are in line with a recent population-based study from Sweden, which found no significant increase in risk for hospitalization, severe COVID-19, or increase in death between CD and non-CD patients with COVID-19.
“Although reassuring, this study is all about outcomes in individuals with diagnosed CD and the potential impact of COVID-19 in patients with undiagnosed CD remains unknown,” the researchers wrote.
The study had no specific funding. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a new study.
Patients with CD are a “population of interest” in terms of the clinical outcomes of COVID-19, Emad Mansoor, MD, Digestive Health Institute, University Hospitals of Cleveland, and colleagues said.
There is emerging evidence that chronic disorders may have an impact on COVID-19 outcomes. But until now, the consequences of COVID-19 in patients with CD have been unclear.
The study was published online Nov. 11, 2021, in Gut.
To investigate, Dr. Mansoor and colleagues used the TriNetX EHR database to identify 599 patients with CD and confirmed COVID-19 and 810,972 patients without CD but with confirmed COVID-19 from 51 health care organizations in the United States.
After propensity-score matching, the CD and non-CD cohorts were “relatively balanced”; there were 598 patients in each group.
Before propensity-score matching, COVID-19 patients with CD were significantly more likely to be hospitalized than peers without CD (18.2% vs. 11.3%; odds ratio, 1.74; 95% confidence interval, 1.41-2.14; P < .0001).
After matching, however, this association became insignificant (OR, 0.96; 95% CI, 0.71-1.11; P = .0906).
Before matching, patients with CD were also more apt to develop blood clots (5.3% vs. 2.1%; OR, 2.69; 95% CI, 1.88-3.83; P < .0001) but not after matching (OR, 0.938; 95% CI, 0.57-1.54; P = .800).
The same pattern was observed for the two other outcomes of interest: mortality and need for care in the ICU.
Overall, there were no significant differences among any of the measured outcomes between CD and non-CD patients with COVID-19 after propensity-score matching, Dr. Mansoor and colleagues reported.
“This is the largest study characterizing CD patients with COVID-19 to date to systematically investigate outcomes of CD patients with COVID-19,” Dr. Mansoor and colleagues wrote.
They also say that their findings are in line with a recent population-based study from Sweden, which found no significant increase in risk for hospitalization, severe COVID-19, or increase in death between CD and non-CD patients with COVID-19.
“Although reassuring, this study is all about outcomes in individuals with diagnosed CD and the potential impact of COVID-19 in patients with undiagnosed CD remains unknown,” the researchers wrote.
The study had no specific funding. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a new study.
Patients with CD are a “population of interest” in terms of the clinical outcomes of COVID-19, Emad Mansoor, MD, Digestive Health Institute, University Hospitals of Cleveland, and colleagues said.
There is emerging evidence that chronic disorders may have an impact on COVID-19 outcomes. But until now, the consequences of COVID-19 in patients with CD have been unclear.
The study was published online Nov. 11, 2021, in Gut.
To investigate, Dr. Mansoor and colleagues used the TriNetX EHR database to identify 599 patients with CD and confirmed COVID-19 and 810,972 patients without CD but with confirmed COVID-19 from 51 health care organizations in the United States.
After propensity-score matching, the CD and non-CD cohorts were “relatively balanced”; there were 598 patients in each group.
Before propensity-score matching, COVID-19 patients with CD were significantly more likely to be hospitalized than peers without CD (18.2% vs. 11.3%; odds ratio, 1.74; 95% confidence interval, 1.41-2.14; P < .0001).
After matching, however, this association became insignificant (OR, 0.96; 95% CI, 0.71-1.11; P = .0906).
Before matching, patients with CD were also more apt to develop blood clots (5.3% vs. 2.1%; OR, 2.69; 95% CI, 1.88-3.83; P < .0001) but not after matching (OR, 0.938; 95% CI, 0.57-1.54; P = .800).
The same pattern was observed for the two other outcomes of interest: mortality and need for care in the ICU.
Overall, there were no significant differences among any of the measured outcomes between CD and non-CD patients with COVID-19 after propensity-score matching, Dr. Mansoor and colleagues reported.
“This is the largest study characterizing CD patients with COVID-19 to date to systematically investigate outcomes of CD patients with COVID-19,” Dr. Mansoor and colleagues wrote.
They also say that their findings are in line with a recent population-based study from Sweden, which found no significant increase in risk for hospitalization, severe COVID-19, or increase in death between CD and non-CD patients with COVID-19.
“Although reassuring, this study is all about outcomes in individuals with diagnosed CD and the potential impact of COVID-19 in patients with undiagnosed CD remains unknown,” the researchers wrote.
The study had no specific funding. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM GUT
Ten changes that could keep clinicians in the workforce in a pandemic
Indeed, a recent poll of 1,000 health care workers conducted Sept. 2-8 by Morning Consult, showed that 18% of medical workers polled quit their jobs during the pandemic. Additionally, 31% said they had at least thought about leaving their work.
“As physicians, educators, peers and friends of COVID-19 responders, we are gravely concerned about our colleagues’ exhaustion, burnout, and disillusionment,” wrote lead author Eileen Barrett, MD, and coauthors of the new action plan, which was published in the Annals of Internal Medicine.
The 10-point, one-page checklist includes providing “practical support in the areas that clinicians identify as causing emotional stress or moral injury,” such as managing anger and grief when patients have chosen not to be vaccinated or confronting misinformation.
“Those are the things that are making people’s mental health worse” psychiatrist Jessi Gold, MD, MS, said in an interview. “I don’t think I’ve seen that mentioned other places.”
Among the other action items are:
- Reduce administrative tasks that are not “mission critical,” such as mandatory training that has no evidence of improving patient outcomes and meetings that could be skipped.
- Offer free and confidential resources to support clinicians’ mental health, such as easy access to crisis hotlines and peer support groups.
- Maintain transparency about personal protective equipment and contingency plans when there are shortages to restore trust.
- Encourage clinicians to use vacation time; leaders should model this.
- Implement suicide prevention strategies, including wellness check-ins for clinicians in hard-hit areas.
The action plan was based on the authors’ own experiences and the stories of colleagues and information in literature. It includes 10 changes health care leaders could make to help retain providers who may be on the brink of leaving their jobs or leaving medicine
Action items intended to be easily achievable, low cost
Dr. Barrett, who is a hospitalist in Albuquerque, said the goal was to present easily achievable and low-cost action items that clinicians and health care leaders could use as a starting point when change seems insurmountable and evidence on what works is slow to come.
She said one of the things that spurred her to coauthor the list was becoming aware of other clinicians’ “secret shame” in thinking about leaving medicine.
“Maybe a person who is not being listened to could take this journal article and say ‘we don’t know where to start. It looks like we can start here,’ ” said Dr. Barrett, who is also an associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.
She noted that some of the good ideas floated around did not make the list, because they required daunting budget commitments and too much time to put into place.
Numerous other proposed solutions were of the wrong tone, according to Dr. Barrett.
“It’s not just about a hug or a piece of pizza,” she said.
Dr. Gold, who is an assistant professor at Washington University, St. Louis, and specializes in the mental health of health care workers, noted that, even though the list was pared to 10 action items, it is still hard for health care organizations to prioritize mental health.
“Many hospitals are still struggling with the active bleed of the pandemic and financially recovering,” she said. “If you’re dealing with a full ER and people are still dying of COVID and you don’t have the resources to support them, it’s really hard to then find magic money to deal with mental health. I’d love for that to be true.”
Every organization, however, can start with removing questions about mental and physical health diagnoses from credentialing and employment applications, which is one of the items on the list, she said.
“It’s the lowest-bar thing that you can fix for making people in crisis not fear getting help,” she said. That change must come on a state-by-state and individual hospital level.
Favorable reactions to list
Dr. Barrett, who also serves on the editorial advisory board of Internal Medicine News, said the reactions to the checklist have been “overwhelmingly favorable and appreciative.”
Eric J. Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News, tweeted about this list: “For COVID-19, more than ever before, it’s vital to keep clinicians in the U.S. health care workforce. These are 10 steps that will help.” The tweet was retweeted more than 100 times.
Lotte Dyrbye, MD, MHPE, a primary care physician and codirector of the program on physician well-being at the Mayo Clinic in Rochester, Minn., said in an interview that managing the anger around patients who choose to be unvaccinated is critical and something that has gotten little notice since the vaccines became available.
“Physicians and nurses are working extremely hard and seeing a lot of suffering and are taking care of patients very sick with COVID-19, knowing they had access to the vaccine. That is causing anger and frustration. We haven’t prepared health care workers to deal with that,” she said.
Outside expert: Not all items may be easy to implement
Dr. Dyrbye said that, though she found adding time to address COVID misinformation questions in appointments is very important, it may be wishful thinking.
The authors suggested training other members of the care team to answer those questions to free up time, but she said, for patients who have been swayed by misinformation, hearing information from someone other than the physician they have a relationship with won’t be convincing.
According to Dr. Dyrbye, the items on the list are not easy to implement, but the action plan is worthwhile to consider adopting as a multipronged approach.
“Most of these things are hard and we need to be in it for the long run,” she said.
The need is clear for efforts to address the mental health of not just experienced clinicians but those in training as well, she noted.
Related research
A study that was also recently published in the Annals of Internal Medicine suggested that making a few simple changes can help improve the mental health of residents. The research, which included nearly 17,000 first-year residents who started training between 2007 and 2019, addressed indicators of mental health in light of interventions such as limiting residents’ work hours and providing more services.
The investigators found that, though depression remains high among residents, depressive symptoms among first-year residents dropped 24.4% from 2007 to 2019 in parallel with four main factors: an increase in mental health services; restrictions on work hours for residents; more sleep hours; and higher-quality feedback from faculty.
Dr. Barrett said she hopes her colleagues and health care workers everywhere will find some solace in seeing that the new checklist she coauthored was published in a prominent journal.
The message Dr. Barrett said she hopes they see is: “Someone is validating it is not in their head. They are validating we can do better. They are validating that we must.”
Dr. Barrett and coauthors had no conflicts of interest. Dr. Gold and Dr. Dyrbye also disclosed having no relevant financial relationships.
Indeed, a recent poll of 1,000 health care workers conducted Sept. 2-8 by Morning Consult, showed that 18% of medical workers polled quit their jobs during the pandemic. Additionally, 31% said they had at least thought about leaving their work.
“As physicians, educators, peers and friends of COVID-19 responders, we are gravely concerned about our colleagues’ exhaustion, burnout, and disillusionment,” wrote lead author Eileen Barrett, MD, and coauthors of the new action plan, which was published in the Annals of Internal Medicine.
The 10-point, one-page checklist includes providing “practical support in the areas that clinicians identify as causing emotional stress or moral injury,” such as managing anger and grief when patients have chosen not to be vaccinated or confronting misinformation.
“Those are the things that are making people’s mental health worse” psychiatrist Jessi Gold, MD, MS, said in an interview. “I don’t think I’ve seen that mentioned other places.”
Among the other action items are:
- Reduce administrative tasks that are not “mission critical,” such as mandatory training that has no evidence of improving patient outcomes and meetings that could be skipped.
- Offer free and confidential resources to support clinicians’ mental health, such as easy access to crisis hotlines and peer support groups.
- Maintain transparency about personal protective equipment and contingency plans when there are shortages to restore trust.
- Encourage clinicians to use vacation time; leaders should model this.
- Implement suicide prevention strategies, including wellness check-ins for clinicians in hard-hit areas.
The action plan was based on the authors’ own experiences and the stories of colleagues and information in literature. It includes 10 changes health care leaders could make to help retain providers who may be on the brink of leaving their jobs or leaving medicine
Action items intended to be easily achievable, low cost
Dr. Barrett, who is a hospitalist in Albuquerque, said the goal was to present easily achievable and low-cost action items that clinicians and health care leaders could use as a starting point when change seems insurmountable and evidence on what works is slow to come.
She said one of the things that spurred her to coauthor the list was becoming aware of other clinicians’ “secret shame” in thinking about leaving medicine.
“Maybe a person who is not being listened to could take this journal article and say ‘we don’t know where to start. It looks like we can start here,’ ” said Dr. Barrett, who is also an associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.
She noted that some of the good ideas floated around did not make the list, because they required daunting budget commitments and too much time to put into place.
Numerous other proposed solutions were of the wrong tone, according to Dr. Barrett.
“It’s not just about a hug or a piece of pizza,” she said.
Dr. Gold, who is an assistant professor at Washington University, St. Louis, and specializes in the mental health of health care workers, noted that, even though the list was pared to 10 action items, it is still hard for health care organizations to prioritize mental health.
“Many hospitals are still struggling with the active bleed of the pandemic and financially recovering,” she said. “If you’re dealing with a full ER and people are still dying of COVID and you don’t have the resources to support them, it’s really hard to then find magic money to deal with mental health. I’d love for that to be true.”
Every organization, however, can start with removing questions about mental and physical health diagnoses from credentialing and employment applications, which is one of the items on the list, she said.
“It’s the lowest-bar thing that you can fix for making people in crisis not fear getting help,” she said. That change must come on a state-by-state and individual hospital level.
Favorable reactions to list
Dr. Barrett, who also serves on the editorial advisory board of Internal Medicine News, said the reactions to the checklist have been “overwhelmingly favorable and appreciative.”
Eric J. Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News, tweeted about this list: “For COVID-19, more than ever before, it’s vital to keep clinicians in the U.S. health care workforce. These are 10 steps that will help.” The tweet was retweeted more than 100 times.
Lotte Dyrbye, MD, MHPE, a primary care physician and codirector of the program on physician well-being at the Mayo Clinic in Rochester, Minn., said in an interview that managing the anger around patients who choose to be unvaccinated is critical and something that has gotten little notice since the vaccines became available.
“Physicians and nurses are working extremely hard and seeing a lot of suffering and are taking care of patients very sick with COVID-19, knowing they had access to the vaccine. That is causing anger and frustration. We haven’t prepared health care workers to deal with that,” she said.
Outside expert: Not all items may be easy to implement
Dr. Dyrbye said that, though she found adding time to address COVID misinformation questions in appointments is very important, it may be wishful thinking.
The authors suggested training other members of the care team to answer those questions to free up time, but she said, for patients who have been swayed by misinformation, hearing information from someone other than the physician they have a relationship with won’t be convincing.
According to Dr. Dyrbye, the items on the list are not easy to implement, but the action plan is worthwhile to consider adopting as a multipronged approach.
“Most of these things are hard and we need to be in it for the long run,” she said.
The need is clear for efforts to address the mental health of not just experienced clinicians but those in training as well, she noted.
Related research
A study that was also recently published in the Annals of Internal Medicine suggested that making a few simple changes can help improve the mental health of residents. The research, which included nearly 17,000 first-year residents who started training between 2007 and 2019, addressed indicators of mental health in light of interventions such as limiting residents’ work hours and providing more services.
The investigators found that, though depression remains high among residents, depressive symptoms among first-year residents dropped 24.4% from 2007 to 2019 in parallel with four main factors: an increase in mental health services; restrictions on work hours for residents; more sleep hours; and higher-quality feedback from faculty.
Dr. Barrett said she hopes her colleagues and health care workers everywhere will find some solace in seeing that the new checklist she coauthored was published in a prominent journal.
The message Dr. Barrett said she hopes they see is: “Someone is validating it is not in their head. They are validating we can do better. They are validating that we must.”
Dr. Barrett and coauthors had no conflicts of interest. Dr. Gold and Dr. Dyrbye also disclosed having no relevant financial relationships.
Indeed, a recent poll of 1,000 health care workers conducted Sept. 2-8 by Morning Consult, showed that 18% of medical workers polled quit their jobs during the pandemic. Additionally, 31% said they had at least thought about leaving their work.
“As physicians, educators, peers and friends of COVID-19 responders, we are gravely concerned about our colleagues’ exhaustion, burnout, and disillusionment,” wrote lead author Eileen Barrett, MD, and coauthors of the new action plan, which was published in the Annals of Internal Medicine.
The 10-point, one-page checklist includes providing “practical support in the areas that clinicians identify as causing emotional stress or moral injury,” such as managing anger and grief when patients have chosen not to be vaccinated or confronting misinformation.
“Those are the things that are making people’s mental health worse” psychiatrist Jessi Gold, MD, MS, said in an interview. “I don’t think I’ve seen that mentioned other places.”
Among the other action items are:
- Reduce administrative tasks that are not “mission critical,” such as mandatory training that has no evidence of improving patient outcomes and meetings that could be skipped.
- Offer free and confidential resources to support clinicians’ mental health, such as easy access to crisis hotlines and peer support groups.
- Maintain transparency about personal protective equipment and contingency plans when there are shortages to restore trust.
- Encourage clinicians to use vacation time; leaders should model this.
- Implement suicide prevention strategies, including wellness check-ins for clinicians in hard-hit areas.
The action plan was based on the authors’ own experiences and the stories of colleagues and information in literature. It includes 10 changes health care leaders could make to help retain providers who may be on the brink of leaving their jobs or leaving medicine
Action items intended to be easily achievable, low cost
Dr. Barrett, who is a hospitalist in Albuquerque, said the goal was to present easily achievable and low-cost action items that clinicians and health care leaders could use as a starting point when change seems insurmountable and evidence on what works is slow to come.
She said one of the things that spurred her to coauthor the list was becoming aware of other clinicians’ “secret shame” in thinking about leaving medicine.
“Maybe a person who is not being listened to could take this journal article and say ‘we don’t know where to start. It looks like we can start here,’ ” said Dr. Barrett, who is also an associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque.
She noted that some of the good ideas floated around did not make the list, because they required daunting budget commitments and too much time to put into place.
Numerous other proposed solutions were of the wrong tone, according to Dr. Barrett.
“It’s not just about a hug or a piece of pizza,” she said.
Dr. Gold, who is an assistant professor at Washington University, St. Louis, and specializes in the mental health of health care workers, noted that, even though the list was pared to 10 action items, it is still hard for health care organizations to prioritize mental health.
“Many hospitals are still struggling with the active bleed of the pandemic and financially recovering,” she said. “If you’re dealing with a full ER and people are still dying of COVID and you don’t have the resources to support them, it’s really hard to then find magic money to deal with mental health. I’d love for that to be true.”
Every organization, however, can start with removing questions about mental and physical health diagnoses from credentialing and employment applications, which is one of the items on the list, she said.
“It’s the lowest-bar thing that you can fix for making people in crisis not fear getting help,” she said. That change must come on a state-by-state and individual hospital level.
Favorable reactions to list
Dr. Barrett, who also serves on the editorial advisory board of Internal Medicine News, said the reactions to the checklist have been “overwhelmingly favorable and appreciative.”
Eric J. Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News, tweeted about this list: “For COVID-19, more than ever before, it’s vital to keep clinicians in the U.S. health care workforce. These are 10 steps that will help.” The tweet was retweeted more than 100 times.
Lotte Dyrbye, MD, MHPE, a primary care physician and codirector of the program on physician well-being at the Mayo Clinic in Rochester, Minn., said in an interview that managing the anger around patients who choose to be unvaccinated is critical and something that has gotten little notice since the vaccines became available.
“Physicians and nurses are working extremely hard and seeing a lot of suffering and are taking care of patients very sick with COVID-19, knowing they had access to the vaccine. That is causing anger and frustration. We haven’t prepared health care workers to deal with that,” she said.
Outside expert: Not all items may be easy to implement
Dr. Dyrbye said that, though she found adding time to address COVID misinformation questions in appointments is very important, it may be wishful thinking.
The authors suggested training other members of the care team to answer those questions to free up time, but she said, for patients who have been swayed by misinformation, hearing information from someone other than the physician they have a relationship with won’t be convincing.
According to Dr. Dyrbye, the items on the list are not easy to implement, but the action plan is worthwhile to consider adopting as a multipronged approach.
“Most of these things are hard and we need to be in it for the long run,” she said.
The need is clear for efforts to address the mental health of not just experienced clinicians but those in training as well, she noted.
Related research
A study that was also recently published in the Annals of Internal Medicine suggested that making a few simple changes can help improve the mental health of residents. The research, which included nearly 17,000 first-year residents who started training between 2007 and 2019, addressed indicators of mental health in light of interventions such as limiting residents’ work hours and providing more services.
The investigators found that, though depression remains high among residents, depressive symptoms among first-year residents dropped 24.4% from 2007 to 2019 in parallel with four main factors: an increase in mental health services; restrictions on work hours for residents; more sleep hours; and higher-quality feedback from faculty.
Dr. Barrett said she hopes her colleagues and health care workers everywhere will find some solace in seeing that the new checklist she coauthored was published in a prominent journal.
The message Dr. Barrett said she hopes they see is: “Someone is validating it is not in their head. They are validating we can do better. They are validating that we must.”
Dr. Barrett and coauthors had no conflicts of interest. Dr. Gold and Dr. Dyrbye also disclosed having no relevant financial relationships.
FROM ANNALS OF INTERNAL MEDICINE
Second U.S. COVID-19 case caused by Omicron found
A second U.S. case of COVID-19 caused by the Omicron variant has been picked up by genetic testing in Minnesota.
The man, from Hennepin County, Minn., fell ill on Nov. 22 after attending the Anime NYC 2021 conference at the Javits Center in New York City a few days before. He sought testing on Nov. 24. His symptoms have resolved, according to a press release on the case from the Minnesota Department of Health. The man was fully vaccinated, the department said.
He was advised to isolate from others, but it’s unclear if he had contact with anyone else before he learning he was infected.
“This news is concerning, but it is not a surprise,” said Governor Tim Walz in a news release. “We know that this virus is highly infectious and moves quickly throughout the world. Minnesotans know what to do to keep each other safe now — get the vaccine, get tested, wear a mask indoors, and get a booster. Together, we can fight this virus and help keep Minnesotans safe,”
The first case of COVID-19 caused by Omicron was detected Dec. 1 in California. That case was in a traveler who had recently returned from South Africa.
This breaking news story will be updated.
A version of this article first appeared on WebMD.com.
A second U.S. case of COVID-19 caused by the Omicron variant has been picked up by genetic testing in Minnesota.
The man, from Hennepin County, Minn., fell ill on Nov. 22 after attending the Anime NYC 2021 conference at the Javits Center in New York City a few days before. He sought testing on Nov. 24. His symptoms have resolved, according to a press release on the case from the Minnesota Department of Health. The man was fully vaccinated, the department said.
He was advised to isolate from others, but it’s unclear if he had contact with anyone else before he learning he was infected.
“This news is concerning, but it is not a surprise,” said Governor Tim Walz in a news release. “We know that this virus is highly infectious and moves quickly throughout the world. Minnesotans know what to do to keep each other safe now — get the vaccine, get tested, wear a mask indoors, and get a booster. Together, we can fight this virus and help keep Minnesotans safe,”
The first case of COVID-19 caused by Omicron was detected Dec. 1 in California. That case was in a traveler who had recently returned from South Africa.
This breaking news story will be updated.
A version of this article first appeared on WebMD.com.
A second U.S. case of COVID-19 caused by the Omicron variant has been picked up by genetic testing in Minnesota.
The man, from Hennepin County, Minn., fell ill on Nov. 22 after attending the Anime NYC 2021 conference at the Javits Center in New York City a few days before. He sought testing on Nov. 24. His symptoms have resolved, according to a press release on the case from the Minnesota Department of Health. The man was fully vaccinated, the department said.
He was advised to isolate from others, but it’s unclear if he had contact with anyone else before he learning he was infected.
“This news is concerning, but it is not a surprise,” said Governor Tim Walz in a news release. “We know that this virus is highly infectious and moves quickly throughout the world. Minnesotans know what to do to keep each other safe now — get the vaccine, get tested, wear a mask indoors, and get a booster. Together, we can fight this virus and help keep Minnesotans safe,”
The first case of COVID-19 caused by Omicron was detected Dec. 1 in California. That case was in a traveler who had recently returned from South Africa.
This breaking news story will be updated.
A version of this article first appeared on WebMD.com.