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Texas hospital workers sue over vaccine mandates
objecting to its policy of requiring employees and contractors to be vaccinated against COVID-19 or risk losing their jobs.
Plaintiffs include Jennifer Bridges, RN, a medical-surgical nurse at the hospital who has become the public face and voice of health care workers who object to mandatory vaccination, as well as Bob Nevens, the hospital’s director of corporate risk.
Mr. Nevens said the hospital was requiring him to be vaccinated even though he doesn’t treat patients and has been working from home for most of the past year.
“My civil rights and liberties have been trampled on,” he said in comments posted on an online petition. “My right to protect myself from unknown side effects of these vaccines has been placed below the optics of ‘leading medicine,’ “ he said.
Mr. Nevens says in his comments that he was fired on April 15, although the lawsuit says he is currently employed by the hospital’s corporate office.
The Texas attorney who filed the lawsuit, Jared Woodfill, is known to champion conservative causes. In March 2020, he challenged Harris County’s stay-at-home order, charging that it violated religious liberty. He was chairman of the Harris County Republican Party for more than a decade. His website says he is a frequent guest on the local Fox News affiliate.
The lawsuit hinges on a section of the federal law that authorizes emergency use of medical products – US Code 360bbb-3.
That law says that individuals to whom the product is administered should be informed “of the option to accept or refuse administration of the product, of the consequence, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”
Legal experts are split as to what the provision means for vaccination mandates. Courts have not yet weighed in with their interpretations of the law.
The petition also repeats a popular antivaccination argument that likens requiring a vaccine approved for emergency use to the kind of medical experimentation performed by Nazi doctors on Jewish prisoners in concentration camps. It says forcing people to choose between an experimental vaccine and a job is a violation of the Nuremberg Code, which says that people must voluntarily and knowingly consent to participating in research.
The vaccines have already been tested in clinical trials. People who are getting them now are not part of those studies, though vaccine manufacturers, regulators, and safety experts are still watching closely for any sign of problems tied to the new shots.
It is true, however, that the emergency use authorization granted by the U.S. Food and Drug Administraiton sped up the process of getting the vaccines onto market. Vaccine manufacturers are currently completing the process of submitting documentation required for a full biologics license application, the mechanism the FDA uses for full approval.
Houston Methodist sent an email to employees in April notifying them that they had until June 7 to start the vaccination process or apply for a medical or religious exemption. Those who decide not to will be terminated.
Marc Boom, MD, the health care system’s president and CEO, has explained that the policy is in place to protect patients and that it was the first hospital in the United States to require it. Since then, other hospitals, including the University of Pennsylvania Health System, have required COVID vaccines.
A version of this article first appeared on Medscape.com.
objecting to its policy of requiring employees and contractors to be vaccinated against COVID-19 or risk losing their jobs.
Plaintiffs include Jennifer Bridges, RN, a medical-surgical nurse at the hospital who has become the public face and voice of health care workers who object to mandatory vaccination, as well as Bob Nevens, the hospital’s director of corporate risk.
Mr. Nevens said the hospital was requiring him to be vaccinated even though he doesn’t treat patients and has been working from home for most of the past year.
“My civil rights and liberties have been trampled on,” he said in comments posted on an online petition. “My right to protect myself from unknown side effects of these vaccines has been placed below the optics of ‘leading medicine,’ “ he said.
Mr. Nevens says in his comments that he was fired on April 15, although the lawsuit says he is currently employed by the hospital’s corporate office.
The Texas attorney who filed the lawsuit, Jared Woodfill, is known to champion conservative causes. In March 2020, he challenged Harris County’s stay-at-home order, charging that it violated religious liberty. He was chairman of the Harris County Republican Party for more than a decade. His website says he is a frequent guest on the local Fox News affiliate.
The lawsuit hinges on a section of the federal law that authorizes emergency use of medical products – US Code 360bbb-3.
That law says that individuals to whom the product is administered should be informed “of the option to accept or refuse administration of the product, of the consequence, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”
Legal experts are split as to what the provision means for vaccination mandates. Courts have not yet weighed in with their interpretations of the law.
The petition also repeats a popular antivaccination argument that likens requiring a vaccine approved for emergency use to the kind of medical experimentation performed by Nazi doctors on Jewish prisoners in concentration camps. It says forcing people to choose between an experimental vaccine and a job is a violation of the Nuremberg Code, which says that people must voluntarily and knowingly consent to participating in research.
The vaccines have already been tested in clinical trials. People who are getting them now are not part of those studies, though vaccine manufacturers, regulators, and safety experts are still watching closely for any sign of problems tied to the new shots.
It is true, however, that the emergency use authorization granted by the U.S. Food and Drug Administraiton sped up the process of getting the vaccines onto market. Vaccine manufacturers are currently completing the process of submitting documentation required for a full biologics license application, the mechanism the FDA uses for full approval.
Houston Methodist sent an email to employees in April notifying them that they had until June 7 to start the vaccination process or apply for a medical or religious exemption. Those who decide not to will be terminated.
Marc Boom, MD, the health care system’s president and CEO, has explained that the policy is in place to protect patients and that it was the first hospital in the United States to require it. Since then, other hospitals, including the University of Pennsylvania Health System, have required COVID vaccines.
A version of this article first appeared on Medscape.com.
objecting to its policy of requiring employees and contractors to be vaccinated against COVID-19 or risk losing their jobs.
Plaintiffs include Jennifer Bridges, RN, a medical-surgical nurse at the hospital who has become the public face and voice of health care workers who object to mandatory vaccination, as well as Bob Nevens, the hospital’s director of corporate risk.
Mr. Nevens said the hospital was requiring him to be vaccinated even though he doesn’t treat patients and has been working from home for most of the past year.
“My civil rights and liberties have been trampled on,” he said in comments posted on an online petition. “My right to protect myself from unknown side effects of these vaccines has been placed below the optics of ‘leading medicine,’ “ he said.
Mr. Nevens says in his comments that he was fired on April 15, although the lawsuit says he is currently employed by the hospital’s corporate office.
The Texas attorney who filed the lawsuit, Jared Woodfill, is known to champion conservative causes. In March 2020, he challenged Harris County’s stay-at-home order, charging that it violated religious liberty. He was chairman of the Harris County Republican Party for more than a decade. His website says he is a frequent guest on the local Fox News affiliate.
The lawsuit hinges on a section of the federal law that authorizes emergency use of medical products – US Code 360bbb-3.
That law says that individuals to whom the product is administered should be informed “of the option to accept or refuse administration of the product, of the consequence, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”
Legal experts are split as to what the provision means for vaccination mandates. Courts have not yet weighed in with their interpretations of the law.
The petition also repeats a popular antivaccination argument that likens requiring a vaccine approved for emergency use to the kind of medical experimentation performed by Nazi doctors on Jewish prisoners in concentration camps. It says forcing people to choose between an experimental vaccine and a job is a violation of the Nuremberg Code, which says that people must voluntarily and knowingly consent to participating in research.
The vaccines have already been tested in clinical trials. People who are getting them now are not part of those studies, though vaccine manufacturers, regulators, and safety experts are still watching closely for any sign of problems tied to the new shots.
It is true, however, that the emergency use authorization granted by the U.S. Food and Drug Administraiton sped up the process of getting the vaccines onto market. Vaccine manufacturers are currently completing the process of submitting documentation required for a full biologics license application, the mechanism the FDA uses for full approval.
Houston Methodist sent an email to employees in April notifying them that they had until June 7 to start the vaccination process or apply for a medical or religious exemption. Those who decide not to will be terminated.
Marc Boom, MD, the health care system’s president and CEO, has explained that the policy is in place to protect patients and that it was the first hospital in the United States to require it. Since then, other hospitals, including the University of Pennsylvania Health System, have required COVID vaccines.
A version of this article first appeared on Medscape.com.
DOJ charges 14 with COVID-19–related fraud nearing $150M
The U.S. Department of Justice (DOJ) on May 26 announced charges against 14 defendants across the country who allegedly engaged in health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings to Medicare.
Among the defendants, a DOJ news release said, were a telemedicine company executive, a physician, marketers, and medical business owners.
In addition, the Centers for Medicare and Medicaid Services separately announced that it had taken “adverse administrative actions” against more than 50 providers for their involvement in fraud schemes related to COVID-19 or the abuse of CMS programs that were designed to encourage access to medical care during the pandemic.
Several of the defendants allegedly offered COVID-19 tests to Medicare beneficiaries in senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or a blood sample.
The DOJ charges claim the defendants then misused the information and the samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive lab tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests.
In some cases, it’s alleged, the lab results were not provided to the individuals in a timely fashion or were not reliable.
Other defendants are charged with exploiting temporary changes in CMS telehealth regulations that were designed to increase access to health care during the pandemic. In these cases, which the DOJ said were the first charges related to the expansion of telehealth under the COVID-19 emergency declaration, the defendants allegedly submitted false and fraudulent claims to Medicare for sham telemedicine encounters that did not occur.
“As part of these cases, medical professionals are alleged to have [been] offered and paid bribes in exchange for the medical professionals’ referral of unnecessary testing,” the DOJ news release said. However, no physicians were identified by the department.
Commenting on this aspect of the law enforcement action, FBI Director Christopher Wray said in the release: “Medical providers have been the unsung heroes for the American public throughout the pandemic. It’s disheartening that some have abused their authorities and committed COVID-19–related fraud against trusting citizens. The FBI, along with our federal law enforcement and private sector partners, are committed to continuing to combat health care fraud and protect the American people.”
The law enforcement action includes the third set of criminal charges related to the misuse of Provider Relief Fund monies, according to the release.
More than 340 individuals were charged in September 2020 with submitting $6 billion in fraudulent claims to federal health care programs and private insurers for telehealth consultations and substance abuse treatment. About $4.5 billion of that was related to telehealth, as reported by this news organization.
The new criminal charges were brought in federal district courts in Arkansas, California, Louisiana, Florida, New Jersey, and New York.
Case summaries
The DOJ provided several case summaries. One defendant, lab owner Billy Joe Taylor of Lavaca, Ark., was charged with participating in a scheme to defraud the government of over $42 million by filing false claims that were billed in combination with COVID-19 testing claims. He also allegedly billed for tests that were not performed.
Petros Hannesyan of Burbank, Calif., the owner of a home health agency, was charged with obtaining over $229,000 from COVID-19 relief programs under false pretenses. His firm allegedly misappropriated funds from the CARES Act Provider Relief Fund and submitted false loan applications and a false loan agreement to the Economic Injury Disaster Loan Program.
Michael Stein and Leonel Palatnik of Palm Beach County, Fla., were charged in a connection with an alleged $73 million conspiracy to defraud the government and to pay and receive health care kickbacks during the pandemic.
Mr. Stein, who owned a “purported” consulting company, and Mr. Palatnik, who owned testing labs in Texas, allegedly exploited Medicare’s waiver of telehealth restrictions “by offering telehealth providers access to Medicare beneficiaries for whom they could bill consultations. In exchange, these providers agreed to refer beneficiaries to [Mr. Palatnik’s] laboratories for expensive and medically unnecessary cancer and cardiovascular genetic testing.”
A version of this article first appeared on Medscape.com.
The U.S. Department of Justice (DOJ) on May 26 announced charges against 14 defendants across the country who allegedly engaged in health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings to Medicare.
Among the defendants, a DOJ news release said, were a telemedicine company executive, a physician, marketers, and medical business owners.
In addition, the Centers for Medicare and Medicaid Services separately announced that it had taken “adverse administrative actions” against more than 50 providers for their involvement in fraud schemes related to COVID-19 or the abuse of CMS programs that were designed to encourage access to medical care during the pandemic.
Several of the defendants allegedly offered COVID-19 tests to Medicare beneficiaries in senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or a blood sample.
The DOJ charges claim the defendants then misused the information and the samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive lab tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests.
In some cases, it’s alleged, the lab results were not provided to the individuals in a timely fashion or were not reliable.
Other defendants are charged with exploiting temporary changes in CMS telehealth regulations that were designed to increase access to health care during the pandemic. In these cases, which the DOJ said were the first charges related to the expansion of telehealth under the COVID-19 emergency declaration, the defendants allegedly submitted false and fraudulent claims to Medicare for sham telemedicine encounters that did not occur.
“As part of these cases, medical professionals are alleged to have [been] offered and paid bribes in exchange for the medical professionals’ referral of unnecessary testing,” the DOJ news release said. However, no physicians were identified by the department.
Commenting on this aspect of the law enforcement action, FBI Director Christopher Wray said in the release: “Medical providers have been the unsung heroes for the American public throughout the pandemic. It’s disheartening that some have abused their authorities and committed COVID-19–related fraud against trusting citizens. The FBI, along with our federal law enforcement and private sector partners, are committed to continuing to combat health care fraud and protect the American people.”
The law enforcement action includes the third set of criminal charges related to the misuse of Provider Relief Fund monies, according to the release.
More than 340 individuals were charged in September 2020 with submitting $6 billion in fraudulent claims to federal health care programs and private insurers for telehealth consultations and substance abuse treatment. About $4.5 billion of that was related to telehealth, as reported by this news organization.
The new criminal charges were brought in federal district courts in Arkansas, California, Louisiana, Florida, New Jersey, and New York.
Case summaries
The DOJ provided several case summaries. One defendant, lab owner Billy Joe Taylor of Lavaca, Ark., was charged with participating in a scheme to defraud the government of over $42 million by filing false claims that were billed in combination with COVID-19 testing claims. He also allegedly billed for tests that were not performed.
Petros Hannesyan of Burbank, Calif., the owner of a home health agency, was charged with obtaining over $229,000 from COVID-19 relief programs under false pretenses. His firm allegedly misappropriated funds from the CARES Act Provider Relief Fund and submitted false loan applications and a false loan agreement to the Economic Injury Disaster Loan Program.
Michael Stein and Leonel Palatnik of Palm Beach County, Fla., were charged in a connection with an alleged $73 million conspiracy to defraud the government and to pay and receive health care kickbacks during the pandemic.
Mr. Stein, who owned a “purported” consulting company, and Mr. Palatnik, who owned testing labs in Texas, allegedly exploited Medicare’s waiver of telehealth restrictions “by offering telehealth providers access to Medicare beneficiaries for whom they could bill consultations. In exchange, these providers agreed to refer beneficiaries to [Mr. Palatnik’s] laboratories for expensive and medically unnecessary cancer and cardiovascular genetic testing.”
A version of this article first appeared on Medscape.com.
The U.S. Department of Justice (DOJ) on May 26 announced charges against 14 defendants across the country who allegedly engaged in health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings to Medicare.
Among the defendants, a DOJ news release said, were a telemedicine company executive, a physician, marketers, and medical business owners.
In addition, the Centers for Medicare and Medicaid Services separately announced that it had taken “adverse administrative actions” against more than 50 providers for their involvement in fraud schemes related to COVID-19 or the abuse of CMS programs that were designed to encourage access to medical care during the pandemic.
Several of the defendants allegedly offered COVID-19 tests to Medicare beneficiaries in senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or a blood sample.
The DOJ charges claim the defendants then misused the information and the samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive lab tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests.
In some cases, it’s alleged, the lab results were not provided to the individuals in a timely fashion or were not reliable.
Other defendants are charged with exploiting temporary changes in CMS telehealth regulations that were designed to increase access to health care during the pandemic. In these cases, which the DOJ said were the first charges related to the expansion of telehealth under the COVID-19 emergency declaration, the defendants allegedly submitted false and fraudulent claims to Medicare for sham telemedicine encounters that did not occur.
“As part of these cases, medical professionals are alleged to have [been] offered and paid bribes in exchange for the medical professionals’ referral of unnecessary testing,” the DOJ news release said. However, no physicians were identified by the department.
Commenting on this aspect of the law enforcement action, FBI Director Christopher Wray said in the release: “Medical providers have been the unsung heroes for the American public throughout the pandemic. It’s disheartening that some have abused their authorities and committed COVID-19–related fraud against trusting citizens. The FBI, along with our federal law enforcement and private sector partners, are committed to continuing to combat health care fraud and protect the American people.”
The law enforcement action includes the third set of criminal charges related to the misuse of Provider Relief Fund monies, according to the release.
More than 340 individuals were charged in September 2020 with submitting $6 billion in fraudulent claims to federal health care programs and private insurers for telehealth consultations and substance abuse treatment. About $4.5 billion of that was related to telehealth, as reported by this news organization.
The new criminal charges were brought in federal district courts in Arkansas, California, Louisiana, Florida, New Jersey, and New York.
Case summaries
The DOJ provided several case summaries. One defendant, lab owner Billy Joe Taylor of Lavaca, Ark., was charged with participating in a scheme to defraud the government of over $42 million by filing false claims that were billed in combination with COVID-19 testing claims. He also allegedly billed for tests that were not performed.
Petros Hannesyan of Burbank, Calif., the owner of a home health agency, was charged with obtaining over $229,000 from COVID-19 relief programs under false pretenses. His firm allegedly misappropriated funds from the CARES Act Provider Relief Fund and submitted false loan applications and a false loan agreement to the Economic Injury Disaster Loan Program.
Michael Stein and Leonel Palatnik of Palm Beach County, Fla., were charged in a connection with an alleged $73 million conspiracy to defraud the government and to pay and receive health care kickbacks during the pandemic.
Mr. Stein, who owned a “purported” consulting company, and Mr. Palatnik, who owned testing labs in Texas, allegedly exploited Medicare’s waiver of telehealth restrictions “by offering telehealth providers access to Medicare beneficiaries for whom they could bill consultations. In exchange, these providers agreed to refer beneficiaries to [Mr. Palatnik’s] laboratories for expensive and medically unnecessary cancer and cardiovascular genetic testing.”
A version of this article first appeared on Medscape.com.
Elevated factor VIII troughs can lead to a higher proportion of zero bleeds in hemophilia
Rurioctocog alfa pegol prophylaxis was linked to fewer bleeding episodes in people with hemophilia A when it targeted higher levels of factor VIII (FVIII) troughs, according to a report published in Blood (2021;137[13]:1818-27).
Earlier studies demonstrated that the treatment effectively prevented bleeds with an acceptable safety profile in people with hemophilia A. The current prospective, randomized, open label PROPEL trial compared safety and efficacy of two target FVIII troughs in this population. Targeting 1%-3% and 8%-12% FVIII troughs was efficacious, with fewer bleeds in the latter arm and acceptable safety across both, according to Robert Klamroth, MD, of Vivantes Klinikum Friedrichshain, Berlin, and colleagues.
The PROPEL trial (NCT02585960) population comprised 155 patients with hepatitis A, aged 12-65 years, with severe disease and an annualized bleeding rate of at least 2 during the 12 months before enrollment in the study. All had previous FVIII treatment. Patients were randomized to 12 months’ pharmacokinetic rurioctocog alfa pegol prophylaxis targeting FVIII troughs of 1%-3% (reference arm) or 8%-12%.
The primary endpoint was absence of bleeds during the second 6-month period. A total of 95 patients completed the protocol.
Promising results
In the 1%-3% and 8%-12% arms, the proportions of patients who completed the protocol and had no bleeds were 40% and 67% respectively (P = .015). Serious adverse events occurred in 7 of 115 (6%) patients, including one treatment-related event in the 8%-12% arm. There were no deaths, serious thrombotic events, or adverse event-related discontinuations.
“Targeting 8% to 12% FVIII troughs resulted in a higher proportion of [patients] with no bleeds than prophylaxis that targeted 1% to 3% FVIII troughs. These results support the hypothesis that an elevated FVIII trough can benefit [patients]without changing the safety profile,” the researchers reported. Personalized treatment in this patient population should be considered, they added.
Problems remain
In an invited commentary, Christine L. Kempton, MD, of Emory University, Atlanta, pointed out that the study did not answer the question of what trough level is best, and that the target trough level may be up to a patient’s individual clinician to decide. “Many participants (42%) treated with the target trough level of 1% to 3% had no bleeding events during the study period, but some (38%) continued to have bleeding events despite higher target trough levels,” Dr. Kempton wrote. She added that, beyond this concern, the presence of subclinical bleeding is difficult to study and quantify, but its presence is supported in the literature by magnetic resonance imaging that demonstrated joint damage despite a lack of clinically evident bleeding.
“Thus, targeting zero clinical bleeding events does not mean that all joint disease, dysfunction, and pain will be eliminated. This reality underscores the need for better, not just more convenient, therapies,” she concluded.
The authors reported numerous relationships with a variety of pharmaceutical companies including grants, honoraria, and participation in speakers bureaus. Dr. Kempton reported honoraria from Takeda, Spark, Octapharma, and Pfizer, and research grants from Novo Nordisk.
Rurioctocog alfa pegol prophylaxis was linked to fewer bleeding episodes in people with hemophilia A when it targeted higher levels of factor VIII (FVIII) troughs, according to a report published in Blood (2021;137[13]:1818-27).
Earlier studies demonstrated that the treatment effectively prevented bleeds with an acceptable safety profile in people with hemophilia A. The current prospective, randomized, open label PROPEL trial compared safety and efficacy of two target FVIII troughs in this population. Targeting 1%-3% and 8%-12% FVIII troughs was efficacious, with fewer bleeds in the latter arm and acceptable safety across both, according to Robert Klamroth, MD, of Vivantes Klinikum Friedrichshain, Berlin, and colleagues.
The PROPEL trial (NCT02585960) population comprised 155 patients with hepatitis A, aged 12-65 years, with severe disease and an annualized bleeding rate of at least 2 during the 12 months before enrollment in the study. All had previous FVIII treatment. Patients were randomized to 12 months’ pharmacokinetic rurioctocog alfa pegol prophylaxis targeting FVIII troughs of 1%-3% (reference arm) or 8%-12%.
The primary endpoint was absence of bleeds during the second 6-month period. A total of 95 patients completed the protocol.
Promising results
In the 1%-3% and 8%-12% arms, the proportions of patients who completed the protocol and had no bleeds were 40% and 67% respectively (P = .015). Serious adverse events occurred in 7 of 115 (6%) patients, including one treatment-related event in the 8%-12% arm. There were no deaths, serious thrombotic events, or adverse event-related discontinuations.
“Targeting 8% to 12% FVIII troughs resulted in a higher proportion of [patients] with no bleeds than prophylaxis that targeted 1% to 3% FVIII troughs. These results support the hypothesis that an elevated FVIII trough can benefit [patients]without changing the safety profile,” the researchers reported. Personalized treatment in this patient population should be considered, they added.
Problems remain
In an invited commentary, Christine L. Kempton, MD, of Emory University, Atlanta, pointed out that the study did not answer the question of what trough level is best, and that the target trough level may be up to a patient’s individual clinician to decide. “Many participants (42%) treated with the target trough level of 1% to 3% had no bleeding events during the study period, but some (38%) continued to have bleeding events despite higher target trough levels,” Dr. Kempton wrote. She added that, beyond this concern, the presence of subclinical bleeding is difficult to study and quantify, but its presence is supported in the literature by magnetic resonance imaging that demonstrated joint damage despite a lack of clinically evident bleeding.
“Thus, targeting zero clinical bleeding events does not mean that all joint disease, dysfunction, and pain will be eliminated. This reality underscores the need for better, not just more convenient, therapies,” she concluded.
The authors reported numerous relationships with a variety of pharmaceutical companies including grants, honoraria, and participation in speakers bureaus. Dr. Kempton reported honoraria from Takeda, Spark, Octapharma, and Pfizer, and research grants from Novo Nordisk.
Rurioctocog alfa pegol prophylaxis was linked to fewer bleeding episodes in people with hemophilia A when it targeted higher levels of factor VIII (FVIII) troughs, according to a report published in Blood (2021;137[13]:1818-27).
Earlier studies demonstrated that the treatment effectively prevented bleeds with an acceptable safety profile in people with hemophilia A. The current prospective, randomized, open label PROPEL trial compared safety and efficacy of two target FVIII troughs in this population. Targeting 1%-3% and 8%-12% FVIII troughs was efficacious, with fewer bleeds in the latter arm and acceptable safety across both, according to Robert Klamroth, MD, of Vivantes Klinikum Friedrichshain, Berlin, and colleagues.
The PROPEL trial (NCT02585960) population comprised 155 patients with hepatitis A, aged 12-65 years, with severe disease and an annualized bleeding rate of at least 2 during the 12 months before enrollment in the study. All had previous FVIII treatment. Patients were randomized to 12 months’ pharmacokinetic rurioctocog alfa pegol prophylaxis targeting FVIII troughs of 1%-3% (reference arm) or 8%-12%.
The primary endpoint was absence of bleeds during the second 6-month period. A total of 95 patients completed the protocol.
Promising results
In the 1%-3% and 8%-12% arms, the proportions of patients who completed the protocol and had no bleeds were 40% and 67% respectively (P = .015). Serious adverse events occurred in 7 of 115 (6%) patients, including one treatment-related event in the 8%-12% arm. There were no deaths, serious thrombotic events, or adverse event-related discontinuations.
“Targeting 8% to 12% FVIII troughs resulted in a higher proportion of [patients] with no bleeds than prophylaxis that targeted 1% to 3% FVIII troughs. These results support the hypothesis that an elevated FVIII trough can benefit [patients]without changing the safety profile,” the researchers reported. Personalized treatment in this patient population should be considered, they added.
Problems remain
In an invited commentary, Christine L. Kempton, MD, of Emory University, Atlanta, pointed out that the study did not answer the question of what trough level is best, and that the target trough level may be up to a patient’s individual clinician to decide. “Many participants (42%) treated with the target trough level of 1% to 3% had no bleeding events during the study period, but some (38%) continued to have bleeding events despite higher target trough levels,” Dr. Kempton wrote. She added that, beyond this concern, the presence of subclinical bleeding is difficult to study and quantify, but its presence is supported in the literature by magnetic resonance imaging that demonstrated joint damage despite a lack of clinically evident bleeding.
“Thus, targeting zero clinical bleeding events does not mean that all joint disease, dysfunction, and pain will be eliminated. This reality underscores the need for better, not just more convenient, therapies,” she concluded.
The authors reported numerous relationships with a variety of pharmaceutical companies including grants, honoraria, and participation in speakers bureaus. Dr. Kempton reported honoraria from Takeda, Spark, Octapharma, and Pfizer, and research grants from Novo Nordisk.
FROM BLOOD
Single subcutaneous shot offers fast, potent platelet inhibition in STEMI
A subcutaneous dose of the second-generation glycoprotein IIb/IIIa inhibitor RUC-4 achieved rapid dose-dependent platelet inhibition in patients with ST-segment elevation MI (STEMI) undergoing stenting in the CEL-02 study.
Platelet inhibition occurred within 15 minutes among the 27 patients, and wore off rapidly, with almost 50% of platelet function recovered within 122 minutes.
The drug was well tolerated, with no thrombocytopenia in the first 72 hours after administration, one injection-site reaction, and two major bleeds likely caused by catheter-based trauma to the proximal radial artery, reported Jurrien ten Berg, MD, PhD, St. Antonius Hospital, Nieuwegein, the Netherlands.
The results were reported during the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR 2021) and published simultaneously in EuroIntervention.
Dr. ten Berg noted that there is a need for drugs like RUC-4 in the early treatment of STEMI because oral P2Y12 inhibitors have a “seriously delayed” onset by about 2-4 hours. Prehospital use of the glycoprotein inhibitor (GPI) tirofiban was shown to improve reperfusion and late outcomes in the ON-TIME 2 trial, but GPIs require continuous intravenous administration and are associated with thrombocytopenia.
“Since RUC-4 is unique among small-molecule GPI in not inducing the receptor to undergo a major conformational change that has been implicated in the development of thrombocytopenia, it is possible that RUC-4 may be associated with fewer episodes of thrombocytopenia than current GPI,” the authors wrote.
RUC-4, also called zalunfiban, can be delivered with a single subcutaneous dose and, in a phase 1 study, demonstrated platelet inhibition within 15 minutes and was well tolerated up to a dose of 0.075 mg/kg among healthy volunteers and patients with stable coronary artery disease on aspirin.
In the CEL-02 study, 27 STEMI patients received a weight-adjusted subcutaneous injection of RUC-4 before primary percutaneous coronary intervention (PCI) in escalating doses of 0.075 mg/kg, 0.090 mg/kg, and 0.110 mg/kg. Patients were given standard treatment in the ambulance, which included aspirin (93%), ticagrelor (93%), and unfractionated heparin (96%). The activated clotting time was less than 200 seconds in 92% of patients who received additional heparin during cardiac catheterization.
The patients’ mean age was 62 years, 26% were women, and 96% were White. Pharmacodynamic data were available for 24 patients.
The average platelet inhibition 15 minutes after the injection was 77.5%, 87.5%, and 91.7%, respectively, for the three escalating doses (P = .002 for trend).
The primary endpoint of at least 77% inhibition of the iso-TRAP channel – which corresponds to 80% inhibition of light transmission aggregometry stimulated by 20 mcM adenosine diphosphate within 15 minutes – was achieved in three of eight patients at the lowest dose and in seven of eight patients at the middle and highest doses.
“Single-dose subcutaneous RUC-4 induces a fast, potent dose-dependent response of platelet inhibition in patients with STEMI presenting for primary PCI,” Dr. ten Berg concluded. “It is therefore promising for prehospital platelet inhibition in STEMI patients, and the results support further research on clinical benefit.”
The double-blind, randomized phase 2b CELEBRATE trial is underway, evaluating 1,668 STEMI patients treated with a 0.110 mg/kg or 0.130 mg/kg dose of RUC-4 or placebo in the ambulance. The coprimary outcomes are restoration of coronary artery blood flow and resolution of ST-segment deviation post-PCI/angiography. Primary completion is set for March 2023.
Marco Valgimigli, MD, who was not involved in the study, said in an interview that RUC-4 has “some theoretical advantages, compared with conventional IIb/IIIa inhibitors, namely the absence of thrombocytopenia which is, however, relatively rare, especially with tirofiban or eptifibatide.”
The subcutaneous approach may also offer an advantage. Yet, if the administration of RUC-4 is “to happen in the ambulance – a setting where an IV line is usually established – whether the subcutaneous versus IV administration of the treatment proves to be advantageous remains to be seen,” said Dr. Valgimigli, from Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland.
“We would need to see the results of large randomized trials embracing this treatment option before a clinical decision can be made, especially considering that IIb/IIa inhibitors in the ambulance have been tested in the past but ultimately abandoned,” he said.
Limitations of the study are its open-label design, the fact that iso-TRAP channel assay data were not reported by the VeryifyNow instrument and had to be calculated from the raw data, and the fact that the timing of the RUC-4 injection immediately before PCI does not fully resemble the expected use of RUC-4 in clinical practice, where RUC-4 would be administered at the same time as the aspirin, ticagrelor, and heparin, and about an hour before PCI, ten Berg and colleagues wrote.
CeleCor Therapeutics sponsored the study and provided study materials. Dr. ten Berg reported receiving lecture or consultancy fees from AstraZeneca, Eli Lilly, Daiichi Sankyo, The Medicines Company, AccuMetrics, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Bayer, Ferrer, and Idorsia, and institutional research grants from ZonMw and AstraZeneca. Coauthor Barry S. Coller is an inventor of RUC-4 and a founder, equity holder, and consultant to CeleCor. He also receives royalties from Centocor/Janssen and the VerifyNow assays. Dr. Valgimigli has received grants from Abbott, Terumo, Medicure, and AstraZeneca, and personal fees from Abbott, Chiesi, Bayer, Daiichi Sankyo, Amgen, Terumo, Alvimedica, AstraZeneca, Biosensors, and Idorsia.
A version of this article first appeared on Medscape.com.
A subcutaneous dose of the second-generation glycoprotein IIb/IIIa inhibitor RUC-4 achieved rapid dose-dependent platelet inhibition in patients with ST-segment elevation MI (STEMI) undergoing stenting in the CEL-02 study.
Platelet inhibition occurred within 15 minutes among the 27 patients, and wore off rapidly, with almost 50% of platelet function recovered within 122 minutes.
The drug was well tolerated, with no thrombocytopenia in the first 72 hours after administration, one injection-site reaction, and two major bleeds likely caused by catheter-based trauma to the proximal radial artery, reported Jurrien ten Berg, MD, PhD, St. Antonius Hospital, Nieuwegein, the Netherlands.
The results were reported during the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR 2021) and published simultaneously in EuroIntervention.
Dr. ten Berg noted that there is a need for drugs like RUC-4 in the early treatment of STEMI because oral P2Y12 inhibitors have a “seriously delayed” onset by about 2-4 hours. Prehospital use of the glycoprotein inhibitor (GPI) tirofiban was shown to improve reperfusion and late outcomes in the ON-TIME 2 trial, but GPIs require continuous intravenous administration and are associated with thrombocytopenia.
“Since RUC-4 is unique among small-molecule GPI in not inducing the receptor to undergo a major conformational change that has been implicated in the development of thrombocytopenia, it is possible that RUC-4 may be associated with fewer episodes of thrombocytopenia than current GPI,” the authors wrote.
RUC-4, also called zalunfiban, can be delivered with a single subcutaneous dose and, in a phase 1 study, demonstrated platelet inhibition within 15 minutes and was well tolerated up to a dose of 0.075 mg/kg among healthy volunteers and patients with stable coronary artery disease on aspirin.
In the CEL-02 study, 27 STEMI patients received a weight-adjusted subcutaneous injection of RUC-4 before primary percutaneous coronary intervention (PCI) in escalating doses of 0.075 mg/kg, 0.090 mg/kg, and 0.110 mg/kg. Patients were given standard treatment in the ambulance, which included aspirin (93%), ticagrelor (93%), and unfractionated heparin (96%). The activated clotting time was less than 200 seconds in 92% of patients who received additional heparin during cardiac catheterization.
The patients’ mean age was 62 years, 26% were women, and 96% were White. Pharmacodynamic data were available for 24 patients.
The average platelet inhibition 15 minutes after the injection was 77.5%, 87.5%, and 91.7%, respectively, for the three escalating doses (P = .002 for trend).
The primary endpoint of at least 77% inhibition of the iso-TRAP channel – which corresponds to 80% inhibition of light transmission aggregometry stimulated by 20 mcM adenosine diphosphate within 15 minutes – was achieved in three of eight patients at the lowest dose and in seven of eight patients at the middle and highest doses.
“Single-dose subcutaneous RUC-4 induces a fast, potent dose-dependent response of platelet inhibition in patients with STEMI presenting for primary PCI,” Dr. ten Berg concluded. “It is therefore promising for prehospital platelet inhibition in STEMI patients, and the results support further research on clinical benefit.”
The double-blind, randomized phase 2b CELEBRATE trial is underway, evaluating 1,668 STEMI patients treated with a 0.110 mg/kg or 0.130 mg/kg dose of RUC-4 or placebo in the ambulance. The coprimary outcomes are restoration of coronary artery blood flow and resolution of ST-segment deviation post-PCI/angiography. Primary completion is set for March 2023.
Marco Valgimigli, MD, who was not involved in the study, said in an interview that RUC-4 has “some theoretical advantages, compared with conventional IIb/IIIa inhibitors, namely the absence of thrombocytopenia which is, however, relatively rare, especially with tirofiban or eptifibatide.”
The subcutaneous approach may also offer an advantage. Yet, if the administration of RUC-4 is “to happen in the ambulance – a setting where an IV line is usually established – whether the subcutaneous versus IV administration of the treatment proves to be advantageous remains to be seen,” said Dr. Valgimigli, from Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland.
“We would need to see the results of large randomized trials embracing this treatment option before a clinical decision can be made, especially considering that IIb/IIa inhibitors in the ambulance have been tested in the past but ultimately abandoned,” he said.
Limitations of the study are its open-label design, the fact that iso-TRAP channel assay data were not reported by the VeryifyNow instrument and had to be calculated from the raw data, and the fact that the timing of the RUC-4 injection immediately before PCI does not fully resemble the expected use of RUC-4 in clinical practice, where RUC-4 would be administered at the same time as the aspirin, ticagrelor, and heparin, and about an hour before PCI, ten Berg and colleagues wrote.
CeleCor Therapeutics sponsored the study and provided study materials. Dr. ten Berg reported receiving lecture or consultancy fees from AstraZeneca, Eli Lilly, Daiichi Sankyo, The Medicines Company, AccuMetrics, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Bayer, Ferrer, and Idorsia, and institutional research grants from ZonMw and AstraZeneca. Coauthor Barry S. Coller is an inventor of RUC-4 and a founder, equity holder, and consultant to CeleCor. He also receives royalties from Centocor/Janssen and the VerifyNow assays. Dr. Valgimigli has received grants from Abbott, Terumo, Medicure, and AstraZeneca, and personal fees from Abbott, Chiesi, Bayer, Daiichi Sankyo, Amgen, Terumo, Alvimedica, AstraZeneca, Biosensors, and Idorsia.
A version of this article first appeared on Medscape.com.
A subcutaneous dose of the second-generation glycoprotein IIb/IIIa inhibitor RUC-4 achieved rapid dose-dependent platelet inhibition in patients with ST-segment elevation MI (STEMI) undergoing stenting in the CEL-02 study.
Platelet inhibition occurred within 15 minutes among the 27 patients, and wore off rapidly, with almost 50% of platelet function recovered within 122 minutes.
The drug was well tolerated, with no thrombocytopenia in the first 72 hours after administration, one injection-site reaction, and two major bleeds likely caused by catheter-based trauma to the proximal radial artery, reported Jurrien ten Berg, MD, PhD, St. Antonius Hospital, Nieuwegein, the Netherlands.
The results were reported during the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR 2021) and published simultaneously in EuroIntervention.
Dr. ten Berg noted that there is a need for drugs like RUC-4 in the early treatment of STEMI because oral P2Y12 inhibitors have a “seriously delayed” onset by about 2-4 hours. Prehospital use of the glycoprotein inhibitor (GPI) tirofiban was shown to improve reperfusion and late outcomes in the ON-TIME 2 trial, but GPIs require continuous intravenous administration and are associated with thrombocytopenia.
“Since RUC-4 is unique among small-molecule GPI in not inducing the receptor to undergo a major conformational change that has been implicated in the development of thrombocytopenia, it is possible that RUC-4 may be associated with fewer episodes of thrombocytopenia than current GPI,” the authors wrote.
RUC-4, also called zalunfiban, can be delivered with a single subcutaneous dose and, in a phase 1 study, demonstrated platelet inhibition within 15 minutes and was well tolerated up to a dose of 0.075 mg/kg among healthy volunteers and patients with stable coronary artery disease on aspirin.
In the CEL-02 study, 27 STEMI patients received a weight-adjusted subcutaneous injection of RUC-4 before primary percutaneous coronary intervention (PCI) in escalating doses of 0.075 mg/kg, 0.090 mg/kg, and 0.110 mg/kg. Patients were given standard treatment in the ambulance, which included aspirin (93%), ticagrelor (93%), and unfractionated heparin (96%). The activated clotting time was less than 200 seconds in 92% of patients who received additional heparin during cardiac catheterization.
The patients’ mean age was 62 years, 26% were women, and 96% were White. Pharmacodynamic data were available for 24 patients.
The average platelet inhibition 15 minutes after the injection was 77.5%, 87.5%, and 91.7%, respectively, for the three escalating doses (P = .002 for trend).
The primary endpoint of at least 77% inhibition of the iso-TRAP channel – which corresponds to 80% inhibition of light transmission aggregometry stimulated by 20 mcM adenosine diphosphate within 15 minutes – was achieved in three of eight patients at the lowest dose and in seven of eight patients at the middle and highest doses.
“Single-dose subcutaneous RUC-4 induces a fast, potent dose-dependent response of platelet inhibition in patients with STEMI presenting for primary PCI,” Dr. ten Berg concluded. “It is therefore promising for prehospital platelet inhibition in STEMI patients, and the results support further research on clinical benefit.”
The double-blind, randomized phase 2b CELEBRATE trial is underway, evaluating 1,668 STEMI patients treated with a 0.110 mg/kg or 0.130 mg/kg dose of RUC-4 or placebo in the ambulance. The coprimary outcomes are restoration of coronary artery blood flow and resolution of ST-segment deviation post-PCI/angiography. Primary completion is set for March 2023.
Marco Valgimigli, MD, who was not involved in the study, said in an interview that RUC-4 has “some theoretical advantages, compared with conventional IIb/IIIa inhibitors, namely the absence of thrombocytopenia which is, however, relatively rare, especially with tirofiban or eptifibatide.”
The subcutaneous approach may also offer an advantage. Yet, if the administration of RUC-4 is “to happen in the ambulance – a setting where an IV line is usually established – whether the subcutaneous versus IV administration of the treatment proves to be advantageous remains to be seen,” said Dr. Valgimigli, from Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland.
“We would need to see the results of large randomized trials embracing this treatment option before a clinical decision can be made, especially considering that IIb/IIa inhibitors in the ambulance have been tested in the past but ultimately abandoned,” he said.
Limitations of the study are its open-label design, the fact that iso-TRAP channel assay data were not reported by the VeryifyNow instrument and had to be calculated from the raw data, and the fact that the timing of the RUC-4 injection immediately before PCI does not fully resemble the expected use of RUC-4 in clinical practice, where RUC-4 would be administered at the same time as the aspirin, ticagrelor, and heparin, and about an hour before PCI, ten Berg and colleagues wrote.
CeleCor Therapeutics sponsored the study and provided study materials. Dr. ten Berg reported receiving lecture or consultancy fees from AstraZeneca, Eli Lilly, Daiichi Sankyo, The Medicines Company, AccuMetrics, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Bayer, Ferrer, and Idorsia, and institutional research grants from ZonMw and AstraZeneca. Coauthor Barry S. Coller is an inventor of RUC-4 and a founder, equity holder, and consultant to CeleCor. He also receives royalties from Centocor/Janssen and the VerifyNow assays. Dr. Valgimigli has received grants from Abbott, Terumo, Medicure, and AstraZeneca, and personal fees from Abbott, Chiesi, Bayer, Daiichi Sankyo, Amgen, Terumo, Alvimedica, AstraZeneca, Biosensors, and Idorsia.
A version of this article first appeared on Medscape.com.
Venetoclax shows activity against T-ALL in children
Data from a small retrospective study suggest that venetoclax-based regimens may have activity against relapsed or refractory T-lineage acute lymphoblastic leukemia (T-ALL) in children and young adults.
Among seven patients with T-ALL treated with venetoclax (Venclexta) in combination with chemotherapy, four had complete remissions and one had a CR with incomplete recovery of blood counts (CRi), and all four patients had undetectable minimal residual disease (MRD), reported pediatric hematology/oncology fellow Amber Gibson, MD, and colleagues from the University of Texas MD Anderson Cancer Center Children’s Cancer Hospital in Houston.
“This single-institution retrospective review found that venetoclax was safe and well tolerated in combination chemotherapy regimens, thrombocytopenia and neutropenia were the most common toxicities identified, [and] venetoclax should be considered for patients with refractory T-cell ALL and investigated as up-front therapy for this patient population,” they wrote in the abstract accompanying a poster presentation at the annual meeting of the American Society of Pediatric Hematology/Oncology.
Children with relapsed T-ALL and T-lymphoblastic lymphoma (T-LL) have a dismal prognosis, with a 3-year event-free survival rate less than 10%, according to the researchers.
To see whether venetoclax, an inhibitor of the antiapoptotic protein B-cell lymphoma-2 (BCL-2), could improve outcomes for children with ALL, the investigators conducted a retrospective chart review of the safety and efficacy of venetoclax in young patients with relapsed/refractory ALL/LL who received the drug at their center.
They identified 10 patients aged 6-21 years (median, 18), 5 of whom had T-ALL (1 with early T-cell precursor ALL), 2 with T-LL, and 3 with B-lineage ALL (B-ALL).
The median number of prior lines of therapy was 3.5. Three of the 10 patients had received hematopoietic stem cell transplants, and the 3 patients with B-ALL had all received prior CD19-directed chimeric antigen receptor T-cell (CAR T) therapy. One of these patients received a dual CD19/CD22 CAR T product, one received CD19-directed blinotumumab.
There were no new safety signals with venetoclax, no treatment-related deaths, and no deaths within 30 days of starting venetoclax.
All 10 patients had grade 4 thrombocytopenias, 6 had grade 4 neutropenia, 3 had grade 4 febrile neutropenia, 2 had grade 4 anemia, and 1 each had grade 4 sepsis, pneumonia, or coagulopathy.
As noted, there were three CRs and one CRi, all in patients with T-ALL. All four of these patients were MRD negative by flow cytometry at a median of 22 days. The median duration of response was 17.4 months (range, 2-18 months).
At the most recent follow-up five patients were still alive, three without disease, one was still undergoing treatment, and one was alive following an allogeneic HSCT.
Early studies
Shilpa Shahani, MD, a pediatric oncologist and assistant clinical professor of pediatrics at City of Hope in Duarte, Calif., who was not involved in the study, said that there are early studies exploring the use of venetoclax in infants with ALL.
“Venetoclax is a BCL-2 inhibitor that is pretty well tolerated, but you can also have cytopenias with it,” she said.
She noted that it is not typically used in the frontline setting in pediatric populations, but may be considered for patients with difficult-to-treat disease or for whom the relatively good toxicity profile might be appropriate.
The MD Anderson investigators did not report a funding source. The authors and Dr. Shahani reported no relevant conflicts of interest.
Data from a small retrospective study suggest that venetoclax-based regimens may have activity against relapsed or refractory T-lineage acute lymphoblastic leukemia (T-ALL) in children and young adults.
Among seven patients with T-ALL treated with venetoclax (Venclexta) in combination with chemotherapy, four had complete remissions and one had a CR with incomplete recovery of blood counts (CRi), and all four patients had undetectable minimal residual disease (MRD), reported pediatric hematology/oncology fellow Amber Gibson, MD, and colleagues from the University of Texas MD Anderson Cancer Center Children’s Cancer Hospital in Houston.
“This single-institution retrospective review found that venetoclax was safe and well tolerated in combination chemotherapy regimens, thrombocytopenia and neutropenia were the most common toxicities identified, [and] venetoclax should be considered for patients with refractory T-cell ALL and investigated as up-front therapy for this patient population,” they wrote in the abstract accompanying a poster presentation at the annual meeting of the American Society of Pediatric Hematology/Oncology.
Children with relapsed T-ALL and T-lymphoblastic lymphoma (T-LL) have a dismal prognosis, with a 3-year event-free survival rate less than 10%, according to the researchers.
To see whether venetoclax, an inhibitor of the antiapoptotic protein B-cell lymphoma-2 (BCL-2), could improve outcomes for children with ALL, the investigators conducted a retrospective chart review of the safety and efficacy of venetoclax in young patients with relapsed/refractory ALL/LL who received the drug at their center.
They identified 10 patients aged 6-21 years (median, 18), 5 of whom had T-ALL (1 with early T-cell precursor ALL), 2 with T-LL, and 3 with B-lineage ALL (B-ALL).
The median number of prior lines of therapy was 3.5. Three of the 10 patients had received hematopoietic stem cell transplants, and the 3 patients with B-ALL had all received prior CD19-directed chimeric antigen receptor T-cell (CAR T) therapy. One of these patients received a dual CD19/CD22 CAR T product, one received CD19-directed blinotumumab.
There were no new safety signals with venetoclax, no treatment-related deaths, and no deaths within 30 days of starting venetoclax.
All 10 patients had grade 4 thrombocytopenias, 6 had grade 4 neutropenia, 3 had grade 4 febrile neutropenia, 2 had grade 4 anemia, and 1 each had grade 4 sepsis, pneumonia, or coagulopathy.
As noted, there were three CRs and one CRi, all in patients with T-ALL. All four of these patients were MRD negative by flow cytometry at a median of 22 days. The median duration of response was 17.4 months (range, 2-18 months).
At the most recent follow-up five patients were still alive, three without disease, one was still undergoing treatment, and one was alive following an allogeneic HSCT.
Early studies
Shilpa Shahani, MD, a pediatric oncologist and assistant clinical professor of pediatrics at City of Hope in Duarte, Calif., who was not involved in the study, said that there are early studies exploring the use of venetoclax in infants with ALL.
“Venetoclax is a BCL-2 inhibitor that is pretty well tolerated, but you can also have cytopenias with it,” she said.
She noted that it is not typically used in the frontline setting in pediatric populations, but may be considered for patients with difficult-to-treat disease or for whom the relatively good toxicity profile might be appropriate.
The MD Anderson investigators did not report a funding source. The authors and Dr. Shahani reported no relevant conflicts of interest.
Data from a small retrospective study suggest that venetoclax-based regimens may have activity against relapsed or refractory T-lineage acute lymphoblastic leukemia (T-ALL) in children and young adults.
Among seven patients with T-ALL treated with venetoclax (Venclexta) in combination with chemotherapy, four had complete remissions and one had a CR with incomplete recovery of blood counts (CRi), and all four patients had undetectable minimal residual disease (MRD), reported pediatric hematology/oncology fellow Amber Gibson, MD, and colleagues from the University of Texas MD Anderson Cancer Center Children’s Cancer Hospital in Houston.
“This single-institution retrospective review found that venetoclax was safe and well tolerated in combination chemotherapy regimens, thrombocytopenia and neutropenia were the most common toxicities identified, [and] venetoclax should be considered for patients with refractory T-cell ALL and investigated as up-front therapy for this patient population,” they wrote in the abstract accompanying a poster presentation at the annual meeting of the American Society of Pediatric Hematology/Oncology.
Children with relapsed T-ALL and T-lymphoblastic lymphoma (T-LL) have a dismal prognosis, with a 3-year event-free survival rate less than 10%, according to the researchers.
To see whether venetoclax, an inhibitor of the antiapoptotic protein B-cell lymphoma-2 (BCL-2), could improve outcomes for children with ALL, the investigators conducted a retrospective chart review of the safety and efficacy of venetoclax in young patients with relapsed/refractory ALL/LL who received the drug at their center.
They identified 10 patients aged 6-21 years (median, 18), 5 of whom had T-ALL (1 with early T-cell precursor ALL), 2 with T-LL, and 3 with B-lineage ALL (B-ALL).
The median number of prior lines of therapy was 3.5. Three of the 10 patients had received hematopoietic stem cell transplants, and the 3 patients with B-ALL had all received prior CD19-directed chimeric antigen receptor T-cell (CAR T) therapy. One of these patients received a dual CD19/CD22 CAR T product, one received CD19-directed blinotumumab.
There were no new safety signals with venetoclax, no treatment-related deaths, and no deaths within 30 days of starting venetoclax.
All 10 patients had grade 4 thrombocytopenias, 6 had grade 4 neutropenia, 3 had grade 4 febrile neutropenia, 2 had grade 4 anemia, and 1 each had grade 4 sepsis, pneumonia, or coagulopathy.
As noted, there were three CRs and one CRi, all in patients with T-ALL. All four of these patients were MRD negative by flow cytometry at a median of 22 days. The median duration of response was 17.4 months (range, 2-18 months).
At the most recent follow-up five patients were still alive, three without disease, one was still undergoing treatment, and one was alive following an allogeneic HSCT.
Early studies
Shilpa Shahani, MD, a pediatric oncologist and assistant clinical professor of pediatrics at City of Hope in Duarte, Calif., who was not involved in the study, said that there are early studies exploring the use of venetoclax in infants with ALL.
“Venetoclax is a BCL-2 inhibitor that is pretty well tolerated, but you can also have cytopenias with it,” she said.
She noted that it is not typically used in the frontline setting in pediatric populations, but may be considered for patients with difficult-to-treat disease or for whom the relatively good toxicity profile might be appropriate.
The MD Anderson investigators did not report a funding source. The authors and Dr. Shahani reported no relevant conflicts of interest.
FROM ASPHO 2021
Poloxamer 188 disappoints for painful SCD vaso-occlusive episodes, study showsteaser
Poloxamer 188, a nonionic block polymer surfactant reported to reduce blood viscosity and cell-cell interactions, failed to shorten painful vaso-occlusive episodes in adults and children with sickle cell disease (SCD) in a randomized, placebo-controlled, phase 3 trial.
The findings contrast with those from a prior phase 3 trial showing benefits with treatment, James F. Casella, MD, professor of pediatrics and chief of pediatric hematology at Johns Hopkins University, Baltimore, and colleagues reported.
The time from randomization to the last dose of parenteral opioids in the current study did not differ in 194 patients randomized to the active treatment and 194 randomized to a placebo group (81.8 hours with poloxamer 188 vs. 77.8 hours with placebo), the authors found.
The study results were reported online in JAMA.
Participants in the double-blind study were individuals aged 4-65 years (mean, 15.2 years) with acute moderate to severe painful vaso-occlusive episodes requiring hospitalization. They were recruited between May 2013 and February 2016 from 66 hospitals in 12 countries.
Adverse events that were more common in the poloxamer 188 group included hyperbilirubinemia, which occurred in 12.7% of patients versus 5.2% in the placebo group. Hypoxia occurred more often in the placebo group (12.0% vs. 5.3%).
“Poloxamer 188 has been evaluated in three clinical trials of SCD demonstrating safety and possible efficacy for painful vaso-occlusive episodes and acute chest syndrome, which involves intrapulmonary vascular occlusion and/or infection,” the authors noted. “These studies included a previous phase 3 trial that suggested efficacy for painful vaso-occlusive episodes, particularly in children and participants receiving hydroxyurea.”
The mean duration of vaso-occlusive crisis was reduced by 8.8 hours overall, by 21 hours in those aged under 16 years, and by 16 hours in those receiving hydroxyurea. A small, nonsignificant difference was also seen in the incidence of acute chest syndrome for children in that study.
The findings were encouraging given the lack of disease-modifying therapies for ongoing painful vaso-occlusive episodes, which are associated with higher mortality in patients with SCD; although three agents are available for the prevention vaso-occlusive episodes, including hydroxyurea, L-glutamine, and crizanlizumab-tmca, no available agent effectively manages vaso-occlusive episodes once they have begun, the authors noted.
Current treatment therefore remains supportive, with analgesia and hydration, they added.
This is concerning since “acute pain is estimated to account for 95% of hospital admissions for those with SCD, creating a burden for individuals with SCD, their families, and health care systems,” they explained, adding that the ability to reduce the severity and duration of vaso-occlusive episodes would be a significant advance.
“Because intravenous poloxamer 188 is neither approved by the Food and Drug Administration nor available for clinical use and because other drugs for managing ongoing vaso-occlusive episodes are absent, the present trial was designed to determine whether poloxamer 188 is efficacious for painful vaso-occlusive episodes in SCD,” they said.
However, no benefit was seen for episode duration with treatment in the current study, nor was any beneficial effect on acute chest syndrome observed.
“Rather, although not statistically significant, there were more participants younger than 16 years who developed acute chest syndrome in the poloxamer 188 group than in the placebo group, paralleling the direction of effects on the primary outcome for participants younger than 16 years [in the current study],” they wrote, adding that there were also “no apparent effects on readmission for painful vaso-occlusive episodes in participants receiving hydroxyurea, despite the known effect of hydroxyurea in reducing rates of painful vaso-occlusive episodes and acute chest syndrome.”
Though limited by subjective aspects of assessing the primary outcome in this study and by challenges with effectively blinding poloxamer 188 use, the current findings do not support the use of poloxamer 188 for vaso-occlusive episodes, they concluded.
In an accompanying editorial, JAMA deputy editor Jody Zylke, MD, suggested that the most likely explanation for the differing conclusions in the current and prior phase 3 trials relates to the choice of primary outcome.
In the prior study, the primary outcome was time from randomization to crisis resolution.
“The resolution of pain is subjective, and the criteria to determine crisis resolution established by the investigators were extremely stringent and difficult to implement, leading to a high proportion of participants with incomplete documentation,” Dr. Zylke noted. “Also, incomplete documentation occurred more often in the placebo group than the intervention group, resulting in more imputation of missing values for the placebo group, which favored the poloxamer 188 group.”
In the current trial, a “more easily verified primary outcome was selected, with data available for 99% of participants.”
The report by Dr. Casella and colleagues “adds to the evidence base and illustrates some of the challenges in finding effective treatments for patients with sickle cell disease,” he said.
This study was funded by Mast Therapeutics (previously Adventrx Therapeutics). Dr. Casella reported receiving grants from Mast Therapeutics and receiving an honorarium, travel expenses, and salary support through Johns Hopkins for providing consultative advice to Mast Pharmaceuticals during development of the clinical trial and for serving as the principal investigator for the clinical trial; being an inventor and a named party on a patent and licensing agreement to ImmunArray through Johns Hopkins for a panel of brain biomarkers for the detection of brain injury; and holding a patent for aptamers as a potential treatment for sickle cell disease. Dr. Zylke reported having no disclosures.
Poloxamer 188, a nonionic block polymer surfactant reported to reduce blood viscosity and cell-cell interactions, failed to shorten painful vaso-occlusive episodes in adults and children with sickle cell disease (SCD) in a randomized, placebo-controlled, phase 3 trial.
The findings contrast with those from a prior phase 3 trial showing benefits with treatment, James F. Casella, MD, professor of pediatrics and chief of pediatric hematology at Johns Hopkins University, Baltimore, and colleagues reported.
The time from randomization to the last dose of parenteral opioids in the current study did not differ in 194 patients randomized to the active treatment and 194 randomized to a placebo group (81.8 hours with poloxamer 188 vs. 77.8 hours with placebo), the authors found.
The study results were reported online in JAMA.
Participants in the double-blind study were individuals aged 4-65 years (mean, 15.2 years) with acute moderate to severe painful vaso-occlusive episodes requiring hospitalization. They were recruited between May 2013 and February 2016 from 66 hospitals in 12 countries.
Adverse events that were more common in the poloxamer 188 group included hyperbilirubinemia, which occurred in 12.7% of patients versus 5.2% in the placebo group. Hypoxia occurred more often in the placebo group (12.0% vs. 5.3%).
“Poloxamer 188 has been evaluated in three clinical trials of SCD demonstrating safety and possible efficacy for painful vaso-occlusive episodes and acute chest syndrome, which involves intrapulmonary vascular occlusion and/or infection,” the authors noted. “These studies included a previous phase 3 trial that suggested efficacy for painful vaso-occlusive episodes, particularly in children and participants receiving hydroxyurea.”
The mean duration of vaso-occlusive crisis was reduced by 8.8 hours overall, by 21 hours in those aged under 16 years, and by 16 hours in those receiving hydroxyurea. A small, nonsignificant difference was also seen in the incidence of acute chest syndrome for children in that study.
The findings were encouraging given the lack of disease-modifying therapies for ongoing painful vaso-occlusive episodes, which are associated with higher mortality in patients with SCD; although three agents are available for the prevention vaso-occlusive episodes, including hydroxyurea, L-glutamine, and crizanlizumab-tmca, no available agent effectively manages vaso-occlusive episodes once they have begun, the authors noted.
Current treatment therefore remains supportive, with analgesia and hydration, they added.
This is concerning since “acute pain is estimated to account for 95% of hospital admissions for those with SCD, creating a burden for individuals with SCD, their families, and health care systems,” they explained, adding that the ability to reduce the severity and duration of vaso-occlusive episodes would be a significant advance.
“Because intravenous poloxamer 188 is neither approved by the Food and Drug Administration nor available for clinical use and because other drugs for managing ongoing vaso-occlusive episodes are absent, the present trial was designed to determine whether poloxamer 188 is efficacious for painful vaso-occlusive episodes in SCD,” they said.
However, no benefit was seen for episode duration with treatment in the current study, nor was any beneficial effect on acute chest syndrome observed.
“Rather, although not statistically significant, there were more participants younger than 16 years who developed acute chest syndrome in the poloxamer 188 group than in the placebo group, paralleling the direction of effects on the primary outcome for participants younger than 16 years [in the current study],” they wrote, adding that there were also “no apparent effects on readmission for painful vaso-occlusive episodes in participants receiving hydroxyurea, despite the known effect of hydroxyurea in reducing rates of painful vaso-occlusive episodes and acute chest syndrome.”
Though limited by subjective aspects of assessing the primary outcome in this study and by challenges with effectively blinding poloxamer 188 use, the current findings do not support the use of poloxamer 188 for vaso-occlusive episodes, they concluded.
In an accompanying editorial, JAMA deputy editor Jody Zylke, MD, suggested that the most likely explanation for the differing conclusions in the current and prior phase 3 trials relates to the choice of primary outcome.
In the prior study, the primary outcome was time from randomization to crisis resolution.
“The resolution of pain is subjective, and the criteria to determine crisis resolution established by the investigators were extremely stringent and difficult to implement, leading to a high proportion of participants with incomplete documentation,” Dr. Zylke noted. “Also, incomplete documentation occurred more often in the placebo group than the intervention group, resulting in more imputation of missing values for the placebo group, which favored the poloxamer 188 group.”
In the current trial, a “more easily verified primary outcome was selected, with data available for 99% of participants.”
The report by Dr. Casella and colleagues “adds to the evidence base and illustrates some of the challenges in finding effective treatments for patients with sickle cell disease,” he said.
This study was funded by Mast Therapeutics (previously Adventrx Therapeutics). Dr. Casella reported receiving grants from Mast Therapeutics and receiving an honorarium, travel expenses, and salary support through Johns Hopkins for providing consultative advice to Mast Pharmaceuticals during development of the clinical trial and for serving as the principal investigator for the clinical trial; being an inventor and a named party on a patent and licensing agreement to ImmunArray through Johns Hopkins for a panel of brain biomarkers for the detection of brain injury; and holding a patent for aptamers as a potential treatment for sickle cell disease. Dr. Zylke reported having no disclosures.
Poloxamer 188, a nonionic block polymer surfactant reported to reduce blood viscosity and cell-cell interactions, failed to shorten painful vaso-occlusive episodes in adults and children with sickle cell disease (SCD) in a randomized, placebo-controlled, phase 3 trial.
The findings contrast with those from a prior phase 3 trial showing benefits with treatment, James F. Casella, MD, professor of pediatrics and chief of pediatric hematology at Johns Hopkins University, Baltimore, and colleagues reported.
The time from randomization to the last dose of parenteral opioids in the current study did not differ in 194 patients randomized to the active treatment and 194 randomized to a placebo group (81.8 hours with poloxamer 188 vs. 77.8 hours with placebo), the authors found.
The study results were reported online in JAMA.
Participants in the double-blind study were individuals aged 4-65 years (mean, 15.2 years) with acute moderate to severe painful vaso-occlusive episodes requiring hospitalization. They were recruited between May 2013 and February 2016 from 66 hospitals in 12 countries.
Adverse events that were more common in the poloxamer 188 group included hyperbilirubinemia, which occurred in 12.7% of patients versus 5.2% in the placebo group. Hypoxia occurred more often in the placebo group (12.0% vs. 5.3%).
“Poloxamer 188 has been evaluated in three clinical trials of SCD demonstrating safety and possible efficacy for painful vaso-occlusive episodes and acute chest syndrome, which involves intrapulmonary vascular occlusion and/or infection,” the authors noted. “These studies included a previous phase 3 trial that suggested efficacy for painful vaso-occlusive episodes, particularly in children and participants receiving hydroxyurea.”
The mean duration of vaso-occlusive crisis was reduced by 8.8 hours overall, by 21 hours in those aged under 16 years, and by 16 hours in those receiving hydroxyurea. A small, nonsignificant difference was also seen in the incidence of acute chest syndrome for children in that study.
The findings were encouraging given the lack of disease-modifying therapies for ongoing painful vaso-occlusive episodes, which are associated with higher mortality in patients with SCD; although three agents are available for the prevention vaso-occlusive episodes, including hydroxyurea, L-glutamine, and crizanlizumab-tmca, no available agent effectively manages vaso-occlusive episodes once they have begun, the authors noted.
Current treatment therefore remains supportive, with analgesia and hydration, they added.
This is concerning since “acute pain is estimated to account for 95% of hospital admissions for those with SCD, creating a burden for individuals with SCD, their families, and health care systems,” they explained, adding that the ability to reduce the severity and duration of vaso-occlusive episodes would be a significant advance.
“Because intravenous poloxamer 188 is neither approved by the Food and Drug Administration nor available for clinical use and because other drugs for managing ongoing vaso-occlusive episodes are absent, the present trial was designed to determine whether poloxamer 188 is efficacious for painful vaso-occlusive episodes in SCD,” they said.
However, no benefit was seen for episode duration with treatment in the current study, nor was any beneficial effect on acute chest syndrome observed.
“Rather, although not statistically significant, there were more participants younger than 16 years who developed acute chest syndrome in the poloxamer 188 group than in the placebo group, paralleling the direction of effects on the primary outcome for participants younger than 16 years [in the current study],” they wrote, adding that there were also “no apparent effects on readmission for painful vaso-occlusive episodes in participants receiving hydroxyurea, despite the known effect of hydroxyurea in reducing rates of painful vaso-occlusive episodes and acute chest syndrome.”
Though limited by subjective aspects of assessing the primary outcome in this study and by challenges with effectively blinding poloxamer 188 use, the current findings do not support the use of poloxamer 188 for vaso-occlusive episodes, they concluded.
In an accompanying editorial, JAMA deputy editor Jody Zylke, MD, suggested that the most likely explanation for the differing conclusions in the current and prior phase 3 trials relates to the choice of primary outcome.
In the prior study, the primary outcome was time from randomization to crisis resolution.
“The resolution of pain is subjective, and the criteria to determine crisis resolution established by the investigators were extremely stringent and difficult to implement, leading to a high proportion of participants with incomplete documentation,” Dr. Zylke noted. “Also, incomplete documentation occurred more often in the placebo group than the intervention group, resulting in more imputation of missing values for the placebo group, which favored the poloxamer 188 group.”
In the current trial, a “more easily verified primary outcome was selected, with data available for 99% of participants.”
The report by Dr. Casella and colleagues “adds to the evidence base and illustrates some of the challenges in finding effective treatments for patients with sickle cell disease,” he said.
This study was funded by Mast Therapeutics (previously Adventrx Therapeutics). Dr. Casella reported receiving grants from Mast Therapeutics and receiving an honorarium, travel expenses, and salary support through Johns Hopkins for providing consultative advice to Mast Pharmaceuticals during development of the clinical trial and for serving as the principal investigator for the clinical trial; being an inventor and a named party on a patent and licensing agreement to ImmunArray through Johns Hopkins for a panel of brain biomarkers for the detection of brain injury; and holding a patent for aptamers as a potential treatment for sickle cell disease. Dr. Zylke reported having no disclosures.
FROM JAMA
Bill seeks to streamline prior authorization in Medicare Advantage plans
A group of bipartisan lawmakers intends to compel insurers to streamline prior authorization processes for Medicare Advantage plans, including a bid to end the use of faxes and develop systems that can allow for real-time decisions.
Rep. Suzan DelBene (D-Wash.); Rep. Mike Kelly (R-Pa.); Rep. Ami Bera, MD (D-Calif.); and Rep. Larry Bucshon, MD, (R-Ind.) on May 13 introduced a bill that would task federal officials with refining standards regarding prior authorization for Medicare Advantage. Titled the Improving Seniors’ Timely Access to Care Act of 2021, the bill would direct the Department of Health & Human Services to create rules intended to make prior authorization more transparent and speedy for the insurer-run Medicare plans. Known as Medicare Advantage, these plans cover about 24.1 million people of the 62 million enrolled in the giant federal health program, according to the nonprofit Kaiser Family Foundation.
These revamped prior authorization systems could not rely on faxes nor could they employ proprietary payer portals that did not meet HHS’ standards, says the text of the bill released by Rep. DelBene. Insurers would also have to report to the Centers for Medicare & Medicaid Services about the extent of their use of prior authorization and the rate of approvals or denials. The bill seeks to encourage plans to adopt prior authorization programs that adhere to evidence-based medical guidelines in consultation with physicians.
There were several reasons for focusing on Medicare Advantage plans, although prior authorization concerns extend more broadly in the U.S. health care system, said Susan Bailey, MD, president of the American Medical Association.
There’s an ample body of research about issues seen in the Medicare Advantage plans. Dr. Bailey also said that, in her experience, Medicare Advantage plans have had some of the most restrictive policies. And, by starting with Medicare Advantage, there’s a potential for a ripple effect in the industry, easing this issue when physicians work with other insurers as well.
“When Medicare adopts a policy whether it be a payment policy or a coverage policy, private insurers typically follow along,” she said.
Strong support among health care groups
There’s strong support for streamlining prior authorization both in the medical community and in Congress.
The bill has the support of about 70 health care organizations, including the AMA and the American Academy of Family Physicians, according to its sponsors. As of May 17, the bill had attracted the backing of 97 members of the House of Representatives, roughly evenly split among Democrats and Republicans.
Rep. DelBene’s previous version of this bill, the Improving Seniors’ Timely Access to Care Act of 2019, attracted 143 Democratic cosponsors and 137 Republican ones, or more than half of the members of the House. This bill was not completed during the previous session of Congress (January 2019–January 2021) because of the more urgent needs of pandemic response, said Rep. Bucshon, who practiced cardiothoracic surgery before joining Congress.
“It wasn’t quite on the radar as much as it might have been if we didn’t have COVID,” Rep. Bucshon said.
Rep. Bucshon added that he expects strong Senate support for a companion measure of the House bill, which could make the difference for efforts to pass it this year.
Insurers have become more aggressive over time in denying payments through prior authorization systems for services that physicians say their patients need, according to Rep. Bucshon. There may be some “bad actors” in medicine who would order unnecessary procedures, Rep. Bucshon allowed, but in most cases, the cumbersome prior authorization processes only put a hurdle for patients seeking needed treatments, he said.
“The premise is that it controls health care costs but actually what it does is it helps insurance company’s bottom line,” Rep. Bucshon said.
In a prepared statement, former Pennsylvania representative Allyson Y. Schwartz, now CEO of the Better Medicare Alliance, said her group had spoken with sponsors of this legislation and appreciates “their receptiveness to feedback in this process.”
“Prior authorization ensures beneficiaries receive clinically appropriate care and reduces exposures to duplicative and unnecessary services,” Ms. Schwartz said. “We share an interest in ensuring prior authorization works as smoothly and effectively as possible for beneficiaries while protecting its essential function of facilitating safe, evidenced-based care.”
The Better Medicare Alliance said its funders include UnitedHealth, Humana, and CVS Health/Aetna, which run Advantage plans. The group also lists as its partners many medical organizations.
“Rationing care by hassling”
Like Rep. Bucshon, Dr. Bailey sees a different motivation in insurers’ persistence in keeping the prior authorization process cumbersome.
Phone calls and faxes remain the key methods for handling prior authorization for medical services, according to the results of a survey done by the AMA in December. Phone calls were always or often required for prior authorization for medical services (59%), with faxes the second-most common approach (46%), followed by health plans’ online portals (39%), electronic health records and practice management systems (29%), and email or U.S. mail (26%), according to the AMA’s report on the survey.
“It seems like every step in the process is designed to make the patient less likely to get the therapy that the doctor thinks that the patient needs,” Dr. Bailey said. “It’s almost like rationing care by hassling the patient and the physician.”
The findings of an investigation by HHS’ internal watchdog unit appear to support Dr. Bailey’s view, showing that insurer-run Medicare plans had a pattern of often walking back their initial rejections.
In 2018, the Office of the Inspector General for HHS reported that Medicare Advantage organizations (MAOs) overturned 75% of their own denials during 2014-16. In addition, independent reviewers within the appeals process overturned additional denials in favor of patients and clinicians, OIG said.
“The high number of overturned denials raises concerns that some Medicare Advantage beneficiaries and providers were initially denied services and payments that should have been provided,” the OIG said in the report. “This is especially concerning because beneficiaries and providers rarely used the appeals process, which is designed to ensure access to care and payment.”
During 2014-2016, patients and clinicians appealed only 1% of denials to the first level of appeal, OIG said. In the report, the watchdog group noted that CMS audits had highlighted “widespread and persistent MAO performance problems related to denials of care and payment.” In 2015, for example, CMS cited 56% of audited contracts for making inappropriate denials.
Dr. Bailey also said in an interview that she routinely encounters problems with prior authorization in her own practice as an allergist and immunologist in Fort Worth, Tex.
In late May, for example, a Medicare Advantage plan made a patient whose chronic asthma had been stable for years change to a new inhaler that resulted in him developing a yeast infection in his mouth, Dr. Bailey said.
“We treated the yeast infection, made some changes in the way he uses his inhaler, so hopefully he would tolerate it better,” Dr. Bailey said. “He had a reaction to the medication to treat the yeast infection and ended up in the hospital. How is that helping anyone? It certainly hasn’t helped my patient.”
Dr. Bailey said insurers have also asked to seek prior authorization to prescribe medications that have been generic for years and have used the process to challenge her on cases of what seem to be common sense in medical practice. This included a bid to have Dr. Bailey prescribe a medication in pill form for a 6-month-old baby who had no teeth.
“Every doctor has got absurd stories like that, but unfortunately, every doctor is going to have tragic stories where prior authorization has resulted in death and harm to the patients,” Dr. Bailey said.
Some physicians leave it to the patient to try to overcome insurers’ decisions on prior authorization, seeing this task as falling outside of their duties, Dr. Bailey said.
“I don’t do that. I fight. I spend a lot of time fighting. I don’t like to lose. I don’t like my patients to lose, so I will go to the mat for them,” Dr. Bailey said. “But I’m blessed to be in a specialty where I’ve got loads more control over my schedule than many other specialties do.”
A version of this article first appeared on Medscape.com.
A group of bipartisan lawmakers intends to compel insurers to streamline prior authorization processes for Medicare Advantage plans, including a bid to end the use of faxes and develop systems that can allow for real-time decisions.
Rep. Suzan DelBene (D-Wash.); Rep. Mike Kelly (R-Pa.); Rep. Ami Bera, MD (D-Calif.); and Rep. Larry Bucshon, MD, (R-Ind.) on May 13 introduced a bill that would task federal officials with refining standards regarding prior authorization for Medicare Advantage. Titled the Improving Seniors’ Timely Access to Care Act of 2021, the bill would direct the Department of Health & Human Services to create rules intended to make prior authorization more transparent and speedy for the insurer-run Medicare plans. Known as Medicare Advantage, these plans cover about 24.1 million people of the 62 million enrolled in the giant federal health program, according to the nonprofit Kaiser Family Foundation.
These revamped prior authorization systems could not rely on faxes nor could they employ proprietary payer portals that did not meet HHS’ standards, says the text of the bill released by Rep. DelBene. Insurers would also have to report to the Centers for Medicare & Medicaid Services about the extent of their use of prior authorization and the rate of approvals or denials. The bill seeks to encourage plans to adopt prior authorization programs that adhere to evidence-based medical guidelines in consultation with physicians.
There were several reasons for focusing on Medicare Advantage plans, although prior authorization concerns extend more broadly in the U.S. health care system, said Susan Bailey, MD, president of the American Medical Association.
There’s an ample body of research about issues seen in the Medicare Advantage plans. Dr. Bailey also said that, in her experience, Medicare Advantage plans have had some of the most restrictive policies. And, by starting with Medicare Advantage, there’s a potential for a ripple effect in the industry, easing this issue when physicians work with other insurers as well.
“When Medicare adopts a policy whether it be a payment policy or a coverage policy, private insurers typically follow along,” she said.
Strong support among health care groups
There’s strong support for streamlining prior authorization both in the medical community and in Congress.
The bill has the support of about 70 health care organizations, including the AMA and the American Academy of Family Physicians, according to its sponsors. As of May 17, the bill had attracted the backing of 97 members of the House of Representatives, roughly evenly split among Democrats and Republicans.
Rep. DelBene’s previous version of this bill, the Improving Seniors’ Timely Access to Care Act of 2019, attracted 143 Democratic cosponsors and 137 Republican ones, or more than half of the members of the House. This bill was not completed during the previous session of Congress (January 2019–January 2021) because of the more urgent needs of pandemic response, said Rep. Bucshon, who practiced cardiothoracic surgery before joining Congress.
“It wasn’t quite on the radar as much as it might have been if we didn’t have COVID,” Rep. Bucshon said.
Rep. Bucshon added that he expects strong Senate support for a companion measure of the House bill, which could make the difference for efforts to pass it this year.
Insurers have become more aggressive over time in denying payments through prior authorization systems for services that physicians say their patients need, according to Rep. Bucshon. There may be some “bad actors” in medicine who would order unnecessary procedures, Rep. Bucshon allowed, but in most cases, the cumbersome prior authorization processes only put a hurdle for patients seeking needed treatments, he said.
“The premise is that it controls health care costs but actually what it does is it helps insurance company’s bottom line,” Rep. Bucshon said.
In a prepared statement, former Pennsylvania representative Allyson Y. Schwartz, now CEO of the Better Medicare Alliance, said her group had spoken with sponsors of this legislation and appreciates “their receptiveness to feedback in this process.”
“Prior authorization ensures beneficiaries receive clinically appropriate care and reduces exposures to duplicative and unnecessary services,” Ms. Schwartz said. “We share an interest in ensuring prior authorization works as smoothly and effectively as possible for beneficiaries while protecting its essential function of facilitating safe, evidenced-based care.”
The Better Medicare Alliance said its funders include UnitedHealth, Humana, and CVS Health/Aetna, which run Advantage plans. The group also lists as its partners many medical organizations.
“Rationing care by hassling”
Like Rep. Bucshon, Dr. Bailey sees a different motivation in insurers’ persistence in keeping the prior authorization process cumbersome.
Phone calls and faxes remain the key methods for handling prior authorization for medical services, according to the results of a survey done by the AMA in December. Phone calls were always or often required for prior authorization for medical services (59%), with faxes the second-most common approach (46%), followed by health plans’ online portals (39%), electronic health records and practice management systems (29%), and email or U.S. mail (26%), according to the AMA’s report on the survey.
“It seems like every step in the process is designed to make the patient less likely to get the therapy that the doctor thinks that the patient needs,” Dr. Bailey said. “It’s almost like rationing care by hassling the patient and the physician.”
The findings of an investigation by HHS’ internal watchdog unit appear to support Dr. Bailey’s view, showing that insurer-run Medicare plans had a pattern of often walking back their initial rejections.
In 2018, the Office of the Inspector General for HHS reported that Medicare Advantage organizations (MAOs) overturned 75% of their own denials during 2014-16. In addition, independent reviewers within the appeals process overturned additional denials in favor of patients and clinicians, OIG said.
“The high number of overturned denials raises concerns that some Medicare Advantage beneficiaries and providers were initially denied services and payments that should have been provided,” the OIG said in the report. “This is especially concerning because beneficiaries and providers rarely used the appeals process, which is designed to ensure access to care and payment.”
During 2014-2016, patients and clinicians appealed only 1% of denials to the first level of appeal, OIG said. In the report, the watchdog group noted that CMS audits had highlighted “widespread and persistent MAO performance problems related to denials of care and payment.” In 2015, for example, CMS cited 56% of audited contracts for making inappropriate denials.
Dr. Bailey also said in an interview that she routinely encounters problems with prior authorization in her own practice as an allergist and immunologist in Fort Worth, Tex.
In late May, for example, a Medicare Advantage plan made a patient whose chronic asthma had been stable for years change to a new inhaler that resulted in him developing a yeast infection in his mouth, Dr. Bailey said.
“We treated the yeast infection, made some changes in the way he uses his inhaler, so hopefully he would tolerate it better,” Dr. Bailey said. “He had a reaction to the medication to treat the yeast infection and ended up in the hospital. How is that helping anyone? It certainly hasn’t helped my patient.”
Dr. Bailey said insurers have also asked to seek prior authorization to prescribe medications that have been generic for years and have used the process to challenge her on cases of what seem to be common sense in medical practice. This included a bid to have Dr. Bailey prescribe a medication in pill form for a 6-month-old baby who had no teeth.
“Every doctor has got absurd stories like that, but unfortunately, every doctor is going to have tragic stories where prior authorization has resulted in death and harm to the patients,” Dr. Bailey said.
Some physicians leave it to the patient to try to overcome insurers’ decisions on prior authorization, seeing this task as falling outside of their duties, Dr. Bailey said.
“I don’t do that. I fight. I spend a lot of time fighting. I don’t like to lose. I don’t like my patients to lose, so I will go to the mat for them,” Dr. Bailey said. “But I’m blessed to be in a specialty where I’ve got loads more control over my schedule than many other specialties do.”
A version of this article first appeared on Medscape.com.
A group of bipartisan lawmakers intends to compel insurers to streamline prior authorization processes for Medicare Advantage plans, including a bid to end the use of faxes and develop systems that can allow for real-time decisions.
Rep. Suzan DelBene (D-Wash.); Rep. Mike Kelly (R-Pa.); Rep. Ami Bera, MD (D-Calif.); and Rep. Larry Bucshon, MD, (R-Ind.) on May 13 introduced a bill that would task federal officials with refining standards regarding prior authorization for Medicare Advantage. Titled the Improving Seniors’ Timely Access to Care Act of 2021, the bill would direct the Department of Health & Human Services to create rules intended to make prior authorization more transparent and speedy for the insurer-run Medicare plans. Known as Medicare Advantage, these plans cover about 24.1 million people of the 62 million enrolled in the giant federal health program, according to the nonprofit Kaiser Family Foundation.
These revamped prior authorization systems could not rely on faxes nor could they employ proprietary payer portals that did not meet HHS’ standards, says the text of the bill released by Rep. DelBene. Insurers would also have to report to the Centers for Medicare & Medicaid Services about the extent of their use of prior authorization and the rate of approvals or denials. The bill seeks to encourage plans to adopt prior authorization programs that adhere to evidence-based medical guidelines in consultation with physicians.
There were several reasons for focusing on Medicare Advantage plans, although prior authorization concerns extend more broadly in the U.S. health care system, said Susan Bailey, MD, president of the American Medical Association.
There’s an ample body of research about issues seen in the Medicare Advantage plans. Dr. Bailey also said that, in her experience, Medicare Advantage plans have had some of the most restrictive policies. And, by starting with Medicare Advantage, there’s a potential for a ripple effect in the industry, easing this issue when physicians work with other insurers as well.
“When Medicare adopts a policy whether it be a payment policy or a coverage policy, private insurers typically follow along,” she said.
Strong support among health care groups
There’s strong support for streamlining prior authorization both in the medical community and in Congress.
The bill has the support of about 70 health care organizations, including the AMA and the American Academy of Family Physicians, according to its sponsors. As of May 17, the bill had attracted the backing of 97 members of the House of Representatives, roughly evenly split among Democrats and Republicans.
Rep. DelBene’s previous version of this bill, the Improving Seniors’ Timely Access to Care Act of 2019, attracted 143 Democratic cosponsors and 137 Republican ones, or more than half of the members of the House. This bill was not completed during the previous session of Congress (January 2019–January 2021) because of the more urgent needs of pandemic response, said Rep. Bucshon, who practiced cardiothoracic surgery before joining Congress.
“It wasn’t quite on the radar as much as it might have been if we didn’t have COVID,” Rep. Bucshon said.
Rep. Bucshon added that he expects strong Senate support for a companion measure of the House bill, which could make the difference for efforts to pass it this year.
Insurers have become more aggressive over time in denying payments through prior authorization systems for services that physicians say their patients need, according to Rep. Bucshon. There may be some “bad actors” in medicine who would order unnecessary procedures, Rep. Bucshon allowed, but in most cases, the cumbersome prior authorization processes only put a hurdle for patients seeking needed treatments, he said.
“The premise is that it controls health care costs but actually what it does is it helps insurance company’s bottom line,” Rep. Bucshon said.
In a prepared statement, former Pennsylvania representative Allyson Y. Schwartz, now CEO of the Better Medicare Alliance, said her group had spoken with sponsors of this legislation and appreciates “their receptiveness to feedback in this process.”
“Prior authorization ensures beneficiaries receive clinically appropriate care and reduces exposures to duplicative and unnecessary services,” Ms. Schwartz said. “We share an interest in ensuring prior authorization works as smoothly and effectively as possible for beneficiaries while protecting its essential function of facilitating safe, evidenced-based care.”
The Better Medicare Alliance said its funders include UnitedHealth, Humana, and CVS Health/Aetna, which run Advantage plans. The group also lists as its partners many medical organizations.
“Rationing care by hassling”
Like Rep. Bucshon, Dr. Bailey sees a different motivation in insurers’ persistence in keeping the prior authorization process cumbersome.
Phone calls and faxes remain the key methods for handling prior authorization for medical services, according to the results of a survey done by the AMA in December. Phone calls were always or often required for prior authorization for medical services (59%), with faxes the second-most common approach (46%), followed by health plans’ online portals (39%), electronic health records and practice management systems (29%), and email or U.S. mail (26%), according to the AMA’s report on the survey.
“It seems like every step in the process is designed to make the patient less likely to get the therapy that the doctor thinks that the patient needs,” Dr. Bailey said. “It’s almost like rationing care by hassling the patient and the physician.”
The findings of an investigation by HHS’ internal watchdog unit appear to support Dr. Bailey’s view, showing that insurer-run Medicare plans had a pattern of often walking back their initial rejections.
In 2018, the Office of the Inspector General for HHS reported that Medicare Advantage organizations (MAOs) overturned 75% of their own denials during 2014-16. In addition, independent reviewers within the appeals process overturned additional denials in favor of patients and clinicians, OIG said.
“The high number of overturned denials raises concerns that some Medicare Advantage beneficiaries and providers were initially denied services and payments that should have been provided,” the OIG said in the report. “This is especially concerning because beneficiaries and providers rarely used the appeals process, which is designed to ensure access to care and payment.”
During 2014-2016, patients and clinicians appealed only 1% of denials to the first level of appeal, OIG said. In the report, the watchdog group noted that CMS audits had highlighted “widespread and persistent MAO performance problems related to denials of care and payment.” In 2015, for example, CMS cited 56% of audited contracts for making inappropriate denials.
Dr. Bailey also said in an interview that she routinely encounters problems with prior authorization in her own practice as an allergist and immunologist in Fort Worth, Tex.
In late May, for example, a Medicare Advantage plan made a patient whose chronic asthma had been stable for years change to a new inhaler that resulted in him developing a yeast infection in his mouth, Dr. Bailey said.
“We treated the yeast infection, made some changes in the way he uses his inhaler, so hopefully he would tolerate it better,” Dr. Bailey said. “He had a reaction to the medication to treat the yeast infection and ended up in the hospital. How is that helping anyone? It certainly hasn’t helped my patient.”
Dr. Bailey said insurers have also asked to seek prior authorization to prescribe medications that have been generic for years and have used the process to challenge her on cases of what seem to be common sense in medical practice. This included a bid to have Dr. Bailey prescribe a medication in pill form for a 6-month-old baby who had no teeth.
“Every doctor has got absurd stories like that, but unfortunately, every doctor is going to have tragic stories where prior authorization has resulted in death and harm to the patients,” Dr. Bailey said.
Some physicians leave it to the patient to try to overcome insurers’ decisions on prior authorization, seeing this task as falling outside of their duties, Dr. Bailey said.
“I don’t do that. I fight. I spend a lot of time fighting. I don’t like to lose. I don’t like my patients to lose, so I will go to the mat for them,” Dr. Bailey said. “But I’m blessed to be in a specialty where I’ve got loads more control over my schedule than many other specialties do.”
A version of this article first appeared on Medscape.com.
New AHA/ASA guideline on secondary stroke prevention
When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.
“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.
“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.
The updated guideline was published online May 24, 2021, in Stroke.
“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.
The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
Let pathogenic subtype guide prevention
For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.
Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.
“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.
For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.
Among the recommendations:
- Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
- Screen for and initiate anticoagulant drug therapy to reduce recurrent events.
- Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
- Consider or carotid artery stenting for select patients with narrowing of carotid arteries.
- Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
- In some patients, it’s reasonable to consider percutaneous closure of .
The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.
“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.
The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.
“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.
“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.
The updated guideline was published online May 24, 2021, in Stroke.
“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.
The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
Let pathogenic subtype guide prevention
For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.
Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.
“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.
For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.
Among the recommendations:
- Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
- Screen for and initiate anticoagulant drug therapy to reduce recurrent events.
- Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
- Consider or carotid artery stenting for select patients with narrowing of carotid arteries.
- Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
- In some patients, it’s reasonable to consider percutaneous closure of .
The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.
“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.
The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.
“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.
“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.
The updated guideline was published online May 24, 2021, in Stroke.
“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.
The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
Let pathogenic subtype guide prevention
For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.
Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.
“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.
For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.
Among the recommendations:
- Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
- Screen for and initiate anticoagulant drug therapy to reduce recurrent events.
- Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
- Consider or carotid artery stenting for select patients with narrowing of carotid arteries.
- Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
- In some patients, it’s reasonable to consider percutaneous closure of .
The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.
“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.
The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.
The research had no commercial funding.
A version of this article first appeared on Medscape.com.
Large vessel stroke linked to AstraZeneca COVID vaccine
The three cases (one of which was fatal) occurred in two women and one man in their 30s or 40s and involved blockages of the carotid and middle cerebral artery. Two of the three patients also had venous thrombosis involving the portal and cerebral venous system. All three also had extremely low platelet counts, confirmed antibodies to platelet factor 4, and raised D-dimer levels, all characteristic of the vaccine-induced immune thrombotic thrombocytopenia (VITT) reaction associated with the AstraZeneca vaccine.
They are described in detail in a letter published online on May 25 in the Journal of Neurology, Neurosurgery & Psychiatry
“These are [the] first detailed reports of arterial stroke believed to be caused by VITT after the AstraZeneca COVID vaccine, although stroke has been mentioned previously in the VITT data,” said senior author David Werring, PhD, FRCP.
“VITT has more commonly presented as CVST [Cerebral venous sinus thrombosis] which is stroke caused by a venous thrombosis; these cases are showing that it can also cause stroke caused by an arterial thrombosis,” explained Dr. Werring, professor of clinical neurology at the Stroke Research Centre, University College London.
“In patients who present with ischemic stroke, especially younger patients, and who have had the AstraZeneca vaccine within the past month, clinicians need to consider VITT as a possible cause, as there is a specific treatment needed for this syndrome,” he said.
Young patients presenting with ischemic stroke after receiving the AstraZeneca vaccine should urgently be evaluated for VITT with laboratory tests, including platelet count, D-dimers, fibrinogen, and anti-PF4 antibodies, the authors wrote, and then managed by a multidisciplinary team, including hematology, neurology, stroke, neurosurgery, and neuroradiology, for rapid access to treatments including intravenous immune globulin, methylprednisolone, plasmapheresis, and nonheparin anticoagulants such as fondaparinux, argatroban, or direct oral anticoagulants.
Dr. Werring noted that these reports do not add anything to the overall risk/benefit of the vaccine, as they are only describing three cases. “While VITT is very serious, the benefit of the vaccine still outweighs its risks,” he said. “Around 40% of patients hospitalized with COVID-19 experience some sort of thrombosis and about 1.5% have an ischemic stroke. Whereas latest figures from the U.K. estimate the incidence of VITT with the AstraZeneca vaccine of 1 in 50,000 to 1 in 100,000.
“Our report doesn’t suggest that VITT is more common than these latest figures estimate, but we are just drawing attention to an alternative presentation,” he added.
Three cases
The first patient in the current case series, a woman in her 30s, experienced an intermittent headache on the right side and around her eyes 6 days after the vaccine. Five days later, she awoke feeling drowsy and with weakness to her left face, arm, and leg.
Imaging revealed a blocked right middle cerebral artery with brain infarction and clots in the right portal vein. She underwent brain surgery to reduce the pressure in her skull, plasma removal and replacement, and received the anticoagulant fondaparinux, but she still unfortunately died.
The second patient, a woman in her late 30s, presented with headache, confusion, weakness in her left arm, and loss of vision on the left side 12 days after having received the vaccine. Imaging showed occlusion of both carotid arteries, as well as pulmonary embolism and a left cerebral venous sinus thrombosis.
Her platelet count increased following plasma removal and replacement and intravenous corticosteroids, and her condition improved after fondaparinux treatment.
The third patient, a man in his early 40s, presented 3 weeks after receiving his vaccination with problems speaking. Imaging showed a clot in the left middle cerebral artery, but there was no evidence of clots in the cerebral venous sinuses. He received a platelet and plasma transfusion, and fondaparinux, and remains stable.
High index of suspicion required
In a linked commentary, Hugh Markus, PhD, FRCP, professor of stroke medicine at the University of Cambridge, United Kingdom, wrote: “This report emphasizes that the immune mediated coagulopathy can also cause arterial thrombosis, including ischemic stroke, although venous thrombosis and especially cerebral venous sinus thrombosis appear more frequent.
“During the current period of COVID vaccination, a high index of suspicion is required to identify thrombotic episodes following vaccination,” he added. “However, it is important to remember that these side effects are rare and much less common than both cerebral venous thrombosis and ischemic stroke associated with COVID-19 infection itself.”
Risk/benefit unaltered
Several experts who commented on these reports for the Science Media Centre all agreed with Dr. Werring and Dr. Markus that these reports do not alter the current risk/benefit estimates with the vaccine.
Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, who sits on the U.K.’s Medicines and Healthcare Products Regulatory Agency’s Pharmacovigilance Expert Advisory Group, said: “The picture regarding the rare syndrome of blood clots combined with low platelet counts associated with the AstraZeneca vaccine is becoming clearer. Until now, the cases described have tended to involve clots in veins such as cerebral vein thrombosis. In this series of three case reports, we now have some evidence that the types of blood vessels affected include arteries as well as veins.”
“It’s important to stress that such cases remain very rare, and it’s certainly much rarer in people who have had the AstraZeneca vaccine than it is in people affected by COVID-19 itself,” Dr. Douglas emphasized.
“The description of the cases suggests the patients involved presented with the same kind of symptoms as already described in cases involving cerebral vein thrombosis, and they don’t suggest patients need to be on the alert for anything different,” he added.
“However, the emergence of details like this will help guide health professionals who may be faced with similar cases in future; the sooner such cases are recognized, the more chance they will quickly receive the right kind of treatment, hopefully leading to better outcomes.”
Will Lester, MBChB, PhD, consultant hematologist, University Hospitals Birmingham NHS Foundation Trust, said: “VITT remains a rare complication, and patients with a history of thrombosis, including stroke, should not consider themselves to be at any higher risk of this type of rare thrombosis after vaccination, and COVID infection itself is a significant risk for stroke and other types of thrombosis.”
Many countries have paused use of the AstraZeneca vaccine because of its link to the VITT syndrome or restricted its use to older people as the VITT reaction appears to be slightly more common in younger people. In the United Kingdom, the current recommendation is that individuals under 40 years of age should be offered an alternative to the AstraZeneca vaccine where possible.
A version of this article first appeared on Medscape.com.
The three cases (one of which was fatal) occurred in two women and one man in their 30s or 40s and involved blockages of the carotid and middle cerebral artery. Two of the three patients also had venous thrombosis involving the portal and cerebral venous system. All three also had extremely low platelet counts, confirmed antibodies to platelet factor 4, and raised D-dimer levels, all characteristic of the vaccine-induced immune thrombotic thrombocytopenia (VITT) reaction associated with the AstraZeneca vaccine.
They are described in detail in a letter published online on May 25 in the Journal of Neurology, Neurosurgery & Psychiatry
“These are [the] first detailed reports of arterial stroke believed to be caused by VITT after the AstraZeneca COVID vaccine, although stroke has been mentioned previously in the VITT data,” said senior author David Werring, PhD, FRCP.
“VITT has more commonly presented as CVST [Cerebral venous sinus thrombosis] which is stroke caused by a venous thrombosis; these cases are showing that it can also cause stroke caused by an arterial thrombosis,” explained Dr. Werring, professor of clinical neurology at the Stroke Research Centre, University College London.
“In patients who present with ischemic stroke, especially younger patients, and who have had the AstraZeneca vaccine within the past month, clinicians need to consider VITT as a possible cause, as there is a specific treatment needed for this syndrome,” he said.
Young patients presenting with ischemic stroke after receiving the AstraZeneca vaccine should urgently be evaluated for VITT with laboratory tests, including platelet count, D-dimers, fibrinogen, and anti-PF4 antibodies, the authors wrote, and then managed by a multidisciplinary team, including hematology, neurology, stroke, neurosurgery, and neuroradiology, for rapid access to treatments including intravenous immune globulin, methylprednisolone, plasmapheresis, and nonheparin anticoagulants such as fondaparinux, argatroban, or direct oral anticoagulants.
Dr. Werring noted that these reports do not add anything to the overall risk/benefit of the vaccine, as they are only describing three cases. “While VITT is very serious, the benefit of the vaccine still outweighs its risks,” he said. “Around 40% of patients hospitalized with COVID-19 experience some sort of thrombosis and about 1.5% have an ischemic stroke. Whereas latest figures from the U.K. estimate the incidence of VITT with the AstraZeneca vaccine of 1 in 50,000 to 1 in 100,000.
“Our report doesn’t suggest that VITT is more common than these latest figures estimate, but we are just drawing attention to an alternative presentation,” he added.
Three cases
The first patient in the current case series, a woman in her 30s, experienced an intermittent headache on the right side and around her eyes 6 days after the vaccine. Five days later, she awoke feeling drowsy and with weakness to her left face, arm, and leg.
Imaging revealed a blocked right middle cerebral artery with brain infarction and clots in the right portal vein. She underwent brain surgery to reduce the pressure in her skull, plasma removal and replacement, and received the anticoagulant fondaparinux, but she still unfortunately died.
The second patient, a woman in her late 30s, presented with headache, confusion, weakness in her left arm, and loss of vision on the left side 12 days after having received the vaccine. Imaging showed occlusion of both carotid arteries, as well as pulmonary embolism and a left cerebral venous sinus thrombosis.
Her platelet count increased following plasma removal and replacement and intravenous corticosteroids, and her condition improved after fondaparinux treatment.
The third patient, a man in his early 40s, presented 3 weeks after receiving his vaccination with problems speaking. Imaging showed a clot in the left middle cerebral artery, but there was no evidence of clots in the cerebral venous sinuses. He received a platelet and plasma transfusion, and fondaparinux, and remains stable.
High index of suspicion required
In a linked commentary, Hugh Markus, PhD, FRCP, professor of stroke medicine at the University of Cambridge, United Kingdom, wrote: “This report emphasizes that the immune mediated coagulopathy can also cause arterial thrombosis, including ischemic stroke, although venous thrombosis and especially cerebral venous sinus thrombosis appear more frequent.
“During the current period of COVID vaccination, a high index of suspicion is required to identify thrombotic episodes following vaccination,” he added. “However, it is important to remember that these side effects are rare and much less common than both cerebral venous thrombosis and ischemic stroke associated with COVID-19 infection itself.”
Risk/benefit unaltered
Several experts who commented on these reports for the Science Media Centre all agreed with Dr. Werring and Dr. Markus that these reports do not alter the current risk/benefit estimates with the vaccine.
Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, who sits on the U.K.’s Medicines and Healthcare Products Regulatory Agency’s Pharmacovigilance Expert Advisory Group, said: “The picture regarding the rare syndrome of blood clots combined with low platelet counts associated with the AstraZeneca vaccine is becoming clearer. Until now, the cases described have tended to involve clots in veins such as cerebral vein thrombosis. In this series of three case reports, we now have some evidence that the types of blood vessels affected include arteries as well as veins.”
“It’s important to stress that such cases remain very rare, and it’s certainly much rarer in people who have had the AstraZeneca vaccine than it is in people affected by COVID-19 itself,” Dr. Douglas emphasized.
“The description of the cases suggests the patients involved presented with the same kind of symptoms as already described in cases involving cerebral vein thrombosis, and they don’t suggest patients need to be on the alert for anything different,” he added.
“However, the emergence of details like this will help guide health professionals who may be faced with similar cases in future; the sooner such cases are recognized, the more chance they will quickly receive the right kind of treatment, hopefully leading to better outcomes.”
Will Lester, MBChB, PhD, consultant hematologist, University Hospitals Birmingham NHS Foundation Trust, said: “VITT remains a rare complication, and patients with a history of thrombosis, including stroke, should not consider themselves to be at any higher risk of this type of rare thrombosis after vaccination, and COVID infection itself is a significant risk for stroke and other types of thrombosis.”
Many countries have paused use of the AstraZeneca vaccine because of its link to the VITT syndrome or restricted its use to older people as the VITT reaction appears to be slightly more common in younger people. In the United Kingdom, the current recommendation is that individuals under 40 years of age should be offered an alternative to the AstraZeneca vaccine where possible.
A version of this article first appeared on Medscape.com.
The three cases (one of which was fatal) occurred in two women and one man in their 30s or 40s and involved blockages of the carotid and middle cerebral artery. Two of the three patients also had venous thrombosis involving the portal and cerebral venous system. All three also had extremely low platelet counts, confirmed antibodies to platelet factor 4, and raised D-dimer levels, all characteristic of the vaccine-induced immune thrombotic thrombocytopenia (VITT) reaction associated with the AstraZeneca vaccine.
They are described in detail in a letter published online on May 25 in the Journal of Neurology, Neurosurgery & Psychiatry
“These are [the] first detailed reports of arterial stroke believed to be caused by VITT after the AstraZeneca COVID vaccine, although stroke has been mentioned previously in the VITT data,” said senior author David Werring, PhD, FRCP.
“VITT has more commonly presented as CVST [Cerebral venous sinus thrombosis] which is stroke caused by a venous thrombosis; these cases are showing that it can also cause stroke caused by an arterial thrombosis,” explained Dr. Werring, professor of clinical neurology at the Stroke Research Centre, University College London.
“In patients who present with ischemic stroke, especially younger patients, and who have had the AstraZeneca vaccine within the past month, clinicians need to consider VITT as a possible cause, as there is a specific treatment needed for this syndrome,” he said.
Young patients presenting with ischemic stroke after receiving the AstraZeneca vaccine should urgently be evaluated for VITT with laboratory tests, including platelet count, D-dimers, fibrinogen, and anti-PF4 antibodies, the authors wrote, and then managed by a multidisciplinary team, including hematology, neurology, stroke, neurosurgery, and neuroradiology, for rapid access to treatments including intravenous immune globulin, methylprednisolone, plasmapheresis, and nonheparin anticoagulants such as fondaparinux, argatroban, or direct oral anticoagulants.
Dr. Werring noted that these reports do not add anything to the overall risk/benefit of the vaccine, as they are only describing three cases. “While VITT is very serious, the benefit of the vaccine still outweighs its risks,” he said. “Around 40% of patients hospitalized with COVID-19 experience some sort of thrombosis and about 1.5% have an ischemic stroke. Whereas latest figures from the U.K. estimate the incidence of VITT with the AstraZeneca vaccine of 1 in 50,000 to 1 in 100,000.
“Our report doesn’t suggest that VITT is more common than these latest figures estimate, but we are just drawing attention to an alternative presentation,” he added.
Three cases
The first patient in the current case series, a woman in her 30s, experienced an intermittent headache on the right side and around her eyes 6 days after the vaccine. Five days later, she awoke feeling drowsy and with weakness to her left face, arm, and leg.
Imaging revealed a blocked right middle cerebral artery with brain infarction and clots in the right portal vein. She underwent brain surgery to reduce the pressure in her skull, plasma removal and replacement, and received the anticoagulant fondaparinux, but she still unfortunately died.
The second patient, a woman in her late 30s, presented with headache, confusion, weakness in her left arm, and loss of vision on the left side 12 days after having received the vaccine. Imaging showed occlusion of both carotid arteries, as well as pulmonary embolism and a left cerebral venous sinus thrombosis.
Her platelet count increased following plasma removal and replacement and intravenous corticosteroids, and her condition improved after fondaparinux treatment.
The third patient, a man in his early 40s, presented 3 weeks after receiving his vaccination with problems speaking. Imaging showed a clot in the left middle cerebral artery, but there was no evidence of clots in the cerebral venous sinuses. He received a platelet and plasma transfusion, and fondaparinux, and remains stable.
High index of suspicion required
In a linked commentary, Hugh Markus, PhD, FRCP, professor of stroke medicine at the University of Cambridge, United Kingdom, wrote: “This report emphasizes that the immune mediated coagulopathy can also cause arterial thrombosis, including ischemic stroke, although venous thrombosis and especially cerebral venous sinus thrombosis appear more frequent.
“During the current period of COVID vaccination, a high index of suspicion is required to identify thrombotic episodes following vaccination,” he added. “However, it is important to remember that these side effects are rare and much less common than both cerebral venous thrombosis and ischemic stroke associated with COVID-19 infection itself.”
Risk/benefit unaltered
Several experts who commented on these reports for the Science Media Centre all agreed with Dr. Werring and Dr. Markus that these reports do not alter the current risk/benefit estimates with the vaccine.
Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, who sits on the U.K.’s Medicines and Healthcare Products Regulatory Agency’s Pharmacovigilance Expert Advisory Group, said: “The picture regarding the rare syndrome of blood clots combined with low platelet counts associated with the AstraZeneca vaccine is becoming clearer. Until now, the cases described have tended to involve clots in veins such as cerebral vein thrombosis. In this series of three case reports, we now have some evidence that the types of blood vessels affected include arteries as well as veins.”
“It’s important to stress that such cases remain very rare, and it’s certainly much rarer in people who have had the AstraZeneca vaccine than it is in people affected by COVID-19 itself,” Dr. Douglas emphasized.
“The description of the cases suggests the patients involved presented with the same kind of symptoms as already described in cases involving cerebral vein thrombosis, and they don’t suggest patients need to be on the alert for anything different,” he added.
“However, the emergence of details like this will help guide health professionals who may be faced with similar cases in future; the sooner such cases are recognized, the more chance they will quickly receive the right kind of treatment, hopefully leading to better outcomes.”
Will Lester, MBChB, PhD, consultant hematologist, University Hospitals Birmingham NHS Foundation Trust, said: “VITT remains a rare complication, and patients with a history of thrombosis, including stroke, should not consider themselves to be at any higher risk of this type of rare thrombosis after vaccination, and COVID infection itself is a significant risk for stroke and other types of thrombosis.”
Many countries have paused use of the AstraZeneca vaccine because of its link to the VITT syndrome or restricted its use to older people as the VITT reaction appears to be slightly more common in younger people. In the United Kingdom, the current recommendation is that individuals under 40 years of age should be offered an alternative to the AstraZeneca vaccine where possible.
A version of this article first appeared on Medscape.com.
AHA reassures myocarditis rare after COVID vaccination, benefits overwhelm risks
The benefits of COVID-19 vaccination “enormously outweigh” the rare possible risk for heart-related complications, including myocarditis, the American Heart Association/American Stroke Association (ASA) says in new statement.
The message follows a Centers for Disease Control and Prevention report that the agency is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.
The “relatively few” reported cases myocarditis in adolescents or young adults have involved males more often than females, more often followed the second dose rather than the first, and were usually seen in the 4 days after vaccination, the CDC’s COVID-19 Vaccine Safety Technical Work Group (VaST) found.
“Most cases appear to be mild, and follow-up of cases is ongoing,” the CDC says. “Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates.”
In their statement, the AHA/ASA “strongly urge” all adults and children 12 years and older to receive a COVID-19 vaccine as soon as possible.
“The evidence continues to indicate that the COVID-19 vaccines are nearly 100% effective at preventing death and hospitalization due to COVID-19 infection,” the groups say.
Although the investigation of cases of myocarditis related to COVID-19 vaccination is ongoing, the AHA/ASA notes that myocarditis is typically the result of an actual viral infection, “and it is yet to be determined if these cases have any correlation to receiving a COVID-19 vaccine.”
“We’ve lost hundreds of children, and there have been thousands who have been hospitalized, thousands who developed an inflammatory syndrome, and one of the pieces of that can be myocarditis,” Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation (RWJF), said today on ABC’s Good Morning America.
Still, “from my perspective, the risk of COVID is so much greater than any theoretical risk from the vaccine,” said Dr. Besser, former acting director of the CDC.
The symptoms that can occur after COVID-19 vaccination include tiredness, headache, muscle pain, chills, fever, and nausea, reminds the AHA/ASA statement. Such symptoms would “typically appear within 24-48 hours and usually pass within 36-48 hours after receiving the vaccine.”
All health care providers should be aware of the “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation, it says.
“Health care professionals should strongly consider inquiring about the timing of any recent COVID vaccination among patients presenting with these conditions, as needed, in order to provide appropriate treatment quickly,” the statement advises.
A version of this article first appeared on Medscape.com.
The benefits of COVID-19 vaccination “enormously outweigh” the rare possible risk for heart-related complications, including myocarditis, the American Heart Association/American Stroke Association (ASA) says in new statement.
The message follows a Centers for Disease Control and Prevention report that the agency is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.
The “relatively few” reported cases myocarditis in adolescents or young adults have involved males more often than females, more often followed the second dose rather than the first, and were usually seen in the 4 days after vaccination, the CDC’s COVID-19 Vaccine Safety Technical Work Group (VaST) found.
“Most cases appear to be mild, and follow-up of cases is ongoing,” the CDC says. “Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates.”
In their statement, the AHA/ASA “strongly urge” all adults and children 12 years and older to receive a COVID-19 vaccine as soon as possible.
“The evidence continues to indicate that the COVID-19 vaccines are nearly 100% effective at preventing death and hospitalization due to COVID-19 infection,” the groups say.
Although the investigation of cases of myocarditis related to COVID-19 vaccination is ongoing, the AHA/ASA notes that myocarditis is typically the result of an actual viral infection, “and it is yet to be determined if these cases have any correlation to receiving a COVID-19 vaccine.”
“We’ve lost hundreds of children, and there have been thousands who have been hospitalized, thousands who developed an inflammatory syndrome, and one of the pieces of that can be myocarditis,” Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation (RWJF), said today on ABC’s Good Morning America.
Still, “from my perspective, the risk of COVID is so much greater than any theoretical risk from the vaccine,” said Dr. Besser, former acting director of the CDC.
The symptoms that can occur after COVID-19 vaccination include tiredness, headache, muscle pain, chills, fever, and nausea, reminds the AHA/ASA statement. Such symptoms would “typically appear within 24-48 hours and usually pass within 36-48 hours after receiving the vaccine.”
All health care providers should be aware of the “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation, it says.
“Health care professionals should strongly consider inquiring about the timing of any recent COVID vaccination among patients presenting with these conditions, as needed, in order to provide appropriate treatment quickly,” the statement advises.
A version of this article first appeared on Medscape.com.
The benefits of COVID-19 vaccination “enormously outweigh” the rare possible risk for heart-related complications, including myocarditis, the American Heart Association/American Stroke Association (ASA) says in new statement.
The message follows a Centers for Disease Control and Prevention report that the agency is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.
The “relatively few” reported cases myocarditis in adolescents or young adults have involved males more often than females, more often followed the second dose rather than the first, and were usually seen in the 4 days after vaccination, the CDC’s COVID-19 Vaccine Safety Technical Work Group (VaST) found.
“Most cases appear to be mild, and follow-up of cases is ongoing,” the CDC says. “Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates.”
In their statement, the AHA/ASA “strongly urge” all adults and children 12 years and older to receive a COVID-19 vaccine as soon as possible.
“The evidence continues to indicate that the COVID-19 vaccines are nearly 100% effective at preventing death and hospitalization due to COVID-19 infection,” the groups say.
Although the investigation of cases of myocarditis related to COVID-19 vaccination is ongoing, the AHA/ASA notes that myocarditis is typically the result of an actual viral infection, “and it is yet to be determined if these cases have any correlation to receiving a COVID-19 vaccine.”
“We’ve lost hundreds of children, and there have been thousands who have been hospitalized, thousands who developed an inflammatory syndrome, and one of the pieces of that can be myocarditis,” Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation (RWJF), said today on ABC’s Good Morning America.
Still, “from my perspective, the risk of COVID is so much greater than any theoretical risk from the vaccine,” said Dr. Besser, former acting director of the CDC.
The symptoms that can occur after COVID-19 vaccination include tiredness, headache, muscle pain, chills, fever, and nausea, reminds the AHA/ASA statement. Such symptoms would “typically appear within 24-48 hours and usually pass within 36-48 hours after receiving the vaccine.”
All health care providers should be aware of the “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation, it says.
“Health care professionals should strongly consider inquiring about the timing of any recent COVID vaccination among patients presenting with these conditions, as needed, in order to provide appropriate treatment quickly,” the statement advises.
A version of this article first appeared on Medscape.com.