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Doctor wins restraining order against CVS after prescription ban
In an Aug. 11 decision, District Court Judge William Bertelsman ordered CVS to stop refusing prescriptions written by Kendall E. Hansen, MD. Judge Bertelsman ruled that Dr. Hansen is likely to succeed in his claim that CVS barred his prescriptions without evidence that he violated any law or professional protocol. The restraining order will remain in place while Dr. Hansen’s lawsuit against CVS Pharmacy proceeds.
Ronald W. Chapman II, an attorney representing Dr. Hansen, said the order is groundbreaking and that, to his knowledge, it’s the first time a federal court has overturned a pharmacy’s decision to block a prescriber.
“We believe that CVS’ decision was based solely on algorithms they use to analyze prescriber practices and not an any individual review of patient records,” Mr. Chapman said. “In fact, we invited CVS to come out to Dr. Hansen’s practice and look at how he was treating patients and ensure things were compliant, but they refused. Instead, they had a phone call with him then cut his patients off.”
Michael DeAngelis, a spokesman for CVS, said the court’s order illustrates the proverbial rock and hard place that pharmacies are placed between in the country’s fight against the misuse of prescription opioids.
“It is alleged in many lawsuits that pharmacies fill too many opioid prescriptions and should operate programs that use data to block prescriptions written by some doctors,” Mr. DeAngelis told this news organization. “And yet other lawsuits, including this one, argue that we should not operate programs that may block prescriptions. Such contradictions are grossly unfair to the pharmacy profession.”
Mr. DeAngelis declined to comment about Dr. Hansen’s claims or specify what led CVS to refuse his prescriptions.
Dr. Hansen declined to comment for this story through his attorney.
Dr. Hansen is no stranger to the spotlight. The Northern Kentucky pain doctor made headlines in 2012 when two of his horses, Fast and Accurate, and Hansen, ran in the Kentucky Derby. In February 2019, he drew media attention when his practice, Interventional Pain Specialists in Crestview Hills, Ky., was raided by federal agents. Dr. Hansen owns and operates the facility, which serves patients in Kentucky, Ohio, and Indiana.
The search yielded no findings, and no charges were filed, according to Mr. Chapman. Scott Hardcorn, director of the Northern Kentucky Drug Strike Force, confirmed that his agency assisted in the operation but said he was unaware of the outcome and that his officers generated no reports from the investigation. A spokesperson for the Drug Enforcement Administration would not comment about the investigation and directed a reporter for this news organization to the DEA website where enforcement actions are listed. No records or actions against Dr. Hansen can be found.
The CVS complaint stems from actions taken by the pharmacy against Dr. Hansen earlier this year. In June, a pharmacy representative allegedly contacted Dr. Hansen by phone and asked him questions about his practice and his prescribing practices, according to his lawsuit filed in U.S. District Court for the Eastern District of Kentucky. During the call, the representative did not inform Dr. Hansen that any of his prescriptions were in question or were suspected of being medically unnecessary, the complaint alleges.
On July 28, 2021, CVS sent Dr. Hansen a letter announcing that its pharmacies would no longer be honoring his prescriptions. The letter, entered as an exhibit in the lawsuit, states that CVS contacted Dr. Hansen twice in 2021 about his prescribing practices, once in May and again in June.
“Despite our attempts to resolve the concerns with your controlled substance prescribing patterns, these concerns persist,” Kahra Lutkiewicz, director of CVS’ retail pharmacy professional practice, wrote in the letter. “Thus, we are writing to inform you that effective Aug. 5, 2021, CVS/pharmacy stores will no longer be able to fill prescriptions that you write for controlled substances. We take our compliance obligations very seriously, and after careful consideration, find it necessary to take this action.”
The letter does not explain the details behind CVS’ concerns.
Dr. Hansen sued CVS on Aug. 4 for tortious interference with a business relationship and defamation, among other claims. His complaint alleges that Dr. Hansen and his patients will suffer irreparable injury if the prescription decision stands. More than 250 of Dr. Hansen’s patients use CVS pharmacies for their prescriptions, and some are locked into using the pharmacy because of insurance contracts, Mr. Chapman said.
“There really is nowhere else for these patients to go,” Mr. Chapman said. “They would have to go to a new doctor and establish a new relationship, and obviously that has devastating consequences when we’re talking about people who need their medication.”
CVS has not yet issued a written response to the lawsuit. In his order, Judge Bertelsman stated that a preliminary conference was held in which all parties were represented and stated their positions to the judge.
“Plaintiffs are likely to succeed on the merits of their claims that defendant has interfered with plaintiffs’ relationships with their patients by refusing to fill prescriptions written by plaintiffs, and defendant has done so without evidence that plaintiffs have violated any law or professional protocol related to such prescriptions,” Judge Bertelsman wrote. “The balance of the hardships between the parties weighs in favor of issuing a temporary restraining order inasmuch as defendant’s actions pose a threat to plaintiffs’ professional reputation and livelihood and ... because plaintiffs’ patients’ medical care is implicated by defendant’s actions, the public interest weighs in favor of issuance of the temporary restraining order.”
Dr. Hansen is currently embroiled in several other legal battles as both a plaintiff and a defendant.
In 2019, a patient sued him for negligence and fraud for allegedly performing medically unnecessary and excessive injection therapy. The suit claims the patient was required to undergo injection therapy on a continuing basis in order to receive her narcotic pain medication, according to the lawsuit filed in Kenton Circuit Court. The complaint alleges that Dr. Hansen made false representations to the patient and to her insurers that the injections were necessary for the treatment of the patient’s chronic pain.
The federal government is not involved in the case.
The negligence lawsuit is in the discovery stage, and attorneys plan to collect Dr. Hansen’s deposition soon, said Eric Deters, a spokesman for Deters Law, a law firm based in Independence, Ky., that is representing the patient.
“The crux is that he performs unnecessary pain procedures and forces you to get an unnecessary procedure before giving you your medication,” Mr. Deters said.
However, Dr. Hansen’s and Mr. Deters’ history together includes a recent riff, according to an August 2021 lawsuit filed by Dr. Hansen against the law firm. Dr. Hansen was a former medical expert in cases for Deters and Associates, but the relationship turned sour when attorneys believed Dr. Hansen was retained as an expert in a case against their clients, according to Dr. Hansen’s suit. Dr. Hansen claims that as retribution, Deters and Associates issued a medical malpractice lawsuit against him in 2020, even though attorneys allegedly knew the statute of limitations had run out. A trial court dismissed the 2020 lawsuit against Dr. Hansen as being untimely filed. Dr. Hansen’s lawsuit alleges wrongful use of civil proceedings and requests compensatory, punitive damages and court costs from the law firm.
The law firm has faced trouble in the past. In August 2021, the Ohio Supreme Court ordered that Mr. Deters pay a $6,500 fine for engaging in the unauthorized practice of law. Mr. Deters’ Kentucky law license has been suspended since 2013 for ethics infractions, according to court records. He retired from law in 2014 and now acts as a spokesperson and office manager for the law firm. The fine resulted from legal advice given by Mr. Deters to two clients at the law firm, according to the Ohio Supreme Court decision.
As for the CVS lawsuit, an upcoming hearing will determine whether the federal court issues a permanent injunction against CVS’s actions. CVS officials have not said whether they will fight the temporary restraining order or the withdrawal of their prescription ban against Dr. Hansen.
A version of this article first appeared on Medscape.com.
In an Aug. 11 decision, District Court Judge William Bertelsman ordered CVS to stop refusing prescriptions written by Kendall E. Hansen, MD. Judge Bertelsman ruled that Dr. Hansen is likely to succeed in his claim that CVS barred his prescriptions without evidence that he violated any law or professional protocol. The restraining order will remain in place while Dr. Hansen’s lawsuit against CVS Pharmacy proceeds.
Ronald W. Chapman II, an attorney representing Dr. Hansen, said the order is groundbreaking and that, to his knowledge, it’s the first time a federal court has overturned a pharmacy’s decision to block a prescriber.
“We believe that CVS’ decision was based solely on algorithms they use to analyze prescriber practices and not an any individual review of patient records,” Mr. Chapman said. “In fact, we invited CVS to come out to Dr. Hansen’s practice and look at how he was treating patients and ensure things were compliant, but they refused. Instead, they had a phone call with him then cut his patients off.”
Michael DeAngelis, a spokesman for CVS, said the court’s order illustrates the proverbial rock and hard place that pharmacies are placed between in the country’s fight against the misuse of prescription opioids.
“It is alleged in many lawsuits that pharmacies fill too many opioid prescriptions and should operate programs that use data to block prescriptions written by some doctors,” Mr. DeAngelis told this news organization. “And yet other lawsuits, including this one, argue that we should not operate programs that may block prescriptions. Such contradictions are grossly unfair to the pharmacy profession.”
Mr. DeAngelis declined to comment about Dr. Hansen’s claims or specify what led CVS to refuse his prescriptions.
Dr. Hansen declined to comment for this story through his attorney.
Dr. Hansen is no stranger to the spotlight. The Northern Kentucky pain doctor made headlines in 2012 when two of his horses, Fast and Accurate, and Hansen, ran in the Kentucky Derby. In February 2019, he drew media attention when his practice, Interventional Pain Specialists in Crestview Hills, Ky., was raided by federal agents. Dr. Hansen owns and operates the facility, which serves patients in Kentucky, Ohio, and Indiana.
The search yielded no findings, and no charges were filed, according to Mr. Chapman. Scott Hardcorn, director of the Northern Kentucky Drug Strike Force, confirmed that his agency assisted in the operation but said he was unaware of the outcome and that his officers generated no reports from the investigation. A spokesperson for the Drug Enforcement Administration would not comment about the investigation and directed a reporter for this news organization to the DEA website where enforcement actions are listed. No records or actions against Dr. Hansen can be found.
The CVS complaint stems from actions taken by the pharmacy against Dr. Hansen earlier this year. In June, a pharmacy representative allegedly contacted Dr. Hansen by phone and asked him questions about his practice and his prescribing practices, according to his lawsuit filed in U.S. District Court for the Eastern District of Kentucky. During the call, the representative did not inform Dr. Hansen that any of his prescriptions were in question or were suspected of being medically unnecessary, the complaint alleges.
On July 28, 2021, CVS sent Dr. Hansen a letter announcing that its pharmacies would no longer be honoring his prescriptions. The letter, entered as an exhibit in the lawsuit, states that CVS contacted Dr. Hansen twice in 2021 about his prescribing practices, once in May and again in June.
“Despite our attempts to resolve the concerns with your controlled substance prescribing patterns, these concerns persist,” Kahra Lutkiewicz, director of CVS’ retail pharmacy professional practice, wrote in the letter. “Thus, we are writing to inform you that effective Aug. 5, 2021, CVS/pharmacy stores will no longer be able to fill prescriptions that you write for controlled substances. We take our compliance obligations very seriously, and after careful consideration, find it necessary to take this action.”
The letter does not explain the details behind CVS’ concerns.
Dr. Hansen sued CVS on Aug. 4 for tortious interference with a business relationship and defamation, among other claims. His complaint alleges that Dr. Hansen and his patients will suffer irreparable injury if the prescription decision stands. More than 250 of Dr. Hansen’s patients use CVS pharmacies for their prescriptions, and some are locked into using the pharmacy because of insurance contracts, Mr. Chapman said.
“There really is nowhere else for these patients to go,” Mr. Chapman said. “They would have to go to a new doctor and establish a new relationship, and obviously that has devastating consequences when we’re talking about people who need their medication.”
CVS has not yet issued a written response to the lawsuit. In his order, Judge Bertelsman stated that a preliminary conference was held in which all parties were represented and stated their positions to the judge.
“Plaintiffs are likely to succeed on the merits of their claims that defendant has interfered with plaintiffs’ relationships with their patients by refusing to fill prescriptions written by plaintiffs, and defendant has done so without evidence that plaintiffs have violated any law or professional protocol related to such prescriptions,” Judge Bertelsman wrote. “The balance of the hardships between the parties weighs in favor of issuing a temporary restraining order inasmuch as defendant’s actions pose a threat to plaintiffs’ professional reputation and livelihood and ... because plaintiffs’ patients’ medical care is implicated by defendant’s actions, the public interest weighs in favor of issuance of the temporary restraining order.”
Dr. Hansen is currently embroiled in several other legal battles as both a plaintiff and a defendant.
In 2019, a patient sued him for negligence and fraud for allegedly performing medically unnecessary and excessive injection therapy. The suit claims the patient was required to undergo injection therapy on a continuing basis in order to receive her narcotic pain medication, according to the lawsuit filed in Kenton Circuit Court. The complaint alleges that Dr. Hansen made false representations to the patient and to her insurers that the injections were necessary for the treatment of the patient’s chronic pain.
The federal government is not involved in the case.
The negligence lawsuit is in the discovery stage, and attorneys plan to collect Dr. Hansen’s deposition soon, said Eric Deters, a spokesman for Deters Law, a law firm based in Independence, Ky., that is representing the patient.
“The crux is that he performs unnecessary pain procedures and forces you to get an unnecessary procedure before giving you your medication,” Mr. Deters said.
However, Dr. Hansen’s and Mr. Deters’ history together includes a recent riff, according to an August 2021 lawsuit filed by Dr. Hansen against the law firm. Dr. Hansen was a former medical expert in cases for Deters and Associates, but the relationship turned sour when attorneys believed Dr. Hansen was retained as an expert in a case against their clients, according to Dr. Hansen’s suit. Dr. Hansen claims that as retribution, Deters and Associates issued a medical malpractice lawsuit against him in 2020, even though attorneys allegedly knew the statute of limitations had run out. A trial court dismissed the 2020 lawsuit against Dr. Hansen as being untimely filed. Dr. Hansen’s lawsuit alleges wrongful use of civil proceedings and requests compensatory, punitive damages and court costs from the law firm.
The law firm has faced trouble in the past. In August 2021, the Ohio Supreme Court ordered that Mr. Deters pay a $6,500 fine for engaging in the unauthorized practice of law. Mr. Deters’ Kentucky law license has been suspended since 2013 for ethics infractions, according to court records. He retired from law in 2014 and now acts as a spokesperson and office manager for the law firm. The fine resulted from legal advice given by Mr. Deters to two clients at the law firm, according to the Ohio Supreme Court decision.
As for the CVS lawsuit, an upcoming hearing will determine whether the federal court issues a permanent injunction against CVS’s actions. CVS officials have not said whether they will fight the temporary restraining order or the withdrawal of their prescription ban against Dr. Hansen.
A version of this article first appeared on Medscape.com.
In an Aug. 11 decision, District Court Judge William Bertelsman ordered CVS to stop refusing prescriptions written by Kendall E. Hansen, MD. Judge Bertelsman ruled that Dr. Hansen is likely to succeed in his claim that CVS barred his prescriptions without evidence that he violated any law or professional protocol. The restraining order will remain in place while Dr. Hansen’s lawsuit against CVS Pharmacy proceeds.
Ronald W. Chapman II, an attorney representing Dr. Hansen, said the order is groundbreaking and that, to his knowledge, it’s the first time a federal court has overturned a pharmacy’s decision to block a prescriber.
“We believe that CVS’ decision was based solely on algorithms they use to analyze prescriber practices and not an any individual review of patient records,” Mr. Chapman said. “In fact, we invited CVS to come out to Dr. Hansen’s practice and look at how he was treating patients and ensure things were compliant, but they refused. Instead, they had a phone call with him then cut his patients off.”
Michael DeAngelis, a spokesman for CVS, said the court’s order illustrates the proverbial rock and hard place that pharmacies are placed between in the country’s fight against the misuse of prescription opioids.
“It is alleged in many lawsuits that pharmacies fill too many opioid prescriptions and should operate programs that use data to block prescriptions written by some doctors,” Mr. DeAngelis told this news organization. “And yet other lawsuits, including this one, argue that we should not operate programs that may block prescriptions. Such contradictions are grossly unfair to the pharmacy profession.”
Mr. DeAngelis declined to comment about Dr. Hansen’s claims or specify what led CVS to refuse his prescriptions.
Dr. Hansen declined to comment for this story through his attorney.
Dr. Hansen is no stranger to the spotlight. The Northern Kentucky pain doctor made headlines in 2012 when two of his horses, Fast and Accurate, and Hansen, ran in the Kentucky Derby. In February 2019, he drew media attention when his practice, Interventional Pain Specialists in Crestview Hills, Ky., was raided by federal agents. Dr. Hansen owns and operates the facility, which serves patients in Kentucky, Ohio, and Indiana.
The search yielded no findings, and no charges were filed, according to Mr. Chapman. Scott Hardcorn, director of the Northern Kentucky Drug Strike Force, confirmed that his agency assisted in the operation but said he was unaware of the outcome and that his officers generated no reports from the investigation. A spokesperson for the Drug Enforcement Administration would not comment about the investigation and directed a reporter for this news organization to the DEA website where enforcement actions are listed. No records or actions against Dr. Hansen can be found.
The CVS complaint stems from actions taken by the pharmacy against Dr. Hansen earlier this year. In June, a pharmacy representative allegedly contacted Dr. Hansen by phone and asked him questions about his practice and his prescribing practices, according to his lawsuit filed in U.S. District Court for the Eastern District of Kentucky. During the call, the representative did not inform Dr. Hansen that any of his prescriptions were in question or were suspected of being medically unnecessary, the complaint alleges.
On July 28, 2021, CVS sent Dr. Hansen a letter announcing that its pharmacies would no longer be honoring his prescriptions. The letter, entered as an exhibit in the lawsuit, states that CVS contacted Dr. Hansen twice in 2021 about his prescribing practices, once in May and again in June.
“Despite our attempts to resolve the concerns with your controlled substance prescribing patterns, these concerns persist,” Kahra Lutkiewicz, director of CVS’ retail pharmacy professional practice, wrote in the letter. “Thus, we are writing to inform you that effective Aug. 5, 2021, CVS/pharmacy stores will no longer be able to fill prescriptions that you write for controlled substances. We take our compliance obligations very seriously, and after careful consideration, find it necessary to take this action.”
The letter does not explain the details behind CVS’ concerns.
Dr. Hansen sued CVS on Aug. 4 for tortious interference with a business relationship and defamation, among other claims. His complaint alleges that Dr. Hansen and his patients will suffer irreparable injury if the prescription decision stands. More than 250 of Dr. Hansen’s patients use CVS pharmacies for their prescriptions, and some are locked into using the pharmacy because of insurance contracts, Mr. Chapman said.
“There really is nowhere else for these patients to go,” Mr. Chapman said. “They would have to go to a new doctor and establish a new relationship, and obviously that has devastating consequences when we’re talking about people who need their medication.”
CVS has not yet issued a written response to the lawsuit. In his order, Judge Bertelsman stated that a preliminary conference was held in which all parties were represented and stated their positions to the judge.
“Plaintiffs are likely to succeed on the merits of their claims that defendant has interfered with plaintiffs’ relationships with their patients by refusing to fill prescriptions written by plaintiffs, and defendant has done so without evidence that plaintiffs have violated any law or professional protocol related to such prescriptions,” Judge Bertelsman wrote. “The balance of the hardships between the parties weighs in favor of issuing a temporary restraining order inasmuch as defendant’s actions pose a threat to plaintiffs’ professional reputation and livelihood and ... because plaintiffs’ patients’ medical care is implicated by defendant’s actions, the public interest weighs in favor of issuance of the temporary restraining order.”
Dr. Hansen is currently embroiled in several other legal battles as both a plaintiff and a defendant.
In 2019, a patient sued him for negligence and fraud for allegedly performing medically unnecessary and excessive injection therapy. The suit claims the patient was required to undergo injection therapy on a continuing basis in order to receive her narcotic pain medication, according to the lawsuit filed in Kenton Circuit Court. The complaint alleges that Dr. Hansen made false representations to the patient and to her insurers that the injections were necessary for the treatment of the patient’s chronic pain.
The federal government is not involved in the case.
The negligence lawsuit is in the discovery stage, and attorneys plan to collect Dr. Hansen’s deposition soon, said Eric Deters, a spokesman for Deters Law, a law firm based in Independence, Ky., that is representing the patient.
“The crux is that he performs unnecessary pain procedures and forces you to get an unnecessary procedure before giving you your medication,” Mr. Deters said.
However, Dr. Hansen’s and Mr. Deters’ history together includes a recent riff, according to an August 2021 lawsuit filed by Dr. Hansen against the law firm. Dr. Hansen was a former medical expert in cases for Deters and Associates, but the relationship turned sour when attorneys believed Dr. Hansen was retained as an expert in a case against their clients, according to Dr. Hansen’s suit. Dr. Hansen claims that as retribution, Deters and Associates issued a medical malpractice lawsuit against him in 2020, even though attorneys allegedly knew the statute of limitations had run out. A trial court dismissed the 2020 lawsuit against Dr. Hansen as being untimely filed. Dr. Hansen’s lawsuit alleges wrongful use of civil proceedings and requests compensatory, punitive damages and court costs from the law firm.
The law firm has faced trouble in the past. In August 2021, the Ohio Supreme Court ordered that Mr. Deters pay a $6,500 fine for engaging in the unauthorized practice of law. Mr. Deters’ Kentucky law license has been suspended since 2013 for ethics infractions, according to court records. He retired from law in 2014 and now acts as a spokesperson and office manager for the law firm. The fine resulted from legal advice given by Mr. Deters to two clients at the law firm, according to the Ohio Supreme Court decision.
As for the CVS lawsuit, an upcoming hearing will determine whether the federal court issues a permanent injunction against CVS’s actions. CVS officials have not said whether they will fight the temporary restraining order or the withdrawal of their prescription ban against Dr. Hansen.
A version of this article first appeared on Medscape.com.
Increased risk of hospitalization and death with Parkinson’s drug
, according to a new study.
A retrospective cohort study of elderly patients with Parkinson’s disease who were in long-term care facilities found that the use of pimavanserin (Nuplazid) was associated with an increased risk of 30-day hospitalization and mortality for up to a year.
“Given that a previous study showed typical and atypical antipsychotics more than doubled mortality risk in patients with Parkinson’s disease, we aimed to assess the risk of hospitalization and death associated with pimavanserin,” wrote lead author Y. Joseph Hwang, MD, Johns Hopkins University, Baltimore, and colleagues in the paper. “These findings, in a large real-world cohort within long-term care facilities, may help to inform decisions regarding its risk-benefit balance among patients with Parkinson’s disease.”
The findings were published online Aug. 13 in Neurology.
The researchers enrolled 2,186 patients with Parkinson’s disease aged 65 years and older in Medicare-certified long-term care facilities who also had a pimavanserin prescription and 18,212 nonusers of pimavanserin between Nov. 1, 2015, and December 31, 2018. Patients in the pimavanserin group used the drug over the course of the entire study period. Hospitalization and mortality were calculated from the date of pimavanserin prescription. Propensity score–based inverse probability of treatment weighting (IPTW) was used to balance the two groups on 24 baseline characteristics such as age, sex, and comorbidities.
Pimavanserin use was associated with a 24% higher risk of 30-day hospitalization (adjusted hazard ratio, 1.24; 95% confidence interval, 1.06-1.43). However, “the association did not reach statistical significance in a smaller subcohort of propensity score-matched users and nonusers,” Dr. Hwang and colleagues wrote.
Pimavanserin use was also linked to higher mortality at:
- 90 days (aHR, 1.20; 95% CI, 1.02-1.41).
- 180 days (aHR, 1.28; 95% CI, 1.13-1.45).
- 365 days (aHR, 1.56; 95% CI, 1.42-1.72).
No associations were found between pimavanserin use and 90-day hospitalization (aHR, 1.10; 95% CI, 0.99-1.24) nor with 30-day mortality (aHR, 0.76; 95% CI, 0.56-1.03).
Important considerations
“This study raises three important points to consider for any practicing neurology provider: 1) how to address and interpret risks associated with pimavanserin use in this patient population 2) utility of pimavanserin 3) interpretation of data showing increased mortality in patients being treated for Parkinson’s disease psychosis,” wrote Farwa Ali, MBBS, of the Mayo Clinic, Rochester, Minn., in an accompanying editorial published in Neurology.
Hallucinations and delusions are highly prevalent in Parkinson’s disease; as many as 60% of patients will develop psychosis over the course of their illness. Pimavanserin is a selective serotonin inverse agonist which targets 5-HT2A serotonin receptors in the brain, decreasing their activity in order to attenuate hallucinations and delusions.
“Pimavanserin has been approved by the FDA [Food and Drug Administration] for Parkinson’s disease psychosis, but its safety has been called into question based on previous reports of increased mortality risk, compared with a rather modest benefit seen in a 6-week clinical trial, the duration of which limits determination of long-term safety,” wrote Dr. Ali.
Pimavanserin carries a boxed warning that elderly patients with dementia may be at an increased risk of death. After its approval in 2016, the U.S. FDA later reviewed 893 deaths in association with pimavanserin during the postmarketing surveillance period – “an unexpected number in a new drug,” Dr. Hwang and colleagues noted. “It [the FDA] noted that most reports occurred in a population with high underlying death rates and did not signal any additional risk beyond the current warning for all antipsychotics, which could have resulted in annual mortality rates of up to 60%.”
As the first cohort study to examine hospitalization and death between pimavanserin users and nonusers, “the study confirms previous concerns regarding safety of pimavanserin and more importantly brings to attention the importance of carefully considering risks and benefits of pharmacotherapy in Parkinson’s disease psychosis, clear communication with patients and families, and close observation to ensure safety,” wrote Dr. Ali.
The study limitations include its observational design, which subjected the findings to residual confounding.
“While we developed models to maximize the strength of causal inference, our comparison group was pimavanserin nonusers and the very reason for prescription of pimavanserin could have predisposed its users to the outcomes of hospitalization and death, introducing confounding by indication,” Dr. Hwang and colleagues wrote in the paper.
Additionally, “while robust analyses were conducted to ensure pimavanserin users and nonusers were comparable, Dr. Hwang et al. did find that pimavanserin users were more likely to concomitantly use other antipsychotic drugs which has been demonstrated as increasing the mortality risk,” Dr. Ali pointed out.
Since patients living in long-term care facilities may have a higher risk of mortality because of more severe or later-stage Parkinson’s disease, the study results “may not be generalizable to community-dwelling PD patients,” Dr. Ali wrote. “These factors are important to consider while making individual management decisions.”
Dr. Hwang and Dr. Ali disclosed no relevant financial relationships. The study authors reported no targeted funding.
, according to a new study.
A retrospective cohort study of elderly patients with Parkinson’s disease who were in long-term care facilities found that the use of pimavanserin (Nuplazid) was associated with an increased risk of 30-day hospitalization and mortality for up to a year.
“Given that a previous study showed typical and atypical antipsychotics more than doubled mortality risk in patients with Parkinson’s disease, we aimed to assess the risk of hospitalization and death associated with pimavanserin,” wrote lead author Y. Joseph Hwang, MD, Johns Hopkins University, Baltimore, and colleagues in the paper. “These findings, in a large real-world cohort within long-term care facilities, may help to inform decisions regarding its risk-benefit balance among patients with Parkinson’s disease.”
The findings were published online Aug. 13 in Neurology.
The researchers enrolled 2,186 patients with Parkinson’s disease aged 65 years and older in Medicare-certified long-term care facilities who also had a pimavanserin prescription and 18,212 nonusers of pimavanserin between Nov. 1, 2015, and December 31, 2018. Patients in the pimavanserin group used the drug over the course of the entire study period. Hospitalization and mortality were calculated from the date of pimavanserin prescription. Propensity score–based inverse probability of treatment weighting (IPTW) was used to balance the two groups on 24 baseline characteristics such as age, sex, and comorbidities.
Pimavanserin use was associated with a 24% higher risk of 30-day hospitalization (adjusted hazard ratio, 1.24; 95% confidence interval, 1.06-1.43). However, “the association did not reach statistical significance in a smaller subcohort of propensity score-matched users and nonusers,” Dr. Hwang and colleagues wrote.
Pimavanserin use was also linked to higher mortality at:
- 90 days (aHR, 1.20; 95% CI, 1.02-1.41).
- 180 days (aHR, 1.28; 95% CI, 1.13-1.45).
- 365 days (aHR, 1.56; 95% CI, 1.42-1.72).
No associations were found between pimavanserin use and 90-day hospitalization (aHR, 1.10; 95% CI, 0.99-1.24) nor with 30-day mortality (aHR, 0.76; 95% CI, 0.56-1.03).
Important considerations
“This study raises three important points to consider for any practicing neurology provider: 1) how to address and interpret risks associated with pimavanserin use in this patient population 2) utility of pimavanserin 3) interpretation of data showing increased mortality in patients being treated for Parkinson’s disease psychosis,” wrote Farwa Ali, MBBS, of the Mayo Clinic, Rochester, Minn., in an accompanying editorial published in Neurology.
Hallucinations and delusions are highly prevalent in Parkinson’s disease; as many as 60% of patients will develop psychosis over the course of their illness. Pimavanserin is a selective serotonin inverse agonist which targets 5-HT2A serotonin receptors in the brain, decreasing their activity in order to attenuate hallucinations and delusions.
“Pimavanserin has been approved by the FDA [Food and Drug Administration] for Parkinson’s disease psychosis, but its safety has been called into question based on previous reports of increased mortality risk, compared with a rather modest benefit seen in a 6-week clinical trial, the duration of which limits determination of long-term safety,” wrote Dr. Ali.
Pimavanserin carries a boxed warning that elderly patients with dementia may be at an increased risk of death. After its approval in 2016, the U.S. FDA later reviewed 893 deaths in association with pimavanserin during the postmarketing surveillance period – “an unexpected number in a new drug,” Dr. Hwang and colleagues noted. “It [the FDA] noted that most reports occurred in a population with high underlying death rates and did not signal any additional risk beyond the current warning for all antipsychotics, which could have resulted in annual mortality rates of up to 60%.”
As the first cohort study to examine hospitalization and death between pimavanserin users and nonusers, “the study confirms previous concerns regarding safety of pimavanserin and more importantly brings to attention the importance of carefully considering risks and benefits of pharmacotherapy in Parkinson’s disease psychosis, clear communication with patients and families, and close observation to ensure safety,” wrote Dr. Ali.
The study limitations include its observational design, which subjected the findings to residual confounding.
“While we developed models to maximize the strength of causal inference, our comparison group was pimavanserin nonusers and the very reason for prescription of pimavanserin could have predisposed its users to the outcomes of hospitalization and death, introducing confounding by indication,” Dr. Hwang and colleagues wrote in the paper.
Additionally, “while robust analyses were conducted to ensure pimavanserin users and nonusers were comparable, Dr. Hwang et al. did find that pimavanserin users were more likely to concomitantly use other antipsychotic drugs which has been demonstrated as increasing the mortality risk,” Dr. Ali pointed out.
Since patients living in long-term care facilities may have a higher risk of mortality because of more severe or later-stage Parkinson’s disease, the study results “may not be generalizable to community-dwelling PD patients,” Dr. Ali wrote. “These factors are important to consider while making individual management decisions.”
Dr. Hwang and Dr. Ali disclosed no relevant financial relationships. The study authors reported no targeted funding.
, according to a new study.
A retrospective cohort study of elderly patients with Parkinson’s disease who were in long-term care facilities found that the use of pimavanserin (Nuplazid) was associated with an increased risk of 30-day hospitalization and mortality for up to a year.
“Given that a previous study showed typical and atypical antipsychotics more than doubled mortality risk in patients with Parkinson’s disease, we aimed to assess the risk of hospitalization and death associated with pimavanserin,” wrote lead author Y. Joseph Hwang, MD, Johns Hopkins University, Baltimore, and colleagues in the paper. “These findings, in a large real-world cohort within long-term care facilities, may help to inform decisions regarding its risk-benefit balance among patients with Parkinson’s disease.”
The findings were published online Aug. 13 in Neurology.
The researchers enrolled 2,186 patients with Parkinson’s disease aged 65 years and older in Medicare-certified long-term care facilities who also had a pimavanserin prescription and 18,212 nonusers of pimavanserin between Nov. 1, 2015, and December 31, 2018. Patients in the pimavanserin group used the drug over the course of the entire study period. Hospitalization and mortality were calculated from the date of pimavanserin prescription. Propensity score–based inverse probability of treatment weighting (IPTW) was used to balance the two groups on 24 baseline characteristics such as age, sex, and comorbidities.
Pimavanserin use was associated with a 24% higher risk of 30-day hospitalization (adjusted hazard ratio, 1.24; 95% confidence interval, 1.06-1.43). However, “the association did not reach statistical significance in a smaller subcohort of propensity score-matched users and nonusers,” Dr. Hwang and colleagues wrote.
Pimavanserin use was also linked to higher mortality at:
- 90 days (aHR, 1.20; 95% CI, 1.02-1.41).
- 180 days (aHR, 1.28; 95% CI, 1.13-1.45).
- 365 days (aHR, 1.56; 95% CI, 1.42-1.72).
No associations were found between pimavanserin use and 90-day hospitalization (aHR, 1.10; 95% CI, 0.99-1.24) nor with 30-day mortality (aHR, 0.76; 95% CI, 0.56-1.03).
Important considerations
“This study raises three important points to consider for any practicing neurology provider: 1) how to address and interpret risks associated with pimavanserin use in this patient population 2) utility of pimavanserin 3) interpretation of data showing increased mortality in patients being treated for Parkinson’s disease psychosis,” wrote Farwa Ali, MBBS, of the Mayo Clinic, Rochester, Minn., in an accompanying editorial published in Neurology.
Hallucinations and delusions are highly prevalent in Parkinson’s disease; as many as 60% of patients will develop psychosis over the course of their illness. Pimavanserin is a selective serotonin inverse agonist which targets 5-HT2A serotonin receptors in the brain, decreasing their activity in order to attenuate hallucinations and delusions.
“Pimavanserin has been approved by the FDA [Food and Drug Administration] for Parkinson’s disease psychosis, but its safety has been called into question based on previous reports of increased mortality risk, compared with a rather modest benefit seen in a 6-week clinical trial, the duration of which limits determination of long-term safety,” wrote Dr. Ali.
Pimavanserin carries a boxed warning that elderly patients with dementia may be at an increased risk of death. After its approval in 2016, the U.S. FDA later reviewed 893 deaths in association with pimavanserin during the postmarketing surveillance period – “an unexpected number in a new drug,” Dr. Hwang and colleagues noted. “It [the FDA] noted that most reports occurred in a population with high underlying death rates and did not signal any additional risk beyond the current warning for all antipsychotics, which could have resulted in annual mortality rates of up to 60%.”
As the first cohort study to examine hospitalization and death between pimavanserin users and nonusers, “the study confirms previous concerns regarding safety of pimavanserin and more importantly brings to attention the importance of carefully considering risks and benefits of pharmacotherapy in Parkinson’s disease psychosis, clear communication with patients and families, and close observation to ensure safety,” wrote Dr. Ali.
The study limitations include its observational design, which subjected the findings to residual confounding.
“While we developed models to maximize the strength of causal inference, our comparison group was pimavanserin nonusers and the very reason for prescription of pimavanserin could have predisposed its users to the outcomes of hospitalization and death, introducing confounding by indication,” Dr. Hwang and colleagues wrote in the paper.
Additionally, “while robust analyses were conducted to ensure pimavanserin users and nonusers were comparable, Dr. Hwang et al. did find that pimavanserin users were more likely to concomitantly use other antipsychotic drugs which has been demonstrated as increasing the mortality risk,” Dr. Ali pointed out.
Since patients living in long-term care facilities may have a higher risk of mortality because of more severe or later-stage Parkinson’s disease, the study results “may not be generalizable to community-dwelling PD patients,” Dr. Ali wrote. “These factors are important to consider while making individual management decisions.”
Dr. Hwang and Dr. Ali disclosed no relevant financial relationships. The study authors reported no targeted funding.
FROM NEUROLOGY
Medicinal liquor and edited mosquitoes
Drink to your health?
Whether you drink or not, most of us can agree that liquor is not the first thing that comes to mind when looking to make health improvements. But researchers have found a small exception in something traditional.
We’ve added buckwheat to pancakes, bread, and other baked goodies we made during the height of quarantine, but it’s also used to create a traditional liquor in some East Asian countries, where it is used medicinally.
Investigators have found that extracts in the Tartary buckwheat used to make the liquor induce autophagy, a process cells go through to remove proteins that are damaged or not needed anymore – sort of like a cellular spring cleaning.
To test this, the researchers treated liver and skin cells with Tartary buckwheat extract and looked to see how the cells responded with fluorescent markers. The results were clear.
“Treating cells with the extract stimulated the formation of autophagosomes, specialized cellular structures that carry out autophagy, and altered the location of proteins involved in regulating autophagy,” said senior author Takeshi Noda of Osaka (Japan) University.
Looking deeper, the researchers found that quercetin, a component of the buckwheat extract, had the same autophagic effect. And both the buckwheat and the quercetin gave the green light for liver cells to induce aggrephagy, the process of cleaning up protein aggregates.
Those protein aggregates in liver cells are closely linked to alcoholic liver disease, suggesting that quercetin could be a game changer in its treatment. In other words, liquor could help fix the problem that liquor started. Go figure.
From hospital bills to X-rated
Ralph Puglisi was an accounting manager for the University Medical Service Association (UMSA), a nonprofit that supports the massive University of South Florida health system. The association took in over $300 million in revenue in the 2019-2020 fiscal year, which is a rather large sum of money, but we’ll glide over the ethics of a “nonprofit” making a few hundred million for now.
Mr. Puglisi was in very close proximity to the money, generated from patient care, and he pled guilty to stealing it using UMSA credit cards. Now, that wouldn’t be LOTME worthy on its own, but what elevates this above garden-variety embezzlement is how the intrepid Mr. Puglisi chose to spend the millions he stole from the university health system: Adult entertainment.
And before you ask, he didn’t spend $11.5 million on something most people so inclined can find for free with judicious Google searches. What Mr. Puglisi actually did was invest in a website providing adult content through individual user profiles, one of which is believed to belong to his stepson’s fiancée, which brings a whole new level of sleaze to this enterprise. Over the course of 2 years, he visited her profile 2,800 times, an amount some might view as excessive.
While the vast majority of the embezzled money went to the adult website, Mr. Puglisi also used thousands of UMSA dollars to pay for travel, household improvements, rent, the works. Almost $44,000 was spent at a resort sometimes known as the happiest place on earth.
Then there’s Mr. Puglisi’s wife. Oh yes, this guy is married. He poured over $600,000 into a company he and his wife owned, which is a lot, but how much do you think went to the woman he married? Probably quite a bit. Go ahead, try to think of a number. It’s not like it was his money.
Did you guess $100 went into his wife’s PayPal account? No? Clearly you don’t understand the criminal mind. His stepson’s fiancée got millions, and his wife got a hundred. Now there are some priorities.
Step 1: Sit at desk. Step 2: Get in shape
Being a physician is not really a desk job, but doctors must spend a fair share of their time sitting, yes? Dealing with recalcitrant EHRs or talking on the phone to insurers or PBMs? If you are one of these physicians, or if you have patients who spend a lot of time sitting at their desks and might need to get a bit of exercise, then we’ve got a multitasking tip for you.
It came to us via one of our favorite websites, Sad and Useless. It’s the site that declares itself “the most depressive humor site on the Internet” and they’re offering up the “12 Best Exercises To Do At Your Desk.” It may not sound like much, but we think that the gang at Dunder-Mifflin would approve. And besides, who couldn’t stand to burn a few calories without having to leave the chair?
We won’t spoil your fun by going through all 12 – each one comes with step-by-step instructions and a helpful illustration or GIF – but here are just a few:
- Bending over backwards: “Agree to do something you don’t want to do. Spend twice as long as expected doing that thing. Hate yourself.”
- Fake laughter: “Hear a joke that isn’t even remotely funny. Open your mouth and make laughing sounds.”
- Bang your head: Feel the “pointlessness of your job overwhelm you” and then “bring your head forcefully down to your desk.”
Now, we here at LOTME are, of course [Bang!], highly skilled, professional wordsmithing humorists [Bang!], so when we tell you that this is a great workout [Bang!] … that this is a great workout [Bang!] … it’s great … uggh.
Wooooo. Feel the burn.
One order of mosquitoes, extra Crispr
What would it be like to have a barbecue in your backyard on a humid summer night and not get eaten alive by mosquitoes? If you’re like us, you probably thought you’d never see that day.
Mosquitoes cause itchy bites, but, more importantly, they can carry dengue, malaria, yellow fever, and Zika virus. New research shows that protection from these diseases may be possible with use of the Crispr-Cas9 gene-editing tool, which could make humans invisible to mosquitoes by taking away their light-sensing abilities and, thus, their ability to find us.
“The better we understand how they sense the human, the better we can control the mosquito in an eco-friendly manner,” Yinpeng Zhan, a postdoctoral researcher at the University of California, Santa Barbara, and the study’s lead author, told the New York Times.
After studying the mosquitoes and figuring out their hunting patterns, the researchers found that mosquitoes are attracted to dark spots more than white spots and used this to their advantage. After knocking out two of the proteins that mosquitoes need for vision – via Crispr – the little suckers could not distinguish the difference between the white and dark spots.
We’re sure mosquitoes don’t mean any harm – they’re just trying to survive and reproduce like any other species – but thanks to this new tool, gone might be the days of having to douse yourself in bug spray that smells like a mix of chemicals and melon.
Drink to your health?
Whether you drink or not, most of us can agree that liquor is not the first thing that comes to mind when looking to make health improvements. But researchers have found a small exception in something traditional.
We’ve added buckwheat to pancakes, bread, and other baked goodies we made during the height of quarantine, but it’s also used to create a traditional liquor in some East Asian countries, where it is used medicinally.
Investigators have found that extracts in the Tartary buckwheat used to make the liquor induce autophagy, a process cells go through to remove proteins that are damaged or not needed anymore – sort of like a cellular spring cleaning.
To test this, the researchers treated liver and skin cells with Tartary buckwheat extract and looked to see how the cells responded with fluorescent markers. The results were clear.
“Treating cells with the extract stimulated the formation of autophagosomes, specialized cellular structures that carry out autophagy, and altered the location of proteins involved in regulating autophagy,” said senior author Takeshi Noda of Osaka (Japan) University.
Looking deeper, the researchers found that quercetin, a component of the buckwheat extract, had the same autophagic effect. And both the buckwheat and the quercetin gave the green light for liver cells to induce aggrephagy, the process of cleaning up protein aggregates.
Those protein aggregates in liver cells are closely linked to alcoholic liver disease, suggesting that quercetin could be a game changer in its treatment. In other words, liquor could help fix the problem that liquor started. Go figure.
From hospital bills to X-rated
Ralph Puglisi was an accounting manager for the University Medical Service Association (UMSA), a nonprofit that supports the massive University of South Florida health system. The association took in over $300 million in revenue in the 2019-2020 fiscal year, which is a rather large sum of money, but we’ll glide over the ethics of a “nonprofit” making a few hundred million for now.
Mr. Puglisi was in very close proximity to the money, generated from patient care, and he pled guilty to stealing it using UMSA credit cards. Now, that wouldn’t be LOTME worthy on its own, but what elevates this above garden-variety embezzlement is how the intrepid Mr. Puglisi chose to spend the millions he stole from the university health system: Adult entertainment.
And before you ask, he didn’t spend $11.5 million on something most people so inclined can find for free with judicious Google searches. What Mr. Puglisi actually did was invest in a website providing adult content through individual user profiles, one of which is believed to belong to his stepson’s fiancée, which brings a whole new level of sleaze to this enterprise. Over the course of 2 years, he visited her profile 2,800 times, an amount some might view as excessive.
While the vast majority of the embezzled money went to the adult website, Mr. Puglisi also used thousands of UMSA dollars to pay for travel, household improvements, rent, the works. Almost $44,000 was spent at a resort sometimes known as the happiest place on earth.
Then there’s Mr. Puglisi’s wife. Oh yes, this guy is married. He poured over $600,000 into a company he and his wife owned, which is a lot, but how much do you think went to the woman he married? Probably quite a bit. Go ahead, try to think of a number. It’s not like it was his money.
Did you guess $100 went into his wife’s PayPal account? No? Clearly you don’t understand the criminal mind. His stepson’s fiancée got millions, and his wife got a hundred. Now there are some priorities.
Step 1: Sit at desk. Step 2: Get in shape
Being a physician is not really a desk job, but doctors must spend a fair share of their time sitting, yes? Dealing with recalcitrant EHRs or talking on the phone to insurers or PBMs? If you are one of these physicians, or if you have patients who spend a lot of time sitting at their desks and might need to get a bit of exercise, then we’ve got a multitasking tip for you.
It came to us via one of our favorite websites, Sad and Useless. It’s the site that declares itself “the most depressive humor site on the Internet” and they’re offering up the “12 Best Exercises To Do At Your Desk.” It may not sound like much, but we think that the gang at Dunder-Mifflin would approve. And besides, who couldn’t stand to burn a few calories without having to leave the chair?
We won’t spoil your fun by going through all 12 – each one comes with step-by-step instructions and a helpful illustration or GIF – but here are just a few:
- Bending over backwards: “Agree to do something you don’t want to do. Spend twice as long as expected doing that thing. Hate yourself.”
- Fake laughter: “Hear a joke that isn’t even remotely funny. Open your mouth and make laughing sounds.”
- Bang your head: Feel the “pointlessness of your job overwhelm you” and then “bring your head forcefully down to your desk.”
Now, we here at LOTME are, of course [Bang!], highly skilled, professional wordsmithing humorists [Bang!], so when we tell you that this is a great workout [Bang!] … that this is a great workout [Bang!] … it’s great … uggh.
Wooooo. Feel the burn.
One order of mosquitoes, extra Crispr
What would it be like to have a barbecue in your backyard on a humid summer night and not get eaten alive by mosquitoes? If you’re like us, you probably thought you’d never see that day.
Mosquitoes cause itchy bites, but, more importantly, they can carry dengue, malaria, yellow fever, and Zika virus. New research shows that protection from these diseases may be possible with use of the Crispr-Cas9 gene-editing tool, which could make humans invisible to mosquitoes by taking away their light-sensing abilities and, thus, their ability to find us.
“The better we understand how they sense the human, the better we can control the mosquito in an eco-friendly manner,” Yinpeng Zhan, a postdoctoral researcher at the University of California, Santa Barbara, and the study’s lead author, told the New York Times.
After studying the mosquitoes and figuring out their hunting patterns, the researchers found that mosquitoes are attracted to dark spots more than white spots and used this to their advantage. After knocking out two of the proteins that mosquitoes need for vision – via Crispr – the little suckers could not distinguish the difference between the white and dark spots.
We’re sure mosquitoes don’t mean any harm – they’re just trying to survive and reproduce like any other species – but thanks to this new tool, gone might be the days of having to douse yourself in bug spray that smells like a mix of chemicals and melon.
Drink to your health?
Whether you drink or not, most of us can agree that liquor is not the first thing that comes to mind when looking to make health improvements. But researchers have found a small exception in something traditional.
We’ve added buckwheat to pancakes, bread, and other baked goodies we made during the height of quarantine, but it’s also used to create a traditional liquor in some East Asian countries, where it is used medicinally.
Investigators have found that extracts in the Tartary buckwheat used to make the liquor induce autophagy, a process cells go through to remove proteins that are damaged or not needed anymore – sort of like a cellular spring cleaning.
To test this, the researchers treated liver and skin cells with Tartary buckwheat extract and looked to see how the cells responded with fluorescent markers. The results were clear.
“Treating cells with the extract stimulated the formation of autophagosomes, specialized cellular structures that carry out autophagy, and altered the location of proteins involved in regulating autophagy,” said senior author Takeshi Noda of Osaka (Japan) University.
Looking deeper, the researchers found that quercetin, a component of the buckwheat extract, had the same autophagic effect. And both the buckwheat and the quercetin gave the green light for liver cells to induce aggrephagy, the process of cleaning up protein aggregates.
Those protein aggregates in liver cells are closely linked to alcoholic liver disease, suggesting that quercetin could be a game changer in its treatment. In other words, liquor could help fix the problem that liquor started. Go figure.
From hospital bills to X-rated
Ralph Puglisi was an accounting manager for the University Medical Service Association (UMSA), a nonprofit that supports the massive University of South Florida health system. The association took in over $300 million in revenue in the 2019-2020 fiscal year, which is a rather large sum of money, but we’ll glide over the ethics of a “nonprofit” making a few hundred million for now.
Mr. Puglisi was in very close proximity to the money, generated from patient care, and he pled guilty to stealing it using UMSA credit cards. Now, that wouldn’t be LOTME worthy on its own, but what elevates this above garden-variety embezzlement is how the intrepid Mr. Puglisi chose to spend the millions he stole from the university health system: Adult entertainment.
And before you ask, he didn’t spend $11.5 million on something most people so inclined can find for free with judicious Google searches. What Mr. Puglisi actually did was invest in a website providing adult content through individual user profiles, one of which is believed to belong to his stepson’s fiancée, which brings a whole new level of sleaze to this enterprise. Over the course of 2 years, he visited her profile 2,800 times, an amount some might view as excessive.
While the vast majority of the embezzled money went to the adult website, Mr. Puglisi also used thousands of UMSA dollars to pay for travel, household improvements, rent, the works. Almost $44,000 was spent at a resort sometimes known as the happiest place on earth.
Then there’s Mr. Puglisi’s wife. Oh yes, this guy is married. He poured over $600,000 into a company he and his wife owned, which is a lot, but how much do you think went to the woman he married? Probably quite a bit. Go ahead, try to think of a number. It’s not like it was his money.
Did you guess $100 went into his wife’s PayPal account? No? Clearly you don’t understand the criminal mind. His stepson’s fiancée got millions, and his wife got a hundred. Now there are some priorities.
Step 1: Sit at desk. Step 2: Get in shape
Being a physician is not really a desk job, but doctors must spend a fair share of their time sitting, yes? Dealing with recalcitrant EHRs or talking on the phone to insurers or PBMs? If you are one of these physicians, or if you have patients who spend a lot of time sitting at their desks and might need to get a bit of exercise, then we’ve got a multitasking tip for you.
It came to us via one of our favorite websites, Sad and Useless. It’s the site that declares itself “the most depressive humor site on the Internet” and they’re offering up the “12 Best Exercises To Do At Your Desk.” It may not sound like much, but we think that the gang at Dunder-Mifflin would approve. And besides, who couldn’t stand to burn a few calories without having to leave the chair?
We won’t spoil your fun by going through all 12 – each one comes with step-by-step instructions and a helpful illustration or GIF – but here are just a few:
- Bending over backwards: “Agree to do something you don’t want to do. Spend twice as long as expected doing that thing. Hate yourself.”
- Fake laughter: “Hear a joke that isn’t even remotely funny. Open your mouth and make laughing sounds.”
- Bang your head: Feel the “pointlessness of your job overwhelm you” and then “bring your head forcefully down to your desk.”
Now, we here at LOTME are, of course [Bang!], highly skilled, professional wordsmithing humorists [Bang!], so when we tell you that this is a great workout [Bang!] … that this is a great workout [Bang!] … it’s great … uggh.
Wooooo. Feel the burn.
One order of mosquitoes, extra Crispr
What would it be like to have a barbecue in your backyard on a humid summer night and not get eaten alive by mosquitoes? If you’re like us, you probably thought you’d never see that day.
Mosquitoes cause itchy bites, but, more importantly, they can carry dengue, malaria, yellow fever, and Zika virus. New research shows that protection from these diseases may be possible with use of the Crispr-Cas9 gene-editing tool, which could make humans invisible to mosquitoes by taking away their light-sensing abilities and, thus, their ability to find us.
“The better we understand how they sense the human, the better we can control the mosquito in an eco-friendly manner,” Yinpeng Zhan, a postdoctoral researcher at the University of California, Santa Barbara, and the study’s lead author, told the New York Times.
After studying the mosquitoes and figuring out their hunting patterns, the researchers found that mosquitoes are attracted to dark spots more than white spots and used this to their advantage. After knocking out two of the proteins that mosquitoes need for vision – via Crispr – the little suckers could not distinguish the difference between the white and dark spots.
We’re sure mosquitoes don’t mean any harm – they’re just trying to survive and reproduce like any other species – but thanks to this new tool, gone might be the days of having to douse yourself in bug spray that smells like a mix of chemicals and melon.
Increased stroke risk linked with excess sitting in those under 60
While the risk of stroke increased more than fourfold among sedentary people under the age of 60, no significant increase in risk was observed among older individuals, according to the study based on self-reported data from more than 140,000 people. This highlights the need for relevant public health messaging directed at younger people, reported lead author, Raed A. Joundi, MD, DPhil, a stroke fellow at the University of Calgary (Alta.), and colleagues, in the paper published in Stroke.
“Sedentary time has increased over the past 2 decades in the United States and Canada, particularly in the young, raising the importance of characterizing its effect on long-term health , ” the investigators wrote. “A better understanding of the risk of sedentary time specific to stroke may be important for public health campaigns to reduce sedentary behavior.” Dr. Joundi and colleagues reviewed data from the Canadian Community Health Survey, including 143,180 healthy individuals without baseline history of cancer, heart disease, or stroke. Those under the age of 40 years were also excluded from the analysis.
Excess sedentary leisure time was defined as 8 or more hours of sedentary leisure time per day, whereas low physical activity was defined as less than 3.5 metabolic equivalent hours per week. The analysis also included a range of demographic and medical covariates, such as age, sex, marital status, smoking status, presence of hypertension, and others.
After a median follow-up of 9.4 years, 2,965 stroke events occurred, with a median time from survey response of 5.6 years. Risk of stroke among individuals aged younger than 60 years who engaged in low physical activity and excess sedentary leisure time was increased 4.5-fold, compared with individuals with low physical activity who were sedentary less than 4 hours per day (fully adjusted hazard ratio, 4.50; 95% confidence interval, 1.64-12.3).
Findings highlight benefits of physical activity
Similar risk elevations were not observed among individuals aged 60-79 years, or those older than 80. And among people younger than 60, high physical activity appeared to eliminate the additional risk imposed by excess sedentary leisure time.
“Sedentary time is associated with higher risk of stroke in inactive individuals, but not an active individual, ” Dr. Joundi said in an interview. “So it suggests that there’s two ways to lower risk: One would be to lower your sedentary time, and the other would be to engage in physical activity.”
These interpretations are speculative, Dr. Joundi cautioned, as the study was not interventional. Even so, he said that the findings “bring the spotlight back on physical activity,” thereby aligning with previous research.
“The more you exercise, the more that relationship between sedentary time and poor health outcomes is blunted, and in fact, can be completely negated with enough physical activity,” he said.
How exactly physical activity offers such protection remains unclear, Dr. Joundi added. He speculated that regularity of exercise may be key, with each session counteracting the adverse effects of prolonged sedentary time, which may include reduced blood flow, increased insulin resistance, and inflammatory changes that can affect blood vessels.
“This study is particularly a message for younger individuals,” Dr. Joundi said, suggesting that the findings may alter behavior, as many people have witnessed, or are aware of, the long-term impacts of stroke.
“There’s a sort of social or cognitive aversion to stroke, I think, in the general population, because of how disabling it can be, and how it can lower your quality of life,” he said.
Subtle lifestyle changes may be enough.
For those aiming to lower their risk of stroke, Dr. Joundi suggested that subtle lifestyle changes may be enough.
“Ultimately, what we saw is that even minimal amounts of physical activity – walking 3 hours a week, for example – could blunt the impact of sedentary time,” he said. “Doing what you can, even if it’s a small amount, tends to be quite meaningful over a long period of time.”
Daniel T. Lackland, DrPH, professor of epidemiology in the department of neurology at the Medical University of South Carolina, Charleston, offered a similar takeaway, noting that small efforts can lead to great benefits.
“Less intense activity is still better than being sedentary,” he said in an interview. “For many people, if you do get up and you just walk around, move your arms around – do any kind of movement – that’s better than being sedentary.”
Dr. Lackland applauded the practicality of studying sedentary leisure time, versus overall leisure time, as many people can’t control their work environment.
“You can’t do very much about how you work your job,” Dr. Lackland said. “Sometimes we have to sit, and I guess there are things you can do – you can put a treadmill instead of a chair and that kind of thing – but more often than not, you don’t really have that choice to do something. With leisure time, though, you’re in full control. And so what do you do with your leisure time? Do you sit and watch TV, or do you engage in some type of activity? Not necessarily aerobic activity, but some type of activity that would not let you be sedentary. You want to be active as much as you possibly can.”
Dr. Joundi disclosed grant support from the Canadian Institutes of Health Research. The other investigators and Dr. Lackland reported no relevant disclosures.
While the risk of stroke increased more than fourfold among sedentary people under the age of 60, no significant increase in risk was observed among older individuals, according to the study based on self-reported data from more than 140,000 people. This highlights the need for relevant public health messaging directed at younger people, reported lead author, Raed A. Joundi, MD, DPhil, a stroke fellow at the University of Calgary (Alta.), and colleagues, in the paper published in Stroke.
“Sedentary time has increased over the past 2 decades in the United States and Canada, particularly in the young, raising the importance of characterizing its effect on long-term health , ” the investigators wrote. “A better understanding of the risk of sedentary time specific to stroke may be important for public health campaigns to reduce sedentary behavior.” Dr. Joundi and colleagues reviewed data from the Canadian Community Health Survey, including 143,180 healthy individuals without baseline history of cancer, heart disease, or stroke. Those under the age of 40 years were also excluded from the analysis.
Excess sedentary leisure time was defined as 8 or more hours of sedentary leisure time per day, whereas low physical activity was defined as less than 3.5 metabolic equivalent hours per week. The analysis also included a range of demographic and medical covariates, such as age, sex, marital status, smoking status, presence of hypertension, and others.
After a median follow-up of 9.4 years, 2,965 stroke events occurred, with a median time from survey response of 5.6 years. Risk of stroke among individuals aged younger than 60 years who engaged in low physical activity and excess sedentary leisure time was increased 4.5-fold, compared with individuals with low physical activity who were sedentary less than 4 hours per day (fully adjusted hazard ratio, 4.50; 95% confidence interval, 1.64-12.3).
Findings highlight benefits of physical activity
Similar risk elevations were not observed among individuals aged 60-79 years, or those older than 80. And among people younger than 60, high physical activity appeared to eliminate the additional risk imposed by excess sedentary leisure time.
“Sedentary time is associated with higher risk of stroke in inactive individuals, but not an active individual, ” Dr. Joundi said in an interview. “So it suggests that there’s two ways to lower risk: One would be to lower your sedentary time, and the other would be to engage in physical activity.”
These interpretations are speculative, Dr. Joundi cautioned, as the study was not interventional. Even so, he said that the findings “bring the spotlight back on physical activity,” thereby aligning with previous research.
“The more you exercise, the more that relationship between sedentary time and poor health outcomes is blunted, and in fact, can be completely negated with enough physical activity,” he said.
How exactly physical activity offers such protection remains unclear, Dr. Joundi added. He speculated that regularity of exercise may be key, with each session counteracting the adverse effects of prolonged sedentary time, which may include reduced blood flow, increased insulin resistance, and inflammatory changes that can affect blood vessels.
“This study is particularly a message for younger individuals,” Dr. Joundi said, suggesting that the findings may alter behavior, as many people have witnessed, or are aware of, the long-term impacts of stroke.
“There’s a sort of social or cognitive aversion to stroke, I think, in the general population, because of how disabling it can be, and how it can lower your quality of life,” he said.
Subtle lifestyle changes may be enough.
For those aiming to lower their risk of stroke, Dr. Joundi suggested that subtle lifestyle changes may be enough.
“Ultimately, what we saw is that even minimal amounts of physical activity – walking 3 hours a week, for example – could blunt the impact of sedentary time,” he said. “Doing what you can, even if it’s a small amount, tends to be quite meaningful over a long period of time.”
Daniel T. Lackland, DrPH, professor of epidemiology in the department of neurology at the Medical University of South Carolina, Charleston, offered a similar takeaway, noting that small efforts can lead to great benefits.
“Less intense activity is still better than being sedentary,” he said in an interview. “For many people, if you do get up and you just walk around, move your arms around – do any kind of movement – that’s better than being sedentary.”
Dr. Lackland applauded the practicality of studying sedentary leisure time, versus overall leisure time, as many people can’t control their work environment.
“You can’t do very much about how you work your job,” Dr. Lackland said. “Sometimes we have to sit, and I guess there are things you can do – you can put a treadmill instead of a chair and that kind of thing – but more often than not, you don’t really have that choice to do something. With leisure time, though, you’re in full control. And so what do you do with your leisure time? Do you sit and watch TV, or do you engage in some type of activity? Not necessarily aerobic activity, but some type of activity that would not let you be sedentary. You want to be active as much as you possibly can.”
Dr. Joundi disclosed grant support from the Canadian Institutes of Health Research. The other investigators and Dr. Lackland reported no relevant disclosures.
While the risk of stroke increased more than fourfold among sedentary people under the age of 60, no significant increase in risk was observed among older individuals, according to the study based on self-reported data from more than 140,000 people. This highlights the need for relevant public health messaging directed at younger people, reported lead author, Raed A. Joundi, MD, DPhil, a stroke fellow at the University of Calgary (Alta.), and colleagues, in the paper published in Stroke.
“Sedentary time has increased over the past 2 decades in the United States and Canada, particularly in the young, raising the importance of characterizing its effect on long-term health , ” the investigators wrote. “A better understanding of the risk of sedentary time specific to stroke may be important for public health campaigns to reduce sedentary behavior.” Dr. Joundi and colleagues reviewed data from the Canadian Community Health Survey, including 143,180 healthy individuals without baseline history of cancer, heart disease, or stroke. Those under the age of 40 years were also excluded from the analysis.
Excess sedentary leisure time was defined as 8 or more hours of sedentary leisure time per day, whereas low physical activity was defined as less than 3.5 metabolic equivalent hours per week. The analysis also included a range of demographic and medical covariates, such as age, sex, marital status, smoking status, presence of hypertension, and others.
After a median follow-up of 9.4 years, 2,965 stroke events occurred, with a median time from survey response of 5.6 years. Risk of stroke among individuals aged younger than 60 years who engaged in low physical activity and excess sedentary leisure time was increased 4.5-fold, compared with individuals with low physical activity who were sedentary less than 4 hours per day (fully adjusted hazard ratio, 4.50; 95% confidence interval, 1.64-12.3).
Findings highlight benefits of physical activity
Similar risk elevations were not observed among individuals aged 60-79 years, or those older than 80. And among people younger than 60, high physical activity appeared to eliminate the additional risk imposed by excess sedentary leisure time.
“Sedentary time is associated with higher risk of stroke in inactive individuals, but not an active individual, ” Dr. Joundi said in an interview. “So it suggests that there’s two ways to lower risk: One would be to lower your sedentary time, and the other would be to engage in physical activity.”
These interpretations are speculative, Dr. Joundi cautioned, as the study was not interventional. Even so, he said that the findings “bring the spotlight back on physical activity,” thereby aligning with previous research.
“The more you exercise, the more that relationship between sedentary time and poor health outcomes is blunted, and in fact, can be completely negated with enough physical activity,” he said.
How exactly physical activity offers such protection remains unclear, Dr. Joundi added. He speculated that regularity of exercise may be key, with each session counteracting the adverse effects of prolonged sedentary time, which may include reduced blood flow, increased insulin resistance, and inflammatory changes that can affect blood vessels.
“This study is particularly a message for younger individuals,” Dr. Joundi said, suggesting that the findings may alter behavior, as many people have witnessed, or are aware of, the long-term impacts of stroke.
“There’s a sort of social or cognitive aversion to stroke, I think, in the general population, because of how disabling it can be, and how it can lower your quality of life,” he said.
Subtle lifestyle changes may be enough.
For those aiming to lower their risk of stroke, Dr. Joundi suggested that subtle lifestyle changes may be enough.
“Ultimately, what we saw is that even minimal amounts of physical activity – walking 3 hours a week, for example – could blunt the impact of sedentary time,” he said. “Doing what you can, even if it’s a small amount, tends to be quite meaningful over a long period of time.”
Daniel T. Lackland, DrPH, professor of epidemiology in the department of neurology at the Medical University of South Carolina, Charleston, offered a similar takeaway, noting that small efforts can lead to great benefits.
“Less intense activity is still better than being sedentary,” he said in an interview. “For many people, if you do get up and you just walk around, move your arms around – do any kind of movement – that’s better than being sedentary.”
Dr. Lackland applauded the practicality of studying sedentary leisure time, versus overall leisure time, as many people can’t control their work environment.
“You can’t do very much about how you work your job,” Dr. Lackland said. “Sometimes we have to sit, and I guess there are things you can do – you can put a treadmill instead of a chair and that kind of thing – but more often than not, you don’t really have that choice to do something. With leisure time, though, you’re in full control. And so what do you do with your leisure time? Do you sit and watch TV, or do you engage in some type of activity? Not necessarily aerobic activity, but some type of activity that would not let you be sedentary. You want to be active as much as you possibly can.”
Dr. Joundi disclosed grant support from the Canadian Institutes of Health Research. The other investigators and Dr. Lackland reported no relevant disclosures.
FROM STROKE
COVID-19 booster shots to start in September: Officials
at a press briefing August 18.
Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.
“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”
The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.
“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”
Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.
At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.
“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
Data driving the plan
CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.
Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.
Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.
Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
Immunologic facts
Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.
“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”
A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
Booster details
“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.
The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
Big picture
Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”
Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”
Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”
A version of this article first appeared on WebMD.com.
at a press briefing August 18.
Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.
“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”
The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.
“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”
Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.
At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.
“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
Data driving the plan
CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.
Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.
Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.
Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
Immunologic facts
Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.
“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”
A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
Booster details
“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.
The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
Big picture
Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”
Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”
Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”
A version of this article first appeared on WebMD.com.
at a press briefing August 18.
Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.
“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”
The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.
“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”
Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.
At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.
“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
Data driving the plan
CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.
Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.
Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.
Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
Immunologic facts
Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.
“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”
A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
Booster details
“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.
The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
Big picture
Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”
Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”
Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”
A version of this article first appeared on WebMD.com.
Latest data show increase in breakthrough COVID-19 cases
Breakthrough cases accounted for about one in five newly diagnosed cases in six of the states, according to the New York Times. Hospitalizations and deaths among vaccinated people may be higher than previously thought as well.
“Remember when the early vaccine studies came out, it was like nobody gets hospitalized, nobody dies,” Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, said in an interview. “That clearly is not true.”
The New York Times analyzed data in seven states – California, Colorado, Massachusetts, Oregon, Utah, Vermont, and Virginia – that are tracking the most detailed information. The trends in these states may not reflect the numbers throughout the country, the newspaper reported.
Even still, the numbers back up the idea that vaccinated people may need booster shots this fall to support their earlier vaccine doses. Federal health officials are scheduled to approve the extra shots in coming weeks, potentially in September. The first people to receive booster shots will likely be health care workers and nursing home residents who took the first vaccines in December and January.
“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was, I think the case for boosters goes up pretty quickly,” Dr. Wachter said.
Previous analyses of breakthrough cases included data from June and earlier, the newspaper reported. But since July, COVID-19 cases have soared again because of the Delta variant, and the most recent numbers show an uptick among vaccinated people. In Los Angeles County, for instance, fully vaccinated people account for 20% of new COVID-19 cases, which is up from 11% in May, 5% in April, and 2% in March, according to a late July report from the Los Angeles County Department of Public Health.
What’s more, breakthrough infections in the seven states accounted for 12%-24% of COVID-19 hospitalizations in those states. About 8,000 breakthrough hospitalizations have been reported to the CDC. Still, the overall numbers remain low – in California, for instance, about 1,615 people have been hospitalized with breakthrough infections, which accounts for 0.007% of the state’s 22 million vaccinated people, the Times reported.
The breakthrough infections appear to be more severe among vaccinated people who are older or have weakened immune systems. About 74% of breakthrough cases are among adults 65 or older, the CDC reported.
The increase may shift how vaccinated people see their risks for infection and interact with loved ones. Public health officials have suggested that people follow some COVID-19 safety protocols again, such as wearing masks in public indoor spaces regardless of vaccination status.
As the Delta variant continues to circulate this fall, public health researchers will be researching more about breakthrough cases among vaccinated people, including whether they have prolonged symptoms and how easily they may pass the virus to others.
“I think some of us have been challenged by the numbers of clusters that we’ve seen,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told this news organization.
“I think that really needs to be examined more,” he said.
A version of this article first appeared on WebMD.com.
Breakthrough cases accounted for about one in five newly diagnosed cases in six of the states, according to the New York Times. Hospitalizations and deaths among vaccinated people may be higher than previously thought as well.
“Remember when the early vaccine studies came out, it was like nobody gets hospitalized, nobody dies,” Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, said in an interview. “That clearly is not true.”
The New York Times analyzed data in seven states – California, Colorado, Massachusetts, Oregon, Utah, Vermont, and Virginia – that are tracking the most detailed information. The trends in these states may not reflect the numbers throughout the country, the newspaper reported.
Even still, the numbers back up the idea that vaccinated people may need booster shots this fall to support their earlier vaccine doses. Federal health officials are scheduled to approve the extra shots in coming weeks, potentially in September. The first people to receive booster shots will likely be health care workers and nursing home residents who took the first vaccines in December and January.
“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was, I think the case for boosters goes up pretty quickly,” Dr. Wachter said.
Previous analyses of breakthrough cases included data from June and earlier, the newspaper reported. But since July, COVID-19 cases have soared again because of the Delta variant, and the most recent numbers show an uptick among vaccinated people. In Los Angeles County, for instance, fully vaccinated people account for 20% of new COVID-19 cases, which is up from 11% in May, 5% in April, and 2% in March, according to a late July report from the Los Angeles County Department of Public Health.
What’s more, breakthrough infections in the seven states accounted for 12%-24% of COVID-19 hospitalizations in those states. About 8,000 breakthrough hospitalizations have been reported to the CDC. Still, the overall numbers remain low – in California, for instance, about 1,615 people have been hospitalized with breakthrough infections, which accounts for 0.007% of the state’s 22 million vaccinated people, the Times reported.
The breakthrough infections appear to be more severe among vaccinated people who are older or have weakened immune systems. About 74% of breakthrough cases are among adults 65 or older, the CDC reported.
The increase may shift how vaccinated people see their risks for infection and interact with loved ones. Public health officials have suggested that people follow some COVID-19 safety protocols again, such as wearing masks in public indoor spaces regardless of vaccination status.
As the Delta variant continues to circulate this fall, public health researchers will be researching more about breakthrough cases among vaccinated people, including whether they have prolonged symptoms and how easily they may pass the virus to others.
“I think some of us have been challenged by the numbers of clusters that we’ve seen,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told this news organization.
“I think that really needs to be examined more,” he said.
A version of this article first appeared on WebMD.com.
Breakthrough cases accounted for about one in five newly diagnosed cases in six of the states, according to the New York Times. Hospitalizations and deaths among vaccinated people may be higher than previously thought as well.
“Remember when the early vaccine studies came out, it was like nobody gets hospitalized, nobody dies,” Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, said in an interview. “That clearly is not true.”
The New York Times analyzed data in seven states – California, Colorado, Massachusetts, Oregon, Utah, Vermont, and Virginia – that are tracking the most detailed information. The trends in these states may not reflect the numbers throughout the country, the newspaper reported.
Even still, the numbers back up the idea that vaccinated people may need booster shots this fall to support their earlier vaccine doses. Federal health officials are scheduled to approve the extra shots in coming weeks, potentially in September. The first people to receive booster shots will likely be health care workers and nursing home residents who took the first vaccines in December and January.
“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was, I think the case for boosters goes up pretty quickly,” Dr. Wachter said.
Previous analyses of breakthrough cases included data from June and earlier, the newspaper reported. But since July, COVID-19 cases have soared again because of the Delta variant, and the most recent numbers show an uptick among vaccinated people. In Los Angeles County, for instance, fully vaccinated people account for 20% of new COVID-19 cases, which is up from 11% in May, 5% in April, and 2% in March, according to a late July report from the Los Angeles County Department of Public Health.
What’s more, breakthrough infections in the seven states accounted for 12%-24% of COVID-19 hospitalizations in those states. About 8,000 breakthrough hospitalizations have been reported to the CDC. Still, the overall numbers remain low – in California, for instance, about 1,615 people have been hospitalized with breakthrough infections, which accounts for 0.007% of the state’s 22 million vaccinated people, the Times reported.
The breakthrough infections appear to be more severe among vaccinated people who are older or have weakened immune systems. About 74% of breakthrough cases are among adults 65 or older, the CDC reported.
The increase may shift how vaccinated people see their risks for infection and interact with loved ones. Public health officials have suggested that people follow some COVID-19 safety protocols again, such as wearing masks in public indoor spaces regardless of vaccination status.
As the Delta variant continues to circulate this fall, public health researchers will be researching more about breakthrough cases among vaccinated people, including whether they have prolonged symptoms and how easily they may pass the virus to others.
“I think some of us have been challenged by the numbers of clusters that we’ve seen,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told this news organization.
“I think that really needs to be examined more,” he said.
A version of this article first appeared on WebMD.com.
FDA approves Abbott’s Amplatzer Amulet for AFib
The Food and Drug Administration has approved the Amplatzer Amulet left atrial appendage occluder (Abbott) to treat people with nonvalvular atrial fibrillation who are at increased risk for stroke and systemic embolism.
The Amulet and its competitor, Boston Scientific’s Watchman, are minimally invasive devices used to close off the left atrial appendage (LAA), an area where blood clots tend to form in people with atrial fibrillation.
Amulet uses dual-seal technology to completely and immediately seal the LAA, the company says, whereas the other minimally invasive solution uses a single component to seal the LAA that requires blood-thinning drugs to heal and additional patient monitoring. The Amulet also has the widest range of occluder sizes on the market and is recapturable and repositionable to ensure optimal placement.
“As the world’s population continues to age, we’re seeing a surge in atrial fibrillation cases, and with that comes increased risk of stroke. The approval of Abbott’s Amulet device provides physicians with a treatment option that reduces the risk of stroke and eliminates the need for blood-thinning medication immediately after the procedure, which is incredibly valuable given the bleeding risks associated with these medicines,” Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute at HCA Midwest Health, Overland Park, Kan., and principal investigator for the study that led to FDA approval, said in a news release from Abbott.
The FDA approval is supported by findings from the global Amulet IDE trial, a head-to-head comparison of the Amulet and Watchman devices in 1,878 participants with nonvalvular atrial fibrillation. The results will be presented virtually on Aug. 30 at the 2021 annual congress of the European Society of Cardiology.
The Amplatzer Amulet received CE Mark designation in 2013 and is approved for use in more than 80 countries, including in Australia, Canada, and European countries.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved the Amplatzer Amulet left atrial appendage occluder (Abbott) to treat people with nonvalvular atrial fibrillation who are at increased risk for stroke and systemic embolism.
The Amulet and its competitor, Boston Scientific’s Watchman, are minimally invasive devices used to close off the left atrial appendage (LAA), an area where blood clots tend to form in people with atrial fibrillation.
Amulet uses dual-seal technology to completely and immediately seal the LAA, the company says, whereas the other minimally invasive solution uses a single component to seal the LAA that requires blood-thinning drugs to heal and additional patient monitoring. The Amulet also has the widest range of occluder sizes on the market and is recapturable and repositionable to ensure optimal placement.
“As the world’s population continues to age, we’re seeing a surge in atrial fibrillation cases, and with that comes increased risk of stroke. The approval of Abbott’s Amulet device provides physicians with a treatment option that reduces the risk of stroke and eliminates the need for blood-thinning medication immediately after the procedure, which is incredibly valuable given the bleeding risks associated with these medicines,” Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute at HCA Midwest Health, Overland Park, Kan., and principal investigator for the study that led to FDA approval, said in a news release from Abbott.
The FDA approval is supported by findings from the global Amulet IDE trial, a head-to-head comparison of the Amulet and Watchman devices in 1,878 participants with nonvalvular atrial fibrillation. The results will be presented virtually on Aug. 30 at the 2021 annual congress of the European Society of Cardiology.
The Amplatzer Amulet received CE Mark designation in 2013 and is approved for use in more than 80 countries, including in Australia, Canada, and European countries.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved the Amplatzer Amulet left atrial appendage occluder (Abbott) to treat people with nonvalvular atrial fibrillation who are at increased risk for stroke and systemic embolism.
The Amulet and its competitor, Boston Scientific’s Watchman, are minimally invasive devices used to close off the left atrial appendage (LAA), an area where blood clots tend to form in people with atrial fibrillation.
Amulet uses dual-seal technology to completely and immediately seal the LAA, the company says, whereas the other minimally invasive solution uses a single component to seal the LAA that requires blood-thinning drugs to heal and additional patient monitoring. The Amulet also has the widest range of occluder sizes on the market and is recapturable and repositionable to ensure optimal placement.
“As the world’s population continues to age, we’re seeing a surge in atrial fibrillation cases, and with that comes increased risk of stroke. The approval of Abbott’s Amulet device provides physicians with a treatment option that reduces the risk of stroke and eliminates the need for blood-thinning medication immediately after the procedure, which is incredibly valuable given the bleeding risks associated with these medicines,” Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute at HCA Midwest Health, Overland Park, Kan., and principal investigator for the study that led to FDA approval, said in a news release from Abbott.
The FDA approval is supported by findings from the global Amulet IDE trial, a head-to-head comparison of the Amulet and Watchman devices in 1,878 participants with nonvalvular atrial fibrillation. The results will be presented virtually on Aug. 30 at the 2021 annual congress of the European Society of Cardiology.
The Amplatzer Amulet received CE Mark designation in 2013 and is approved for use in more than 80 countries, including in Australia, Canada, and European countries.
A version of this article first appeared on Medscape.com.
Trial finds that intranasal DHE is well tolerated and may reduce migraine symptoms
, a new study suggests.
A phase 3, open-label trial of INP104, or Trudhesa – Impel NeuroPharma’s proprietary Precision Olfactory Delivery of DHE – found that most patients experienced symptom relief within 2 hours and reported that the medication was easy to use and preferable to their current therapy.
Another treatment option?
Of about 18 million diagnosed migraine patients in the United States, 4 million receive prescription treatment. Nearly 80% of migraine therapies involve triptans, but 30%-40% of patients don’t find adequate relief with triptans. Moreover, the majority of patients who do respond to triptans report that they’d like to try a different therapy.
“INP104 has the potential to deliver rapid symptom relief, without injection, that is well tolerated and suitable for outpatient us,” lead author Timothy Smith, MD, of StudyMetrix Research, St. Louis, and colleagues wrote in the paper.
The results were published online Aug. 7 in Headache.
A total of 360 patients aged 18-65 years with a diagnosis of migraine with or without aura with at least two attacks per month over the course of the previous 6 months were enrolled in the 24-week safety study, which had a 28-week extension period. Participants used their “best usual care” to treat their migraines during the initial 28-day screening period. Afterward, they were given 1.45-mg doses of INP04 to self-administer into the upper nasal space to treat self-recognized attacks. No more than two doses per 24 hours and three doses per 7 days were allowed. The Full Safety Set analysis comprised 354 patients who dosed at least once. The Primary Safety Set involved 185 patients who administered an average of two or more doses per 28-day period during the 24-week treatment period. A total of 4,515 self-recognized migraines were treated during the 24-week period; 6,332 doses of INP04 were analyzed.
Nearly 37% (130/354) of patients reported treatment-emergent adverse events (TEAEs); 6.8% (24/354) discontinued treatment because of the TEAEs over the 24 weeks. The most common TEAE was nasal congestion (15%, 53/354), followed by nausea (6.8%, 24/354).
Within an hour of INP104 administration, 47.6% of patients reported pain relief. After 2 hours of INP104 administration, 38% reported pain freedom and 66.3% reported pain relief. Headache recurrence was observed in 7.1% and 14.3% of patients at 24 and 48 hours, respectively.
In a questionnaire, 84% of patients agreed or strongly agreed that INP04 was easy to use. Most reported that INP104 slowed the recurrence of their migraines and was more rapidly and consistently effective than their previous best usual care treatment.
Intranasal delivery of DHE was developed in response to the challenges of traditional IV administration.
“While intravenous (IV) dihydroergotamine (DHE) mesylate has a long, established history as an effective migraine therapy, its use as an acute treatment can be limited by the high rate of nausea and vomiting reported by patients, which often requires pretreatment with antiemetics,” Dr. Smith and colleagues wrote. “Furthermore, IV DHE mesylate needs to be administered in emergency room settings or by headache specialists, limiting convenience.”
A novel delivery system
“There’s already a nasal spray on the market right now which doesn’t seem to work that well in a large number of people. This device [INP04] was designed to get the same substances to a part of the nose that’s higher and farther back, where there may be better absorption,” said Alan Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said in an interview. Dr. Rapoport was not involved with the study.
The proprietary Precision Olfactory Delivery (POD) is meant to improve on current nasal delivery methods such as sprays, droppers, and pumps, which may deliver “less than 5% of the active drug to the upper nasal space,” according to a press release from Impel NeuroPharma.
Nasal delivery also may have advantages over oral medications. People with migraines may be more likely to have gastroparesis – delayed stomach emptying – which may affect their ability to absorb oral medications and delay symptom relief. However, patients may hesitate to agree to a medication that involves nasal delivery, Dr. Rapoport said.
“I will say it’s a little more difficult getting your patients to take a nasal spray,” Dr. Rapoport said. “Patients are used to taking tablets for their headaches,” he said. “But if the doctor spends a little more time with the patient and says, ‘Look, this could work faster for your migraine as a nasal spray. Why don’t you try it a couple of times and see if you like it or not?’ patients are usually willing to give it a try.”
The study’s limitations include the lack of a control group given that it was an open-label trial. It was carried out at 38 sites in one geographical area, which may affect the generalizability of the results. The study did not assess patients with new-onset migraine or chronic migraine.
The Food and Drug Administration approved Trudhesa on Sept. 2, 2021.
The study was funded by Impel NeuroPharma. Dr. Smith has received funding from a number of pharmaceutical companies. Dr. Rapoport disclosed no relevant financial relationships.
, a new study suggests.
A phase 3, open-label trial of INP104, or Trudhesa – Impel NeuroPharma’s proprietary Precision Olfactory Delivery of DHE – found that most patients experienced symptom relief within 2 hours and reported that the medication was easy to use and preferable to their current therapy.
Another treatment option?
Of about 18 million diagnosed migraine patients in the United States, 4 million receive prescription treatment. Nearly 80% of migraine therapies involve triptans, but 30%-40% of patients don’t find adequate relief with triptans. Moreover, the majority of patients who do respond to triptans report that they’d like to try a different therapy.
“INP104 has the potential to deliver rapid symptom relief, without injection, that is well tolerated and suitable for outpatient us,” lead author Timothy Smith, MD, of StudyMetrix Research, St. Louis, and colleagues wrote in the paper.
The results were published online Aug. 7 in Headache.
A total of 360 patients aged 18-65 years with a diagnosis of migraine with or without aura with at least two attacks per month over the course of the previous 6 months were enrolled in the 24-week safety study, which had a 28-week extension period. Participants used their “best usual care” to treat their migraines during the initial 28-day screening period. Afterward, they were given 1.45-mg doses of INP04 to self-administer into the upper nasal space to treat self-recognized attacks. No more than two doses per 24 hours and three doses per 7 days were allowed. The Full Safety Set analysis comprised 354 patients who dosed at least once. The Primary Safety Set involved 185 patients who administered an average of two or more doses per 28-day period during the 24-week treatment period. A total of 4,515 self-recognized migraines were treated during the 24-week period; 6,332 doses of INP04 were analyzed.
Nearly 37% (130/354) of patients reported treatment-emergent adverse events (TEAEs); 6.8% (24/354) discontinued treatment because of the TEAEs over the 24 weeks. The most common TEAE was nasal congestion (15%, 53/354), followed by nausea (6.8%, 24/354).
Within an hour of INP104 administration, 47.6% of patients reported pain relief. After 2 hours of INP104 administration, 38% reported pain freedom and 66.3% reported pain relief. Headache recurrence was observed in 7.1% and 14.3% of patients at 24 and 48 hours, respectively.
In a questionnaire, 84% of patients agreed or strongly agreed that INP04 was easy to use. Most reported that INP104 slowed the recurrence of their migraines and was more rapidly and consistently effective than their previous best usual care treatment.
Intranasal delivery of DHE was developed in response to the challenges of traditional IV administration.
“While intravenous (IV) dihydroergotamine (DHE) mesylate has a long, established history as an effective migraine therapy, its use as an acute treatment can be limited by the high rate of nausea and vomiting reported by patients, which often requires pretreatment with antiemetics,” Dr. Smith and colleagues wrote. “Furthermore, IV DHE mesylate needs to be administered in emergency room settings or by headache specialists, limiting convenience.”
A novel delivery system
“There’s already a nasal spray on the market right now which doesn’t seem to work that well in a large number of people. This device [INP04] was designed to get the same substances to a part of the nose that’s higher and farther back, where there may be better absorption,” said Alan Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said in an interview. Dr. Rapoport was not involved with the study.
The proprietary Precision Olfactory Delivery (POD) is meant to improve on current nasal delivery methods such as sprays, droppers, and pumps, which may deliver “less than 5% of the active drug to the upper nasal space,” according to a press release from Impel NeuroPharma.
Nasal delivery also may have advantages over oral medications. People with migraines may be more likely to have gastroparesis – delayed stomach emptying – which may affect their ability to absorb oral medications and delay symptom relief. However, patients may hesitate to agree to a medication that involves nasal delivery, Dr. Rapoport said.
“I will say it’s a little more difficult getting your patients to take a nasal spray,” Dr. Rapoport said. “Patients are used to taking tablets for their headaches,” he said. “But if the doctor spends a little more time with the patient and says, ‘Look, this could work faster for your migraine as a nasal spray. Why don’t you try it a couple of times and see if you like it or not?’ patients are usually willing to give it a try.”
The study’s limitations include the lack of a control group given that it was an open-label trial. It was carried out at 38 sites in one geographical area, which may affect the generalizability of the results. The study did not assess patients with new-onset migraine or chronic migraine.
The Food and Drug Administration approved Trudhesa on Sept. 2, 2021.
The study was funded by Impel NeuroPharma. Dr. Smith has received funding from a number of pharmaceutical companies. Dr. Rapoport disclosed no relevant financial relationships.
, a new study suggests.
A phase 3, open-label trial of INP104, or Trudhesa – Impel NeuroPharma’s proprietary Precision Olfactory Delivery of DHE – found that most patients experienced symptom relief within 2 hours and reported that the medication was easy to use and preferable to their current therapy.
Another treatment option?
Of about 18 million diagnosed migraine patients in the United States, 4 million receive prescription treatment. Nearly 80% of migraine therapies involve triptans, but 30%-40% of patients don’t find adequate relief with triptans. Moreover, the majority of patients who do respond to triptans report that they’d like to try a different therapy.
“INP104 has the potential to deliver rapid symptom relief, without injection, that is well tolerated and suitable for outpatient us,” lead author Timothy Smith, MD, of StudyMetrix Research, St. Louis, and colleagues wrote in the paper.
The results were published online Aug. 7 in Headache.
A total of 360 patients aged 18-65 years with a diagnosis of migraine with or without aura with at least two attacks per month over the course of the previous 6 months were enrolled in the 24-week safety study, which had a 28-week extension period. Participants used their “best usual care” to treat their migraines during the initial 28-day screening period. Afterward, they were given 1.45-mg doses of INP04 to self-administer into the upper nasal space to treat self-recognized attacks. No more than two doses per 24 hours and three doses per 7 days were allowed. The Full Safety Set analysis comprised 354 patients who dosed at least once. The Primary Safety Set involved 185 patients who administered an average of two or more doses per 28-day period during the 24-week treatment period. A total of 4,515 self-recognized migraines were treated during the 24-week period; 6,332 doses of INP04 were analyzed.
Nearly 37% (130/354) of patients reported treatment-emergent adverse events (TEAEs); 6.8% (24/354) discontinued treatment because of the TEAEs over the 24 weeks. The most common TEAE was nasal congestion (15%, 53/354), followed by nausea (6.8%, 24/354).
Within an hour of INP104 administration, 47.6% of patients reported pain relief. After 2 hours of INP104 administration, 38% reported pain freedom and 66.3% reported pain relief. Headache recurrence was observed in 7.1% and 14.3% of patients at 24 and 48 hours, respectively.
In a questionnaire, 84% of patients agreed or strongly agreed that INP04 was easy to use. Most reported that INP104 slowed the recurrence of their migraines and was more rapidly and consistently effective than their previous best usual care treatment.
Intranasal delivery of DHE was developed in response to the challenges of traditional IV administration.
“While intravenous (IV) dihydroergotamine (DHE) mesylate has a long, established history as an effective migraine therapy, its use as an acute treatment can be limited by the high rate of nausea and vomiting reported by patients, which often requires pretreatment with antiemetics,” Dr. Smith and colleagues wrote. “Furthermore, IV DHE mesylate needs to be administered in emergency room settings or by headache specialists, limiting convenience.”
A novel delivery system
“There’s already a nasal spray on the market right now which doesn’t seem to work that well in a large number of people. This device [INP04] was designed to get the same substances to a part of the nose that’s higher and farther back, where there may be better absorption,” said Alan Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said in an interview. Dr. Rapoport was not involved with the study.
The proprietary Precision Olfactory Delivery (POD) is meant to improve on current nasal delivery methods such as sprays, droppers, and pumps, which may deliver “less than 5% of the active drug to the upper nasal space,” according to a press release from Impel NeuroPharma.
Nasal delivery also may have advantages over oral medications. People with migraines may be more likely to have gastroparesis – delayed stomach emptying – which may affect their ability to absorb oral medications and delay symptom relief. However, patients may hesitate to agree to a medication that involves nasal delivery, Dr. Rapoport said.
“I will say it’s a little more difficult getting your patients to take a nasal spray,” Dr. Rapoport said. “Patients are used to taking tablets for their headaches,” he said. “But if the doctor spends a little more time with the patient and says, ‘Look, this could work faster for your migraine as a nasal spray. Why don’t you try it a couple of times and see if you like it or not?’ patients are usually willing to give it a try.”
The study’s limitations include the lack of a control group given that it was an open-label trial. It was carried out at 38 sites in one geographical area, which may affect the generalizability of the results. The study did not assess patients with new-onset migraine or chronic migraine.
The Food and Drug Administration approved Trudhesa on Sept. 2, 2021.
The study was funded by Impel NeuroPharma. Dr. Smith has received funding from a number of pharmaceutical companies. Dr. Rapoport disclosed no relevant financial relationships.
From Headache
‘No justification’ for suicide warning on all antiseizure meds
, new research shows. “There appears to be no justification for the FDA to label every new antiseizure medication with a warning that it may increase risk of suicidality,” said study investigator Michael R. Sperling, MD, professor of neurology, Thomas Jefferson University, Philadelphia.
“How many patients are afraid of their medication and do not take it because of the warning – and are consequently at risk because of that? We do not know, but have anecdotal experience that this is certainly an issue,” Dr. Sperling, who is director of the Jefferson Comprehensive Epilepsy Center, added.
The study was published online August 2 in JAMA Neurology.
Blanket warning
In 2008, the FDA issued an alert stating that antiseizure medications increase suicidality. The alert was based on pooled data from placebo-controlled clinical trials that included 11 antiseizure medications – carbamazepine, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine, topiramate, valproate, and zonisamide.
The meta-analytic review showed that, compared with placebo, antiseizure medications nearly doubled suicide risk among patients treated for epilepsy, psychiatric disorders, and other diseases. As a result of the FDA study, all antiseizure medications that have been approved since 2008 carry a warning for suicidality.
However, subsequent analyses did not show the same results, Dr. Sperling and colleagues noted.
“Pivotal” antiseizure medication epilepsy trials since 2008 have evaluated suicidality prospectively. Since 2011, trials have included the validated Columbia Suicidality Severity Rating Scale, they noted.
Meta analysis showed no increased risk
Dr. Sperling and colleagues conducted a meta-analysis of 17 randomized placebo-controlled epilepsy trials of five antiseizure medications approved since 2008. These antiseizure medications were eslicarbazepine, perampanel, brivaracetam, cannabidiol, and cenobamate. The trials involved 5,996 patients, including 4,000 who were treated with antiseizure medications and 1,996 who were treated with placebo.
Confining the analysis to epilepsy trials avoids potential confounders, such as possible differences in suicidality risks between different diseases, the researchers noted.
They found no evidence of increased risk for suicidal ideation (overall risk ratio, antiseizure medications vs. placebo: 0.75; 95% confidence interval: 0.35-1.60) or suicide attempt (risk ratio, 0.75; 95% CI: 0.30-1.87) overall or for any individual antiseizure medication.
Suicidal ideation occurred in 12 of 4,000 patients treated with antiseizure medications (0.30%), versus 7 of 1,996 patients treated with placebo (0.35%) (P = .74). Three patients who were treated with antiseizure medications attempted suicide; no patients who were treated with placebo attempted suicide (P = .22). There were no completed suicides.
“There is no current evidence that the five antiseizure medications evaluated in this study increase suicidality in epilepsy and merit a suicidality class warning,” the investigators wrote. When prescribed for epilepsy, “evidence does not support the FDA’s labeling practice of a blanket assumption of increased suicidality,” said Dr. Sperling.
“Our findings indicate the nonspecific suicide warning for all epilepsy drugs is simply not justifiable,” he said. “The results are not surprising. Different drugs affect cells in different ways. So there’s no reason to expect that every drug would increase suicide risk for every patient,” Dr. Sperling said in a statement.
“It’s important to recognize that epilepsy has many causes – perinatal injury, stroke, tumor, head trauma, developmental malformations, genetic causes, and others – and these underlying etiologies may well contribute to the presence of depression and suicidality in this population,” he said in an interview. “Psychodynamic influences also may occur as a consequence of having seizures. This is a complicated area, and drugs are simply one piece of the puzzle,” he added.
Dr. Sperling said the FDA has accomplished “one useful thing with its warning – it highlighted that physicians and other health care providers must pay attention to their patients’ psychological state, ask questions, and treat accordingly.”
The study had no specific funding. Dr. Sperling has received grants from Eisai, Medtronic, Neurelis, SK Life Science, Sunovion, Takeda, Xenon, Cerevel Therapeutics, UCB Pharma, and Engage Pharma; personal fees from Neurelis, Medscape, Neurology Live, International Medical Press, UCB Pharma, Eisai, Oxford University Press, and Projects in Knowledge. He has also consulted for Medtronic outside the submitted work; payments went to Thomas Jefferson University. A complete list of authors’ disclosures is available with the original article.
A version of this article first appeared on Medscape.com.
, new research shows. “There appears to be no justification for the FDA to label every new antiseizure medication with a warning that it may increase risk of suicidality,” said study investigator Michael R. Sperling, MD, professor of neurology, Thomas Jefferson University, Philadelphia.
“How many patients are afraid of their medication and do not take it because of the warning – and are consequently at risk because of that? We do not know, but have anecdotal experience that this is certainly an issue,” Dr. Sperling, who is director of the Jefferson Comprehensive Epilepsy Center, added.
The study was published online August 2 in JAMA Neurology.
Blanket warning
In 2008, the FDA issued an alert stating that antiseizure medications increase suicidality. The alert was based on pooled data from placebo-controlled clinical trials that included 11 antiseizure medications – carbamazepine, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine, topiramate, valproate, and zonisamide.
The meta-analytic review showed that, compared with placebo, antiseizure medications nearly doubled suicide risk among patients treated for epilepsy, psychiatric disorders, and other diseases. As a result of the FDA study, all antiseizure medications that have been approved since 2008 carry a warning for suicidality.
However, subsequent analyses did not show the same results, Dr. Sperling and colleagues noted.
“Pivotal” antiseizure medication epilepsy trials since 2008 have evaluated suicidality prospectively. Since 2011, trials have included the validated Columbia Suicidality Severity Rating Scale, they noted.
Meta analysis showed no increased risk
Dr. Sperling and colleagues conducted a meta-analysis of 17 randomized placebo-controlled epilepsy trials of five antiseizure medications approved since 2008. These antiseizure medications were eslicarbazepine, perampanel, brivaracetam, cannabidiol, and cenobamate. The trials involved 5,996 patients, including 4,000 who were treated with antiseizure medications and 1,996 who were treated with placebo.
Confining the analysis to epilepsy trials avoids potential confounders, such as possible differences in suicidality risks between different diseases, the researchers noted.
They found no evidence of increased risk for suicidal ideation (overall risk ratio, antiseizure medications vs. placebo: 0.75; 95% confidence interval: 0.35-1.60) or suicide attempt (risk ratio, 0.75; 95% CI: 0.30-1.87) overall or for any individual antiseizure medication.
Suicidal ideation occurred in 12 of 4,000 patients treated with antiseizure medications (0.30%), versus 7 of 1,996 patients treated with placebo (0.35%) (P = .74). Three patients who were treated with antiseizure medications attempted suicide; no patients who were treated with placebo attempted suicide (P = .22). There were no completed suicides.
“There is no current evidence that the five antiseizure medications evaluated in this study increase suicidality in epilepsy and merit a suicidality class warning,” the investigators wrote. When prescribed for epilepsy, “evidence does not support the FDA’s labeling practice of a blanket assumption of increased suicidality,” said Dr. Sperling.
“Our findings indicate the nonspecific suicide warning for all epilepsy drugs is simply not justifiable,” he said. “The results are not surprising. Different drugs affect cells in different ways. So there’s no reason to expect that every drug would increase suicide risk for every patient,” Dr. Sperling said in a statement.
“It’s important to recognize that epilepsy has many causes – perinatal injury, stroke, tumor, head trauma, developmental malformations, genetic causes, and others – and these underlying etiologies may well contribute to the presence of depression and suicidality in this population,” he said in an interview. “Psychodynamic influences also may occur as a consequence of having seizures. This is a complicated area, and drugs are simply one piece of the puzzle,” he added.
Dr. Sperling said the FDA has accomplished “one useful thing with its warning – it highlighted that physicians and other health care providers must pay attention to their patients’ psychological state, ask questions, and treat accordingly.”
The study had no specific funding. Dr. Sperling has received grants from Eisai, Medtronic, Neurelis, SK Life Science, Sunovion, Takeda, Xenon, Cerevel Therapeutics, UCB Pharma, and Engage Pharma; personal fees from Neurelis, Medscape, Neurology Live, International Medical Press, UCB Pharma, Eisai, Oxford University Press, and Projects in Knowledge. He has also consulted for Medtronic outside the submitted work; payments went to Thomas Jefferson University. A complete list of authors’ disclosures is available with the original article.
A version of this article first appeared on Medscape.com.
, new research shows. “There appears to be no justification for the FDA to label every new antiseizure medication with a warning that it may increase risk of suicidality,” said study investigator Michael R. Sperling, MD, professor of neurology, Thomas Jefferson University, Philadelphia.
“How many patients are afraid of their medication and do not take it because of the warning – and are consequently at risk because of that? We do not know, but have anecdotal experience that this is certainly an issue,” Dr. Sperling, who is director of the Jefferson Comprehensive Epilepsy Center, added.
The study was published online August 2 in JAMA Neurology.
Blanket warning
In 2008, the FDA issued an alert stating that antiseizure medications increase suicidality. The alert was based on pooled data from placebo-controlled clinical trials that included 11 antiseizure medications – carbamazepine, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine, topiramate, valproate, and zonisamide.
The meta-analytic review showed that, compared with placebo, antiseizure medications nearly doubled suicide risk among patients treated for epilepsy, psychiatric disorders, and other diseases. As a result of the FDA study, all antiseizure medications that have been approved since 2008 carry a warning for suicidality.
However, subsequent analyses did not show the same results, Dr. Sperling and colleagues noted.
“Pivotal” antiseizure medication epilepsy trials since 2008 have evaluated suicidality prospectively. Since 2011, trials have included the validated Columbia Suicidality Severity Rating Scale, they noted.
Meta analysis showed no increased risk
Dr. Sperling and colleagues conducted a meta-analysis of 17 randomized placebo-controlled epilepsy trials of five antiseizure medications approved since 2008. These antiseizure medications were eslicarbazepine, perampanel, brivaracetam, cannabidiol, and cenobamate. The trials involved 5,996 patients, including 4,000 who were treated with antiseizure medications and 1,996 who were treated with placebo.
Confining the analysis to epilepsy trials avoids potential confounders, such as possible differences in suicidality risks between different diseases, the researchers noted.
They found no evidence of increased risk for suicidal ideation (overall risk ratio, antiseizure medications vs. placebo: 0.75; 95% confidence interval: 0.35-1.60) or suicide attempt (risk ratio, 0.75; 95% CI: 0.30-1.87) overall or for any individual antiseizure medication.
Suicidal ideation occurred in 12 of 4,000 patients treated with antiseizure medications (0.30%), versus 7 of 1,996 patients treated with placebo (0.35%) (P = .74). Three patients who were treated with antiseizure medications attempted suicide; no patients who were treated with placebo attempted suicide (P = .22). There were no completed suicides.
“There is no current evidence that the five antiseizure medications evaluated in this study increase suicidality in epilepsy and merit a suicidality class warning,” the investigators wrote. When prescribed for epilepsy, “evidence does not support the FDA’s labeling practice of a blanket assumption of increased suicidality,” said Dr. Sperling.
“Our findings indicate the nonspecific suicide warning for all epilepsy drugs is simply not justifiable,” he said. “The results are not surprising. Different drugs affect cells in different ways. So there’s no reason to expect that every drug would increase suicide risk for every patient,” Dr. Sperling said in a statement.
“It’s important to recognize that epilepsy has many causes – perinatal injury, stroke, tumor, head trauma, developmental malformations, genetic causes, and others – and these underlying etiologies may well contribute to the presence of depression and suicidality in this population,” he said in an interview. “Psychodynamic influences also may occur as a consequence of having seizures. This is a complicated area, and drugs are simply one piece of the puzzle,” he added.
Dr. Sperling said the FDA has accomplished “one useful thing with its warning – it highlighted that physicians and other health care providers must pay attention to their patients’ psychological state, ask questions, and treat accordingly.”
The study had no specific funding. Dr. Sperling has received grants from Eisai, Medtronic, Neurelis, SK Life Science, Sunovion, Takeda, Xenon, Cerevel Therapeutics, UCB Pharma, and Engage Pharma; personal fees from Neurelis, Medscape, Neurology Live, International Medical Press, UCB Pharma, Eisai, Oxford University Press, and Projects in Knowledge. He has also consulted for Medtronic outside the submitted work; payments went to Thomas Jefferson University. A complete list of authors’ disclosures is available with the original article.
A version of this article first appeared on Medscape.com.
FROM JAMA NEUROLOGY
Walking through time
In the Phoenix summer days of 1998 I did a lot of walking. It wasn’t for exercise, though it was pretty good for that, I guess.
I had privileges at three hospitals, and used their staff directories to make a map of every medical office building in the area I was trying to start my practice in. I was 32, idealistic, married for a year, a child on the way, and we’d just bought our first house. So I had a lot of incentive.
The Phoenix summer isn’t conducive to walking, especially in standard medical office attire (I didn’t give that up until 2006). But I did it. I went into one office after another, introduced myself, gave them my CV, some business cards, and my pager number (yeah, I had a pager). I cooled off and drank water in my car as I drove to the next building – wash, rinse, repeat.
Occasionally the doctors I met would have a few minutes to meet me, which I appreciated. One of them, who’d been in the same boat a few years earlier himself, invited me back to his office, and we chatted for maybe 10 minutes.
We got along, and worked well together for several years. We tended to round at the same times of day and so ran into each other a lot. He sent me patients, I sent him patients, and when we met on rounds we’d talk about nothing in particular for a few minutes.
After I cut back on my hospital work I didn’t see him as much, though we still referred patients back and forth and occasionally crossed paths while covering weekends.
I found out that he retired recently.
It gave me an odd pause. I thought of our first encounter 23 years ago, me trying to get started in my profession, him established, but close enough to recall what it was like to be starting out that he spared a few minutes for me. Remembering that, I still try to make an effort to meet new physicians who come by for the same reason. Hell, they might end up taking care of me someday. Assuming a medical career is 30-40 years, I’m past the halfway point.
Not today, not tomorrow, but in the years to come my generation of physicians will start to retire, walking away from a role that has defined both our personal and professional lives.
I both am and am not looking forward to it. This was just another reminder that .
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
In the Phoenix summer days of 1998 I did a lot of walking. It wasn’t for exercise, though it was pretty good for that, I guess.
I had privileges at three hospitals, and used their staff directories to make a map of every medical office building in the area I was trying to start my practice in. I was 32, idealistic, married for a year, a child on the way, and we’d just bought our first house. So I had a lot of incentive.
The Phoenix summer isn’t conducive to walking, especially in standard medical office attire (I didn’t give that up until 2006). But I did it. I went into one office after another, introduced myself, gave them my CV, some business cards, and my pager number (yeah, I had a pager). I cooled off and drank water in my car as I drove to the next building – wash, rinse, repeat.
Occasionally the doctors I met would have a few minutes to meet me, which I appreciated. One of them, who’d been in the same boat a few years earlier himself, invited me back to his office, and we chatted for maybe 10 minutes.
We got along, and worked well together for several years. We tended to round at the same times of day and so ran into each other a lot. He sent me patients, I sent him patients, and when we met on rounds we’d talk about nothing in particular for a few minutes.
After I cut back on my hospital work I didn’t see him as much, though we still referred patients back and forth and occasionally crossed paths while covering weekends.
I found out that he retired recently.
It gave me an odd pause. I thought of our first encounter 23 years ago, me trying to get started in my profession, him established, but close enough to recall what it was like to be starting out that he spared a few minutes for me. Remembering that, I still try to make an effort to meet new physicians who come by for the same reason. Hell, they might end up taking care of me someday. Assuming a medical career is 30-40 years, I’m past the halfway point.
Not today, not tomorrow, but in the years to come my generation of physicians will start to retire, walking away from a role that has defined both our personal and professional lives.
I both am and am not looking forward to it. This was just another reminder that .
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
In the Phoenix summer days of 1998 I did a lot of walking. It wasn’t for exercise, though it was pretty good for that, I guess.
I had privileges at three hospitals, and used their staff directories to make a map of every medical office building in the area I was trying to start my practice in. I was 32, idealistic, married for a year, a child on the way, and we’d just bought our first house. So I had a lot of incentive.
The Phoenix summer isn’t conducive to walking, especially in standard medical office attire (I didn’t give that up until 2006). But I did it. I went into one office after another, introduced myself, gave them my CV, some business cards, and my pager number (yeah, I had a pager). I cooled off and drank water in my car as I drove to the next building – wash, rinse, repeat.
Occasionally the doctors I met would have a few minutes to meet me, which I appreciated. One of them, who’d been in the same boat a few years earlier himself, invited me back to his office, and we chatted for maybe 10 minutes.
We got along, and worked well together for several years. We tended to round at the same times of day and so ran into each other a lot. He sent me patients, I sent him patients, and when we met on rounds we’d talk about nothing in particular for a few minutes.
After I cut back on my hospital work I didn’t see him as much, though we still referred patients back and forth and occasionally crossed paths while covering weekends.
I found out that he retired recently.
It gave me an odd pause. I thought of our first encounter 23 years ago, me trying to get started in my profession, him established, but close enough to recall what it was like to be starting out that he spared a few minutes for me. Remembering that, I still try to make an effort to meet new physicians who come by for the same reason. Hell, they might end up taking care of me someday. Assuming a medical career is 30-40 years, I’m past the halfway point.
Not today, not tomorrow, but in the years to come my generation of physicians will start to retire, walking away from a role that has defined both our personal and professional lives.
I both am and am not looking forward to it. This was just another reminder that .
Dr. Block has a solo neurology practice in Scottsdale, Ariz.