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Macitentan produces similar results in PAH-SSc and IPAH/HPAH
NEW ORLEANS – Real-world data support the use of macitentan to treat pulmonary arterial hypertension (PAH) associated with connective tissue disease, according to a speaker at the annual meeting of the American College of Chest Physicians.
Outcomes of macitentan (Opsumit) treatment were similar in patients who had PAH associated with systemic sclerosis (PAH-SSc) and patients who had idiopathic PAH (IPAH) or heritable PAH (HPAH), Vallerie McLaughlin, MD, of the University of Michigan, Ann Arbor, said at the meeting.
“Within the limits of a real-world registry, these data add to the growing body of evidence supporting the use of macitentan for treatment in patients with CTD [connective tissue disease],” Dr. McLaughlin said.
She and her colleagues evaluated data from the prospective OPUS registry (NCT02126943) and the retrospective OrPHeUS study (NCT03197688), both of which included patients who were newly started on macitentan.
Dr. McLaughlin presented data on 2,311 patients with IPAH/HPAH and 668 patients with PAH-SSc. She also presented data on patients with PAH-systemic lupus erythematosus and PAH-mixed CTD, but numbers in these groups were small, and outcomes were similar to those in the PAH-SSc group.
Demographic and disease characteristics at the start of macitentan were similar between the IPAH/HPAH and PAH-SSc groups. The median age was 64 years in both groups. The median time from PAH diagnosis was 7.6 months in the IPAH/HPAH group and 8.5 months in the PAH-SSc group.
The median duration of macitentan exposure was 13.4 months in the IPAH/HPAH group and 14.4 months in the PAH-SSc group. The proportion of patients receiving macitentan in combination with other therapies (double or triple combinations) increased from baseline to 6 months in both groups.
Hepatic adverse events occurred in 7.4% of IPAH/HPAH patients and 7.9% of PAH-SSc patients. The most common adverse events among the IPAH/HPAH and PAH-SSc groups in the OPUS registry alone were dyspnea (19% and 26.1%, respectively), peripheral edema (9.8% and 12.4%), fatigue (6.8% and 11.7%), anemia (6.7% and 11.7%), headache (10.2% and 11%), and dizziness (6.7% and 10.7%).
About 39% of patients in both groups discontinued macitentan. Similar proportions in each group discontinued because of adverse events (17% in the IPAH/HPAH group and 18.3% in the PAH-SSc group) and hepatic adverse events (0.2% and 0.7%, respectively).
The proportion of patients with at least one hospitalization was 36.2% in the IPAH/HPAH group and 40.1% in the PAH-SSc group.
The 12-month Kaplan-Meier survival estimate was 92.9% in the IPAH/HPAH group and 91.3% in the PAH-SSc group. The 24-month estimated survival rate was 85.6% and 82.1%, respectively.
The OPUS registry and OrPHeUS study are sponsored by Actelion. Dr. McLaughlin disclosed relationships with Actelion, Acceleron, Bayer, Caremark, CiVi Biopharma, Reata, Sonovie, and United Therapeutics.
SOURCE: McLaughlin V et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.827.
NEW ORLEANS – Real-world data support the use of macitentan to treat pulmonary arterial hypertension (PAH) associated with connective tissue disease, according to a speaker at the annual meeting of the American College of Chest Physicians.
Outcomes of macitentan (Opsumit) treatment were similar in patients who had PAH associated with systemic sclerosis (PAH-SSc) and patients who had idiopathic PAH (IPAH) or heritable PAH (HPAH), Vallerie McLaughlin, MD, of the University of Michigan, Ann Arbor, said at the meeting.
“Within the limits of a real-world registry, these data add to the growing body of evidence supporting the use of macitentan for treatment in patients with CTD [connective tissue disease],” Dr. McLaughlin said.
She and her colleagues evaluated data from the prospective OPUS registry (NCT02126943) and the retrospective OrPHeUS study (NCT03197688), both of which included patients who were newly started on macitentan.
Dr. McLaughlin presented data on 2,311 patients with IPAH/HPAH and 668 patients with PAH-SSc. She also presented data on patients with PAH-systemic lupus erythematosus and PAH-mixed CTD, but numbers in these groups were small, and outcomes were similar to those in the PAH-SSc group.
Demographic and disease characteristics at the start of macitentan were similar between the IPAH/HPAH and PAH-SSc groups. The median age was 64 years in both groups. The median time from PAH diagnosis was 7.6 months in the IPAH/HPAH group and 8.5 months in the PAH-SSc group.
The median duration of macitentan exposure was 13.4 months in the IPAH/HPAH group and 14.4 months in the PAH-SSc group. The proportion of patients receiving macitentan in combination with other therapies (double or triple combinations) increased from baseline to 6 months in both groups.
Hepatic adverse events occurred in 7.4% of IPAH/HPAH patients and 7.9% of PAH-SSc patients. The most common adverse events among the IPAH/HPAH and PAH-SSc groups in the OPUS registry alone were dyspnea (19% and 26.1%, respectively), peripheral edema (9.8% and 12.4%), fatigue (6.8% and 11.7%), anemia (6.7% and 11.7%), headache (10.2% and 11%), and dizziness (6.7% and 10.7%).
About 39% of patients in both groups discontinued macitentan. Similar proportions in each group discontinued because of adverse events (17% in the IPAH/HPAH group and 18.3% in the PAH-SSc group) and hepatic adverse events (0.2% and 0.7%, respectively).
The proportion of patients with at least one hospitalization was 36.2% in the IPAH/HPAH group and 40.1% in the PAH-SSc group.
The 12-month Kaplan-Meier survival estimate was 92.9% in the IPAH/HPAH group and 91.3% in the PAH-SSc group. The 24-month estimated survival rate was 85.6% and 82.1%, respectively.
The OPUS registry and OrPHeUS study are sponsored by Actelion. Dr. McLaughlin disclosed relationships with Actelion, Acceleron, Bayer, Caremark, CiVi Biopharma, Reata, Sonovie, and United Therapeutics.
SOURCE: McLaughlin V et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.827.
NEW ORLEANS – Real-world data support the use of macitentan to treat pulmonary arterial hypertension (PAH) associated with connective tissue disease, according to a speaker at the annual meeting of the American College of Chest Physicians.
Outcomes of macitentan (Opsumit) treatment were similar in patients who had PAH associated with systemic sclerosis (PAH-SSc) and patients who had idiopathic PAH (IPAH) or heritable PAH (HPAH), Vallerie McLaughlin, MD, of the University of Michigan, Ann Arbor, said at the meeting.
“Within the limits of a real-world registry, these data add to the growing body of evidence supporting the use of macitentan for treatment in patients with CTD [connective tissue disease],” Dr. McLaughlin said.
She and her colleagues evaluated data from the prospective OPUS registry (NCT02126943) and the retrospective OrPHeUS study (NCT03197688), both of which included patients who were newly started on macitentan.
Dr. McLaughlin presented data on 2,311 patients with IPAH/HPAH and 668 patients with PAH-SSc. She also presented data on patients with PAH-systemic lupus erythematosus and PAH-mixed CTD, but numbers in these groups were small, and outcomes were similar to those in the PAH-SSc group.
Demographic and disease characteristics at the start of macitentan were similar between the IPAH/HPAH and PAH-SSc groups. The median age was 64 years in both groups. The median time from PAH diagnosis was 7.6 months in the IPAH/HPAH group and 8.5 months in the PAH-SSc group.
The median duration of macitentan exposure was 13.4 months in the IPAH/HPAH group and 14.4 months in the PAH-SSc group. The proportion of patients receiving macitentan in combination with other therapies (double or triple combinations) increased from baseline to 6 months in both groups.
Hepatic adverse events occurred in 7.4% of IPAH/HPAH patients and 7.9% of PAH-SSc patients. The most common adverse events among the IPAH/HPAH and PAH-SSc groups in the OPUS registry alone were dyspnea (19% and 26.1%, respectively), peripheral edema (9.8% and 12.4%), fatigue (6.8% and 11.7%), anemia (6.7% and 11.7%), headache (10.2% and 11%), and dizziness (6.7% and 10.7%).
About 39% of patients in both groups discontinued macitentan. Similar proportions in each group discontinued because of adverse events (17% in the IPAH/HPAH group and 18.3% in the PAH-SSc group) and hepatic adverse events (0.2% and 0.7%, respectively).
The proportion of patients with at least one hospitalization was 36.2% in the IPAH/HPAH group and 40.1% in the PAH-SSc group.
The 12-month Kaplan-Meier survival estimate was 92.9% in the IPAH/HPAH group and 91.3% in the PAH-SSc group. The 24-month estimated survival rate was 85.6% and 82.1%, respectively.
The OPUS registry and OrPHeUS study are sponsored by Actelion. Dr. McLaughlin disclosed relationships with Actelion, Acceleron, Bayer, Caremark, CiVi Biopharma, Reata, Sonovie, and United Therapeutics.
SOURCE: McLaughlin V et al. CHEST 2019. Abstract, doi: 10.1016/j.chest.2019.08.827.
REPORTING FROM CHEST 2019
Net prices of drugs rising four-times faster than inflation
NATIONAL HARBOR, MD. – The net prices of drugs are increasing four times faster than the rate of inflation, despite being offset 43% from list prices.
List prices increased by 232% from 2007 to 2018 (12% per year) and net prices increased 133% during that same time period. For Medicaid, the gross-to-net discount increased from 40% in 2007 to 68% in 2018. For all other payers, the increase was 22%-50% during that same period, Inmaculada Hernandez, PharmD, and colleagues reported at annual meeting of the Academy of Managed Care Pharmacy.
The investigators also found a wide variation on discounts across therapeutic classes. For example, list price for drugs in the multiple sclerosis category increased 407% over the study period while net price increased 221%. Insulins came in second in terms of gross price increases (337%) but saw only net prices increases by 83% due to increasing discounts, according to Dr. Hernandez, assistant professor of pharmacy and therapeutics at the University of Pittsburgh.
List prices for noninsulin diabetes treatments tripled during the observation period, but net prices went up only 24%. List price increases were lowest in the antineoplastic class, averaging 135%, though there were only 34% in rebates to offset the list price, resulting in an average net price increase of 89%.
Research was based on pricing data supplied by investment firm SSR Health for branded products and U.S. sales reported by publicly traded companies. The National Heart, Lung, and Blood Institute sponsored the study.
SOURCE: Hernandez I et a. AMCP Nexus, poster U2.
NATIONAL HARBOR, MD. – The net prices of drugs are increasing four times faster than the rate of inflation, despite being offset 43% from list prices.
List prices increased by 232% from 2007 to 2018 (12% per year) and net prices increased 133% during that same time period. For Medicaid, the gross-to-net discount increased from 40% in 2007 to 68% in 2018. For all other payers, the increase was 22%-50% during that same period, Inmaculada Hernandez, PharmD, and colleagues reported at annual meeting of the Academy of Managed Care Pharmacy.
The investigators also found a wide variation on discounts across therapeutic classes. For example, list price for drugs in the multiple sclerosis category increased 407% over the study period while net price increased 221%. Insulins came in second in terms of gross price increases (337%) but saw only net prices increases by 83% due to increasing discounts, according to Dr. Hernandez, assistant professor of pharmacy and therapeutics at the University of Pittsburgh.
List prices for noninsulin diabetes treatments tripled during the observation period, but net prices went up only 24%. List price increases were lowest in the antineoplastic class, averaging 135%, though there were only 34% in rebates to offset the list price, resulting in an average net price increase of 89%.
Research was based on pricing data supplied by investment firm SSR Health for branded products and U.S. sales reported by publicly traded companies. The National Heart, Lung, and Blood Institute sponsored the study.
SOURCE: Hernandez I et a. AMCP Nexus, poster U2.
NATIONAL HARBOR, MD. – The net prices of drugs are increasing four times faster than the rate of inflation, despite being offset 43% from list prices.
List prices increased by 232% from 2007 to 2018 (12% per year) and net prices increased 133% during that same time period. For Medicaid, the gross-to-net discount increased from 40% in 2007 to 68% in 2018. For all other payers, the increase was 22%-50% during that same period, Inmaculada Hernandez, PharmD, and colleagues reported at annual meeting of the Academy of Managed Care Pharmacy.
The investigators also found a wide variation on discounts across therapeutic classes. For example, list price for drugs in the multiple sclerosis category increased 407% over the study period while net price increased 221%. Insulins came in second in terms of gross price increases (337%) but saw only net prices increases by 83% due to increasing discounts, according to Dr. Hernandez, assistant professor of pharmacy and therapeutics at the University of Pittsburgh.
List prices for noninsulin diabetes treatments tripled during the observation period, but net prices went up only 24%. List price increases were lowest in the antineoplastic class, averaging 135%, though there were only 34% in rebates to offset the list price, resulting in an average net price increase of 89%.
Research was based on pricing data supplied by investment firm SSR Health for branded products and U.S. sales reported by publicly traded companies. The National Heart, Lung, and Blood Institute sponsored the study.
SOURCE: Hernandez I et a. AMCP Nexus, poster U2.
REPORTING FROM AMCP NEXUS 2019
Quick Byte: DeepMind emerges
The science of prediction
Hundreds of scientists around the world enter a competition every 2 years called the Critical Assessment of Structure Prediction.
“Tackling a biological puzzle they call ‘the protein folding problem,’ they try to predict the three-dimensional shape of proteins in the human body. No one knows how to solve the problem. Even the winners only chip away at it. But a solution could streamline the way scientists create new medicines and fight disease,” according to a report in the New York Times.
In 2019, those scientists did not win the contest. “It was won by DeepMind, the artificial intelligence lab owned by Google’s parent company. DeepMind specializes in ‘deep learning,’ a type of artificial intelligence that is rapidly changing drug discovery science.”
Reference
1. Metz C. “Making New Drugs With a Dose of Artificial Intelligence,” New York Times. Feb. 5, 2019. https://www.nytimes.com/2019/02/05/technology/artificial-intelligence-drug-research-deepmind.html. Accessed Feb 7, 2019.
The science of prediction
The science of prediction
Hundreds of scientists around the world enter a competition every 2 years called the Critical Assessment of Structure Prediction.
“Tackling a biological puzzle they call ‘the protein folding problem,’ they try to predict the three-dimensional shape of proteins in the human body. No one knows how to solve the problem. Even the winners only chip away at it. But a solution could streamline the way scientists create new medicines and fight disease,” according to a report in the New York Times.
In 2019, those scientists did not win the contest. “It was won by DeepMind, the artificial intelligence lab owned by Google’s parent company. DeepMind specializes in ‘deep learning,’ a type of artificial intelligence that is rapidly changing drug discovery science.”
Reference
1. Metz C. “Making New Drugs With a Dose of Artificial Intelligence,” New York Times. Feb. 5, 2019. https://www.nytimes.com/2019/02/05/technology/artificial-intelligence-drug-research-deepmind.html. Accessed Feb 7, 2019.
Hundreds of scientists around the world enter a competition every 2 years called the Critical Assessment of Structure Prediction.
“Tackling a biological puzzle they call ‘the protein folding problem,’ they try to predict the three-dimensional shape of proteins in the human body. No one knows how to solve the problem. Even the winners only chip away at it. But a solution could streamline the way scientists create new medicines and fight disease,” according to a report in the New York Times.
In 2019, those scientists did not win the contest. “It was won by DeepMind, the artificial intelligence lab owned by Google’s parent company. DeepMind specializes in ‘deep learning,’ a type of artificial intelligence that is rapidly changing drug discovery science.”
Reference
1. Metz C. “Making New Drugs With a Dose of Artificial Intelligence,” New York Times. Feb. 5, 2019. https://www.nytimes.com/2019/02/05/technology/artificial-intelligence-drug-research-deepmind.html. Accessed Feb 7, 2019.
Thousands of Emergency-Care Claims Were Denied; Court Rules VA Must Reimburse
When veterans receive emergency care at non-VA facilities, they can file for reimbursement of non-VA emergency care costs. If the claims are denied or rejected, non-VA facilities and providers can bill the veterans for some or all of the costs.
A stunning VA Office of Inspector General (OIG) report issued in August revealed that the VA had wrongfully rejected thousands of those emergency-care claims between April 1, 2017 and September 30, 2017. The OIG report said VA supervisors had pressured staff to quickly decide claims and even deny claims to maximize productivity. That culture of “speed over accuracy” led to 31% of claims being “inappropriately processed.”
Under regulations, when a claim is denied it is because there is no basis for payment, but a claim may also be rejected, meaning it cannot be decided until the claimant provides additional or corrected information. When the Claims Adjudication and Reimbursement Directorate (CAR) in the VA Office of Community Care (OCC) denies a claim, the claimant may have to pay out of pocket for emergency care.
The billed amount of inappropriately processed claims in those 5 months that were denied or rejected was “large in the aggregate,” the report said: an estimated $716 million, presenting potential undue financial risk to an estimated 60,800 veterans. The OIG estimated that about 17,400 veterans, with bills of at least $53.3 million, were negatively affected during the audit period. If corrective actions are not taken, the OIG estimates that the errors could result in $533 million in improper underpayments over 5 years.
The OIG audit was initiated after then Representative Tim Walz (D-MN) raised the concern in September 2017 about claims processors denying non-VA claims not only to meet production goals, but also to receive incentives such as high-performance ratings, bonuses, and telework privileges. The OIG audit also found that examiners who did not consistently meet the production numbers were not considered for overtime and had their telework privileges removed.
Other processing errors were also significant, the report says. For example, claimants did not receive complete and accurate information regarding why their claims were denied or rejected. Those errors created a risk that claimants could not effectively respond with information to get their claims approved.
The pressure to approve or deny claims quickly stemmed from a backlog of claims > 30 days old, which OCC and CAR leaders tried to reduce, the report says.
The OIG notes that since FY 2017 the OCC “experienced several leadership changes,” including 3 CAR directors. While the audit’s findings cannot be tied directly to those changes, the instability “provided the context in which problems were allowed to continue without remediation.”
In May, VHA officials reported to the audit team that they had implemented process improvements and initiatives that affect claims processing nationwide, and “the environment in which claims are processed.” Richard Stone, executive in charge of the VHA, submitted plans to comply with the IG’s 11 recommendations, which included tying incentives to all performance standards rather than just production quantity.
The US Court of Appeals for Veterans Claims recently ruled that the VA must reimburse veterans for emergency medical care at non-VA facilities—potentially between $1.8 billion and $6.5 billion in reimbursements for veterans who have filed or will file claims between 2016 and 2025. The court also struck down an internal VA regulation that blocked such payments. In 2015, the court had struck down a previous version of the internal regulation that refused coverage for an emergency claim when another form of insurance covered even a small part of the bill. The court said that regulation violated a 2010 federal law. In last month’s ruling, the court found the department had violated the same federal law with its revision of the reimbursement regulation, issued in 2018. The new rule, the panel said, created a new obstacle for veterans.
When veterans receive emergency care at non-VA facilities, they can file for reimbursement of non-VA emergency care costs. If the claims are denied or rejected, non-VA facilities and providers can bill the veterans for some or all of the costs.
A stunning VA Office of Inspector General (OIG) report issued in August revealed that the VA had wrongfully rejected thousands of those emergency-care claims between April 1, 2017 and September 30, 2017. The OIG report said VA supervisors had pressured staff to quickly decide claims and even deny claims to maximize productivity. That culture of “speed over accuracy” led to 31% of claims being “inappropriately processed.”
Under regulations, when a claim is denied it is because there is no basis for payment, but a claim may also be rejected, meaning it cannot be decided until the claimant provides additional or corrected information. When the Claims Adjudication and Reimbursement Directorate (CAR) in the VA Office of Community Care (OCC) denies a claim, the claimant may have to pay out of pocket for emergency care.
The billed amount of inappropriately processed claims in those 5 months that were denied or rejected was “large in the aggregate,” the report said: an estimated $716 million, presenting potential undue financial risk to an estimated 60,800 veterans. The OIG estimated that about 17,400 veterans, with bills of at least $53.3 million, were negatively affected during the audit period. If corrective actions are not taken, the OIG estimates that the errors could result in $533 million in improper underpayments over 5 years.
The OIG audit was initiated after then Representative Tim Walz (D-MN) raised the concern in September 2017 about claims processors denying non-VA claims not only to meet production goals, but also to receive incentives such as high-performance ratings, bonuses, and telework privileges. The OIG audit also found that examiners who did not consistently meet the production numbers were not considered for overtime and had their telework privileges removed.
Other processing errors were also significant, the report says. For example, claimants did not receive complete and accurate information regarding why their claims were denied or rejected. Those errors created a risk that claimants could not effectively respond with information to get their claims approved.
The pressure to approve or deny claims quickly stemmed from a backlog of claims > 30 days old, which OCC and CAR leaders tried to reduce, the report says.
The OIG notes that since FY 2017 the OCC “experienced several leadership changes,” including 3 CAR directors. While the audit’s findings cannot be tied directly to those changes, the instability “provided the context in which problems were allowed to continue without remediation.”
In May, VHA officials reported to the audit team that they had implemented process improvements and initiatives that affect claims processing nationwide, and “the environment in which claims are processed.” Richard Stone, executive in charge of the VHA, submitted plans to comply with the IG’s 11 recommendations, which included tying incentives to all performance standards rather than just production quantity.
The US Court of Appeals for Veterans Claims recently ruled that the VA must reimburse veterans for emergency medical care at non-VA facilities—potentially between $1.8 billion and $6.5 billion in reimbursements for veterans who have filed or will file claims between 2016 and 2025. The court also struck down an internal VA regulation that blocked such payments. In 2015, the court had struck down a previous version of the internal regulation that refused coverage for an emergency claim when another form of insurance covered even a small part of the bill. The court said that regulation violated a 2010 federal law. In last month’s ruling, the court found the department had violated the same federal law with its revision of the reimbursement regulation, issued in 2018. The new rule, the panel said, created a new obstacle for veterans.
When veterans receive emergency care at non-VA facilities, they can file for reimbursement of non-VA emergency care costs. If the claims are denied or rejected, non-VA facilities and providers can bill the veterans for some or all of the costs.
A stunning VA Office of Inspector General (OIG) report issued in August revealed that the VA had wrongfully rejected thousands of those emergency-care claims between April 1, 2017 and September 30, 2017. The OIG report said VA supervisors had pressured staff to quickly decide claims and even deny claims to maximize productivity. That culture of “speed over accuracy” led to 31% of claims being “inappropriately processed.”
Under regulations, when a claim is denied it is because there is no basis for payment, but a claim may also be rejected, meaning it cannot be decided until the claimant provides additional or corrected information. When the Claims Adjudication and Reimbursement Directorate (CAR) in the VA Office of Community Care (OCC) denies a claim, the claimant may have to pay out of pocket for emergency care.
The billed amount of inappropriately processed claims in those 5 months that were denied or rejected was “large in the aggregate,” the report said: an estimated $716 million, presenting potential undue financial risk to an estimated 60,800 veterans. The OIG estimated that about 17,400 veterans, with bills of at least $53.3 million, were negatively affected during the audit period. If corrective actions are not taken, the OIG estimates that the errors could result in $533 million in improper underpayments over 5 years.
The OIG audit was initiated after then Representative Tim Walz (D-MN) raised the concern in September 2017 about claims processors denying non-VA claims not only to meet production goals, but also to receive incentives such as high-performance ratings, bonuses, and telework privileges. The OIG audit also found that examiners who did not consistently meet the production numbers were not considered for overtime and had their telework privileges removed.
Other processing errors were also significant, the report says. For example, claimants did not receive complete and accurate information regarding why their claims were denied or rejected. Those errors created a risk that claimants could not effectively respond with information to get their claims approved.
The pressure to approve or deny claims quickly stemmed from a backlog of claims > 30 days old, which OCC and CAR leaders tried to reduce, the report says.
The OIG notes that since FY 2017 the OCC “experienced several leadership changes,” including 3 CAR directors. While the audit’s findings cannot be tied directly to those changes, the instability “provided the context in which problems were allowed to continue without remediation.”
In May, VHA officials reported to the audit team that they had implemented process improvements and initiatives that affect claims processing nationwide, and “the environment in which claims are processed.” Richard Stone, executive in charge of the VHA, submitted plans to comply with the IG’s 11 recommendations, which included tying incentives to all performance standards rather than just production quantity.
The US Court of Appeals for Veterans Claims recently ruled that the VA must reimburse veterans for emergency medical care at non-VA facilities—potentially between $1.8 billion and $6.5 billion in reimbursements for veterans who have filed or will file claims between 2016 and 2025. The court also struck down an internal VA regulation that blocked such payments. In 2015, the court had struck down a previous version of the internal regulation that refused coverage for an emergency claim when another form of insurance covered even a small part of the bill. The court said that regulation violated a 2010 federal law. In last month’s ruling, the court found the department had violated the same federal law with its revision of the reimbursement regulation, issued in 2018. The new rule, the panel said, created a new obstacle for veterans.
AChR autoantibody subtype testing may improve accuracy of myasthenia gravis evaluations
AUSTIN, TEX. – When testing for acetylcholine receptor (AChR) autoantibodies in patients with suspected myasthenia gravis, testing for binding antibodies and for modulating antibodies is more accurate than testing for either subtype alone, researchers reported at the annual meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine. Testing for both subtypes may be the most accurate approach, regardless of whether patients have coexisting neuromuscular disorders, the researchers said.
“The advent of improved methods of detecting AChR autoantibodies has greatly facilitated the diagnosis of myasthenia gravis,” said Pritikanta Paul, MBBS, a neuromuscular fellow at Mayo Clinic in Rochester, Minn., and his colleagues. AChR antibody assays frequently are part of evaluations for myasthenia gravis, but clinicians lack consensus as to which antibody subtypes – binding, blocking, or modulating – should be tested. Clinicians test for binding antibodies most commonly, while studies have found blocking antibodies to be “least useful as an initial diagnostic test,” Dr. Paul and his colleagues said.
To assess how combinatorial antibody testing and the presence of coexisting neuromuscular disorders affect testing’s sensitivity and specificity, the researchers reviewed clinical and electrophysiologic testing data from 360 patients with suspected myasthenia gravis who underwent serologic autoantibody testing between 2012 and 2015.
Titers of AChR binding antibodies greater than 0.02 nmol/L were considered positive, as were AChR modulating antibodies more than 20%. The researchers used a greater than 10% decrement of the compound muscle action potential to repetitive nerve stimulation at 2 Hz or positive response on single-fiber EMG as electrophysiologic confirmation of myasthenia gravis.
In all, 123 of the 360 patients had a final clinical and electrophysiologic diagnosis of myasthenia gravis, including 23 with ocular myasthenia gravis and 100 with generalized myasthenia gravis.
The sensitivity of testing for AChR binding autoantibodies was 92%, and the sensitivity of testing for modulating autoantibodies was 90%. In comparison, the sensitivity of testing for either antibody subtype or both was 94%.
Among 45 patients with myasthenia gravis and coexisting neuromuscular disorders, including peripheral neuropathy, mononeuropathies, radiculopathy, and motor neuron disease, the sensitivities of testing for binding antibodies, modulating antibodies, and either or both were 96%, 91%, and 96%, respectively.
Of the 237 patients who did not have myasthenia gravis, 89 had electrophysiologic confirmation of alternative diagnoses. Among these 89 patients, AChR autoantibody testing yielded 11 false positives. Three patients tested positive for both binding and modulating antibodies, six for binding antibodies only, and two for modulating antibodies only. Those with false-positive results had diagnoses that were “diverse and clinically distinguishable from myasthenia gravis,” including myalgia, neuropathy, blurred vision, epilepsy, encephalopathy, and hemifacial spasm, the researchers said.
The researchers had no relevant disclosures.
SOURCE: Paul P et al. AANEM 2019, Abstract 236.
AUSTIN, TEX. – When testing for acetylcholine receptor (AChR) autoantibodies in patients with suspected myasthenia gravis, testing for binding antibodies and for modulating antibodies is more accurate than testing for either subtype alone, researchers reported at the annual meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine. Testing for both subtypes may be the most accurate approach, regardless of whether patients have coexisting neuromuscular disorders, the researchers said.
“The advent of improved methods of detecting AChR autoantibodies has greatly facilitated the diagnosis of myasthenia gravis,” said Pritikanta Paul, MBBS, a neuromuscular fellow at Mayo Clinic in Rochester, Minn., and his colleagues. AChR antibody assays frequently are part of evaluations for myasthenia gravis, but clinicians lack consensus as to which antibody subtypes – binding, blocking, or modulating – should be tested. Clinicians test for binding antibodies most commonly, while studies have found blocking antibodies to be “least useful as an initial diagnostic test,” Dr. Paul and his colleagues said.
To assess how combinatorial antibody testing and the presence of coexisting neuromuscular disorders affect testing’s sensitivity and specificity, the researchers reviewed clinical and electrophysiologic testing data from 360 patients with suspected myasthenia gravis who underwent serologic autoantibody testing between 2012 and 2015.
Titers of AChR binding antibodies greater than 0.02 nmol/L were considered positive, as were AChR modulating antibodies more than 20%. The researchers used a greater than 10% decrement of the compound muscle action potential to repetitive nerve stimulation at 2 Hz or positive response on single-fiber EMG as electrophysiologic confirmation of myasthenia gravis.
In all, 123 of the 360 patients had a final clinical and electrophysiologic diagnosis of myasthenia gravis, including 23 with ocular myasthenia gravis and 100 with generalized myasthenia gravis.
The sensitivity of testing for AChR binding autoantibodies was 92%, and the sensitivity of testing for modulating autoantibodies was 90%. In comparison, the sensitivity of testing for either antibody subtype or both was 94%.
Among 45 patients with myasthenia gravis and coexisting neuromuscular disorders, including peripheral neuropathy, mononeuropathies, radiculopathy, and motor neuron disease, the sensitivities of testing for binding antibodies, modulating antibodies, and either or both were 96%, 91%, and 96%, respectively.
Of the 237 patients who did not have myasthenia gravis, 89 had electrophysiologic confirmation of alternative diagnoses. Among these 89 patients, AChR autoantibody testing yielded 11 false positives. Three patients tested positive for both binding and modulating antibodies, six for binding antibodies only, and two for modulating antibodies only. Those with false-positive results had diagnoses that were “diverse and clinically distinguishable from myasthenia gravis,” including myalgia, neuropathy, blurred vision, epilepsy, encephalopathy, and hemifacial spasm, the researchers said.
The researchers had no relevant disclosures.
SOURCE: Paul P et al. AANEM 2019, Abstract 236.
AUSTIN, TEX. – When testing for acetylcholine receptor (AChR) autoantibodies in patients with suspected myasthenia gravis, testing for binding antibodies and for modulating antibodies is more accurate than testing for either subtype alone, researchers reported at the annual meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine. Testing for both subtypes may be the most accurate approach, regardless of whether patients have coexisting neuromuscular disorders, the researchers said.
“The advent of improved methods of detecting AChR autoantibodies has greatly facilitated the diagnosis of myasthenia gravis,” said Pritikanta Paul, MBBS, a neuromuscular fellow at Mayo Clinic in Rochester, Minn., and his colleagues. AChR antibody assays frequently are part of evaluations for myasthenia gravis, but clinicians lack consensus as to which antibody subtypes – binding, blocking, or modulating – should be tested. Clinicians test for binding antibodies most commonly, while studies have found blocking antibodies to be “least useful as an initial diagnostic test,” Dr. Paul and his colleagues said.
To assess how combinatorial antibody testing and the presence of coexisting neuromuscular disorders affect testing’s sensitivity and specificity, the researchers reviewed clinical and electrophysiologic testing data from 360 patients with suspected myasthenia gravis who underwent serologic autoantibody testing between 2012 and 2015.
Titers of AChR binding antibodies greater than 0.02 nmol/L were considered positive, as were AChR modulating antibodies more than 20%. The researchers used a greater than 10% decrement of the compound muscle action potential to repetitive nerve stimulation at 2 Hz or positive response on single-fiber EMG as electrophysiologic confirmation of myasthenia gravis.
In all, 123 of the 360 patients had a final clinical and electrophysiologic diagnosis of myasthenia gravis, including 23 with ocular myasthenia gravis and 100 with generalized myasthenia gravis.
The sensitivity of testing for AChR binding autoantibodies was 92%, and the sensitivity of testing for modulating autoantibodies was 90%. In comparison, the sensitivity of testing for either antibody subtype or both was 94%.
Among 45 patients with myasthenia gravis and coexisting neuromuscular disorders, including peripheral neuropathy, mononeuropathies, radiculopathy, and motor neuron disease, the sensitivities of testing for binding antibodies, modulating antibodies, and either or both were 96%, 91%, and 96%, respectively.
Of the 237 patients who did not have myasthenia gravis, 89 had electrophysiologic confirmation of alternative diagnoses. Among these 89 patients, AChR autoantibody testing yielded 11 false positives. Three patients tested positive for both binding and modulating antibodies, six for binding antibodies only, and two for modulating antibodies only. Those with false-positive results had diagnoses that were “diverse and clinically distinguishable from myasthenia gravis,” including myalgia, neuropathy, blurred vision, epilepsy, encephalopathy, and hemifacial spasm, the researchers said.
The researchers had no relevant disclosures.
SOURCE: Paul P et al. AANEM 2019, Abstract 236.
REPORTING FROM AANEM 2019
Flu vaccine cuts infection severity in kids and adults
WASHINGTON –
During recent U.S. flu seasons, children and adults who contracted influenza despite vaccination had significantly fewer severe infections and infection complications, compared with unimmunized people, according to two separate reports from CDC researchers presented at an annual scientific meeting on infectious diseases.
One of the reports tracked the impact of flu vaccine in children using data that the CDC collected at seven medical centers that participated in the agency’s New Vaccine Surveillance Network, which provided information on children aged 6 months to 17 years who were hospitalized for an acute respiratory illness, including more than 1,700 children during the 2016-2017 flu season and more than 1,900 during the 2017-2018 season. Roughly 10% of these children tested positive for influenza, and the subsequent analysis focused on these cases and compared incidence rates among children who had been vaccinated during the index season and those who had remained unvaccinated.
Combined data from both seasons showed that vaccinated children were 50% less likely to have been hospitalized for an acute influenza infection, compared with unvaccinated kids, a pattern consistently seen both in children aged 6 months to 8 years and in those aged 9-17 years. The pattern of vaccine effectiveness also held regardless of which flu strain caused the infections, reported Angela P. Campbell, MD, a CDC medical officer.
“We saw a nice benefit from vaccination, both in previously healthy children and in those with an underlying medical condition,” a finding that adds to existing evidence of vaccine effectiveness, Dr. Campbell said in a video interview. The results confirmed that flu vaccination does not just prevent infections but also cuts the rate of more severe infections that lead to hospitalization, she explained.
Another CDC study looked at data collected by the agency’s Influenza Hospitalization Surveillance Network from adults at least 18 years old who were hospitalized for a laboratory-confirmed influenza infection during five flu seasons, 2013-2014 through 2017-18. The data, which came from more than 250 acute-care hospitals in 13 states, included more than 43,000 people hospitalized for an identified influenza strain and with a known vaccination history who were not institutionalized and had not received any antiviral treatment.
After propensity-weighted adjustment to create better parity between the vaccinated and unvaccinated patients, the results showed that people 18-64 years old with vaccination had statistically significant decreases in mortality of a relative 36%, need for mechanical ventilation of 34%, pneumonia of 20%, and need for ICU admission of a relative 19%, as well as an 18% drop in average ICU length of stay, Shikha Garg, MD, said at the meeting. The propensity-weighted analysis of data from people at least 65 years old showed statistically significant relative reductions linked with vaccination: 46% reduction in the need for mechanical ventilation, 28% reduction in ICU admissions, and 9% reduction in hospitalized length of stay.
Further analysis of these outcomes by the strains that caused these influenza infections showed that the statistically significant benefits from vaccination were seen only in patients infected with an H1N1 strain. Statistically significant effects on these severe outcomes were not apparent among people infected with the H3N2 or B strains, said Dr. Garg, a medical epidemiologist at the CDC.
“All adults should receive an annual flu vaccination as it can improve outcomes among those who develop influenza despite vaccination,” she concluded.
Results from a third CDC study reported at the meeting examined the importance of two vaccine doses (administered at least 4 weeks apart) given to children aged 6 months to 8 years for the first season they receive flu vaccination, which is the immunization approach for flu recommended by the CDC. The findings from a total of more than 7,500 children immunized during the 2014-2018 seasons showed a clear increment in vaccine protection among kids who received two doses during their first season vaccinated, especially in children who were 2 years old or younger. In that age group, administration of two doses produced vaccine effectiveness of 53% versus a 23% vaccine effectiveness after a single vaccine dose, reported Jessie Chung, a CDC epidemiologist.
WASHINGTON –
During recent U.S. flu seasons, children and adults who contracted influenza despite vaccination had significantly fewer severe infections and infection complications, compared with unimmunized people, according to two separate reports from CDC researchers presented at an annual scientific meeting on infectious diseases.
One of the reports tracked the impact of flu vaccine in children using data that the CDC collected at seven medical centers that participated in the agency’s New Vaccine Surveillance Network, which provided information on children aged 6 months to 17 years who were hospitalized for an acute respiratory illness, including more than 1,700 children during the 2016-2017 flu season and more than 1,900 during the 2017-2018 season. Roughly 10% of these children tested positive for influenza, and the subsequent analysis focused on these cases and compared incidence rates among children who had been vaccinated during the index season and those who had remained unvaccinated.
Combined data from both seasons showed that vaccinated children were 50% less likely to have been hospitalized for an acute influenza infection, compared with unvaccinated kids, a pattern consistently seen both in children aged 6 months to 8 years and in those aged 9-17 years. The pattern of vaccine effectiveness also held regardless of which flu strain caused the infections, reported Angela P. Campbell, MD, a CDC medical officer.
“We saw a nice benefit from vaccination, both in previously healthy children and in those with an underlying medical condition,” a finding that adds to existing evidence of vaccine effectiveness, Dr. Campbell said in a video interview. The results confirmed that flu vaccination does not just prevent infections but also cuts the rate of more severe infections that lead to hospitalization, she explained.
Another CDC study looked at data collected by the agency’s Influenza Hospitalization Surveillance Network from adults at least 18 years old who were hospitalized for a laboratory-confirmed influenza infection during five flu seasons, 2013-2014 through 2017-18. The data, which came from more than 250 acute-care hospitals in 13 states, included more than 43,000 people hospitalized for an identified influenza strain and with a known vaccination history who were not institutionalized and had not received any antiviral treatment.
After propensity-weighted adjustment to create better parity between the vaccinated and unvaccinated patients, the results showed that people 18-64 years old with vaccination had statistically significant decreases in mortality of a relative 36%, need for mechanical ventilation of 34%, pneumonia of 20%, and need for ICU admission of a relative 19%, as well as an 18% drop in average ICU length of stay, Shikha Garg, MD, said at the meeting. The propensity-weighted analysis of data from people at least 65 years old showed statistically significant relative reductions linked with vaccination: 46% reduction in the need for mechanical ventilation, 28% reduction in ICU admissions, and 9% reduction in hospitalized length of stay.
Further analysis of these outcomes by the strains that caused these influenza infections showed that the statistically significant benefits from vaccination were seen only in patients infected with an H1N1 strain. Statistically significant effects on these severe outcomes were not apparent among people infected with the H3N2 or B strains, said Dr. Garg, a medical epidemiologist at the CDC.
“All adults should receive an annual flu vaccination as it can improve outcomes among those who develop influenza despite vaccination,” she concluded.
Results from a third CDC study reported at the meeting examined the importance of two vaccine doses (administered at least 4 weeks apart) given to children aged 6 months to 8 years for the first season they receive flu vaccination, which is the immunization approach for flu recommended by the CDC. The findings from a total of more than 7,500 children immunized during the 2014-2018 seasons showed a clear increment in vaccine protection among kids who received two doses during their first season vaccinated, especially in children who were 2 years old or younger. In that age group, administration of two doses produced vaccine effectiveness of 53% versus a 23% vaccine effectiveness after a single vaccine dose, reported Jessie Chung, a CDC epidemiologist.
WASHINGTON –
During recent U.S. flu seasons, children and adults who contracted influenza despite vaccination had significantly fewer severe infections and infection complications, compared with unimmunized people, according to two separate reports from CDC researchers presented at an annual scientific meeting on infectious diseases.
One of the reports tracked the impact of flu vaccine in children using data that the CDC collected at seven medical centers that participated in the agency’s New Vaccine Surveillance Network, which provided information on children aged 6 months to 17 years who were hospitalized for an acute respiratory illness, including more than 1,700 children during the 2016-2017 flu season and more than 1,900 during the 2017-2018 season. Roughly 10% of these children tested positive for influenza, and the subsequent analysis focused on these cases and compared incidence rates among children who had been vaccinated during the index season and those who had remained unvaccinated.
Combined data from both seasons showed that vaccinated children were 50% less likely to have been hospitalized for an acute influenza infection, compared with unvaccinated kids, a pattern consistently seen both in children aged 6 months to 8 years and in those aged 9-17 years. The pattern of vaccine effectiveness also held regardless of which flu strain caused the infections, reported Angela P. Campbell, MD, a CDC medical officer.
“We saw a nice benefit from vaccination, both in previously healthy children and in those with an underlying medical condition,” a finding that adds to existing evidence of vaccine effectiveness, Dr. Campbell said in a video interview. The results confirmed that flu vaccination does not just prevent infections but also cuts the rate of more severe infections that lead to hospitalization, she explained.
Another CDC study looked at data collected by the agency’s Influenza Hospitalization Surveillance Network from adults at least 18 years old who were hospitalized for a laboratory-confirmed influenza infection during five flu seasons, 2013-2014 through 2017-18. The data, which came from more than 250 acute-care hospitals in 13 states, included more than 43,000 people hospitalized for an identified influenza strain and with a known vaccination history who were not institutionalized and had not received any antiviral treatment.
After propensity-weighted adjustment to create better parity between the vaccinated and unvaccinated patients, the results showed that people 18-64 years old with vaccination had statistically significant decreases in mortality of a relative 36%, need for mechanical ventilation of 34%, pneumonia of 20%, and need for ICU admission of a relative 19%, as well as an 18% drop in average ICU length of stay, Shikha Garg, MD, said at the meeting. The propensity-weighted analysis of data from people at least 65 years old showed statistically significant relative reductions linked with vaccination: 46% reduction in the need for mechanical ventilation, 28% reduction in ICU admissions, and 9% reduction in hospitalized length of stay.
Further analysis of these outcomes by the strains that caused these influenza infections showed that the statistically significant benefits from vaccination were seen only in patients infected with an H1N1 strain. Statistically significant effects on these severe outcomes were not apparent among people infected with the H3N2 or B strains, said Dr. Garg, a medical epidemiologist at the CDC.
“All adults should receive an annual flu vaccination as it can improve outcomes among those who develop influenza despite vaccination,” she concluded.
Results from a third CDC study reported at the meeting examined the importance of two vaccine doses (administered at least 4 weeks apart) given to children aged 6 months to 8 years for the first season they receive flu vaccination, which is the immunization approach for flu recommended by the CDC. The findings from a total of more than 7,500 children immunized during the 2014-2018 seasons showed a clear increment in vaccine protection among kids who received two doses during their first season vaccinated, especially in children who were 2 years old or younger. In that age group, administration of two doses produced vaccine effectiveness of 53% versus a 23% vaccine effectiveness after a single vaccine dose, reported Jessie Chung, a CDC epidemiologist.
REPORTING FROM ID WEEK 2019
Rare Rheumatologic Diseases Special Report 2019
Judge blocks Alabama abortion ban
A federal judge has temporarily barred Alabama’s near total abortion ban from taking effect.
In an Oct. 29 decision, Myron H. Thompson, District Court Judge for the Middle District of Alabama, North Division, wrote . Judge Thompson halted the measure, which was scheduled to take effect on Nov. 15, while the lawsuit continues through the courts.
“As stated previously, banning abortion before viability violates Supreme Court precedent,” Judge Thompson wrote in the opinion. “No alleged state interest can overcome this clear mandate. Thus, as a ban on pre-viability abortion, the act contravenes established law.”
Alabama Gov. Kay Ivey (R) signed the “Human Life Protection Act” into law on May 15. The measure bans abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and charges them with a Class C felony for attempting to perform an abortion. The law includes an exception if a woman’s life is at risk, but not for cases of rape or incest.
The federal court’s decision affirms that women have a right to access safe, legal abortion, Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America said in a statement. Planned Parenthood Federation of America, The American Civil Liberties Union, and the ACLU of Alabama are representing the plaintiffs in the lawsuit, which include Alabama physicians and patients.
“Politicians in Alabama, and across the country, are putting people’s health and lives at risk in their attempts to ban abortion outright in this country,” Ms. Johnson said in the statement. “Today’s victory means people can still access the health care they need across Alabama – for now. We will continue to fight to ensure that everyone can access health care – including safe, legal abortion.”
Alabama Attorney General Steve Marshall said the district court’s decision to temporarily halt the law was not unexpected.
“As we have stated before, the state’s objective is to advance our case to the U.S. Supreme Court where we intend to submit evidence that supports our argument that Roe and Casey were wrongly decided and that the Constitution does not prohibit states from protecting unborn children from abortion,” Mr. Marshall said in a statement.
The Alabama decision comes just weeks after the U.S. Supreme Court agreed to hear an abortion-related challenge out of Louisiana. June Medical Services v. Gee centers on the constitutionality of a Louisiana law that requires any doctor performing an abortion to have admitting privileges at a nearby hospital. The high court likely will hear that case in early 2020.
A federal judge has temporarily barred Alabama’s near total abortion ban from taking effect.
In an Oct. 29 decision, Myron H. Thompson, District Court Judge for the Middle District of Alabama, North Division, wrote . Judge Thompson halted the measure, which was scheduled to take effect on Nov. 15, while the lawsuit continues through the courts.
“As stated previously, banning abortion before viability violates Supreme Court precedent,” Judge Thompson wrote in the opinion. “No alleged state interest can overcome this clear mandate. Thus, as a ban on pre-viability abortion, the act contravenes established law.”
Alabama Gov. Kay Ivey (R) signed the “Human Life Protection Act” into law on May 15. The measure bans abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and charges them with a Class C felony for attempting to perform an abortion. The law includes an exception if a woman’s life is at risk, but not for cases of rape or incest.
The federal court’s decision affirms that women have a right to access safe, legal abortion, Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America said in a statement. Planned Parenthood Federation of America, The American Civil Liberties Union, and the ACLU of Alabama are representing the plaintiffs in the lawsuit, which include Alabama physicians and patients.
“Politicians in Alabama, and across the country, are putting people’s health and lives at risk in their attempts to ban abortion outright in this country,” Ms. Johnson said in the statement. “Today’s victory means people can still access the health care they need across Alabama – for now. We will continue to fight to ensure that everyone can access health care – including safe, legal abortion.”
Alabama Attorney General Steve Marshall said the district court’s decision to temporarily halt the law was not unexpected.
“As we have stated before, the state’s objective is to advance our case to the U.S. Supreme Court where we intend to submit evidence that supports our argument that Roe and Casey were wrongly decided and that the Constitution does not prohibit states from protecting unborn children from abortion,” Mr. Marshall said in a statement.
The Alabama decision comes just weeks after the U.S. Supreme Court agreed to hear an abortion-related challenge out of Louisiana. June Medical Services v. Gee centers on the constitutionality of a Louisiana law that requires any doctor performing an abortion to have admitting privileges at a nearby hospital. The high court likely will hear that case in early 2020.
A federal judge has temporarily barred Alabama’s near total abortion ban from taking effect.
In an Oct. 29 decision, Myron H. Thompson, District Court Judge for the Middle District of Alabama, North Division, wrote . Judge Thompson halted the measure, which was scheduled to take effect on Nov. 15, while the lawsuit continues through the courts.
“As stated previously, banning abortion before viability violates Supreme Court precedent,” Judge Thompson wrote in the opinion. “No alleged state interest can overcome this clear mandate. Thus, as a ban on pre-viability abortion, the act contravenes established law.”
Alabama Gov. Kay Ivey (R) signed the “Human Life Protection Act” into law on May 15. The measure bans abortion at every pregnancy stage and penalizes physicians with a Class A felony for performing an abortion and charges them with a Class C felony for attempting to perform an abortion. The law includes an exception if a woman’s life is at risk, but not for cases of rape or incest.
The federal court’s decision affirms that women have a right to access safe, legal abortion, Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America said in a statement. Planned Parenthood Federation of America, The American Civil Liberties Union, and the ACLU of Alabama are representing the plaintiffs in the lawsuit, which include Alabama physicians and patients.
“Politicians in Alabama, and across the country, are putting people’s health and lives at risk in their attempts to ban abortion outright in this country,” Ms. Johnson said in the statement. “Today’s victory means people can still access the health care they need across Alabama – for now. We will continue to fight to ensure that everyone can access health care – including safe, legal abortion.”
Alabama Attorney General Steve Marshall said the district court’s decision to temporarily halt the law was not unexpected.
“As we have stated before, the state’s objective is to advance our case to the U.S. Supreme Court where we intend to submit evidence that supports our argument that Roe and Casey were wrongly decided and that the Constitution does not prohibit states from protecting unborn children from abortion,” Mr. Marshall said in a statement.
The Alabama decision comes just weeks after the U.S. Supreme Court agreed to hear an abortion-related challenge out of Louisiana. June Medical Services v. Gee centers on the constitutionality of a Louisiana law that requires any doctor performing an abortion to have admitting privileges at a nearby hospital. The high court likely will hear that case in early 2020.
Vitiligo: First-ever RCT is smashing success
MADRID – cream for the treatment of vitiligo, Amit G. Pandya, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
“I have been waiting 30 years for the first clinical trial for vitiligo. I know many of you dermatologists have been waiting for something for vitiligo, so I’m happy to present the results of the first randomized, placebo-controlled, double-blind, prospective trial of a topical agent in history for vitiligo,” said Dr. Pandya, who was clearly overjoyed to present the final results of the 52-week trial.
Ruxolitinib is a Janus kinase (JAK) 1 and 2 inhibitor. Topical ruxolitinib is under study for vitiligo because this chronic autoimmune disease targeting melanocytes is now recognized as being driven by signaling through the JAK 1/2 pathways.
The interim 24-week results of the phase 2 trial, presented earlier in the year at the World Congress of Dermatology in Milan, showed significant repigmentation with ruxolitinib cream. Dr. Pandya’s key message at EADV 2019 was that continued treatment out to a year brought substantial further improvement, and with a benign safety profile indistinguishable from vehicle control.
“We see a tremendous difference between 6 months and 1 year,” said Dr. Pandya, professor of dermatology at the University of Texas, Dallas. “For the first time, we dare talk about F-VASI75 [Facial Vitiligo Area Scoring Index] and F-VASI90 responses. We don’t usually tell patients that they can get 75% or 90% of their color back, and yet the week-52 F-VASI75 rate was 51.5%, up from 30.3% at week 24. And the F-VASI90 response was 33.3%, versus 12.1% at week 24.”
F-VASI is measured using the patient’s hand, which is typically equivalent to about 1% of body surface area. The mean baseline F-VASI was 1.26% in this study of 157 mostly middle-aged adults with longstanding vitiligo of a mean 14-year duration. That’s fairly severe vitiligo, since the total face occupies only about 4% of total body surface area.
The primary study endpoint was achievement of greater than 50% repigmentation in the F-VASI, or an F-VASI50 response. Under double-blind conditions at 52 weeks in the group randomized to 1.5% ruxolitinib cream twice a day, the highest dose used in the trial, the F-VASI50 rate was 57.6%. That’s up from a week-24 F-VASI50 of 45.5%, and a week-34 response rate of 51.5%.
A key secondary endpoint was T-VASI50, reflecting the total body response.
“Patients don’t just want their face to be better, they want their chest, arms, elbows, knees, hands, and feet to be better,” the dermatologist commented.
The week-52 T-VASI50 rate was 36.4%, up substantially from 12.1% at week 24. And that week-52 T-VASI50 rate probably underestimates the full potential benefit. That’s because a safety-based study rule prohibited patients from applying the cream to more than 20% of their body surface area. Adverse effects reported for oral ruxolitinib, approved for treatment of myelofibrosis, polycythemia vera, and acute graft-versus-host disease, include thrombocytopenia and anemia.
“In this early study we didn’t want to take a chance of systemic absorption with serum levels that would potentially affect the bone marrow,” Dr. Pandya explained.
He noted that 57 study participants had a baseline T-VASI greater than 20% of their body surface area and thus weren’t able to treat all of their disease. In the 100 patients with a vitiligo-involved total body surface area of 20% or less, however, the week-52 T-VASI50 reached 45%, compared with 20% at week 24.
Another prespecified secondary endpoint was the proportion of patients who received a facial physician’s global assessment of clear or almost clear. About 21% of patients in the highest-dose group achieved this milestone at 52 weeks.
A phase 3, randomized, controlled trial of ruxolitinib cream is ongoing and should be completed next year. Dr. Pandya reported receiving research funding from and serving as a consultant to Incyte, the study sponsor. He has similar financial relationships with Pfizer, Aclaris Therapeutics, and the Immune Tolerance Network.
MADRID – cream for the treatment of vitiligo, Amit G. Pandya, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
“I have been waiting 30 years for the first clinical trial for vitiligo. I know many of you dermatologists have been waiting for something for vitiligo, so I’m happy to present the results of the first randomized, placebo-controlled, double-blind, prospective trial of a topical agent in history for vitiligo,” said Dr. Pandya, who was clearly overjoyed to present the final results of the 52-week trial.
Ruxolitinib is a Janus kinase (JAK) 1 and 2 inhibitor. Topical ruxolitinib is under study for vitiligo because this chronic autoimmune disease targeting melanocytes is now recognized as being driven by signaling through the JAK 1/2 pathways.
The interim 24-week results of the phase 2 trial, presented earlier in the year at the World Congress of Dermatology in Milan, showed significant repigmentation with ruxolitinib cream. Dr. Pandya’s key message at EADV 2019 was that continued treatment out to a year brought substantial further improvement, and with a benign safety profile indistinguishable from vehicle control.
“We see a tremendous difference between 6 months and 1 year,” said Dr. Pandya, professor of dermatology at the University of Texas, Dallas. “For the first time, we dare talk about F-VASI75 [Facial Vitiligo Area Scoring Index] and F-VASI90 responses. We don’t usually tell patients that they can get 75% or 90% of their color back, and yet the week-52 F-VASI75 rate was 51.5%, up from 30.3% at week 24. And the F-VASI90 response was 33.3%, versus 12.1% at week 24.”
F-VASI is measured using the patient’s hand, which is typically equivalent to about 1% of body surface area. The mean baseline F-VASI was 1.26% in this study of 157 mostly middle-aged adults with longstanding vitiligo of a mean 14-year duration. That’s fairly severe vitiligo, since the total face occupies only about 4% of total body surface area.
The primary study endpoint was achievement of greater than 50% repigmentation in the F-VASI, or an F-VASI50 response. Under double-blind conditions at 52 weeks in the group randomized to 1.5% ruxolitinib cream twice a day, the highest dose used in the trial, the F-VASI50 rate was 57.6%. That’s up from a week-24 F-VASI50 of 45.5%, and a week-34 response rate of 51.5%.
A key secondary endpoint was T-VASI50, reflecting the total body response.
“Patients don’t just want their face to be better, they want their chest, arms, elbows, knees, hands, and feet to be better,” the dermatologist commented.
The week-52 T-VASI50 rate was 36.4%, up substantially from 12.1% at week 24. And that week-52 T-VASI50 rate probably underestimates the full potential benefit. That’s because a safety-based study rule prohibited patients from applying the cream to more than 20% of their body surface area. Adverse effects reported for oral ruxolitinib, approved for treatment of myelofibrosis, polycythemia vera, and acute graft-versus-host disease, include thrombocytopenia and anemia.
“In this early study we didn’t want to take a chance of systemic absorption with serum levels that would potentially affect the bone marrow,” Dr. Pandya explained.
He noted that 57 study participants had a baseline T-VASI greater than 20% of their body surface area and thus weren’t able to treat all of their disease. In the 100 patients with a vitiligo-involved total body surface area of 20% or less, however, the week-52 T-VASI50 reached 45%, compared with 20% at week 24.
Another prespecified secondary endpoint was the proportion of patients who received a facial physician’s global assessment of clear or almost clear. About 21% of patients in the highest-dose group achieved this milestone at 52 weeks.
A phase 3, randomized, controlled trial of ruxolitinib cream is ongoing and should be completed next year. Dr. Pandya reported receiving research funding from and serving as a consultant to Incyte, the study sponsor. He has similar financial relationships with Pfizer, Aclaris Therapeutics, and the Immune Tolerance Network.
MADRID – cream for the treatment of vitiligo, Amit G. Pandya, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
“I have been waiting 30 years for the first clinical trial for vitiligo. I know many of you dermatologists have been waiting for something for vitiligo, so I’m happy to present the results of the first randomized, placebo-controlled, double-blind, prospective trial of a topical agent in history for vitiligo,” said Dr. Pandya, who was clearly overjoyed to present the final results of the 52-week trial.
Ruxolitinib is a Janus kinase (JAK) 1 and 2 inhibitor. Topical ruxolitinib is under study for vitiligo because this chronic autoimmune disease targeting melanocytes is now recognized as being driven by signaling through the JAK 1/2 pathways.
The interim 24-week results of the phase 2 trial, presented earlier in the year at the World Congress of Dermatology in Milan, showed significant repigmentation with ruxolitinib cream. Dr. Pandya’s key message at EADV 2019 was that continued treatment out to a year brought substantial further improvement, and with a benign safety profile indistinguishable from vehicle control.
“We see a tremendous difference between 6 months and 1 year,” said Dr. Pandya, professor of dermatology at the University of Texas, Dallas. “For the first time, we dare talk about F-VASI75 [Facial Vitiligo Area Scoring Index] and F-VASI90 responses. We don’t usually tell patients that they can get 75% or 90% of their color back, and yet the week-52 F-VASI75 rate was 51.5%, up from 30.3% at week 24. And the F-VASI90 response was 33.3%, versus 12.1% at week 24.”
F-VASI is measured using the patient’s hand, which is typically equivalent to about 1% of body surface area. The mean baseline F-VASI was 1.26% in this study of 157 mostly middle-aged adults with longstanding vitiligo of a mean 14-year duration. That’s fairly severe vitiligo, since the total face occupies only about 4% of total body surface area.
The primary study endpoint was achievement of greater than 50% repigmentation in the F-VASI, or an F-VASI50 response. Under double-blind conditions at 52 weeks in the group randomized to 1.5% ruxolitinib cream twice a day, the highest dose used in the trial, the F-VASI50 rate was 57.6%. That’s up from a week-24 F-VASI50 of 45.5%, and a week-34 response rate of 51.5%.
A key secondary endpoint was T-VASI50, reflecting the total body response.
“Patients don’t just want their face to be better, they want their chest, arms, elbows, knees, hands, and feet to be better,” the dermatologist commented.
The week-52 T-VASI50 rate was 36.4%, up substantially from 12.1% at week 24. And that week-52 T-VASI50 rate probably underestimates the full potential benefit. That’s because a safety-based study rule prohibited patients from applying the cream to more than 20% of their body surface area. Adverse effects reported for oral ruxolitinib, approved for treatment of myelofibrosis, polycythemia vera, and acute graft-versus-host disease, include thrombocytopenia and anemia.
“In this early study we didn’t want to take a chance of systemic absorption with serum levels that would potentially affect the bone marrow,” Dr. Pandya explained.
He noted that 57 study participants had a baseline T-VASI greater than 20% of their body surface area and thus weren’t able to treat all of their disease. In the 100 patients with a vitiligo-involved total body surface area of 20% or less, however, the week-52 T-VASI50 reached 45%, compared with 20% at week 24.
Another prespecified secondary endpoint was the proportion of patients who received a facial physician’s global assessment of clear or almost clear. About 21% of patients in the highest-dose group achieved this milestone at 52 weeks.
A phase 3, randomized, controlled trial of ruxolitinib cream is ongoing and should be completed next year. Dr. Pandya reported receiving research funding from and serving as a consultant to Incyte, the study sponsor. He has similar financial relationships with Pfizer, Aclaris Therapeutics, and the Immune Tolerance Network.
REPORTING FROM THE EADV CONGRESS
Stay Informed About Informed Consent
On May 24, 2011, a 53-year-old woman presented to a Wisconsin hospital emergency department (ED) with complaints of severe abdominal pain, a rapid heartbeat, and a fever of 101.3°F. During her 9-hour visit, she was treated by a PA and his supervising physician. She was seen by the physician for a total of 6 minutes; the rest of her care was provided by the PA. The patient was discharged around midnight with instructions to contact her gynecologist in the morning for management of uterine fibroids. At the time of discharge, her temperature was 102.9°F.
The following day, May 25, the patient collapsed in her home and was transported to another hospital. She was treated for septic shock from a group A streptococcus infection. Although the infection was halted, the patient sustained ischemic damage to her extremities and a month later required amputation of her 4 limbs.The plaintiff claimed that the supervising physician was negligent in failing to diagnose the strep A infection, which, left undetected, led to septic shock. She also alleged that the PA should have recognized the potential for her condition’s severity to quickly escalate. She maintained that the supervising physician should have been more involved in her case because of its complexity.
Plaintiff’s counsel also argued that the PA should have provided “alternative medical diagnoses,” which would have prompted consideration of other treatment options. The plaintiff contended that under Wisconsin’s informed consent law, both the PA and the physician failed to disclose enough information about her condition and failed to inform her of any choices for treatment.
The defense argued that the plaintiff received proper treatment based on the information available to the providers at the time.
VERDICT
The jury found for the plaintiff and apportioned 65% liability to the physician and 35% liability to the PA. A total of $25,342,096 was awarded to the plaintiff.
COMMENTARY
This is a huge verdict. Cases involving group A strep or necrotizing fasciitis frequently give rise to large medical malpractice verdicts, because everything about them is difficult to defend: Although there is typically trivial to no trauma involved, the wounds from these infections provide explicit images of damage, intraoperatively and postoperatively. Vasopressors required for hemodynamic support or sepsis itself frequently result in limb ischemia, gangrene, and amputation. In this case, the plaintiff, as a quadruple amputee, was a sympathetic and impressive courtroom presence—the personal toll was evident to anyone in the room.
Two providers—a PA and a physician—saw the patient. We are told only that she complained of severe abdominal pain, rapid heartbeat, and fever, which increased at some point during her ED stay. We aren’t given specifics on the rest of the patient’s vital signs or examination details. However, we can infer that the exam and lab findings were not impressive, because they weren’t mentioned in the case report. But as a result of the failure to catch the group A strep infection, the plaintiff suffered what one judge hearing the case described as a harrowing and unimaginable ordeal: the life-changing amputation of 4 limbs.1 While the jury did not find the PA or physician negligent, they still found the clinicians liable and awarded a staggering verdict.
Continue to: How could this happen?
How could this happen? The answer is the theory of recovery: The jury found that the physician and the PA failed to provide the patient with informed consent in the form of “alternative medical diagnoses.”2 The plaintiff’s attorney argued that the patient was never told a life-threatening bacterial infection was one possible diagnosis and claimed that if she had known, the patient would have pursued other treatment.
As in many malpractice cases, the plaintiff alleged failure to diagnose and failure to provide informed consent. Depending on state law, there are 3 standards for informed consent: subjective patient, reasonable patient, and reasonable physician.3 About half of the states have a physician-focused standard, while the other half have a patient-focused standard.3
Under the subjective patient standard, we would ask, “What would this patient need to know and understand to make an informed decision?”4 The subjective standard requires the clinician to essentially “get in the head” of a specific patient to determine what he or she would want to know when making a medical decision. This standard is problematic because it requires the clinician to have an intimate familiarity with the patient’s belief system and medical decision-making process—a daunting requirement for many clinicians, particularly in the absence of a longstanding clinician-patient relationship, as is the case in most emergency settings. Thankfully, the subjective patient standard is not followed by most states that have a patient-focused standard.
Under the objective reasonable patient standard, we would ask “What would the average patient need to know to be an informed participant in the decision?”4 One could argue that this standard more adequately allows the patient to be an active participant in shared decision-making. However, the drawback is that what is “reasonable” often falls on a spectrum, which would require the clinician to gauge the volume and type of information a patient cohort would want to have when making a medical decision. Under this standard, the plaintiff must prove that the clinician omitted information that a reasonable patient would want to know. Therefore, these standards are more friendly to the plaintiff, whereas the reasonable physician standard is more defendant friendly.
To meet the standard of care under a reasonable physician standard, information must be provided to the patient that a “reasonably prudent practitioner in the same field of practice or specialty” would provide to a patient.5 For a plaintiff to successfully sue under this standard, the plaintiff’s expert must testify that a reasonably prudent physician would have disclosed the omitted information.6 The reasonable physician standard is obviously better for malpractice defendants.
Continue to: While reasonable clinicians...
While reasonable clinicians can disagree (as can reasonable patients), clinicians are more likely to be closer in opinion. Clinicians are a smaller group whose opinions are underpinned by similar education, training, and experience. By contrast, among the general population, beliefs held by one hypothetical “reasonable person” are much less settled, and in some cases, wildly divergent from another’s. For example, vaccine skepticism would probably be considered unreasonable in the majority of jury pools but absolutely reasonable in some. The large size of the general population, coupled with opinions untethered to any definable discipline, make the reasonable patient standard hard to predict.
Additionally, the reasonable physician standard forces the plaintiff to prove his or her case by producing an expert witness (clinician) to specifically testify that the standard of care required the defendant clinician to disclose certain specific information, and that disclosure was lacking. That is an important requirement. Under patient-focused standards, the plaintiff doesn’t need a medical expert on this point and can simply argue to the jury that a reasonable patient would require an exhaustive discussion of each possibility in the differential diagnosis. Therefore, I would argue that the reasonable physician standard is more predictable and workable and should be followed.
At the time of this case, Wisconsin’s informed consent law was based on the reasonable patient standard. As a result of this case, Wisconsin lawmakers changed the law to a “reasonable physician standard,” which states “any physician who treats a patient shall inform the patient about the availability of reasonable alternate medical modes of treatment and about the benefits and risks of these treatments.”7 However, the law stipulates that this duty to inform does not require disclosure of (among others):
- Detailed technical information that in all probability a patient would not understand
- Risks apparent or known to the patient
- Extremely remote possibilities that might falsely or detrimentally alarm the patient
- Information about alternate medical modes of treatment for any condition the physician has not included in his or her diagnosis at the time the physician informs the patient.7
Finally, this case involved an extremely high verdict of more than $25 million. It may surprise you to learn that many states have caps for medical malpractice awards for noneconomic damages, such as pain and suffering. If you’re having a holiday dinner with friends or family members who are plaintiff’s attorneys and you’re itching for a good argument, skip current politics and go all-in: How about liability caps, Uncle Jim? Get ready for a lively debate.
Of the $25 million verdict, $16.5 million was awarded for pain and suffering—the jury was obviously shocked by the extent of the life-changing nature of the plaintiff’s injuries. At the time of this case, Wisconsin had a cap of $750,000 for noneconomic damages.8 However, plaintiffs may challenge state constitutionality of these caps when they feel they have the right case, which the plaintiff and her attorney felt they did. Two lower courts found the state cap unconstitutional and gave the plaintiff the full award. But the state Supreme Court later reversed that decision, upholding the cap.1 The court decided that the legislature had a rational basis for making the law and changes to it should occur through the legislature, not the courts. The dissenting justices argued that there was no rational basis for the $750,000 cap, because there was no evidence that clinicians would flee the state fearing malpractice liability, or practice more defensive medicine, or suffer runaway malpractice insurance premiums without the cap. As a result of this case, the cap was upheld, and there was a “lively debate” on this issue at the highest levels of government.
Continue to: IN SUM
IN SUM
Become familiar with your state’s informed consent laws. Involve patients in decision-making, and convey information related to reasonable treatment options and risks. Document all of these discussions. Lastly, state-level political discussions on issues of tort reform, caps, and malpractice matters are ongoing—so take n
1. Mayo v Wisconsin Injured Patients & Families Compensation Fund. WI 78 (2018).
2. Spivak C. Jury awards Milwaukee woman $25.3 million in medical malpractice case. Milwaukee Journal Sentinel. July 7, 2014.
3. Moore GP, Matlock AG, Kiley JL, et al. Emergency physicians: beware of the consent standard of care. Clin Pract Cases Emerg Med. 2018; 2(2):109-111.
4. Gossman W, Thornton I, Hipskind JE. Informed Consent. StatPearls. www.ncbi.nlm.nih.gov/books/NBK430827/. Updated July 10, 2019. Accessed October 25, 2019.
5. King JS, Moulton BW. Rethinking informed consent: the case for shared medical decision-making. Am J Law Med. 2006;32:429-501.
6. Tashman v Gibbs, 556 SE 2d 772 (263 Va 2002).
7. Wis Stat subchapter 2, §448.30.
8. Wis Stat §893.55.
On May 24, 2011, a 53-year-old woman presented to a Wisconsin hospital emergency department (ED) with complaints of severe abdominal pain, a rapid heartbeat, and a fever of 101.3°F. During her 9-hour visit, she was treated by a PA and his supervising physician. She was seen by the physician for a total of 6 minutes; the rest of her care was provided by the PA. The patient was discharged around midnight with instructions to contact her gynecologist in the morning for management of uterine fibroids. At the time of discharge, her temperature was 102.9°F.
The following day, May 25, the patient collapsed in her home and was transported to another hospital. She was treated for septic shock from a group A streptococcus infection. Although the infection was halted, the patient sustained ischemic damage to her extremities and a month later required amputation of her 4 limbs.The plaintiff claimed that the supervising physician was negligent in failing to diagnose the strep A infection, which, left undetected, led to septic shock. She also alleged that the PA should have recognized the potential for her condition’s severity to quickly escalate. She maintained that the supervising physician should have been more involved in her case because of its complexity.
Plaintiff’s counsel also argued that the PA should have provided “alternative medical diagnoses,” which would have prompted consideration of other treatment options. The plaintiff contended that under Wisconsin’s informed consent law, both the PA and the physician failed to disclose enough information about her condition and failed to inform her of any choices for treatment.
The defense argued that the plaintiff received proper treatment based on the information available to the providers at the time.
VERDICT
The jury found for the plaintiff and apportioned 65% liability to the physician and 35% liability to the PA. A total of $25,342,096 was awarded to the plaintiff.
COMMENTARY
This is a huge verdict. Cases involving group A strep or necrotizing fasciitis frequently give rise to large medical malpractice verdicts, because everything about them is difficult to defend: Although there is typically trivial to no trauma involved, the wounds from these infections provide explicit images of damage, intraoperatively and postoperatively. Vasopressors required for hemodynamic support or sepsis itself frequently result in limb ischemia, gangrene, and amputation. In this case, the plaintiff, as a quadruple amputee, was a sympathetic and impressive courtroom presence—the personal toll was evident to anyone in the room.
Two providers—a PA and a physician—saw the patient. We are told only that she complained of severe abdominal pain, rapid heartbeat, and fever, which increased at some point during her ED stay. We aren’t given specifics on the rest of the patient’s vital signs or examination details. However, we can infer that the exam and lab findings were not impressive, because they weren’t mentioned in the case report. But as a result of the failure to catch the group A strep infection, the plaintiff suffered what one judge hearing the case described as a harrowing and unimaginable ordeal: the life-changing amputation of 4 limbs.1 While the jury did not find the PA or physician negligent, they still found the clinicians liable and awarded a staggering verdict.
Continue to: How could this happen?
How could this happen? The answer is the theory of recovery: The jury found that the physician and the PA failed to provide the patient with informed consent in the form of “alternative medical diagnoses.”2 The plaintiff’s attorney argued that the patient was never told a life-threatening bacterial infection was one possible diagnosis and claimed that if she had known, the patient would have pursued other treatment.
As in many malpractice cases, the plaintiff alleged failure to diagnose and failure to provide informed consent. Depending on state law, there are 3 standards for informed consent: subjective patient, reasonable patient, and reasonable physician.3 About half of the states have a physician-focused standard, while the other half have a patient-focused standard.3
Under the subjective patient standard, we would ask, “What would this patient need to know and understand to make an informed decision?”4 The subjective standard requires the clinician to essentially “get in the head” of a specific patient to determine what he or she would want to know when making a medical decision. This standard is problematic because it requires the clinician to have an intimate familiarity with the patient’s belief system and medical decision-making process—a daunting requirement for many clinicians, particularly in the absence of a longstanding clinician-patient relationship, as is the case in most emergency settings. Thankfully, the subjective patient standard is not followed by most states that have a patient-focused standard.
Under the objective reasonable patient standard, we would ask “What would the average patient need to know to be an informed participant in the decision?”4 One could argue that this standard more adequately allows the patient to be an active participant in shared decision-making. However, the drawback is that what is “reasonable” often falls on a spectrum, which would require the clinician to gauge the volume and type of information a patient cohort would want to have when making a medical decision. Under this standard, the plaintiff must prove that the clinician omitted information that a reasonable patient would want to know. Therefore, these standards are more friendly to the plaintiff, whereas the reasonable physician standard is more defendant friendly.
To meet the standard of care under a reasonable physician standard, information must be provided to the patient that a “reasonably prudent practitioner in the same field of practice or specialty” would provide to a patient.5 For a plaintiff to successfully sue under this standard, the plaintiff’s expert must testify that a reasonably prudent physician would have disclosed the omitted information.6 The reasonable physician standard is obviously better for malpractice defendants.
Continue to: While reasonable clinicians...
While reasonable clinicians can disagree (as can reasonable patients), clinicians are more likely to be closer in opinion. Clinicians are a smaller group whose opinions are underpinned by similar education, training, and experience. By contrast, among the general population, beliefs held by one hypothetical “reasonable person” are much less settled, and in some cases, wildly divergent from another’s. For example, vaccine skepticism would probably be considered unreasonable in the majority of jury pools but absolutely reasonable in some. The large size of the general population, coupled with opinions untethered to any definable discipline, make the reasonable patient standard hard to predict.
Additionally, the reasonable physician standard forces the plaintiff to prove his or her case by producing an expert witness (clinician) to specifically testify that the standard of care required the defendant clinician to disclose certain specific information, and that disclosure was lacking. That is an important requirement. Under patient-focused standards, the plaintiff doesn’t need a medical expert on this point and can simply argue to the jury that a reasonable patient would require an exhaustive discussion of each possibility in the differential diagnosis. Therefore, I would argue that the reasonable physician standard is more predictable and workable and should be followed.
At the time of this case, Wisconsin’s informed consent law was based on the reasonable patient standard. As a result of this case, Wisconsin lawmakers changed the law to a “reasonable physician standard,” which states “any physician who treats a patient shall inform the patient about the availability of reasonable alternate medical modes of treatment and about the benefits and risks of these treatments.”7 However, the law stipulates that this duty to inform does not require disclosure of (among others):
- Detailed technical information that in all probability a patient would not understand
- Risks apparent or known to the patient
- Extremely remote possibilities that might falsely or detrimentally alarm the patient
- Information about alternate medical modes of treatment for any condition the physician has not included in his or her diagnosis at the time the physician informs the patient.7
Finally, this case involved an extremely high verdict of more than $25 million. It may surprise you to learn that many states have caps for medical malpractice awards for noneconomic damages, such as pain and suffering. If you’re having a holiday dinner with friends or family members who are plaintiff’s attorneys and you’re itching for a good argument, skip current politics and go all-in: How about liability caps, Uncle Jim? Get ready for a lively debate.
Of the $25 million verdict, $16.5 million was awarded for pain and suffering—the jury was obviously shocked by the extent of the life-changing nature of the plaintiff’s injuries. At the time of this case, Wisconsin had a cap of $750,000 for noneconomic damages.8 However, plaintiffs may challenge state constitutionality of these caps when they feel they have the right case, which the plaintiff and her attorney felt they did. Two lower courts found the state cap unconstitutional and gave the plaintiff the full award. But the state Supreme Court later reversed that decision, upholding the cap.1 The court decided that the legislature had a rational basis for making the law and changes to it should occur through the legislature, not the courts. The dissenting justices argued that there was no rational basis for the $750,000 cap, because there was no evidence that clinicians would flee the state fearing malpractice liability, or practice more defensive medicine, or suffer runaway malpractice insurance premiums without the cap. As a result of this case, the cap was upheld, and there was a “lively debate” on this issue at the highest levels of government.
Continue to: IN SUM
IN SUM
Become familiar with your state’s informed consent laws. Involve patients in decision-making, and convey information related to reasonable treatment options and risks. Document all of these discussions. Lastly, state-level political discussions on issues of tort reform, caps, and malpractice matters are ongoing—so take n
On May 24, 2011, a 53-year-old woman presented to a Wisconsin hospital emergency department (ED) with complaints of severe abdominal pain, a rapid heartbeat, and a fever of 101.3°F. During her 9-hour visit, she was treated by a PA and his supervising physician. She was seen by the physician for a total of 6 minutes; the rest of her care was provided by the PA. The patient was discharged around midnight with instructions to contact her gynecologist in the morning for management of uterine fibroids. At the time of discharge, her temperature was 102.9°F.
The following day, May 25, the patient collapsed in her home and was transported to another hospital. She was treated for septic shock from a group A streptococcus infection. Although the infection was halted, the patient sustained ischemic damage to her extremities and a month later required amputation of her 4 limbs.The plaintiff claimed that the supervising physician was negligent in failing to diagnose the strep A infection, which, left undetected, led to septic shock. She also alleged that the PA should have recognized the potential for her condition’s severity to quickly escalate. She maintained that the supervising physician should have been more involved in her case because of its complexity.
Plaintiff’s counsel also argued that the PA should have provided “alternative medical diagnoses,” which would have prompted consideration of other treatment options. The plaintiff contended that under Wisconsin’s informed consent law, both the PA and the physician failed to disclose enough information about her condition and failed to inform her of any choices for treatment.
The defense argued that the plaintiff received proper treatment based on the information available to the providers at the time.
VERDICT
The jury found for the plaintiff and apportioned 65% liability to the physician and 35% liability to the PA. A total of $25,342,096 was awarded to the plaintiff.
COMMENTARY
This is a huge verdict. Cases involving group A strep or necrotizing fasciitis frequently give rise to large medical malpractice verdicts, because everything about them is difficult to defend: Although there is typically trivial to no trauma involved, the wounds from these infections provide explicit images of damage, intraoperatively and postoperatively. Vasopressors required for hemodynamic support or sepsis itself frequently result in limb ischemia, gangrene, and amputation. In this case, the plaintiff, as a quadruple amputee, was a sympathetic and impressive courtroom presence—the personal toll was evident to anyone in the room.
Two providers—a PA and a physician—saw the patient. We are told only that she complained of severe abdominal pain, rapid heartbeat, and fever, which increased at some point during her ED stay. We aren’t given specifics on the rest of the patient’s vital signs or examination details. However, we can infer that the exam and lab findings were not impressive, because they weren’t mentioned in the case report. But as a result of the failure to catch the group A strep infection, the plaintiff suffered what one judge hearing the case described as a harrowing and unimaginable ordeal: the life-changing amputation of 4 limbs.1 While the jury did not find the PA or physician negligent, they still found the clinicians liable and awarded a staggering verdict.
Continue to: How could this happen?
How could this happen? The answer is the theory of recovery: The jury found that the physician and the PA failed to provide the patient with informed consent in the form of “alternative medical diagnoses.”2 The plaintiff’s attorney argued that the patient was never told a life-threatening bacterial infection was one possible diagnosis and claimed that if she had known, the patient would have pursued other treatment.
As in many malpractice cases, the plaintiff alleged failure to diagnose and failure to provide informed consent. Depending on state law, there are 3 standards for informed consent: subjective patient, reasonable patient, and reasonable physician.3 About half of the states have a physician-focused standard, while the other half have a patient-focused standard.3
Under the subjective patient standard, we would ask, “What would this patient need to know and understand to make an informed decision?”4 The subjective standard requires the clinician to essentially “get in the head” of a specific patient to determine what he or she would want to know when making a medical decision. This standard is problematic because it requires the clinician to have an intimate familiarity with the patient’s belief system and medical decision-making process—a daunting requirement for many clinicians, particularly in the absence of a longstanding clinician-patient relationship, as is the case in most emergency settings. Thankfully, the subjective patient standard is not followed by most states that have a patient-focused standard.
Under the objective reasonable patient standard, we would ask “What would the average patient need to know to be an informed participant in the decision?”4 One could argue that this standard more adequately allows the patient to be an active participant in shared decision-making. However, the drawback is that what is “reasonable” often falls on a spectrum, which would require the clinician to gauge the volume and type of information a patient cohort would want to have when making a medical decision. Under this standard, the plaintiff must prove that the clinician omitted information that a reasonable patient would want to know. Therefore, these standards are more friendly to the plaintiff, whereas the reasonable physician standard is more defendant friendly.
To meet the standard of care under a reasonable physician standard, information must be provided to the patient that a “reasonably prudent practitioner in the same field of practice or specialty” would provide to a patient.5 For a plaintiff to successfully sue under this standard, the plaintiff’s expert must testify that a reasonably prudent physician would have disclosed the omitted information.6 The reasonable physician standard is obviously better for malpractice defendants.
Continue to: While reasonable clinicians...
While reasonable clinicians can disagree (as can reasonable patients), clinicians are more likely to be closer in opinion. Clinicians are a smaller group whose opinions are underpinned by similar education, training, and experience. By contrast, among the general population, beliefs held by one hypothetical “reasonable person” are much less settled, and in some cases, wildly divergent from another’s. For example, vaccine skepticism would probably be considered unreasonable in the majority of jury pools but absolutely reasonable in some. The large size of the general population, coupled with opinions untethered to any definable discipline, make the reasonable patient standard hard to predict.
Additionally, the reasonable physician standard forces the plaintiff to prove his or her case by producing an expert witness (clinician) to specifically testify that the standard of care required the defendant clinician to disclose certain specific information, and that disclosure was lacking. That is an important requirement. Under patient-focused standards, the plaintiff doesn’t need a medical expert on this point and can simply argue to the jury that a reasonable patient would require an exhaustive discussion of each possibility in the differential diagnosis. Therefore, I would argue that the reasonable physician standard is more predictable and workable and should be followed.
At the time of this case, Wisconsin’s informed consent law was based on the reasonable patient standard. As a result of this case, Wisconsin lawmakers changed the law to a “reasonable physician standard,” which states “any physician who treats a patient shall inform the patient about the availability of reasonable alternate medical modes of treatment and about the benefits and risks of these treatments.”7 However, the law stipulates that this duty to inform does not require disclosure of (among others):
- Detailed technical information that in all probability a patient would not understand
- Risks apparent or known to the patient
- Extremely remote possibilities that might falsely or detrimentally alarm the patient
- Information about alternate medical modes of treatment for any condition the physician has not included in his or her diagnosis at the time the physician informs the patient.7
Finally, this case involved an extremely high verdict of more than $25 million. It may surprise you to learn that many states have caps for medical malpractice awards for noneconomic damages, such as pain and suffering. If you’re having a holiday dinner with friends or family members who are plaintiff’s attorneys and you’re itching for a good argument, skip current politics and go all-in: How about liability caps, Uncle Jim? Get ready for a lively debate.
Of the $25 million verdict, $16.5 million was awarded for pain and suffering—the jury was obviously shocked by the extent of the life-changing nature of the plaintiff’s injuries. At the time of this case, Wisconsin had a cap of $750,000 for noneconomic damages.8 However, plaintiffs may challenge state constitutionality of these caps when they feel they have the right case, which the plaintiff and her attorney felt they did. Two lower courts found the state cap unconstitutional and gave the plaintiff the full award. But the state Supreme Court later reversed that decision, upholding the cap.1 The court decided that the legislature had a rational basis for making the law and changes to it should occur through the legislature, not the courts. The dissenting justices argued that there was no rational basis for the $750,000 cap, because there was no evidence that clinicians would flee the state fearing malpractice liability, or practice more defensive medicine, or suffer runaway malpractice insurance premiums without the cap. As a result of this case, the cap was upheld, and there was a “lively debate” on this issue at the highest levels of government.
Continue to: IN SUM
IN SUM
Become familiar with your state’s informed consent laws. Involve patients in decision-making, and convey information related to reasonable treatment options and risks. Document all of these discussions. Lastly, state-level political discussions on issues of tort reform, caps, and malpractice matters are ongoing—so take n
1. Mayo v Wisconsin Injured Patients & Families Compensation Fund. WI 78 (2018).
2. Spivak C. Jury awards Milwaukee woman $25.3 million in medical malpractice case. Milwaukee Journal Sentinel. July 7, 2014.
3. Moore GP, Matlock AG, Kiley JL, et al. Emergency physicians: beware of the consent standard of care. Clin Pract Cases Emerg Med. 2018; 2(2):109-111.
4. Gossman W, Thornton I, Hipskind JE. Informed Consent. StatPearls. www.ncbi.nlm.nih.gov/books/NBK430827/. Updated July 10, 2019. Accessed October 25, 2019.
5. King JS, Moulton BW. Rethinking informed consent: the case for shared medical decision-making. Am J Law Med. 2006;32:429-501.
6. Tashman v Gibbs, 556 SE 2d 772 (263 Va 2002).
7. Wis Stat subchapter 2, §448.30.
8. Wis Stat §893.55.
1. Mayo v Wisconsin Injured Patients & Families Compensation Fund. WI 78 (2018).
2. Spivak C. Jury awards Milwaukee woman $25.3 million in medical malpractice case. Milwaukee Journal Sentinel. July 7, 2014.
3. Moore GP, Matlock AG, Kiley JL, et al. Emergency physicians: beware of the consent standard of care. Clin Pract Cases Emerg Med. 2018; 2(2):109-111.
4. Gossman W, Thornton I, Hipskind JE. Informed Consent. StatPearls. www.ncbi.nlm.nih.gov/books/NBK430827/. Updated July 10, 2019. Accessed October 25, 2019.
5. King JS, Moulton BW. Rethinking informed consent: the case for shared medical decision-making. Am J Law Med. 2006;32:429-501.
6. Tashman v Gibbs, 556 SE 2d 772 (263 Va 2002).
7. Wis Stat subchapter 2, §448.30.
8. Wis Stat §893.55.
