MDedge Rheumatology

A common sentiment shared by patients who are happy with their health care professionals is, “I feel heard and understood.” How do we become those professionals and make sure that we are doing a good job connecting and communicating with our patients?

Here are a few suggestions on how to do this.
 

Practice intent listening

When a patient shares their symptoms with you, show genuine curiosity and concern. Ask clarifying questions. Ask how the symptom or problem is affecting their day-to-day life. Avoid quick, rapid-fire questions back at the patient. Do not accept a patient self-diagnosis.

When a patient with a first-time headache says they are having a migraine headache, for example, ask many clarifying questions to make sure you can make a diagnosis of headache type, then use all the information you have gathered to educate the patient on what you believe they have.

It is easy to jump to treatment, but we always want to make sure we have the diagnosis correct first. By intently listening, it also makes it much easier to tell a patient you do not know what is causing their symptoms, but that you and the patient will be vigilant for any future clues that may lead to a diagnosis.
 

Use terminology that patients understand

Rachael Gotlieb, MD, and colleagues published an excellent study with eye-opening results on common phrases we use as health care providers and how often patients do not understand them.

Only 9% of patients understood what was meant when they were asked if they have been febrile. Only 2% understood what was meant by “I am concerned the patient has an occult infection.” Only 21% understood that “your xray findings were quite impressive” was bad news.

It is easy to avoid these medical language traps, we just have to check our doctor speak. Ask, “Do you have a fever?” Say, “I am concerned you may have an infection that is hard to find.”

Several other terms we use all the time in explaining things to patients that I have found most patients do not understand are the terms bilateral, systemic, and significant. Think carefully as you explain things to patients and check back to have them repeat to you what they think you said.
 

Be comfortable saying you don’t know

Many symptoms in medicine end up not being diagnosable. When a patient shares symptoms that do not fit a pattern of a disease, it is important to share with them why you think it is okay to wait and watch, even if you do not have a diagnosis.

Patients find it comforting that you are so honest with them. Doing this also has the benefit of gaining patients’ trust when you are sure about something, because it tells them you don’t have an answer for everything.
 

Ask your patients what they think is causing their symptoms

This way, you know what their big fear is. You can address what they are worried about, even if it isn’t something you are considering.

Patients are often fearful of a disease a close friend or relative has, so when they get new symptoms, they fear diseases that we might not think of. By knowing what they are fearful of, you can reassure when appropriate.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A common sentiment shared by patients who are happy with their health care professionals is, “I feel heard and understood.” How do we become those professionals and make sure that we are doing a good job connecting and communicating with our patients?

Here are a few suggestions on how to do this.
 

Practice intent listening

When a patient shares their symptoms with you, show genuine curiosity and concern. Ask clarifying questions. Ask how the symptom or problem is affecting their day-to-day life. Avoid quick, rapid-fire questions back at the patient. Do not accept a patient self-diagnosis.

When a patient with a first-time headache says they are having a migraine headache, for example, ask many clarifying questions to make sure you can make a diagnosis of headache type, then use all the information you have gathered to educate the patient on what you believe they have.

It is easy to jump to treatment, but we always want to make sure we have the diagnosis correct first. By intently listening, it also makes it much easier to tell a patient you do not know what is causing their symptoms, but that you and the patient will be vigilant for any future clues that may lead to a diagnosis.
 

Use terminology that patients understand

Rachael Gotlieb, MD, and colleagues published an excellent study with eye-opening results on common phrases we use as health care providers and how often patients do not understand them.

Only 9% of patients understood what was meant when they were asked if they have been febrile. Only 2% understood what was meant by “I am concerned the patient has an occult infection.” Only 21% understood that “your xray findings were quite impressive” was bad news.

It is easy to avoid these medical language traps, we just have to check our doctor speak. Ask, “Do you have a fever?” Say, “I am concerned you may have an infection that is hard to find.”

Several other terms we use all the time in explaining things to patients that I have found most patients do not understand are the terms bilateral, systemic, and significant. Think carefully as you explain things to patients and check back to have them repeat to you what they think you said.
 

Be comfortable saying you don’t know

Many symptoms in medicine end up not being diagnosable. When a patient shares symptoms that do not fit a pattern of a disease, it is important to share with them why you think it is okay to wait and watch, even if you do not have a diagnosis.

Patients find it comforting that you are so honest with them. Doing this also has the benefit of gaining patients’ trust when you are sure about something, because it tells them you don’t have an answer for everything.
 

Ask your patients what they think is causing their symptoms

This way, you know what their big fear is. You can address what they are worried about, even if it isn’t something you are considering.

Patients are often fearful of a disease a close friend or relative has, so when they get new symptoms, they fear diseases that we might not think of. By knowing what they are fearful of, you can reassure when appropriate.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A common sentiment shared by patients who are happy with their health care professionals is, “I feel heard and understood.” How do we become those professionals and make sure that we are doing a good job connecting and communicating with our patients?

Here are a few suggestions on how to do this.
 

Practice intent listening

When a patient shares their symptoms with you, show genuine curiosity and concern. Ask clarifying questions. Ask how the symptom or problem is affecting their day-to-day life. Avoid quick, rapid-fire questions back at the patient. Do not accept a patient self-diagnosis.

When a patient with a first-time headache says they are having a migraine headache, for example, ask many clarifying questions to make sure you can make a diagnosis of headache type, then use all the information you have gathered to educate the patient on what you believe they have.

It is easy to jump to treatment, but we always want to make sure we have the diagnosis correct first. By intently listening, it also makes it much easier to tell a patient you do not know what is causing their symptoms, but that you and the patient will be vigilant for any future clues that may lead to a diagnosis.
 

Use terminology that patients understand

Rachael Gotlieb, MD, and colleagues published an excellent study with eye-opening results on common phrases we use as health care providers and how often patients do not understand them.

Only 9% of patients understood what was meant when they were asked if they have been febrile. Only 2% understood what was meant by “I am concerned the patient has an occult infection.” Only 21% understood that “your xray findings were quite impressive” was bad news.

It is easy to avoid these medical language traps, we just have to check our doctor speak. Ask, “Do you have a fever?” Say, “I am concerned you may have an infection that is hard to find.”

Several other terms we use all the time in explaining things to patients that I have found most patients do not understand are the terms bilateral, systemic, and significant. Think carefully as you explain things to patients and check back to have them repeat to you what they think you said.
 

Be comfortable saying you don’t know

Many symptoms in medicine end up not being diagnosable. When a patient shares symptoms that do not fit a pattern of a disease, it is important to share with them why you think it is okay to wait and watch, even if you do not have a diagnosis.

Patients find it comforting that you are so honest with them. Doing this also has the benefit of gaining patients’ trust when you are sure about something, because it tells them you don’t have an answer for everything.
 

Ask your patients what they think is causing their symptoms

This way, you know what their big fear is. You can address what they are worried about, even if it isn’t something you are considering.

Patients are often fearful of a disease a close friend or relative has, so when they get new symptoms, they fear diseases that we might not think of. By knowing what they are fearful of, you can reassure when appropriate.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

Nearly 25% of hospital admissions included at least one adverse event, as indicated from data from 2,809 admissions at 11 hospitals.

The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.

“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.

In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.

Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.

A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.

A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.

The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
 

Overcoming barriers to better safety

“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.

“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”

“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.

As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.

The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.

However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
 

Timely reassessment and opportunities to improve

In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.

“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.

“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.

“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.

The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.

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

Nearly 25% of hospital admissions included at least one adverse event, as indicated from data from 2,809 admissions at 11 hospitals.

The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.

“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.

In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.

Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.

A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.

A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.

The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
 

Overcoming barriers to better safety

“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.

“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”

“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.

As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.

The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.

However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
 

Timely reassessment and opportunities to improve

In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.

“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.

“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.

“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.

The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.

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

Nearly 25% of hospital admissions included at least one adverse event, as indicated from data from 2,809 admissions at 11 hospitals.

The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.

“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.

In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.

Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.

A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.

A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.

The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
 

Overcoming barriers to better safety

“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.

“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”

“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.

As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.

The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.

However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
 

Timely reassessment and opportunities to improve

In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.

“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.

“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.

“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.

The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.

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

A new study likely makes the best estimate yet of the degree of retinopathy risk that patients who take the antimalarial drug hydroxychloroquine (HCQ) can expect, deriving mainly from the cumulative dose taken during the first 5 years of use, according to a study published in Annals of Internal Medicine.

HCQ works to decrease activity in a patient’s immune system, which is effective in many cases of systemic lupus erythematosus, one of the most common indications for the drug. However, an adverse outcome of treatment can be HCQ retinopathy, a progressive form of vision loss in patients taking HCQ over an extended period (mostly for longer than 5 years). The disease is often asymptomatic, although some patients do present a paracentral scotoma and a decrease in color vision. Patients may also notice flashing shapes in their vision and find that they have difficulty reading. Eventually, HCQ retinopathy can lead to loss of visual acuity, loss of peripheral vision, and loss of night vision.

Researchers from Kaiser Permanente Northern California and Harvard Medical School analyzed 3,325 persons who received HCQ for 5 or more years between 2004 and 2020. Their goal was to both characterize the long-term risk for incident HCQ retinopathy and examine the degree to which average HCQ dose within the first 5 years of treatment serves as a prediction of the risk.

The researchers then estimated the risk for developing retinopathy after 15 years, according to patients’ average dosing levels during the first 5 years of therapy. Overall, 81 participants developed HCQ retinopathy with overall cumulative incidences of 2.5% after 10 years and 8.6% after 15 years; the risk was greater for those given a higher dose during the first 5 years of treatment.

The mechanism of how HCQ toxicity may occur is still not completely known. There is evidence that toxicity happens because HCQ binds to melanin in both the retinal pigment epithelium and uvea in high concentrations. HCQ can interfere with lysosomal function, leading to oxidation and accumulation of lysosomes, which can cause dysfunction of the retinal pigment epithelium.

Progressive retinopathy can continue even after the drug is stopped. “It’s thought to be a very mild but important risk,” said Nilanjana Bose, MD, MBA, a rheumatologist with Memorial Hermann Health System in Houston. “Patients taking HCQ must be screened for retinal issues, most certainly elderly patients and patients with any kind of comorbidities.”

“Examination alone is not sufficient to evaluate early changes, and specialized testing must be done. These include color photos, visual field tests, optical coherence tomography, fundus autofluorescence and in some cases, multifocal electroretinogram. Also, the AAO [American Academy of Ophthalmology] has specific recommendations related to Asian patients as they may have a different pattern of retinopathy that must also be considered.”
 

More accurate risk measurements

This news organization asked study coauthor April Jorge, MD, assistant professor of medicine in the division of rheumatology, allergy, and immunology at Massachusetts General Hospital and Harvard Medical School, Boston, to discuss the study, how it correlates to past research, and what it adds that’s new and useful to rheumatologists and ophthalmologists:

Question: Your research found that a higher dose of HCQ in the first 5 years of treatment led to a greater risk of retinopathy. Is there any indication that a lower dose given more frequently, either within that 5-year period or longer, would pose a similar risk?

Answer: In our study, we assessed the HCQ dose in the first 5 years of use but followed patients who continued the medication longer than 5 years, through up to 15 years of use. Therefore, we compared the risk of HCQ retinopathy associated with different HCQ dosages but for the same duration of use. We found that for any dose of HCQ, the risk of retinopathy increases the longer the medication is used. However, patients who used a higher dose of HCQ had a higher risk of developing retinopathy over time.

Also unique to our study, we graded the severity of HCQ retinopathy outcomes. This was important, as we found that the majority of retinopathy cases detected through routine screening are mild and presumed to be asymptomatic. This will likely be reassuring news for patients that we can screen for this adverse event to detect it early and prevent vision loss.

Another important difference was that we assessed the risk of retinopathy associated with using over 6 mg/kg per day, between 5 and 6 mg/kg per day, and less than 5 mg/kg per day, whereas the highest dosing group assessed in the 2014 study included all patients using over 5 mg/kg per day. The risk was considerably higher in the > 6 mg/kg per day group than in the 5-6 mg/kg per day group.

Q: How can rheumatologists and ophthalmologists use this new information specifically to better treat their patients?

A: Our study provides more accurate estimates of the risk of HCQ retinopathy than in prior studies. These risk estimates can be used when rheumatologists (and other clinicians who prescribe HCQ) consider the risks and benefits of this otherwise important and well-tolerated medication. The risk associated with different dose ranges could also inform dosing decisions, since dosing over 6 mg/kg per day may be more of a concern than using doses in the 5-6 mg/kg range. Ophthalmologists can also use these new risk estimates to counsel patients of the importance of HCQ retinopathy screening and can also hopefully provide some reassurance to patients that the risk of severe retinopathy is low as long as they are being monitored.

The study authors were supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Rheumatology Research Foundation. The authors report no relevant financial relationships. Dr. Bose and Dr. Mirza had no relevant disclosures.

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

A new study likely makes the best estimate yet of the degree of retinopathy risk that patients who take the antimalarial drug hydroxychloroquine (HCQ) can expect, deriving mainly from the cumulative dose taken during the first 5 years of use, according to a study published in Annals of Internal Medicine.

HCQ works to decrease activity in a patient’s immune system, which is effective in many cases of systemic lupus erythematosus, one of the most common indications for the drug. However, an adverse outcome of treatment can be HCQ retinopathy, a progressive form of vision loss in patients taking HCQ over an extended period (mostly for longer than 5 years). The disease is often asymptomatic, although some patients do present a paracentral scotoma and a decrease in color vision. Patients may also notice flashing shapes in their vision and find that they have difficulty reading. Eventually, HCQ retinopathy can lead to loss of visual acuity, loss of peripheral vision, and loss of night vision.

Researchers from Kaiser Permanente Northern California and Harvard Medical School analyzed 3,325 persons who received HCQ for 5 or more years between 2004 and 2020. Their goal was to both characterize the long-term risk for incident HCQ retinopathy and examine the degree to which average HCQ dose within the first 5 years of treatment serves as a prediction of the risk.

The researchers then estimated the risk for developing retinopathy after 15 years, according to patients’ average dosing levels during the first 5 years of therapy. Overall, 81 participants developed HCQ retinopathy with overall cumulative incidences of 2.5% after 10 years and 8.6% after 15 years; the risk was greater for those given a higher dose during the first 5 years of treatment.

The mechanism of how HCQ toxicity may occur is still not completely known. There is evidence that toxicity happens because HCQ binds to melanin in both the retinal pigment epithelium and uvea in high concentrations. HCQ can interfere with lysosomal function, leading to oxidation and accumulation of lysosomes, which can cause dysfunction of the retinal pigment epithelium.

Progressive retinopathy can continue even after the drug is stopped. “It’s thought to be a very mild but important risk,” said Nilanjana Bose, MD, MBA, a rheumatologist with Memorial Hermann Health System in Houston. “Patients taking HCQ must be screened for retinal issues, most certainly elderly patients and patients with any kind of comorbidities.”

“Examination alone is not sufficient to evaluate early changes, and specialized testing must be done. These include color photos, visual field tests, optical coherence tomography, fundus autofluorescence and in some cases, multifocal electroretinogram. Also, the AAO [American Academy of Ophthalmology] has specific recommendations related to Asian patients as they may have a different pattern of retinopathy that must also be considered.”
 

More accurate risk measurements

This news organization asked study coauthor April Jorge, MD, assistant professor of medicine in the division of rheumatology, allergy, and immunology at Massachusetts General Hospital and Harvard Medical School, Boston, to discuss the study, how it correlates to past research, and what it adds that’s new and useful to rheumatologists and ophthalmologists:

Question: Your research found that a higher dose of HCQ in the first 5 years of treatment led to a greater risk of retinopathy. Is there any indication that a lower dose given more frequently, either within that 5-year period or longer, would pose a similar risk?

Answer: In our study, we assessed the HCQ dose in the first 5 years of use but followed patients who continued the medication longer than 5 years, through up to 15 years of use. Therefore, we compared the risk of HCQ retinopathy associated with different HCQ dosages but for the same duration of use. We found that for any dose of HCQ, the risk of retinopathy increases the longer the medication is used. However, patients who used a higher dose of HCQ had a higher risk of developing retinopathy over time.

Also unique to our study, we graded the severity of HCQ retinopathy outcomes. This was important, as we found that the majority of retinopathy cases detected through routine screening are mild and presumed to be asymptomatic. This will likely be reassuring news for patients that we can screen for this adverse event to detect it early and prevent vision loss.

Another important difference was that we assessed the risk of retinopathy associated with using over 6 mg/kg per day, between 5 and 6 mg/kg per day, and less than 5 mg/kg per day, whereas the highest dosing group assessed in the 2014 study included all patients using over 5 mg/kg per day. The risk was considerably higher in the > 6 mg/kg per day group than in the 5-6 mg/kg per day group.

Q: How can rheumatologists and ophthalmologists use this new information specifically to better treat their patients?

A: Our study provides more accurate estimates of the risk of HCQ retinopathy than in prior studies. These risk estimates can be used when rheumatologists (and other clinicians who prescribe HCQ) consider the risks and benefits of this otherwise important and well-tolerated medication. The risk associated with different dose ranges could also inform dosing decisions, since dosing over 6 mg/kg per day may be more of a concern than using doses in the 5-6 mg/kg range. Ophthalmologists can also use these new risk estimates to counsel patients of the importance of HCQ retinopathy screening and can also hopefully provide some reassurance to patients that the risk of severe retinopathy is low as long as they are being monitored.

The study authors were supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Rheumatology Research Foundation. The authors report no relevant financial relationships. Dr. Bose and Dr. Mirza had no relevant disclosures.

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

A new study likely makes the best estimate yet of the degree of retinopathy risk that patients who take the antimalarial drug hydroxychloroquine (HCQ) can expect, deriving mainly from the cumulative dose taken during the first 5 years of use, according to a study published in Annals of Internal Medicine.

HCQ works to decrease activity in a patient’s immune system, which is effective in many cases of systemic lupus erythematosus, one of the most common indications for the drug. However, an adverse outcome of treatment can be HCQ retinopathy, a progressive form of vision loss in patients taking HCQ over an extended period (mostly for longer than 5 years). The disease is often asymptomatic, although some patients do present a paracentral scotoma and a decrease in color vision. Patients may also notice flashing shapes in their vision and find that they have difficulty reading. Eventually, HCQ retinopathy can lead to loss of visual acuity, loss of peripheral vision, and loss of night vision.

Researchers from Kaiser Permanente Northern California and Harvard Medical School analyzed 3,325 persons who received HCQ for 5 or more years between 2004 and 2020. Their goal was to both characterize the long-term risk for incident HCQ retinopathy and examine the degree to which average HCQ dose within the first 5 years of treatment serves as a prediction of the risk.

The researchers then estimated the risk for developing retinopathy after 15 years, according to patients’ average dosing levels during the first 5 years of therapy. Overall, 81 participants developed HCQ retinopathy with overall cumulative incidences of 2.5% after 10 years and 8.6% after 15 years; the risk was greater for those given a higher dose during the first 5 years of treatment.

The mechanism of how HCQ toxicity may occur is still not completely known. There is evidence that toxicity happens because HCQ binds to melanin in both the retinal pigment epithelium and uvea in high concentrations. HCQ can interfere with lysosomal function, leading to oxidation and accumulation of lysosomes, which can cause dysfunction of the retinal pigment epithelium.

Progressive retinopathy can continue even after the drug is stopped. “It’s thought to be a very mild but important risk,” said Nilanjana Bose, MD, MBA, a rheumatologist with Memorial Hermann Health System in Houston. “Patients taking HCQ must be screened for retinal issues, most certainly elderly patients and patients with any kind of comorbidities.”

“Examination alone is not sufficient to evaluate early changes, and specialized testing must be done. These include color photos, visual field tests, optical coherence tomography, fundus autofluorescence and in some cases, multifocal electroretinogram. Also, the AAO [American Academy of Ophthalmology] has specific recommendations related to Asian patients as they may have a different pattern of retinopathy that must also be considered.”
 

More accurate risk measurements

This news organization asked study coauthor April Jorge, MD, assistant professor of medicine in the division of rheumatology, allergy, and immunology at Massachusetts General Hospital and Harvard Medical School, Boston, to discuss the study, how it correlates to past research, and what it adds that’s new and useful to rheumatologists and ophthalmologists:

Question: Your research found that a higher dose of HCQ in the first 5 years of treatment led to a greater risk of retinopathy. Is there any indication that a lower dose given more frequently, either within that 5-year period or longer, would pose a similar risk?

Answer: In our study, we assessed the HCQ dose in the first 5 years of use but followed patients who continued the medication longer than 5 years, through up to 15 years of use. Therefore, we compared the risk of HCQ retinopathy associated with different HCQ dosages but for the same duration of use. We found that for any dose of HCQ, the risk of retinopathy increases the longer the medication is used. However, patients who used a higher dose of HCQ had a higher risk of developing retinopathy over time.

Also unique to our study, we graded the severity of HCQ retinopathy outcomes. This was important, as we found that the majority of retinopathy cases detected through routine screening are mild and presumed to be asymptomatic. This will likely be reassuring news for patients that we can screen for this adverse event to detect it early and prevent vision loss.

Another important difference was that we assessed the risk of retinopathy associated with using over 6 mg/kg per day, between 5 and 6 mg/kg per day, and less than 5 mg/kg per day, whereas the highest dosing group assessed in the 2014 study included all patients using over 5 mg/kg per day. The risk was considerably higher in the > 6 mg/kg per day group than in the 5-6 mg/kg per day group.

Q: How can rheumatologists and ophthalmologists use this new information specifically to better treat their patients?

A: Our study provides more accurate estimates of the risk of HCQ retinopathy than in prior studies. These risk estimates can be used when rheumatologists (and other clinicians who prescribe HCQ) consider the risks and benefits of this otherwise important and well-tolerated medication. The risk associated with different dose ranges could also inform dosing decisions, since dosing over 6 mg/kg per day may be more of a concern than using doses in the 5-6 mg/kg range. Ophthalmologists can also use these new risk estimates to counsel patients of the importance of HCQ retinopathy screening and can also hopefully provide some reassurance to patients that the risk of severe retinopathy is low as long as they are being monitored.

The study authors were supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Rheumatology Research Foundation. The authors report no relevant financial relationships. Dr. Bose and Dr. Mirza had no relevant disclosures.

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

Some of our worst decisions seemed like really good ideas at the time. We wouldn’t make them otherwise; but often we fall into the unintended consequence of “the cure being worse than the poison.” We have seen this when government is trying to fix a problem, often an emotionally charged problem, without considering the long-term consequences of the “fix.” We have seen the unintended consequences of certain health care policies and programs lead to abuse and negative downstream effects on the same population that they were intended to protect.

It has been postulated that unintended consequences fall into a framework that’s “based upon level of knowledge and the scope for avoidance.” Essentially, that means these consequences fall into one of four categories: knowable and avoidable, knowable and unavoidable, unknowable and avoidable, and unknowable and unavoidable.

What category do the following policies fall into?
 

Pharmacy benefit managers’ safe harbor from the Anti-Kickback Statute

Let’s start with the “safe harbor” from the Anti-Kickback Statute (AKS) for payments from drug companies to health insurance companies and pharmacy benefit managers (PBMs). The AKS was created in 1972 and its “main purpose is to protect patients and the federal health care programs from fraud and abuse by curtailing the corrupting influence of money on health care decisions.” During the 1990s, a number of safe harbor provisions under the AKS were instituted for certain payments to health insurance companies, PBMs, and other providers. The thinking was that these payments needed a safe harbor because, although they might meet the statutory definition of “kickbacks,” they were beneficial because they would reduce the cost of care and, more specifically, the prices of drugs.

While well-intentioned, those safe harbors now protect a system of such perverse incentives that patients are whipsawed back and forth onto drugs that are the most profitable for the PBMs, who create the annual list of insurance covered drugs (i.e., the formulary). It is clear now that protected kickbacks ($$), in the form of rebates and fees paid by pharmaceutical manufacturers to PBMs, determine what drugs will be on the formulary. PBMs then use utilization management tools such as step therapy to force patients to take those drugs first. Consequently, safe harbor protection from the AKS allows manufacturers to buy market share at the expense of patient’s health. Because these protected kickbacks are based on a percentage of the list price of the drugs, PBMs profit more from higher priced drugs, which PBMs call the lowest cost medications (for them, that is). These bids from various manufacturers can change over the course of a year, allowing PBMs to change formulary coverage (even mid-year) and nonmedically switch stable patients to the drug that is the most profitable. Much of this happens as a result of the unintended consequence of this particular safe harbor from the AKS. Ironically, the safe harbor has helped to create the very behavior that the law was supposed to prevent and has harmed the patients it was supposed to protect. Health care decisions are being corrupted by the influence of profits allowed by safe harbor from the AKS.
 

340B drug program lacks oversight

Helping hospitals pay for care of the indigent: What could go wrong with that? The 340B Drug Pricing Program was created in 1992 to help low-income patients have better access to outpatient medications. The program requires drug companies to offer deep discounts to safety-net providers and qualified “disproportionate share hospitals,” which have a minimum percentage threshold of Medicare and Medicaid patients. The idea was that these qualified entities would pass these savings through to their low-income patients who needed the medications. Sounds like a great idea!

Apparently, there is a lot of money to be made under the 340B program because what started in 1992 with 90 covered entities had expanded by 2017 to more than 12,000 covered entities. The program became a profit center in part because reimbursement for 340B-acquired drugs far exceeds the acquisition costs. Over the years, in order to increase profits, qualified entities, such as disproportionate share hospitals, added for-profit contracted outpatient pharmacies, significantly increasing the amount of 340B drugs dispensed to commercial patients. From 2010 to 2020, the number of contract pharmacy arrangements increased from 2,000 to over 100,000, massively increasing profits for the qualified hospitals and their for-profit contracted pharmacies, which included a number of Fortune 25 companies.

Unfortunately, there is no oversight of 340B programs, and there are no requirements that the 340B drug profits be used for charitable care. In fact, nearly 10 years ago, two experts stated in Health Affairs that, “our findings support the criticism that the 340B program is being converted from one that serves vulnerable patient populations to one that enriches hospitals and their affiliated clinics.” In spite of the immense profits generated at 340B hospitals, an analysis by Avalere Health revealed that “65 percent of 340B hospitals provide less charity care than the national average for all short-term acute care hospitals, including for-profit hospitals.”

I have seen this dynamic at work in my own community in south Louisiana. There is a major expanding 340B hospital system that refuses Medicaid patients into its clinics once the hospital has reached its minimum disproportionate share of Medicaid patients. Our community has many young female African American patients with lupus, many of whom are covered by Medicaid. Even though this 340B hospital system has rheumatology fellows, it closes its rheumatology clinic doors to patients with lupus who have Medicaid as soon as it has reached its 11.75% of Medicaid patients. Clearly, this is an abuse of a program instituted specifically to take care of those in need – and here in our community, it creates inequitable access to rheumatologic care for patients with lupus.

The statute that created 340B specifically listed certain nonhospital providers who need – and should continue to receive – access to 340B discounts, such as Federally Qualified Health Centers and others. There are many deserving safety net providers and special disease clinics that are taking care of the truly needy and deserve to get the 340B highly discounted drug pricing. However, many so-called nonprofit hospital systems are spreading into wealthy neighborhoods with contracted pharmacies making large profits without caring for those in need. Five years ago, the U.S. Government Accountability Office stated that more oversight of the 340B program was needed, but that still hasn’t happened. The combination of vague statutory language and a lack of oversight has led to unintended consequences of fraud and abuse of the system, with indigent patients not realizing the benefit of the steep discounts, being sued when they can’t pay their bills, and even turned away from clinics when the qualified hospital reaches it mandated minimum of Medicaid patients.
 

Knowable and avoidable?

Should it have been known that these abuses would result from these policies and programs? And if so, could guardrails have been put in place from the start to avoid these abuses? Maybe the answers to these questions are irrelevant: All we can do now is fix what is not working, which will require changes and oversight to ensure that the safe harbor policy and 340B drug discount program are achieving the desired ends. At this point, unfortunately, it is clear that they’re not. In fact, it looks like they have enabled “profits over patients” all the way.

As recently stated by Dr. Megan Ranney of Brown University: “In this country, we continually forget that the profit motive is not sufficient for the public’s health.” Yes, hindsight is 20/20. But now we need to take off our blinders, see what is happening, and act to finally put “patients over profits.”

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

Some of our worst decisions seemed like really good ideas at the time. We wouldn’t make them otherwise; but often we fall into the unintended consequence of “the cure being worse than the poison.” We have seen this when government is trying to fix a problem, often an emotionally charged problem, without considering the long-term consequences of the “fix.” We have seen the unintended consequences of certain health care policies and programs lead to abuse and negative downstream effects on the same population that they were intended to protect.

It has been postulated that unintended consequences fall into a framework that’s “based upon level of knowledge and the scope for avoidance.” Essentially, that means these consequences fall into one of four categories: knowable and avoidable, knowable and unavoidable, unknowable and avoidable, and unknowable and unavoidable.

What category do the following policies fall into?
 

Pharmacy benefit managers’ safe harbor from the Anti-Kickback Statute

Let’s start with the “safe harbor” from the Anti-Kickback Statute (AKS) for payments from drug companies to health insurance companies and pharmacy benefit managers (PBMs). The AKS was created in 1972 and its “main purpose is to protect patients and the federal health care programs from fraud and abuse by curtailing the corrupting influence of money on health care decisions.” During the 1990s, a number of safe harbor provisions under the AKS were instituted for certain payments to health insurance companies, PBMs, and other providers. The thinking was that these payments needed a safe harbor because, although they might meet the statutory definition of “kickbacks,” they were beneficial because they would reduce the cost of care and, more specifically, the prices of drugs.

While well-intentioned, those safe harbors now protect a system of such perverse incentives that patients are whipsawed back and forth onto drugs that are the most profitable for the PBMs, who create the annual list of insurance covered drugs (i.e., the formulary). It is clear now that protected kickbacks ($$), in the form of rebates and fees paid by pharmaceutical manufacturers to PBMs, determine what drugs will be on the formulary. PBMs then use utilization management tools such as step therapy to force patients to take those drugs first. Consequently, safe harbor protection from the AKS allows manufacturers to buy market share at the expense of patient’s health. Because these protected kickbacks are based on a percentage of the list price of the drugs, PBMs profit more from higher priced drugs, which PBMs call the lowest cost medications (for them, that is). These bids from various manufacturers can change over the course of a year, allowing PBMs to change formulary coverage (even mid-year) and nonmedically switch stable patients to the drug that is the most profitable. Much of this happens as a result of the unintended consequence of this particular safe harbor from the AKS. Ironically, the safe harbor has helped to create the very behavior that the law was supposed to prevent and has harmed the patients it was supposed to protect. Health care decisions are being corrupted by the influence of profits allowed by safe harbor from the AKS.
 

340B drug program lacks oversight

Helping hospitals pay for care of the indigent: What could go wrong with that? The 340B Drug Pricing Program was created in 1992 to help low-income patients have better access to outpatient medications. The program requires drug companies to offer deep discounts to safety-net providers and qualified “disproportionate share hospitals,” which have a minimum percentage threshold of Medicare and Medicaid patients. The idea was that these qualified entities would pass these savings through to their low-income patients who needed the medications. Sounds like a great idea!

Apparently, there is a lot of money to be made under the 340B program because what started in 1992 with 90 covered entities had expanded by 2017 to more than 12,000 covered entities. The program became a profit center in part because reimbursement for 340B-acquired drugs far exceeds the acquisition costs. Over the years, in order to increase profits, qualified entities, such as disproportionate share hospitals, added for-profit contracted outpatient pharmacies, significantly increasing the amount of 340B drugs dispensed to commercial patients. From 2010 to 2020, the number of contract pharmacy arrangements increased from 2,000 to over 100,000, massively increasing profits for the qualified hospitals and their for-profit contracted pharmacies, which included a number of Fortune 25 companies.

Unfortunately, there is no oversight of 340B programs, and there are no requirements that the 340B drug profits be used for charitable care. In fact, nearly 10 years ago, two experts stated in Health Affairs that, “our findings support the criticism that the 340B program is being converted from one that serves vulnerable patient populations to one that enriches hospitals and their affiliated clinics.” In spite of the immense profits generated at 340B hospitals, an analysis by Avalere Health revealed that “65 percent of 340B hospitals provide less charity care than the national average for all short-term acute care hospitals, including for-profit hospitals.”

I have seen this dynamic at work in my own community in south Louisiana. There is a major expanding 340B hospital system that refuses Medicaid patients into its clinics once the hospital has reached its minimum disproportionate share of Medicaid patients. Our community has many young female African American patients with lupus, many of whom are covered by Medicaid. Even though this 340B hospital system has rheumatology fellows, it closes its rheumatology clinic doors to patients with lupus who have Medicaid as soon as it has reached its 11.75% of Medicaid patients. Clearly, this is an abuse of a program instituted specifically to take care of those in need – and here in our community, it creates inequitable access to rheumatologic care for patients with lupus.

The statute that created 340B specifically listed certain nonhospital providers who need – and should continue to receive – access to 340B discounts, such as Federally Qualified Health Centers and others. There are many deserving safety net providers and special disease clinics that are taking care of the truly needy and deserve to get the 340B highly discounted drug pricing. However, many so-called nonprofit hospital systems are spreading into wealthy neighborhoods with contracted pharmacies making large profits without caring for those in need. Five years ago, the U.S. Government Accountability Office stated that more oversight of the 340B program was needed, but that still hasn’t happened. The combination of vague statutory language and a lack of oversight has led to unintended consequences of fraud and abuse of the system, with indigent patients not realizing the benefit of the steep discounts, being sued when they can’t pay their bills, and even turned away from clinics when the qualified hospital reaches it mandated minimum of Medicaid patients.
 

Knowable and avoidable?

Should it have been known that these abuses would result from these policies and programs? And if so, could guardrails have been put in place from the start to avoid these abuses? Maybe the answers to these questions are irrelevant: All we can do now is fix what is not working, which will require changes and oversight to ensure that the safe harbor policy and 340B drug discount program are achieving the desired ends. At this point, unfortunately, it is clear that they’re not. In fact, it looks like they have enabled “profits over patients” all the way.

As recently stated by Dr. Megan Ranney of Brown University: “In this country, we continually forget that the profit motive is not sufficient for the public’s health.” Yes, hindsight is 20/20. But now we need to take off our blinders, see what is happening, and act to finally put “patients over profits.”

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

Some of our worst decisions seemed like really good ideas at the time. We wouldn’t make them otherwise; but often we fall into the unintended consequence of “the cure being worse than the poison.” We have seen this when government is trying to fix a problem, often an emotionally charged problem, without considering the long-term consequences of the “fix.” We have seen the unintended consequences of certain health care policies and programs lead to abuse and negative downstream effects on the same population that they were intended to protect.

It has been postulated that unintended consequences fall into a framework that’s “based upon level of knowledge and the scope for avoidance.” Essentially, that means these consequences fall into one of four categories: knowable and avoidable, knowable and unavoidable, unknowable and avoidable, and unknowable and unavoidable.

What category do the following policies fall into?
 

Pharmacy benefit managers’ safe harbor from the Anti-Kickback Statute

Let’s start with the “safe harbor” from the Anti-Kickback Statute (AKS) for payments from drug companies to health insurance companies and pharmacy benefit managers (PBMs). The AKS was created in 1972 and its “main purpose is to protect patients and the federal health care programs from fraud and abuse by curtailing the corrupting influence of money on health care decisions.” During the 1990s, a number of safe harbor provisions under the AKS were instituted for certain payments to health insurance companies, PBMs, and other providers. The thinking was that these payments needed a safe harbor because, although they might meet the statutory definition of “kickbacks,” they were beneficial because they would reduce the cost of care and, more specifically, the prices of drugs.

While well-intentioned, those safe harbors now protect a system of such perverse incentives that patients are whipsawed back and forth onto drugs that are the most profitable for the PBMs, who create the annual list of insurance covered drugs (i.e., the formulary). It is clear now that protected kickbacks ($$), in the form of rebates and fees paid by pharmaceutical manufacturers to PBMs, determine what drugs will be on the formulary. PBMs then use utilization management tools such as step therapy to force patients to take those drugs first. Consequently, safe harbor protection from the AKS allows manufacturers to buy market share at the expense of patient’s health. Because these protected kickbacks are based on a percentage of the list price of the drugs, PBMs profit more from higher priced drugs, which PBMs call the lowest cost medications (for them, that is). These bids from various manufacturers can change over the course of a year, allowing PBMs to change formulary coverage (even mid-year) and nonmedically switch stable patients to the drug that is the most profitable. Much of this happens as a result of the unintended consequence of this particular safe harbor from the AKS. Ironically, the safe harbor has helped to create the very behavior that the law was supposed to prevent and has harmed the patients it was supposed to protect. Health care decisions are being corrupted by the influence of profits allowed by safe harbor from the AKS.
 

340B drug program lacks oversight

Helping hospitals pay for care of the indigent: What could go wrong with that? The 340B Drug Pricing Program was created in 1992 to help low-income patients have better access to outpatient medications. The program requires drug companies to offer deep discounts to safety-net providers and qualified “disproportionate share hospitals,” which have a minimum percentage threshold of Medicare and Medicaid patients. The idea was that these qualified entities would pass these savings through to their low-income patients who needed the medications. Sounds like a great idea!

Apparently, there is a lot of money to be made under the 340B program because what started in 1992 with 90 covered entities had expanded by 2017 to more than 12,000 covered entities. The program became a profit center in part because reimbursement for 340B-acquired drugs far exceeds the acquisition costs. Over the years, in order to increase profits, qualified entities, such as disproportionate share hospitals, added for-profit contracted outpatient pharmacies, significantly increasing the amount of 340B drugs dispensed to commercial patients. From 2010 to 2020, the number of contract pharmacy arrangements increased from 2,000 to over 100,000, massively increasing profits for the qualified hospitals and their for-profit contracted pharmacies, which included a number of Fortune 25 companies.

Unfortunately, there is no oversight of 340B programs, and there are no requirements that the 340B drug profits be used for charitable care. In fact, nearly 10 years ago, two experts stated in Health Affairs that, “our findings support the criticism that the 340B program is being converted from one that serves vulnerable patient populations to one that enriches hospitals and their affiliated clinics.” In spite of the immense profits generated at 340B hospitals, an analysis by Avalere Health revealed that “65 percent of 340B hospitals provide less charity care than the national average for all short-term acute care hospitals, including for-profit hospitals.”

I have seen this dynamic at work in my own community in south Louisiana. There is a major expanding 340B hospital system that refuses Medicaid patients into its clinics once the hospital has reached its minimum disproportionate share of Medicaid patients. Our community has many young female African American patients with lupus, many of whom are covered by Medicaid. Even though this 340B hospital system has rheumatology fellows, it closes its rheumatology clinic doors to patients with lupus who have Medicaid as soon as it has reached its 11.75% of Medicaid patients. Clearly, this is an abuse of a program instituted specifically to take care of those in need – and here in our community, it creates inequitable access to rheumatologic care for patients with lupus.

The statute that created 340B specifically listed certain nonhospital providers who need – and should continue to receive – access to 340B discounts, such as Federally Qualified Health Centers and others. There are many deserving safety net providers and special disease clinics that are taking care of the truly needy and deserve to get the 340B highly discounted drug pricing. However, many so-called nonprofit hospital systems are spreading into wealthy neighborhoods with contracted pharmacies making large profits without caring for those in need. Five years ago, the U.S. Government Accountability Office stated that more oversight of the 340B program was needed, but that still hasn’t happened. The combination of vague statutory language and a lack of oversight has led to unintended consequences of fraud and abuse of the system, with indigent patients not realizing the benefit of the steep discounts, being sued when they can’t pay their bills, and even turned away from clinics when the qualified hospital reaches it mandated minimum of Medicaid patients.
 

Knowable and avoidable?

Should it have been known that these abuses would result from these policies and programs? And if so, could guardrails have been put in place from the start to avoid these abuses? Maybe the answers to these questions are irrelevant: All we can do now is fix what is not working, which will require changes and oversight to ensure that the safe harbor policy and 340B drug discount program are achieving the desired ends. At this point, unfortunately, it is clear that they’re not. In fact, it looks like they have enabled “profits over patients” all the way.

As recently stated by Dr. Megan Ranney of Brown University: “In this country, we continually forget that the profit motive is not sufficient for the public’s health.” Yes, hindsight is 20/20. But now we need to take off our blinders, see what is happening, and act to finally put “patients over profits.”

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

People with long COVID may have dizziness, headaches, sleep problems, sluggish thinking, and many other problems. But they can also face another problem – stigma.

Most people with long COVID find they’re facing stigma due to their condition, according to a new report from researchers in the United Kingdom. In short: Relatives and friends may not believe they’re truly sick.

The U.K. team found that more than three-quarters of people studied had experienced stigma often or always. 

In fact, 95% of people with long COVID faced at least one type of stigma at least sometimes, according to the study, published in November in the journal PLOS One.

Those conclusions had surprised the study’s lead researcher, Marija Pantelic, PhD, a public health lecturer at Brighton and Sussex Medical School, England.

“After years of working on HIV-related stigma, I was shocked to see how many people were turning a blind eye to and dismissing the difficulties experienced by people with long COVID,” Dr. Pantelic says. “It has also been clear to me from the start that this stigma is detrimental not just for people’s dignity, but also public health.”

Even some doctors argue that the growing attention paid to long COVID is excessive.

“It’s often normal to experience mild fatigue or weaknesses for weeks after being sick and inactive and not eating well. Calling these cases long COVID is the medicalization of modern life,” Marty Makary, MD, a surgeon and public policy researcher at Johns Hopkins University, Baltimore, wrote in a commentary in the Wall Street Journal.

Other doctors strongly disagree, including Alba Azola, MD, codirector of the Johns Hopkins Post-Acute COVID-19 Team and an expert in the stigma surrounding long COVID.

“Putting that spin on things, it’s just hurting people,” she says.

One example is people who cannot return to work.

“A lot of their family members tell me that they’re being lazy,” Dr. Azola says. “That’s part of the public stigma, that these are people just trying to get out of work.”

Some experts say the U.K. study represents a landmark.

“When you have data like this on long COVID stigma, it becomes more difficult to deny its existence or address it,” says Naomi Torres-Mackie, PhD, a clinical psychologist at Lenox Hill Hospital in New York. She also is head of research at the New York–based Mental Health Coalition, a group of experts working to end the stigma surrounding mental health.

She recalls her first patient with long COVID.

“She experienced the discomfort and pain itself, and then she had this crushing feeling that it wasn’t valid, or real. She felt very alone in it,” Dr. Torres-Mackie says.

Another one of her patients is working at her job from home but facing doubt about her condition from her employers.

“Every month, her medical doctor has to produce a letter confirming her medical condition,” Dr. Torres-Mackie says.

Taking part in the British stigma survey were 1,166 people, including 966 residents of the United Kingdom, with the average age of 48. Nearly 85% were female, and more than three-quarters were educated at the university level or higher.

Half of them said they had a clinical diagnosis of long COVID.

More than 60% of them said that at least some of the time, they were cautious about who they talked to about their condition. And fully 34% of those who did disclose their diagnosis said that they regretted having done so.

That’s a difficult experience for those with long COVID, says Leonard Jason, PhD, a professor of psychology at DePaul University in Chicago.

“It’s like they’re traumatized by the initial experience of being sick, and retraumatized by the response of others to them,” he says.

Unexplained illnesses are not well-regarded by the general public, Dr. Jason says.

He gave the example of multiple sclerosis. Before the 1980s, those with MS were considered to have a psychological illness, he says. “Then, in the 1980s, there were biomarkers that said, ‘Here’s the evidence.’ ”

The British study described three types of stigma stemming from the long COVID diagnosis of those questioned:

• Enacted stigma: People were directly treated unfairly because of their condition.
• Internalized stigma: People felt embarrassed by that condition.
• Anticipated stigma: People expected they would be treated poorly because of their diagnosis.

Dr. Azola calls the medical community a major problem when it comes to dealing with long COVID.

“What I see with my patients is medical trauma,” she says. They may have symptoms that send them to the emergency room, and then the tests come back negative. “Instead of tracking the patients’ symptoms, patients get told, ‘Everything looks good, you can go home, this is a panic attack,’ ” she says.

Some people go online to search for treatments, sometimes launching GoFundMe campaigns to raise money for unreliable treatments.

Long COVID patients may have gone through 5 to 10 doctors before they arrive for treatment with the Johns Hopkins Post-Acute COVID-19 Team. The clinic began in April 2020 remotely and in August of that year in person.

Today, the clinic staff spends an hour with a first-time long COVID patient, hearing their stories and helping relieve anxiety, Dr. Azola says.

The phenomenon of long COVID is similar to what patients have had with chronic fatigue syndrome, lupus, or fibromyalgia, where people have symptoms that are hard to explain, says Jennifer Chevinsky, MD, deputy public health officer for Riverside County, Calif.

“Stigma within medicine or health care is nothing new,” she says.

In Chicago, Dr. Jason notes that the federal government’s decision to invest hundreds of millions of dollars in long COVID research “shows the government is helping destigmatize it.”

Dr. Pantelic says she and her colleagues are continuing their research.

“We are interested in understanding the impacts of this stigma, and how to mitigate any adverse outcomes for patients and services,” she says.

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

People with long COVID may have dizziness, headaches, sleep problems, sluggish thinking, and many other problems. But they can also face another problem – stigma.

Most people with long COVID find they’re facing stigma due to their condition, according to a new report from researchers in the United Kingdom. In short: Relatives and friends may not believe they’re truly sick.

The U.K. team found that more than three-quarters of people studied had experienced stigma often or always. 

In fact, 95% of people with long COVID faced at least one type of stigma at least sometimes, according to the study, published in November in the journal PLOS One.

Those conclusions had surprised the study’s lead researcher, Marija Pantelic, PhD, a public health lecturer at Brighton and Sussex Medical School, England.

“After years of working on HIV-related stigma, I was shocked to see how many people were turning a blind eye to and dismissing the difficulties experienced by people with long COVID,” Dr. Pantelic says. “It has also been clear to me from the start that this stigma is detrimental not just for people’s dignity, but also public health.”

Even some doctors argue that the growing attention paid to long COVID is excessive.

“It’s often normal to experience mild fatigue or weaknesses for weeks after being sick and inactive and not eating well. Calling these cases long COVID is the medicalization of modern life,” Marty Makary, MD, a surgeon and public policy researcher at Johns Hopkins University, Baltimore, wrote in a commentary in the Wall Street Journal.

Other doctors strongly disagree, including Alba Azola, MD, codirector of the Johns Hopkins Post-Acute COVID-19 Team and an expert in the stigma surrounding long COVID.

“Putting that spin on things, it’s just hurting people,” she says.

One example is people who cannot return to work.

“A lot of their family members tell me that they’re being lazy,” Dr. Azola says. “That’s part of the public stigma, that these are people just trying to get out of work.”

Some experts say the U.K. study represents a landmark.

“When you have data like this on long COVID stigma, it becomes more difficult to deny its existence or address it,” says Naomi Torres-Mackie, PhD, a clinical psychologist at Lenox Hill Hospital in New York. She also is head of research at the New York–based Mental Health Coalition, a group of experts working to end the stigma surrounding mental health.

She recalls her first patient with long COVID.

“She experienced the discomfort and pain itself, and then she had this crushing feeling that it wasn’t valid, or real. She felt very alone in it,” Dr. Torres-Mackie says.

Another one of her patients is working at her job from home but facing doubt about her condition from her employers.

“Every month, her medical doctor has to produce a letter confirming her medical condition,” Dr. Torres-Mackie says.

Taking part in the British stigma survey were 1,166 people, including 966 residents of the United Kingdom, with the average age of 48. Nearly 85% were female, and more than three-quarters were educated at the university level or higher.

Half of them said they had a clinical diagnosis of long COVID.

More than 60% of them said that at least some of the time, they were cautious about who they talked to about their condition. And fully 34% of those who did disclose their diagnosis said that they regretted having done so.

That’s a difficult experience for those with long COVID, says Leonard Jason, PhD, a professor of psychology at DePaul University in Chicago.

“It’s like they’re traumatized by the initial experience of being sick, and retraumatized by the response of others to them,” he says.

Unexplained illnesses are not well-regarded by the general public, Dr. Jason says.

He gave the example of multiple sclerosis. Before the 1980s, those with MS were considered to have a psychological illness, he says. “Then, in the 1980s, there were biomarkers that said, ‘Here’s the evidence.’ ”

The British study described three types of stigma stemming from the long COVID diagnosis of those questioned:

• Enacted stigma: People were directly treated unfairly because of their condition.
• Internalized stigma: People felt embarrassed by that condition.
• Anticipated stigma: People expected they would be treated poorly because of their diagnosis.

Dr. Azola calls the medical community a major problem when it comes to dealing with long COVID.

“What I see with my patients is medical trauma,” she says. They may have symptoms that send them to the emergency room, and then the tests come back negative. “Instead of tracking the patients’ symptoms, patients get told, ‘Everything looks good, you can go home, this is a panic attack,’ ” she says.

Some people go online to search for treatments, sometimes launching GoFundMe campaigns to raise money for unreliable treatments.

Long COVID patients may have gone through 5 to 10 doctors before they arrive for treatment with the Johns Hopkins Post-Acute COVID-19 Team. The clinic began in April 2020 remotely and in August of that year in person.

Today, the clinic staff spends an hour with a first-time long COVID patient, hearing their stories and helping relieve anxiety, Dr. Azola says.

The phenomenon of long COVID is similar to what patients have had with chronic fatigue syndrome, lupus, or fibromyalgia, where people have symptoms that are hard to explain, says Jennifer Chevinsky, MD, deputy public health officer for Riverside County, Calif.

“Stigma within medicine or health care is nothing new,” she says.

In Chicago, Dr. Jason notes that the federal government’s decision to invest hundreds of millions of dollars in long COVID research “shows the government is helping destigmatize it.”

Dr. Pantelic says she and her colleagues are continuing their research.

“We are interested in understanding the impacts of this stigma, and how to mitigate any adverse outcomes for patients and services,” she says.

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

People with long COVID may have dizziness, headaches, sleep problems, sluggish thinking, and many other problems. But they can also face another problem – stigma.

Most people with long COVID find they’re facing stigma due to their condition, according to a new report from researchers in the United Kingdom. In short: Relatives and friends may not believe they’re truly sick.

The U.K. team found that more than three-quarters of people studied had experienced stigma often or always. 

In fact, 95% of people with long COVID faced at least one type of stigma at least sometimes, according to the study, published in November in the journal PLOS One.

Those conclusions had surprised the study’s lead researcher, Marija Pantelic, PhD, a public health lecturer at Brighton and Sussex Medical School, England.

“After years of working on HIV-related stigma, I was shocked to see how many people were turning a blind eye to and dismissing the difficulties experienced by people with long COVID,” Dr. Pantelic says. “It has also been clear to me from the start that this stigma is detrimental not just for people’s dignity, but also public health.”

Even some doctors argue that the growing attention paid to long COVID is excessive.

“It’s often normal to experience mild fatigue or weaknesses for weeks after being sick and inactive and not eating well. Calling these cases long COVID is the medicalization of modern life,” Marty Makary, MD, a surgeon and public policy researcher at Johns Hopkins University, Baltimore, wrote in a commentary in the Wall Street Journal.

Other doctors strongly disagree, including Alba Azola, MD, codirector of the Johns Hopkins Post-Acute COVID-19 Team and an expert in the stigma surrounding long COVID.

“Putting that spin on things, it’s just hurting people,” she says.

One example is people who cannot return to work.

“A lot of their family members tell me that they’re being lazy,” Dr. Azola says. “That’s part of the public stigma, that these are people just trying to get out of work.”

Some experts say the U.K. study represents a landmark.

“When you have data like this on long COVID stigma, it becomes more difficult to deny its existence or address it,” says Naomi Torres-Mackie, PhD, a clinical psychologist at Lenox Hill Hospital in New York. She also is head of research at the New York–based Mental Health Coalition, a group of experts working to end the stigma surrounding mental health.

She recalls her first patient with long COVID.

“She experienced the discomfort and pain itself, and then she had this crushing feeling that it wasn’t valid, or real. She felt very alone in it,” Dr. Torres-Mackie says.

Another one of her patients is working at her job from home but facing doubt about her condition from her employers.

“Every month, her medical doctor has to produce a letter confirming her medical condition,” Dr. Torres-Mackie says.

Taking part in the British stigma survey were 1,166 people, including 966 residents of the United Kingdom, with the average age of 48. Nearly 85% were female, and more than three-quarters were educated at the university level or higher.

Half of them said they had a clinical diagnosis of long COVID.

More than 60% of them said that at least some of the time, they were cautious about who they talked to about their condition. And fully 34% of those who did disclose their diagnosis said that they regretted having done so.

That’s a difficult experience for those with long COVID, says Leonard Jason, PhD, a professor of psychology at DePaul University in Chicago.

“It’s like they’re traumatized by the initial experience of being sick, and retraumatized by the response of others to them,” he says.

Unexplained illnesses are not well-regarded by the general public, Dr. Jason says.

He gave the example of multiple sclerosis. Before the 1980s, those with MS were considered to have a psychological illness, he says. “Then, in the 1980s, there were biomarkers that said, ‘Here’s the evidence.’ ”

The British study described three types of stigma stemming from the long COVID diagnosis of those questioned:

• Enacted stigma: People were directly treated unfairly because of their condition.
• Internalized stigma: People felt embarrassed by that condition.
• Anticipated stigma: People expected they would be treated poorly because of their diagnosis.

Dr. Azola calls the medical community a major problem when it comes to dealing with long COVID.

“What I see with my patients is medical trauma,” she says. They may have symptoms that send them to the emergency room, and then the tests come back negative. “Instead of tracking the patients’ symptoms, patients get told, ‘Everything looks good, you can go home, this is a panic attack,’ ” she says.

Some people go online to search for treatments, sometimes launching GoFundMe campaigns to raise money for unreliable treatments.

Long COVID patients may have gone through 5 to 10 doctors before they arrive for treatment with the Johns Hopkins Post-Acute COVID-19 Team. The clinic began in April 2020 remotely and in August of that year in person.

Today, the clinic staff spends an hour with a first-time long COVID patient, hearing their stories and helping relieve anxiety, Dr. Azola says.

The phenomenon of long COVID is similar to what patients have had with chronic fatigue syndrome, lupus, or fibromyalgia, where people have symptoms that are hard to explain, says Jennifer Chevinsky, MD, deputy public health officer for Riverside County, Calif.

“Stigma within medicine or health care is nothing new,” she says.

In Chicago, Dr. Jason notes that the federal government’s decision to invest hundreds of millions of dollars in long COVID research “shows the government is helping destigmatize it.”

Dr. Pantelic says she and her colleagues are continuing their research.

“We are interested in understanding the impacts of this stigma, and how to mitigate any adverse outcomes for patients and services,” she says.

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

PARIS – How can the problem of poor treatment compliance in patients with hypertension be resolved? A new therapeutic approach could be a game-changer.

Many approaches have been explored in recent years to make life easier for patients living with chronic conditions that require them to take daily medication: subcutaneous implantable devices, nanogels, and, more specifically in the case of hypertension, renal denervation or small interfering RNA (siRNA) with a long half-life.

It’s siRNA that Michel Azizi, MD, PhD, head of the blood pressure clinic at Georges Pompidou European Hospital (HEGP) in Paris, discussed at the International Meeting of the French Society of Hypertension.

These small molecules have already shown their worth in treating rare diseases such as transthyretin amyloidosis. More recently, treating hypercholesterolemia with the PCSK9 inhibitor inclisiran has proven effective. “One subcutaneous injection of inclisiran reduces LDL cholesterol by 50% for a period of 210 days,” said Dr. Azizi.

The benefit of a new therapeutic siRNA – zilebesiran, administered subcutaneously – in treating hypertension is currently the subject of a phase II clinical trial.

This is a double-stranded RNA. One of the strands is linked to a sugar, N-acetylgalactosamine (GalNAc), which protects these highly fragile siRNA and binds with a very strong affinity in the liver. The second strand binds to a specific area of the RNA to prevent synthesis of the precursor peptide of angiotensin, angiotensinogen. The resulting effect is suppression of the production of angiotensin I and II, which leads to a long-lasting lowering of blood pressure.
 

Lasting efficacy

Phase I studies with zilebesiran have demonstrated a long-term effect, with a reduction of greater than 90% in circulating angiotensinogen over 6 months after a single subcutaneous dose (800 mg). The peak in reduction of circulating angiotensinogen occurs after approximately 3 weeks.

“It’s extremely powerful,” said Dr. Azizi.

Lasting reductions in blood pressure have also been observed, with 24-hour ambulatory blood pressure monitoring showing a reduction in systolic BP of greater than 15 mm Hg 8 weeks after administration of a single dose of zilebesiran (800 mg).

Zilebesiran was also well tolerated, with only mild to moderate reactions at the site of the injection (n = 5/56) and no serious treatment-related adverse events, hypotension, or significant changes in kidney or liver function.

“In terms of benefits, the effect is ongoing. Zilebesiran leads to reduced medication use and causes less variability in blood pressure response. Nevertheless, interfering RNA acts slowly, meaning that zilebesiran would not be suitable for people presenting with a hypertensive crisis. The fact that it blocks the renin-angiotensin system [RAS] for a very long period of time also poses the question of how to reverse its hypotensive effects,” said Dr. Azizi.
 

Unanswered questions

The lasting RAS antagonist and blood pressure–lowering effects pose a potential safety problem in circumstances involving patients in a state of hypovolemia and hypotension who require rapid blood pressure–raising interventions to prevent morbidity and mortality.

In recent studies, Estrellita Uijl et al. have thus examined strategies to counteract the blood pressure–lowering effect of siRNA in spontaneously hypertensive rats.

Fludrocortisone and a high-salt diet were both successful in gradually increasing blood pressure, which returned to its baseline levels on days 5 and 7, respectively. Yet this rate of response would be wholly inadequate in an urgent clinical situation.

However, midodrine could not reduce blood pressure to normal levels, whether administered subcutaneously or orally.

A rapid and short-lasting increase in blood pressure was observed with bolus doses of vasopressors, but clinically, these would need to be administered intravenously to achieve a lasting effect. Such administration would require hospitalization, close monitoring, and the use of human resources and additional health care provisions.

Encouragingly, the laboratory that created this molecule, Alnylam Pharmaceuticals, has come up with an antidote: Reversir. It is a GalNAc-conjugated, single-stranded, high-affinity oligonucleotide complementary to the zilebesiran strand that achieves effective reversal of siRNA activity in 24 hours.

In the future, after the phase 2 trials have been completed, whether or not zilebesiran reduces the incidence of cardiovascular events and mortality remains to be seen. But as for Dr. Azizi, the director of HEGP’s blood pressure clinic in Paris, he has no doubt that “this approach is about to shake up how we treat patients in the cardiovascular field.”
 

On the horizon

Zilebesiran is being studied in phase 2 trials in patients with mild to moderate hypertension not taking antihypertensive drugs (KARDIA-1: 375 patients; double-blind, placebo-controlled, five-arm trial; zilebesiran at 150, 300, and 600 mg twice per year and 300 mg once every 3 months) and in patients whose blood pressure is not controlled (KARDIA-2: 800 patients; initial open-label start-up period of 4 weeks with indapamide/amlodipine/olmesartan, followed by a double-blind, placebo-controlled study over 6 months, then an open-label extension study for up to 12 additional months; zilebesiran at 600 mg on the first day of the initial double-blind period, then every 6 months during the open-label extension period).

This article was translated from the Medscape French edition and a version appeared on Medscape.com.

PARIS – How can the problem of poor treatment compliance in patients with hypertension be resolved? A new therapeutic approach could be a game-changer.

Many approaches have been explored in recent years to make life easier for patients living with chronic conditions that require them to take daily medication: subcutaneous implantable devices, nanogels, and, more specifically in the case of hypertension, renal denervation or small interfering RNA (siRNA) with a long half-life.

It’s siRNA that Michel Azizi, MD, PhD, head of the blood pressure clinic at Georges Pompidou European Hospital (HEGP) in Paris, discussed at the International Meeting of the French Society of Hypertension.

These small molecules have already shown their worth in treating rare diseases such as transthyretin amyloidosis. More recently, treating hypercholesterolemia with the PCSK9 inhibitor inclisiran has proven effective. “One subcutaneous injection of inclisiran reduces LDL cholesterol by 50% for a period of 210 days,” said Dr. Azizi.

The benefit of a new therapeutic siRNA – zilebesiran, administered subcutaneously – in treating hypertension is currently the subject of a phase II clinical trial.

This is a double-stranded RNA. One of the strands is linked to a sugar, N-acetylgalactosamine (GalNAc), which protects these highly fragile siRNA and binds with a very strong affinity in the liver. The second strand binds to a specific area of the RNA to prevent synthesis of the precursor peptide of angiotensin, angiotensinogen. The resulting effect is suppression of the production of angiotensin I and II, which leads to a long-lasting lowering of blood pressure.
 

Lasting efficacy

Phase I studies with zilebesiran have demonstrated a long-term effect, with a reduction of greater than 90% in circulating angiotensinogen over 6 months after a single subcutaneous dose (800 mg). The peak in reduction of circulating angiotensinogen occurs after approximately 3 weeks.

“It’s extremely powerful,” said Dr. Azizi.

Lasting reductions in blood pressure have also been observed, with 24-hour ambulatory blood pressure monitoring showing a reduction in systolic BP of greater than 15 mm Hg 8 weeks after administration of a single dose of zilebesiran (800 mg).

Zilebesiran was also well tolerated, with only mild to moderate reactions at the site of the injection (n = 5/56) and no serious treatment-related adverse events, hypotension, or significant changes in kidney or liver function.

“In terms of benefits, the effect is ongoing. Zilebesiran leads to reduced medication use and causes less variability in blood pressure response. Nevertheless, interfering RNA acts slowly, meaning that zilebesiran would not be suitable for people presenting with a hypertensive crisis. The fact that it blocks the renin-angiotensin system [RAS] for a very long period of time also poses the question of how to reverse its hypotensive effects,” said Dr. Azizi.
 

Unanswered questions

The lasting RAS antagonist and blood pressure–lowering effects pose a potential safety problem in circumstances involving patients in a state of hypovolemia and hypotension who require rapid blood pressure–raising interventions to prevent morbidity and mortality.

In recent studies, Estrellita Uijl et al. have thus examined strategies to counteract the blood pressure–lowering effect of siRNA in spontaneously hypertensive rats.

Fludrocortisone and a high-salt diet were both successful in gradually increasing blood pressure, which returned to its baseline levels on days 5 and 7, respectively. Yet this rate of response would be wholly inadequate in an urgent clinical situation.

However, midodrine could not reduce blood pressure to normal levels, whether administered subcutaneously or orally.

A rapid and short-lasting increase in blood pressure was observed with bolus doses of vasopressors, but clinically, these would need to be administered intravenously to achieve a lasting effect. Such administration would require hospitalization, close monitoring, and the use of human resources and additional health care provisions.

Encouragingly, the laboratory that created this molecule, Alnylam Pharmaceuticals, has come up with an antidote: Reversir. It is a GalNAc-conjugated, single-stranded, high-affinity oligonucleotide complementary to the zilebesiran strand that achieves effective reversal of siRNA activity in 24 hours.

In the future, after the phase 2 trials have been completed, whether or not zilebesiran reduces the incidence of cardiovascular events and mortality remains to be seen. But as for Dr. Azizi, the director of HEGP’s blood pressure clinic in Paris, he has no doubt that “this approach is about to shake up how we treat patients in the cardiovascular field.”
 

On the horizon

Zilebesiran is being studied in phase 2 trials in patients with mild to moderate hypertension not taking antihypertensive drugs (KARDIA-1: 375 patients; double-blind, placebo-controlled, five-arm trial; zilebesiran at 150, 300, and 600 mg twice per year and 300 mg once every 3 months) and in patients whose blood pressure is not controlled (KARDIA-2: 800 patients; initial open-label start-up period of 4 weeks with indapamide/amlodipine/olmesartan, followed by a double-blind, placebo-controlled study over 6 months, then an open-label extension study for up to 12 additional months; zilebesiran at 600 mg on the first day of the initial double-blind period, then every 6 months during the open-label extension period).

This article was translated from the Medscape French edition and a version appeared on Medscape.com.

PARIS – How can the problem of poor treatment compliance in patients with hypertension be resolved? A new therapeutic approach could be a game-changer.

Many approaches have been explored in recent years to make life easier for patients living with chronic conditions that require them to take daily medication: subcutaneous implantable devices, nanogels, and, more specifically in the case of hypertension, renal denervation or small interfering RNA (siRNA) with a long half-life.

It’s siRNA that Michel Azizi, MD, PhD, head of the blood pressure clinic at Georges Pompidou European Hospital (HEGP) in Paris, discussed at the International Meeting of the French Society of Hypertension.

These small molecules have already shown their worth in treating rare diseases such as transthyretin amyloidosis. More recently, treating hypercholesterolemia with the PCSK9 inhibitor inclisiran has proven effective. “One subcutaneous injection of inclisiran reduces LDL cholesterol by 50% for a period of 210 days,” said Dr. Azizi.

The benefit of a new therapeutic siRNA – zilebesiran, administered subcutaneously – in treating hypertension is currently the subject of a phase II clinical trial.

This is a double-stranded RNA. One of the strands is linked to a sugar, N-acetylgalactosamine (GalNAc), which protects these highly fragile siRNA and binds with a very strong affinity in the liver. The second strand binds to a specific area of the RNA to prevent synthesis of the precursor peptide of angiotensin, angiotensinogen. The resulting effect is suppression of the production of angiotensin I and II, which leads to a long-lasting lowering of blood pressure.
 

Lasting efficacy

Phase I studies with zilebesiran have demonstrated a long-term effect, with a reduction of greater than 90% in circulating angiotensinogen over 6 months after a single subcutaneous dose (800 mg). The peak in reduction of circulating angiotensinogen occurs after approximately 3 weeks.

“It’s extremely powerful,” said Dr. Azizi.

Lasting reductions in blood pressure have also been observed, with 24-hour ambulatory blood pressure monitoring showing a reduction in systolic BP of greater than 15 mm Hg 8 weeks after administration of a single dose of zilebesiran (800 mg).

Zilebesiran was also well tolerated, with only mild to moderate reactions at the site of the injection (n = 5/56) and no serious treatment-related adverse events, hypotension, or significant changes in kidney or liver function.

“In terms of benefits, the effect is ongoing. Zilebesiran leads to reduced medication use and causes less variability in blood pressure response. Nevertheless, interfering RNA acts slowly, meaning that zilebesiran would not be suitable for people presenting with a hypertensive crisis. The fact that it blocks the renin-angiotensin system [RAS] for a very long period of time also poses the question of how to reverse its hypotensive effects,” said Dr. Azizi.
 

Unanswered questions

The lasting RAS antagonist and blood pressure–lowering effects pose a potential safety problem in circumstances involving patients in a state of hypovolemia and hypotension who require rapid blood pressure–raising interventions to prevent morbidity and mortality.

In recent studies, Estrellita Uijl et al. have thus examined strategies to counteract the blood pressure–lowering effect of siRNA in spontaneously hypertensive rats.

Fludrocortisone and a high-salt diet were both successful in gradually increasing blood pressure, which returned to its baseline levels on days 5 and 7, respectively. Yet this rate of response would be wholly inadequate in an urgent clinical situation.

However, midodrine could not reduce blood pressure to normal levels, whether administered subcutaneously or orally.

A rapid and short-lasting increase in blood pressure was observed with bolus doses of vasopressors, but clinically, these would need to be administered intravenously to achieve a lasting effect. Such administration would require hospitalization, close monitoring, and the use of human resources and additional health care provisions.

Encouragingly, the laboratory that created this molecule, Alnylam Pharmaceuticals, has come up with an antidote: Reversir. It is a GalNAc-conjugated, single-stranded, high-affinity oligonucleotide complementary to the zilebesiran strand that achieves effective reversal of siRNA activity in 24 hours.

In the future, after the phase 2 trials have been completed, whether or not zilebesiran reduces the incidence of cardiovascular events and mortality remains to be seen. But as for Dr. Azizi, the director of HEGP’s blood pressure clinic in Paris, he has no doubt that “this approach is about to shake up how we treat patients in the cardiovascular field.”
 

On the horizon

Zilebesiran is being studied in phase 2 trials in patients with mild to moderate hypertension not taking antihypertensive drugs (KARDIA-1: 375 patients; double-blind, placebo-controlled, five-arm trial; zilebesiran at 150, 300, and 600 mg twice per year and 300 mg once every 3 months) and in patients whose blood pressure is not controlled (KARDIA-2: 800 patients; initial open-label start-up period of 4 weeks with indapamide/amlodipine/olmesartan, followed by a double-blind, placebo-controlled study over 6 months, then an open-label extension study for up to 12 additional months; zilebesiran at 600 mg on the first day of the initial double-blind period, then every 6 months during the open-label extension period).

This article was translated from the Medscape French edition and a version appeared on Medscape.com.

Physicians and other clinicians could more easily exit contracts and change jobs under the Federal Trade Commission’s new proposed rule that would block companies from limiting employees’ ability to work for a rival.

The proposed rule seeks to ban companies from enforcing noncompete clauses in employment contracts, a practice that represents an “unfair method of competition” with “exploitative and widespread” impacts, including suppression of wages, innovation, and entrepreneurial spirit, the FTC said. The public has 60 days to submit comments on the proposal before the FTC issues the final rule.

Employers often include noncompete clauses in physician contracts because they want to avoid having patients leave their health care system and follow a doctor to a competitor. A 2018 survey of primary care physicians found that about half of office-based physicians and 37% of physicians employed at hospitals or freestanding care centers were bound by restrictive covenants.

“A federal ban on noncompete agreements will ensure that physicians nationwide can finally change jobs without fear of being sued,” Erik B. Smith, MD, JD, clinical assistant professor of anesthesiology at the University of Southern California, Los Angeles, said in an interview.

Many doctors would like to see noncompete agreements vanish, but some physicians still favor them.

“As a small-practice owner, I am personally against this. The noncompete helps me take a risk and hire a physician. It typically takes 2-3 years for me to break even. I think this will further consolidate employment with large hospital systems unfortunately,” Texas cardiologist Rishin Shah, MD, recently tweeted in response to the FTC announcement.

Dr. Smith, who has advocated for noncompete reform, said about half of states currently allow the controversial clauses.

However, several states have recently passed laws restricting their use. California, North Dakota, and Oklahoma ban noncompetes, although some narrowly defined exceptions, such as the sale of a business, remain.

Other states, like Colorado, Illinois, and Oregon, broadly ban noncompete clauses, except for workers earning above a certain threshold. For example, in Colorado, noncompete agreements are permitted for highly compensated employees earning more than $101,250.

Despite additional restrictions on noncompete agreements for workers in the District of Columbia, the new legislation does not apply to physicians earning total compensation of $250,000 or more. However, their employers must define the geographic parameters of the noncompete and limit postemployment restrictions to 2 years.

Restrictive covenants are “uniquely challenging to family medicine’s emphasis on longitudinal care and the patient-physician relationship,” said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians. The limitations imposed by noncompete agreements “potentially reduce patient choice, lower the quality of care for patients, and ultimately harm the foundation of family medicine – our relationships with our patients.”

Although the proposed rule aligns with President Biden’s executive order promoting economic competition, Dr. Smith said a national ban on noncompete agreements may push the limits of FTC authority.

“This new rule will certainly result in a ‘major questions doctrine’ Supreme Court challenge,” said Dr. Smith, and possibly be struck down if the court determines an administrative overstep into areas of “vast economic or political significance.”
 

A controversial policy

The American Medical Association’s code of ethics discourages covenants that “unreasonably restrict” the ability of physicians to practice following contract termination. And in 2022, the AMA cited “overly broad” noncompete language as a red flag young physicians should watch out for during contract negotiations.

But in 2020, the AMA asked the FTC not to use its rulemaking authority to regulate noncompete clauses in physician employment contracts, and instead, relegate enforcement of such agreements to each state. The American Hospital Association expressed similar views.

Still, the FTC said that eliminating noncompete clauses will increase annual wages by $300 billion, allow 30 million Americans to pursue better job opportunities, and encourage hiring competition among employers. It will also save consumers up to $148 billion in health care costs annually.

“Noncompetes block workers from freely switching jobs, depriving them of higher wages and better working conditions, and depriving businesses of a talent pool that they need to build and expand,” Lina M. Khan, FTC chair, said in a press release about the proposal.

A national ban on noncompetes would keep more physicians in the industry and practicing in their communities, a win for patients and providers, said Dr. Smith. It could also compel employers to offer more competitive employment packages, including fair wages, better work conditions, and a culture of well-being and patient safety.

“Whatever the final rule is, I’m certain it will be legally challenged,” said Dr. Smith, adding that the nation’s most prominent business lobbying group, the Chamber of Commerce, has already issued a statement calling the rule “blatantly unlawful."

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

Physicians and other clinicians could more easily exit contracts and change jobs under the Federal Trade Commission’s new proposed rule that would block companies from limiting employees’ ability to work for a rival.

The proposed rule seeks to ban companies from enforcing noncompete clauses in employment contracts, a practice that represents an “unfair method of competition” with “exploitative and widespread” impacts, including suppression of wages, innovation, and entrepreneurial spirit, the FTC said. The public has 60 days to submit comments on the proposal before the FTC issues the final rule.

Employers often include noncompete clauses in physician contracts because they want to avoid having patients leave their health care system and follow a doctor to a competitor. A 2018 survey of primary care physicians found that about half of office-based physicians and 37% of physicians employed at hospitals or freestanding care centers were bound by restrictive covenants.

“A federal ban on noncompete agreements will ensure that physicians nationwide can finally change jobs without fear of being sued,” Erik B. Smith, MD, JD, clinical assistant professor of anesthesiology at the University of Southern California, Los Angeles, said in an interview.

Many doctors would like to see noncompete agreements vanish, but some physicians still favor them.

“As a small-practice owner, I am personally against this. The noncompete helps me take a risk and hire a physician. It typically takes 2-3 years for me to break even. I think this will further consolidate employment with large hospital systems unfortunately,” Texas cardiologist Rishin Shah, MD, recently tweeted in response to the FTC announcement.

Dr. Smith, who has advocated for noncompete reform, said about half of states currently allow the controversial clauses.

However, several states have recently passed laws restricting their use. California, North Dakota, and Oklahoma ban noncompetes, although some narrowly defined exceptions, such as the sale of a business, remain.

Other states, like Colorado, Illinois, and Oregon, broadly ban noncompete clauses, except for workers earning above a certain threshold. For example, in Colorado, noncompete agreements are permitted for highly compensated employees earning more than $101,250.

Despite additional restrictions on noncompete agreements for workers in the District of Columbia, the new legislation does not apply to physicians earning total compensation of $250,000 or more. However, their employers must define the geographic parameters of the noncompete and limit postemployment restrictions to 2 years.

Restrictive covenants are “uniquely challenging to family medicine’s emphasis on longitudinal care and the patient-physician relationship,” said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians. The limitations imposed by noncompete agreements “potentially reduce patient choice, lower the quality of care for patients, and ultimately harm the foundation of family medicine – our relationships with our patients.”

Although the proposed rule aligns with President Biden’s executive order promoting economic competition, Dr. Smith said a national ban on noncompete agreements may push the limits of FTC authority.

“This new rule will certainly result in a ‘major questions doctrine’ Supreme Court challenge,” said Dr. Smith, and possibly be struck down if the court determines an administrative overstep into areas of “vast economic or political significance.”
 

A controversial policy

The American Medical Association’s code of ethics discourages covenants that “unreasonably restrict” the ability of physicians to practice following contract termination. And in 2022, the AMA cited “overly broad” noncompete language as a red flag young physicians should watch out for during contract negotiations.

But in 2020, the AMA asked the FTC not to use its rulemaking authority to regulate noncompete clauses in physician employment contracts, and instead, relegate enforcement of such agreements to each state. The American Hospital Association expressed similar views.

Still, the FTC said that eliminating noncompete clauses will increase annual wages by $300 billion, allow 30 million Americans to pursue better job opportunities, and encourage hiring competition among employers. It will also save consumers up to $148 billion in health care costs annually.

“Noncompetes block workers from freely switching jobs, depriving them of higher wages and better working conditions, and depriving businesses of a talent pool that they need to build and expand,” Lina M. Khan, FTC chair, said in a press release about the proposal.

A national ban on noncompetes would keep more physicians in the industry and practicing in their communities, a win for patients and providers, said Dr. Smith. It could also compel employers to offer more competitive employment packages, including fair wages, better work conditions, and a culture of well-being and patient safety.

“Whatever the final rule is, I’m certain it will be legally challenged,” said Dr. Smith, adding that the nation’s most prominent business lobbying group, the Chamber of Commerce, has already issued a statement calling the rule “blatantly unlawful."

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

Physicians and other clinicians could more easily exit contracts and change jobs under the Federal Trade Commission’s new proposed rule that would block companies from limiting employees’ ability to work for a rival.

The proposed rule seeks to ban companies from enforcing noncompete clauses in employment contracts, a practice that represents an “unfair method of competition” with “exploitative and widespread” impacts, including suppression of wages, innovation, and entrepreneurial spirit, the FTC said. The public has 60 days to submit comments on the proposal before the FTC issues the final rule.

Employers often include noncompete clauses in physician contracts because they want to avoid having patients leave their health care system and follow a doctor to a competitor. A 2018 survey of primary care physicians found that about half of office-based physicians and 37% of physicians employed at hospitals or freestanding care centers were bound by restrictive covenants.

“A federal ban on noncompete agreements will ensure that physicians nationwide can finally change jobs without fear of being sued,” Erik B. Smith, MD, JD, clinical assistant professor of anesthesiology at the University of Southern California, Los Angeles, said in an interview.

Many doctors would like to see noncompete agreements vanish, but some physicians still favor them.

“As a small-practice owner, I am personally against this. The noncompete helps me take a risk and hire a physician. It typically takes 2-3 years for me to break even. I think this will further consolidate employment with large hospital systems unfortunately,” Texas cardiologist Rishin Shah, MD, recently tweeted in response to the FTC announcement.

Dr. Smith, who has advocated for noncompete reform, said about half of states currently allow the controversial clauses.

However, several states have recently passed laws restricting their use. California, North Dakota, and Oklahoma ban noncompetes, although some narrowly defined exceptions, such as the sale of a business, remain.

Other states, like Colorado, Illinois, and Oregon, broadly ban noncompete clauses, except for workers earning above a certain threshold. For example, in Colorado, noncompete agreements are permitted for highly compensated employees earning more than $101,250.

Despite additional restrictions on noncompete agreements for workers in the District of Columbia, the new legislation does not apply to physicians earning total compensation of $250,000 or more. However, their employers must define the geographic parameters of the noncompete and limit postemployment restrictions to 2 years.

Restrictive covenants are “uniquely challenging to family medicine’s emphasis on longitudinal care and the patient-physician relationship,” said Tochi Iroku-Malize, MD, MPH, president of the American Academy of Family Physicians. The limitations imposed by noncompete agreements “potentially reduce patient choice, lower the quality of care for patients, and ultimately harm the foundation of family medicine – our relationships with our patients.”

Although the proposed rule aligns with President Biden’s executive order promoting economic competition, Dr. Smith said a national ban on noncompete agreements may push the limits of FTC authority.

“This new rule will certainly result in a ‘major questions doctrine’ Supreme Court challenge,” said Dr. Smith, and possibly be struck down if the court determines an administrative overstep into areas of “vast economic or political significance.”
 

A controversial policy

The American Medical Association’s code of ethics discourages covenants that “unreasonably restrict” the ability of physicians to practice following contract termination. And in 2022, the AMA cited “overly broad” noncompete language as a red flag young physicians should watch out for during contract negotiations.

But in 2020, the AMA asked the FTC not to use its rulemaking authority to regulate noncompete clauses in physician employment contracts, and instead, relegate enforcement of such agreements to each state. The American Hospital Association expressed similar views.

Still, the FTC said that eliminating noncompete clauses will increase annual wages by $300 billion, allow 30 million Americans to pursue better job opportunities, and encourage hiring competition among employers. It will also save consumers up to $148 billion in health care costs annually.

“Noncompetes block workers from freely switching jobs, depriving them of higher wages and better working conditions, and depriving businesses of a talent pool that they need to build and expand,” Lina M. Khan, FTC chair, said in a press release about the proposal.

A national ban on noncompetes would keep more physicians in the industry and practicing in their communities, a win for patients and providers, said Dr. Smith. It could also compel employers to offer more competitive employment packages, including fair wages, better work conditions, and a culture of well-being and patient safety.

“Whatever the final rule is, I’m certain it will be legally challenged,” said Dr. Smith, adding that the nation’s most prominent business lobbying group, the Chamber of Commerce, has already issued a statement calling the rule “blatantly unlawful."

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

Every year, during the relatively slow winter-months period, I like to take a tour of my office from the paradigm of a patient visiting our facility for the first time. When was the last time you did a comprehensive inspection, looking for problems that your patients might see?

We tend not to notice gradual deterioration in the workplace we inhabit every day: Carpets fade and dull with constant traffic and cleaning; wallpaper and paint accumulate dirt, stains, and damage; furniture gets dirty and dented, fabric rips, hardware goes missing; laminate peels off the edges of desks and cabinets.

When did you last take a good look at your waiting room? How clean is it? Patients expect cleanliness in doctor’s offices, and they expect the reception area to be neat. How are the carpeting and upholstery holding up? Sit in your chairs; how do they feel? Patients don’t appreciate a sore back or bottom from any chairs, especially in a medical office. Consider investing in new furniture that will be attractive and comfortable for your patients.

Look at the decor itself; is it dated or just plain “old-looking?” Any interior designer will tell you they can determine quite accurately when a space was last decorated, simply by the color and style of the materials used. If your office is stuck in the ‘90s, it’s probably time for a change. Even if you don’t find anything obvious, it’s wise to check periodically for subtle evidence of age: Find some patches of protected carpeting and flooring under stationary furniture and compare them to exposed floors.

If your color scheme is hopelessly out of date and style, or if you are just tired of it, change it. Wallpaper and carpeting should be long-wearing industrial quality; paint should be high-quality “eggshell” finish to facilitate cleaning, and everything should be professionally applied. (This is neither the time nor place for do-it-yourself experiments.) Consider updating your overhead lighting. The harsh glow of fluorescent lights amid an uninspired decor creates a sterile, uninviting atmosphere.

During renovation, get your building’s maintenance crew to fix any nagging plumbing, electrical, or heating/air conditioning problems while pipes, ducts, and wires are more readily accessible. This is also a good time to clear out old textbooks, journals, and files that you will never open again, in this digital age.

If your wall decorations are dated and unattractive, now would be a good time to replace at least some of them. This need not be an expensive proposition; a few years ago, I redecorated my exam room walls with framed photos from my travel adventures – to very positive responses from patients and staff alike. If you’re not an artist or photographer, invite a family member, or local artists or talented patients, to display some of their creations on your walls. If you get too many contributions, you can rotate them on a periodic basis.

Plants are great aesthetic accents, yet many offices have little or no plant life. Plants naturally aerate an office suite and help make it feel less stuffy. Also, multiple studies have found that plants promote productivity among office staff and create a sense of calm for apprehensive patients. Improvements like this can make a big difference. They show an attention to detail and a willingness to make your practice as inviting as possible for patients and employees alike.

Spruce-up time is also an excellent opportunity to inventory your medical equipment. We’ve all seen “vintage” offices full of gadgets that were state-of-the-art decades ago. Nostalgia is nice; but would you want to be treated by a physician whose office could be a Smithsonian exhibit titled, “Doctor’s Office Circa 1975?” Neither would your patients, for the most part; many – particularly younger ones – assume that doctors who don’t keep up with technological innovations don’t keep up with anything else, either.

If you’re planning a vacation this year (and I hope you are), that would be the perfect time for a re-do. Your patients will be spared the dust and turmoil, tradespeople won’t have to work around your office hours, and you won’t have to cancel any hours that weren’t already canceled. Best of all, you’ll come back to a clean, fresh environment.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Every year, during the relatively slow winter-months period, I like to take a tour of my office from the paradigm of a patient visiting our facility for the first time. When was the last time you did a comprehensive inspection, looking for problems that your patients might see?

We tend not to notice gradual deterioration in the workplace we inhabit every day: Carpets fade and dull with constant traffic and cleaning; wallpaper and paint accumulate dirt, stains, and damage; furniture gets dirty and dented, fabric rips, hardware goes missing; laminate peels off the edges of desks and cabinets.

When did you last take a good look at your waiting room? How clean is it? Patients expect cleanliness in doctor’s offices, and they expect the reception area to be neat. How are the carpeting and upholstery holding up? Sit in your chairs; how do they feel? Patients don’t appreciate a sore back or bottom from any chairs, especially in a medical office. Consider investing in new furniture that will be attractive and comfortable for your patients.

Look at the decor itself; is it dated or just plain “old-looking?” Any interior designer will tell you they can determine quite accurately when a space was last decorated, simply by the color and style of the materials used. If your office is stuck in the ‘90s, it’s probably time for a change. Even if you don’t find anything obvious, it’s wise to check periodically for subtle evidence of age: Find some patches of protected carpeting and flooring under stationary furniture and compare them to exposed floors.

If your color scheme is hopelessly out of date and style, or if you are just tired of it, change it. Wallpaper and carpeting should be long-wearing industrial quality; paint should be high-quality “eggshell” finish to facilitate cleaning, and everything should be professionally applied. (This is neither the time nor place for do-it-yourself experiments.) Consider updating your overhead lighting. The harsh glow of fluorescent lights amid an uninspired decor creates a sterile, uninviting atmosphere.

During renovation, get your building’s maintenance crew to fix any nagging plumbing, electrical, or heating/air conditioning problems while pipes, ducts, and wires are more readily accessible. This is also a good time to clear out old textbooks, journals, and files that you will never open again, in this digital age.

If your wall decorations are dated and unattractive, now would be a good time to replace at least some of them. This need not be an expensive proposition; a few years ago, I redecorated my exam room walls with framed photos from my travel adventures – to very positive responses from patients and staff alike. If you’re not an artist or photographer, invite a family member, or local artists or talented patients, to display some of their creations on your walls. If you get too many contributions, you can rotate them on a periodic basis.

Plants are great aesthetic accents, yet many offices have little or no plant life. Plants naturally aerate an office suite and help make it feel less stuffy. Also, multiple studies have found that plants promote productivity among office staff and create a sense of calm for apprehensive patients. Improvements like this can make a big difference. They show an attention to detail and a willingness to make your practice as inviting as possible for patients and employees alike.

Spruce-up time is also an excellent opportunity to inventory your medical equipment. We’ve all seen “vintage” offices full of gadgets that were state-of-the-art decades ago. Nostalgia is nice; but would you want to be treated by a physician whose office could be a Smithsonian exhibit titled, “Doctor’s Office Circa 1975?” Neither would your patients, for the most part; many – particularly younger ones – assume that doctors who don’t keep up with technological innovations don’t keep up with anything else, either.

If you’re planning a vacation this year (and I hope you are), that would be the perfect time for a re-do. Your patients will be spared the dust and turmoil, tradespeople won’t have to work around your office hours, and you won’t have to cancel any hours that weren’t already canceled. Best of all, you’ll come back to a clean, fresh environment.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Every year, during the relatively slow winter-months period, I like to take a tour of my office from the paradigm of a patient visiting our facility for the first time. When was the last time you did a comprehensive inspection, looking for problems that your patients might see?

We tend not to notice gradual deterioration in the workplace we inhabit every day: Carpets fade and dull with constant traffic and cleaning; wallpaper and paint accumulate dirt, stains, and damage; furniture gets dirty and dented, fabric rips, hardware goes missing; laminate peels off the edges of desks and cabinets.

When did you last take a good look at your waiting room? How clean is it? Patients expect cleanliness in doctor’s offices, and they expect the reception area to be neat. How are the carpeting and upholstery holding up? Sit in your chairs; how do they feel? Patients don’t appreciate a sore back or bottom from any chairs, especially in a medical office. Consider investing in new furniture that will be attractive and comfortable for your patients.

Look at the decor itself; is it dated or just plain “old-looking?” Any interior designer will tell you they can determine quite accurately when a space was last decorated, simply by the color and style of the materials used. If your office is stuck in the ‘90s, it’s probably time for a change. Even if you don’t find anything obvious, it’s wise to check periodically for subtle evidence of age: Find some patches of protected carpeting and flooring under stationary furniture and compare them to exposed floors.

If your color scheme is hopelessly out of date and style, or if you are just tired of it, change it. Wallpaper and carpeting should be long-wearing industrial quality; paint should be high-quality “eggshell” finish to facilitate cleaning, and everything should be professionally applied. (This is neither the time nor place for do-it-yourself experiments.) Consider updating your overhead lighting. The harsh glow of fluorescent lights amid an uninspired decor creates a sterile, uninviting atmosphere.

During renovation, get your building’s maintenance crew to fix any nagging plumbing, electrical, or heating/air conditioning problems while pipes, ducts, and wires are more readily accessible. This is also a good time to clear out old textbooks, journals, and files that you will never open again, in this digital age.

If your wall decorations are dated and unattractive, now would be a good time to replace at least some of them. This need not be an expensive proposition; a few years ago, I redecorated my exam room walls with framed photos from my travel adventures – to very positive responses from patients and staff alike. If you’re not an artist or photographer, invite a family member, or local artists or talented patients, to display some of their creations on your walls. If you get too many contributions, you can rotate them on a periodic basis.

Plants are great aesthetic accents, yet many offices have little or no plant life. Plants naturally aerate an office suite and help make it feel less stuffy. Also, multiple studies have found that plants promote productivity among office staff and create a sense of calm for apprehensive patients. Improvements like this can make a big difference. They show an attention to detail and a willingness to make your practice as inviting as possible for patients and employees alike.

Spruce-up time is also an excellent opportunity to inventory your medical equipment. We’ve all seen “vintage” offices full of gadgets that were state-of-the-art decades ago. Nostalgia is nice; but would you want to be treated by a physician whose office could be a Smithsonian exhibit titled, “Doctor’s Office Circa 1975?” Neither would your patients, for the most part; many – particularly younger ones – assume that doctors who don’t keep up with technological innovations don’t keep up with anything else, either.

If you’re planning a vacation this year (and I hope you are), that would be the perfect time for a re-do. Your patients will be spared the dust and turmoil, tradespeople won’t have to work around your office hours, and you won’t have to cancel any hours that weren’t already canceled. Best of all, you’ll come back to a clean, fresh environment.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

The largest combined analysis of birth outcome data for women with systemic lupus erythematosus (SLE) who took belimumab (Benlysta) during pregnancy appears to indicate that the biologic is “unlikely to cause very frequent birth defects,” but the full extent of possible risk remains unknown. The drug’s effect on B cells, immune function, and infections in exposed offspring were not captured in the data, but a separate case report published after the belimumab pregnancy data report indicates that the drug does cross the placenta and builds up in the blood of the newborn, reducing B cells at birth.

Children of women with SLE have increased birth defect risks, and standard SLE therapeutic agents (for example, cyclophosphamide, methotrexate, mycophenolate mofetil) have been implicated in birth defects and pregnancy loss, but birth defect data for biologic drugs such as belimumab are limited. While belimumab animal data revealed no evidence of fetal harm or pregnancy loss rates, there was evidence of immature and mature B-cell count reductions.

Belimumab is approved by the Food and Drug Administration for use in patients aged 5 years and older with active, autoantibody-positive SLE who are taking standard therapy, and also for those with lupus nephritis.

Michelle Petri, MD, of Johns Hopkins University, Baltimore, and coauthors reported in Annals of the Rheumatic Diseases on data they compiled through March 8, 2020, from belimumab clinical trials, the Belimumab Pregnancy Registry (BPR), and postmarketing/spontaneous reports that encompassed 319 pregnancies with known outcomes.

Across 18 clinical trials with 223 live births, birth defects occurred in 4 of 72 (5.6%) belimumab-exposed pregnancies and in 0 of 9 in placebo-exposed pregnancies. Pregnancy loss (excluding elective terminations) occurred in 31.8% (35 of 110) of belimumab-exposed women and 43.8% (7 of 16) of placebo-exposed women in clinical trials. In the BPR retrospective cohort, 4.2% had pregnancy loss. Postmarketing and spontaneous reports had a pregnancy loss rate of 31.4% (43 of 137). Concomitant medications, confounding factors, and/or missing data were noted in all belimumab-exposed women in clinical trials and the BPR cohort. Dr. Petri and colleagues reported no consistent pattern of birth defects across datasets but stated: “Low numbers of exposed pregnancies, presence of confounding factors/other biases, and incomplete information preclude informed recommendations regarding risk of birth defects and pregnancy loss with belimumab use.”

In an interview, coauthor Megan E. B. Clowse, MD, MPH, associate professor of medicine and director of the division of rheumatology and immunology at Duke University, Durham, N.C., said that “the Annals of the Rheumatic Diseases article provides some reassurance that belimumab is unlikely to cause very frequent birth defects. It is clearly not in the risk-range for thalidomide or mycophenolate. However, due to the complexity of collecting these data, this manuscript can’t explore the full extent of possible risks. It also did not provide information about B cells, immune function, or infection risks in exposed offspring.”

A separate case report by Helle Bitter of the department of rheumatology at Sorlandet Hospital Kristiansand (Norway) in Annals of the Rheumatic Diseases is the first to show transplacental passage of belimumab in humans. Other prior reports have shown such transplacental passage for monoclonal IgG antibodies (tumor necrosis factor inhibitors and rituximab). Even though the last infusion was given late in the second trimester, belimumab was present in cord serum at birth, suggesting much higher concentrations before treatment was stopped. While B-cell numbers were reduced at birth, they returned to normal ranges by 4 months post partum when they were undetectable. In the mother, B-cell numbers remained low throughout the study period extending to 7 months after delivery. The authors stated that the child had a normal vaccination response, and except for the reduced B-cell levels at birth, had no adverse effects of prenatal exposure to maternal medication through age 6 years.

“The belimumab transfer in the case report is the level that we would anticipate based on similar studies in infant/mother pairs on other IgG1 antibody biologics like adalimumab – about 60% higher than the maternal level at birth,” Dr. Clowse said. “That the baby has very low B cells at birth is worrisome to me, demonstrating the lasting effect of maternal belimumab on the infant’s immune system, even when the drug was stopped 14 weeks prior to delivery. While this single infant did not have problems with infections, with more widespread use it seems possible that infants would be found to have higher rates of infections after in utero belimumab exposure.”

The field of lupus research greatly needs controlled studies of newer biologics in pregnancy, Dr. Clowse said. “Women with active lupus in pregnancy – particularly with active lupus nephritis – continue to suffer tragic outcomes at an alarming rate. Newer treatments for lupus nephritis provide some hope that we might be able to control lupus nephritis in pregnancy more effectively. The available data suggests the risks of these medications are not so large as to make studies unreasonable. Our current data doesn’t allow us to sufficiently balance the potential risks and benefits in a way that provides clinically useful guidance. Trials of these medications, however, would enable us to identify improved treatment strategies that could result in healthier women, pregnancies, and babies.”

GlaxoSmithKline funded the study. Dr. Clowse reported receiving consulting fees and grants from UCB and GlaxoSmithKline that relate to pregnancy in women with lupus.

The largest combined analysis of birth outcome data for women with systemic lupus erythematosus (SLE) who took belimumab (Benlysta) during pregnancy appears to indicate that the biologic is “unlikely to cause very frequent birth defects,” but the full extent of possible risk remains unknown. The drug’s effect on B cells, immune function, and infections in exposed offspring were not captured in the data, but a separate case report published after the belimumab pregnancy data report indicates that the drug does cross the placenta and builds up in the blood of the newborn, reducing B cells at birth.

Children of women with SLE have increased birth defect risks, and standard SLE therapeutic agents (for example, cyclophosphamide, methotrexate, mycophenolate mofetil) have been implicated in birth defects and pregnancy loss, but birth defect data for biologic drugs such as belimumab are limited. While belimumab animal data revealed no evidence of fetal harm or pregnancy loss rates, there was evidence of immature and mature B-cell count reductions.

Belimumab is approved by the Food and Drug Administration for use in patients aged 5 years and older with active, autoantibody-positive SLE who are taking standard therapy, and also for those with lupus nephritis.

Michelle Petri, MD, of Johns Hopkins University, Baltimore, and coauthors reported in Annals of the Rheumatic Diseases on data they compiled through March 8, 2020, from belimumab clinical trials, the Belimumab Pregnancy Registry (BPR), and postmarketing/spontaneous reports that encompassed 319 pregnancies with known outcomes.

Across 18 clinical trials with 223 live births, birth defects occurred in 4 of 72 (5.6%) belimumab-exposed pregnancies and in 0 of 9 in placebo-exposed pregnancies. Pregnancy loss (excluding elective terminations) occurred in 31.8% (35 of 110) of belimumab-exposed women and 43.8% (7 of 16) of placebo-exposed women in clinical trials. In the BPR retrospective cohort, 4.2% had pregnancy loss. Postmarketing and spontaneous reports had a pregnancy loss rate of 31.4% (43 of 137). Concomitant medications, confounding factors, and/or missing data were noted in all belimumab-exposed women in clinical trials and the BPR cohort. Dr. Petri and colleagues reported no consistent pattern of birth defects across datasets but stated: “Low numbers of exposed pregnancies, presence of confounding factors/other biases, and incomplete information preclude informed recommendations regarding risk of birth defects and pregnancy loss with belimumab use.”

In an interview, coauthor Megan E. B. Clowse, MD, MPH, associate professor of medicine and director of the division of rheumatology and immunology at Duke University, Durham, N.C., said that “the Annals of the Rheumatic Diseases article provides some reassurance that belimumab is unlikely to cause very frequent birth defects. It is clearly not in the risk-range for thalidomide or mycophenolate. However, due to the complexity of collecting these data, this manuscript can’t explore the full extent of possible risks. It also did not provide information about B cells, immune function, or infection risks in exposed offspring.”

A separate case report by Helle Bitter of the department of rheumatology at Sorlandet Hospital Kristiansand (Norway) in Annals of the Rheumatic Diseases is the first to show transplacental passage of belimumab in humans. Other prior reports have shown such transplacental passage for monoclonal IgG antibodies (tumor necrosis factor inhibitors and rituximab). Even though the last infusion was given late in the second trimester, belimumab was present in cord serum at birth, suggesting much higher concentrations before treatment was stopped. While B-cell numbers were reduced at birth, they returned to normal ranges by 4 months post partum when they were undetectable. In the mother, B-cell numbers remained low throughout the study period extending to 7 months after delivery. The authors stated that the child had a normal vaccination response, and except for the reduced B-cell levels at birth, had no adverse effects of prenatal exposure to maternal medication through age 6 years.

“The belimumab transfer in the case report is the level that we would anticipate based on similar studies in infant/mother pairs on other IgG1 antibody biologics like adalimumab – about 60% higher than the maternal level at birth,” Dr. Clowse said. “That the baby has very low B cells at birth is worrisome to me, demonstrating the lasting effect of maternal belimumab on the infant’s immune system, even when the drug was stopped 14 weeks prior to delivery. While this single infant did not have problems with infections, with more widespread use it seems possible that infants would be found to have higher rates of infections after in utero belimumab exposure.”

The field of lupus research greatly needs controlled studies of newer biologics in pregnancy, Dr. Clowse said. “Women with active lupus in pregnancy – particularly with active lupus nephritis – continue to suffer tragic outcomes at an alarming rate. Newer treatments for lupus nephritis provide some hope that we might be able to control lupus nephritis in pregnancy more effectively. The available data suggests the risks of these medications are not so large as to make studies unreasonable. Our current data doesn’t allow us to sufficiently balance the potential risks and benefits in a way that provides clinically useful guidance. Trials of these medications, however, would enable us to identify improved treatment strategies that could result in healthier women, pregnancies, and babies.”

GlaxoSmithKline funded the study. Dr. Clowse reported receiving consulting fees and grants from UCB and GlaxoSmithKline that relate to pregnancy in women with lupus.

The largest combined analysis of birth outcome data for women with systemic lupus erythematosus (SLE) who took belimumab (Benlysta) during pregnancy appears to indicate that the biologic is “unlikely to cause very frequent birth defects,” but the full extent of possible risk remains unknown. The drug’s effect on B cells, immune function, and infections in exposed offspring were not captured in the data, but a separate case report published after the belimumab pregnancy data report indicates that the drug does cross the placenta and builds up in the blood of the newborn, reducing B cells at birth.

Children of women with SLE have increased birth defect risks, and standard SLE therapeutic agents (for example, cyclophosphamide, methotrexate, mycophenolate mofetil) have been implicated in birth defects and pregnancy loss, but birth defect data for biologic drugs such as belimumab are limited. While belimumab animal data revealed no evidence of fetal harm or pregnancy loss rates, there was evidence of immature and mature B-cell count reductions.

Belimumab is approved by the Food and Drug Administration for use in patients aged 5 years and older with active, autoantibody-positive SLE who are taking standard therapy, and also for those with lupus nephritis.

Michelle Petri, MD, of Johns Hopkins University, Baltimore, and coauthors reported in Annals of the Rheumatic Diseases on data they compiled through March 8, 2020, from belimumab clinical trials, the Belimumab Pregnancy Registry (BPR), and postmarketing/spontaneous reports that encompassed 319 pregnancies with known outcomes.

Across 18 clinical trials with 223 live births, birth defects occurred in 4 of 72 (5.6%) belimumab-exposed pregnancies and in 0 of 9 in placebo-exposed pregnancies. Pregnancy loss (excluding elective terminations) occurred in 31.8% (35 of 110) of belimumab-exposed women and 43.8% (7 of 16) of placebo-exposed women in clinical trials. In the BPR retrospective cohort, 4.2% had pregnancy loss. Postmarketing and spontaneous reports had a pregnancy loss rate of 31.4% (43 of 137). Concomitant medications, confounding factors, and/or missing data were noted in all belimumab-exposed women in clinical trials and the BPR cohort. Dr. Petri and colleagues reported no consistent pattern of birth defects across datasets but stated: “Low numbers of exposed pregnancies, presence of confounding factors/other biases, and incomplete information preclude informed recommendations regarding risk of birth defects and pregnancy loss with belimumab use.”

In an interview, coauthor Megan E. B. Clowse, MD, MPH, associate professor of medicine and director of the division of rheumatology and immunology at Duke University, Durham, N.C., said that “the Annals of the Rheumatic Diseases article provides some reassurance that belimumab is unlikely to cause very frequent birth defects. It is clearly not in the risk-range for thalidomide or mycophenolate. However, due to the complexity of collecting these data, this manuscript can’t explore the full extent of possible risks. It also did not provide information about B cells, immune function, or infection risks in exposed offspring.”

A separate case report by Helle Bitter of the department of rheumatology at Sorlandet Hospital Kristiansand (Norway) in Annals of the Rheumatic Diseases is the first to show transplacental passage of belimumab in humans. Other prior reports have shown such transplacental passage for monoclonal IgG antibodies (tumor necrosis factor inhibitors and rituximab). Even though the last infusion was given late in the second trimester, belimumab was present in cord serum at birth, suggesting much higher concentrations before treatment was stopped. While B-cell numbers were reduced at birth, they returned to normal ranges by 4 months post partum when they were undetectable. In the mother, B-cell numbers remained low throughout the study period extending to 7 months after delivery. The authors stated that the child had a normal vaccination response, and except for the reduced B-cell levels at birth, had no adverse effects of prenatal exposure to maternal medication through age 6 years.

“The belimumab transfer in the case report is the level that we would anticipate based on similar studies in infant/mother pairs on other IgG1 antibody biologics like adalimumab – about 60% higher than the maternal level at birth,” Dr. Clowse said. “That the baby has very low B cells at birth is worrisome to me, demonstrating the lasting effect of maternal belimumab on the infant’s immune system, even when the drug was stopped 14 weeks prior to delivery. While this single infant did not have problems with infections, with more widespread use it seems possible that infants would be found to have higher rates of infections after in utero belimumab exposure.”

The field of lupus research greatly needs controlled studies of newer biologics in pregnancy, Dr. Clowse said. “Women with active lupus in pregnancy – particularly with active lupus nephritis – continue to suffer tragic outcomes at an alarming rate. Newer treatments for lupus nephritis provide some hope that we might be able to control lupus nephritis in pregnancy more effectively. The available data suggests the risks of these medications are not so large as to make studies unreasonable. Our current data doesn’t allow us to sufficiently balance the potential risks and benefits in a way that provides clinically useful guidance. Trials of these medications, however, would enable us to identify improved treatment strategies that could result in healthier women, pregnancies, and babies.”

GlaxoSmithKline funded the study. Dr. Clowse reported receiving consulting fees and grants from UCB and GlaxoSmithKline that relate to pregnancy in women with lupus.

Delay in treatment will cost hospital millions

A Texas hospital must pay a multimillion-dollar judgment for failing to treat a woman’s spinal injury in time to prevent paralysis, according to a report on WFAA.com, among other news sites.

On March 21, 2019, Judy “Jessie” Adams, then part of a singing-songwriting duo with her husband, Richard, went to Premier Interventional Pain Management, in Flower Mound, Tex., prior to the couple’s drive to Ohio for a funeral. At Premier, Jesse received an epidural steroid injection (ESI) that she hoped would ease her back pain during the long drive.

Instead, the injection ended up increasing her pain.

“He [the pain physician] gave me the shot, but I couldn’t feel my legs. They were tingling, but I couldn’t feel them,” Mrs. Adams explained. “The pain was so bad in my back.” In their suit, Adams and her husband alleged that the doctor had probably “nicked a blood vessel during the ESI procedure, causing Jessie to hemorrhage.” (The couple’s suit against the doctor was settled prior to trial.)

Mrs. Adams remained under observation at the pain facility for about 1½ hours, at which point she was taken by ambulance to nearby Texas Health Presbyterian Hospital. There, in the emergency department, staff ordered a “STAT MRI” in preparation for an emergency laminectomy.

For reasons that remain murky, the MRI wasn’t performed for 1 hour and 37 minutes. The emergency laminectomy itself wasn’t started until more than 5 hours after Adams had been admitted to the ED. This was a direct violation of hospital protocol, which required that emergency surgeries be performed within 1 hour of admittance in the first available surgical suite. (At trial, Mrs. Adams’s attorneys from Lyons & Simmons offered evidence that a suite became available 49 minutes after Adams had arrived at the ED.)

During the wait, Mrs. Adams continued to experience excruciating pain. “I kept screaming: ‘Help me,’ ” she recalled. At trial, her attorneys argued that the hospital’s delay in addressing her spinal emergency led directly to her current paralysis, which keeps her confined to a wheelchair and renders her incontinent.

The hospital disagreed. In court, it maintained that Mrs. Adams was already paralyzed when she arrived at the ED and that there was no delay in care.

The jury saw things differently, however. Siding with the plaintiffs, it awarded Mrs. Adams and her husband $10.1 million, including $500,000 for Mr. Adams’s loss of future earnings and $1 million for his “loss of consortium” with his wife.

Their music career now effectively over, Mr. Adams spends most of his time taking care of Mrs. Adams.

“Music was our lifeblood for so many years, and he can’t do it anymore,” Mrs. Adams said. “He goes upstairs to play his guitar and write, and suddenly I need him to come and cath me. I just feel like I’m going to wake up from this bad dream, but it’s the same routine.”
 

Two doctors are absolved in woman’s sudden death

In a 3-2 decision in December 2022, the Pennsylvania Supreme Court ruled that the state’s 2-year statute of limitations in wrongful-death cases applies even in cases in which plaintiffs fail to identify the cause of death in a timely manner, as a report in the Claims Journal indicates.

The decision stems from a lawsuit filed by Linda Reibenstein on behalf of her mother, Mary Ann Whitman, who died in late April 2010 from a ruptured aortic aneurysm.

On April 12, 2010, Ms. Whitman visited Patrick D. Conaboy, MD, a Scranton family physician, complaining of a persistent cough, fever, and lower-back pain. Following an initial examination, Dr. Conaboy ordered an aortic duplex ultrasound scan and a CT scan of the patient’s abdomen.

The ultrasound was performed by radiologist Charles Barax, MD, who reviewed both scans. He identified a “poorly visualized aortic aneurysm.” At this point, Dr. Conaboy referred Ms. Whitman to a vascular surgeon. But before this visit could take place, Whitman’s aneurysm ruptured, killing her. This was listed as the medical cause of death on the patient’s death certificate.

In April 2011, Ms. Reibenstein filed a claim against Dr. Barax, alleging that he had failed to gauge the severity of her mother’s condition. Ms. Reibenstein’s attorney wasn’t able to question Dr. Barax on the record until well after the state’s 2-year statute of limitations had elapsed. When he did testify, Dr. Barax explained that the scans’ image quality prevented him from determining whether Whitman’s aneurysm was rupturing or simply bleeding. Despite this, he insisted that he had warned Dr. Conaboy of the potential for Ms. Whitman’s aneurysm to rupture.

In March 2016, nearly 6 years after her mother’s death, Ms. Reibenstein filed a new lawsuit, this one against Dr. Conaboy, whom she alleged had failed to properly treat her mother’s condition. Dr. Conaboy, in turn, asked the court for summary judgment – that is, a judgment in his favor without a full trial – arguing that the state’s window for filing a wrongful-death claim had long since closed. For their part, Ms. Reibenstein and her attorney argued that the state’s 2-year statute of limitations didn’t start until the plaintiff had discovered the cause of her mother’s death.

Initially refusing to dismiss the case, a lower court reconsidered Dr. Conaboy’s motion for summary judgment and ruled that Ms. Reibenstein had failed to present any evidence of “affirmative misrepresentation or fraudulent concealment.” In other words, in the absence of any willful attempt on the part of the defendant to hide the legal cause of death, which includes “acts, omissions, or events having some causative connection with the death,” the statute of limitations remained in effect, and the defendant’s motion was thereby granted.

Continuing the legal seesaw, a state appeals court reversed the lower-court ruling. Noting that the Pennsylvania malpractice statute was ambiguous, the court argued that it should be interpreted in a way that protects plaintiffs who seek “fair compensation” but encounter willfully erected obstacles in pursuit of their claim.

Dr. Conaboy then took his case to the state’s highest court. In its majority decision, the Pennsylvania Supreme Court staked out a narrow definition of cause of death – one based on the death certificate – and ruled that only willful fraud in that document would constitute the necessary condition for halting the claim’s clock. Furthermore, the high court said, when lawmakers adopted the Medical Care Availability and Reduction of Error Act in 2002, they did so with no guarantee “that all of the information necessary to sustain a claim will be gathered in the limitations period.”

Similarly, the court ruled, “at some point the clock must run out, lest health care providers remain subject to liability exposure indefinitely, with the prospect of a trial marred by the death or diminished memory of material witnesses or the loss of critical evidence.”

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

Delay in treatment will cost hospital millions

A Texas hospital must pay a multimillion-dollar judgment for failing to treat a woman’s spinal injury in time to prevent paralysis, according to a report on WFAA.com, among other news sites.

On March 21, 2019, Judy “Jessie” Adams, then part of a singing-songwriting duo with her husband, Richard, went to Premier Interventional Pain Management, in Flower Mound, Tex., prior to the couple’s drive to Ohio for a funeral. At Premier, Jesse received an epidural steroid injection (ESI) that she hoped would ease her back pain during the long drive.

Instead, the injection ended up increasing her pain.

“He [the pain physician] gave me the shot, but I couldn’t feel my legs. They were tingling, but I couldn’t feel them,” Mrs. Adams explained. “The pain was so bad in my back.” In their suit, Adams and her husband alleged that the doctor had probably “nicked a blood vessel during the ESI procedure, causing Jessie to hemorrhage.” (The couple’s suit against the doctor was settled prior to trial.)

Mrs. Adams remained under observation at the pain facility for about 1½ hours, at which point she was taken by ambulance to nearby Texas Health Presbyterian Hospital. There, in the emergency department, staff ordered a “STAT MRI” in preparation for an emergency laminectomy.

For reasons that remain murky, the MRI wasn’t performed for 1 hour and 37 minutes. The emergency laminectomy itself wasn’t started until more than 5 hours after Adams had been admitted to the ED. This was a direct violation of hospital protocol, which required that emergency surgeries be performed within 1 hour of admittance in the first available surgical suite. (At trial, Mrs. Adams’s attorneys from Lyons & Simmons offered evidence that a suite became available 49 minutes after Adams had arrived at the ED.)

During the wait, Mrs. Adams continued to experience excruciating pain. “I kept screaming: ‘Help me,’ ” she recalled. At trial, her attorneys argued that the hospital’s delay in addressing her spinal emergency led directly to her current paralysis, which keeps her confined to a wheelchair and renders her incontinent.

The hospital disagreed. In court, it maintained that Mrs. Adams was already paralyzed when she arrived at the ED and that there was no delay in care.

The jury saw things differently, however. Siding with the plaintiffs, it awarded Mrs. Adams and her husband $10.1 million, including $500,000 for Mr. Adams’s loss of future earnings and $1 million for his “loss of consortium” with his wife.

Their music career now effectively over, Mr. Adams spends most of his time taking care of Mrs. Adams.

“Music was our lifeblood for so many years, and he can’t do it anymore,” Mrs. Adams said. “He goes upstairs to play his guitar and write, and suddenly I need him to come and cath me. I just feel like I’m going to wake up from this bad dream, but it’s the same routine.”
 

Two doctors are absolved in woman’s sudden death

In a 3-2 decision in December 2022, the Pennsylvania Supreme Court ruled that the state’s 2-year statute of limitations in wrongful-death cases applies even in cases in which plaintiffs fail to identify the cause of death in a timely manner, as a report in the Claims Journal indicates.

The decision stems from a lawsuit filed by Linda Reibenstein on behalf of her mother, Mary Ann Whitman, who died in late April 2010 from a ruptured aortic aneurysm.

On April 12, 2010, Ms. Whitman visited Patrick D. Conaboy, MD, a Scranton family physician, complaining of a persistent cough, fever, and lower-back pain. Following an initial examination, Dr. Conaboy ordered an aortic duplex ultrasound scan and a CT scan of the patient’s abdomen.

The ultrasound was performed by radiologist Charles Barax, MD, who reviewed both scans. He identified a “poorly visualized aortic aneurysm.” At this point, Dr. Conaboy referred Ms. Whitman to a vascular surgeon. But before this visit could take place, Whitman’s aneurysm ruptured, killing her. This was listed as the medical cause of death on the patient’s death certificate.

In April 2011, Ms. Reibenstein filed a claim against Dr. Barax, alleging that he had failed to gauge the severity of her mother’s condition. Ms. Reibenstein’s attorney wasn’t able to question Dr. Barax on the record until well after the state’s 2-year statute of limitations had elapsed. When he did testify, Dr. Barax explained that the scans’ image quality prevented him from determining whether Whitman’s aneurysm was rupturing or simply bleeding. Despite this, he insisted that he had warned Dr. Conaboy of the potential for Ms. Whitman’s aneurysm to rupture.

In March 2016, nearly 6 years after her mother’s death, Ms. Reibenstein filed a new lawsuit, this one against Dr. Conaboy, whom she alleged had failed to properly treat her mother’s condition. Dr. Conaboy, in turn, asked the court for summary judgment – that is, a judgment in his favor without a full trial – arguing that the state’s window for filing a wrongful-death claim had long since closed. For their part, Ms. Reibenstein and her attorney argued that the state’s 2-year statute of limitations didn’t start until the plaintiff had discovered the cause of her mother’s death.

Initially refusing to dismiss the case, a lower court reconsidered Dr. Conaboy’s motion for summary judgment and ruled that Ms. Reibenstein had failed to present any evidence of “affirmative misrepresentation or fraudulent concealment.” In other words, in the absence of any willful attempt on the part of the defendant to hide the legal cause of death, which includes “acts, omissions, or events having some causative connection with the death,” the statute of limitations remained in effect, and the defendant’s motion was thereby granted.

Continuing the legal seesaw, a state appeals court reversed the lower-court ruling. Noting that the Pennsylvania malpractice statute was ambiguous, the court argued that it should be interpreted in a way that protects plaintiffs who seek “fair compensation” but encounter willfully erected obstacles in pursuit of their claim.

Dr. Conaboy then took his case to the state’s highest court. In its majority decision, the Pennsylvania Supreme Court staked out a narrow definition of cause of death – one based on the death certificate – and ruled that only willful fraud in that document would constitute the necessary condition for halting the claim’s clock. Furthermore, the high court said, when lawmakers adopted the Medical Care Availability and Reduction of Error Act in 2002, they did so with no guarantee “that all of the information necessary to sustain a claim will be gathered in the limitations period.”

Similarly, the court ruled, “at some point the clock must run out, lest health care providers remain subject to liability exposure indefinitely, with the prospect of a trial marred by the death or diminished memory of material witnesses or the loss of critical evidence.”

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

Delay in treatment will cost hospital millions

A Texas hospital must pay a multimillion-dollar judgment for failing to treat a woman’s spinal injury in time to prevent paralysis, according to a report on WFAA.com, among other news sites.

On March 21, 2019, Judy “Jessie” Adams, then part of a singing-songwriting duo with her husband, Richard, went to Premier Interventional Pain Management, in Flower Mound, Tex., prior to the couple’s drive to Ohio for a funeral. At Premier, Jesse received an epidural steroid injection (ESI) that she hoped would ease her back pain during the long drive.

Instead, the injection ended up increasing her pain.

“He [the pain physician] gave me the shot, but I couldn’t feel my legs. They were tingling, but I couldn’t feel them,” Mrs. Adams explained. “The pain was so bad in my back.” In their suit, Adams and her husband alleged that the doctor had probably “nicked a blood vessel during the ESI procedure, causing Jessie to hemorrhage.” (The couple’s suit against the doctor was settled prior to trial.)

Mrs. Adams remained under observation at the pain facility for about 1½ hours, at which point she was taken by ambulance to nearby Texas Health Presbyterian Hospital. There, in the emergency department, staff ordered a “STAT MRI” in preparation for an emergency laminectomy.

For reasons that remain murky, the MRI wasn’t performed for 1 hour and 37 minutes. The emergency laminectomy itself wasn’t started until more than 5 hours after Adams had been admitted to the ED. This was a direct violation of hospital protocol, which required that emergency surgeries be performed within 1 hour of admittance in the first available surgical suite. (At trial, Mrs. Adams’s attorneys from Lyons & Simmons offered evidence that a suite became available 49 minutes after Adams had arrived at the ED.)

During the wait, Mrs. Adams continued to experience excruciating pain. “I kept screaming: ‘Help me,’ ” she recalled. At trial, her attorneys argued that the hospital’s delay in addressing her spinal emergency led directly to her current paralysis, which keeps her confined to a wheelchair and renders her incontinent.

The hospital disagreed. In court, it maintained that Mrs. Adams was already paralyzed when she arrived at the ED and that there was no delay in care.

The jury saw things differently, however. Siding with the plaintiffs, it awarded Mrs. Adams and her husband $10.1 million, including $500,000 for Mr. Adams’s loss of future earnings and $1 million for his “loss of consortium” with his wife.

Their music career now effectively over, Mr. Adams spends most of his time taking care of Mrs. Adams.

“Music was our lifeblood for so many years, and he can’t do it anymore,” Mrs. Adams said. “He goes upstairs to play his guitar and write, and suddenly I need him to come and cath me. I just feel like I’m going to wake up from this bad dream, but it’s the same routine.”
 

Two doctors are absolved in woman’s sudden death

In a 3-2 decision in December 2022, the Pennsylvania Supreme Court ruled that the state’s 2-year statute of limitations in wrongful-death cases applies even in cases in which plaintiffs fail to identify the cause of death in a timely manner, as a report in the Claims Journal indicates.

The decision stems from a lawsuit filed by Linda Reibenstein on behalf of her mother, Mary Ann Whitman, who died in late April 2010 from a ruptured aortic aneurysm.

On April 12, 2010, Ms. Whitman visited Patrick D. Conaboy, MD, a Scranton family physician, complaining of a persistent cough, fever, and lower-back pain. Following an initial examination, Dr. Conaboy ordered an aortic duplex ultrasound scan and a CT scan of the patient’s abdomen.

The ultrasound was performed by radiologist Charles Barax, MD, who reviewed both scans. He identified a “poorly visualized aortic aneurysm.” At this point, Dr. Conaboy referred Ms. Whitman to a vascular surgeon. But before this visit could take place, Whitman’s aneurysm ruptured, killing her. This was listed as the medical cause of death on the patient’s death certificate.

In April 2011, Ms. Reibenstein filed a claim against Dr. Barax, alleging that he had failed to gauge the severity of her mother’s condition. Ms. Reibenstein’s attorney wasn’t able to question Dr. Barax on the record until well after the state’s 2-year statute of limitations had elapsed. When he did testify, Dr. Barax explained that the scans’ image quality prevented him from determining whether Whitman’s aneurysm was rupturing or simply bleeding. Despite this, he insisted that he had warned Dr. Conaboy of the potential for Ms. Whitman’s aneurysm to rupture.

In March 2016, nearly 6 years after her mother’s death, Ms. Reibenstein filed a new lawsuit, this one against Dr. Conaboy, whom she alleged had failed to properly treat her mother’s condition. Dr. Conaboy, in turn, asked the court for summary judgment – that is, a judgment in his favor without a full trial – arguing that the state’s window for filing a wrongful-death claim had long since closed. For their part, Ms. Reibenstein and her attorney argued that the state’s 2-year statute of limitations didn’t start until the plaintiff had discovered the cause of her mother’s death.

Initially refusing to dismiss the case, a lower court reconsidered Dr. Conaboy’s motion for summary judgment and ruled that Ms. Reibenstein had failed to present any evidence of “affirmative misrepresentation or fraudulent concealment.” In other words, in the absence of any willful attempt on the part of the defendant to hide the legal cause of death, which includes “acts, omissions, or events having some causative connection with the death,” the statute of limitations remained in effect, and the defendant’s motion was thereby granted.

Continuing the legal seesaw, a state appeals court reversed the lower-court ruling. Noting that the Pennsylvania malpractice statute was ambiguous, the court argued that it should be interpreted in a way that protects plaintiffs who seek “fair compensation” but encounter willfully erected obstacles in pursuit of their claim.

Dr. Conaboy then took his case to the state’s highest court. In its majority decision, the Pennsylvania Supreme Court staked out a narrow definition of cause of death – one based on the death certificate – and ruled that only willful fraud in that document would constitute the necessary condition for halting the claim’s clock. Furthermore, the high court said, when lawmakers adopted the Medical Care Availability and Reduction of Error Act in 2002, they did so with no guarantee “that all of the information necessary to sustain a claim will be gathered in the limitations period.”

Similarly, the court ruled, “at some point the clock must run out, lest health care providers remain subject to liability exposure indefinitely, with the prospect of a trial marred by the death or diminished memory of material witnesses or the loss of critical evidence.”

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