A former nursing assistant and Army veteran pleaded guilty to federal murder charges this week in connection with the 2017-2018 deaths of seven patients in a West Virginia veteran’s hospital, according to news reports.

Prosecutors said in court documents filed on July 13 that Reta Mays, 46, injected lethal doses of insulin into seven veterans at the Louis A. Johnson VA Medical Center (VAMC) in rural Clarksburg, W.Va.

Their blood glucose levels plummeted, and each died shortly after their injections, according to the Tennessean.

An eighth patient, a 92-year-old man whom Mays is accused of assaulting with an insulin injection, initially survived after staff were able to stabilize him but died 2 weeks later at a nursing home, NPR reports.

According to NPR, US Attorney Jarod Douglas told the court Tuesday that the medical investigator could not determine whether the insulin contributed to the man’s death but that it was Mays’ intention to kill him.

“No one watched while she injected them with lethal doses of insulin during an 11-month killing rampage,” the Washington Post reported.
 

No motive offered

The Post article said no motive has been established, but after a 2-year investigation into a pattern of suspicious deaths that took the hospital almost a year to detect, Mays, who had denied any wrongdoing in multiple interviews with investigators, told a federal judge she preyed on some of the country›s most vulnerable service members.

An attorney for Mays, Brian Kornbrath, contacted by Medscape Medical News, said: “The defense team decided that we would have no public comment at this time.”

According to court documents from the Northern District of West Virginia, Mays was charged with seven counts of second-degree murder and one count of assault with intent to commit murder in connection with the patient who died later.

Mays was hired at the VAMC in Clarksburg in June 2015. She worked from 7:30 PM to 8:00 AM in the medical surgical unit, court documents say.

According to the documents, “VAMC Clarksburg did not require a nursing assistant to have a certification or licensure for initial appointment or as a condition of continuing employment.”

The documents indicate that in June 2018, a hospitalist employed by VAMC Clarksburg reported concern about several deaths from unexplained hypoglycemic events in the same ward and noted that many of the affected patients did not have diabetes.

By that time, according to the Tennessean, “at least eight patients had died under suspicious circumstances. Several had been embalmed and buried, destroying potential evidence. One veteran had been cremated.”

An internal investigation began, followed by a criminal investigation, and in July 2018, Mays was removed from patient care.
 

Mays fired in 2019 because of lies on resume; claims suffers from PTSD

The Post reports that Mays was fired from the hospital in 2019, 7 months after she was banned from patient care, «after it was discovered she had lied about her qualifications on her resume.»

Court documents indicate that her duties included acting as a sitter for patients, checking vital signs, intake and output, and testing blood glucose levels, but she was not qualified to administer medications, including insulin.

Similarities in the deaths were evident, the Post reported. Citing sources familiar with the case, the report said, “elderly patients in private rooms were injected in their abdomen and limbs with insulin the hospital had not ordered.”

The Post reported that Mays sobbed by the end of the hearing on Tuesday.

The article notes that Mays has three sons and served in the Army National Guard from November 2000 to April 2001 and again from February 2003 to May 2004, when she was deployed to Iraq and Kuwait. She told the judge she was taking medication for posttraumatic stress disorder.

By pleading guilty, she waived her right to have the case presented to a grand jury. A sentencing hearing has not been scheduled, the Post reports.

NPR notes that prosecutors have requested that Mays serve seven consecutive life sentences and an additional 20 years in prison.
 

“Our hearts go out to those affected by these tragic deaths”

A spokesman for VAMC Clarksburg said in a statement to Medscape Medical News: “Our hearts go out to those affected by these tragic deaths. Clarksburg VA Medical Center discovered these allegations and reported them to VA›s independent inspector general more than 2 years ago. Clarksburg VA Medical Center also fired the individual at the center of the allegations.

“We’re glad the Department of Justice stepped in to push this investigation across the finish line and hopeful our court system will deliver the justice Clarksburg-area Veterans and families deserve.”

According to the Tennessean, Michael Missal, inspector general for the Department of Veteran Affairs, said the agency is investigating the hospital’s practices, “including medication management and communications among staffers.”

This article first appeared on Medscape.com.

A former nursing assistant and Army veteran pleaded guilty to federal murder charges this week in connection with the 2017-2018 deaths of seven patients in a West Virginia veteran’s hospital, according to news reports.

Prosecutors said in court documents filed on July 13 that Reta Mays, 46, injected lethal doses of insulin into seven veterans at the Louis A. Johnson VA Medical Center (VAMC) in rural Clarksburg, W.Va.

Their blood glucose levels plummeted, and each died shortly after their injections, according to the Tennessean.

An eighth patient, a 92-year-old man whom Mays is accused of assaulting with an insulin injection, initially survived after staff were able to stabilize him but died 2 weeks later at a nursing home, NPR reports.

According to NPR, US Attorney Jarod Douglas told the court Tuesday that the medical investigator could not determine whether the insulin contributed to the man’s death but that it was Mays’ intention to kill him.

“No one watched while she injected them with lethal doses of insulin during an 11-month killing rampage,” the Washington Post reported.
 

No motive offered

The Post article said no motive has been established, but after a 2-year investigation into a pattern of suspicious deaths that took the hospital almost a year to detect, Mays, who had denied any wrongdoing in multiple interviews with investigators, told a federal judge she preyed on some of the country›s most vulnerable service members.

An attorney for Mays, Brian Kornbrath, contacted by Medscape Medical News, said: “The defense team decided that we would have no public comment at this time.”

According to court documents from the Northern District of West Virginia, Mays was charged with seven counts of second-degree murder and one count of assault with intent to commit murder in connection with the patient who died later.

Mays was hired at the VAMC in Clarksburg in June 2015. She worked from 7:30 PM to 8:00 AM in the medical surgical unit, court documents say.

According to the documents, “VAMC Clarksburg did not require a nursing assistant to have a certification or licensure for initial appointment or as a condition of continuing employment.”

The documents indicate that in June 2018, a hospitalist employed by VAMC Clarksburg reported concern about several deaths from unexplained hypoglycemic events in the same ward and noted that many of the affected patients did not have diabetes.

By that time, according to the Tennessean, “at least eight patients had died under suspicious circumstances. Several had been embalmed and buried, destroying potential evidence. One veteran had been cremated.”

An internal investigation began, followed by a criminal investigation, and in July 2018, Mays was removed from patient care.
 

Mays fired in 2019 because of lies on resume; claims suffers from PTSD

The Post reports that Mays was fired from the hospital in 2019, 7 months after she was banned from patient care, «after it was discovered she had lied about her qualifications on her resume.»

Court documents indicate that her duties included acting as a sitter for patients, checking vital signs, intake and output, and testing blood glucose levels, but she was not qualified to administer medications, including insulin.

Similarities in the deaths were evident, the Post reported. Citing sources familiar with the case, the report said, “elderly patients in private rooms were injected in their abdomen and limbs with insulin the hospital had not ordered.”

The Post reported that Mays sobbed by the end of the hearing on Tuesday.

The article notes that Mays has three sons and served in the Army National Guard from November 2000 to April 2001 and again from February 2003 to May 2004, when she was deployed to Iraq and Kuwait. She told the judge she was taking medication for posttraumatic stress disorder.

By pleading guilty, she waived her right to have the case presented to a grand jury. A sentencing hearing has not been scheduled, the Post reports.

NPR notes that prosecutors have requested that Mays serve seven consecutive life sentences and an additional 20 years in prison.
 

“Our hearts go out to those affected by these tragic deaths”

A spokesman for VAMC Clarksburg said in a statement to Medscape Medical News: “Our hearts go out to those affected by these tragic deaths. Clarksburg VA Medical Center discovered these allegations and reported them to VA›s independent inspector general more than 2 years ago. Clarksburg VA Medical Center also fired the individual at the center of the allegations.

“We’re glad the Department of Justice stepped in to push this investigation across the finish line and hopeful our court system will deliver the justice Clarksburg-area Veterans and families deserve.”

According to the Tennessean, Michael Missal, inspector general for the Department of Veteran Affairs, said the agency is investigating the hospital’s practices, “including medication management and communications among staffers.”

This article first appeared on Medscape.com.

A former nursing assistant and Army veteran pleaded guilty to federal murder charges this week in connection with the 2017-2018 deaths of seven patients in a West Virginia veteran’s hospital, according to news reports.

Prosecutors said in court documents filed on July 13 that Reta Mays, 46, injected lethal doses of insulin into seven veterans at the Louis A. Johnson VA Medical Center (VAMC) in rural Clarksburg, W.Va.

Their blood glucose levels plummeted, and each died shortly after their injections, according to the Tennessean.

An eighth patient, a 92-year-old man whom Mays is accused of assaulting with an insulin injection, initially survived after staff were able to stabilize him but died 2 weeks later at a nursing home, NPR reports.

According to NPR, US Attorney Jarod Douglas told the court Tuesday that the medical investigator could not determine whether the insulin contributed to the man’s death but that it was Mays’ intention to kill him.

“No one watched while she injected them with lethal doses of insulin during an 11-month killing rampage,” the Washington Post reported.
 

No motive offered

The Post article said no motive has been established, but after a 2-year investigation into a pattern of suspicious deaths that took the hospital almost a year to detect, Mays, who had denied any wrongdoing in multiple interviews with investigators, told a federal judge she preyed on some of the country›s most vulnerable service members.

An attorney for Mays, Brian Kornbrath, contacted by Medscape Medical News, said: “The defense team decided that we would have no public comment at this time.”

According to court documents from the Northern District of West Virginia, Mays was charged with seven counts of second-degree murder and one count of assault with intent to commit murder in connection with the patient who died later.

Mays was hired at the VAMC in Clarksburg in June 2015. She worked from 7:30 PM to 8:00 AM in the medical surgical unit, court documents say.

According to the documents, “VAMC Clarksburg did not require a nursing assistant to have a certification or licensure for initial appointment or as a condition of continuing employment.”

The documents indicate that in June 2018, a hospitalist employed by VAMC Clarksburg reported concern about several deaths from unexplained hypoglycemic events in the same ward and noted that many of the affected patients did not have diabetes.

By that time, according to the Tennessean, “at least eight patients had died under suspicious circumstances. Several had been embalmed and buried, destroying potential evidence. One veteran had been cremated.”

An internal investigation began, followed by a criminal investigation, and in July 2018, Mays was removed from patient care.
 

Mays fired in 2019 because of lies on resume; claims suffers from PTSD

The Post reports that Mays was fired from the hospital in 2019, 7 months after she was banned from patient care, «after it was discovered she had lied about her qualifications on her resume.»

Court documents indicate that her duties included acting as a sitter for patients, checking vital signs, intake and output, and testing blood glucose levels, but she was not qualified to administer medications, including insulin.

Similarities in the deaths were evident, the Post reported. Citing sources familiar with the case, the report said, “elderly patients in private rooms were injected in their abdomen and limbs with insulin the hospital had not ordered.”

The Post reported that Mays sobbed by the end of the hearing on Tuesday.

The article notes that Mays has three sons and served in the Army National Guard from November 2000 to April 2001 and again from February 2003 to May 2004, when she was deployed to Iraq and Kuwait. She told the judge she was taking medication for posttraumatic stress disorder.

By pleading guilty, she waived her right to have the case presented to a grand jury. A sentencing hearing has not been scheduled, the Post reports.

NPR notes that prosecutors have requested that Mays serve seven consecutive life sentences and an additional 20 years in prison.
 

“Our hearts go out to those affected by these tragic deaths”

A spokesman for VAMC Clarksburg said in a statement to Medscape Medical News: “Our hearts go out to those affected by these tragic deaths. Clarksburg VA Medical Center discovered these allegations and reported them to VA›s independent inspector general more than 2 years ago. Clarksburg VA Medical Center also fired the individual at the center of the allegations.

“We’re glad the Department of Justice stepped in to push this investigation across the finish line and hopeful our court system will deliver the justice Clarksburg-area Veterans and families deserve.”

According to the Tennessean, Michael Missal, inspector general for the Department of Veteran Affairs, said the agency is investigating the hospital’s practices, “including medication management and communications among staffers.”

This article first appeared on Medscape.com.

Chester Good, MD, MPH, is professor of medicine and pharmacy, University of Pittsburgh School of Medicine and School of Pharmacy. He is also the senior medical director, UPMC Health Plan Insurance Division, as well as the director for the Center for Value-Based Pharmacy Initiatives.
 

What are the potential benefits of value-based contracting for patients with multiple sclerosis, as well as for health systems and payers?

CHESTER GOOD, MD, MPH: I think for all 3, value-based contracting really is about moving from volume to value. And in doing so, what we're trying to do is recognize the value of pharmaceuticals perhaps in ways that we previously have not.

Patients with conditions such as multiple sclerosis (MS) want to be able to live their lives where they can continue to work, maintain their activities of daily living, and maintain their quality of life. Value-based contracting ideally recognizes those patient values and leverages contracting of pharmaceuticals that have been shown to help maintain those qualities in patients. For health systems, our greatest duty is to our patients in terms of maintaining their quality of life, maintaining their health, and preventing disease progression. By developing value-based contracts in which we recognize these measurable outcomes, we're showing a commitment to our patients and trying to hopefully establish the value of our pharmacy benefit.

For most health plans and payers, MS especially has become an increasingly expensive disease, with MS-related medications representing a significant cost burden. It's no secret that MS drugs have gone up significantly in recent years.

In a paper published in JAMA Neurology,¹ we looked at the costs of these self-administered disease-modifying therapies for MS. From 2006 to 2016, the costs more than quadrupled, from a mean of $18,660 a year to more than $75,000, which means they increased at an annual rate of almost 13%. For payers, pharmaceutical spending per 1000 beneficiaries increased tenfold; and out-of-pocket expenses to our patients also increased significantly.

So, that's the reality. But the other reality is that there have been significant advancements in the treatment of MS using pharmaceuticals. And some of these newer treatments are more effective. Moreover, some are easier to take than some of the older therapies, and some are better tolerated from a patient perspective.

As a result of dramatic increase in costs of MS drugs, payers are asking about what they are getting in return for all these dramatic increases in costs. One of the ways to demonstrate that value is to link paying for these drugs with a value-based contract.

Why is a disease such as MS a good fit for value-based contracting?

CHESTER GOOD, MD, MPH: MS is a fairly prevalent disease. Fortunately, pharmacotherapy has gotten better over the years, to the point where it's clear that the pharmacotherapy of MS has really changed the course of the disease for our patients, allowing them to maintain their quality of life and functional abilities.

On a personal level, I had a family member growing up who had MS. And she did not have the benefits of the newer drugs. And through my childhood and early adulthood, I watched as she went from a very productive working person to someone who could no longer work, was unable to take care of her children, and was institutionalized and eventually died from complications of MS. That would be unusual today.

In a value-based contract, what MS outcomes are linked to reimbursement, and how are they measured?

CHESTER GOOD, MD, MPH: Traditionally, outcomes-based agreements focused on things that would be easily measured through administrative data. These are things that either a drug manufacturer or insurer, or both, have identified as being what they think are important outcomes for that disease state, but also things that they think they would be able to measure. Oftentimes, these were intermediate outcomes. Did the patient remain on a drug? Were they adherent? What was the impact on hemoglobin A1c in patients with diabetes? Although these outcomes may be important, they  may not be as important to our patients.

So for MS, I would argue that it's really important to try to expand on this idea of which MS-specific outcomes are meaningful to our patients, and then try to link them to reimbursement. One of the things that we do at the University of Pittsburgh Medical Center (UPMC) is survey our stakeholders, and we ask what outcomes are important, using the Delphi method. Our most important stakeholder, of course, is our patient. But we also survey the physicians who care for these patients, other clinicians who care for these patients, our pharmacists, pharmacy benefit managers, our industry partners, and sometimes other stakeholders such as employers.

Sometimes, the things that are important to the patients are easily measured. It may be that patients with heart disease don't want to have another heart attack, and typically with a heart attack you end up going into the hospital. In the case of other disease states, however, it may be that what's most important to our patients differs from what we think is most important. We don't make any assumptions. We measure what our patients tell us.

In the case of MS, before we entered into a value-based contract, we did a Delphi survey including patients, physicians, industry partners, payers, and our pharmacy benefits manager.² We did several rounds of surveys, and in the second round we had our stakeholders rank outcomes. What we found was that the most important outcome was “worsening physical disability.” One hundred percent of our stakeholders—not just our patients, but everyone—ranked worsening physical disability as important.

I would've thought that patients would've said, “Well, I don't want an MS flare.” And we could argue that MS flares may result in worsening physical disability, but not always. When we asked what would be the easiest thing to measure, of course MS flares are the easiest thing, because they require an emergency department visit or use of corticosteroids or hospitalization.

Based on our survey, we picked disability progression as our outcome of interest and the basis for our value-based contract. We entered into a contract with Biogen for a couple of their drugs, dimethyl fumarate (Tecfidera) and interferon beta-1a (Avonex), 2 very important MS drugs. This is a classic patient-reported outcome, and of course that poses a lot of interesting challenges about how you actually measure it. So, we had to work with our subject matter experts in the clinics to identify and externally validate a patient-reported outcome that measured disability progression. We worked very hard so that we’re able to collect that in a way that doesn’t inconvenience our physicians or our patients.

There are other tools that can be used, one of which is the PROMIS tool developed through the National Institutes of Health (NIH). That's a way to quantify changes in patient-reported outcomes. The interesting thing is NIH specifically developed this tool with certain disease states in mind, one of which was MS. So, some of the PROMIS domains include pain, fatigue, physical functioning, emotional distress, cognitive functioning, and social functioning. And all these things could be very important to our MS patients.

We actually do use PROMIS measures and PROMIS questionnaires routinely with our patients who come to our neurology clinic. It's not part of our value-based contracts at this point, but it's something that is a potentially interesting way to measure patient-reported outcomes.

What are the key challenges to implementing a value-based contract?

CHESTER GOOD, MD, MPH: Value-based contracting has been far more laborious than I ever imagined. These are legal documents that are very long and complex, and quite daunting. We've tried our best to incorporate figures and diagrams to simplify issues and ensure that we all are understanding things similarly. But at the end of the day, despite our best efforts, these contracts remain very complex, and questions and unexpected situations develop as we implement them. So, that's been one of the challenges.

The pandemic has also posed some challenges. It has affected everything. That includes fewer patient clinic encounters, which is a challenge when some of our value-based contracts require vital signs, lab work, or other things dependent on patient visits. There are also fewer patients presenting with disease states. It’s been well documented that hospitalizations and patient visits to the emergency departments for various conditions have really plummeted in the face of the coronavirus. So, the pandemic is a clear confounder as we try to identify the value of these pharmaceuticals and how they've impacted care. That's been a huge challenge for us.

Another thing to mention is that we’ve tried to be very innovative in our value-based outcomes. But it's been very challenging to do the analyses. What seems to be clear in a contract may not be clear once you start to analyze things, as there are all sorts of scenarios that one cannot anticipate. That has required going back and forth with our industry partners. Fortunately, we have good working relationships with them, and we've been able to work out those wrinkles; but that's been a challenge.

I mentioned the importance of patient-reported outcomes, but they are a challenge to measure. How do you collect patient-reported outcomes in a way that does not pose a burden on our patients or clinicians?

Finally, a significant challenge for health care organizations and insurers that hope to do value-based contracting is that drug companies do not typically  place a lot of risk on the table. While we've been very pleased with our value-based contracts thus far, in the future we hope to see greater risk in these contracts, especially for areas such as gene therapy.

What are the next steps in value-based contracting for MS?

CHESTER GOOD, MD, MPH: Multiple sclerosis can be a progressive disease, and it's over a lifetime. It can affect people's quality of life. It can affect their ability to work. It can affect the quality of their work and what sort of things that they can do.

Because MS can affect every aspect of life, it's not enough to simply measure things like disease flares or MRI lesions. Rather, we need to figure out ways to understand how these drugs impact our patients’ day-to-day lives, the quality of their lives, and their ability to function as normally as possible. I think these other patient-reported outcomes would represent important next steps in MS outcomes measurement. Our current value-based contract has 1 simple, albeit very important, outcome that we're looking at, but are there other ways to measure patients’ quality of life? Perhaps this will involve using PROMIS measures or  other innovative ways to measure patient outcomes. We’ve discussed with some patient interest groups how to incorporate other measures that are very important to our patients.

From a payer perspective, it may not show up in terms of impacting total cost of care. Depending on the disease states, oftentimes if things progress slowly over years, it is difficult to demonstrate an impact. But it's not all only about decreasing our costs because we decrease hospitalizations; it’s also about improving the quality of our patients’ lives.

The next step for us at UPMC is to continue to gather our data and to analyze our outcomes. And based on that, we're hoping to expand our portfolio of drugs for the MS disease state and expand outcomes that we're measuring.

Chester Good, MD, MPH, is professor of medicine and pharmacy, University of Pittsburgh School of Medicine and School of Pharmacy. He is also the senior medical director, UPMC Health Plan Insurance Division, as well as the director for the Center for Value-Based Pharmacy Initiatives.
 

What are the potential benefits of value-based contracting for patients with multiple sclerosis, as well as for health systems and payers?

CHESTER GOOD, MD, MPH: I think for all 3, value-based contracting really is about moving from volume to value. And in doing so, what we're trying to do is recognize the value of pharmaceuticals perhaps in ways that we previously have not.

Patients with conditions such as multiple sclerosis (MS) want to be able to live their lives where they can continue to work, maintain their activities of daily living, and maintain their quality of life. Value-based contracting ideally recognizes those patient values and leverages contracting of pharmaceuticals that have been shown to help maintain those qualities in patients. For health systems, our greatest duty is to our patients in terms of maintaining their quality of life, maintaining their health, and preventing disease progression. By developing value-based contracts in which we recognize these measurable outcomes, we're showing a commitment to our patients and trying to hopefully establish the value of our pharmacy benefit.

For most health plans and payers, MS especially has become an increasingly expensive disease, with MS-related medications representing a significant cost burden. It's no secret that MS drugs have gone up significantly in recent years.

In a paper published in JAMA Neurology,¹ we looked at the costs of these self-administered disease-modifying therapies for MS. From 2006 to 2016, the costs more than quadrupled, from a mean of $18,660 a year to more than $75,000, which means they increased at an annual rate of almost 13%. For payers, pharmaceutical spending per 1000 beneficiaries increased tenfold; and out-of-pocket expenses to our patients also increased significantly.

So, that's the reality. But the other reality is that there have been significant advancements in the treatment of MS using pharmaceuticals. And some of these newer treatments are more effective. Moreover, some are easier to take than some of the older therapies, and some are better tolerated from a patient perspective.

As a result of dramatic increase in costs of MS drugs, payers are asking about what they are getting in return for all these dramatic increases in costs. One of the ways to demonstrate that value is to link paying for these drugs with a value-based contract.

Why is a disease such as MS a good fit for value-based contracting?

CHESTER GOOD, MD, MPH: MS is a fairly prevalent disease. Fortunately, pharmacotherapy has gotten better over the years, to the point where it's clear that the pharmacotherapy of MS has really changed the course of the disease for our patients, allowing them to maintain their quality of life and functional abilities.

On a personal level, I had a family member growing up who had MS. And she did not have the benefits of the newer drugs. And through my childhood and early adulthood, I watched as she went from a very productive working person to someone who could no longer work, was unable to take care of her children, and was institutionalized and eventually died from complications of MS. That would be unusual today.

In a value-based contract, what MS outcomes are linked to reimbursement, and how are they measured?

CHESTER GOOD, MD, MPH: Traditionally, outcomes-based agreements focused on things that would be easily measured through administrative data. These are things that either a drug manufacturer or insurer, or both, have identified as being what they think are important outcomes for that disease state, but also things that they think they would be able to measure. Oftentimes, these were intermediate outcomes. Did the patient remain on a drug? Were they adherent? What was the impact on hemoglobin A1c in patients with diabetes? Although these outcomes may be important, they  may not be as important to our patients.

So for MS, I would argue that it's really important to try to expand on this idea of which MS-specific outcomes are meaningful to our patients, and then try to link them to reimbursement. One of the things that we do at the University of Pittsburgh Medical Center (UPMC) is survey our stakeholders, and we ask what outcomes are important, using the Delphi method. Our most important stakeholder, of course, is our patient. But we also survey the physicians who care for these patients, other clinicians who care for these patients, our pharmacists, pharmacy benefit managers, our industry partners, and sometimes other stakeholders such as employers.

Sometimes, the things that are important to the patients are easily measured. It may be that patients with heart disease don't want to have another heart attack, and typically with a heart attack you end up going into the hospital. In the case of other disease states, however, it may be that what's most important to our patients differs from what we think is most important. We don't make any assumptions. We measure what our patients tell us.

In the case of MS, before we entered into a value-based contract, we did a Delphi survey including patients, physicians, industry partners, payers, and our pharmacy benefits manager.² We did several rounds of surveys, and in the second round we had our stakeholders rank outcomes. What we found was that the most important outcome was “worsening physical disability.” One hundred percent of our stakeholders—not just our patients, but everyone—ranked worsening physical disability as important.

I would've thought that patients would've said, “Well, I don't want an MS flare.” And we could argue that MS flares may result in worsening physical disability, but not always. When we asked what would be the easiest thing to measure, of course MS flares are the easiest thing, because they require an emergency department visit or use of corticosteroids or hospitalization.

Based on our survey, we picked disability progression as our outcome of interest and the basis for our value-based contract. We entered into a contract with Biogen for a couple of their drugs, dimethyl fumarate (Tecfidera) and interferon beta-1a (Avonex), 2 very important MS drugs. This is a classic patient-reported outcome, and of course that poses a lot of interesting challenges about how you actually measure it. So, we had to work with our subject matter experts in the clinics to identify and externally validate a patient-reported outcome that measured disability progression. We worked very hard so that we’re able to collect that in a way that doesn’t inconvenience our physicians or our patients.

There are other tools that can be used, one of which is the PROMIS tool developed through the National Institutes of Health (NIH). That's a way to quantify changes in patient-reported outcomes. The interesting thing is NIH specifically developed this tool with certain disease states in mind, one of which was MS. So, some of the PROMIS domains include pain, fatigue, physical functioning, emotional distress, cognitive functioning, and social functioning. And all these things could be very important to our MS patients.

We actually do use PROMIS measures and PROMIS questionnaires routinely with our patients who come to our neurology clinic. It's not part of our value-based contracts at this point, but it's something that is a potentially interesting way to measure patient-reported outcomes.

What are the key challenges to implementing a value-based contract?

CHESTER GOOD, MD, MPH: Value-based contracting has been far more laborious than I ever imagined. These are legal documents that are very long and complex, and quite daunting. We've tried our best to incorporate figures and diagrams to simplify issues and ensure that we all are understanding things similarly. But at the end of the day, despite our best efforts, these contracts remain very complex, and questions and unexpected situations develop as we implement them. So, that's been one of the challenges.

The pandemic has also posed some challenges. It has affected everything. That includes fewer patient clinic encounters, which is a challenge when some of our value-based contracts require vital signs, lab work, or other things dependent on patient visits. There are also fewer patients presenting with disease states. It’s been well documented that hospitalizations and patient visits to the emergency departments for various conditions have really plummeted in the face of the coronavirus. So, the pandemic is a clear confounder as we try to identify the value of these pharmaceuticals and how they've impacted care. That's been a huge challenge for us.

Another thing to mention is that we’ve tried to be very innovative in our value-based outcomes. But it's been very challenging to do the analyses. What seems to be clear in a contract may not be clear once you start to analyze things, as there are all sorts of scenarios that one cannot anticipate. That has required going back and forth with our industry partners. Fortunately, we have good working relationships with them, and we've been able to work out those wrinkles; but that's been a challenge.

I mentioned the importance of patient-reported outcomes, but they are a challenge to measure. How do you collect patient-reported outcomes in a way that does not pose a burden on our patients or clinicians?

Finally, a significant challenge for health care organizations and insurers that hope to do value-based contracting is that drug companies do not typically  place a lot of risk on the table. While we've been very pleased with our value-based contracts thus far, in the future we hope to see greater risk in these contracts, especially for areas such as gene therapy.

What are the next steps in value-based contracting for MS?

CHESTER GOOD, MD, MPH: Multiple sclerosis can be a progressive disease, and it's over a lifetime. It can affect people's quality of life. It can affect their ability to work. It can affect the quality of their work and what sort of things that they can do.

Because MS can affect every aspect of life, it's not enough to simply measure things like disease flares or MRI lesions. Rather, we need to figure out ways to understand how these drugs impact our patients’ day-to-day lives, the quality of their lives, and their ability to function as normally as possible. I think these other patient-reported outcomes would represent important next steps in MS outcomes measurement. Our current value-based contract has 1 simple, albeit very important, outcome that we're looking at, but are there other ways to measure patients’ quality of life? Perhaps this will involve using PROMIS measures or  other innovative ways to measure patient outcomes. We’ve discussed with some patient interest groups how to incorporate other measures that are very important to our patients.

From a payer perspective, it may not show up in terms of impacting total cost of care. Depending on the disease states, oftentimes if things progress slowly over years, it is difficult to demonstrate an impact. But it's not all only about decreasing our costs because we decrease hospitalizations; it’s also about improving the quality of our patients’ lives.

The next step for us at UPMC is to continue to gather our data and to analyze our outcomes. And based on that, we're hoping to expand our portfolio of drugs for the MS disease state and expand outcomes that we're measuring.

Chester Good, MD, MPH, is professor of medicine and pharmacy, University of Pittsburgh School of Medicine and School of Pharmacy. He is also the senior medical director, UPMC Health Plan Insurance Division, as well as the director for the Center for Value-Based Pharmacy Initiatives.
 

What are the potential benefits of value-based contracting for patients with multiple sclerosis, as well as for health systems and payers?

CHESTER GOOD, MD, MPH: I think for all 3, value-based contracting really is about moving from volume to value. And in doing so, what we're trying to do is recognize the value of pharmaceuticals perhaps in ways that we previously have not.

Patients with conditions such as multiple sclerosis (MS) want to be able to live their lives where they can continue to work, maintain their activities of daily living, and maintain their quality of life. Value-based contracting ideally recognizes those patient values and leverages contracting of pharmaceuticals that have been shown to help maintain those qualities in patients. For health systems, our greatest duty is to our patients in terms of maintaining their quality of life, maintaining their health, and preventing disease progression. By developing value-based contracts in which we recognize these measurable outcomes, we're showing a commitment to our patients and trying to hopefully establish the value of our pharmacy benefit.

For most health plans and payers, MS especially has become an increasingly expensive disease, with MS-related medications representing a significant cost burden. It's no secret that MS drugs have gone up significantly in recent years.

In a paper published in JAMA Neurology,¹ we looked at the costs of these self-administered disease-modifying therapies for MS. From 2006 to 2016, the costs more than quadrupled, from a mean of $18,660 a year to more than $75,000, which means they increased at an annual rate of almost 13%. For payers, pharmaceutical spending per 1000 beneficiaries increased tenfold; and out-of-pocket expenses to our patients also increased significantly.

So, that's the reality. But the other reality is that there have been significant advancements in the treatment of MS using pharmaceuticals. And some of these newer treatments are more effective. Moreover, some are easier to take than some of the older therapies, and some are better tolerated from a patient perspective.

As a result of dramatic increase in costs of MS drugs, payers are asking about what they are getting in return for all these dramatic increases in costs. One of the ways to demonstrate that value is to link paying for these drugs with a value-based contract.

Why is a disease such as MS a good fit for value-based contracting?

CHESTER GOOD, MD, MPH: MS is a fairly prevalent disease. Fortunately, pharmacotherapy has gotten better over the years, to the point where it's clear that the pharmacotherapy of MS has really changed the course of the disease for our patients, allowing them to maintain their quality of life and functional abilities.

On a personal level, I had a family member growing up who had MS. And she did not have the benefits of the newer drugs. And through my childhood and early adulthood, I watched as she went from a very productive working person to someone who could no longer work, was unable to take care of her children, and was institutionalized and eventually died from complications of MS. That would be unusual today.

In a value-based contract, what MS outcomes are linked to reimbursement, and how are they measured?

CHESTER GOOD, MD, MPH: Traditionally, outcomes-based agreements focused on things that would be easily measured through administrative data. These are things that either a drug manufacturer or insurer, or both, have identified as being what they think are important outcomes for that disease state, but also things that they think they would be able to measure. Oftentimes, these were intermediate outcomes. Did the patient remain on a drug? Were they adherent? What was the impact on hemoglobin A1c in patients with diabetes? Although these outcomes may be important, they  may not be as important to our patients.

So for MS, I would argue that it's really important to try to expand on this idea of which MS-specific outcomes are meaningful to our patients, and then try to link them to reimbursement. One of the things that we do at the University of Pittsburgh Medical Center (UPMC) is survey our stakeholders, and we ask what outcomes are important, using the Delphi method. Our most important stakeholder, of course, is our patient. But we also survey the physicians who care for these patients, other clinicians who care for these patients, our pharmacists, pharmacy benefit managers, our industry partners, and sometimes other stakeholders such as employers.

Sometimes, the things that are important to the patients are easily measured. It may be that patients with heart disease don't want to have another heart attack, and typically with a heart attack you end up going into the hospital. In the case of other disease states, however, it may be that what's most important to our patients differs from what we think is most important. We don't make any assumptions. We measure what our patients tell us.

In the case of MS, before we entered into a value-based contract, we did a Delphi survey including patients, physicians, industry partners, payers, and our pharmacy benefits manager.² We did several rounds of surveys, and in the second round we had our stakeholders rank outcomes. What we found was that the most important outcome was “worsening physical disability.” One hundred percent of our stakeholders—not just our patients, but everyone—ranked worsening physical disability as important.

I would've thought that patients would've said, “Well, I don't want an MS flare.” And we could argue that MS flares may result in worsening physical disability, but not always. When we asked what would be the easiest thing to measure, of course MS flares are the easiest thing, because they require an emergency department visit or use of corticosteroids or hospitalization.

Based on our survey, we picked disability progression as our outcome of interest and the basis for our value-based contract. We entered into a contract with Biogen for a couple of their drugs, dimethyl fumarate (Tecfidera) and interferon beta-1a (Avonex), 2 very important MS drugs. This is a classic patient-reported outcome, and of course that poses a lot of interesting challenges about how you actually measure it. So, we had to work with our subject matter experts in the clinics to identify and externally validate a patient-reported outcome that measured disability progression. We worked very hard so that we’re able to collect that in a way that doesn’t inconvenience our physicians or our patients.

There are other tools that can be used, one of which is the PROMIS tool developed through the National Institutes of Health (NIH). That's a way to quantify changes in patient-reported outcomes. The interesting thing is NIH specifically developed this tool with certain disease states in mind, one of which was MS. So, some of the PROMIS domains include pain, fatigue, physical functioning, emotional distress, cognitive functioning, and social functioning. And all these things could be very important to our MS patients.

We actually do use PROMIS measures and PROMIS questionnaires routinely with our patients who come to our neurology clinic. It's not part of our value-based contracts at this point, but it's something that is a potentially interesting way to measure patient-reported outcomes.

What are the key challenges to implementing a value-based contract?

CHESTER GOOD, MD, MPH: Value-based contracting has been far more laborious than I ever imagined. These are legal documents that are very long and complex, and quite daunting. We've tried our best to incorporate figures and diagrams to simplify issues and ensure that we all are understanding things similarly. But at the end of the day, despite our best efforts, these contracts remain very complex, and questions and unexpected situations develop as we implement them. So, that's been one of the challenges.

The pandemic has also posed some challenges. It has affected everything. That includes fewer patient clinic encounters, which is a challenge when some of our value-based contracts require vital signs, lab work, or other things dependent on patient visits. There are also fewer patients presenting with disease states. It’s been well documented that hospitalizations and patient visits to the emergency departments for various conditions have really plummeted in the face of the coronavirus. So, the pandemic is a clear confounder as we try to identify the value of these pharmaceuticals and how they've impacted care. That's been a huge challenge for us.

Another thing to mention is that we’ve tried to be very innovative in our value-based outcomes. But it's been very challenging to do the analyses. What seems to be clear in a contract may not be clear once you start to analyze things, as there are all sorts of scenarios that one cannot anticipate. That has required going back and forth with our industry partners. Fortunately, we have good working relationships with them, and we've been able to work out those wrinkles; but that's been a challenge.

I mentioned the importance of patient-reported outcomes, but they are a challenge to measure. How do you collect patient-reported outcomes in a way that does not pose a burden on our patients or clinicians?

Finally, a significant challenge for health care organizations and insurers that hope to do value-based contracting is that drug companies do not typically  place a lot of risk on the table. While we've been very pleased with our value-based contracts thus far, in the future we hope to see greater risk in these contracts, especially for areas such as gene therapy.

What are the next steps in value-based contracting for MS?

CHESTER GOOD, MD, MPH: Multiple sclerosis can be a progressive disease, and it's over a lifetime. It can affect people's quality of life. It can affect their ability to work. It can affect the quality of their work and what sort of things that they can do.

Because MS can affect every aspect of life, it's not enough to simply measure things like disease flares or MRI lesions. Rather, we need to figure out ways to understand how these drugs impact our patients’ day-to-day lives, the quality of their lives, and their ability to function as normally as possible. I think these other patient-reported outcomes would represent important next steps in MS outcomes measurement. Our current value-based contract has 1 simple, albeit very important, outcome that we're looking at, but are there other ways to measure patients’ quality of life? Perhaps this will involve using PROMIS measures or  other innovative ways to measure patient outcomes. We’ve discussed with some patient interest groups how to incorporate other measures that are very important to our patients.

From a payer perspective, it may not show up in terms of impacting total cost of care. Depending on the disease states, oftentimes if things progress slowly over years, it is difficult to demonstrate an impact. But it's not all only about decreasing our costs because we decrease hospitalizations; it’s also about improving the quality of our patients’ lives.

The next step for us at UPMC is to continue to gather our data and to analyze our outcomes. And based on that, we're hoping to expand our portfolio of drugs for the MS disease state and expand outcomes that we're measuring.

Over the past months, society has reflected on the role of law enforcement. The shocking murder of George Floyd has forced Americans to reconsider the place of police officers in maintaining order.

The death of Mr. Floyd is certainly not a lone incident; in 2019, 1,098 people were killed by those tasked with protecting us.¹ The United States holds 25% of the world’s incarcerated, though it makes up only 5% of the world’s population.² Society is demanding a newer and better system.

The phrase “defund the police” can easily be dismissed because, to many, it implies an appeal to lawlessness. While we certainly cannot speak for any one protester, we think that many of the necessary changes are painfully obvious.³ Society wants law enforcement where force is not the default position but the last option. Society wants law enforcement where verbal conflict resolution is the primary focus of training and intervention. Society wants a correctional system that is more rehabilitative than it is punitive.⁴

Major U.S. cities spend up to 40% of their funds on police budgeting, much more than what is dedicated to community resources and infrastructure. This trend continues to increase between 1986 and 2013, state spending for correctional facilities increased by 141%.⁵ Yet, as psychiatrists, we are well aware that social determinants are a strong factor in future criminality.⁶ Increasing police budgets without addressing structural root causes and risk factors for future asocial behavior is not a wise approach to reducing unlawful behavior. Investing more into programs and policies that reduce these risks is essential.

Using the adverse childhood experiences (ACE) questionnaires, researchers have supported the idea that social programs are a key player in an improved criminal system. The ACE study identified 10 forms of childhood trauma in 17,000 patients, including abuse, neglect, abandonment, household dysfunction, and exposure to violence, that were strongly associated with negative psychological outcomes, engagement in high-risk behaviors, significant medical consequences, and even early death.⁷ More recent research has shown that those ACEs were four times more prevalent in a criminal offender group than in the general population.⁸ Psychiatry is in a unique position to address and provide education about ACEs as a tool to identify and help at-risk youths.

Many protesters have asked for mental health providers to have a primary role in this societal reflection and in providing a solution.⁹ This makes particular sense when considering that almost 20% of calls to law enforcement are for persons with impaired judgment from mental illness or intoxication, and one in four patients with mental illness has been arrested.^10,11 We are humbled by this public trust and request. We believe psychiatry can provide many answers to this societal angst. After all, psychiatry is a specialty dedicated to addressing behavioral problems in an evidence-based way.

Yet, we should not forget psychiatry’s imperfect past and our own role in the creation of this system. While this article does not attempt to catalog psychiatry’s faults, one can start by recognizing that mass incarceration is partly a response to how poorly human beings were treated in asylums. Psychiatry was at one time a main enforcer of societal disenfranchisement. After most asylums were closed in 1963 with the Community Mental Health Act, correctional facilities became the largest purveyors of mental health care, often with damaging results.¹² If psychiatry were to advocate for the reestablishment of asylums as a solution, we fear that psychiatry would have missed the point. We wonder whether the psychiatrists who have railed against deinstitutionalization since the 1970s do not realize that violence, unethical experimentation, and even racism were at times attributes of asylums.¹³

Psychiatry can and should be much more than what it once was. Instead of indirectly and inaccurately suggesting that our patients commit mass murders, we should improve research in the field of violence risk assessment and management. As many have already pointed out, violence risk assessment is permeated with overestimation of its potential and, more concerningly, tainted by evidence of implicit racism.¹⁴ Implicit racism extends to rights-limiting treatments as well. As previously studied, involuntary outpatient programs often referred to as assisted outpatient treatment are disproportionately levied on Black Americans.¹⁵ Instead of routinely seeking to expand abilities to involuntary treat and limit the rights of our patients, we should strive to be a violence-free alternative to law enforcement, not the medical version of police.

Psychiatrists should start actively training, practicing, and researching how to address nonviolent emergency calls. Training should include more robust deescalation training, techniques on the evaluation of patients outside of health care facilities (for example, the street), and a broadening of interventions to include proficiency in the treatment of subclinical populations seeking emergency care without the need to be formally labeled with a psychiatric disorder. Ride-alongs with police officers, volunteering at crisis hotlines, and home calls should not be volunteer or elective experiences for psychiatrists but a required part of training.

Thankfully, some local jurisdictions already have started promising practices that merit replication or at least academic review. Austin, Tex., recently implemented the capability of requesting mental health emergency calls when contacting 911.¹⁷ Eugene, Ore., has had the CAHOOTS (Crisis Assistance Helping Out On The Streets) program since 1989, where a medical provider and a mental health provider respond to calls without any law enforcement officers.¹⁸ Our own San Diego County has an innovative PERT (Psychiatric Emergency Response Team) program, which partners a mental health provider to a police patrol, allowing an ability to quickly provide different types of services.¹⁹ Programs like these show us what is possible. At this time, there is little research to evaluate many programs’ effectiveness.²⁰ Psychiatry should seize this moment to be at the forefront of studying, then educating the public on what works and how to reproduce it.

Police officers have a difficult profession. They are tasked with preventing and predicting crime, often to the point of risking their own lives. Historically, police have been the first call to handle issues for which they are not equipped, ranging from fixing homelessness to arresting violent people using nonviolent means. The idea that police should be able to protect us in all situations has been mistakenly ingrained in our minds. Officers themselves do not feel adequately trained to handle mental health crises.²¹ “Defund the police” also means a recognition by governments, the public, and police themselves that officers should not be on the front lines for every emergency situation. We must diversify our first responders. Psychiatry should hear this call and be ready.

Since the death of Mr. Floyd, mental health professionals have attempted to voice empathy and warmth to those feeling left out and disenfranchised. Mental health professionals have voiced a desire to educate themselves on systemic biases and antiracism. However, we argue that psychiatry is not and has never been a bystander to the societal debate on the management of different and criminal behavior. While it may be enough for many fields to express sympathy from the sidelines, psychiatry has been and continues to be an active player in the disenfranchisement of minority populations in the criminal justice system. Society appears to be offering us a chance at repairing our past and helping the future. Let’s take it with honor and humility.
 

References

1. Collins S. Police killings can be captured in data. The terror police create cannot. Vox.com. 2020 Jun 19.

2. Lee MYH. Yes, U.S. locks people up at a higher rate than any other country. The Washington Post. 2015 Jul 7.

3. McDowell MG, Fernandez LA. Critical Criminology. 2018;26(3):373-91.

4. Thielo AJ et al. Criminology & Public Policy. 2016;15(1):137-70.

5. The Center for Popular Democracy. Freedom to Thrive.

6. Hipp JR. Criminology. 2007;45(3):665-97.

7. Felitti VJ et al. Am J Prev Med. 1998;14(4):245-58.

8. Reavis JA. Perm J. 2013 Spring;17(2):44-8.

9. McHarris PV, McHarris T. No more money for the police. The New York Times. 2020 May 20.

10. Kaminski RJ et al. Police Quarterly. 2004;7(3):311-38.

11. Livington JD. Psychiatr Serv. 2016 Aug 1;67(8):850-7.

12. Galanek JD. Cult Med Psychiatry. 2013 Mar;37(1):195-225.

13. Raz M. Nature. Book Review. 2020 Apr 21.

14. Dressel J, Farid H. Sci Adv. 2018 J 17;4(1):eaao5580.

15. Swartz MS et al. New York State assisted outpatient treatment program evaluation. 2009 Jun 30.

16. Barnes SS and Badre N. Psychiatr Serv. 2016 Jul 1;67(7):784-6.

17. Fox A. Austin budget adds millions for mental health response in 911 services. efficientgov.com. 2019 Sep 13.

18. Elinson Z. When mental health experts, not police, are the first responders. The Wall Street Journal. 2018 Nov 14.

19. Improved responses in psychiatric crises: The Psychiatric Emergency Response Team.

20. Kane E et al. Crim Behav Ment Health. 2018 Apr;28(2):108-19.

21. Wells W, Schafer JA. Officer perceptions of police responses to persons with a mental illness, in “Policing: An International Journal of Police Strategies & Management,” 2006 Oct;29(4):578-61.

Dr. Malik is a first-year psychiatry resident at the University of California, San Diego. She has a background in policy and grassroots organizing through her time working at the National Coalition for the Homeless and the Women’s Law Project. Dr. Malik has no disclosures.

Dr. Amendolara is a first-year psychiatry resident at University of California, San Diego. He spent years advocating for survivors of rape and domestic violence at the Crime Victims Treatment Center in New York and conducted public health research at Lourdes Center for Public Health in Camden, N.J. Dr. Amendolara has no disclosures.

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Among his writings is chapter 7 in the book “Critical Psychiatry: Controversies and Clinical Implications” (Cham, Switzerland: Springer, 2019). He has no disclosures.

Over the past months, society has reflected on the role of law enforcement. The shocking murder of George Floyd has forced Americans to reconsider the place of police officers in maintaining order.

The death of Mr. Floyd is certainly not a lone incident; in 2019, 1,098 people were killed by those tasked with protecting us.¹ The United States holds 25% of the world’s incarcerated, though it makes up only 5% of the world’s population.² Society is demanding a newer and better system.

The phrase “defund the police” can easily be dismissed because, to many, it implies an appeal to lawlessness. While we certainly cannot speak for any one protester, we think that many of the necessary changes are painfully obvious.³ Society wants law enforcement where force is not the default position but the last option. Society wants law enforcement where verbal conflict resolution is the primary focus of training and intervention. Society wants a correctional system that is more rehabilitative than it is punitive.⁴

Major U.S. cities spend up to 40% of their funds on police budgeting, much more than what is dedicated to community resources and infrastructure. This trend continues to increase between 1986 and 2013, state spending for correctional facilities increased by 141%.⁵ Yet, as psychiatrists, we are well aware that social determinants are a strong factor in future criminality.⁶ Increasing police budgets without addressing structural root causes and risk factors for future asocial behavior is not a wise approach to reducing unlawful behavior. Investing more into programs and policies that reduce these risks is essential.

Using the adverse childhood experiences (ACE) questionnaires, researchers have supported the idea that social programs are a key player in an improved criminal system. The ACE study identified 10 forms of childhood trauma in 17,000 patients, including abuse, neglect, abandonment, household dysfunction, and exposure to violence, that were strongly associated with negative psychological outcomes, engagement in high-risk behaviors, significant medical consequences, and even early death.⁷ More recent research has shown that those ACEs were four times more prevalent in a criminal offender group than in the general population.⁸ Psychiatry is in a unique position to address and provide education about ACEs as a tool to identify and help at-risk youths.

Many protesters have asked for mental health providers to have a primary role in this societal reflection and in providing a solution.⁹ This makes particular sense when considering that almost 20% of calls to law enforcement are for persons with impaired judgment from mental illness or intoxication, and one in four patients with mental illness has been arrested.^10,11 We are humbled by this public trust and request. We believe psychiatry can provide many answers to this societal angst. After all, psychiatry is a specialty dedicated to addressing behavioral problems in an evidence-based way.

Yet, we should not forget psychiatry’s imperfect past and our own role in the creation of this system. While this article does not attempt to catalog psychiatry’s faults, one can start by recognizing that mass incarceration is partly a response to how poorly human beings were treated in asylums. Psychiatry was at one time a main enforcer of societal disenfranchisement. After most asylums were closed in 1963 with the Community Mental Health Act, correctional facilities became the largest purveyors of mental health care, often with damaging results.¹² If psychiatry were to advocate for the reestablishment of asylums as a solution, we fear that psychiatry would have missed the point. We wonder whether the psychiatrists who have railed against deinstitutionalization since the 1970s do not realize that violence, unethical experimentation, and even racism were at times attributes of asylums.¹³

Psychiatry can and should be much more than what it once was. Instead of indirectly and inaccurately suggesting that our patients commit mass murders, we should improve research in the field of violence risk assessment and management. As many have already pointed out, violence risk assessment is permeated with overestimation of its potential and, more concerningly, tainted by evidence of implicit racism.¹⁴ Implicit racism extends to rights-limiting treatments as well. As previously studied, involuntary outpatient programs often referred to as assisted outpatient treatment are disproportionately levied on Black Americans.¹⁵ Instead of routinely seeking to expand abilities to involuntary treat and limit the rights of our patients, we should strive to be a violence-free alternative to law enforcement, not the medical version of police.

Psychiatrists should start actively training, practicing, and researching how to address nonviolent emergency calls. Training should include more robust deescalation training, techniques on the evaluation of patients outside of health care facilities (for example, the street), and a broadening of interventions to include proficiency in the treatment of subclinical populations seeking emergency care without the need to be formally labeled with a psychiatric disorder. Ride-alongs with police officers, volunteering at crisis hotlines, and home calls should not be volunteer or elective experiences for psychiatrists but a required part of training.

Thankfully, some local jurisdictions already have started promising practices that merit replication or at least academic review. Austin, Tex., recently implemented the capability of requesting mental health emergency calls when contacting 911.¹⁷ Eugene, Ore., has had the CAHOOTS (Crisis Assistance Helping Out On The Streets) program since 1989, where a medical provider and a mental health provider respond to calls without any law enforcement officers.¹⁸ Our own San Diego County has an innovative PERT (Psychiatric Emergency Response Team) program, which partners a mental health provider to a police patrol, allowing an ability to quickly provide different types of services.¹⁹ Programs like these show us what is possible. At this time, there is little research to evaluate many programs’ effectiveness.²⁰ Psychiatry should seize this moment to be at the forefront of studying, then educating the public on what works and how to reproduce it.

Police officers have a difficult profession. They are tasked with preventing and predicting crime, often to the point of risking their own lives. Historically, police have been the first call to handle issues for which they are not equipped, ranging from fixing homelessness to arresting violent people using nonviolent means. The idea that police should be able to protect us in all situations has been mistakenly ingrained in our minds. Officers themselves do not feel adequately trained to handle mental health crises.²¹ “Defund the police” also means a recognition by governments, the public, and police themselves that officers should not be on the front lines for every emergency situation. We must diversify our first responders. Psychiatry should hear this call and be ready.

Since the death of Mr. Floyd, mental health professionals have attempted to voice empathy and warmth to those feeling left out and disenfranchised. Mental health professionals have voiced a desire to educate themselves on systemic biases and antiracism. However, we argue that psychiatry is not and has never been a bystander to the societal debate on the management of different and criminal behavior. While it may be enough for many fields to express sympathy from the sidelines, psychiatry has been and continues to be an active player in the disenfranchisement of minority populations in the criminal justice system. Society appears to be offering us a chance at repairing our past and helping the future. Let’s take it with honor and humility.
 

References

1. Collins S. Police killings can be captured in data. The terror police create cannot. Vox.com. 2020 Jun 19.

2. Lee MYH. Yes, U.S. locks people up at a higher rate than any other country. The Washington Post. 2015 Jul 7.

3. McDowell MG, Fernandez LA. Critical Criminology. 2018;26(3):373-91.

4. Thielo AJ et al. Criminology & Public Policy. 2016;15(1):137-70.

5. The Center for Popular Democracy. Freedom to Thrive.

6. Hipp JR. Criminology. 2007;45(3):665-97.

7. Felitti VJ et al. Am J Prev Med. 1998;14(4):245-58.

8. Reavis JA. Perm J. 2013 Spring;17(2):44-8.

9. McHarris PV, McHarris T. No more money for the police. The New York Times. 2020 May 20.

10. Kaminski RJ et al. Police Quarterly. 2004;7(3):311-38.

11. Livington JD. Psychiatr Serv. 2016 Aug 1;67(8):850-7.

12. Galanek JD. Cult Med Psychiatry. 2013 Mar;37(1):195-225.

13. Raz M. Nature. Book Review. 2020 Apr 21.

14. Dressel J, Farid H. Sci Adv. 2018 J 17;4(1):eaao5580.

15. Swartz MS et al. New York State assisted outpatient treatment program evaluation. 2009 Jun 30.

16. Barnes SS and Badre N. Psychiatr Serv. 2016 Jul 1;67(7):784-6.

17. Fox A. Austin budget adds millions for mental health response in 911 services. efficientgov.com. 2019 Sep 13.

18. Elinson Z. When mental health experts, not police, are the first responders. The Wall Street Journal. 2018 Nov 14.

19. Improved responses in psychiatric crises: The Psychiatric Emergency Response Team.

20. Kane E et al. Crim Behav Ment Health. 2018 Apr;28(2):108-19.

21. Wells W, Schafer JA. Officer perceptions of police responses to persons with a mental illness, in “Policing: An International Journal of Police Strategies & Management,” 2006 Oct;29(4):578-61.

Dr. Malik is a first-year psychiatry resident at the University of California, San Diego. She has a background in policy and grassroots organizing through her time working at the National Coalition for the Homeless and the Women’s Law Project. Dr. Malik has no disclosures.

Dr. Amendolara is a first-year psychiatry resident at University of California, San Diego. He spent years advocating for survivors of rape and domestic violence at the Crime Victims Treatment Center in New York and conducted public health research at Lourdes Center for Public Health in Camden, N.J. Dr. Amendolara has no disclosures.

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Among his writings is chapter 7 in the book “Critical Psychiatry: Controversies and Clinical Implications” (Cham, Switzerland: Springer, 2019). He has no disclosures.

Over the past months, society has reflected on the role of law enforcement. The shocking murder of George Floyd has forced Americans to reconsider the place of police officers in maintaining order.

The death of Mr. Floyd is certainly not a lone incident; in 2019, 1,098 people were killed by those tasked with protecting us.¹ The United States holds 25% of the world’s incarcerated, though it makes up only 5% of the world’s population.² Society is demanding a newer and better system.

The phrase “defund the police” can easily be dismissed because, to many, it implies an appeal to lawlessness. While we certainly cannot speak for any one protester, we think that many of the necessary changes are painfully obvious.³ Society wants law enforcement where force is not the default position but the last option. Society wants law enforcement where verbal conflict resolution is the primary focus of training and intervention. Society wants a correctional system that is more rehabilitative than it is punitive.⁴

Major U.S. cities spend up to 40% of their funds on police budgeting, much more than what is dedicated to community resources and infrastructure. This trend continues to increase between 1986 and 2013, state spending for correctional facilities increased by 141%.⁵ Yet, as psychiatrists, we are well aware that social determinants are a strong factor in future criminality.⁶ Increasing police budgets without addressing structural root causes and risk factors for future asocial behavior is not a wise approach to reducing unlawful behavior. Investing more into programs and policies that reduce these risks is essential.

Using the adverse childhood experiences (ACE) questionnaires, researchers have supported the idea that social programs are a key player in an improved criminal system. The ACE study identified 10 forms of childhood trauma in 17,000 patients, including abuse, neglect, abandonment, household dysfunction, and exposure to violence, that were strongly associated with negative psychological outcomes, engagement in high-risk behaviors, significant medical consequences, and even early death.⁷ More recent research has shown that those ACEs were four times more prevalent in a criminal offender group than in the general population.⁸ Psychiatry is in a unique position to address and provide education about ACEs as a tool to identify and help at-risk youths.

Many protesters have asked for mental health providers to have a primary role in this societal reflection and in providing a solution.⁹ This makes particular sense when considering that almost 20% of calls to law enforcement are for persons with impaired judgment from mental illness or intoxication, and one in four patients with mental illness has been arrested.^10,11 We are humbled by this public trust and request. We believe psychiatry can provide many answers to this societal angst. After all, psychiatry is a specialty dedicated to addressing behavioral problems in an evidence-based way.

Yet, we should not forget psychiatry’s imperfect past and our own role in the creation of this system. While this article does not attempt to catalog psychiatry’s faults, one can start by recognizing that mass incarceration is partly a response to how poorly human beings were treated in asylums. Psychiatry was at one time a main enforcer of societal disenfranchisement. After most asylums were closed in 1963 with the Community Mental Health Act, correctional facilities became the largest purveyors of mental health care, often with damaging results.¹² If psychiatry were to advocate for the reestablishment of asylums as a solution, we fear that psychiatry would have missed the point. We wonder whether the psychiatrists who have railed against deinstitutionalization since the 1970s do not realize that violence, unethical experimentation, and even racism were at times attributes of asylums.¹³

Psychiatry can and should be much more than what it once was. Instead of indirectly and inaccurately suggesting that our patients commit mass murders, we should improve research in the field of violence risk assessment and management. As many have already pointed out, violence risk assessment is permeated with overestimation of its potential and, more concerningly, tainted by evidence of implicit racism.¹⁴ Implicit racism extends to rights-limiting treatments as well. As previously studied, involuntary outpatient programs often referred to as assisted outpatient treatment are disproportionately levied on Black Americans.¹⁵ Instead of routinely seeking to expand abilities to involuntary treat and limit the rights of our patients, we should strive to be a violence-free alternative to law enforcement, not the medical version of police.

Psychiatrists should start actively training, practicing, and researching how to address nonviolent emergency calls. Training should include more robust deescalation training, techniques on the evaluation of patients outside of health care facilities (for example, the street), and a broadening of interventions to include proficiency in the treatment of subclinical populations seeking emergency care without the need to be formally labeled with a psychiatric disorder. Ride-alongs with police officers, volunteering at crisis hotlines, and home calls should not be volunteer or elective experiences for psychiatrists but a required part of training.

Thankfully, some local jurisdictions already have started promising practices that merit replication or at least academic review. Austin, Tex., recently implemented the capability of requesting mental health emergency calls when contacting 911.¹⁷ Eugene, Ore., has had the CAHOOTS (Crisis Assistance Helping Out On The Streets) program since 1989, where a medical provider and a mental health provider respond to calls without any law enforcement officers.¹⁸ Our own San Diego County has an innovative PERT (Psychiatric Emergency Response Team) program, which partners a mental health provider to a police patrol, allowing an ability to quickly provide different types of services.¹⁹ Programs like these show us what is possible. At this time, there is little research to evaluate many programs’ effectiveness.²⁰ Psychiatry should seize this moment to be at the forefront of studying, then educating the public on what works and how to reproduce it.

Police officers have a difficult profession. They are tasked with preventing and predicting crime, often to the point of risking their own lives. Historically, police have been the first call to handle issues for which they are not equipped, ranging from fixing homelessness to arresting violent people using nonviolent means. The idea that police should be able to protect us in all situations has been mistakenly ingrained in our minds. Officers themselves do not feel adequately trained to handle mental health crises.²¹ “Defund the police” also means a recognition by governments, the public, and police themselves that officers should not be on the front lines for every emergency situation. We must diversify our first responders. Psychiatry should hear this call and be ready.

Since the death of Mr. Floyd, mental health professionals have attempted to voice empathy and warmth to those feeling left out and disenfranchised. Mental health professionals have voiced a desire to educate themselves on systemic biases and antiracism. However, we argue that psychiatry is not and has never been a bystander to the societal debate on the management of different and criminal behavior. While it may be enough for many fields to express sympathy from the sidelines, psychiatry has been and continues to be an active player in the disenfranchisement of minority populations in the criminal justice system. Society appears to be offering us a chance at repairing our past and helping the future. Let’s take it with honor and humility.
 

References

1. Collins S. Police killings can be captured in data. The terror police create cannot. Vox.com. 2020 Jun 19.

2. Lee MYH. Yes, U.S. locks people up at a higher rate than any other country. The Washington Post. 2015 Jul 7.

3. McDowell MG, Fernandez LA. Critical Criminology. 2018;26(3):373-91.

4. Thielo AJ et al. Criminology & Public Policy. 2016;15(1):137-70.

5. The Center for Popular Democracy. Freedom to Thrive.

6. Hipp JR. Criminology. 2007;45(3):665-97.

7. Felitti VJ et al. Am J Prev Med. 1998;14(4):245-58.

8. Reavis JA. Perm J. 2013 Spring;17(2):44-8.

9. McHarris PV, McHarris T. No more money for the police. The New York Times. 2020 May 20.

10. Kaminski RJ et al. Police Quarterly. 2004;7(3):311-38.

11. Livington JD. Psychiatr Serv. 2016 Aug 1;67(8):850-7.

12. Galanek JD. Cult Med Psychiatry. 2013 Mar;37(1):195-225.

13. Raz M. Nature. Book Review. 2020 Apr 21.

14. Dressel J, Farid H. Sci Adv. 2018 J 17;4(1):eaao5580.

15. Swartz MS et al. New York State assisted outpatient treatment program evaluation. 2009 Jun 30.

16. Barnes SS and Badre N. Psychiatr Serv. 2016 Jul 1;67(7):784-6.

17. Fox A. Austin budget adds millions for mental health response in 911 services. efficientgov.com. 2019 Sep 13.

18. Elinson Z. When mental health experts, not police, are the first responders. The Wall Street Journal. 2018 Nov 14.

19. Improved responses in psychiatric crises: The Psychiatric Emergency Response Team.

20. Kane E et al. Crim Behav Ment Health. 2018 Apr;28(2):108-19.

21. Wells W, Schafer JA. Officer perceptions of police responses to persons with a mental illness, in “Policing: An International Journal of Police Strategies & Management,” 2006 Oct;29(4):578-61.

Dr. Malik is a first-year psychiatry resident at the University of California, San Diego. She has a background in policy and grassroots organizing through her time working at the National Coalition for the Homeless and the Women’s Law Project. Dr. Malik has no disclosures.

Dr. Amendolara is a first-year psychiatry resident at University of California, San Diego. He spent years advocating for survivors of rape and domestic violence at the Crime Victims Treatment Center in New York and conducted public health research at Lourdes Center for Public Health in Camden, N.J. Dr. Amendolara has no disclosures.

Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Among his writings is chapter 7 in the book “Critical Psychiatry: Controversies and Clinical Implications” (Cham, Switzerland: Springer, 2019). He has no disclosures.

Physicians have been slow to embrace biosimilar versions of infliximab, but are more likely to prescribe it to new patients, based on data from a review of nearly 50,000 infliximab claims through Medicare in the first 2 years that biosimilars were available in the United States.

“Although biosimilar versions are as safe and effective as the biologic, patients and physicians may be more reluctant to switch from a working biologic regimen in a chronic setting than an acute one,” wrote Alice J. Chen, PhD, of the University of Southern California, Los Angeles, and colleagues.

In a research letter published in JAMA Internal Medicine, the investigators examined prescribing patterns of physicians switching between the originator infliximab (Remicade) and two of its biosimilars (Inflectra and Renflexis).

They reviewed infliximab use and reimbursement in the 100% Medicare Part B quarterly claims database from Jan. 1, 2017, to Dec. 31, 2018. The study population included Medicare patients classified as new if they had no infliximab claims in the prior 6 months; those with claims were considered returning patients.

In a comparison of claims reflecting 49,771 patients and 4,289 physicians in 2018, a total of 1,418 new patients (17.4%) and 4,495 (10.8%) returning patients used a biosimilar. “Of returning patients, half used the biosimilar version exclusively, whereas the other half switched between biologic and biosimilar versions,” the researchers noted.

Of the 4,289 physicians who prescribed infliximab, 3,124 prescribed no biosimilars, 1,015 prescribed both biologics and biosimilars, and 150 prescribed biosimilars only. Of the physicians who prescribed both, approximately 61% switched some patients from the biologic to the biosimilar; “the remainder kept individual patients on only 1 version of the drug but treated patients with both versions,” the researchers wrote.

The adoption of biosimilars may be slower for chronic vs. acute conditions, the researchers noted. “Prescribers may hesitate to switch clinically stable chronic patients from biologic regimens if they are unfamiliar with the biosimilar or face financial disincentives from prescribing it.”

The study findings were limited by several factors including the use of only 2 years of data and a focus only on Medicare Part B. Switching medications may have been influenced by factors such as lower copays for patients and rebates or discounts for physicians; however, “further research is needed to better understand biosimilar pricing dynamics and the barriers to adopting biosimilars for chronic conditions,” they concluded.

The study was supported by the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California, Los Angeles, and the National Institute on Aging. Lead author Dr. Chen also disclosed receiving personal fees from Amgen outside of the current study.

SOURCE: Chen AJ et al. JAMA Intern Med. 2020 July 20. doi: 10.1001/jamainternmed.2020.3188.

Help your patients understand biologics and biosimilars by using AGA resources for providers and patients available at www.gastro.org/biosimilars.

Physicians have been slow to embrace biosimilar versions of infliximab, but are more likely to prescribe it to new patients, based on data from a review of nearly 50,000 infliximab claims through Medicare in the first 2 years that biosimilars were available in the United States.

“Although biosimilar versions are as safe and effective as the biologic, patients and physicians may be more reluctant to switch from a working biologic regimen in a chronic setting than an acute one,” wrote Alice J. Chen, PhD, of the University of Southern California, Los Angeles, and colleagues.

In a research letter published in JAMA Internal Medicine, the investigators examined prescribing patterns of physicians switching between the originator infliximab (Remicade) and two of its biosimilars (Inflectra and Renflexis).

They reviewed infliximab use and reimbursement in the 100% Medicare Part B quarterly claims database from Jan. 1, 2017, to Dec. 31, 2018. The study population included Medicare patients classified as new if they had no infliximab claims in the prior 6 months; those with claims were considered returning patients.

In a comparison of claims reflecting 49,771 patients and 4,289 physicians in 2018, a total of 1,418 new patients (17.4%) and 4,495 (10.8%) returning patients used a biosimilar. “Of returning patients, half used the biosimilar version exclusively, whereas the other half switched between biologic and biosimilar versions,” the researchers noted.

Of the 4,289 physicians who prescribed infliximab, 3,124 prescribed no biosimilars, 1,015 prescribed both biologics and biosimilars, and 150 prescribed biosimilars only. Of the physicians who prescribed both, approximately 61% switched some patients from the biologic to the biosimilar; “the remainder kept individual patients on only 1 version of the drug but treated patients with both versions,” the researchers wrote.

The adoption of biosimilars may be slower for chronic vs. acute conditions, the researchers noted. “Prescribers may hesitate to switch clinically stable chronic patients from biologic regimens if they are unfamiliar with the biosimilar or face financial disincentives from prescribing it.”

The study findings were limited by several factors including the use of only 2 years of data and a focus only on Medicare Part B. Switching medications may have been influenced by factors such as lower copays for patients and rebates or discounts for physicians; however, “further research is needed to better understand biosimilar pricing dynamics and the barriers to adopting biosimilars for chronic conditions,” they concluded.

The study was supported by the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California, Los Angeles, and the National Institute on Aging. Lead author Dr. Chen also disclosed receiving personal fees from Amgen outside of the current study.

SOURCE: Chen AJ et al. JAMA Intern Med. 2020 July 20. doi: 10.1001/jamainternmed.2020.3188.

Help your patients understand biologics and biosimilars by using AGA resources for providers and patients available at www.gastro.org/biosimilars.

Physicians have been slow to embrace biosimilar versions of infliximab, but are more likely to prescribe it to new patients, based on data from a review of nearly 50,000 infliximab claims through Medicare in the first 2 years that biosimilars were available in the United States.

“Although biosimilar versions are as safe and effective as the biologic, patients and physicians may be more reluctant to switch from a working biologic regimen in a chronic setting than an acute one,” wrote Alice J. Chen, PhD, of the University of Southern California, Los Angeles, and colleagues.

In a research letter published in JAMA Internal Medicine, the investigators examined prescribing patterns of physicians switching between the originator infliximab (Remicade) and two of its biosimilars (Inflectra and Renflexis).

They reviewed infliximab use and reimbursement in the 100% Medicare Part B quarterly claims database from Jan. 1, 2017, to Dec. 31, 2018. The study population included Medicare patients classified as new if they had no infliximab claims in the prior 6 months; those with claims were considered returning patients.

In a comparison of claims reflecting 49,771 patients and 4,289 physicians in 2018, a total of 1,418 new patients (17.4%) and 4,495 (10.8%) returning patients used a biosimilar. “Of returning patients, half used the biosimilar version exclusively, whereas the other half switched between biologic and biosimilar versions,” the researchers noted.

Of the 4,289 physicians who prescribed infliximab, 3,124 prescribed no biosimilars, 1,015 prescribed both biologics and biosimilars, and 150 prescribed biosimilars only. Of the physicians who prescribed both, approximately 61% switched some patients from the biologic to the biosimilar; “the remainder kept individual patients on only 1 version of the drug but treated patients with both versions,” the researchers wrote.

The adoption of biosimilars may be slower for chronic vs. acute conditions, the researchers noted. “Prescribers may hesitate to switch clinically stable chronic patients from biologic regimens if they are unfamiliar with the biosimilar or face financial disincentives from prescribing it.”

The study findings were limited by several factors including the use of only 2 years of data and a focus only on Medicare Part B. Switching medications may have been influenced by factors such as lower copays for patients and rebates or discounts for physicians; however, “further research is needed to better understand biosimilar pricing dynamics and the barriers to adopting biosimilars for chronic conditions,” they concluded.

The study was supported by the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California, Los Angeles, and the National Institute on Aging. Lead author Dr. Chen also disclosed receiving personal fees from Amgen outside of the current study.

SOURCE: Chen AJ et al. JAMA Intern Med. 2020 July 20. doi: 10.1001/jamainternmed.2020.3188.

Help your patients understand biologics and biosimilars by using AGA resources for providers and patients available at www.gastro.org/biosimilars.

Physicians have been slow to embrace biosimilar versions of infliximab, but are more likely to prescribe it to new patients, based on data from a review of nearly 50,000 infliximab claims through Medicare in the first 2 years that biosimilars were available in the United States.

“Although biosimilar versions are as safe and effective as the biologic, patients and physicians may be more reluctant to switch from a working biologic regimen in a chronic setting than an acute one,” wrote Alice J. Chen, PhD, of the University of Southern California, Los Angeles, and colleagues.

In a research letter published in JAMA Internal Medicine, the investigators examined prescribing patterns of physicians switching between the originator infliximab (Remicade) and two of its biosimilars (Inflectra and Renflexis).

They reviewed infliximab use and reimbursement in the 100% Medicare Part B quarterly claims database from Jan. 1, 2017, to Dec. 31, 2018. The study population included Medicare patients classified as new if they had no infliximab claims in the prior 6 months; those with claims were considered returning patients.

In a comparison of claims reflecting 49,771 patients and 4,289 physicians in 2018, a total of 1,418 new patients (17.4%) and 4,495 (10.8%) returning patients used a biosimilar. “Of returning patients, half used the biosimilar version exclusively, whereas the other half switched between biologic and biosimilar versions,” the researchers noted.

Of the 4,289 physicians who prescribed infliximab, 3,124 prescribed no biosimilars, 1,015 prescribed both biologics and biosimilars, and 150 prescribed biosimilars only. Of the physicians who prescribed both, approximately 61% switched some patients from the biologic to the biosimilar; “the remainder kept individual patients on only 1 version of the drug but treated patients with both versions,” the researchers wrote.

The adoption of biosimilars may be slower for chronic vs. acute conditions, the researchers noted. “Prescribers may hesitate to switch clinically stable chronic patients from biologic regimens if they are unfamiliar with the biosimilar or face financial disincentives from prescribing it.”

The study findings were limited by several factors including the use of only 2 years of data and a focus only on Medicare Part B. Switching medications may have been influenced by factors such as lower copays for patients and rebates or discounts for physicians; however, “further research is needed to better understand biosimilar pricing dynamics and the barriers to adopting biosimilars for chronic conditions,” they concluded.

The study was supported by the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California, Los Angeles, and the National Institute on Aging. Lead author Dr. Chen also disclosed receiving personal fees from Amgen outside of the current study.

SOURCE: Chen AJ et al. JAMA Intern Med. 2020 July 20. doi: 10.1001/jamainternmed.2020.3188.

Physicians have been slow to embrace biosimilar versions of infliximab, but are more likely to prescribe it to new patients, based on data from a review of nearly 50,000 infliximab claims through Medicare in the first 2 years that biosimilars were available in the United States.

“Although biosimilar versions are as safe and effective as the biologic, patients and physicians may be more reluctant to switch from a working biologic regimen in a chronic setting than an acute one,” wrote Alice J. Chen, PhD, of the University of Southern California, Los Angeles, and colleagues.

In a research letter published in JAMA Internal Medicine, the investigators examined prescribing patterns of physicians switching between the originator infliximab (Remicade) and two of its biosimilars (Inflectra and Renflexis).

They reviewed infliximab use and reimbursement in the 100% Medicare Part B quarterly claims database from Jan. 1, 2017, to Dec. 31, 2018. The study population included Medicare patients classified as new if they had no infliximab claims in the prior 6 months; those with claims were considered returning patients.

In a comparison of claims reflecting 49,771 patients and 4,289 physicians in 2018, a total of 1,418 new patients (17.4%) and 4,495 (10.8%) returning patients used a biosimilar. “Of returning patients, half used the biosimilar version exclusively, whereas the other half switched between biologic and biosimilar versions,” the researchers noted.

Of the 4,289 physicians who prescribed infliximab, 3,124 prescribed no biosimilars, 1,015 prescribed both biologics and biosimilars, and 150 prescribed biosimilars only. Of the physicians who prescribed both, approximately 61% switched some patients from the biologic to the biosimilar; “the remainder kept individual patients on only 1 version of the drug but treated patients with both versions,” the researchers wrote.

The adoption of biosimilars may be slower for chronic vs. acute conditions, the researchers noted. “Prescribers may hesitate to switch clinically stable chronic patients from biologic regimens if they are unfamiliar with the biosimilar or face financial disincentives from prescribing it.”

The study findings were limited by several factors including the use of only 2 years of data and a focus only on Medicare Part B. Switching medications may have been influenced by factors such as lower copays for patients and rebates or discounts for physicians; however, “further research is needed to better understand biosimilar pricing dynamics and the barriers to adopting biosimilars for chronic conditions,” they concluded.

The study was supported by the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California, Los Angeles, and the National Institute on Aging. Lead author Dr. Chen also disclosed receiving personal fees from Amgen outside of the current study.

SOURCE: Chen AJ et al. JAMA Intern Med. 2020 July 20. doi: 10.1001/jamainternmed.2020.3188.

Physicians have been slow to embrace biosimilar versions of infliximab, but are more likely to prescribe it to new patients, based on data from a review of nearly 50,000 infliximab claims through Medicare in the first 2 years that biosimilars were available in the United States.

“Although biosimilar versions are as safe and effective as the biologic, patients and physicians may be more reluctant to switch from a working biologic regimen in a chronic setting than an acute one,” wrote Alice J. Chen, PhD, of the University of Southern California, Los Angeles, and colleagues.

In a research letter published in JAMA Internal Medicine, the investigators examined prescribing patterns of physicians switching between the originator infliximab (Remicade) and two of its biosimilars (Inflectra and Renflexis).

They reviewed infliximab use and reimbursement in the 100% Medicare Part B quarterly claims database from Jan. 1, 2017, to Dec. 31, 2018. The study population included Medicare patients classified as new if they had no infliximab claims in the prior 6 months; those with claims were considered returning patients.

In a comparison of claims reflecting 49,771 patients and 4,289 physicians in 2018, a total of 1,418 new patients (17.4%) and 4,495 (10.8%) returning patients used a biosimilar. “Of returning patients, half used the biosimilar version exclusively, whereas the other half switched between biologic and biosimilar versions,” the researchers noted.

Of the 4,289 physicians who prescribed infliximab, 3,124 prescribed no biosimilars, 1,015 prescribed both biologics and biosimilars, and 150 prescribed biosimilars only. Of the physicians who prescribed both, approximately 61% switched some patients from the biologic to the biosimilar; “the remainder kept individual patients on only 1 version of the drug but treated patients with both versions,” the researchers wrote.

The adoption of biosimilars may be slower for chronic vs. acute conditions, the researchers noted. “Prescribers may hesitate to switch clinically stable chronic patients from biologic regimens if they are unfamiliar with the biosimilar or face financial disincentives from prescribing it.”

The study findings were limited by several factors including the use of only 2 years of data and a focus only on Medicare Part B. Switching medications may have been influenced by factors such as lower copays for patients and rebates or discounts for physicians; however, “further research is needed to better understand biosimilar pricing dynamics and the barriers to adopting biosimilars for chronic conditions,” they concluded.

The study was supported by the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California, Los Angeles, and the National Institute on Aging. Lead author Dr. Chen also disclosed receiving personal fees from Amgen outside of the current study.

SOURCE: Chen AJ et al. JAMA Intern Med. 2020 July 20. doi: 10.1001/jamainternmed.2020.3188.

With the world currently really listening and engaged (hopefully) on making positive changes with regards to racism and systemic racial injustices, skin color has come to the forefront. Racism because of skin color has been an unfortunate part of our history and foundation of the United States with a capitalist society built and thriving on the profits of slavery, and a democracy founded on equality – unless you had black skin. These issues are at the forefront in the United States, but have also significantly impacted other parts of the world, including the Caribbean and South America having a significant African slave trade history and impacts, with Brazil currently facing the same systemic racial injustices and police brutality among black men, and King Leopold II of Belgium slaughtering an estimated 10-15 million Congolese people in the name of colonialism, slavery, and robbing resources (natural resources as well as servitude) in the Congo as late as the early 1900s.

These are just a few of the many historical examples of racial injustice, which remains ingrained in many parts of our society today. With this worldwide history, it has been advantageous for people to have lighter skin with regards to money, politics, jobs, education, the justice system, modeling/acting opportunities and contracts, home ownership, and opportunities for generational wealth for years to come. It has ingrained some unfortunate beliefs among some that having lighter skin is better, advantageous, and will make them more desirable or more beautiful.

Colorism, its social impact, and consequences on the beauty industry with skin-whitening products is evident all over the world, particularly parts of Asia (especially South Korea and China), India, and across the African continent. It is estimated that 77% of women in Nigeria and 55% of women in China use bleaching creams to achieve overall skin lightening. Unilever’s Fair & Lovely skin-whitening cream has long been a popular over-the-counter product in India, with an estimated market worth of 270 billion rupees ($4 billion USD). On June 25, 2020, Unilever vowed to rename and rebrand Fair & Lovely. With such an offensive name for a product that further promotes colorism, this is an effort in the right direction and has been a long time coming since its debut in 1975. Unilever’s Fair and Lovely Foundation for women’s causes still exists, and has not been renamed at the time of this writing.

Controversy remains on whether this product and other products such as these should exist for the purposes they are used for. Johnson & Johnson has decided that it will no longer produce and sell the Neutrogena Fine Fairness line, sold only in Asia and the Middle East, and the Clean & Clear Fairness line, sold in India. There are arguments to the contrary that halting production of skin-lightening products altogether may result in an influx of unsafe alternatives.

As dermatologists, we use skin-lightening products appropriately for the purposes of treating skin conditions such as postinflammatory hyperpigmentation, melasma, and photoaging. This is where the use of such products should largely end. While it is up to individuals about what they do with their skin and their bodies, we, as health care skin professionals, should be furthering the notion that all skin colors and types are beautiful. Moreover, we should not be encouraging the use of these products for overall skin whitening. Part of the issue is that these products are available often at high concentrations over the counter or in the illegal market, especially in parts of Asia and Africa where colorism is more common and skin whitening is more commonly practiced. The dangers are not only the risk of ochronosis with high concentrations or long term use of hydroquinone, but also what the Centre for Science and Environment found in a 2014 study, that 44% of the skin “fairness” creams in India contained mercury, which is illegal and a health concern.

In my practice, I have also had patients (several originally from Nigeria) who have admitted to long term use of skin-bleaching products for the purposes of all over face- and body-skin lightening who now suffer from very sensitive skin and experience bouts of eczematous dermatitis from time to time, despite having stopped using lightening cream. While there are adverse physical effects resulting from the use of these topicals for this purpose, the effects on the psyche are what concern me the most.

The beauty industry has also been an unfortunate part of furthering thoughts and attitudes concerning colorism over the years with lighter skin and Caucasian ideals being set as standards of beauty. One of many examples is a deodorant ad in the Middle East with the tagline “White is Purity” on a woman, which was pulled by Nivea in 2017 after it was slammed as racist. Another is the 2017 Dove ad for body wash that showed a smiling black woman peel off her brown shirt to reveal a white woman in a lighter-color shirt.

A shift has occurred in recent years with more ethnic images of beauty appearing in magazines and film. However, such opportunities are still less plentiful, pay discrepancies still occur, and sexual objectification of women of color as opposed to beautification is still rampant. As such, it is also up to us to do our part in studying and utilizing ethnic and racial differences in skin and beauty to maximize our efforts in promoting what is inherently beautiful as opposed to one standard of beauty. The education begins with the images we see, what we teach our children, loving ourselves, and as doctors, being knowledgeable about the right aesthetic choices for patients with different skin colors and types.

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at dermnews@mdedge.com. They had no relevant disclosures.

With the world currently really listening and engaged (hopefully) on making positive changes with regards to racism and systemic racial injustices, skin color has come to the forefront. Racism because of skin color has been an unfortunate part of our history and foundation of the United States with a capitalist society built and thriving on the profits of slavery, and a democracy founded on equality – unless you had black skin. These issues are at the forefront in the United States, but have also significantly impacted other parts of the world, including the Caribbean and South America having a significant African slave trade history and impacts, with Brazil currently facing the same systemic racial injustices and police brutality among black men, and King Leopold II of Belgium slaughtering an estimated 10-15 million Congolese people in the name of colonialism, slavery, and robbing resources (natural resources as well as servitude) in the Congo as late as the early 1900s.

These are just a few of the many historical examples of racial injustice, which remains ingrained in many parts of our society today. With this worldwide history, it has been advantageous for people to have lighter skin with regards to money, politics, jobs, education, the justice system, modeling/acting opportunities and contracts, home ownership, and opportunities for generational wealth for years to come. It has ingrained some unfortunate beliefs among some that having lighter skin is better, advantageous, and will make them more desirable or more beautiful.

Colorism, its social impact, and consequences on the beauty industry with skin-whitening products is evident all over the world, particularly parts of Asia (especially South Korea and China), India, and across the African continent. It is estimated that 77% of women in Nigeria and 55% of women in China use bleaching creams to achieve overall skin lightening. Unilever’s Fair & Lovely skin-whitening cream has long been a popular over-the-counter product in India, with an estimated market worth of 270 billion rupees ($4 billion USD). On June 25, 2020, Unilever vowed to rename and rebrand Fair & Lovely. With such an offensive name for a product that further promotes colorism, this is an effort in the right direction and has been a long time coming since its debut in 1975. Unilever’s Fair and Lovely Foundation for women’s causes still exists, and has not been renamed at the time of this writing.

Controversy remains on whether this product and other products such as these should exist for the purposes they are used for. Johnson & Johnson has decided that it will no longer produce and sell the Neutrogena Fine Fairness line, sold only in Asia and the Middle East, and the Clean & Clear Fairness line, sold in India. There are arguments to the contrary that halting production of skin-lightening products altogether may result in an influx of unsafe alternatives.

As dermatologists, we use skin-lightening products appropriately for the purposes of treating skin conditions such as postinflammatory hyperpigmentation, melasma, and photoaging. This is where the use of such products should largely end. While it is up to individuals about what they do with their skin and their bodies, we, as health care skin professionals, should be furthering the notion that all skin colors and types are beautiful. Moreover, we should not be encouraging the use of these products for overall skin whitening. Part of the issue is that these products are available often at high concentrations over the counter or in the illegal market, especially in parts of Asia and Africa where colorism is more common and skin whitening is more commonly practiced. The dangers are not only the risk of ochronosis with high concentrations or long term use of hydroquinone, but also what the Centre for Science and Environment found in a 2014 study, that 44% of the skin “fairness” creams in India contained mercury, which is illegal and a health concern.

In my practice, I have also had patients (several originally from Nigeria) who have admitted to long term use of skin-bleaching products for the purposes of all over face- and body-skin lightening who now suffer from very sensitive skin and experience bouts of eczematous dermatitis from time to time, despite having stopped using lightening cream. While there are adverse physical effects resulting from the use of these topicals for this purpose, the effects on the psyche are what concern me the most.

The beauty industry has also been an unfortunate part of furthering thoughts and attitudes concerning colorism over the years with lighter skin and Caucasian ideals being set as standards of beauty. One of many examples is a deodorant ad in the Middle East with the tagline “White is Purity” on a woman, which was pulled by Nivea in 2017 after it was slammed as racist. Another is the 2017 Dove ad for body wash that showed a smiling black woman peel off her brown shirt to reveal a white woman in a lighter-color shirt.

A shift has occurred in recent years with more ethnic images of beauty appearing in magazines and film. However, such opportunities are still less plentiful, pay discrepancies still occur, and sexual objectification of women of color as opposed to beautification is still rampant. As such, it is also up to us to do our part in studying and utilizing ethnic and racial differences in skin and beauty to maximize our efforts in promoting what is inherently beautiful as opposed to one standard of beauty. The education begins with the images we see, what we teach our children, loving ourselves, and as doctors, being knowledgeable about the right aesthetic choices for patients with different skin colors and types.

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at dermnews@mdedge.com. They had no relevant disclosures.

With the world currently really listening and engaged (hopefully) on making positive changes with regards to racism and systemic racial injustices, skin color has come to the forefront. Racism because of skin color has been an unfortunate part of our history and foundation of the United States with a capitalist society built and thriving on the profits of slavery, and a democracy founded on equality – unless you had black skin. These issues are at the forefront in the United States, but have also significantly impacted other parts of the world, including the Caribbean and South America having a significant African slave trade history and impacts, with Brazil currently facing the same systemic racial injustices and police brutality among black men, and King Leopold II of Belgium slaughtering an estimated 10-15 million Congolese people in the name of colonialism, slavery, and robbing resources (natural resources as well as servitude) in the Congo as late as the early 1900s.

These are just a few of the many historical examples of racial injustice, which remains ingrained in many parts of our society today. With this worldwide history, it has been advantageous for people to have lighter skin with regards to money, politics, jobs, education, the justice system, modeling/acting opportunities and contracts, home ownership, and opportunities for generational wealth for years to come. It has ingrained some unfortunate beliefs among some that having lighter skin is better, advantageous, and will make them more desirable or more beautiful.

Colorism, its social impact, and consequences on the beauty industry with skin-whitening products is evident all over the world, particularly parts of Asia (especially South Korea and China), India, and across the African continent. It is estimated that 77% of women in Nigeria and 55% of women in China use bleaching creams to achieve overall skin lightening. Unilever’s Fair & Lovely skin-whitening cream has long been a popular over-the-counter product in India, with an estimated market worth of 270 billion rupees ($4 billion USD). On June 25, 2020, Unilever vowed to rename and rebrand Fair & Lovely. With such an offensive name for a product that further promotes colorism, this is an effort in the right direction and has been a long time coming since its debut in 1975. Unilever’s Fair and Lovely Foundation for women’s causes still exists, and has not been renamed at the time of this writing.

Controversy remains on whether this product and other products such as these should exist for the purposes they are used for. Johnson & Johnson has decided that it will no longer produce and sell the Neutrogena Fine Fairness line, sold only in Asia and the Middle East, and the Clean & Clear Fairness line, sold in India. There are arguments to the contrary that halting production of skin-lightening products altogether may result in an influx of unsafe alternatives.

As dermatologists, we use skin-lightening products appropriately for the purposes of treating skin conditions such as postinflammatory hyperpigmentation, melasma, and photoaging. This is where the use of such products should largely end. While it is up to individuals about what they do with their skin and their bodies, we, as health care skin professionals, should be furthering the notion that all skin colors and types are beautiful. Moreover, we should not be encouraging the use of these products for overall skin whitening. Part of the issue is that these products are available often at high concentrations over the counter or in the illegal market, especially in parts of Asia and Africa where colorism is more common and skin whitening is more commonly practiced. The dangers are not only the risk of ochronosis with high concentrations or long term use of hydroquinone, but also what the Centre for Science and Environment found in a 2014 study, that 44% of the skin “fairness” creams in India contained mercury, which is illegal and a health concern.

In my practice, I have also had patients (several originally from Nigeria) who have admitted to long term use of skin-bleaching products for the purposes of all over face- and body-skin lightening who now suffer from very sensitive skin and experience bouts of eczematous dermatitis from time to time, despite having stopped using lightening cream. While there are adverse physical effects resulting from the use of these topicals for this purpose, the effects on the psyche are what concern me the most.

The beauty industry has also been an unfortunate part of furthering thoughts and attitudes concerning colorism over the years with lighter skin and Caucasian ideals being set as standards of beauty. One of many examples is a deodorant ad in the Middle East with the tagline “White is Purity” on a woman, which was pulled by Nivea in 2017 after it was slammed as racist. Another is the 2017 Dove ad for body wash that showed a smiling black woman peel off her brown shirt to reveal a white woman in a lighter-color shirt.

A shift has occurred in recent years with more ethnic images of beauty appearing in magazines and film. However, such opportunities are still less plentiful, pay discrepancies still occur, and sexual objectification of women of color as opposed to beautification is still rampant. As such, it is also up to us to do our part in studying and utilizing ethnic and racial differences in skin and beauty to maximize our efforts in promoting what is inherently beautiful as opposed to one standard of beauty. The education begins with the images we see, what we teach our children, loving ourselves, and as doctors, being knowledgeable about the right aesthetic choices for patients with different skin colors and types.

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at dermnews@mdedge.com. They had no relevant disclosures.

The DynamX Bioadaptor – arguably the most original concept in coronary stent design to come along in 3 decades – demonstrated excellent safety and efficacy in a 12-month international, proof-of-concept study, Stefan Verheye, MD, said at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“There has been no fundamental change in stent design in over 30 years,” declared Dr. Verheye, codirector of the Antwerp (Belgium) Cardiovascular Center. “The DynamX Bioadaptor is a fundamental innovation in device design.”

The investigational device is a 71-mcm-thick, cobalt-chromium metal platform that elutes novolimus from a biodegradable polymer. Circumferential rings in low-stress sections of the device are held together by polymer connectors, and when the polymer erodes at about 6 months the stent segments are able to disengage from each other while maintaining longitudinal continuity. Dr. Verheye called this process “uncaging” the stented artery. The result is restoration of normal vessel angulation and compliance; the artery is no longer artificially straightened and constrained by a relatively stiff stent. Positive adaptive remodeling is preserved with enhanced vessel pulsatility and maintenance of lumenal area for good blood flow.

Dr. Verheye said the impetus for developing this outside-the-box novel stent platform lies in the recognition of a major unmet need for better drug-eluting stent (DES) performance. “Despite excellent acute outcomes, data with current-generation DES show long-term event rates are high and accrue at a rate of 2%-3% per year without a plateau.”

He was coprincipal investigator for the international study, which included 50 patients who received a DynamX Bioadaptor for a single de novo coronary artery lesion no more than 24 mm in length. The acute performance of the device was similar to that of second-generation DES, with a mean acute gain post procedure of 1.63 mm by quantitative coronary angiography and a mean late lumen loss of 0.12 mm when measured again at 9 or 12 months.

Intravascular ultrasound imaging showed a 3% increase in mean target vessel area and a 5% increase in the stented area from post procedure to 9 or 12 months’ follow-up, with no change in mean lumen area, all of which translates into maintenance of good blood flow over time. In contrast, what typically occurs following implantation of current DES is maintenance of target vessel and device areas, but with a loss in mean lumen area, the cardiologist noted.

There were two cardiac deaths but no cases of target lesion revascularization, device thrombosis, or strut fracture within 12 months of the procedure.

“The Bioadaptor performs similarly to second-generation DES in terms of implantation technique, deliverability, conformability, and radial strength during the healing phase, while showing the promise of mitigating the 2%-3% annualized event rate beyond 1 year,” Dr. Verheye concluded, adding, “Obviously, longer-term follow-up in comparative studies will be needed to show a reduction in the device-oriented events that have been observed with current DES.”

Session cochair Davide Capodanno, MD, PhD, of the University of Catania (Italy), declared: “This is an intriguing device because it’s metal, but it’s a kind of pulsatile metal after the biodegradation of the connectors. It’s something I’ve never seen.”

Discussant William Wijns, MD, PhD, said he was “thrilled” by the innovative aspect of the DynamX Bioadaptor, but he’s a long way from being persuaded that the device’s potential physiological advantages will translate into improved clinical outcomes relative to current DES.

“Don’t we all have a strange feeling of deja vu because all these anticipated benefits are the same as those we were told we would see with fully bioresorbable scaffolds? And we know so much after 10 years of experience with bioresorbable scaffolds that probably we will not accept this great story unless we get more and more evidence,” cautioned Dr. Wijns, professor of interventional cardiology at the National University of Ireland, Galway, and chairman of EuroPCR.

The claim regarding bioresorbable scaffolds was that, even though the acute results weren’t as good as with DES, that disadvantage would be outweighed by superior long-term clinical outcomes. But in fact the long-term outcomes turned out to be worse as well.

“We had to give up immediate results with the bioresorbable scaffolds. I don’t think we want to go that route again this time,” the cardiologist said.

Thus, the first thing that’s needed in order to make a convincing case for the Bioadaptor is evidence from a large, randomized, comparative trial demonstrating that the acute performance of the novel device is noninferior to that of current DES, including data on complex lesions. Such a study was supposed to be underway now but has been delayed by the COVID-19 pandemic, he noted.

Once there is evidence that the acute results with the Bioadaptor are truly comparable with those achieved with current DES, there will be a need for long-term data showing that the device reduces the 2%-3% annualized event rate seen with DES beyond 1 year, Dr. Wijns added.

Dr. Verheye reported receiving consultation fees from study sponsor Elixir Medical as well as from Biotronik. Dr. Wijns reported receiving research grants from MicroPort.

bjancin@mdedge.com

The DynamX Bioadaptor – arguably the most original concept in coronary stent design to come along in 3 decades – demonstrated excellent safety and efficacy in a 12-month international, proof-of-concept study, Stefan Verheye, MD, said at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“There has been no fundamental change in stent design in over 30 years,” declared Dr. Verheye, codirector of the Antwerp (Belgium) Cardiovascular Center. “The DynamX Bioadaptor is a fundamental innovation in device design.”

The investigational device is a 71-mcm-thick, cobalt-chromium metal platform that elutes novolimus from a biodegradable polymer. Circumferential rings in low-stress sections of the device are held together by polymer connectors, and when the polymer erodes at about 6 months the stent segments are able to disengage from each other while maintaining longitudinal continuity. Dr. Verheye called this process “uncaging” the stented artery. The result is restoration of normal vessel angulation and compliance; the artery is no longer artificially straightened and constrained by a relatively stiff stent. Positive adaptive remodeling is preserved with enhanced vessel pulsatility and maintenance of lumenal area for good blood flow.

Dr. Verheye said the impetus for developing this outside-the-box novel stent platform lies in the recognition of a major unmet need for better drug-eluting stent (DES) performance. “Despite excellent acute outcomes, data with current-generation DES show long-term event rates are high and accrue at a rate of 2%-3% per year without a plateau.”

He was coprincipal investigator for the international study, which included 50 patients who received a DynamX Bioadaptor for a single de novo coronary artery lesion no more than 24 mm in length. The acute performance of the device was similar to that of second-generation DES, with a mean acute gain post procedure of 1.63 mm by quantitative coronary angiography and a mean late lumen loss of 0.12 mm when measured again at 9 or 12 months.

Intravascular ultrasound imaging showed a 3% increase in mean target vessel area and a 5% increase in the stented area from post procedure to 9 or 12 months’ follow-up, with no change in mean lumen area, all of which translates into maintenance of good blood flow over time. In contrast, what typically occurs following implantation of current DES is maintenance of target vessel and device areas, but with a loss in mean lumen area, the cardiologist noted.

There were two cardiac deaths but no cases of target lesion revascularization, device thrombosis, or strut fracture within 12 months of the procedure.

“The Bioadaptor performs similarly to second-generation DES in terms of implantation technique, deliverability, conformability, and radial strength during the healing phase, while showing the promise of mitigating the 2%-3% annualized event rate beyond 1 year,” Dr. Verheye concluded, adding, “Obviously, longer-term follow-up in comparative studies will be needed to show a reduction in the device-oriented events that have been observed with current DES.”

Session cochair Davide Capodanno, MD, PhD, of the University of Catania (Italy), declared: “This is an intriguing device because it’s metal, but it’s a kind of pulsatile metal after the biodegradation of the connectors. It’s something I’ve never seen.”

Discussant William Wijns, MD, PhD, said he was “thrilled” by the innovative aspect of the DynamX Bioadaptor, but he’s a long way from being persuaded that the device’s potential physiological advantages will translate into improved clinical outcomes relative to current DES.

“Don’t we all have a strange feeling of deja vu because all these anticipated benefits are the same as those we were told we would see with fully bioresorbable scaffolds? And we know so much after 10 years of experience with bioresorbable scaffolds that probably we will not accept this great story unless we get more and more evidence,” cautioned Dr. Wijns, professor of interventional cardiology at the National University of Ireland, Galway, and chairman of EuroPCR.

The claim regarding bioresorbable scaffolds was that, even though the acute results weren’t as good as with DES, that disadvantage would be outweighed by superior long-term clinical outcomes. But in fact the long-term outcomes turned out to be worse as well.

“We had to give up immediate results with the bioresorbable scaffolds. I don’t think we want to go that route again this time,” the cardiologist said.

Thus, the first thing that’s needed in order to make a convincing case for the Bioadaptor is evidence from a large, randomized, comparative trial demonstrating that the acute performance of the novel device is noninferior to that of current DES, including data on complex lesions. Such a study was supposed to be underway now but has been delayed by the COVID-19 pandemic, he noted.

Once there is evidence that the acute results with the Bioadaptor are truly comparable with those achieved with current DES, there will be a need for long-term data showing that the device reduces the 2%-3% annualized event rate seen with DES beyond 1 year, Dr. Wijns added.

Dr. Verheye reported receiving consultation fees from study sponsor Elixir Medical as well as from Biotronik. Dr. Wijns reported receiving research grants from MicroPort.

bjancin@mdedge.com

The DynamX Bioadaptor – arguably the most original concept in coronary stent design to come along in 3 decades – demonstrated excellent safety and efficacy in a 12-month international, proof-of-concept study, Stefan Verheye, MD, said at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“There has been no fundamental change in stent design in over 30 years,” declared Dr. Verheye, codirector of the Antwerp (Belgium) Cardiovascular Center. “The DynamX Bioadaptor is a fundamental innovation in device design.”

The investigational device is a 71-mcm-thick, cobalt-chromium metal platform that elutes novolimus from a biodegradable polymer. Circumferential rings in low-stress sections of the device are held together by polymer connectors, and when the polymer erodes at about 6 months the stent segments are able to disengage from each other while maintaining longitudinal continuity. Dr. Verheye called this process “uncaging” the stented artery. The result is restoration of normal vessel angulation and compliance; the artery is no longer artificially straightened and constrained by a relatively stiff stent. Positive adaptive remodeling is preserved with enhanced vessel pulsatility and maintenance of lumenal area for good blood flow.

Dr. Verheye said the impetus for developing this outside-the-box novel stent platform lies in the recognition of a major unmet need for better drug-eluting stent (DES) performance. “Despite excellent acute outcomes, data with current-generation DES show long-term event rates are high and accrue at a rate of 2%-3% per year without a plateau.”

He was coprincipal investigator for the international study, which included 50 patients who received a DynamX Bioadaptor for a single de novo coronary artery lesion no more than 24 mm in length. The acute performance of the device was similar to that of second-generation DES, with a mean acute gain post procedure of 1.63 mm by quantitative coronary angiography and a mean late lumen loss of 0.12 mm when measured again at 9 or 12 months.

Intravascular ultrasound imaging showed a 3% increase in mean target vessel area and a 5% increase in the stented area from post procedure to 9 or 12 months’ follow-up, with no change in mean lumen area, all of which translates into maintenance of good blood flow over time. In contrast, what typically occurs following implantation of current DES is maintenance of target vessel and device areas, but with a loss in mean lumen area, the cardiologist noted.

There were two cardiac deaths but no cases of target lesion revascularization, device thrombosis, or strut fracture within 12 months of the procedure.

“The Bioadaptor performs similarly to second-generation DES in terms of implantation technique, deliverability, conformability, and radial strength during the healing phase, while showing the promise of mitigating the 2%-3% annualized event rate beyond 1 year,” Dr. Verheye concluded, adding, “Obviously, longer-term follow-up in comparative studies will be needed to show a reduction in the device-oriented events that have been observed with current DES.”

Session cochair Davide Capodanno, MD, PhD, of the University of Catania (Italy), declared: “This is an intriguing device because it’s metal, but it’s a kind of pulsatile metal after the biodegradation of the connectors. It’s something I’ve never seen.”

Discussant William Wijns, MD, PhD, said he was “thrilled” by the innovative aspect of the DynamX Bioadaptor, but he’s a long way from being persuaded that the device’s potential physiological advantages will translate into improved clinical outcomes relative to current DES.

“Don’t we all have a strange feeling of deja vu because all these anticipated benefits are the same as those we were told we would see with fully bioresorbable scaffolds? And we know so much after 10 years of experience with bioresorbable scaffolds that probably we will not accept this great story unless we get more and more evidence,” cautioned Dr. Wijns, professor of interventional cardiology at the National University of Ireland, Galway, and chairman of EuroPCR.

The claim regarding bioresorbable scaffolds was that, even though the acute results weren’t as good as with DES, that disadvantage would be outweighed by superior long-term clinical outcomes. But in fact the long-term outcomes turned out to be worse as well.

“We had to give up immediate results with the bioresorbable scaffolds. I don’t think we want to go that route again this time,” the cardiologist said.

Thus, the first thing that’s needed in order to make a convincing case for the Bioadaptor is evidence from a large, randomized, comparative trial demonstrating that the acute performance of the novel device is noninferior to that of current DES, including data on complex lesions. Such a study was supposed to be underway now but has been delayed by the COVID-19 pandemic, he noted.

Once there is evidence that the acute results with the Bioadaptor are truly comparable with those achieved with current DES, there will be a need for long-term data showing that the device reduces the 2%-3% annualized event rate seen with DES beyond 1 year, Dr. Wijns added.

Dr. Verheye reported receiving consultation fees from study sponsor Elixir Medical as well as from Biotronik. Dr. Wijns reported receiving research grants from MicroPort.

bjancin@mdedge.com

ANSWER

The correct answer is lichen planus (choice “c”).

DISCUSSION

Condyloma accuminata can demonstrate amazing lability, sometimes appearing decades after exposure. And spouses may not always be truthful when questioned about such exposure. To further confuse the issue, it's entirely possible that a patient may be unaware he or she has condyloma. So, this might well have been condyloma. But the differential for penile lesions would include this condition—and more.

Psoriasis (choice “a”) commonly affects the penis, manifesting as pinkish plaques and papules. But there is a good chance that examination would have revealed corroborative signs of this disease. Furthermore, the histologic results would have been entirely different.

While syphilis (choice “b”), especially in its primary stage, can present with nonhealing sores, in no way do they resemble the patient’s lesions. There is also no source for such an infection. And biopsy would have shown a predominately plasma cell infiltrate in an entirely different pattern.

Lichen sclerosus et atrophicus (choice “d”) is quite uncommon, especially on the penis, where it is usually known as balanitis xerotica obliterans (BXO). As its name suggests, BXO is usually atrophic—therefore macular—and whitish. Exclusive to uncircumcised men, it bears no resemblance to condyloma.

Though idiopathic, lichen planus is not contagious. Unless neglected, this condition seldom causes any suffering aside from mental anguish over its appearance. To make a more accurate diagnosis, it is always helpful for providers to consider a mnemonic device for “7 Ps” associated with lichen planus:

• Penile
• Pruritic
• Plaque-like
• Purple
• Papular
• Planar
• Puzzling.

TREATMENT

Fortunately, lichen planus affecting the penis responds readily to treatment with mid-strength topical steroid cream and the "tincture of time," which improves its appearance until it eventually disappears. For this patient, the PCP treated the affected area with triamcinolone 0.1% cream bid for 2 weeks. This was then applied once a day every other day for a month, which cleared the patient’s lesions.

ANSWER

The correct answer is lichen planus (choice “c”).

DISCUSSION

Condyloma accuminata can demonstrate amazing lability, sometimes appearing decades after exposure. And spouses may not always be truthful when questioned about such exposure. To further confuse the issue, it's entirely possible that a patient may be unaware he or she has condyloma. So, this might well have been condyloma. But the differential for penile lesions would include this condition—and more.

Psoriasis (choice “a”) commonly affects the penis, manifesting as pinkish plaques and papules. But there is a good chance that examination would have revealed corroborative signs of this disease. Furthermore, the histologic results would have been entirely different.

While syphilis (choice “b”), especially in its primary stage, can present with nonhealing sores, in no way do they resemble the patient’s lesions. There is also no source for such an infection. And biopsy would have shown a predominately plasma cell infiltrate in an entirely different pattern.

Lichen sclerosus et atrophicus (choice “d”) is quite uncommon, especially on the penis, where it is usually known as balanitis xerotica obliterans (BXO). As its name suggests, BXO is usually atrophic—therefore macular—and whitish. Exclusive to uncircumcised men, it bears no resemblance to condyloma.

Though idiopathic, lichen planus is not contagious. Unless neglected, this condition seldom causes any suffering aside from mental anguish over its appearance. To make a more accurate diagnosis, it is always helpful for providers to consider a mnemonic device for “7 Ps” associated with lichen planus:

• Penile
• Pruritic
• Plaque-like
• Purple
• Papular
• Planar
• Puzzling.

TREATMENT

Fortunately, lichen planus affecting the penis responds readily to treatment with mid-strength topical steroid cream and the "tincture of time," which improves its appearance until it eventually disappears. For this patient, the PCP treated the affected area with triamcinolone 0.1% cream bid for 2 weeks. This was then applied once a day every other day for a month, which cleared the patient’s lesions.

ANSWER

The correct answer is lichen planus (choice “c”).

DISCUSSION

Condyloma accuminata can demonstrate amazing lability, sometimes appearing decades after exposure. And spouses may not always be truthful when questioned about such exposure. To further confuse the issue, it's entirely possible that a patient may be unaware he or she has condyloma. So, this might well have been condyloma. But the differential for penile lesions would include this condition—and more.

Psoriasis (choice “a”) commonly affects the penis, manifesting as pinkish plaques and papules. But there is a good chance that examination would have revealed corroborative signs of this disease. Furthermore, the histologic results would have been entirely different.

While syphilis (choice “b”), especially in its primary stage, can present with nonhealing sores, in no way do they resemble the patient’s lesions. There is also no source for such an infection. And biopsy would have shown a predominately plasma cell infiltrate in an entirely different pattern.

Lichen sclerosus et atrophicus (choice “d”) is quite uncommon, especially on the penis, where it is usually known as balanitis xerotica obliterans (BXO). As its name suggests, BXO is usually atrophic—therefore macular—and whitish. Exclusive to uncircumcised men, it bears no resemblance to condyloma.

Though idiopathic, lichen planus is not contagious. Unless neglected, this condition seldom causes any suffering aside from mental anguish over its appearance. To make a more accurate diagnosis, it is always helpful for providers to consider a mnemonic device for “7 Ps” associated with lichen planus:

• Penile
• Pruritic
• Plaque-like
• Purple
• Papular
• Planar
• Puzzling.

TREATMENT

Fortunately, lichen planus affecting the penis responds readily to treatment with mid-strength topical steroid cream and the "tincture of time," which improves its appearance until it eventually disappears. For this patient, the PCP treated the affected area with triamcinolone 0.1% cream bid for 2 weeks. This was then applied once a day every other day for a month, which cleared the patient’s lesions.

With a median follow-up of 10 years after coronary artery bypass grafting (CABG), patients who received a radial artery graft rather than a saphenous vein graft as a second conduit were less likely to experience death, MI, or repeat revascularization, according to pooled data from five randomized trials.

The same result from the same set of data was produced after a median of 5 years, but the longer follow-up provides a more compelling case for the superiority of the radial artery graft, according to the authors of this meta-analysis, led by Mario F.L. Gaudino, MD, professor of cardiothoracic surgery at Weill Cornell Medicine, New York.

For the primary composite endpoint of death, MI, or repeat revascularization, the favorable hazard ratio at 5 years corresponded to a 33% risk reduction (HR, 0.67; P = .01), according to the previously published results (Gaudino M et al. N Engl J Med. 2018;378:2069-77).

The new data at 10 years show about the same risk reduction for the primary endpoint, but with more robust statistical significance (HR, 0.73; P < .001).

More importantly, because of the greater number of events by 10 years, the advantage of radial artery graft for the secondary composite outcome of death or MI has now reached statistical significance (HR, 0.77; P = .01).

In addition, there was a 27% reduction in risk of all-cause mortality (HR, 0.73; 95% confidence interval, 0.57-0.93) at 10 years associated with the radial artery graft. But this was not a prespecified endpoint, and so this is a hypothesis-generating post hoc finding.

The data was drawn from five randomized trials with a total of 1,036 patients. When used as an additional conduit to an internal thoracic artery in CABG, radial artery grafts relative to saphenous vein grafts were associated with a lower but nonsignificant risk of adverse outcomes in all five trials.

The advantage of radial artery grafts in the meta-analysis at 5 and now 10 years supports a series of observational studies that have also claimed better results with radial artery grafts.

The analysis was published July 14 in JAMA with essentially the same outcomes reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation in March.

However, a editorial that accompanied this meta-analysis in JAMA raised fundamental questions about revascularization.

“Intuitively, high-severity coronary lesions with significant ischemic burden, poor collateralization, and significant myocardium at risk may benefit from a durable revascularization option,” observed the editorial coauthors, Steven E. Nissen, MD, and Faisal G. Bakaeen, MD, both of the Cleveland Clinic. However, they cautioned that there is no definitive evidence that “any revascularization procedure reduces cardiovascular morbidity or mortality in patients with anatomically and physiologically stable coronary artery disease.”

They called the 10-year outcomes from the meta-analysis “the best available long-term data on the potential value of using the radial artery as a bypass conduit,” but warned that no randomized trial has confirmed that two or more conduits are superior to a single internal thoracic artery in CABG to for preventing death and major adverse cardiovascular events.

Such a trial, called ROMA, is now underway (Eur J Cardiothorac Surg. 2017;52:1031-40), but results are not expected until 2025.

In the meantime, placement of second conduits remains common in CABG procedures, about 400,000 of which are performed each year in the United States. According to Dr. Gaudino, there are indications and contraindications for second conduits, but radial artery should be the preferred standard when these are considered.

“Our data indicate that the radial artery graft should be used to complement the left internal thoracic artery in all patients who meet the indications for radial artery grafts,” he explained in an interview.

“Unfortunately, at the moment radial artery grafts are used in less than 10% of CABG cases in the U.S.,” he reported. “Hopefully, our data will lead to a larger use of this conduit by the surgical community.”

Dr. Gaudino, the principal investigator, reported no potential conflicts of interest relevant to this study.

SOURCE: Gaudino MFL et al. JAMA. 2020;324:179-87.

With a median follow-up of 10 years after coronary artery bypass grafting (CABG), patients who received a radial artery graft rather than a saphenous vein graft as a second conduit were less likely to experience death, MI, or repeat revascularization, according to pooled data from five randomized trials.

The same result from the same set of data was produced after a median of 5 years, but the longer follow-up provides a more compelling case for the superiority of the radial artery graft, according to the authors of this meta-analysis, led by Mario F.L. Gaudino, MD, professor of cardiothoracic surgery at Weill Cornell Medicine, New York.

For the primary composite endpoint of death, MI, or repeat revascularization, the favorable hazard ratio at 5 years corresponded to a 33% risk reduction (HR, 0.67; P = .01), according to the previously published results (Gaudino M et al. N Engl J Med. 2018;378:2069-77).

The new data at 10 years show about the same risk reduction for the primary endpoint, but with more robust statistical significance (HR, 0.73; P < .001).

More importantly, because of the greater number of events by 10 years, the advantage of radial artery graft for the secondary composite outcome of death or MI has now reached statistical significance (HR, 0.77; P = .01).

In addition, there was a 27% reduction in risk of all-cause mortality (HR, 0.73; 95% confidence interval, 0.57-0.93) at 10 years associated with the radial artery graft. But this was not a prespecified endpoint, and so this is a hypothesis-generating post hoc finding.

The data was drawn from five randomized trials with a total of 1,036 patients. When used as an additional conduit to an internal thoracic artery in CABG, radial artery grafts relative to saphenous vein grafts were associated with a lower but nonsignificant risk of adverse outcomes in all five trials.

The advantage of radial artery grafts in the meta-analysis at 5 and now 10 years supports a series of observational studies that have also claimed better results with radial artery grafts.

The analysis was published July 14 in JAMA with essentially the same outcomes reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation in March.

However, a editorial that accompanied this meta-analysis in JAMA raised fundamental questions about revascularization.

“Intuitively, high-severity coronary lesions with significant ischemic burden, poor collateralization, and significant myocardium at risk may benefit from a durable revascularization option,” observed the editorial coauthors, Steven E. Nissen, MD, and Faisal G. Bakaeen, MD, both of the Cleveland Clinic. However, they cautioned that there is no definitive evidence that “any revascularization procedure reduces cardiovascular morbidity or mortality in patients with anatomically and physiologically stable coronary artery disease.”

They called the 10-year outcomes from the meta-analysis “the best available long-term data on the potential value of using the radial artery as a bypass conduit,” but warned that no randomized trial has confirmed that two or more conduits are superior to a single internal thoracic artery in CABG to for preventing death and major adverse cardiovascular events.

Such a trial, called ROMA, is now underway (Eur J Cardiothorac Surg. 2017;52:1031-40), but results are not expected until 2025.

In the meantime, placement of second conduits remains common in CABG procedures, about 400,000 of which are performed each year in the United States. According to Dr. Gaudino, there are indications and contraindications for second conduits, but radial artery should be the preferred standard when these are considered.

“Our data indicate that the radial artery graft should be used to complement the left internal thoracic artery in all patients who meet the indications for radial artery grafts,” he explained in an interview.

“Unfortunately, at the moment radial artery grafts are used in less than 10% of CABG cases in the U.S.,” he reported. “Hopefully, our data will lead to a larger use of this conduit by the surgical community.”

Dr. Gaudino, the principal investigator, reported no potential conflicts of interest relevant to this study.

SOURCE: Gaudino MFL et al. JAMA. 2020;324:179-87.

With a median follow-up of 10 years after coronary artery bypass grafting (CABG), patients who received a radial artery graft rather than a saphenous vein graft as a second conduit were less likely to experience death, MI, or repeat revascularization, according to pooled data from five randomized trials.

The same result from the same set of data was produced after a median of 5 years, but the longer follow-up provides a more compelling case for the superiority of the radial artery graft, according to the authors of this meta-analysis, led by Mario F.L. Gaudino, MD, professor of cardiothoracic surgery at Weill Cornell Medicine, New York.

For the primary composite endpoint of death, MI, or repeat revascularization, the favorable hazard ratio at 5 years corresponded to a 33% risk reduction (HR, 0.67; P = .01), according to the previously published results (Gaudino M et al. N Engl J Med. 2018;378:2069-77).

The new data at 10 years show about the same risk reduction for the primary endpoint, but with more robust statistical significance (HR, 0.73; P < .001).

More importantly, because of the greater number of events by 10 years, the advantage of radial artery graft for the secondary composite outcome of death or MI has now reached statistical significance (HR, 0.77; P = .01).

In addition, there was a 27% reduction in risk of all-cause mortality (HR, 0.73; 95% confidence interval, 0.57-0.93) at 10 years associated with the radial artery graft. But this was not a prespecified endpoint, and so this is a hypothesis-generating post hoc finding.

The data was drawn from five randomized trials with a total of 1,036 patients. When used as an additional conduit to an internal thoracic artery in CABG, radial artery grafts relative to saphenous vein grafts were associated with a lower but nonsignificant risk of adverse outcomes in all five trials.

The advantage of radial artery grafts in the meta-analysis at 5 and now 10 years supports a series of observational studies that have also claimed better results with radial artery grafts.

The analysis was published July 14 in JAMA with essentially the same outcomes reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation in March.

However, a editorial that accompanied this meta-analysis in JAMA raised fundamental questions about revascularization.

“Intuitively, high-severity coronary lesions with significant ischemic burden, poor collateralization, and significant myocardium at risk may benefit from a durable revascularization option,” observed the editorial coauthors, Steven E. Nissen, MD, and Faisal G. Bakaeen, MD, both of the Cleveland Clinic. However, they cautioned that there is no definitive evidence that “any revascularization procedure reduces cardiovascular morbidity or mortality in patients with anatomically and physiologically stable coronary artery disease.”

They called the 10-year outcomes from the meta-analysis “the best available long-term data on the potential value of using the radial artery as a bypass conduit,” but warned that no randomized trial has confirmed that two or more conduits are superior to a single internal thoracic artery in CABG to for preventing death and major adverse cardiovascular events.

Such a trial, called ROMA, is now underway (Eur J Cardiothorac Surg. 2017;52:1031-40), but results are not expected until 2025.

In the meantime, placement of second conduits remains common in CABG procedures, about 400,000 of which are performed each year in the United States. According to Dr. Gaudino, there are indications and contraindications for second conduits, but radial artery should be the preferred standard when these are considered.

“Our data indicate that the radial artery graft should be used to complement the left internal thoracic artery in all patients who meet the indications for radial artery grafts,” he explained in an interview.

“Unfortunately, at the moment radial artery grafts are used in less than 10% of CABG cases in the U.S.,” he reported. “Hopefully, our data will lead to a larger use of this conduit by the surgical community.”

Dr. Gaudino, the principal investigator, reported no potential conflicts of interest relevant to this study.

SOURCE: Gaudino MFL et al. JAMA. 2020;324:179-87.

Viral testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) of all patients admitted to the hospital is an appealing objective given the recognition of asymptomatic or minimally symptomatic infections. Yet such testing requires that all admitted patients be classified as persons under investigation (PUIs) until their test results are known. If an outside laboratory is used for the SARS-CoV-2 testing, the delay in obtaining results for these PUIs may cause significant personal protective equipment (PPE) use, postpone some care for non-coronavirus disease 2019 (COVID-19) conditions, block beds, and produce anxiety among staff and other patients. Rapid in-house testing of all admitted patients may resolve these issues but may be limited by the supply of reagents. To address this challenge, we piloted a pooled testing strategy for patients at low risk for SARS-CoV-2 admitted to a community hospital.

From April 17, 2020, to May 11, 2020, we implemented a pooled testing strategy using the GeneXpert^® System (Cepheid, Sunnyvale, California) at Saratoga Hospital, a 171-bed community hospital in upstate New York. Under normal procedures for this system, a single patient swab is placed in a vial containing viral transport media (VTM). An aliquot of this media is then transferred into a Xpert^® Xpress SARS CoV-2 test cartridge and assayed on the GeneXpert® instrument in our laboratory. Obtaining immediate results allowed us to assign admitted patients to either a COVID-19 or a non–COVID-19 unit, improving the issues associated with PUIs. Unfortunately, we did not have enough test cartridges to sustain this strategy of rapid individual testing of all admitted patients, and supply lines have remained uncertain.

We sought to conserve our limited Xpert Xpress SARS CoV-2 test cartridges using the strategy of pooled testing, a technique reported in Germany and by the University of Nebraska.^1,2 In this method, variable numbers of tests are pooled for a single analysis. If the test from the pooled vial is negative, these patients are all considered negative. If the pooled test is positive, all those patients need individual testing. This pooling method has been theorized to preserve test cartridges when the expected frequency of positive results is low.³

All patients admitted or placed on observation underwent SARS-CoV-2 PCR testing. The Emergency Department (ED) staff stratified patients into high or low risk to determine if they would be tested in a single send-out test (high risk) or a rapid in-house pooled group (low risk). High-risk patients were those with compatible history, physical exam, laboratory markers, and radiographic studies for COVID-19 disease. This often included increased supplemental oxygen requirement, multiple elevated inflammatory markers (including D-dimer, C-reactive protein, erythrocyte sedimentation rate, and ferritin levels), lymphopenia, and findings on chest radiograph or computed tomography scan including ground glass changes, multifocal pneumonia, or pneumonia. High-risk patients were admitted to the COVID unit or intensive care unit, had a send-out SARS-CoV-2 polymerase chain reaction (PCR) test, and were treated as a PUI until the results of their testing was known and correlated with their clinical course. Low-risk patients were those without complaints suggestive of COVID-19 infection and who may have had negative inflammatory markers, no significant lymphopenia, and negative imaging. 

The samples from 3 admitted patients thought to be at low-risk for COVID-19 using the clinical judgement of our ED staff were pooled for testing. All samples were obtained using nasopharyngeal swabs by experienced staff. The swabs from these patients were placed into a single vial of 3 mL VTM, maintaining the recommended 1 swab per mL of VTM. An aliquot of this media was then transferred into an Xpert Xpress SARS CoV-2 test cartridge and assayed on the GeneXpert instrument in our laboratory following manufacturer’s instructions. Based on analytic laboratory studies of the Cepheid Xpert Express SARS-CoV-2 test,⁴ we assume a clinical performance comparable to other reverse-transcriptase PCR (RT-PCR) tests, which have so far demonstrated sensitivities of 60% to 80% and specificities of 95% to 99%.⁵

Validation studies were performed on pools made from samples obtained from admitted patients with previously known positive and negative samples tested at the New York State Department of Health, Wadsworth Center laboratory (Albany, New York). A total of 14 samples were used for the instrument validation study, including three samples for pooled testing. The cycle threshold (Ct) value is defined as the number of PCR cycles required for the signal to be detectable. Ct values for each nucleic acid target of a known positive sample tested singly and in the pool with known negative patients were compared. A small shift in Ct values was noted between single and pooled testing, demonstrating no decrease in analytic sensitivity and suggesting that we would experience no decrease in clinical sensitivity.

We selected the pooling of 3 samples into 1 cartridge for several reasons: (1) 3-sample pools are well within the appropriate pooling size for the percentage positive rate in the population being tested. The use of larger pool sizes results in the need for more repeat testing when a positive result is obtained; (2) Given our supply lines, the projected savings would allow us to continue this strategy; and (3) Holding 3 patients in the ED until a pool was ready was manageable given our rate of admissions and ED volume.

The strategy required patients being held in the ED until a pooled group of 3 could be tested. On select occasions when holding patients in the ED to obtain a pool of 3 was not practical, 2 patients were tested in the pool. These decisions required close coordination between the laboratory, ED, and nursing staff.

This strategy resulted in 530 unique patient tests in 179 cartridges (172 with three swabs and 7 with two swabs). We had 4 positive pooled tests, requiring the use of 11 additional cartridges, for a positive rate of 0.8% (4/530) in this low-risk population (patients without COVID-19–related symptoms). There were no patients from negative pools who developed evidence of COVID-19 disease or tested positive for SARS-CoV-2 during their hospitalization. The total number of cartridges used was 190 and the number saved was 340.

The strategy of pooled testing for SARS-CoV-2 in patients admitted to our community hospital allowed us to continue rapid testing of admitted patients at low risk for COVID-19 disease during a period when supplies would otherwise not have been sufficient. We believe this strategy conserved PPE, led to a marked reduction in staff and patient anxiety, and improved patient care. Our impression is that testing all admitted patients has also been reassuring to our community. Like many others, we have observed that public fear of entering the hospital during this pandemic has caused delays in patients seeking care for non–COVID-19 conditions. We believe this strategy will help reduce those fears.

This strategy may require modification as the pandemic progresses. Our ED physicians were able to identify patients who they felt to be low risk for having COVID-19 disease based on signs, symptoms, and clinical impression during a time when we had an 8% positive rate among symptomatic outpatients and an estimated community positive rate in the range of 1% to 2%. If the rate of positive tests in our community rises, the use of pooling may need to be limited or the pool size reduced. If our supply of reagents is further limited or patient testing demand increases, the pool size may need to be increased. This will need to be balanced with our ability to hold patients in the ED while waiting for the pool size to be reached.

The strategy of pooled testing for SARS-CoV-2 has allowed us to continue to immediately test all admitted patients, thus improving patient care. It has required close coordination between multiple members of our laboratory and clinical staff and may require adjustment as the pandemic progresses. We believe it is a valuable tool during a time of limited resources that may have application in testing other low-risk groups, including healthcare workers and clients of occupational medicine services.

The authors gratefully acknowledge the support of Kirsten St. George, MAppSc, PhD, Director, Virology Laboratory, Wadsworth, NYSDOH, and the services supplied by the Wadsworth laboratory to our region.

Viral testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) of all patients admitted to the hospital is an appealing objective given the recognition of asymptomatic or minimally symptomatic infections. Yet such testing requires that all admitted patients be classified as persons under investigation (PUIs) until their test results are known. If an outside laboratory is used for the SARS-CoV-2 testing, the delay in obtaining results for these PUIs may cause significant personal protective equipment (PPE) use, postpone some care for non-coronavirus disease 2019 (COVID-19) conditions, block beds, and produce anxiety among staff and other patients. Rapid in-house testing of all admitted patients may resolve these issues but may be limited by the supply of reagents. To address this challenge, we piloted a pooled testing strategy for patients at low risk for SARS-CoV-2 admitted to a community hospital.

From April 17, 2020, to May 11, 2020, we implemented a pooled testing strategy using the GeneXpert^® System (Cepheid, Sunnyvale, California) at Saratoga Hospital, a 171-bed community hospital in upstate New York. Under normal procedures for this system, a single patient swab is placed in a vial containing viral transport media (VTM). An aliquot of this media is then transferred into a Xpert^® Xpress SARS CoV-2 test cartridge and assayed on the GeneXpert® instrument in our laboratory. Obtaining immediate results allowed us to assign admitted patients to either a COVID-19 or a non–COVID-19 unit, improving the issues associated with PUIs. Unfortunately, we did not have enough test cartridges to sustain this strategy of rapid individual testing of all admitted patients, and supply lines have remained uncertain.

We sought to conserve our limited Xpert Xpress SARS CoV-2 test cartridges using the strategy of pooled testing, a technique reported in Germany and by the University of Nebraska.^1,2 In this method, variable numbers of tests are pooled for a single analysis. If the test from the pooled vial is negative, these patients are all considered negative. If the pooled test is positive, all those patients need individual testing. This pooling method has been theorized to preserve test cartridges when the expected frequency of positive results is low.³

All patients admitted or placed on observation underwent SARS-CoV-2 PCR testing. The Emergency Department (ED) staff stratified patients into high or low risk to determine if they would be tested in a single send-out test (high risk) or a rapid in-house pooled group (low risk). High-risk patients were those with compatible history, physical exam, laboratory markers, and radiographic studies for COVID-19 disease. This often included increased supplemental oxygen requirement, multiple elevated inflammatory markers (including D-dimer, C-reactive protein, erythrocyte sedimentation rate, and ferritin levels), lymphopenia, and findings on chest radiograph or computed tomography scan including ground glass changes, multifocal pneumonia, or pneumonia. High-risk patients were admitted to the COVID unit or intensive care unit, had a send-out SARS-CoV-2 polymerase chain reaction (PCR) test, and were treated as a PUI until the results of their testing was known and correlated with their clinical course. Low-risk patients were those without complaints suggestive of COVID-19 infection and who may have had negative inflammatory markers, no significant lymphopenia, and negative imaging. 

The samples from 3 admitted patients thought to be at low-risk for COVID-19 using the clinical judgement of our ED staff were pooled for testing. All samples were obtained using nasopharyngeal swabs by experienced staff. The swabs from these patients were placed into a single vial of 3 mL VTM, maintaining the recommended 1 swab per mL of VTM. An aliquot of this media was then transferred into an Xpert Xpress SARS CoV-2 test cartridge and assayed on the GeneXpert instrument in our laboratory following manufacturer’s instructions. Based on analytic laboratory studies of the Cepheid Xpert Express SARS-CoV-2 test,⁴ we assume a clinical performance comparable to other reverse-transcriptase PCR (RT-PCR) tests, which have so far demonstrated sensitivities of 60% to 80% and specificities of 95% to 99%.⁵

Validation studies were performed on pools made from samples obtained from admitted patients with previously known positive and negative samples tested at the New York State Department of Health, Wadsworth Center laboratory (Albany, New York). A total of 14 samples were used for the instrument validation study, including three samples for pooled testing. The cycle threshold (Ct) value is defined as the number of PCR cycles required for the signal to be detectable. Ct values for each nucleic acid target of a known positive sample tested singly and in the pool with known negative patients were compared. A small shift in Ct values was noted between single and pooled testing, demonstrating no decrease in analytic sensitivity and suggesting that we would experience no decrease in clinical sensitivity.

We selected the pooling of 3 samples into 1 cartridge for several reasons: (1) 3-sample pools are well within the appropriate pooling size for the percentage positive rate in the population being tested. The use of larger pool sizes results in the need for more repeat testing when a positive result is obtained; (2) Given our supply lines, the projected savings would allow us to continue this strategy; and (3) Holding 3 patients in the ED until a pool was ready was manageable given our rate of admissions and ED volume.

The strategy required patients being held in the ED until a pooled group of 3 could be tested. On select occasions when holding patients in the ED to obtain a pool of 3 was not practical, 2 patients were tested in the pool. These decisions required close coordination between the laboratory, ED, and nursing staff.

This strategy resulted in 530 unique patient tests in 179 cartridges (172 with three swabs and 7 with two swabs). We had 4 positive pooled tests, requiring the use of 11 additional cartridges, for a positive rate of 0.8% (4/530) in this low-risk population (patients without COVID-19–related symptoms). There were no patients from negative pools who developed evidence of COVID-19 disease or tested positive for SARS-CoV-2 during their hospitalization. The total number of cartridges used was 190 and the number saved was 340.

The strategy of pooled testing for SARS-CoV-2 in patients admitted to our community hospital allowed us to continue rapid testing of admitted patients at low risk for COVID-19 disease during a period when supplies would otherwise not have been sufficient. We believe this strategy conserved PPE, led to a marked reduction in staff and patient anxiety, and improved patient care. Our impression is that testing all admitted patients has also been reassuring to our community. Like many others, we have observed that public fear of entering the hospital during this pandemic has caused delays in patients seeking care for non–COVID-19 conditions. We believe this strategy will help reduce those fears.

This strategy may require modification as the pandemic progresses. Our ED physicians were able to identify patients who they felt to be low risk for having COVID-19 disease based on signs, symptoms, and clinical impression during a time when we had an 8% positive rate among symptomatic outpatients and an estimated community positive rate in the range of 1% to 2%. If the rate of positive tests in our community rises, the use of pooling may need to be limited or the pool size reduced. If our supply of reagents is further limited or patient testing demand increases, the pool size may need to be increased. This will need to be balanced with our ability to hold patients in the ED while waiting for the pool size to be reached.

The strategy of pooled testing for SARS-CoV-2 has allowed us to continue to immediately test all admitted patients, thus improving patient care. It has required close coordination between multiple members of our laboratory and clinical staff and may require adjustment as the pandemic progresses. We believe it is a valuable tool during a time of limited resources that may have application in testing other low-risk groups, including healthcare workers and clients of occupational medicine services.

The authors gratefully acknowledge the support of Kirsten St. George, MAppSc, PhD, Director, Virology Laboratory, Wadsworth, NYSDOH, and the services supplied by the Wadsworth laboratory to our region.

Viral testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) of all patients admitted to the hospital is an appealing objective given the recognition of asymptomatic or minimally symptomatic infections. Yet such testing requires that all admitted patients be classified as persons under investigation (PUIs) until their test results are known. If an outside laboratory is used for the SARS-CoV-2 testing, the delay in obtaining results for these PUIs may cause significant personal protective equipment (PPE) use, postpone some care for non-coronavirus disease 2019 (COVID-19) conditions, block beds, and produce anxiety among staff and other patients. Rapid in-house testing of all admitted patients may resolve these issues but may be limited by the supply of reagents. To address this challenge, we piloted a pooled testing strategy for patients at low risk for SARS-CoV-2 admitted to a community hospital.

From April 17, 2020, to May 11, 2020, we implemented a pooled testing strategy using the GeneXpert^® System (Cepheid, Sunnyvale, California) at Saratoga Hospital, a 171-bed community hospital in upstate New York. Under normal procedures for this system, a single patient swab is placed in a vial containing viral transport media (VTM). An aliquot of this media is then transferred into a Xpert^® Xpress SARS CoV-2 test cartridge and assayed on the GeneXpert® instrument in our laboratory. Obtaining immediate results allowed us to assign admitted patients to either a COVID-19 or a non–COVID-19 unit, improving the issues associated with PUIs. Unfortunately, we did not have enough test cartridges to sustain this strategy of rapid individual testing of all admitted patients, and supply lines have remained uncertain.

We sought to conserve our limited Xpert Xpress SARS CoV-2 test cartridges using the strategy of pooled testing, a technique reported in Germany and by the University of Nebraska.^1,2 In this method, variable numbers of tests are pooled for a single analysis. If the test from the pooled vial is negative, these patients are all considered negative. If the pooled test is positive, all those patients need individual testing. This pooling method has been theorized to preserve test cartridges when the expected frequency of positive results is low.³

All patients admitted or placed on observation underwent SARS-CoV-2 PCR testing. The Emergency Department (ED) staff stratified patients into high or low risk to determine if they would be tested in a single send-out test (high risk) or a rapid in-house pooled group (low risk). High-risk patients were those with compatible history, physical exam, laboratory markers, and radiographic studies for COVID-19 disease. This often included increased supplemental oxygen requirement, multiple elevated inflammatory markers (including D-dimer, C-reactive protein, erythrocyte sedimentation rate, and ferritin levels), lymphopenia, and findings on chest radiograph or computed tomography scan including ground glass changes, multifocal pneumonia, or pneumonia. High-risk patients were admitted to the COVID unit or intensive care unit, had a send-out SARS-CoV-2 polymerase chain reaction (PCR) test, and were treated as a PUI until the results of their testing was known and correlated with their clinical course. Low-risk patients were those without complaints suggestive of COVID-19 infection and who may have had negative inflammatory markers, no significant lymphopenia, and negative imaging. 

The samples from 3 admitted patients thought to be at low-risk for COVID-19 using the clinical judgement of our ED staff were pooled for testing. All samples were obtained using nasopharyngeal swabs by experienced staff. The swabs from these patients were placed into a single vial of 3 mL VTM, maintaining the recommended 1 swab per mL of VTM. An aliquot of this media was then transferred into an Xpert Xpress SARS CoV-2 test cartridge and assayed on the GeneXpert instrument in our laboratory following manufacturer’s instructions. Based on analytic laboratory studies of the Cepheid Xpert Express SARS-CoV-2 test,⁴ we assume a clinical performance comparable to other reverse-transcriptase PCR (RT-PCR) tests, which have so far demonstrated sensitivities of 60% to 80% and specificities of 95% to 99%.⁵

Validation studies were performed on pools made from samples obtained from admitted patients with previously known positive and negative samples tested at the New York State Department of Health, Wadsworth Center laboratory (Albany, New York). A total of 14 samples were used for the instrument validation study, including three samples for pooled testing. The cycle threshold (Ct) value is defined as the number of PCR cycles required for the signal to be detectable. Ct values for each nucleic acid target of a known positive sample tested singly and in the pool with known negative patients were compared. A small shift in Ct values was noted between single and pooled testing, demonstrating no decrease in analytic sensitivity and suggesting that we would experience no decrease in clinical sensitivity.

We selected the pooling of 3 samples into 1 cartridge for several reasons: (1) 3-sample pools are well within the appropriate pooling size for the percentage positive rate in the population being tested. The use of larger pool sizes results in the need for more repeat testing when a positive result is obtained; (2) Given our supply lines, the projected savings would allow us to continue this strategy; and (3) Holding 3 patients in the ED until a pool was ready was manageable given our rate of admissions and ED volume.

The strategy required patients being held in the ED until a pooled group of 3 could be tested. On select occasions when holding patients in the ED to obtain a pool of 3 was not practical, 2 patients were tested in the pool. These decisions required close coordination between the laboratory, ED, and nursing staff.

This strategy resulted in 530 unique patient tests in 179 cartridges (172 with three swabs and 7 with two swabs). We had 4 positive pooled tests, requiring the use of 11 additional cartridges, for a positive rate of 0.8% (4/530) in this low-risk population (patients without COVID-19–related symptoms). There were no patients from negative pools who developed evidence of COVID-19 disease or tested positive for SARS-CoV-2 during their hospitalization. The total number of cartridges used was 190 and the number saved was 340.

The strategy of pooled testing for SARS-CoV-2 in patients admitted to our community hospital allowed us to continue rapid testing of admitted patients at low risk for COVID-19 disease during a period when supplies would otherwise not have been sufficient. We believe this strategy conserved PPE, led to a marked reduction in staff and patient anxiety, and improved patient care. Our impression is that testing all admitted patients has also been reassuring to our community. Like many others, we have observed that public fear of entering the hospital during this pandemic has caused delays in patients seeking care for non–COVID-19 conditions. We believe this strategy will help reduce those fears.

This strategy may require modification as the pandemic progresses. Our ED physicians were able to identify patients who they felt to be low risk for having COVID-19 disease based on signs, symptoms, and clinical impression during a time when we had an 8% positive rate among symptomatic outpatients and an estimated community positive rate in the range of 1% to 2%. If the rate of positive tests in our community rises, the use of pooling may need to be limited or the pool size reduced. If our supply of reagents is further limited or patient testing demand increases, the pool size may need to be increased. This will need to be balanced with our ability to hold patients in the ED while waiting for the pool size to be reached.

The strategy of pooled testing for SARS-CoV-2 has allowed us to continue to immediately test all admitted patients, thus improving patient care. It has required close coordination between multiple members of our laboratory and clinical staff and may require adjustment as the pandemic progresses. We believe it is a valuable tool during a time of limited resources that may have application in testing other low-risk groups, including healthcare workers and clients of occupational medicine services.

The authors gratefully acknowledge the support of Kirsten St. George, MAppSc, PhD, Director, Virology Laboratory, Wadsworth, NYSDOH, and the services supplied by the Wadsworth laboratory to our region.