Leah Croll, MD

With the Food and Drug Administration’s full stamp of approval in hand, Leqembi (lecanemab) is poised to catapult us into a new era of treatment for Alzheimer’s disease. And now that the donanemab trial data are out, there’s another antiamyloid drug waiting in the wings.

To finally have true disease-modifying therapies for Alzheimer’s disease is a massive step forward for a field that’s been plagued with disappointment. But these drugs come with serious concerns and unknowns. They will require complex decision-making, putting doctors, patients, and their families in a medical quandary.

Striking the right balance between cautious optimism and realistic expectations will be a formidable challenge.
 

Managing patient and family expectations

These drugs are no magic bullet. They slow down the dementia’s progression, buying patients more time (on the order of months) before they begin to experience significant worsening. We’ll need a lot more information from research and clinical experience before we can understand how meaningful that treatment effect is. Right now, it is unclear whether eligible patients and their families will even perceive tangible differences.

In the CLARITY-AD trial, participants on lecanemab experienced a 27% slowing in the rate of cognitive decline over 18 months. Donanemab was shown to slow decline in memory and cognition by about 35% over the same time frame in the TRAILBLAZER-ALZ 2 trial. That translates to more time for patients and their families to enjoy independence, maintain normal life, and stave off the most distressing parts of the disease.

But what happens after 18 months of treatment – will the treatment effect magnify or dissipate? How much time are we really buying in the long run? Counseling patients and their families is made all the more difficult when the answers to important questions like these remain to be seen.
 

Only a sliver of Alzheimer’s patients are current candidates

The fact is that most patients living with Alzheimer’s disease will not qualify for treatment with these drugs. Lecanemab is approved for people with early-stage disease, meaning their dementia is mild or they have mild cognitive impairment, which is a precursor to full-blown Alzheimer’s disease. Of the 6 million people in the United States living with Alzheimer’s, about 1.5 million are estimated to fall into that category. We can expect to see a similar qualifier for donanemab if it receives FDA approval, especially because that trial suggested a more pronounced treatment effect for patients in the earliest stages of the disease.

Even if a patient hits the sweet spot where they have just enough cognitive impairment, but not too much, they aren’t technically therapeutic candidates until prerequisite testing confirms amyloid protein accumulation in the brain via PET scan or cerebrospinal fluid analysis.

Even then, the FDA’s boxed warning for lecanemab recommends that patients undergo genetic testing for the apo E4 mutation to identify those at a particularly high risk for severe adverse effects including brain bleeding and swelling. This recommendation is not unreasonable considering that 15% of the Alzheimer’s population has two copies of the apo E4 mutation and fall into that high-risk group.
 

Significant risks

Antiamyloid drugs are well-known to cause serious side effects. In the lecanemab trial, 13% of participants receiving Leqembi experienced brain swelling (vs. 2% of participants receiving placebo) and 17% of participants had brain bleeding (vs. 9% of participants on placebo). In the donanemab trial, brain bleeding occurred in 31.4% of participants on the drug (vs. 13.6% on placebo) and swelling occurred in 24% (vs. 2.1% receiving placebo). Thankfully, in both trials, most of these adverse events did not produce significant symptoms, but in rare cases these events caused severe or catastrophic neurologic injury, including death.

How can we best guide patients and their families to weigh the uncertain benefits against potentially serious risks? We can start by considering the patient characteristics most likely to portend increased risk for serious side effects: apo E4 mutations, blood thinner use, and the presence of microhemorrhages on brain imaging. But after that, we’re left with a lot of uncertainty in terms of which patients are most likely to see meaningful clinical improvements from the drug and unknown factors that may increase the risks of treatment.
 

A costly therapy

Medicare plans to cover 80% of lecanemab’s steep cost of $26,500 per year. Still, that will leave many patients with a hefty copay, potentially over $6,000 per year. But that only scratches the surface. Consider the frequent medical visits, repeated brain scans, laboratory tests, and infusion center appointments. It’s been estimated that all-in, the treatment will actually cost about $90,000 per year.

Yes, Medicare will reimburse a large portion of that cost, but it adds up to an estimated $2 billion per year for about 85,000 patients. This will probably spur increases to Medicare premiums, among other economic consequences for the health care system.

We’ll probably have to wait for an FDA approval decision before we know where donanemab will be priced.
 

Logistical challenges could be a rate-limiting step

Ask anyone who’s tried to see a neurologist recently, and they’ll tell you that the wait for a new patient appointment is months long. The shortage of neurologists in the United States is already a crisis, and there are even fewer cognitive neurologists. How long will patients be forced to wait for their diagnosis?

Many geriatricians will get comfortable prescribing these drugs, but will our already overburdened primary care providers have the bandwidth to do the same? It’s a tall order.

A new world of Alzheimer’s treatments also means that the infrastructure of our health care systems will need to be ramped up. Lecanemab infusions are administered every 2 weeks and donanemab every 4 weeks. Infusion centers will need to accommodate a lot more patients. And those patients will need frequent brain scans, so neuroimaging centers will need to increase their capacity to perform many more brain MRI and PET scans.
 

Antiamyloid drugs: An exciting first step

The bottom line is that these drugs aren’t the Alzheimer’s holy grail: An accessible treatment that could stop the disease in its tracks or reverse cognitive impairment. They are, however, a very promising breakthrough.

Yes, there are a ton of kinks to work out here, but this is an exciting start. Alzheimer’s research is entering a renaissance era that will hopefully bring more groundbreaking developments. Better biomarkers to facilitate faster, easier diagnosis. More drugs that go beyond amyloid proteins for their therapeutic targets. Treatments for later-stage disease. Drugs that prevent dementia altogether.

Ultimately, these new antiamyloid beta drugs are an exciting indication that we will eventually have a toolkit of Alzheimer’s drugs to choose from. For now, we’ve taken a solid step forward and there is ample reason to be hopeful for the future.

Dr. Croll is assistant professor of neurology at Temple University, Philadelphia. She reported no relevant conflicts of interest.

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

With the Food and Drug Administration’s full stamp of approval in hand, Leqembi (lecanemab) is poised to catapult us into a new era of treatment for Alzheimer’s disease. And now that the donanemab trial data are out, there’s another antiamyloid drug waiting in the wings.

To finally have true disease-modifying therapies for Alzheimer’s disease is a massive step forward for a field that’s been plagued with disappointment. But these drugs come with serious concerns and unknowns. They will require complex decision-making, putting doctors, patients, and their families in a medical quandary.

Striking the right balance between cautious optimism and realistic expectations will be a formidable challenge.
 

Managing patient and family expectations

These drugs are no magic bullet. They slow down the dementia’s progression, buying patients more time (on the order of months) before they begin to experience significant worsening. We’ll need a lot more information from research and clinical experience before we can understand how meaningful that treatment effect is. Right now, it is unclear whether eligible patients and their families will even perceive tangible differences.

In the CLARITY-AD trial, participants on lecanemab experienced a 27% slowing in the rate of cognitive decline over 18 months. Donanemab was shown to slow decline in memory and cognition by about 35% over the same time frame in the TRAILBLAZER-ALZ 2 trial. That translates to more time for patients and their families to enjoy independence, maintain normal life, and stave off the most distressing parts of the disease.

But what happens after 18 months of treatment – will the treatment effect magnify or dissipate? How much time are we really buying in the long run? Counseling patients and their families is made all the more difficult when the answers to important questions like these remain to be seen.
 

Only a sliver of Alzheimer’s patients are current candidates

The fact is that most patients living with Alzheimer’s disease will not qualify for treatment with these drugs. Lecanemab is approved for people with early-stage disease, meaning their dementia is mild or they have mild cognitive impairment, which is a precursor to full-blown Alzheimer’s disease. Of the 6 million people in the United States living with Alzheimer’s, about 1.5 million are estimated to fall into that category. We can expect to see a similar qualifier for donanemab if it receives FDA approval, especially because that trial suggested a more pronounced treatment effect for patients in the earliest stages of the disease.

Even if a patient hits the sweet spot where they have just enough cognitive impairment, but not too much, they aren’t technically therapeutic candidates until prerequisite testing confirms amyloid protein accumulation in the brain via PET scan or cerebrospinal fluid analysis.

Even then, the FDA’s boxed warning for lecanemab recommends that patients undergo genetic testing for the apo E4 mutation to identify those at a particularly high risk for severe adverse effects including brain bleeding and swelling. This recommendation is not unreasonable considering that 15% of the Alzheimer’s population has two copies of the apo E4 mutation and fall into that high-risk group.
 

Significant risks

Antiamyloid drugs are well-known to cause serious side effects. In the lecanemab trial, 13% of participants receiving Leqembi experienced brain swelling (vs. 2% of participants receiving placebo) and 17% of participants had brain bleeding (vs. 9% of participants on placebo). In the donanemab trial, brain bleeding occurred in 31.4% of participants on the drug (vs. 13.6% on placebo) and swelling occurred in 24% (vs. 2.1% receiving placebo). Thankfully, in both trials, most of these adverse events did not produce significant symptoms, but in rare cases these events caused severe or catastrophic neurologic injury, including death.

How can we best guide patients and their families to weigh the uncertain benefits against potentially serious risks? We can start by considering the patient characteristics most likely to portend increased risk for serious side effects: apo E4 mutations, blood thinner use, and the presence of microhemorrhages on brain imaging. But after that, we’re left with a lot of uncertainty in terms of which patients are most likely to see meaningful clinical improvements from the drug and unknown factors that may increase the risks of treatment.
 

A costly therapy

Medicare plans to cover 80% of lecanemab’s steep cost of $26,500 per year. Still, that will leave many patients with a hefty copay, potentially over $6,000 per year. But that only scratches the surface. Consider the frequent medical visits, repeated brain scans, laboratory tests, and infusion center appointments. It’s been estimated that all-in, the treatment will actually cost about $90,000 per year.

Yes, Medicare will reimburse a large portion of that cost, but it adds up to an estimated $2 billion per year for about 85,000 patients. This will probably spur increases to Medicare premiums, among other economic consequences for the health care system.

We’ll probably have to wait for an FDA approval decision before we know where donanemab will be priced.
 

Logistical challenges could be a rate-limiting step

Ask anyone who’s tried to see a neurologist recently, and they’ll tell you that the wait for a new patient appointment is months long. The shortage of neurologists in the United States is already a crisis, and there are even fewer cognitive neurologists. How long will patients be forced to wait for their diagnosis?

Many geriatricians will get comfortable prescribing these drugs, but will our already overburdened primary care providers have the bandwidth to do the same? It’s a tall order.

A new world of Alzheimer’s treatments also means that the infrastructure of our health care systems will need to be ramped up. Lecanemab infusions are administered every 2 weeks and donanemab every 4 weeks. Infusion centers will need to accommodate a lot more patients. And those patients will need frequent brain scans, so neuroimaging centers will need to increase their capacity to perform many more brain MRI and PET scans.
 

Antiamyloid drugs: An exciting first step

The bottom line is that these drugs aren’t the Alzheimer’s holy grail: An accessible treatment that could stop the disease in its tracks or reverse cognitive impairment. They are, however, a very promising breakthrough.

Yes, there are a ton of kinks to work out here, but this is an exciting start. Alzheimer’s research is entering a renaissance era that will hopefully bring more groundbreaking developments. Better biomarkers to facilitate faster, easier diagnosis. More drugs that go beyond amyloid proteins for their therapeutic targets. Treatments for later-stage disease. Drugs that prevent dementia altogether.

Ultimately, these new antiamyloid beta drugs are an exciting indication that we will eventually have a toolkit of Alzheimer’s drugs to choose from. For now, we’ve taken a solid step forward and there is ample reason to be hopeful for the future.

Dr. Croll is assistant professor of neurology at Temple University, Philadelphia. She reported no relevant conflicts of interest.

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

With the Food and Drug Administration’s full stamp of approval in hand, Leqembi (lecanemab) is poised to catapult us into a new era of treatment for Alzheimer’s disease. And now that the donanemab trial data are out, there’s another antiamyloid drug waiting in the wings.

To finally have true disease-modifying therapies for Alzheimer’s disease is a massive step forward for a field that’s been plagued with disappointment. But these drugs come with serious concerns and unknowns. They will require complex decision-making, putting doctors, patients, and their families in a medical quandary.

Striking the right balance between cautious optimism and realistic expectations will be a formidable challenge.
 

Managing patient and family expectations

These drugs are no magic bullet. They slow down the dementia’s progression, buying patients more time (on the order of months) before they begin to experience significant worsening. We’ll need a lot more information from research and clinical experience before we can understand how meaningful that treatment effect is. Right now, it is unclear whether eligible patients and their families will even perceive tangible differences.

In the CLARITY-AD trial, participants on lecanemab experienced a 27% slowing in the rate of cognitive decline over 18 months. Donanemab was shown to slow decline in memory and cognition by about 35% over the same time frame in the TRAILBLAZER-ALZ 2 trial. That translates to more time for patients and their families to enjoy independence, maintain normal life, and stave off the most distressing parts of the disease.

But what happens after 18 months of treatment – will the treatment effect magnify or dissipate? How much time are we really buying in the long run? Counseling patients and their families is made all the more difficult when the answers to important questions like these remain to be seen.
 

Only a sliver of Alzheimer’s patients are current candidates

The fact is that most patients living with Alzheimer’s disease will not qualify for treatment with these drugs. Lecanemab is approved for people with early-stage disease, meaning their dementia is mild or they have mild cognitive impairment, which is a precursor to full-blown Alzheimer’s disease. Of the 6 million people in the United States living with Alzheimer’s, about 1.5 million are estimated to fall into that category. We can expect to see a similar qualifier for donanemab if it receives FDA approval, especially because that trial suggested a more pronounced treatment effect for patients in the earliest stages of the disease.

Even if a patient hits the sweet spot where they have just enough cognitive impairment, but not too much, they aren’t technically therapeutic candidates until prerequisite testing confirms amyloid protein accumulation in the brain via PET scan or cerebrospinal fluid analysis.

Even then, the FDA’s boxed warning for lecanemab recommends that patients undergo genetic testing for the apo E4 mutation to identify those at a particularly high risk for severe adverse effects including brain bleeding and swelling. This recommendation is not unreasonable considering that 15% of the Alzheimer’s population has two copies of the apo E4 mutation and fall into that high-risk group.
 

Significant risks

Antiamyloid drugs are well-known to cause serious side effects. In the lecanemab trial, 13% of participants receiving Leqembi experienced brain swelling (vs. 2% of participants receiving placebo) and 17% of participants had brain bleeding (vs. 9% of participants on placebo). In the donanemab trial, brain bleeding occurred in 31.4% of participants on the drug (vs. 13.6% on placebo) and swelling occurred in 24% (vs. 2.1% receiving placebo). Thankfully, in both trials, most of these adverse events did not produce significant symptoms, but in rare cases these events caused severe or catastrophic neurologic injury, including death.

How can we best guide patients and their families to weigh the uncertain benefits against potentially serious risks? We can start by considering the patient characteristics most likely to portend increased risk for serious side effects: apo E4 mutations, blood thinner use, and the presence of microhemorrhages on brain imaging. But after that, we’re left with a lot of uncertainty in terms of which patients are most likely to see meaningful clinical improvements from the drug and unknown factors that may increase the risks of treatment.
 

A costly therapy

Medicare plans to cover 80% of lecanemab’s steep cost of $26,500 per year. Still, that will leave many patients with a hefty copay, potentially over $6,000 per year. But that only scratches the surface. Consider the frequent medical visits, repeated brain scans, laboratory tests, and infusion center appointments. It’s been estimated that all-in, the treatment will actually cost about $90,000 per year.

Yes, Medicare will reimburse a large portion of that cost, but it adds up to an estimated $2 billion per year for about 85,000 patients. This will probably spur increases to Medicare premiums, among other economic consequences for the health care system.

We’ll probably have to wait for an FDA approval decision before we know where donanemab will be priced.
 

Logistical challenges could be a rate-limiting step

Ask anyone who’s tried to see a neurologist recently, and they’ll tell you that the wait for a new patient appointment is months long. The shortage of neurologists in the United States is already a crisis, and there are even fewer cognitive neurologists. How long will patients be forced to wait for their diagnosis?

Many geriatricians will get comfortable prescribing these drugs, but will our already overburdened primary care providers have the bandwidth to do the same? It’s a tall order.

A new world of Alzheimer’s treatments also means that the infrastructure of our health care systems will need to be ramped up. Lecanemab infusions are administered every 2 weeks and donanemab every 4 weeks. Infusion centers will need to accommodate a lot more patients. And those patients will need frequent brain scans, so neuroimaging centers will need to increase their capacity to perform many more brain MRI and PET scans.
 

Antiamyloid drugs: An exciting first step

The bottom line is that these drugs aren’t the Alzheimer’s holy grail: An accessible treatment that could stop the disease in its tracks or reverse cognitive impairment. They are, however, a very promising breakthrough.

Yes, there are a ton of kinks to work out here, but this is an exciting start. Alzheimer’s research is entering a renaissance era that will hopefully bring more groundbreaking developments. Better biomarkers to facilitate faster, easier diagnosis. More drugs that go beyond amyloid proteins for their therapeutic targets. Treatments for later-stage disease. Drugs that prevent dementia altogether.

Ultimately, these new antiamyloid beta drugs are an exciting indication that we will eventually have a toolkit of Alzheimer’s drugs to choose from. For now, we’ve taken a solid step forward and there is ample reason to be hopeful for the future.

Dr. Croll is assistant professor of neurology at Temple University, Philadelphia. She reported no relevant conflicts of interest.

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

“I’m happy to contribute, but can you keep it anonymous? It’s a safety concern for me.”

On the day that the Supreme Court of the United States voted to strike down Roe v. Wade, I reached out to ob.gyn.s across the country, wanting to hear their reactions. My own response, like that of many doctors and women, was a visceral mix of anger, fear, and grief. I could only begin to imagine what the real experts on reproductive health care were going through.

When the first ob.gyn. responded to my request by expressing concerns around anonymity and personal safety, I was shocked – but I shouldn’t have been. For starters, there is already a storied history in this country of deadly attacks on abortion providers. David Gunn, MD; Barnett Slepian, MD; and George Tiller, MD, were all tragically murdered by antiabortion extremists. Then, there’s the existence of websites that keep logs of abortion providers and sometimes include photos, office contact information, or even home addresses.

The idea that any reproductive health care provider should have to think twice before offering their uniquely qualified opinion is profoundly disturbing, nearly as disturbing as the Supreme Court’s decision itself. But it’s more critical than ever for ob.gyn. voices to be amplified. This is the time for the healthcare community to rally around women’s health providers, to learn from them, to support them.

I asked ob.gyns. around the country to tell me what they were thinking and feeling on the day that Roe v. Wade was overturned. We agreed to keep the responses anonymous, given that several people expressed very understandable safety concerns.

Here’s what they had to say.
 

Tennessee ob.gyn.

“Today is an emotionally charged day for many people in this country, yet as I type this, with my ob.gyn. practice continuing around me, with my own almost 10-week pregnancy growing inside me, I feel quite blunted. I feel powerless to answer questions that are variations on ‘what next?’ or ‘how do we fight back?’ All I can think of is, I am so glad I do not have anyone on my schedule right now who does not want to be pregnant. But what will happen when that eventually changes? What about my colleagues who do have these patients on their schedules today? On a personal level, what if my prenatal genetic testing comes back abnormal? How can we so blatantly disregard a separation of church and state in this country? What ways will our government interfere with my practice next? My head is spinning, but I have to go see my next patient. She is a 25-year-old who is here to have an IUD placed, and that seems like the most important thing I can do today.”

South Carolina ob.gyn.

“I’m really scared. For my patients and for myself. I don’t know how to be a good ob.gyn. if my ability to offer safe and accessible abortion care is being threatened.”

Massachusetts ob.gyn.

“Livid and devastated and sad and terrified.” 

California family planning specialist

“The fact is that about one in four people with uteruses have had an abortion. I can’t tell you how many abortions I’ve provided for people who say that they don’t ‘believe’ in them or that they thought they’d never be in this situation. ... The fact is that pregnancy is a life-threatening condition in and of itself. I am an ob.gyn., a medical doctor, and an abortion provider. I will not stop providing abortions or helping people access them. I will dedicate my life to ensuring this right to bodily autonomy. Today I am devastated by the Supreme Court’s decision to force parenthood that will result in increased maternal mortality. I am broken, but I have never been more proud to be an abortion provider.”

New York ob.gyn.

“Grateful to live in a state and work for a hospital where I can provide abortions but feel terrible for so many people less fortunate and underserved.”

Illinois maternal-fetal medicine specialist

“As a maternal-fetal medicine specialist, I fear for my patients who are at the highest risk of pregnancy complications having their freedom taken away. For the tragic ultrasound findings that make a pregnant person carry a baby who will never live. For the patients who cannot use most forms of contraception because of their medical comorbidities. For the patients who are victims of intimate partner violence or under the influence of their culture, to continue having children regardless of their desires or their health. ... The freedom to prevent or end a pregnancy has enabled women to become independent and productive members of society on their own terms, with or without children. My heart breaks for the children and adolescents and adults who are being told they are second-class citizens, not worthy of making their own decisions. Politicians and Supreme Court justices are not in the clinic room, ultrasound suite, operating room, or delivery room when we have these intense conversations and pregnancy outcomes. They have no idea that of which they speak, and it’s unconscionable that they can determine what healthcare decisions my patients can make for their own lives. Nobody knows a body better than the patient themselves.”

Texas ob.gyn.

“In the area where I live and practice, it feels like guns and the people who use them have more legal rights than people with uteruses in desperate or life-threatening situations. I’m afraid for my personal safety as a women’s health practitioner in this political climate. I feel helpless, but I’m supposed to be able to help my patients.”

Missouri family planning specialist

“Abortion is an essential part of healthcare, and the only people that should get a say in it are the patient and their doctor. Period. The fact that some far-off court without any medical expertise can insert itself into individual medical decisions is oppressive and unethical.”

Georgia ob.gyn.

“I can’t even think straight right now. I feel sick. Honestly, I’ve been thinking about moving for a long time now. Somewhere where I would actually be able to offer good, comprehensive care.”

New York ob.gyn.

“I graduated from my ob.gyn. residency hours after the Roe v. Wade news broke. It was so emotional for me. I’ve dedicated my life to caring for people with uteruses and I will not let this heartbreaking news change that. I feel more committed than ever to women’s health. I fully plan to continue delivering babies, providing contraception, and performing abortions. I will be there to help women with desired pregnancies who received unspeakably bad news about fetal anomalies. I will be there to help women with life-threatening pregnancy complications before fetal viability. I will be there to help women with ectopic pregnancies. I will be there to help women who were raped or otherwise forced into pregnancy. I will always be there to help women.”

Dr. Croll is a neurovascular fellow at New York University Langone Health. She disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

“I’m happy to contribute, but can you keep it anonymous? It’s a safety concern for me.”

On the day that the Supreme Court of the United States voted to strike down Roe v. Wade, I reached out to ob.gyn.s across the country, wanting to hear their reactions. My own response, like that of many doctors and women, was a visceral mix of anger, fear, and grief. I could only begin to imagine what the real experts on reproductive health care were going through.

When the first ob.gyn. responded to my request by expressing concerns around anonymity and personal safety, I was shocked – but I shouldn’t have been. For starters, there is already a storied history in this country of deadly attacks on abortion providers. David Gunn, MD; Barnett Slepian, MD; and George Tiller, MD, were all tragically murdered by antiabortion extremists. Then, there’s the existence of websites that keep logs of abortion providers and sometimes include photos, office contact information, or even home addresses.

The idea that any reproductive health care provider should have to think twice before offering their uniquely qualified opinion is profoundly disturbing, nearly as disturbing as the Supreme Court’s decision itself. But it’s more critical than ever for ob.gyn. voices to be amplified. This is the time for the healthcare community to rally around women’s health providers, to learn from them, to support them.

I asked ob.gyns. around the country to tell me what they were thinking and feeling on the day that Roe v. Wade was overturned. We agreed to keep the responses anonymous, given that several people expressed very understandable safety concerns.

Here’s what they had to say.
 

Tennessee ob.gyn.

“Today is an emotionally charged day for many people in this country, yet as I type this, with my ob.gyn. practice continuing around me, with my own almost 10-week pregnancy growing inside me, I feel quite blunted. I feel powerless to answer questions that are variations on ‘what next?’ or ‘how do we fight back?’ All I can think of is, I am so glad I do not have anyone on my schedule right now who does not want to be pregnant. But what will happen when that eventually changes? What about my colleagues who do have these patients on their schedules today? On a personal level, what if my prenatal genetic testing comes back abnormal? How can we so blatantly disregard a separation of church and state in this country? What ways will our government interfere with my practice next? My head is spinning, but I have to go see my next patient. She is a 25-year-old who is here to have an IUD placed, and that seems like the most important thing I can do today.”

South Carolina ob.gyn.

“I’m really scared. For my patients and for myself. I don’t know how to be a good ob.gyn. if my ability to offer safe and accessible abortion care is being threatened.”

Massachusetts ob.gyn.

“Livid and devastated and sad and terrified.” 

California family planning specialist

“The fact is that about one in four people with uteruses have had an abortion. I can’t tell you how many abortions I’ve provided for people who say that they don’t ‘believe’ in them or that they thought they’d never be in this situation. ... The fact is that pregnancy is a life-threatening condition in and of itself. I am an ob.gyn., a medical doctor, and an abortion provider. I will not stop providing abortions or helping people access them. I will dedicate my life to ensuring this right to bodily autonomy. Today I am devastated by the Supreme Court’s decision to force parenthood that will result in increased maternal mortality. I am broken, but I have never been more proud to be an abortion provider.”

New York ob.gyn.

“Grateful to live in a state and work for a hospital where I can provide abortions but feel terrible for so many people less fortunate and underserved.”

Illinois maternal-fetal medicine specialist

“As a maternal-fetal medicine specialist, I fear for my patients who are at the highest risk of pregnancy complications having their freedom taken away. For the tragic ultrasound findings that make a pregnant person carry a baby who will never live. For the patients who cannot use most forms of contraception because of their medical comorbidities. For the patients who are victims of intimate partner violence or under the influence of their culture, to continue having children regardless of their desires or their health. ... The freedom to prevent or end a pregnancy has enabled women to become independent and productive members of society on their own terms, with or without children. My heart breaks for the children and adolescents and adults who are being told they are second-class citizens, not worthy of making their own decisions. Politicians and Supreme Court justices are not in the clinic room, ultrasound suite, operating room, or delivery room when we have these intense conversations and pregnancy outcomes. They have no idea that of which they speak, and it’s unconscionable that they can determine what healthcare decisions my patients can make for their own lives. Nobody knows a body better than the patient themselves.”

Texas ob.gyn.

“In the area where I live and practice, it feels like guns and the people who use them have more legal rights than people with uteruses in desperate or life-threatening situations. I’m afraid for my personal safety as a women’s health practitioner in this political climate. I feel helpless, but I’m supposed to be able to help my patients.”

Missouri family planning specialist

“Abortion is an essential part of healthcare, and the only people that should get a say in it are the patient and their doctor. Period. The fact that some far-off court without any medical expertise can insert itself into individual medical decisions is oppressive and unethical.”

Georgia ob.gyn.

“I can’t even think straight right now. I feel sick. Honestly, I’ve been thinking about moving for a long time now. Somewhere where I would actually be able to offer good, comprehensive care.”

New York ob.gyn.

“I graduated from my ob.gyn. residency hours after the Roe v. Wade news broke. It was so emotional for me. I’ve dedicated my life to caring for people with uteruses and I will not let this heartbreaking news change that. I feel more committed than ever to women’s health. I fully plan to continue delivering babies, providing contraception, and performing abortions. I will be there to help women with desired pregnancies who received unspeakably bad news about fetal anomalies. I will be there to help women with life-threatening pregnancy complications before fetal viability. I will be there to help women with ectopic pregnancies. I will be there to help women who were raped or otherwise forced into pregnancy. I will always be there to help women.”

Dr. Croll is a neurovascular fellow at New York University Langone Health. She disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

“I’m happy to contribute, but can you keep it anonymous? It’s a safety concern for me.”

On the day that the Supreme Court of the United States voted to strike down Roe v. Wade, I reached out to ob.gyn.s across the country, wanting to hear their reactions. My own response, like that of many doctors and women, was a visceral mix of anger, fear, and grief. I could only begin to imagine what the real experts on reproductive health care were going through.

When the first ob.gyn. responded to my request by expressing concerns around anonymity and personal safety, I was shocked – but I shouldn’t have been. For starters, there is already a storied history in this country of deadly attacks on abortion providers. David Gunn, MD; Barnett Slepian, MD; and George Tiller, MD, were all tragically murdered by antiabortion extremists. Then, there’s the existence of websites that keep logs of abortion providers and sometimes include photos, office contact information, or even home addresses.

The idea that any reproductive health care provider should have to think twice before offering their uniquely qualified opinion is profoundly disturbing, nearly as disturbing as the Supreme Court’s decision itself. But it’s more critical than ever for ob.gyn. voices to be amplified. This is the time for the healthcare community to rally around women’s health providers, to learn from them, to support them.

I asked ob.gyns. around the country to tell me what they were thinking and feeling on the day that Roe v. Wade was overturned. We agreed to keep the responses anonymous, given that several people expressed very understandable safety concerns.

Here’s what they had to say.
 

Tennessee ob.gyn.

“Today is an emotionally charged day for many people in this country, yet as I type this, with my ob.gyn. practice continuing around me, with my own almost 10-week pregnancy growing inside me, I feel quite blunted. I feel powerless to answer questions that are variations on ‘what next?’ or ‘how do we fight back?’ All I can think of is, I am so glad I do not have anyone on my schedule right now who does not want to be pregnant. But what will happen when that eventually changes? What about my colleagues who do have these patients on their schedules today? On a personal level, what if my prenatal genetic testing comes back abnormal? How can we so blatantly disregard a separation of church and state in this country? What ways will our government interfere with my practice next? My head is spinning, but I have to go see my next patient. She is a 25-year-old who is here to have an IUD placed, and that seems like the most important thing I can do today.”

South Carolina ob.gyn.

“I’m really scared. For my patients and for myself. I don’t know how to be a good ob.gyn. if my ability to offer safe and accessible abortion care is being threatened.”

Massachusetts ob.gyn.

“Livid and devastated and sad and terrified.” 

California family planning specialist

“The fact is that about one in four people with uteruses have had an abortion. I can’t tell you how many abortions I’ve provided for people who say that they don’t ‘believe’ in them or that they thought they’d never be in this situation. ... The fact is that pregnancy is a life-threatening condition in and of itself. I am an ob.gyn., a medical doctor, and an abortion provider. I will not stop providing abortions or helping people access them. I will dedicate my life to ensuring this right to bodily autonomy. Today I am devastated by the Supreme Court’s decision to force parenthood that will result in increased maternal mortality. I am broken, but I have never been more proud to be an abortion provider.”

New York ob.gyn.

“Grateful to live in a state and work for a hospital where I can provide abortions but feel terrible for so many people less fortunate and underserved.”

Illinois maternal-fetal medicine specialist

“As a maternal-fetal medicine specialist, I fear for my patients who are at the highest risk of pregnancy complications having their freedom taken away. For the tragic ultrasound findings that make a pregnant person carry a baby who will never live. For the patients who cannot use most forms of contraception because of their medical comorbidities. For the patients who are victims of intimate partner violence or under the influence of their culture, to continue having children regardless of their desires or their health. ... The freedom to prevent or end a pregnancy has enabled women to become independent and productive members of society on their own terms, with or without children. My heart breaks for the children and adolescents and adults who are being told they are second-class citizens, not worthy of making their own decisions. Politicians and Supreme Court justices are not in the clinic room, ultrasound suite, operating room, or delivery room when we have these intense conversations and pregnancy outcomes. They have no idea that of which they speak, and it’s unconscionable that they can determine what healthcare decisions my patients can make for their own lives. Nobody knows a body better than the patient themselves.”

Texas ob.gyn.

“In the area where I live and practice, it feels like guns and the people who use them have more legal rights than people with uteruses in desperate or life-threatening situations. I’m afraid for my personal safety as a women’s health practitioner in this political climate. I feel helpless, but I’m supposed to be able to help my patients.”

Missouri family planning specialist

“Abortion is an essential part of healthcare, and the only people that should get a say in it are the patient and their doctor. Period. The fact that some far-off court without any medical expertise can insert itself into individual medical decisions is oppressive and unethical.”

Georgia ob.gyn.

“I can’t even think straight right now. I feel sick. Honestly, I’ve been thinking about moving for a long time now. Somewhere where I would actually be able to offer good, comprehensive care.”

New York ob.gyn.

“I graduated from my ob.gyn. residency hours after the Roe v. Wade news broke. It was so emotional for me. I’ve dedicated my life to caring for people with uteruses and I will not let this heartbreaking news change that. I feel more committed than ever to women’s health. I fully plan to continue delivering babies, providing contraception, and performing abortions. I will be there to help women with desired pregnancies who received unspeakably bad news about fetal anomalies. I will be there to help women with life-threatening pregnancy complications before fetal viability. I will be there to help women with ectopic pregnancies. I will be there to help women who were raped or otherwise forced into pregnancy. I will always be there to help women.”

Dr. Croll is a neurovascular fellow at New York University Langone Health. She disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

In recent years, a new genre of medical intervention has started to emerge – digital therapeutics. In the wake of promising results in a number of conditions, one high-profile approval by the Food and Drug Administration, and several ongoing clinical studies, neurologists (and other doctors) may soon be prescribing video games alongside conventional therapies for several conditions.

“Digital therapeutics refers to a software-based intervention. It’s not just digital information or digital monitoring, it’s an alternative treatment option based on software,” said John Krakauer, MD, professor of neurology, neuroscience, and physical medicine and rehabilitation at The Johns Hopkins University, Baltimore.

Dr. Krakauer explained that the nervous system is especially amenable to gamified therapies because of its unique ability to learn. “It’s an experience-dependent plastic system. You really want to have a high-intensity, high-dose behavioral intervention to try and rewire and train the nervous system.

“In other words, digital therapeutics complements what happens in physical and occupational therapy sessions with scientifically-informed behavioral interventions based on technology and software,” he said.
 

The digital dolphin treating stroke

Dr. Krakauer, chief scientific adviser to the company MindMaze, studies immersive digital therapies to enhance neurorehabilitation following stroke. He works on MindPod Dolphin, a virtual reality game that trains motor control of the upper extremities by having the patient simulate swimming in the ocean like a dolphin.

“Your movement is tracked, there are artificial intelligence algorithms controlling the difficulty, and the whole purpose is to take your nervous system for a ride, outside the context of activities of daily living. Patients are so engaged and immersed that they don’t even realize they’re making high-quality, high-intensity, high-dose movements of their arm.”

In a pilot trial called SMARTS2, his group found that MindPod Dolphin was about twice as effective as regular rehabilitation for upper extremity motor recovery in patients who had had a stroke. A larger trial is currently underway in New Zealand.

Another preliminary study found that MindPod Dolphin had positive effects on the physical and cognitive health of elderly patients in an assisted-living facility. Now, MindPod Dolphin is being studied around the world in patients with multiple sclerosis, Parkinson’s disease, concussion, and traumatic brain injury (TBI). There is even a Department of Defense–funded trial underway for veterans with TBI.
 

Reaching young patients through virtual play

Isabela Granic, PhD, director of the Games for Emotional and Mental Health Lab, and professor and chair of the developmental psychopathology department in the Behavioural Science Institute at Radboud University in the Netherlands, studies gamified therapy for depression and anxiety.

“We take evidence-based techniques in the mental health clinical world or developmental research, such as cognitive-behavioral therapy (CBT) or exposure therapy, and then embed them in games to use a different engine for delivering something we otherwise know works,” she said.

Data for a game she developed called MindLight are promising so far. “We have randomized controlled trials showing that we can cut young people’s anxiety in half after they have as little as five 1-hour sessions per week. We’ve shown that we can get the same benefits as CBT for these young people, which is huge.” MindLight also has proved effective for treating anxiety in children with autism.
 

A first for therapeutic video games

In the summer of 2020, EndeavorRx, made by Akili Interactive, became the first prescription video game to be approved by the FDA. The game, which is designed to improve attention function, is currently authorized for children aged 8-12 with attention-deficit/hyperactivity disorder.

Players complete “missions” by steering an aircraft through complex obstacle courses and collecting targets. The prescription directs the child to complete five missions each day for 5 days per week. It is recommended that patients use EndeavorRx for at least 4 weeks. Researchers are hopeful that, moving forward, the game will also prove effective for other cognitive disorders, including dementias and mild cognitive impairment.

EndeavorRx is even being studied for its efficacy in combating brain fog in COVID-19 long-haulers. A team of researchers led by Faith Gunning, PhD, psychologist and vice chair of research in the department of psychiatry at Weill Cornell Medicine, New York, is performing a trial of EndeavorRx for post–COVID-19 cognitive dysfunction.

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

In recent years, a new genre of medical intervention has started to emerge – digital therapeutics. In the wake of promising results in a number of conditions, one high-profile approval by the Food and Drug Administration, and several ongoing clinical studies, neurologists (and other doctors) may soon be prescribing video games alongside conventional therapies for several conditions.

“Digital therapeutics refers to a software-based intervention. It’s not just digital information or digital monitoring, it’s an alternative treatment option based on software,” said John Krakauer, MD, professor of neurology, neuroscience, and physical medicine and rehabilitation at The Johns Hopkins University, Baltimore.

Dr. Krakauer explained that the nervous system is especially amenable to gamified therapies because of its unique ability to learn. “It’s an experience-dependent plastic system. You really want to have a high-intensity, high-dose behavioral intervention to try and rewire and train the nervous system.

“In other words, digital therapeutics complements what happens in physical and occupational therapy sessions with scientifically-informed behavioral interventions based on technology and software,” he said.
 

The digital dolphin treating stroke

Dr. Krakauer, chief scientific adviser to the company MindMaze, studies immersive digital therapies to enhance neurorehabilitation following stroke. He works on MindPod Dolphin, a virtual reality game that trains motor control of the upper extremities by having the patient simulate swimming in the ocean like a dolphin.

“Your movement is tracked, there are artificial intelligence algorithms controlling the difficulty, and the whole purpose is to take your nervous system for a ride, outside the context of activities of daily living. Patients are so engaged and immersed that they don’t even realize they’re making high-quality, high-intensity, high-dose movements of their arm.”

In a pilot trial called SMARTS2, his group found that MindPod Dolphin was about twice as effective as regular rehabilitation for upper extremity motor recovery in patients who had had a stroke. A larger trial is currently underway in New Zealand.

Another preliminary study found that MindPod Dolphin had positive effects on the physical and cognitive health of elderly patients in an assisted-living facility. Now, MindPod Dolphin is being studied around the world in patients with multiple sclerosis, Parkinson’s disease, concussion, and traumatic brain injury (TBI). There is even a Department of Defense–funded trial underway for veterans with TBI.
 

Reaching young patients through virtual play

Isabela Granic, PhD, director of the Games for Emotional and Mental Health Lab, and professor and chair of the developmental psychopathology department in the Behavioural Science Institute at Radboud University in the Netherlands, studies gamified therapy for depression and anxiety.

“We take evidence-based techniques in the mental health clinical world or developmental research, such as cognitive-behavioral therapy (CBT) or exposure therapy, and then embed them in games to use a different engine for delivering something we otherwise know works,” she said.

Data for a game she developed called MindLight are promising so far. “We have randomized controlled trials showing that we can cut young people’s anxiety in half after they have as little as five 1-hour sessions per week. We’ve shown that we can get the same benefits as CBT for these young people, which is huge.” MindLight also has proved effective for treating anxiety in children with autism.
 

A first for therapeutic video games

In the summer of 2020, EndeavorRx, made by Akili Interactive, became the first prescription video game to be approved by the FDA. The game, which is designed to improve attention function, is currently authorized for children aged 8-12 with attention-deficit/hyperactivity disorder.

Players complete “missions” by steering an aircraft through complex obstacle courses and collecting targets. The prescription directs the child to complete five missions each day for 5 days per week. It is recommended that patients use EndeavorRx for at least 4 weeks. Researchers are hopeful that, moving forward, the game will also prove effective for other cognitive disorders, including dementias and mild cognitive impairment.

EndeavorRx is even being studied for its efficacy in combating brain fog in COVID-19 long-haulers. A team of researchers led by Faith Gunning, PhD, psychologist and vice chair of research in the department of psychiatry at Weill Cornell Medicine, New York, is performing a trial of EndeavorRx for post–COVID-19 cognitive dysfunction.

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

In recent years, a new genre of medical intervention has started to emerge – digital therapeutics. In the wake of promising results in a number of conditions, one high-profile approval by the Food and Drug Administration, and several ongoing clinical studies, neurologists (and other doctors) may soon be prescribing video games alongside conventional therapies for several conditions.

“Digital therapeutics refers to a software-based intervention. It’s not just digital information or digital monitoring, it’s an alternative treatment option based on software,” said John Krakauer, MD, professor of neurology, neuroscience, and physical medicine and rehabilitation at The Johns Hopkins University, Baltimore.

Dr. Krakauer explained that the nervous system is especially amenable to gamified therapies because of its unique ability to learn. “It’s an experience-dependent plastic system. You really want to have a high-intensity, high-dose behavioral intervention to try and rewire and train the nervous system.

“In other words, digital therapeutics complements what happens in physical and occupational therapy sessions with scientifically-informed behavioral interventions based on technology and software,” he said.
 

The digital dolphin treating stroke

Dr. Krakauer, chief scientific adviser to the company MindMaze, studies immersive digital therapies to enhance neurorehabilitation following stroke. He works on MindPod Dolphin, a virtual reality game that trains motor control of the upper extremities by having the patient simulate swimming in the ocean like a dolphin.

“Your movement is tracked, there are artificial intelligence algorithms controlling the difficulty, and the whole purpose is to take your nervous system for a ride, outside the context of activities of daily living. Patients are so engaged and immersed that they don’t even realize they’re making high-quality, high-intensity, high-dose movements of their arm.”

In a pilot trial called SMARTS2, his group found that MindPod Dolphin was about twice as effective as regular rehabilitation for upper extremity motor recovery in patients who had had a stroke. A larger trial is currently underway in New Zealand.

Another preliminary study found that MindPod Dolphin had positive effects on the physical and cognitive health of elderly patients in an assisted-living facility. Now, MindPod Dolphin is being studied around the world in patients with multiple sclerosis, Parkinson’s disease, concussion, and traumatic brain injury (TBI). There is even a Department of Defense–funded trial underway for veterans with TBI.
 

Reaching young patients through virtual play

Isabela Granic, PhD, director of the Games for Emotional and Mental Health Lab, and professor and chair of the developmental psychopathology department in the Behavioural Science Institute at Radboud University in the Netherlands, studies gamified therapy for depression and anxiety.

“We take evidence-based techniques in the mental health clinical world or developmental research, such as cognitive-behavioral therapy (CBT) or exposure therapy, and then embed them in games to use a different engine for delivering something we otherwise know works,” she said.

Data for a game she developed called MindLight are promising so far. “We have randomized controlled trials showing that we can cut young people’s anxiety in half after they have as little as five 1-hour sessions per week. We’ve shown that we can get the same benefits as CBT for these young people, which is huge.” MindLight also has proved effective for treating anxiety in children with autism.
 

A first for therapeutic video games

In the summer of 2020, EndeavorRx, made by Akili Interactive, became the first prescription video game to be approved by the FDA. The game, which is designed to improve attention function, is currently authorized for children aged 8-12 with attention-deficit/hyperactivity disorder.

Players complete “missions” by steering an aircraft through complex obstacle courses and collecting targets. The prescription directs the child to complete five missions each day for 5 days per week. It is recommended that patients use EndeavorRx for at least 4 weeks. Researchers are hopeful that, moving forward, the game will also prove effective for other cognitive disorders, including dementias and mild cognitive impairment.

EndeavorRx is even being studied for its efficacy in combating brain fog in COVID-19 long-haulers. A team of researchers led by Faith Gunning, PhD, psychologist and vice chair of research in the department of psychiatry at Weill Cornell Medicine, New York, is performing a trial of EndeavorRx for post–COVID-19 cognitive dysfunction.

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