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extacy
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slaveing
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sluting
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smuting
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smuttying
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snipered
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snipering
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snort
snorted
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sodomed
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sodoming
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sumofabiatch
sumofabiatched
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tard
tarded
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terded
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tit
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transsexualed
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trashy
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tubgirl
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tubgirler
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tubgirling
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turded
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turding
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tushed
tusher
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tushing
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twated
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twates
twating
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uzied
uzier
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vaging
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valiuming
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virginer
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vixened
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vixening
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vodkaing
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wazoos
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wedgieing
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More on using expired medications
A patient inquires about whether he or she can use an EpiPen after the expiration date. What should you advise?
A. The EpiPen is unlikely to be effective after the expiration date.
B. The EpiPen may be dangerous to use after the expiration date.
C. The EpiPen is likely to be okay up to 2 years past the expiration date.
I think that choice C is the most accurate and will get to all the evidence shortly. It is a date, required by law, that the manufacturer can guarantee greater than 90% original potency of the medication.
Epinephrine is a costly drug and is usually replaced when the Epipen expires. Weir and colleagues studied six epinephrine syringes 30 months past their expiration date.1 Three of the syringes and one control, nonexpired syringe were analyzed using liquid chromatography-mass spectrometry and nuclear magnetic resonance to determine epinephrine content. The contents of the other three syringes of epinephrine were cultured for bacteria and fungus, which yielded no microbial growth. The study showed that the content of epinephrine present in the original sample remained unchanged, compared with the control.
Rachid et al. looked at 35 EpiPens 3-36 months past their expiration dates.2 The percentage of epinephrine found remained 84%-101%, with all EpiPens less than 24 months past expiration having > 90% of the labeled epinephrine dose. Cantrell and colleagues evaluated a combination of 40 EpiPens and Epipen Jrs that were 1-50 months past expiration.3 These pens had not been kept in ideal conditions, as some had been in cars, outdoor cabins, and other environments without temperature control. Sixty-one percent of the Epipens and 56% of the EpiPen Juniors had > 90% of the labeled epinephrine content. I think expired Epipens can be used as a back-up option – that is, they are safe to use if there is not an Epipen available that is not expired.
Shelf life extension program
Lyon and colleagues reported data from the Shelf Life Extension Program (SLEP).4 A total of 122 drugs were studied representing 3,005 lots. Based on testing and stability assessment, 88% of the lots were extended at least 1 year beyond their original expiration date for an average extension of 66 months, but the additional stability period was highly variable. Several antibiotics were studied, including ciprofloxacin (mean extension, 55 months), amoxicillin (mean extension, 23 months), and doxycycline (mean extension, 50 months).
What about other drugs not in pill form?
I am frequently asked about the longevity of medication formulations that are not in pill form. For example, I have been asked about using expired eye drops. There are few data on this. Reis at al. studied whether travoprost that was past the expiration date still lowered intraocular pressures.5 Intraocular pressures in glaucoma patients treated with travoprost 6 weeks after the seal was broken were compared with pressures when drops were used immediately after the container seal was broken. There was no significant difference in intraocular pressure between the two treatment groups during the study.
I found one case report of harm from using expired eye medications. Use of expired eye drops was associated with a case of bilateral toxic epithelial keratopathy.6 Eye drops can be contaminated and cause irritation from the breakdown products of preservatives.
Many people use inhalers for many years. This is especially true for albuterol, which is often used for very intermittent symptoms. I found one recent study on the stability of albuterol. Kutty et al. studied expired albuterol inhalers and solutions up to 20 years past expiration.7 Almost all lots of albuterol maintained > 90% of product (73%-103%), many years past their expiration date. Even at 73% retained activity, the dose would likely be effective.
Pearl: Expired epinephrine and albuterol appear to retain activity several years past expiration.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He has no conflicts of interest. Contact Dr. Paauw at dpaauw@uw.edu.
References
1. Weir WB et al. Prehosp Emerg Care. 2018 Jul-Aug;22(4):414-8.
2. Rachid O et al. Ann Allergy Asthma Immunol. 2015 Apr;114(4):354-6.
3. Cantrell FL et al. Ann Intern Med. 2017 Jun 20;166(12):918-9.
4. Lyon RC et al. J Pharmaceut Sci. 2006;95(7):1549-60.
5. Reis R et al. Clin Ther. 2004 Dec;26(12):2121-7.
6. AlGhadeer H, AlHumaiden A. J Clin Pharm Ther. 2022 Dec;47(12):2379-82.
7. Kutty RG et al. Heliyon. 2022 Aug 5;8(8):e10104.
A patient inquires about whether he or she can use an EpiPen after the expiration date. What should you advise?
A. The EpiPen is unlikely to be effective after the expiration date.
B. The EpiPen may be dangerous to use after the expiration date.
C. The EpiPen is likely to be okay up to 2 years past the expiration date.
I think that choice C is the most accurate and will get to all the evidence shortly. It is a date, required by law, that the manufacturer can guarantee greater than 90% original potency of the medication.
Epinephrine is a costly drug and is usually replaced when the Epipen expires. Weir and colleagues studied six epinephrine syringes 30 months past their expiration date.1 Three of the syringes and one control, nonexpired syringe were analyzed using liquid chromatography-mass spectrometry and nuclear magnetic resonance to determine epinephrine content. The contents of the other three syringes of epinephrine were cultured for bacteria and fungus, which yielded no microbial growth. The study showed that the content of epinephrine present in the original sample remained unchanged, compared with the control.
Rachid et al. looked at 35 EpiPens 3-36 months past their expiration dates.2 The percentage of epinephrine found remained 84%-101%, with all EpiPens less than 24 months past expiration having > 90% of the labeled epinephrine dose. Cantrell and colleagues evaluated a combination of 40 EpiPens and Epipen Jrs that were 1-50 months past expiration.3 These pens had not been kept in ideal conditions, as some had been in cars, outdoor cabins, and other environments without temperature control. Sixty-one percent of the Epipens and 56% of the EpiPen Juniors had > 90% of the labeled epinephrine content. I think expired Epipens can be used as a back-up option – that is, they are safe to use if there is not an Epipen available that is not expired.
Shelf life extension program
Lyon and colleagues reported data from the Shelf Life Extension Program (SLEP).4 A total of 122 drugs were studied representing 3,005 lots. Based on testing and stability assessment, 88% of the lots were extended at least 1 year beyond their original expiration date for an average extension of 66 months, but the additional stability period was highly variable. Several antibiotics were studied, including ciprofloxacin (mean extension, 55 months), amoxicillin (mean extension, 23 months), and doxycycline (mean extension, 50 months).
What about other drugs not in pill form?
I am frequently asked about the longevity of medication formulations that are not in pill form. For example, I have been asked about using expired eye drops. There are few data on this. Reis at al. studied whether travoprost that was past the expiration date still lowered intraocular pressures.5 Intraocular pressures in glaucoma patients treated with travoprost 6 weeks after the seal was broken were compared with pressures when drops were used immediately after the container seal was broken. There was no significant difference in intraocular pressure between the two treatment groups during the study.
I found one case report of harm from using expired eye medications. Use of expired eye drops was associated with a case of bilateral toxic epithelial keratopathy.6 Eye drops can be contaminated and cause irritation from the breakdown products of preservatives.
Many people use inhalers for many years. This is especially true for albuterol, which is often used for very intermittent symptoms. I found one recent study on the stability of albuterol. Kutty et al. studied expired albuterol inhalers and solutions up to 20 years past expiration.7 Almost all lots of albuterol maintained > 90% of product (73%-103%), many years past their expiration date. Even at 73% retained activity, the dose would likely be effective.
Pearl: Expired epinephrine and albuterol appear to retain activity several years past expiration.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He has no conflicts of interest. Contact Dr. Paauw at dpaauw@uw.edu.
References
1. Weir WB et al. Prehosp Emerg Care. 2018 Jul-Aug;22(4):414-8.
2. Rachid O et al. Ann Allergy Asthma Immunol. 2015 Apr;114(4):354-6.
3. Cantrell FL et al. Ann Intern Med. 2017 Jun 20;166(12):918-9.
4. Lyon RC et al. J Pharmaceut Sci. 2006;95(7):1549-60.
5. Reis R et al. Clin Ther. 2004 Dec;26(12):2121-7.
6. AlGhadeer H, AlHumaiden A. J Clin Pharm Ther. 2022 Dec;47(12):2379-82.
7. Kutty RG et al. Heliyon. 2022 Aug 5;8(8):e10104.
A patient inquires about whether he or she can use an EpiPen after the expiration date. What should you advise?
A. The EpiPen is unlikely to be effective after the expiration date.
B. The EpiPen may be dangerous to use after the expiration date.
C. The EpiPen is likely to be okay up to 2 years past the expiration date.
I think that choice C is the most accurate and will get to all the evidence shortly. It is a date, required by law, that the manufacturer can guarantee greater than 90% original potency of the medication.
Epinephrine is a costly drug and is usually replaced when the Epipen expires. Weir and colleagues studied six epinephrine syringes 30 months past their expiration date.1 Three of the syringes and one control, nonexpired syringe were analyzed using liquid chromatography-mass spectrometry and nuclear magnetic resonance to determine epinephrine content. The contents of the other three syringes of epinephrine were cultured for bacteria and fungus, which yielded no microbial growth. The study showed that the content of epinephrine present in the original sample remained unchanged, compared with the control.
Rachid et al. looked at 35 EpiPens 3-36 months past their expiration dates.2 The percentage of epinephrine found remained 84%-101%, with all EpiPens less than 24 months past expiration having > 90% of the labeled epinephrine dose. Cantrell and colleagues evaluated a combination of 40 EpiPens and Epipen Jrs that were 1-50 months past expiration.3 These pens had not been kept in ideal conditions, as some had been in cars, outdoor cabins, and other environments without temperature control. Sixty-one percent of the Epipens and 56% of the EpiPen Juniors had > 90% of the labeled epinephrine content. I think expired Epipens can be used as a back-up option – that is, they are safe to use if there is not an Epipen available that is not expired.
Shelf life extension program
Lyon and colleagues reported data from the Shelf Life Extension Program (SLEP).4 A total of 122 drugs were studied representing 3,005 lots. Based on testing and stability assessment, 88% of the lots were extended at least 1 year beyond their original expiration date for an average extension of 66 months, but the additional stability period was highly variable. Several antibiotics were studied, including ciprofloxacin (mean extension, 55 months), amoxicillin (mean extension, 23 months), and doxycycline (mean extension, 50 months).
What about other drugs not in pill form?
I am frequently asked about the longevity of medication formulations that are not in pill form. For example, I have been asked about using expired eye drops. There are few data on this. Reis at al. studied whether travoprost that was past the expiration date still lowered intraocular pressures.5 Intraocular pressures in glaucoma patients treated with travoprost 6 weeks after the seal was broken were compared with pressures when drops were used immediately after the container seal was broken. There was no significant difference in intraocular pressure between the two treatment groups during the study.
I found one case report of harm from using expired eye medications. Use of expired eye drops was associated with a case of bilateral toxic epithelial keratopathy.6 Eye drops can be contaminated and cause irritation from the breakdown products of preservatives.
Many people use inhalers for many years. This is especially true for albuterol, which is often used for very intermittent symptoms. I found one recent study on the stability of albuterol. Kutty et al. studied expired albuterol inhalers and solutions up to 20 years past expiration.7 Almost all lots of albuterol maintained > 90% of product (73%-103%), many years past their expiration date. Even at 73% retained activity, the dose would likely be effective.
Pearl: Expired epinephrine and albuterol appear to retain activity several years past expiration.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He has no conflicts of interest. Contact Dr. Paauw at dpaauw@uw.edu.
References
1. Weir WB et al. Prehosp Emerg Care. 2018 Jul-Aug;22(4):414-8.
2. Rachid O et al. Ann Allergy Asthma Immunol. 2015 Apr;114(4):354-6.
3. Cantrell FL et al. Ann Intern Med. 2017 Jun 20;166(12):918-9.
4. Lyon RC et al. J Pharmaceut Sci. 2006;95(7):1549-60.
5. Reis R et al. Clin Ther. 2004 Dec;26(12):2121-7.
6. AlGhadeer H, AlHumaiden A. J Clin Pharm Ther. 2022 Dec;47(12):2379-82.
7. Kutty RG et al. Heliyon. 2022 Aug 5;8(8):e10104.
Two landmark papers change treatment paradigm for advanced endometrial cancer
I wanted to very briefly highlight a truly extraordinary event in my professional experience as a clinical investigator for almost 40 years in the area of the gynecologic malignancies:
In my career, of course, I’ve treated endometrial cancer, but the paradigm, the algorithms, and the strategies we’ve used have, for the most part, simply followed what we’ve done for ovarian cancer. If platinums worked in ovarian cancer, they probably worked in endometrial cancer, and that was true. If paclitaxel worked and had activity in ovarian cancer, it probably would in endometrial cancer, and that was true. It took some time, but basically, we use the same frontline chemotherapy in advanced or recurrent endometrial cancer as we’ve used in ovarian cancer, and on and on.
That world has changed, very much for the positive. Not only have pharmaceutical companies, academic investigators, and individual investigators in the community setting seen endometrial cancer as a major priority, but we have exciting new developments, and very specifically, of course, the immunotherapeutic agents known as checkpoint inhibitors.
One of these two papers was titled “Pembrolizumab Plus Chemotherapy in Advanced Endometrial Cancer” and the second one was titled “Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer.” Obviously, these were separate studies, but both used checkpoint inhibitor plus the chemotherapeutic agents carboplatin-paclitaxel, compared with chemotherapy alone as frontline therapy for advanced or recurrent ovarian cancer and demonstrated a statistically significant, and in my opinion, highly clinically meaningful improvement, in progression-free survival in favor of the regimen that included the checkpoint inhibitors.
Clearly, we will need longer follow-up to see both the overall magnitude of the effect of these therapies on overall survival and the duration of the effect – the shape of the curve. Do we cure many more people? Do we delay time to progression and death? That remains to be seen.
But the outcomes we have now are remarkably positive for patients and have absolutely changed the standard of care in the management of recurrent or advanced endometrial cancer.
I should note that this includes both patients who have evidence of mismatch repair deficiency and those patients who do not have evidence of deficiency, which is a large patient population. These studies demonstrated the benefit to the entire population of patients.
However, on the basis of the data that we have – not only in endometrial cancer, but in other tumor types – the greatest impact was seen in patients with evidence of mismatch repair deficiency, where the immunotherapy agent has been shown to be most relevant; not exclusively, but most relevant.
These are very important papers. If you have an interest in endometrial cancer or immunotherapy, I would encourage you to read these papers. They change the paradigm of management for advanced endometrial cancer, and they clearly point out directions for future research in the management of this class of gynecologic cancers.
Dr. Markman is a professor in the department of medical oncology and therapeutics research at City of Hope in Duarte, Calif., and the president of Medicine & Science at City of Hope Atlanta, Chicago, and Phoenix. He reported conflicts of interest with AstraZeneca and GlaxoSmithKline.
This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.
I wanted to very briefly highlight a truly extraordinary event in my professional experience as a clinical investigator for almost 40 years in the area of the gynecologic malignancies:
In my career, of course, I’ve treated endometrial cancer, but the paradigm, the algorithms, and the strategies we’ve used have, for the most part, simply followed what we’ve done for ovarian cancer. If platinums worked in ovarian cancer, they probably worked in endometrial cancer, and that was true. If paclitaxel worked and had activity in ovarian cancer, it probably would in endometrial cancer, and that was true. It took some time, but basically, we use the same frontline chemotherapy in advanced or recurrent endometrial cancer as we’ve used in ovarian cancer, and on and on.
That world has changed, very much for the positive. Not only have pharmaceutical companies, academic investigators, and individual investigators in the community setting seen endometrial cancer as a major priority, but we have exciting new developments, and very specifically, of course, the immunotherapeutic agents known as checkpoint inhibitors.
One of these two papers was titled “Pembrolizumab Plus Chemotherapy in Advanced Endometrial Cancer” and the second one was titled “Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer.” Obviously, these were separate studies, but both used checkpoint inhibitor plus the chemotherapeutic agents carboplatin-paclitaxel, compared with chemotherapy alone as frontline therapy for advanced or recurrent ovarian cancer and demonstrated a statistically significant, and in my opinion, highly clinically meaningful improvement, in progression-free survival in favor of the regimen that included the checkpoint inhibitors.
Clearly, we will need longer follow-up to see both the overall magnitude of the effect of these therapies on overall survival and the duration of the effect – the shape of the curve. Do we cure many more people? Do we delay time to progression and death? That remains to be seen.
But the outcomes we have now are remarkably positive for patients and have absolutely changed the standard of care in the management of recurrent or advanced endometrial cancer.
I should note that this includes both patients who have evidence of mismatch repair deficiency and those patients who do not have evidence of deficiency, which is a large patient population. These studies demonstrated the benefit to the entire population of patients.
However, on the basis of the data that we have – not only in endometrial cancer, but in other tumor types – the greatest impact was seen in patients with evidence of mismatch repair deficiency, where the immunotherapy agent has been shown to be most relevant; not exclusively, but most relevant.
These are very important papers. If you have an interest in endometrial cancer or immunotherapy, I would encourage you to read these papers. They change the paradigm of management for advanced endometrial cancer, and they clearly point out directions for future research in the management of this class of gynecologic cancers.
Dr. Markman is a professor in the department of medical oncology and therapeutics research at City of Hope in Duarte, Calif., and the president of Medicine & Science at City of Hope Atlanta, Chicago, and Phoenix. He reported conflicts of interest with AstraZeneca and GlaxoSmithKline.
This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.
I wanted to very briefly highlight a truly extraordinary event in my professional experience as a clinical investigator for almost 40 years in the area of the gynecologic malignancies:
In my career, of course, I’ve treated endometrial cancer, but the paradigm, the algorithms, and the strategies we’ve used have, for the most part, simply followed what we’ve done for ovarian cancer. If platinums worked in ovarian cancer, they probably worked in endometrial cancer, and that was true. If paclitaxel worked and had activity in ovarian cancer, it probably would in endometrial cancer, and that was true. It took some time, but basically, we use the same frontline chemotherapy in advanced or recurrent endometrial cancer as we’ve used in ovarian cancer, and on and on.
That world has changed, very much for the positive. Not only have pharmaceutical companies, academic investigators, and individual investigators in the community setting seen endometrial cancer as a major priority, but we have exciting new developments, and very specifically, of course, the immunotherapeutic agents known as checkpoint inhibitors.
One of these two papers was titled “Pembrolizumab Plus Chemotherapy in Advanced Endometrial Cancer” and the second one was titled “Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer.” Obviously, these were separate studies, but both used checkpoint inhibitor plus the chemotherapeutic agents carboplatin-paclitaxel, compared with chemotherapy alone as frontline therapy for advanced or recurrent ovarian cancer and demonstrated a statistically significant, and in my opinion, highly clinically meaningful improvement, in progression-free survival in favor of the regimen that included the checkpoint inhibitors.
Clearly, we will need longer follow-up to see both the overall magnitude of the effect of these therapies on overall survival and the duration of the effect – the shape of the curve. Do we cure many more people? Do we delay time to progression and death? That remains to be seen.
But the outcomes we have now are remarkably positive for patients and have absolutely changed the standard of care in the management of recurrent or advanced endometrial cancer.
I should note that this includes both patients who have evidence of mismatch repair deficiency and those patients who do not have evidence of deficiency, which is a large patient population. These studies demonstrated the benefit to the entire population of patients.
However, on the basis of the data that we have – not only in endometrial cancer, but in other tumor types – the greatest impact was seen in patients with evidence of mismatch repair deficiency, where the immunotherapy agent has been shown to be most relevant; not exclusively, but most relevant.
These are very important papers. If you have an interest in endometrial cancer or immunotherapy, I would encourage you to read these papers. They change the paradigm of management for advanced endometrial cancer, and they clearly point out directions for future research in the management of this class of gynecologic cancers.
Dr. Markman is a professor in the department of medical oncology and therapeutics research at City of Hope in Duarte, Calif., and the president of Medicine & Science at City of Hope Atlanta, Chicago, and Phoenix. He reported conflicts of interest with AstraZeneca and GlaxoSmithKline.
This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.
Laboratory testing: No doctor required?
This transcript has been edited for clarity.
Let’s assume, for the sake of argument, that I am a healthy 43-year old man. Nevertheless, I am interested in getting my vitamin D level checked. My primary care doc says it’s unnecessary, but that doesn’t matter because a variety of direct-to-consumer testing companies will do it without a doctor’s prescription – for a fee of course.
Is that okay? Should I be able to get the test?
What if instead of my vitamin D level, I want to test my testosterone level, or my PSA, or my cadmium level, or my Lyme disease antibodies, or even have a full-body MRI scan?
These questions are becoming more and more common, because the direct-to-consumer testing market is exploding.
We’re talking about direct-to-consumer testing, thanks to this paper: Policies of US Companies Offering Direct-to-Consumer Laboratory Tests, appearing in JAMA Internal Medicine, which characterizes the testing practices of direct-to-consumer testing companies.
But before we get to the study, a word on this market. Direct-to-consumer lab testing is projected to be a $2 billion industry by 2025, and lab testing megacorporations Quest Diagnostics and Labcorp are both jumping headlong into this space.
Why is this happening? A couple of reasons, I think. First, the increasing cost of health care has led payers to place significant restrictions on what tests can be ordered and under what circumstances. Physicians are all too familiar with the “prior authorization” system that seeks to limit even the tests we think would benefit our patients.
Frustrated with such a system, it’s no wonder that patients are increasingly deciding to go it on their own. Sure, insurance won’t cover these tests, but the prices are transparent and competition actually keeps them somewhat reasonable. So, is this a win-win? Shouldn’t we allow people to get the tests they want, at least if they are willing to pay for it?
Of course, it’s not quite that simple. If the tests are normal, or negative, then sure – no harm, no foul. But when they are positive, everything changes. What happens when the PSA test I got myself via a direct-to-consumer testing company comes back elevated? Well, at that point, I am right back into the traditional mode of medicine – seeing my doctor, probably getting repeat testing, biopsies, etc., – and some payer will be on the hook for that, which is to say that all of us will be on the hook for that.
One other reason direct-to-consumer testing is getting more popular is a more difficult-to-characterize phenomenon which I might call postpandemic individualism. I’ve seen this across several domains, but I think in some ways the pandemic led people to focus more attention on themselves, perhaps because we were so isolated from each other. Optimizing health through data – whether using a fitness tracking watch, meticulously counting macronutrient intake, or ordering your own lab tests – may be a form of exerting control over a universe that feels increasingly chaotic. But what do I know? I’m not a psychologist.
The study characterizes a total of 21 direct-to-consumer testing companies. They offer a variety of services, as you can see here, with the majority in the endocrine space: thyroid, diabetes, men’s and women’s health. A smattering of companies offer more esoteric testing, such as heavy metals and Lyme disease.
Who’s in charge of all this? It’s fairly regulated, actually, but perhaps not in the way you think. The FDA uses its CLIA authority to ensure that these tests are accurate. The FTC ensures that the companies do not engage in false advertising. But no one is minding the store as to whether the tests are actually beneficial either to an individual or to society.
The 21 companies varied dramatically in regard to how they handle communicating the risks and results of these tests. All of them had a disclaimer that the information does not represent comprehensive medical advice. Fine. But a minority acknowledged any risks or limitations of the tests. Less than half had a statement of HIPAA compliance. And 17 out of 21 provided no information as to whether customers could request their data to be deleted, while 18 out of 21 stated that there could be follow-up for abnormal results, but often it was unclear exactly how that would work.
So, let’s circle back to the first question: Should a healthy person be able to get a laboratory test simply because they want to? The libertarians among us would argue certainly yes, though perhaps without thinking through the societal implications of abnormal results. The evidence-based medicine folks will, accurately, state that there are no clinical trials to suggest that screening healthy people with tests like these has any benefit.
But we should be cautious here. This question is scienceable; you could design a trial to test whether screening healthy 43-year-olds for testosterone level led to significant improvements in overall mortality. It would just take a few million people and about 40 years of follow-up.
And even if it didn’t help, we let people throw their money away on useless things all the time. The only difference between someone spending money on a useless test or on a useless dietary supplement is that someone has to deal with the result.
So, can you do this right? Can you make a direct-to-consumer testing company that is not essentially a free-rider on the rest of the health care ecosystem?
I think there are ways. You’d need physicians involved at all stages to help interpret the testing and guide next steps. You’d need some transparent guidelines, written in language that patients can understand, for what will happen given any conceivable result – and what costs those results might lead to for them and their insurance company. Most important, you’d need longitudinal follow-up and the ability to recommend changes, retest in the future, and potentially address the cost implications of the downstream findings. In the end, it starts to sound very much like a doctor’s office.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and public health and director of Yale’s Clinical and Translational Research Accelerator in New Haven, Conn. He reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Let’s assume, for the sake of argument, that I am a healthy 43-year old man. Nevertheless, I am interested in getting my vitamin D level checked. My primary care doc says it’s unnecessary, but that doesn’t matter because a variety of direct-to-consumer testing companies will do it without a doctor’s prescription – for a fee of course.
Is that okay? Should I be able to get the test?
What if instead of my vitamin D level, I want to test my testosterone level, or my PSA, or my cadmium level, or my Lyme disease antibodies, or even have a full-body MRI scan?
These questions are becoming more and more common, because the direct-to-consumer testing market is exploding.
We’re talking about direct-to-consumer testing, thanks to this paper: Policies of US Companies Offering Direct-to-Consumer Laboratory Tests, appearing in JAMA Internal Medicine, which characterizes the testing practices of direct-to-consumer testing companies.
But before we get to the study, a word on this market. Direct-to-consumer lab testing is projected to be a $2 billion industry by 2025, and lab testing megacorporations Quest Diagnostics and Labcorp are both jumping headlong into this space.
Why is this happening? A couple of reasons, I think. First, the increasing cost of health care has led payers to place significant restrictions on what tests can be ordered and under what circumstances. Physicians are all too familiar with the “prior authorization” system that seeks to limit even the tests we think would benefit our patients.
Frustrated with such a system, it’s no wonder that patients are increasingly deciding to go it on their own. Sure, insurance won’t cover these tests, but the prices are transparent and competition actually keeps them somewhat reasonable. So, is this a win-win? Shouldn’t we allow people to get the tests they want, at least if they are willing to pay for it?
Of course, it’s not quite that simple. If the tests are normal, or negative, then sure – no harm, no foul. But when they are positive, everything changes. What happens when the PSA test I got myself via a direct-to-consumer testing company comes back elevated? Well, at that point, I am right back into the traditional mode of medicine – seeing my doctor, probably getting repeat testing, biopsies, etc., – and some payer will be on the hook for that, which is to say that all of us will be on the hook for that.
One other reason direct-to-consumer testing is getting more popular is a more difficult-to-characterize phenomenon which I might call postpandemic individualism. I’ve seen this across several domains, but I think in some ways the pandemic led people to focus more attention on themselves, perhaps because we were so isolated from each other. Optimizing health through data – whether using a fitness tracking watch, meticulously counting macronutrient intake, or ordering your own lab tests – may be a form of exerting control over a universe that feels increasingly chaotic. But what do I know? I’m not a psychologist.
The study characterizes a total of 21 direct-to-consumer testing companies. They offer a variety of services, as you can see here, with the majority in the endocrine space: thyroid, diabetes, men’s and women’s health. A smattering of companies offer more esoteric testing, such as heavy metals and Lyme disease.
Who’s in charge of all this? It’s fairly regulated, actually, but perhaps not in the way you think. The FDA uses its CLIA authority to ensure that these tests are accurate. The FTC ensures that the companies do not engage in false advertising. But no one is minding the store as to whether the tests are actually beneficial either to an individual or to society.
The 21 companies varied dramatically in regard to how they handle communicating the risks and results of these tests. All of them had a disclaimer that the information does not represent comprehensive medical advice. Fine. But a minority acknowledged any risks or limitations of the tests. Less than half had a statement of HIPAA compliance. And 17 out of 21 provided no information as to whether customers could request their data to be deleted, while 18 out of 21 stated that there could be follow-up for abnormal results, but often it was unclear exactly how that would work.
So, let’s circle back to the first question: Should a healthy person be able to get a laboratory test simply because they want to? The libertarians among us would argue certainly yes, though perhaps without thinking through the societal implications of abnormal results. The evidence-based medicine folks will, accurately, state that there are no clinical trials to suggest that screening healthy people with tests like these has any benefit.
But we should be cautious here. This question is scienceable; you could design a trial to test whether screening healthy 43-year-olds for testosterone level led to significant improvements in overall mortality. It would just take a few million people and about 40 years of follow-up.
And even if it didn’t help, we let people throw their money away on useless things all the time. The only difference between someone spending money on a useless test or on a useless dietary supplement is that someone has to deal with the result.
So, can you do this right? Can you make a direct-to-consumer testing company that is not essentially a free-rider on the rest of the health care ecosystem?
I think there are ways. You’d need physicians involved at all stages to help interpret the testing and guide next steps. You’d need some transparent guidelines, written in language that patients can understand, for what will happen given any conceivable result – and what costs those results might lead to for them and their insurance company. Most important, you’d need longitudinal follow-up and the ability to recommend changes, retest in the future, and potentially address the cost implications of the downstream findings. In the end, it starts to sound very much like a doctor’s office.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and public health and director of Yale’s Clinical and Translational Research Accelerator in New Haven, Conn. He reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Let’s assume, for the sake of argument, that I am a healthy 43-year old man. Nevertheless, I am interested in getting my vitamin D level checked. My primary care doc says it’s unnecessary, but that doesn’t matter because a variety of direct-to-consumer testing companies will do it without a doctor’s prescription – for a fee of course.
Is that okay? Should I be able to get the test?
What if instead of my vitamin D level, I want to test my testosterone level, or my PSA, or my cadmium level, or my Lyme disease antibodies, or even have a full-body MRI scan?
These questions are becoming more and more common, because the direct-to-consumer testing market is exploding.
We’re talking about direct-to-consumer testing, thanks to this paper: Policies of US Companies Offering Direct-to-Consumer Laboratory Tests, appearing in JAMA Internal Medicine, which characterizes the testing practices of direct-to-consumer testing companies.
But before we get to the study, a word on this market. Direct-to-consumer lab testing is projected to be a $2 billion industry by 2025, and lab testing megacorporations Quest Diagnostics and Labcorp are both jumping headlong into this space.
Why is this happening? A couple of reasons, I think. First, the increasing cost of health care has led payers to place significant restrictions on what tests can be ordered and under what circumstances. Physicians are all too familiar with the “prior authorization” system that seeks to limit even the tests we think would benefit our patients.
Frustrated with such a system, it’s no wonder that patients are increasingly deciding to go it on their own. Sure, insurance won’t cover these tests, but the prices are transparent and competition actually keeps them somewhat reasonable. So, is this a win-win? Shouldn’t we allow people to get the tests they want, at least if they are willing to pay for it?
Of course, it’s not quite that simple. If the tests are normal, or negative, then sure – no harm, no foul. But when they are positive, everything changes. What happens when the PSA test I got myself via a direct-to-consumer testing company comes back elevated? Well, at that point, I am right back into the traditional mode of medicine – seeing my doctor, probably getting repeat testing, biopsies, etc., – and some payer will be on the hook for that, which is to say that all of us will be on the hook for that.
One other reason direct-to-consumer testing is getting more popular is a more difficult-to-characterize phenomenon which I might call postpandemic individualism. I’ve seen this across several domains, but I think in some ways the pandemic led people to focus more attention on themselves, perhaps because we were so isolated from each other. Optimizing health through data – whether using a fitness tracking watch, meticulously counting macronutrient intake, or ordering your own lab tests – may be a form of exerting control over a universe that feels increasingly chaotic. But what do I know? I’m not a psychologist.
The study characterizes a total of 21 direct-to-consumer testing companies. They offer a variety of services, as you can see here, with the majority in the endocrine space: thyroid, diabetes, men’s and women’s health. A smattering of companies offer more esoteric testing, such as heavy metals and Lyme disease.
Who’s in charge of all this? It’s fairly regulated, actually, but perhaps not in the way you think. The FDA uses its CLIA authority to ensure that these tests are accurate. The FTC ensures that the companies do not engage in false advertising. But no one is minding the store as to whether the tests are actually beneficial either to an individual or to society.
The 21 companies varied dramatically in regard to how they handle communicating the risks and results of these tests. All of them had a disclaimer that the information does not represent comprehensive medical advice. Fine. But a minority acknowledged any risks or limitations of the tests. Less than half had a statement of HIPAA compliance. And 17 out of 21 provided no information as to whether customers could request their data to be deleted, while 18 out of 21 stated that there could be follow-up for abnormal results, but often it was unclear exactly how that would work.
So, let’s circle back to the first question: Should a healthy person be able to get a laboratory test simply because they want to? The libertarians among us would argue certainly yes, though perhaps without thinking through the societal implications of abnormal results. The evidence-based medicine folks will, accurately, state that there are no clinical trials to suggest that screening healthy people with tests like these has any benefit.
But we should be cautious here. This question is scienceable; you could design a trial to test whether screening healthy 43-year-olds for testosterone level led to significant improvements in overall mortality. It would just take a few million people and about 40 years of follow-up.
And even if it didn’t help, we let people throw their money away on useless things all the time. The only difference between someone spending money on a useless test or on a useless dietary supplement is that someone has to deal with the result.
So, can you do this right? Can you make a direct-to-consumer testing company that is not essentially a free-rider on the rest of the health care ecosystem?
I think there are ways. You’d need physicians involved at all stages to help interpret the testing and guide next steps. You’d need some transparent guidelines, written in language that patients can understand, for what will happen given any conceivable result – and what costs those results might lead to for them and their insurance company. Most important, you’d need longitudinal follow-up and the ability to recommend changes, retest in the future, and potentially address the cost implications of the downstream findings. In the end, it starts to sound very much like a doctor’s office.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and public health and director of Yale’s Clinical and Translational Research Accelerator in New Haven, Conn. He reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Surgery approach may improve survival in advanced ovarian cancer
TOPLINE:
Neoadjuvant chemotherapy followed by interval cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) significantly improves progression-free survival (PFS) and overall survival, compared with interval cytoreductive surgery alone, in patients with advanced ovarian cancer, new research shows.
METHODOLOGY:
- Several randomized controlled trials have shown survival benefits with HIPEC followed by interval cytoreductive surgery in advanced ovarian cancer. Despite the data, the use of HIPEC in clinical practice remains limited.
- Potential downsides of HIPEC include longer operative time and treatment-related complications.
- This prospective, multicenter, comparative effectiveness study evaluated the safety and effectiveness of interval cytoreductive surgery with HIPEC versus the surgery alone.
- The study, conducted at seven Korean Gynecologic Oncology Group institutions, included 196 patients (mean age, 58 years) with stage III or IV ovarian cancer who had received at least three cycles of neoadjuvant chemotherapy followed by interval cytoreductive surgery with HIPEC (n = 109) or without HIPEC (n = 87).
- The researchers reported progression-free survival as well as overall survival and treatment-related toxic effects.
TAKEAWAY:
- During a median follow-up of 28.2 months, 128 patients (65%) had a recurrence and 30 died (15.3%) – 8.3% in the HIPEC group and 24.1% in the non-HIPEC group.
- Compared with no HIPEC, interval cytoreductive surgery with HIPEC led to a significant improvement in median PFS (22.9 months vs. 14.2 months; P = .005) and median overall survival (not reached vs. 53 months; P = .002).
- The frequency of grade 3 or 4 postoperative complications was similar in both groups: 2.8% with HIPEC versus 3.4% without HIPEC.
- Among patients with recurrence, the frequency of peritoneal recurrence was significantly lower among those who received HIPEC (32.8% vs. 64.1% without HIPEC; P = .001).
IN PRACTICE:
“We observed a significantly superior survival benefit associated with [interval cytoreductive surgery] with HIPEC, without higher rates of postoperative complications,” the authors concluded, adding that “the survival benefit remained consistent, irrespective of maintenance therapy.”
SOURCE:
The study, led by Jung-Yun Lee, MD, PhD, Yonsei University College of Medicine, Seoul, Korea, was published online in JAMA Surgery.
LIMITATIONS:
The patients were not randomly assigned and the decision to give HIPEC was at the clinician’s discretion, introducing the possibility of selection and treatment bias. The different types of drugs used in HIPEC could result in bias in data interpretation.
DISCLOSURES:
The authors reported no conflicts of interest. The study had no specific funding.
A version of this article first appeared on Medscape.com.
TOPLINE:
Neoadjuvant chemotherapy followed by interval cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) significantly improves progression-free survival (PFS) and overall survival, compared with interval cytoreductive surgery alone, in patients with advanced ovarian cancer, new research shows.
METHODOLOGY:
- Several randomized controlled trials have shown survival benefits with HIPEC followed by interval cytoreductive surgery in advanced ovarian cancer. Despite the data, the use of HIPEC in clinical practice remains limited.
- Potential downsides of HIPEC include longer operative time and treatment-related complications.
- This prospective, multicenter, comparative effectiveness study evaluated the safety and effectiveness of interval cytoreductive surgery with HIPEC versus the surgery alone.
- The study, conducted at seven Korean Gynecologic Oncology Group institutions, included 196 patients (mean age, 58 years) with stage III or IV ovarian cancer who had received at least three cycles of neoadjuvant chemotherapy followed by interval cytoreductive surgery with HIPEC (n = 109) or without HIPEC (n = 87).
- The researchers reported progression-free survival as well as overall survival and treatment-related toxic effects.
TAKEAWAY:
- During a median follow-up of 28.2 months, 128 patients (65%) had a recurrence and 30 died (15.3%) – 8.3% in the HIPEC group and 24.1% in the non-HIPEC group.
- Compared with no HIPEC, interval cytoreductive surgery with HIPEC led to a significant improvement in median PFS (22.9 months vs. 14.2 months; P = .005) and median overall survival (not reached vs. 53 months; P = .002).
- The frequency of grade 3 or 4 postoperative complications was similar in both groups: 2.8% with HIPEC versus 3.4% without HIPEC.
- Among patients with recurrence, the frequency of peritoneal recurrence was significantly lower among those who received HIPEC (32.8% vs. 64.1% without HIPEC; P = .001).
IN PRACTICE:
“We observed a significantly superior survival benefit associated with [interval cytoreductive surgery] with HIPEC, without higher rates of postoperative complications,” the authors concluded, adding that “the survival benefit remained consistent, irrespective of maintenance therapy.”
SOURCE:
The study, led by Jung-Yun Lee, MD, PhD, Yonsei University College of Medicine, Seoul, Korea, was published online in JAMA Surgery.
LIMITATIONS:
The patients were not randomly assigned and the decision to give HIPEC was at the clinician’s discretion, introducing the possibility of selection and treatment bias. The different types of drugs used in HIPEC could result in bias in data interpretation.
DISCLOSURES:
The authors reported no conflicts of interest. The study had no specific funding.
A version of this article first appeared on Medscape.com.
TOPLINE:
Neoadjuvant chemotherapy followed by interval cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) significantly improves progression-free survival (PFS) and overall survival, compared with interval cytoreductive surgery alone, in patients with advanced ovarian cancer, new research shows.
METHODOLOGY:
- Several randomized controlled trials have shown survival benefits with HIPEC followed by interval cytoreductive surgery in advanced ovarian cancer. Despite the data, the use of HIPEC in clinical practice remains limited.
- Potential downsides of HIPEC include longer operative time and treatment-related complications.
- This prospective, multicenter, comparative effectiveness study evaluated the safety and effectiveness of interval cytoreductive surgery with HIPEC versus the surgery alone.
- The study, conducted at seven Korean Gynecologic Oncology Group institutions, included 196 patients (mean age, 58 years) with stage III or IV ovarian cancer who had received at least three cycles of neoadjuvant chemotherapy followed by interval cytoreductive surgery with HIPEC (n = 109) or without HIPEC (n = 87).
- The researchers reported progression-free survival as well as overall survival and treatment-related toxic effects.
TAKEAWAY:
- During a median follow-up of 28.2 months, 128 patients (65%) had a recurrence and 30 died (15.3%) – 8.3% in the HIPEC group and 24.1% in the non-HIPEC group.
- Compared with no HIPEC, interval cytoreductive surgery with HIPEC led to a significant improvement in median PFS (22.9 months vs. 14.2 months; P = .005) and median overall survival (not reached vs. 53 months; P = .002).
- The frequency of grade 3 or 4 postoperative complications was similar in both groups: 2.8% with HIPEC versus 3.4% without HIPEC.
- Among patients with recurrence, the frequency of peritoneal recurrence was significantly lower among those who received HIPEC (32.8% vs. 64.1% without HIPEC; P = .001).
IN PRACTICE:
“We observed a significantly superior survival benefit associated with [interval cytoreductive surgery] with HIPEC, without higher rates of postoperative complications,” the authors concluded, adding that “the survival benefit remained consistent, irrespective of maintenance therapy.”
SOURCE:
The study, led by Jung-Yun Lee, MD, PhD, Yonsei University College of Medicine, Seoul, Korea, was published online in JAMA Surgery.
LIMITATIONS:
The patients were not randomly assigned and the decision to give HIPEC was at the clinician’s discretion, introducing the possibility of selection and treatment bias. The different types of drugs used in HIPEC could result in bias in data interpretation.
DISCLOSURES:
The authors reported no conflicts of interest. The study had no specific funding.
A version of this article first appeared on Medscape.com.
FROM JAMA SURGERY
Nationwide hematologists shortage: What’s being done?
Over decades, the shrinking pool of CHs – who are compensated far less than hematologist-oncologists – has put patients at risk without access to adequate and timely care. To alleviate this crisis, individual doctors and national organizations are taking action and making more resources available to CHs and their patients.
`Vicious cycle’
The root cause of the CH shortage can be traced to a dramatic reduction in the number of physicians trained in this field, as Leonard Valentino, MD, President of the National Bleeding Disorders Foundation in New York, explained in an interview.
“There is a vicious cycle where there’s not enough classical hematologists to be program directors, and therefore trainees are often steered to fellowships in oncology,” said Dr. Valentino.
According to data published in JAMA, in 1995 there were 74 classical hematology programs in the United States; by 2018, there were only 2, During this same time period, the number of combined hematology/oncology training programs (HOPs) nearly doubled, from 75 to 146. However, it is estimated that less than 5% of graduates of adult HOPs pursued a career in classical hematology, as reported in Blood Advances. This low percentage can be attributed, at least in part, to the emphasis that most HOPs place on oncology.
Dr. Valentino noted that financial pressures are also diverting medical students from becoming CHs, adding that a hematologist-oncologist can make three times the annual salary of a CH.
Furthermore, when CHs treat bleeding and clotting disorders, they often need to meet with a patient for a 60- to 90-minute initial consultation, then they go on to provide a lifetime of labor-intensive care.
“This work is neither verticalized [that is, supported by radiologists, surgeons, and a cadre of nurses], nor is it billable per hour on a scale comparable to what oncologists can charge,” Dr. Valentino explained.
The survey published in Blood Advances illustrates the consequences of such a disparity in income potential: 34% of hematology/oncology fellows surveyed were likely to enter solid tumor oncology, while 20% and 4.6% would proceed to malignant hematology and CH, respectively.
Toll on patients
Primary care doctors treat some common blood disorders, but they almost always refer more difficult or complicated cases to a shrinking population of CHs.
“For many Americans, it is getting more difficult to find providers who subspecialize in hemostasis and thrombosis disorders. Patients can expect prolonged waiting times to get evaluated after a referral” said Mukul Singal, MD, of the Indiana Hemophilia and Thrombosis Center in Indianapolis.
Dr. Singal said the shortage is so acute that “at many institutions, malignant hematologists or oncologists are having to staff in-patient hematology consult services and see outpatient classical hematology patients. General hematologist/oncologists or medical oncologists are often not as comfortable or experienced with dealing with some of the complex CH conditions.”
A working care model, without enough doctors
In 1975, responding to patient advocacy groups, the federal government began funding hemophilia treatment centers (HTCs). Such centers offer a comprehensive care model that gives patients access to practitioners and administrative staff with the expertise to help them stay as healthy as possible. According to the Centers for Disease Control and Prevention, people with hemophilia who used an HTC were 40% less likely to die of a hemophilia-related complication and 40% less likely to be hospitalized for bleeding complications, compared to those who did not receive such specialized care.
“HTCs are effective at keeping patients out of the hospital and engaged in their lives. Between 80% and 95% of hemophilia patients get their care from an HTC and more patients want more services from them,” said Joe Pugliese, president of the Hemophilia Alliance in Lansdale, Pa.
Expanding care to meet patient demand is challenged by the restrictions on doctors’ salaries. All 140 U.S.-based HTCs share a $4.9 million federal grant but, by law, they can’t pay any provider more than $211,000 a year. “These restrictions push many people to industry, leaving too few doctors to meet patient demand,” Mr. Pugliese explained.
The fact that most HTCs are located in or near major cities also presents patients with the challenge of commuting, sometimes across state lines, to see a specialist. However, an uptick in telemedicine has provided one bright spot for many patients, allowing care to be brought to them.
The Hemophilia Alliance is also working on a multifaceted approach to change the rules, so that CHs are offered better compensation. “We have lobbyists in Washington, as well as an advocacy committee and a payer committee working to better support the HTC model,” Mr. Pugliese said.
Beyond the paycheck: Supporting CHs and patients
As market and regulatory restrictions make it difficult to boost the pay of CHs, doctors and nonprofit organizations are collaborating to support young CHs and bring more into the field. The American Society of Hematology has started and fully funded the Hematology Focused Fellowship Training Program (HFFTP). This program pairs comprehensive classical hematology training with education in transfusion medicine, sickle cell disease, hemostasis/thrombosis, systems-based hematology, health equity research, and global health. According to the program’s website, HFFTP’s goal is to add 50 new academic hematologists nationwide by 2030, in an effort to “improve the lives of patients with blood and bone marrow disorders.”
Additionally, classic hematologists are aiming to attract younger physicians and trainees to their field by introducing them to the various rewarding aspects of dealing with patients with inherited, chronic blood diseases. Programs like the Partners Physicians Academy (PPA), a 5-day training course that is specifically designed to encourage and retain young hematology students as classical hematologists, are essential to this effort.
“Along with preparing physicians to work in an HTC, programs like the Hematology Focused Fellowship Training Program and the Partners Physicians Academy are so important because they might convince young doctors to stick with non–oncology-based hematology careers, through the right mix of knowing about exciting research like gene therapy, financial and mentorship support, and a desire to meet unmet medical need,” explained Dr. Valentino.
The next PPA is taking place Sept. 18-22 in Indianapolis.
Dr. Singal, Dr. Valentino, and Mr. Pugliese had no financial disclosures to report.
Over decades, the shrinking pool of CHs – who are compensated far less than hematologist-oncologists – has put patients at risk without access to adequate and timely care. To alleviate this crisis, individual doctors and national organizations are taking action and making more resources available to CHs and their patients.
`Vicious cycle’
The root cause of the CH shortage can be traced to a dramatic reduction in the number of physicians trained in this field, as Leonard Valentino, MD, President of the National Bleeding Disorders Foundation in New York, explained in an interview.
“There is a vicious cycle where there’s not enough classical hematologists to be program directors, and therefore trainees are often steered to fellowships in oncology,” said Dr. Valentino.
According to data published in JAMA, in 1995 there were 74 classical hematology programs in the United States; by 2018, there were only 2, During this same time period, the number of combined hematology/oncology training programs (HOPs) nearly doubled, from 75 to 146. However, it is estimated that less than 5% of graduates of adult HOPs pursued a career in classical hematology, as reported in Blood Advances. This low percentage can be attributed, at least in part, to the emphasis that most HOPs place on oncology.
Dr. Valentino noted that financial pressures are also diverting medical students from becoming CHs, adding that a hematologist-oncologist can make three times the annual salary of a CH.
Furthermore, when CHs treat bleeding and clotting disorders, they often need to meet with a patient for a 60- to 90-minute initial consultation, then they go on to provide a lifetime of labor-intensive care.
“This work is neither verticalized [that is, supported by radiologists, surgeons, and a cadre of nurses], nor is it billable per hour on a scale comparable to what oncologists can charge,” Dr. Valentino explained.
The survey published in Blood Advances illustrates the consequences of such a disparity in income potential: 34% of hematology/oncology fellows surveyed were likely to enter solid tumor oncology, while 20% and 4.6% would proceed to malignant hematology and CH, respectively.
Toll on patients
Primary care doctors treat some common blood disorders, but they almost always refer more difficult or complicated cases to a shrinking population of CHs.
“For many Americans, it is getting more difficult to find providers who subspecialize in hemostasis and thrombosis disorders. Patients can expect prolonged waiting times to get evaluated after a referral” said Mukul Singal, MD, of the Indiana Hemophilia and Thrombosis Center in Indianapolis.
Dr. Singal said the shortage is so acute that “at many institutions, malignant hematologists or oncologists are having to staff in-patient hematology consult services and see outpatient classical hematology patients. General hematologist/oncologists or medical oncologists are often not as comfortable or experienced with dealing with some of the complex CH conditions.”
A working care model, without enough doctors
In 1975, responding to patient advocacy groups, the federal government began funding hemophilia treatment centers (HTCs). Such centers offer a comprehensive care model that gives patients access to practitioners and administrative staff with the expertise to help them stay as healthy as possible. According to the Centers for Disease Control and Prevention, people with hemophilia who used an HTC were 40% less likely to die of a hemophilia-related complication and 40% less likely to be hospitalized for bleeding complications, compared to those who did not receive such specialized care.
“HTCs are effective at keeping patients out of the hospital and engaged in their lives. Between 80% and 95% of hemophilia patients get their care from an HTC and more patients want more services from them,” said Joe Pugliese, president of the Hemophilia Alliance in Lansdale, Pa.
Expanding care to meet patient demand is challenged by the restrictions on doctors’ salaries. All 140 U.S.-based HTCs share a $4.9 million federal grant but, by law, they can’t pay any provider more than $211,000 a year. “These restrictions push many people to industry, leaving too few doctors to meet patient demand,” Mr. Pugliese explained.
The fact that most HTCs are located in or near major cities also presents patients with the challenge of commuting, sometimes across state lines, to see a specialist. However, an uptick in telemedicine has provided one bright spot for many patients, allowing care to be brought to them.
The Hemophilia Alliance is also working on a multifaceted approach to change the rules, so that CHs are offered better compensation. “We have lobbyists in Washington, as well as an advocacy committee and a payer committee working to better support the HTC model,” Mr. Pugliese said.
Beyond the paycheck: Supporting CHs and patients
As market and regulatory restrictions make it difficult to boost the pay of CHs, doctors and nonprofit organizations are collaborating to support young CHs and bring more into the field. The American Society of Hematology has started and fully funded the Hematology Focused Fellowship Training Program (HFFTP). This program pairs comprehensive classical hematology training with education in transfusion medicine, sickle cell disease, hemostasis/thrombosis, systems-based hematology, health equity research, and global health. According to the program’s website, HFFTP’s goal is to add 50 new academic hematologists nationwide by 2030, in an effort to “improve the lives of patients with blood and bone marrow disorders.”
Additionally, classic hematologists are aiming to attract younger physicians and trainees to their field by introducing them to the various rewarding aspects of dealing with patients with inherited, chronic blood diseases. Programs like the Partners Physicians Academy (PPA), a 5-day training course that is specifically designed to encourage and retain young hematology students as classical hematologists, are essential to this effort.
“Along with preparing physicians to work in an HTC, programs like the Hematology Focused Fellowship Training Program and the Partners Physicians Academy are so important because they might convince young doctors to stick with non–oncology-based hematology careers, through the right mix of knowing about exciting research like gene therapy, financial and mentorship support, and a desire to meet unmet medical need,” explained Dr. Valentino.
The next PPA is taking place Sept. 18-22 in Indianapolis.
Dr. Singal, Dr. Valentino, and Mr. Pugliese had no financial disclosures to report.
Over decades, the shrinking pool of CHs – who are compensated far less than hematologist-oncologists – has put patients at risk without access to adequate and timely care. To alleviate this crisis, individual doctors and national organizations are taking action and making more resources available to CHs and their patients.
`Vicious cycle’
The root cause of the CH shortage can be traced to a dramatic reduction in the number of physicians trained in this field, as Leonard Valentino, MD, President of the National Bleeding Disorders Foundation in New York, explained in an interview.
“There is a vicious cycle where there’s not enough classical hematologists to be program directors, and therefore trainees are often steered to fellowships in oncology,” said Dr. Valentino.
According to data published in JAMA, in 1995 there were 74 classical hematology programs in the United States; by 2018, there were only 2, During this same time period, the number of combined hematology/oncology training programs (HOPs) nearly doubled, from 75 to 146. However, it is estimated that less than 5% of graduates of adult HOPs pursued a career in classical hematology, as reported in Blood Advances. This low percentage can be attributed, at least in part, to the emphasis that most HOPs place on oncology.
Dr. Valentino noted that financial pressures are also diverting medical students from becoming CHs, adding that a hematologist-oncologist can make three times the annual salary of a CH.
Furthermore, when CHs treat bleeding and clotting disorders, they often need to meet with a patient for a 60- to 90-minute initial consultation, then they go on to provide a lifetime of labor-intensive care.
“This work is neither verticalized [that is, supported by radiologists, surgeons, and a cadre of nurses], nor is it billable per hour on a scale comparable to what oncologists can charge,” Dr. Valentino explained.
The survey published in Blood Advances illustrates the consequences of such a disparity in income potential: 34% of hematology/oncology fellows surveyed were likely to enter solid tumor oncology, while 20% and 4.6% would proceed to malignant hematology and CH, respectively.
Toll on patients
Primary care doctors treat some common blood disorders, but they almost always refer more difficult or complicated cases to a shrinking population of CHs.
“For many Americans, it is getting more difficult to find providers who subspecialize in hemostasis and thrombosis disorders. Patients can expect prolonged waiting times to get evaluated after a referral” said Mukul Singal, MD, of the Indiana Hemophilia and Thrombosis Center in Indianapolis.
Dr. Singal said the shortage is so acute that “at many institutions, malignant hematologists or oncologists are having to staff in-patient hematology consult services and see outpatient classical hematology patients. General hematologist/oncologists or medical oncologists are often not as comfortable or experienced with dealing with some of the complex CH conditions.”
A working care model, without enough doctors
In 1975, responding to patient advocacy groups, the federal government began funding hemophilia treatment centers (HTCs). Such centers offer a comprehensive care model that gives patients access to practitioners and administrative staff with the expertise to help them stay as healthy as possible. According to the Centers for Disease Control and Prevention, people with hemophilia who used an HTC were 40% less likely to die of a hemophilia-related complication and 40% less likely to be hospitalized for bleeding complications, compared to those who did not receive such specialized care.
“HTCs are effective at keeping patients out of the hospital and engaged in their lives. Between 80% and 95% of hemophilia patients get their care from an HTC and more patients want more services from them,” said Joe Pugliese, president of the Hemophilia Alliance in Lansdale, Pa.
Expanding care to meet patient demand is challenged by the restrictions on doctors’ salaries. All 140 U.S.-based HTCs share a $4.9 million federal grant but, by law, they can’t pay any provider more than $211,000 a year. “These restrictions push many people to industry, leaving too few doctors to meet patient demand,” Mr. Pugliese explained.
The fact that most HTCs are located in or near major cities also presents patients with the challenge of commuting, sometimes across state lines, to see a specialist. However, an uptick in telemedicine has provided one bright spot for many patients, allowing care to be brought to them.
The Hemophilia Alliance is also working on a multifaceted approach to change the rules, so that CHs are offered better compensation. “We have lobbyists in Washington, as well as an advocacy committee and a payer committee working to better support the HTC model,” Mr. Pugliese said.
Beyond the paycheck: Supporting CHs and patients
As market and regulatory restrictions make it difficult to boost the pay of CHs, doctors and nonprofit organizations are collaborating to support young CHs and bring more into the field. The American Society of Hematology has started and fully funded the Hematology Focused Fellowship Training Program (HFFTP). This program pairs comprehensive classical hematology training with education in transfusion medicine, sickle cell disease, hemostasis/thrombosis, systems-based hematology, health equity research, and global health. According to the program’s website, HFFTP’s goal is to add 50 new academic hematologists nationwide by 2030, in an effort to “improve the lives of patients with blood and bone marrow disorders.”
Additionally, classic hematologists are aiming to attract younger physicians and trainees to their field by introducing them to the various rewarding aspects of dealing with patients with inherited, chronic blood diseases. Programs like the Partners Physicians Academy (PPA), a 5-day training course that is specifically designed to encourage and retain young hematology students as classical hematologists, are essential to this effort.
“Along with preparing physicians to work in an HTC, programs like the Hematology Focused Fellowship Training Program and the Partners Physicians Academy are so important because they might convince young doctors to stick with non–oncology-based hematology careers, through the right mix of knowing about exciting research like gene therapy, financial and mentorship support, and a desire to meet unmet medical need,” explained Dr. Valentino.
The next PPA is taking place Sept. 18-22 in Indianapolis.
Dr. Singal, Dr. Valentino, and Mr. Pugliese had no financial disclosures to report.
Do doctors have a legal right to work from home because of health issues or disability?
A radiologist who claims he was forced to resign after requesting to work from home has settled his discrimination lawsuit with a New York hospital.
Although the case was resolved without a definitive win, legal analysts say the complaint raises important questions about whether some physicians have the right to work from home.
Since the pandemic, employers across the country have become more accepting of professionals working remotely.
Richard Heiden, MD, sued New York City Health and Hospitals in 2020, claiming discrimination and retaliation violations under the American with Disabilities Act (ADA) and the New York State Human Rights Law. Dr. Heiden, who has ulcerative colitis, had asked to work off-site during the start of the pandemic, but the hospital denied his accommodation request. Shortly later, administrators accused Dr. Heiden of poor performance and requested he resign or administrators would terminate him, according to his lawsuit.
Attorneys for New York City Health and Hospitals contended that Dr. Heiden was a poorly performing radiologist who was undergoing a performance review at the time of his accommodation request. The radiologist’s departure was related to the results of the review and had nothing to do with his disability or accommodation request, according to the hospital.
The undisclosed settlement ends a 3-year court battle between Dr. Heiden and the hospital corporation.
In an email, Laura Williams, an attorney for the hospital corporation, said that “the settlement was in the best interest of all parties.”
Dr. Heiden and his attorneys also did not respond to requests for comment.
A critical piece to the puzzle is understanding who is protected under the ADA and is therefore entitled to reasonable accommodations, said Doron Dorfman, JSD, an associate professor at Seton Hall University Law School in Newark, N.J., who focuses on disability law.
A common misconception is that only physicians with a physical disability are “disabled,” he said. However, under the law, a disabled individual is anyone with a physical or mental impairment – including mental illness – that limits major life activities; a person with a history of such impairment; or a person who is perceived by others as having an impairment.
“The law is much broader than many people think,” he said. “I think a lot of people don’t think about those with invisible disabilities, such as people with allergies, those who are immunocompromised, those with chronic illnesses. A lot of people don’t see themselves as disabled, and a lot of employers don’t see them as disabled.”
Working from home has not historically been considered a “reasonable accommodation” under the ADA, Mr. Dorfman said. However, that appears to be changing.
“There has been a sea change,” Mr. Dorfman said. “The question is coming before the courts more frequently, and recent legal decisions show judges may be altering their views on the subject.”
What led to the doctor’s lawsuit?
Dr. Heiden, a longtime radiologist, had practiced at Lincoln Medical and Mental Health Center for about a year when he requested to work remotely. (Lincoln is operated by New York City Health and Hospitals.) At the time, the governor of New York had ordered a statewide lockdown because of COVID-19, and Dr. Heiden expressed concern that his ulcerative colitis made him a high-risk individual for the virus, according to court documents.
In his March 22, 2020, request, Dr. Heiden said that, except for fluoroscopy, his job could be done entirely from his home, according to a district court summary of the case. He also offered to pay for any costs associated with the remote work setup.
Around the same time, New York City Health and Hospitals permitted its facilities to issue a limited number of workstations to radiologists to facilitate remote work in the event of COVID-related staffing shortages. Administrators were in the process of acquiring remote radiology workstations and determining which radiologists at Lincoln would receive them, according to the case summary.
On March 24, the chair of radiology at Lincoln met with Dr. Heiden to review the results of a recent focused professional practice evaluation (FPPE). An FPPE refers to an intensive review of an expansive selection of patient cases handled by the subject physician. During the meeting, the chair that claimed Dr. Heiden was a poor performer and was accurate in his assessments 93.8% of the time, which was below the hospital’s 97% threshold, according to Dr. Heiden’s lawsuit. Dr. Heiden disagreed with the results, and the two engaged in several more meetings.
Meanwhile, Dr. Heiden’s accommodation request was forwarded to other administrators. In an email introduced into court evidence, the chair indicated he did not support the accommodation, writing that Dr. Heiden’s “skill set does not meet the criteria for the initial installations” of the workstations.
On March 26, 2020, the chair allegedly asked Dr. Heiden to either resign or he would be terminated and reported to the New York State Office of Professional Medical Conduct. Four days later, Dr. Heiden learned that his accommodation request had been denied. He resigned on April 2, 2020.
In his lawsuit, Dr. Heiden claimed that the hospital discriminated against him on the basis of his disability in violation of ADA by denying him equal terms and conditions of employment and failing to provide a reasonable accommodation.
The defendants, who included the radiology chair, did not dispute that Dr. Heiden was asked to resign or that administrators warned termination, but they argued the impetus was his FPPE results and a history of inaccurate interpretations. Other clinicians and physicians had expressed concerns about Dr. Heiden’s “lack of clarity [and] interpretive errors,” according to deposition testimony. The hospital emphasized the FPPE had concluded before Dr. Heiden’s accommodation request was made.
New York City Health and Hospitals requested a federal judge dismiss the lawsuit for lack of valid claims. In January 2023, U.S. District Judge Lewis Liman allowed the case to proceed, ruling that some of Dr. Heiden’s claims had merit.
“Plaintiff has satisfied his obligation to proffer sufficient evidence to create an inference of retaliatory or discriminatory intent,” Judge Liman wrote in his decision. “[The chair] had not always planned to ask for plaintiff’s resignation based on the results of the FPPE completed on March 10, 2020. The decision to ask for that resignation arose shortly after the request for the accommodation. And there is evidence from which the jury could find that [the chair] was not receptive to making the accommodation.”
A jury trial was scheduled for July 2023, but the parties reached a settlement on May 31, 2023.
Is working from home reasonable for physicians?
The widespread swing to remote work in recent years has paved a smoother road for physicians who request the accommodation, said Peter Poullos, MD, clinical associate professor of radiology, gastroenterology, and hepatology at Stanford (Calif.) University and founder and cochair of the Stanford Medicine Alliance for Disability Inclusion and Equity.
“There is now a precedent and examples all over that working from home for some is a viable alternative to working in the hospital or a clinic,” Dr. Poullos said. “If a lawyer can point to instances of other people having received the same accommodation, even if the accommodation was given to someone without a disability, it’s much harder for an employer to say: ‘It’s not possible.’ Because clearly, it is.”
A key factor is the employee’s job duties and whether the employee can complete them remotely, said Mr. Dorfman. With physicians, the reasonableness would heavily depend on their specialty.
A radiologist, for example, would probably have a stronger case for performing their duties remotely compared with a surgeon, Dr. Poullos said.
In general, whether an accommodation is reasonable is decided on a case-by-case basis and usually includes reviewing supporting documentation from a medical provider, said Emily Harvey, a Denver-based disability law attorney. Employers are allowed to deny accommodations if they would cause an undue burden to the employer or fundamentally alter the nature or operation of the job or business.
“When it comes to the ADA, and disability rights in general, the analysis is based on the need of the individual,” she said. “Two people with identical diagnoses could need vastly different accommodations to be successful in the same job.”
Mr. Dorfman added that employers are only required to provide an accommodation that is reasonable under the circumstances, whether or not that accommodation meets the preferred request of the employee. For instance, if an immunocompromised physician asked to work from home, but the employer could ensure that all those working around the physician will mask, that could be reasonable enough.
A recent case analysis by Bloomberg Law shows that more courts are siding with employees who request remote work, compared with in past years. Employees who made disability-related remote work requests prevailed in 40% of federal court rulings from 2021 to 2023 versusa success rate of 30% from 2017 to 2019, according to the July 2023 analysis.
The analysis shows that employers still win the majority of the time, but that the gap is closing, Mr. Dorfman said.
In a September 2020 decision, for example, a Massachusetts District Court ruled in favor of an employee with asthma who was precluding from working at home by a behavioral and mental health agency. U.S. Magistrate Judge Katherine Robertson said that the manager was entitled to telework as a reasonable accommodation under the ADA for 60 days or until further notice. The lawsuit was settled in 2021.
“I think judges are much more used to working from home themselves,” Mr. Dorfman said. “That may affect their sense of accepting remote work as a reasonable accommodation. Their personal experience with it [may] actually inform their view of the topic.”
Your accommodation request was denied: Now what?
If you are unsure about your rights under the ADA, a first step is understanding the law’s protections and learning the obligations of your employer.
Keep in mind that not everyone at your workplace may understand the law and what is required, said Dr. Poullos. When making a request to work from home, ensure that you’re using the right words and asking the right people, he advised. Some physicians, for instance, may only discuss the request with their direct supervisor and give up when the request is denied. “The employee might say, ‘I’ve been dealing with some medical issues and I’m really tired and need to adjust my schedule.’ They don’t mention the word ‘disability,’ they don’t mention the ADA, they don’t mention the word ‘accommodation,’ and so that might not trigger the appropriate response.”
Lisa Meeks, PhD, an expert and researcher in disabilities in medical education, encourages physicians and others to follow the appeals process at their institution if they feel their accommodation request has been unjustly denied.
Research shows that physicians who make accommodation requests rarely escalate denials to an appeal, grievance, or complaint, said Dr. Meeks, cohost of the Docs With Disabilities podcast and director of the Docs With Disabilities Initiative. The initiative aims to use research, education, and stories to drive change in perceptions, disability policy, and procedures in health professions and in biomedical and science education.
If an accommodation cannot be agreed on, doctors can reach out the Equal Employment Opportunity Commission and file a discrimination charge. The agency will review the case and provide an opinion on whether the charge has merit. The EEOC’s decision is not binding in court, and even if the agency believes the charge has no merit, employees still have the right to sue, he said.
Ms. Harvey added that the EEOC has many resources on its website, and that most states also have civil rights agencies that have additional resources. Every state and U.S. territory also has a protection and advocacy organization that may be able to help. Physicians can also review their state bar to locate and consult with disability rights attorneys.
Although it may seem like an uphill battle to push for an accommodation, it can be worth it in the end, said Michael Argenyi, MD, an addiction medicine specialist and assistant professor at the University of Massachusetts, Worcester. Dr. Argenyi, who has hearing loss, was featured on the Docs With Disabilities podcast.
“It’s difficult to ‘rock the boat’ and ask for support from the C-suite for employees with disabilities, or to rearrange a small medical office budget to establish a byline just for accommodations,” Dr. Argenyi said. “Yet, the payoff is worthwhile – patients and fellow colleagues notice commitments to diversity building and inclusion.”
A version of this article appeared on Medscape.com.
A radiologist who claims he was forced to resign after requesting to work from home has settled his discrimination lawsuit with a New York hospital.
Although the case was resolved without a definitive win, legal analysts say the complaint raises important questions about whether some physicians have the right to work from home.
Since the pandemic, employers across the country have become more accepting of professionals working remotely.
Richard Heiden, MD, sued New York City Health and Hospitals in 2020, claiming discrimination and retaliation violations under the American with Disabilities Act (ADA) and the New York State Human Rights Law. Dr. Heiden, who has ulcerative colitis, had asked to work off-site during the start of the pandemic, but the hospital denied his accommodation request. Shortly later, administrators accused Dr. Heiden of poor performance and requested he resign or administrators would terminate him, according to his lawsuit.
Attorneys for New York City Health and Hospitals contended that Dr. Heiden was a poorly performing radiologist who was undergoing a performance review at the time of his accommodation request. The radiologist’s departure was related to the results of the review and had nothing to do with his disability or accommodation request, according to the hospital.
The undisclosed settlement ends a 3-year court battle between Dr. Heiden and the hospital corporation.
In an email, Laura Williams, an attorney for the hospital corporation, said that “the settlement was in the best interest of all parties.”
Dr. Heiden and his attorneys also did not respond to requests for comment.
A critical piece to the puzzle is understanding who is protected under the ADA and is therefore entitled to reasonable accommodations, said Doron Dorfman, JSD, an associate professor at Seton Hall University Law School in Newark, N.J., who focuses on disability law.
A common misconception is that only physicians with a physical disability are “disabled,” he said. However, under the law, a disabled individual is anyone with a physical or mental impairment – including mental illness – that limits major life activities; a person with a history of such impairment; or a person who is perceived by others as having an impairment.
“The law is much broader than many people think,” he said. “I think a lot of people don’t think about those with invisible disabilities, such as people with allergies, those who are immunocompromised, those with chronic illnesses. A lot of people don’t see themselves as disabled, and a lot of employers don’t see them as disabled.”
Working from home has not historically been considered a “reasonable accommodation” under the ADA, Mr. Dorfman said. However, that appears to be changing.
“There has been a sea change,” Mr. Dorfman said. “The question is coming before the courts more frequently, and recent legal decisions show judges may be altering their views on the subject.”
What led to the doctor’s lawsuit?
Dr. Heiden, a longtime radiologist, had practiced at Lincoln Medical and Mental Health Center for about a year when he requested to work remotely. (Lincoln is operated by New York City Health and Hospitals.) At the time, the governor of New York had ordered a statewide lockdown because of COVID-19, and Dr. Heiden expressed concern that his ulcerative colitis made him a high-risk individual for the virus, according to court documents.
In his March 22, 2020, request, Dr. Heiden said that, except for fluoroscopy, his job could be done entirely from his home, according to a district court summary of the case. He also offered to pay for any costs associated with the remote work setup.
Around the same time, New York City Health and Hospitals permitted its facilities to issue a limited number of workstations to radiologists to facilitate remote work in the event of COVID-related staffing shortages. Administrators were in the process of acquiring remote radiology workstations and determining which radiologists at Lincoln would receive them, according to the case summary.
On March 24, the chair of radiology at Lincoln met with Dr. Heiden to review the results of a recent focused professional practice evaluation (FPPE). An FPPE refers to an intensive review of an expansive selection of patient cases handled by the subject physician. During the meeting, the chair that claimed Dr. Heiden was a poor performer and was accurate in his assessments 93.8% of the time, which was below the hospital’s 97% threshold, according to Dr. Heiden’s lawsuit. Dr. Heiden disagreed with the results, and the two engaged in several more meetings.
Meanwhile, Dr. Heiden’s accommodation request was forwarded to other administrators. In an email introduced into court evidence, the chair indicated he did not support the accommodation, writing that Dr. Heiden’s “skill set does not meet the criteria for the initial installations” of the workstations.
On March 26, 2020, the chair allegedly asked Dr. Heiden to either resign or he would be terminated and reported to the New York State Office of Professional Medical Conduct. Four days later, Dr. Heiden learned that his accommodation request had been denied. He resigned on April 2, 2020.
In his lawsuit, Dr. Heiden claimed that the hospital discriminated against him on the basis of his disability in violation of ADA by denying him equal terms and conditions of employment and failing to provide a reasonable accommodation.
The defendants, who included the radiology chair, did not dispute that Dr. Heiden was asked to resign or that administrators warned termination, but they argued the impetus was his FPPE results and a history of inaccurate interpretations. Other clinicians and physicians had expressed concerns about Dr. Heiden’s “lack of clarity [and] interpretive errors,” according to deposition testimony. The hospital emphasized the FPPE had concluded before Dr. Heiden’s accommodation request was made.
New York City Health and Hospitals requested a federal judge dismiss the lawsuit for lack of valid claims. In January 2023, U.S. District Judge Lewis Liman allowed the case to proceed, ruling that some of Dr. Heiden’s claims had merit.
“Plaintiff has satisfied his obligation to proffer sufficient evidence to create an inference of retaliatory or discriminatory intent,” Judge Liman wrote in his decision. “[The chair] had not always planned to ask for plaintiff’s resignation based on the results of the FPPE completed on March 10, 2020. The decision to ask for that resignation arose shortly after the request for the accommodation. And there is evidence from which the jury could find that [the chair] was not receptive to making the accommodation.”
A jury trial was scheduled for July 2023, but the parties reached a settlement on May 31, 2023.
Is working from home reasonable for physicians?
The widespread swing to remote work in recent years has paved a smoother road for physicians who request the accommodation, said Peter Poullos, MD, clinical associate professor of radiology, gastroenterology, and hepatology at Stanford (Calif.) University and founder and cochair of the Stanford Medicine Alliance for Disability Inclusion and Equity.
“There is now a precedent and examples all over that working from home for some is a viable alternative to working in the hospital or a clinic,” Dr. Poullos said. “If a lawyer can point to instances of other people having received the same accommodation, even if the accommodation was given to someone without a disability, it’s much harder for an employer to say: ‘It’s not possible.’ Because clearly, it is.”
A key factor is the employee’s job duties and whether the employee can complete them remotely, said Mr. Dorfman. With physicians, the reasonableness would heavily depend on their specialty.
A radiologist, for example, would probably have a stronger case for performing their duties remotely compared with a surgeon, Dr. Poullos said.
In general, whether an accommodation is reasonable is decided on a case-by-case basis and usually includes reviewing supporting documentation from a medical provider, said Emily Harvey, a Denver-based disability law attorney. Employers are allowed to deny accommodations if they would cause an undue burden to the employer or fundamentally alter the nature or operation of the job or business.
“When it comes to the ADA, and disability rights in general, the analysis is based on the need of the individual,” she said. “Two people with identical diagnoses could need vastly different accommodations to be successful in the same job.”
Mr. Dorfman added that employers are only required to provide an accommodation that is reasonable under the circumstances, whether or not that accommodation meets the preferred request of the employee. For instance, if an immunocompromised physician asked to work from home, but the employer could ensure that all those working around the physician will mask, that could be reasonable enough.
A recent case analysis by Bloomberg Law shows that more courts are siding with employees who request remote work, compared with in past years. Employees who made disability-related remote work requests prevailed in 40% of federal court rulings from 2021 to 2023 versusa success rate of 30% from 2017 to 2019, according to the July 2023 analysis.
The analysis shows that employers still win the majority of the time, but that the gap is closing, Mr. Dorfman said.
In a September 2020 decision, for example, a Massachusetts District Court ruled in favor of an employee with asthma who was precluding from working at home by a behavioral and mental health agency. U.S. Magistrate Judge Katherine Robertson said that the manager was entitled to telework as a reasonable accommodation under the ADA for 60 days or until further notice. The lawsuit was settled in 2021.
“I think judges are much more used to working from home themselves,” Mr. Dorfman said. “That may affect their sense of accepting remote work as a reasonable accommodation. Their personal experience with it [may] actually inform their view of the topic.”
Your accommodation request was denied: Now what?
If you are unsure about your rights under the ADA, a first step is understanding the law’s protections and learning the obligations of your employer.
Keep in mind that not everyone at your workplace may understand the law and what is required, said Dr. Poullos. When making a request to work from home, ensure that you’re using the right words and asking the right people, he advised. Some physicians, for instance, may only discuss the request with their direct supervisor and give up when the request is denied. “The employee might say, ‘I’ve been dealing with some medical issues and I’m really tired and need to adjust my schedule.’ They don’t mention the word ‘disability,’ they don’t mention the ADA, they don’t mention the word ‘accommodation,’ and so that might not trigger the appropriate response.”
Lisa Meeks, PhD, an expert and researcher in disabilities in medical education, encourages physicians and others to follow the appeals process at their institution if they feel their accommodation request has been unjustly denied.
Research shows that physicians who make accommodation requests rarely escalate denials to an appeal, grievance, or complaint, said Dr. Meeks, cohost of the Docs With Disabilities podcast and director of the Docs With Disabilities Initiative. The initiative aims to use research, education, and stories to drive change in perceptions, disability policy, and procedures in health professions and in biomedical and science education.
If an accommodation cannot be agreed on, doctors can reach out the Equal Employment Opportunity Commission and file a discrimination charge. The agency will review the case and provide an opinion on whether the charge has merit. The EEOC’s decision is not binding in court, and even if the agency believes the charge has no merit, employees still have the right to sue, he said.
Ms. Harvey added that the EEOC has many resources on its website, and that most states also have civil rights agencies that have additional resources. Every state and U.S. territory also has a protection and advocacy organization that may be able to help. Physicians can also review their state bar to locate and consult with disability rights attorneys.
Although it may seem like an uphill battle to push for an accommodation, it can be worth it in the end, said Michael Argenyi, MD, an addiction medicine specialist and assistant professor at the University of Massachusetts, Worcester. Dr. Argenyi, who has hearing loss, was featured on the Docs With Disabilities podcast.
“It’s difficult to ‘rock the boat’ and ask for support from the C-suite for employees with disabilities, or to rearrange a small medical office budget to establish a byline just for accommodations,” Dr. Argenyi said. “Yet, the payoff is worthwhile – patients and fellow colleagues notice commitments to diversity building and inclusion.”
A version of this article appeared on Medscape.com.
A radiologist who claims he was forced to resign after requesting to work from home has settled his discrimination lawsuit with a New York hospital.
Although the case was resolved without a definitive win, legal analysts say the complaint raises important questions about whether some physicians have the right to work from home.
Since the pandemic, employers across the country have become more accepting of professionals working remotely.
Richard Heiden, MD, sued New York City Health and Hospitals in 2020, claiming discrimination and retaliation violations under the American with Disabilities Act (ADA) and the New York State Human Rights Law. Dr. Heiden, who has ulcerative colitis, had asked to work off-site during the start of the pandemic, but the hospital denied his accommodation request. Shortly later, administrators accused Dr. Heiden of poor performance and requested he resign or administrators would terminate him, according to his lawsuit.
Attorneys for New York City Health and Hospitals contended that Dr. Heiden was a poorly performing radiologist who was undergoing a performance review at the time of his accommodation request. The radiologist’s departure was related to the results of the review and had nothing to do with his disability or accommodation request, according to the hospital.
The undisclosed settlement ends a 3-year court battle between Dr. Heiden and the hospital corporation.
In an email, Laura Williams, an attorney for the hospital corporation, said that “the settlement was in the best interest of all parties.”
Dr. Heiden and his attorneys also did not respond to requests for comment.
A critical piece to the puzzle is understanding who is protected under the ADA and is therefore entitled to reasonable accommodations, said Doron Dorfman, JSD, an associate professor at Seton Hall University Law School in Newark, N.J., who focuses on disability law.
A common misconception is that only physicians with a physical disability are “disabled,” he said. However, under the law, a disabled individual is anyone with a physical or mental impairment – including mental illness – that limits major life activities; a person with a history of such impairment; or a person who is perceived by others as having an impairment.
“The law is much broader than many people think,” he said. “I think a lot of people don’t think about those with invisible disabilities, such as people with allergies, those who are immunocompromised, those with chronic illnesses. A lot of people don’t see themselves as disabled, and a lot of employers don’t see them as disabled.”
Working from home has not historically been considered a “reasonable accommodation” under the ADA, Mr. Dorfman said. However, that appears to be changing.
“There has been a sea change,” Mr. Dorfman said. “The question is coming before the courts more frequently, and recent legal decisions show judges may be altering their views on the subject.”
What led to the doctor’s lawsuit?
Dr. Heiden, a longtime radiologist, had practiced at Lincoln Medical and Mental Health Center for about a year when he requested to work remotely. (Lincoln is operated by New York City Health and Hospitals.) At the time, the governor of New York had ordered a statewide lockdown because of COVID-19, and Dr. Heiden expressed concern that his ulcerative colitis made him a high-risk individual for the virus, according to court documents.
In his March 22, 2020, request, Dr. Heiden said that, except for fluoroscopy, his job could be done entirely from his home, according to a district court summary of the case. He also offered to pay for any costs associated with the remote work setup.
Around the same time, New York City Health and Hospitals permitted its facilities to issue a limited number of workstations to radiologists to facilitate remote work in the event of COVID-related staffing shortages. Administrators were in the process of acquiring remote radiology workstations and determining which radiologists at Lincoln would receive them, according to the case summary.
On March 24, the chair of radiology at Lincoln met with Dr. Heiden to review the results of a recent focused professional practice evaluation (FPPE). An FPPE refers to an intensive review of an expansive selection of patient cases handled by the subject physician. During the meeting, the chair that claimed Dr. Heiden was a poor performer and was accurate in his assessments 93.8% of the time, which was below the hospital’s 97% threshold, according to Dr. Heiden’s lawsuit. Dr. Heiden disagreed with the results, and the two engaged in several more meetings.
Meanwhile, Dr. Heiden’s accommodation request was forwarded to other administrators. In an email introduced into court evidence, the chair indicated he did not support the accommodation, writing that Dr. Heiden’s “skill set does not meet the criteria for the initial installations” of the workstations.
On March 26, 2020, the chair allegedly asked Dr. Heiden to either resign or he would be terminated and reported to the New York State Office of Professional Medical Conduct. Four days later, Dr. Heiden learned that his accommodation request had been denied. He resigned on April 2, 2020.
In his lawsuit, Dr. Heiden claimed that the hospital discriminated against him on the basis of his disability in violation of ADA by denying him equal terms and conditions of employment and failing to provide a reasonable accommodation.
The defendants, who included the radiology chair, did not dispute that Dr. Heiden was asked to resign or that administrators warned termination, but they argued the impetus was his FPPE results and a history of inaccurate interpretations. Other clinicians and physicians had expressed concerns about Dr. Heiden’s “lack of clarity [and] interpretive errors,” according to deposition testimony. The hospital emphasized the FPPE had concluded before Dr. Heiden’s accommodation request was made.
New York City Health and Hospitals requested a federal judge dismiss the lawsuit for lack of valid claims. In January 2023, U.S. District Judge Lewis Liman allowed the case to proceed, ruling that some of Dr. Heiden’s claims had merit.
“Plaintiff has satisfied his obligation to proffer sufficient evidence to create an inference of retaliatory or discriminatory intent,” Judge Liman wrote in his decision. “[The chair] had not always planned to ask for plaintiff’s resignation based on the results of the FPPE completed on March 10, 2020. The decision to ask for that resignation arose shortly after the request for the accommodation. And there is evidence from which the jury could find that [the chair] was not receptive to making the accommodation.”
A jury trial was scheduled for July 2023, but the parties reached a settlement on May 31, 2023.
Is working from home reasonable for physicians?
The widespread swing to remote work in recent years has paved a smoother road for physicians who request the accommodation, said Peter Poullos, MD, clinical associate professor of radiology, gastroenterology, and hepatology at Stanford (Calif.) University and founder and cochair of the Stanford Medicine Alliance for Disability Inclusion and Equity.
“There is now a precedent and examples all over that working from home for some is a viable alternative to working in the hospital or a clinic,” Dr. Poullos said. “If a lawyer can point to instances of other people having received the same accommodation, even if the accommodation was given to someone without a disability, it’s much harder for an employer to say: ‘It’s not possible.’ Because clearly, it is.”
A key factor is the employee’s job duties and whether the employee can complete them remotely, said Mr. Dorfman. With physicians, the reasonableness would heavily depend on their specialty.
A radiologist, for example, would probably have a stronger case for performing their duties remotely compared with a surgeon, Dr. Poullos said.
In general, whether an accommodation is reasonable is decided on a case-by-case basis and usually includes reviewing supporting documentation from a medical provider, said Emily Harvey, a Denver-based disability law attorney. Employers are allowed to deny accommodations if they would cause an undue burden to the employer or fundamentally alter the nature or operation of the job or business.
“When it comes to the ADA, and disability rights in general, the analysis is based on the need of the individual,” she said. “Two people with identical diagnoses could need vastly different accommodations to be successful in the same job.”
Mr. Dorfman added that employers are only required to provide an accommodation that is reasonable under the circumstances, whether or not that accommodation meets the preferred request of the employee. For instance, if an immunocompromised physician asked to work from home, but the employer could ensure that all those working around the physician will mask, that could be reasonable enough.
A recent case analysis by Bloomberg Law shows that more courts are siding with employees who request remote work, compared with in past years. Employees who made disability-related remote work requests prevailed in 40% of federal court rulings from 2021 to 2023 versusa success rate of 30% from 2017 to 2019, according to the July 2023 analysis.
The analysis shows that employers still win the majority of the time, but that the gap is closing, Mr. Dorfman said.
In a September 2020 decision, for example, a Massachusetts District Court ruled in favor of an employee with asthma who was precluding from working at home by a behavioral and mental health agency. U.S. Magistrate Judge Katherine Robertson said that the manager was entitled to telework as a reasonable accommodation under the ADA for 60 days or until further notice. The lawsuit was settled in 2021.
“I think judges are much more used to working from home themselves,” Mr. Dorfman said. “That may affect their sense of accepting remote work as a reasonable accommodation. Their personal experience with it [may] actually inform their view of the topic.”
Your accommodation request was denied: Now what?
If you are unsure about your rights under the ADA, a first step is understanding the law’s protections and learning the obligations of your employer.
Keep in mind that not everyone at your workplace may understand the law and what is required, said Dr. Poullos. When making a request to work from home, ensure that you’re using the right words and asking the right people, he advised. Some physicians, for instance, may only discuss the request with their direct supervisor and give up when the request is denied. “The employee might say, ‘I’ve been dealing with some medical issues and I’m really tired and need to adjust my schedule.’ They don’t mention the word ‘disability,’ they don’t mention the ADA, they don’t mention the word ‘accommodation,’ and so that might not trigger the appropriate response.”
Lisa Meeks, PhD, an expert and researcher in disabilities in medical education, encourages physicians and others to follow the appeals process at their institution if they feel their accommodation request has been unjustly denied.
Research shows that physicians who make accommodation requests rarely escalate denials to an appeal, grievance, or complaint, said Dr. Meeks, cohost of the Docs With Disabilities podcast and director of the Docs With Disabilities Initiative. The initiative aims to use research, education, and stories to drive change in perceptions, disability policy, and procedures in health professions and in biomedical and science education.
If an accommodation cannot be agreed on, doctors can reach out the Equal Employment Opportunity Commission and file a discrimination charge. The agency will review the case and provide an opinion on whether the charge has merit. The EEOC’s decision is not binding in court, and even if the agency believes the charge has no merit, employees still have the right to sue, he said.
Ms. Harvey added that the EEOC has many resources on its website, and that most states also have civil rights agencies that have additional resources. Every state and U.S. territory also has a protection and advocacy organization that may be able to help. Physicians can also review their state bar to locate and consult with disability rights attorneys.
Although it may seem like an uphill battle to push for an accommodation, it can be worth it in the end, said Michael Argenyi, MD, an addiction medicine specialist and assistant professor at the University of Massachusetts, Worcester. Dr. Argenyi, who has hearing loss, was featured on the Docs With Disabilities podcast.
“It’s difficult to ‘rock the boat’ and ask for support from the C-suite for employees with disabilities, or to rearrange a small medical office budget to establish a byline just for accommodations,” Dr. Argenyi said. “Yet, the payoff is worthwhile – patients and fellow colleagues notice commitments to diversity building and inclusion.”
A version of this article appeared on Medscape.com.
The top tax breaks that physicians use
Plenty of perks come along with earning a physician’s salary, but a low tax rate isn’t among them. Medscape’s Physicians and Taxes Report 2023 shows that last year, doctors paid an average of nearly $100,000 in state and federal taxes, and three-quarters of them thought that they were paying too much to Uncle Sam. In most cases, it’s impossible to eliminate that tax bill, but physicians told us they have found ways to minimize it.
“The percentage you have to pay in taxes escalates as you earn more money, and most doctors are at the maximum rate,” says Paul Joseph, a certified public accountant and founder of Joseph & Joseph Tax & Payroll in Williamston, Mich. “So every dollar you can deduct from your income is worth more.”
To claim most of these options, you’ll need to itemize your deductions when filing your taxes.
Contribute to charity
Claimed by 70% of physicians in 2022.
Who’s eligible: Anyone.
How it works: If you itemize your taxes, you can deduct the value of cash, securities, or property donations to 501(c)(3) organizations. You’ll need a receipt from the charity and a third-party appraisal for any property donations worth more than $5,000.
Pro tip: Donating stocks that have appreciated in value can deliver additional tax benefits: You get to write off both the value of the contribution and avoid capital gains taxes that you’d face for selling the security.
Contribute to a pre-tax 401(k) account
Claimed by 60% of physicians in 2022.
Who’s eligible: Those who work for a company that sponsors a 401(k) plan.
How it works: Contributions to a 401(k) or 403(b) account come directly out of your paycheck, pre-tax, and grow tax-free until you withdraw them in retirement. Many companies offer a match on contributions. In 2023, you can contribute up to $22,500 ($30,000 if you’re age 50 or older) to a 401(k) account.
Pro tip: If you’re maxing out your 401(k) account, you can stash money in other tax-advantaged accounts such as a health savings account (if you have a high-deductible health plan) or an individual retirement account (IRA). Although employees with access to a 401(k) may not get the pre-tax advantage of the IRA contributions, the money will grow tax-free through retirement, and you may have access to additional investment options unavailable in your workplace plan.
“You want to maximize your retirement contributions,” says Mark Steber, the chief tax information officer for Jackson Hewitt Tax Services. “If you’re not taking full advantage of them, you’re probably leaving some tax dollars on the table.”
If you’re self-employed and don’t have access to a workplace plan, there are several options for tax-advantaged retirement savings, including a SEP IRA and a solo 401(k).
Deduct interest on a home mortgage
Claimed by 52% of physicians.
Who’s eligible: Most homeowners who have a mortgage.
How it works: Homeowners can deduct the interest paid on the first $750,000 of their mortgage. (Those who have had the same mortgage since before December 16, 2007, can deduct interest on the first $1 million of their loan.)
Pro tip: If you purchased a home this year and bought points to reduce the rate, you may be able to deduct the cost of those points on your taxes.
Physicians might also be eligible for other home-related tax benefits, such as for green home improvements under the Inflation Reduction Act or for home equity loans used to improve the value of your home.
Write off eligible business expenses
Claimed by 46% of physicians.
Who’s eligible: Physicians who own all or a portion of their practice, as well as those who work as consultants or contractors paid with a 1099.
How it works: Doctors who run their business using an LLC or S corporation can itemize the deductions on their Schedule C. There are dozens of deductions that might qualify, including for office space and supplies, medical equipment, uniforms, staff wages and benefits, and state and local tax payments. Physicians who work as consultants can deduct home office expenses, travel costs, and the price of supplies purchased for the job.
“For business expenses, you want to make sure that you’re tracking those expenses on an ongoing basis, rather than trying to reconstruct something at the end of the year from 8 months ago,” Mr. Joseph says. “You want to have a system in place that’s calculating those expenses every single day.”
Pro tip: The Tax Cuts and Jobs Act of 2017 also allows owners of pass-through businesses to deduct up to 20% of their business income.
“Not all physicians will qualify for that, because they are in a service-based business and many of them make too much money, but it’s always a good idea to look at whether that’s something they’re eligible for and make sure that they claim it,” says Eric Bronnenkant, head of tax at New York–based investment company Betterment.
Contribute to a 529 college savings plan
Claimed by 27% of physicians.
Who’s eligible: Those who live in the 37 states that offer a credit or deduction for 529 plan contributions.
How it works: The rules and amounts that qualify vary significantly by state. Most states offer benefits for contributions to in-state accounts only, whereas others offer a tax break for contributions to any 529 account.
Although there is no federal income tax benefit for contributions to a 529 plan, the money grows tax-free until tapped for qualified education expenses, which include both private primary and high school tuition and college costs. Starting in 2024, up to $35,000 in unused funds can roll over into a Roth IRA for the beneficiary.
“It’s not just about the immediate deduction with a 529 account,” says Brian Copeland, partner and director of financial planning with Hightower Wealth Advisors in St. Louis. “It’s not saving you a lot on day one; it’s more about as that account grows, you don’t have to pay taxes on it along the way, so you’re sheltering it from taxes for the 18 years you’re saving for your kids’ college.”
Pro tip: Even if you live in a state without a state income tax or without a tax break for 529 contributions, opening an account can be a smart financial move. Because you don’t need to choose an in-state plan for the tax breaks, look for one that offers low fees and investment options that you like.
Sell investments at a loss
Claimed by 22% of physicians.
Who’s eligible: Anyone who has sold stocks, mutual funds, or other investments at a loss.
How it works: After selling a security that has lost value, you can deduct the value of that loss on your taxes to offset capital gains in the same year. If you have more losses than gains, you can use the losses to offset up to $3,000 in ordinary income per year. If you have more than $3,000 in losses, you can carry those losses forward to offset future income or capital gains.
Pro tip: In years with a lot of market volatility, such as this one, there’s potential to engage in “tax loss harvesting” in which you intentionally sell securities that have lost value to realize the losses for the tax benefits. Keep in mind that if you sell a security at a loss, you cannot repurchase the same security within 30 days – the IRS sees that as a “wash sale,” which does not qualify for a capital loss for tax purposes.
Contribute to a backdoor Roth IRA
Claimed by 20% of physicians.
Who’s eligible: Anyone who wishes to contribute to a Roth IRA but is not allowed to do so because their income is too high.
How it works: High earners typically don’t qualify for contributions to a Roth IRA, in which contributions go in after taxes but grow tax-free and distributions in retirement are also tax-free. But there are no income requirements for making after-tax contributions to a traditional and then converting it to a Roth IRA.
There are, however, complex tax rules for those who also have a traditional IRA that’s funded with pre-tax dollars. If that’s the case, work with a tax pro or financial advisor to determine whether a backdoor Roth conversion is the most tax-efficient approach for your situation.
Pro tip: A growing number of workplace retirement plans now include an option for Roth contributions. There are no income limits on a Roth 401(k), so contributing to that type of an account could be a smart route for taxpayers for whom a backdoor conversion doesn’t make sense.
A version of this article appeared on Medscape.com.
Plenty of perks come along with earning a physician’s salary, but a low tax rate isn’t among them. Medscape’s Physicians and Taxes Report 2023 shows that last year, doctors paid an average of nearly $100,000 in state and federal taxes, and three-quarters of them thought that they were paying too much to Uncle Sam. In most cases, it’s impossible to eliminate that tax bill, but physicians told us they have found ways to minimize it.
“The percentage you have to pay in taxes escalates as you earn more money, and most doctors are at the maximum rate,” says Paul Joseph, a certified public accountant and founder of Joseph & Joseph Tax & Payroll in Williamston, Mich. “So every dollar you can deduct from your income is worth more.”
To claim most of these options, you’ll need to itemize your deductions when filing your taxes.
Contribute to charity
Claimed by 70% of physicians in 2022.
Who’s eligible: Anyone.
How it works: If you itemize your taxes, you can deduct the value of cash, securities, or property donations to 501(c)(3) organizations. You’ll need a receipt from the charity and a third-party appraisal for any property donations worth more than $5,000.
Pro tip: Donating stocks that have appreciated in value can deliver additional tax benefits: You get to write off both the value of the contribution and avoid capital gains taxes that you’d face for selling the security.
Contribute to a pre-tax 401(k) account
Claimed by 60% of physicians in 2022.
Who’s eligible: Those who work for a company that sponsors a 401(k) plan.
How it works: Contributions to a 401(k) or 403(b) account come directly out of your paycheck, pre-tax, and grow tax-free until you withdraw them in retirement. Many companies offer a match on contributions. In 2023, you can contribute up to $22,500 ($30,000 if you’re age 50 or older) to a 401(k) account.
Pro tip: If you’re maxing out your 401(k) account, you can stash money in other tax-advantaged accounts such as a health savings account (if you have a high-deductible health plan) or an individual retirement account (IRA). Although employees with access to a 401(k) may not get the pre-tax advantage of the IRA contributions, the money will grow tax-free through retirement, and you may have access to additional investment options unavailable in your workplace plan.
“You want to maximize your retirement contributions,” says Mark Steber, the chief tax information officer for Jackson Hewitt Tax Services. “If you’re not taking full advantage of them, you’re probably leaving some tax dollars on the table.”
If you’re self-employed and don’t have access to a workplace plan, there are several options for tax-advantaged retirement savings, including a SEP IRA and a solo 401(k).
Deduct interest on a home mortgage
Claimed by 52% of physicians.
Who’s eligible: Most homeowners who have a mortgage.
How it works: Homeowners can deduct the interest paid on the first $750,000 of their mortgage. (Those who have had the same mortgage since before December 16, 2007, can deduct interest on the first $1 million of their loan.)
Pro tip: If you purchased a home this year and bought points to reduce the rate, you may be able to deduct the cost of those points on your taxes.
Physicians might also be eligible for other home-related tax benefits, such as for green home improvements under the Inflation Reduction Act or for home equity loans used to improve the value of your home.
Write off eligible business expenses
Claimed by 46% of physicians.
Who’s eligible: Physicians who own all or a portion of their practice, as well as those who work as consultants or contractors paid with a 1099.
How it works: Doctors who run their business using an LLC or S corporation can itemize the deductions on their Schedule C. There are dozens of deductions that might qualify, including for office space and supplies, medical equipment, uniforms, staff wages and benefits, and state and local tax payments. Physicians who work as consultants can deduct home office expenses, travel costs, and the price of supplies purchased for the job.
“For business expenses, you want to make sure that you’re tracking those expenses on an ongoing basis, rather than trying to reconstruct something at the end of the year from 8 months ago,” Mr. Joseph says. “You want to have a system in place that’s calculating those expenses every single day.”
Pro tip: The Tax Cuts and Jobs Act of 2017 also allows owners of pass-through businesses to deduct up to 20% of their business income.
“Not all physicians will qualify for that, because they are in a service-based business and many of them make too much money, but it’s always a good idea to look at whether that’s something they’re eligible for and make sure that they claim it,” says Eric Bronnenkant, head of tax at New York–based investment company Betterment.
Contribute to a 529 college savings plan
Claimed by 27% of physicians.
Who’s eligible: Those who live in the 37 states that offer a credit or deduction for 529 plan contributions.
How it works: The rules and amounts that qualify vary significantly by state. Most states offer benefits for contributions to in-state accounts only, whereas others offer a tax break for contributions to any 529 account.
Although there is no federal income tax benefit for contributions to a 529 plan, the money grows tax-free until tapped for qualified education expenses, which include both private primary and high school tuition and college costs. Starting in 2024, up to $35,000 in unused funds can roll over into a Roth IRA for the beneficiary.
“It’s not just about the immediate deduction with a 529 account,” says Brian Copeland, partner and director of financial planning with Hightower Wealth Advisors in St. Louis. “It’s not saving you a lot on day one; it’s more about as that account grows, you don’t have to pay taxes on it along the way, so you’re sheltering it from taxes for the 18 years you’re saving for your kids’ college.”
Pro tip: Even if you live in a state without a state income tax or without a tax break for 529 contributions, opening an account can be a smart financial move. Because you don’t need to choose an in-state plan for the tax breaks, look for one that offers low fees and investment options that you like.
Sell investments at a loss
Claimed by 22% of physicians.
Who’s eligible: Anyone who has sold stocks, mutual funds, or other investments at a loss.
How it works: After selling a security that has lost value, you can deduct the value of that loss on your taxes to offset capital gains in the same year. If you have more losses than gains, you can use the losses to offset up to $3,000 in ordinary income per year. If you have more than $3,000 in losses, you can carry those losses forward to offset future income or capital gains.
Pro tip: In years with a lot of market volatility, such as this one, there’s potential to engage in “tax loss harvesting” in which you intentionally sell securities that have lost value to realize the losses for the tax benefits. Keep in mind that if you sell a security at a loss, you cannot repurchase the same security within 30 days – the IRS sees that as a “wash sale,” which does not qualify for a capital loss for tax purposes.
Contribute to a backdoor Roth IRA
Claimed by 20% of physicians.
Who’s eligible: Anyone who wishes to contribute to a Roth IRA but is not allowed to do so because their income is too high.
How it works: High earners typically don’t qualify for contributions to a Roth IRA, in which contributions go in after taxes but grow tax-free and distributions in retirement are also tax-free. But there are no income requirements for making after-tax contributions to a traditional and then converting it to a Roth IRA.
There are, however, complex tax rules for those who also have a traditional IRA that’s funded with pre-tax dollars. If that’s the case, work with a tax pro or financial advisor to determine whether a backdoor Roth conversion is the most tax-efficient approach for your situation.
Pro tip: A growing number of workplace retirement plans now include an option for Roth contributions. There are no income limits on a Roth 401(k), so contributing to that type of an account could be a smart route for taxpayers for whom a backdoor conversion doesn’t make sense.
A version of this article appeared on Medscape.com.
Plenty of perks come along with earning a physician’s salary, but a low tax rate isn’t among them. Medscape’s Physicians and Taxes Report 2023 shows that last year, doctors paid an average of nearly $100,000 in state and federal taxes, and three-quarters of them thought that they were paying too much to Uncle Sam. In most cases, it’s impossible to eliminate that tax bill, but physicians told us they have found ways to minimize it.
“The percentage you have to pay in taxes escalates as you earn more money, and most doctors are at the maximum rate,” says Paul Joseph, a certified public accountant and founder of Joseph & Joseph Tax & Payroll in Williamston, Mich. “So every dollar you can deduct from your income is worth more.”
To claim most of these options, you’ll need to itemize your deductions when filing your taxes.
Contribute to charity
Claimed by 70% of physicians in 2022.
Who’s eligible: Anyone.
How it works: If you itemize your taxes, you can deduct the value of cash, securities, or property donations to 501(c)(3) organizations. You’ll need a receipt from the charity and a third-party appraisal for any property donations worth more than $5,000.
Pro tip: Donating stocks that have appreciated in value can deliver additional tax benefits: You get to write off both the value of the contribution and avoid capital gains taxes that you’d face for selling the security.
Contribute to a pre-tax 401(k) account
Claimed by 60% of physicians in 2022.
Who’s eligible: Those who work for a company that sponsors a 401(k) plan.
How it works: Contributions to a 401(k) or 403(b) account come directly out of your paycheck, pre-tax, and grow tax-free until you withdraw them in retirement. Many companies offer a match on contributions. In 2023, you can contribute up to $22,500 ($30,000 if you’re age 50 or older) to a 401(k) account.
Pro tip: If you’re maxing out your 401(k) account, you can stash money in other tax-advantaged accounts such as a health savings account (if you have a high-deductible health plan) or an individual retirement account (IRA). Although employees with access to a 401(k) may not get the pre-tax advantage of the IRA contributions, the money will grow tax-free through retirement, and you may have access to additional investment options unavailable in your workplace plan.
“You want to maximize your retirement contributions,” says Mark Steber, the chief tax information officer for Jackson Hewitt Tax Services. “If you’re not taking full advantage of them, you’re probably leaving some tax dollars on the table.”
If you’re self-employed and don’t have access to a workplace plan, there are several options for tax-advantaged retirement savings, including a SEP IRA and a solo 401(k).
Deduct interest on a home mortgage
Claimed by 52% of physicians.
Who’s eligible: Most homeowners who have a mortgage.
How it works: Homeowners can deduct the interest paid on the first $750,000 of their mortgage. (Those who have had the same mortgage since before December 16, 2007, can deduct interest on the first $1 million of their loan.)
Pro tip: If you purchased a home this year and bought points to reduce the rate, you may be able to deduct the cost of those points on your taxes.
Physicians might also be eligible for other home-related tax benefits, such as for green home improvements under the Inflation Reduction Act or for home equity loans used to improve the value of your home.
Write off eligible business expenses
Claimed by 46% of physicians.
Who’s eligible: Physicians who own all or a portion of their practice, as well as those who work as consultants or contractors paid with a 1099.
How it works: Doctors who run their business using an LLC or S corporation can itemize the deductions on their Schedule C. There are dozens of deductions that might qualify, including for office space and supplies, medical equipment, uniforms, staff wages and benefits, and state and local tax payments. Physicians who work as consultants can deduct home office expenses, travel costs, and the price of supplies purchased for the job.
“For business expenses, you want to make sure that you’re tracking those expenses on an ongoing basis, rather than trying to reconstruct something at the end of the year from 8 months ago,” Mr. Joseph says. “You want to have a system in place that’s calculating those expenses every single day.”
Pro tip: The Tax Cuts and Jobs Act of 2017 also allows owners of pass-through businesses to deduct up to 20% of their business income.
“Not all physicians will qualify for that, because they are in a service-based business and many of them make too much money, but it’s always a good idea to look at whether that’s something they’re eligible for and make sure that they claim it,” says Eric Bronnenkant, head of tax at New York–based investment company Betterment.
Contribute to a 529 college savings plan
Claimed by 27% of physicians.
Who’s eligible: Those who live in the 37 states that offer a credit or deduction for 529 plan contributions.
How it works: The rules and amounts that qualify vary significantly by state. Most states offer benefits for contributions to in-state accounts only, whereas others offer a tax break for contributions to any 529 account.
Although there is no federal income tax benefit for contributions to a 529 plan, the money grows tax-free until tapped for qualified education expenses, which include both private primary and high school tuition and college costs. Starting in 2024, up to $35,000 in unused funds can roll over into a Roth IRA for the beneficiary.
“It’s not just about the immediate deduction with a 529 account,” says Brian Copeland, partner and director of financial planning with Hightower Wealth Advisors in St. Louis. “It’s not saving you a lot on day one; it’s more about as that account grows, you don’t have to pay taxes on it along the way, so you’re sheltering it from taxes for the 18 years you’re saving for your kids’ college.”
Pro tip: Even if you live in a state without a state income tax or without a tax break for 529 contributions, opening an account can be a smart financial move. Because you don’t need to choose an in-state plan for the tax breaks, look for one that offers low fees and investment options that you like.
Sell investments at a loss
Claimed by 22% of physicians.
Who’s eligible: Anyone who has sold stocks, mutual funds, or other investments at a loss.
How it works: After selling a security that has lost value, you can deduct the value of that loss on your taxes to offset capital gains in the same year. If you have more losses than gains, you can use the losses to offset up to $3,000 in ordinary income per year. If you have more than $3,000 in losses, you can carry those losses forward to offset future income or capital gains.
Pro tip: In years with a lot of market volatility, such as this one, there’s potential to engage in “tax loss harvesting” in which you intentionally sell securities that have lost value to realize the losses for the tax benefits. Keep in mind that if you sell a security at a loss, you cannot repurchase the same security within 30 days – the IRS sees that as a “wash sale,” which does not qualify for a capital loss for tax purposes.
Contribute to a backdoor Roth IRA
Claimed by 20% of physicians.
Who’s eligible: Anyone who wishes to contribute to a Roth IRA but is not allowed to do so because their income is too high.
How it works: High earners typically don’t qualify for contributions to a Roth IRA, in which contributions go in after taxes but grow tax-free and distributions in retirement are also tax-free. But there are no income requirements for making after-tax contributions to a traditional and then converting it to a Roth IRA.
There are, however, complex tax rules for those who also have a traditional IRA that’s funded with pre-tax dollars. If that’s the case, work with a tax pro or financial advisor to determine whether a backdoor Roth conversion is the most tax-efficient approach for your situation.
Pro tip: A growing number of workplace retirement plans now include an option for Roth contributions. There are no income limits on a Roth 401(k), so contributing to that type of an account could be a smart route for taxpayers for whom a backdoor conversion doesn’t make sense.
A version of this article appeared on Medscape.com.
Paxlovid and Lagevrio benefit COVID outpatients in Omicron era
The American College of Physicians has issued an updated version of its living, rapid practice point guideline on the best treatment options for outpatients with confirmed COVID-19 in the era of the dominant Omicron variant of SARS-CoV-2. The recommendations in version 2 apply to persons presenting with mild to moderate infection and symptom onset in the past 5 days who are at high risk for progression to severe disease and potential hospitalization or death.
Version 1 appeared in late 2022.
While outpatient management is appropriate for most patients, treatment should be personalized and based on careful risk stratification and informed decision-making, said the guideline authors, led by Amir Qaseem, MD, PhD, MHA, vice president of clinical policy and the Center for Evidence Reviews at the ACP in Philadelphia.
Practice points
- Consider the oral antivirals nirmatrelvir-ritonavir (Paxlovid) or molnupiravir (Lagevrio) for symptomatic outpatients with confirmed mild to moderate COVID-19 who are within 5 days of the onset of symptoms and at high risk for progressing to severe disease.
New evidence for the Omicron variant suggests a possible net benefit of the antiviral molnupiravir versus standard or no treatment in terms of reducing recovery time if treatment is initiated within 5 days of symptom onset. Nirmatrelvir-ritonavir was associated with reductions in COVID-19 hospitalization and all-cause mortality.
“The practice points only address [whether] treatments work compared to placebo, no treatment, or usual care,” cautioned Linda L. Humphrey, MD, MPH, MACP, chair of the ACP’s Population Health and Medical Science Committee and a professor of medicine at Oregon Health and Science University VA Portland Health Care System. The ACP continues to monitor the evidence. “Once enough evidence has emerged, it will be possible to compare treatments to each other. Until that time we are unable to determine if there is an advantage to using one treatment over another.”
- Do not use the antiparasitic ivermectin (Stromectol) or the monoclonal antibody sotrovimab (Xevudy) to treat this patient population. “It is not expected to be effective against the Omicron variant,” Dr. Humphrey said.
There was no evidence to support the use of medications such as corticosteroids, antibiotics, antihistamines, SSRIs, and multiple other agents.
“The guideline is not a departure from previous knowledge and reflects what appears in other guidelines and is already being done generally in practice,” said Mirella Salvatore, MD, an associate professor of medicine and population health sciences at Weill Cornell Medicine, New York, who was not involved in the ACP statement. It is therefore unlikely the recommendations will trigger controversy or negative feedback, added Dr. Salvatore, who is also a spokesperson for the Infectious Diseases Society of America. “We believe that our evidence-based approach, which considers the balance of benefits and harms of various treatments, will be embraced by the physician community,” Dr. Humphrey said.
The updated recommendations are based on new data from the evidence review of multiple treatments, which concluded that both nirmatrelvir-ritonavir and molnupiravir likely improve outcomes for outpatients with mild to moderate COVID-19. The review was conducted after the emergence of the Omicron variant by the ACP Center for Evidence Reviews at Cochrane Austria/University for Continuing Education Krems (Austria).
Review details
Inclusion criteria were modified to focus on the Omicron variant by limiting eligible studies to only those enrolling patients on or after Nov. 26, 2021. The investigators included two randomized controlled trials and six retrospective cohort studies and ranked quality of evidence for the effectiveness of the following treatments, compared with usual care or no treatment: azithromycin, camostat mesylate, chloroquine-hydroxychloroquine, chlorpheniramine, colchicine, convalescent plasma, corticosteroids, ensitrelvir, favipiravir, fluvoxamine, ivermectin, lopinavir-ritonavir, molnupiravir, neutralizing monoclonal antibodies, metformin, niclosamide, nitazoxanide, nirmatrelvir-ritonavir, and remdesivir.
It compared results for all-cause and COVID-specific mortality, recovery, time to recovery, COVID hospitalization, and adverse and serious adverse events.
Nirmatrelvir-ritonavir was associated with a reduction in hospitalization caused by COVID-19 of 0.7% versus 1.2% (moderate certainty of evidence [COE]) and a reduction in all-cause mortality of less than 0.1% versus 0.2% (moderate COE).
Molnupiravir led to a higher recovery rate of 31.8% versus 22.6% (moderate COE) and a reduced time to recovery of 9 versus 15 median days (moderate COE). It had no effect, however, on all-cause mortality: 0.02% versus 0.04% (moderate COE). Nor did it affect the incidence of serious adverse events: 0.4% versus 0.3% (moderate COE).
“There have been no head-to-head comparative studies of these two treatments, but nirmatrelvir-ritonavir appears to be the preferred treatment,” Dr. Salvatore said. She noted that molnupiravir cannot be used in pregnant women or young persons under age 18, while nirmatrelvir-ritonavir carries the risk of drug interactions. Viral rebound and recurrence of symptoms have been reported in some patients receiving nirmatrelvir-ritonavir.
In other review findings, ivermectin had no effect on time to recovery (moderate COE) and adverse events versus placebo (low COE). Sotrovimab resulted in no difference in all-cause mortality, compared with no treatment (low COE). There were no eligible studies for all of the other treatments of interest nor were there any that specifically evaluated the benefits and harms of treatments for the Omicron variant.
The panel pointed to the need for more evaluation of the efficacy, effectiveness, and comparative effectiveness, as well as harms of pharmacologic and biologic treatments of COVID-19 in the outpatient setting, particularly in the context of changing dominant SARS-CoV-2 variants and subvariants.
Another area requiring further research is the effectiveness of retreatment in patients with previous COVID-19 infection. Subgroup analyses are also needed to assess whether the efficacy and effectiveness of outpatient treatments vary by age, sex, socioeconomic status, and comorbid conditions – or by SARS-CoV-2 variant, immunity status (prior SARS-CoV-2 infection, vaccination status, or time since infection or vaccination), symptom duration, or disease severity.
Dr. Salvatore agreed that more research is needed in special convalescent groups. “For instance, those with cancer who are immunocompromised may need longer treatment and adjunctive treatment with convalescent plasma. But is difficult to find a large enough study with 5,000 immunocompromised patients.”
Financial support for the development of the practice points came exclusively from the ACP operating budget. The evidence review was funded by the ACP. The authors disclosed no relevant high-level competing interests with regard to this guidance, although several authors reported intellectual interests in various areas of research. Dr. Salvatore disclosed no conflicts of interest relevant to her comments but is engaged in influenza research for Genentech.
The American College of Physicians has issued an updated version of its living, rapid practice point guideline on the best treatment options for outpatients with confirmed COVID-19 in the era of the dominant Omicron variant of SARS-CoV-2. The recommendations in version 2 apply to persons presenting with mild to moderate infection and symptom onset in the past 5 days who are at high risk for progression to severe disease and potential hospitalization or death.
Version 1 appeared in late 2022.
While outpatient management is appropriate for most patients, treatment should be personalized and based on careful risk stratification and informed decision-making, said the guideline authors, led by Amir Qaseem, MD, PhD, MHA, vice president of clinical policy and the Center for Evidence Reviews at the ACP in Philadelphia.
Practice points
- Consider the oral antivirals nirmatrelvir-ritonavir (Paxlovid) or molnupiravir (Lagevrio) for symptomatic outpatients with confirmed mild to moderate COVID-19 who are within 5 days of the onset of symptoms and at high risk for progressing to severe disease.
New evidence for the Omicron variant suggests a possible net benefit of the antiviral molnupiravir versus standard or no treatment in terms of reducing recovery time if treatment is initiated within 5 days of symptom onset. Nirmatrelvir-ritonavir was associated with reductions in COVID-19 hospitalization and all-cause mortality.
“The practice points only address [whether] treatments work compared to placebo, no treatment, or usual care,” cautioned Linda L. Humphrey, MD, MPH, MACP, chair of the ACP’s Population Health and Medical Science Committee and a professor of medicine at Oregon Health and Science University VA Portland Health Care System. The ACP continues to monitor the evidence. “Once enough evidence has emerged, it will be possible to compare treatments to each other. Until that time we are unable to determine if there is an advantage to using one treatment over another.”
- Do not use the antiparasitic ivermectin (Stromectol) or the monoclonal antibody sotrovimab (Xevudy) to treat this patient population. “It is not expected to be effective against the Omicron variant,” Dr. Humphrey said.
There was no evidence to support the use of medications such as corticosteroids, antibiotics, antihistamines, SSRIs, and multiple other agents.
“The guideline is not a departure from previous knowledge and reflects what appears in other guidelines and is already being done generally in practice,” said Mirella Salvatore, MD, an associate professor of medicine and population health sciences at Weill Cornell Medicine, New York, who was not involved in the ACP statement. It is therefore unlikely the recommendations will trigger controversy or negative feedback, added Dr. Salvatore, who is also a spokesperson for the Infectious Diseases Society of America. “We believe that our evidence-based approach, which considers the balance of benefits and harms of various treatments, will be embraced by the physician community,” Dr. Humphrey said.
The updated recommendations are based on new data from the evidence review of multiple treatments, which concluded that both nirmatrelvir-ritonavir and molnupiravir likely improve outcomes for outpatients with mild to moderate COVID-19. The review was conducted after the emergence of the Omicron variant by the ACP Center for Evidence Reviews at Cochrane Austria/University for Continuing Education Krems (Austria).
Review details
Inclusion criteria were modified to focus on the Omicron variant by limiting eligible studies to only those enrolling patients on or after Nov. 26, 2021. The investigators included two randomized controlled trials and six retrospective cohort studies and ranked quality of evidence for the effectiveness of the following treatments, compared with usual care or no treatment: azithromycin, camostat mesylate, chloroquine-hydroxychloroquine, chlorpheniramine, colchicine, convalescent plasma, corticosteroids, ensitrelvir, favipiravir, fluvoxamine, ivermectin, lopinavir-ritonavir, molnupiravir, neutralizing monoclonal antibodies, metformin, niclosamide, nitazoxanide, nirmatrelvir-ritonavir, and remdesivir.
It compared results for all-cause and COVID-specific mortality, recovery, time to recovery, COVID hospitalization, and adverse and serious adverse events.
Nirmatrelvir-ritonavir was associated with a reduction in hospitalization caused by COVID-19 of 0.7% versus 1.2% (moderate certainty of evidence [COE]) and a reduction in all-cause mortality of less than 0.1% versus 0.2% (moderate COE).
Molnupiravir led to a higher recovery rate of 31.8% versus 22.6% (moderate COE) and a reduced time to recovery of 9 versus 15 median days (moderate COE). It had no effect, however, on all-cause mortality: 0.02% versus 0.04% (moderate COE). Nor did it affect the incidence of serious adverse events: 0.4% versus 0.3% (moderate COE).
“There have been no head-to-head comparative studies of these two treatments, but nirmatrelvir-ritonavir appears to be the preferred treatment,” Dr. Salvatore said. She noted that molnupiravir cannot be used in pregnant women or young persons under age 18, while nirmatrelvir-ritonavir carries the risk of drug interactions. Viral rebound and recurrence of symptoms have been reported in some patients receiving nirmatrelvir-ritonavir.
In other review findings, ivermectin had no effect on time to recovery (moderate COE) and adverse events versus placebo (low COE). Sotrovimab resulted in no difference in all-cause mortality, compared with no treatment (low COE). There were no eligible studies for all of the other treatments of interest nor were there any that specifically evaluated the benefits and harms of treatments for the Omicron variant.
The panel pointed to the need for more evaluation of the efficacy, effectiveness, and comparative effectiveness, as well as harms of pharmacologic and biologic treatments of COVID-19 in the outpatient setting, particularly in the context of changing dominant SARS-CoV-2 variants and subvariants.
Another area requiring further research is the effectiveness of retreatment in patients with previous COVID-19 infection. Subgroup analyses are also needed to assess whether the efficacy and effectiveness of outpatient treatments vary by age, sex, socioeconomic status, and comorbid conditions – or by SARS-CoV-2 variant, immunity status (prior SARS-CoV-2 infection, vaccination status, or time since infection or vaccination), symptom duration, or disease severity.
Dr. Salvatore agreed that more research is needed in special convalescent groups. “For instance, those with cancer who are immunocompromised may need longer treatment and adjunctive treatment with convalescent plasma. But is difficult to find a large enough study with 5,000 immunocompromised patients.”
Financial support for the development of the practice points came exclusively from the ACP operating budget. The evidence review was funded by the ACP. The authors disclosed no relevant high-level competing interests with regard to this guidance, although several authors reported intellectual interests in various areas of research. Dr. Salvatore disclosed no conflicts of interest relevant to her comments but is engaged in influenza research for Genentech.
The American College of Physicians has issued an updated version of its living, rapid practice point guideline on the best treatment options for outpatients with confirmed COVID-19 in the era of the dominant Omicron variant of SARS-CoV-2. The recommendations in version 2 apply to persons presenting with mild to moderate infection and symptom onset in the past 5 days who are at high risk for progression to severe disease and potential hospitalization or death.
Version 1 appeared in late 2022.
While outpatient management is appropriate for most patients, treatment should be personalized and based on careful risk stratification and informed decision-making, said the guideline authors, led by Amir Qaseem, MD, PhD, MHA, vice president of clinical policy and the Center for Evidence Reviews at the ACP in Philadelphia.
Practice points
- Consider the oral antivirals nirmatrelvir-ritonavir (Paxlovid) or molnupiravir (Lagevrio) for symptomatic outpatients with confirmed mild to moderate COVID-19 who are within 5 days of the onset of symptoms and at high risk for progressing to severe disease.
New evidence for the Omicron variant suggests a possible net benefit of the antiviral molnupiravir versus standard or no treatment in terms of reducing recovery time if treatment is initiated within 5 days of symptom onset. Nirmatrelvir-ritonavir was associated with reductions in COVID-19 hospitalization and all-cause mortality.
“The practice points only address [whether] treatments work compared to placebo, no treatment, or usual care,” cautioned Linda L. Humphrey, MD, MPH, MACP, chair of the ACP’s Population Health and Medical Science Committee and a professor of medicine at Oregon Health and Science University VA Portland Health Care System. The ACP continues to monitor the evidence. “Once enough evidence has emerged, it will be possible to compare treatments to each other. Until that time we are unable to determine if there is an advantage to using one treatment over another.”
- Do not use the antiparasitic ivermectin (Stromectol) or the monoclonal antibody sotrovimab (Xevudy) to treat this patient population. “It is not expected to be effective against the Omicron variant,” Dr. Humphrey said.
There was no evidence to support the use of medications such as corticosteroids, antibiotics, antihistamines, SSRIs, and multiple other agents.
“The guideline is not a departure from previous knowledge and reflects what appears in other guidelines and is already being done generally in practice,” said Mirella Salvatore, MD, an associate professor of medicine and population health sciences at Weill Cornell Medicine, New York, who was not involved in the ACP statement. It is therefore unlikely the recommendations will trigger controversy or negative feedback, added Dr. Salvatore, who is also a spokesperson for the Infectious Diseases Society of America. “We believe that our evidence-based approach, which considers the balance of benefits and harms of various treatments, will be embraced by the physician community,” Dr. Humphrey said.
The updated recommendations are based on new data from the evidence review of multiple treatments, which concluded that both nirmatrelvir-ritonavir and molnupiravir likely improve outcomes for outpatients with mild to moderate COVID-19. The review was conducted after the emergence of the Omicron variant by the ACP Center for Evidence Reviews at Cochrane Austria/University for Continuing Education Krems (Austria).
Review details
Inclusion criteria were modified to focus on the Omicron variant by limiting eligible studies to only those enrolling patients on or after Nov. 26, 2021. The investigators included two randomized controlled trials and six retrospective cohort studies and ranked quality of evidence for the effectiveness of the following treatments, compared with usual care or no treatment: azithromycin, camostat mesylate, chloroquine-hydroxychloroquine, chlorpheniramine, colchicine, convalescent plasma, corticosteroids, ensitrelvir, favipiravir, fluvoxamine, ivermectin, lopinavir-ritonavir, molnupiravir, neutralizing monoclonal antibodies, metformin, niclosamide, nitazoxanide, nirmatrelvir-ritonavir, and remdesivir.
It compared results for all-cause and COVID-specific mortality, recovery, time to recovery, COVID hospitalization, and adverse and serious adverse events.
Nirmatrelvir-ritonavir was associated with a reduction in hospitalization caused by COVID-19 of 0.7% versus 1.2% (moderate certainty of evidence [COE]) and a reduction in all-cause mortality of less than 0.1% versus 0.2% (moderate COE).
Molnupiravir led to a higher recovery rate of 31.8% versus 22.6% (moderate COE) and a reduced time to recovery of 9 versus 15 median days (moderate COE). It had no effect, however, on all-cause mortality: 0.02% versus 0.04% (moderate COE). Nor did it affect the incidence of serious adverse events: 0.4% versus 0.3% (moderate COE).
“There have been no head-to-head comparative studies of these two treatments, but nirmatrelvir-ritonavir appears to be the preferred treatment,” Dr. Salvatore said. She noted that molnupiravir cannot be used in pregnant women or young persons under age 18, while nirmatrelvir-ritonavir carries the risk of drug interactions. Viral rebound and recurrence of symptoms have been reported in some patients receiving nirmatrelvir-ritonavir.
In other review findings, ivermectin had no effect on time to recovery (moderate COE) and adverse events versus placebo (low COE). Sotrovimab resulted in no difference in all-cause mortality, compared with no treatment (low COE). There were no eligible studies for all of the other treatments of interest nor were there any that specifically evaluated the benefits and harms of treatments for the Omicron variant.
The panel pointed to the need for more evaluation of the efficacy, effectiveness, and comparative effectiveness, as well as harms of pharmacologic and biologic treatments of COVID-19 in the outpatient setting, particularly in the context of changing dominant SARS-CoV-2 variants and subvariants.
Another area requiring further research is the effectiveness of retreatment in patients with previous COVID-19 infection. Subgroup analyses are also needed to assess whether the efficacy and effectiveness of outpatient treatments vary by age, sex, socioeconomic status, and comorbid conditions – or by SARS-CoV-2 variant, immunity status (prior SARS-CoV-2 infection, vaccination status, or time since infection or vaccination), symptom duration, or disease severity.
Dr. Salvatore agreed that more research is needed in special convalescent groups. “For instance, those with cancer who are immunocompromised may need longer treatment and adjunctive treatment with convalescent plasma. But is difficult to find a large enough study with 5,000 immunocompromised patients.”
Financial support for the development of the practice points came exclusively from the ACP operating budget. The evidence review was funded by the ACP. The authors disclosed no relevant high-level competing interests with regard to this guidance, although several authors reported intellectual interests in various areas of research. Dr. Salvatore disclosed no conflicts of interest relevant to her comments but is engaged in influenza research for Genentech.
FROM ANNALS OF INTERNAL MEDICINE
Many patients with NSCLC receive immunotherapy ‘indefinitely’ – Are they benefiting?
Most patients with non–small cell lung cancer (NSCLC) who are long-term responders to immunotherapy will continue receiving treatment beyond 2 years. However, the best available evidence to date indicates that receiving immunotherapy after this 2-year mark likely offers no survival benefit.
Is it an overabundance of caution? A desire for more definitive data? Or is it simply a judgment call oncologists make on the basis of the individual patient?
Lova Sun, MD, MSCE, of the University of Pennsylvania in Philadelphia, believes the general inconsistency between the data and clinical practice “likely reflects significant hesitation on the part of clinicians, patients, or both to stop a treatment that is still ‘working.’ ”
H. Jack West, MD, agreed, adding that “in an ambiguous situation, a U.S.-based population is going to err on the side of overtreatment.”
Without “incontrovertible evidence” that immunotherapy should stop at 2 years, “many, many, many patients and clinicians are going to favor continuing ‘doing what you’re doing’ in the absence of either prohibitive toxicity or clinically significant disease progression,” said Dr. West of the City of Hope Comprehensive Cancer Center, Duarte, Calif.
One factor adding to this ambiguity: Most pivotal studies that examine first-line immunotherapy in NSCLC limit therapy duration to 2 years.
Another key factor is the absence of prospective data as to when to stop treatment for these patients, according to Martin Reck, MD, PhD, head of thoracic oncology at the Lung Clinic Grosshansdorf (Germany).
“We have never prospectively investigated the correlation of the duration of a checkpoint blockade and the efficacy of treatment,” Dr. Reck said. “And this is a big problem.” It means “we really do not know how long we should treat the patient.”
To make matters muddier, some data do suggest that more therapy may be better. The recent Checkmate 153 trial, for instance, found that patients who had no signs of disease progression and who received 1-year fixed-duration nivolumab had significantly shorter progression-free and overall survival than those who received treatment indefinitely.
However, randomized trials with longer-term follow-up suggest durable responses can be maintained for years after immunotherapy is stopped.
Data from the KEYNOTE-024 trial, for instance, showed that more than 45% of patients with metastatic NSCLC and high tumor PD-L1 expression who received pembrolizumab for 2 years remained alive at 5 years without further treatment or disease progression. Another trial, KEYNOTE-407, demonstrated similar 5-year survival outcomes among patients with advanced squamous NSCLC, regardless of PD-L1 status, who completed 2 years of chemotherapy plus pembrolizumab followed by maintenance pembrolizumab.
With these studies, however, “we can only speculate about whether the proportion of patients alive without progression would be substantially higher if treatment with immunotherapy continued longer,” Dr. West wrote in a recent editorial .
Perhaps the most telling data so far come from a recent retrospective analysis from Dr. Sun and colleagues. The researchers directly compared survival outcomes among patients who continued receiving immunotherapy indefinitely with outcomes among patients for whom immunotherapy was discontinued at 2 years.
The JAMA Oncology study, which focused on 706 patients with NSCLC who completed 2 years of therapy, found that only 16% stopped receiving immune checkpoint inhibitor therapy at 2 years, whereas the remaining 84% continued receiving treatment indefinitely.
Among patients who continued receiving immunotherapy for 2 additional years, overall survival was not better than among those who stopped receiving immunotherapy at the 2-year mark. Even among the 11 patients whose condition progressed when therapy was discontinued, most still did well after treatment was resumed.
However, the retrospective design of the study limits its impact.
Without more definitive “data about when the treatment can be stopped,” many continue “indefinitely as long as the patient is tolerating treatment and the disease is not progressing,” Conor E. Steuer, MD, and Suresh S. Ramalingam, MD, of Winship Cancer Institute at Emory University, Atlanta, wrote in a recent review.
Impact on practice?
Dr. Sun views her team’s findings not as a recommendation to halt immunotherapy for every patient at 2 years but rather as “one piece of data that may provide reassurance to providers and patients who wish to stop at 2 years.”
Ultimately, however, the decision as to when or whether to stop immunotherapy for long-term responders is “an individualized one that requires shared decision-making and consideration of each patient’s clinical history, preferences, and risk tolerance,” Dr. Sun explained.
Dr. Reck agreed, noting that until prospective trials evaluate a fixed approach, the duration of immunotherapy “has to be determined by the treating physician and the individual patient.”
For a patient with metastatic NSCLC who is having an excellent response to checkpoint blockade, “we are somewhat afraid to stop the immunotherapy,” explained Dr. Reck, “because we are afraid the disease might relapse.” However, he noted, for patients who have a stable response to therapy, it may make sense to consider discontinuing checkpoint blockade.
Outside of survival outcomes, oncologists should also consider quality of life. Stopping treatment at 2 years comes with a “lower risk of toxic effects, less time in treatment for patients, and considerably lower costs for our health care system,” said Dr. West.
But for a fixed strategy to become more standard practice, the burden of proof is high, Dr. West said.
Jonathan W. Goldman, MD, says he understands the mentality, “If it’s going well, why would I change?”
In his experience, at 2 years of immunotherapy, most patients “say they’re feeling great” and “don’t mind coming in every 4 or 6 weeks, depending on the drug,” said Dr. Goldman, director of clinical trials in thoracic oncology at UCLA Medical Center in Santa Monica, Calif.
Dr. Goldman noted that in the future, instead of continuing immunotherapy indefinitely, clinicians may aim to maintain the patient “in the best response possible,” adding an intervention, such as stereotactic body radiotherapy or radiologic ablation, when needed.
“It may be that many of these long-term disease control patients are not cured in a traditional sense,” Dr. Goldman said, “but have controlled cancer that could potentially last years or even decades with ongoing care.”
Dr. Sun has relationships with Regeneron, GenMab, Seagen, and Bayer and has received institutional funding from Blueprint Research, Seagen Research, and IO Biotech Research. Dr. West has relationships with AstraZeneca, Genentech/Roche, Merck, and Regeneron outside the submitted work. Dr. Reck has relationships with Amgen, AstraZeneca, BMS, Boehringer-Ingelheim, Daiichi-Sankyo, GSK, Lilly, Merck, MSD, Mirati, Novartis, Roche Regeneron, and Pfizer.
A version of this article appeared on Medscape.com.
Most patients with non–small cell lung cancer (NSCLC) who are long-term responders to immunotherapy will continue receiving treatment beyond 2 years. However, the best available evidence to date indicates that receiving immunotherapy after this 2-year mark likely offers no survival benefit.
Is it an overabundance of caution? A desire for more definitive data? Or is it simply a judgment call oncologists make on the basis of the individual patient?
Lova Sun, MD, MSCE, of the University of Pennsylvania in Philadelphia, believes the general inconsistency between the data and clinical practice “likely reflects significant hesitation on the part of clinicians, patients, or both to stop a treatment that is still ‘working.’ ”
H. Jack West, MD, agreed, adding that “in an ambiguous situation, a U.S.-based population is going to err on the side of overtreatment.”
Without “incontrovertible evidence” that immunotherapy should stop at 2 years, “many, many, many patients and clinicians are going to favor continuing ‘doing what you’re doing’ in the absence of either prohibitive toxicity or clinically significant disease progression,” said Dr. West of the City of Hope Comprehensive Cancer Center, Duarte, Calif.
One factor adding to this ambiguity: Most pivotal studies that examine first-line immunotherapy in NSCLC limit therapy duration to 2 years.
Another key factor is the absence of prospective data as to when to stop treatment for these patients, according to Martin Reck, MD, PhD, head of thoracic oncology at the Lung Clinic Grosshansdorf (Germany).
“We have never prospectively investigated the correlation of the duration of a checkpoint blockade and the efficacy of treatment,” Dr. Reck said. “And this is a big problem.” It means “we really do not know how long we should treat the patient.”
To make matters muddier, some data do suggest that more therapy may be better. The recent Checkmate 153 trial, for instance, found that patients who had no signs of disease progression and who received 1-year fixed-duration nivolumab had significantly shorter progression-free and overall survival than those who received treatment indefinitely.
However, randomized trials with longer-term follow-up suggest durable responses can be maintained for years after immunotherapy is stopped.
Data from the KEYNOTE-024 trial, for instance, showed that more than 45% of patients with metastatic NSCLC and high tumor PD-L1 expression who received pembrolizumab for 2 years remained alive at 5 years without further treatment or disease progression. Another trial, KEYNOTE-407, demonstrated similar 5-year survival outcomes among patients with advanced squamous NSCLC, regardless of PD-L1 status, who completed 2 years of chemotherapy plus pembrolizumab followed by maintenance pembrolizumab.
With these studies, however, “we can only speculate about whether the proportion of patients alive without progression would be substantially higher if treatment with immunotherapy continued longer,” Dr. West wrote in a recent editorial .
Perhaps the most telling data so far come from a recent retrospective analysis from Dr. Sun and colleagues. The researchers directly compared survival outcomes among patients who continued receiving immunotherapy indefinitely with outcomes among patients for whom immunotherapy was discontinued at 2 years.
The JAMA Oncology study, which focused on 706 patients with NSCLC who completed 2 years of therapy, found that only 16% stopped receiving immune checkpoint inhibitor therapy at 2 years, whereas the remaining 84% continued receiving treatment indefinitely.
Among patients who continued receiving immunotherapy for 2 additional years, overall survival was not better than among those who stopped receiving immunotherapy at the 2-year mark. Even among the 11 patients whose condition progressed when therapy was discontinued, most still did well after treatment was resumed.
However, the retrospective design of the study limits its impact.
Without more definitive “data about when the treatment can be stopped,” many continue “indefinitely as long as the patient is tolerating treatment and the disease is not progressing,” Conor E. Steuer, MD, and Suresh S. Ramalingam, MD, of Winship Cancer Institute at Emory University, Atlanta, wrote in a recent review.
Impact on practice?
Dr. Sun views her team’s findings not as a recommendation to halt immunotherapy for every patient at 2 years but rather as “one piece of data that may provide reassurance to providers and patients who wish to stop at 2 years.”
Ultimately, however, the decision as to when or whether to stop immunotherapy for long-term responders is “an individualized one that requires shared decision-making and consideration of each patient’s clinical history, preferences, and risk tolerance,” Dr. Sun explained.
Dr. Reck agreed, noting that until prospective trials evaluate a fixed approach, the duration of immunotherapy “has to be determined by the treating physician and the individual patient.”
For a patient with metastatic NSCLC who is having an excellent response to checkpoint blockade, “we are somewhat afraid to stop the immunotherapy,” explained Dr. Reck, “because we are afraid the disease might relapse.” However, he noted, for patients who have a stable response to therapy, it may make sense to consider discontinuing checkpoint blockade.
Outside of survival outcomes, oncologists should also consider quality of life. Stopping treatment at 2 years comes with a “lower risk of toxic effects, less time in treatment for patients, and considerably lower costs for our health care system,” said Dr. West.
But for a fixed strategy to become more standard practice, the burden of proof is high, Dr. West said.
Jonathan W. Goldman, MD, says he understands the mentality, “If it’s going well, why would I change?”
In his experience, at 2 years of immunotherapy, most patients “say they’re feeling great” and “don’t mind coming in every 4 or 6 weeks, depending on the drug,” said Dr. Goldman, director of clinical trials in thoracic oncology at UCLA Medical Center in Santa Monica, Calif.
Dr. Goldman noted that in the future, instead of continuing immunotherapy indefinitely, clinicians may aim to maintain the patient “in the best response possible,” adding an intervention, such as stereotactic body radiotherapy or radiologic ablation, when needed.
“It may be that many of these long-term disease control patients are not cured in a traditional sense,” Dr. Goldman said, “but have controlled cancer that could potentially last years or even decades with ongoing care.”
Dr. Sun has relationships with Regeneron, GenMab, Seagen, and Bayer and has received institutional funding from Blueprint Research, Seagen Research, and IO Biotech Research. Dr. West has relationships with AstraZeneca, Genentech/Roche, Merck, and Regeneron outside the submitted work. Dr. Reck has relationships with Amgen, AstraZeneca, BMS, Boehringer-Ingelheim, Daiichi-Sankyo, GSK, Lilly, Merck, MSD, Mirati, Novartis, Roche Regeneron, and Pfizer.
A version of this article appeared on Medscape.com.
Most patients with non–small cell lung cancer (NSCLC) who are long-term responders to immunotherapy will continue receiving treatment beyond 2 years. However, the best available evidence to date indicates that receiving immunotherapy after this 2-year mark likely offers no survival benefit.
Is it an overabundance of caution? A desire for more definitive data? Or is it simply a judgment call oncologists make on the basis of the individual patient?
Lova Sun, MD, MSCE, of the University of Pennsylvania in Philadelphia, believes the general inconsistency between the data and clinical practice “likely reflects significant hesitation on the part of clinicians, patients, or both to stop a treatment that is still ‘working.’ ”
H. Jack West, MD, agreed, adding that “in an ambiguous situation, a U.S.-based population is going to err on the side of overtreatment.”
Without “incontrovertible evidence” that immunotherapy should stop at 2 years, “many, many, many patients and clinicians are going to favor continuing ‘doing what you’re doing’ in the absence of either prohibitive toxicity or clinically significant disease progression,” said Dr. West of the City of Hope Comprehensive Cancer Center, Duarte, Calif.
One factor adding to this ambiguity: Most pivotal studies that examine first-line immunotherapy in NSCLC limit therapy duration to 2 years.
Another key factor is the absence of prospective data as to when to stop treatment for these patients, according to Martin Reck, MD, PhD, head of thoracic oncology at the Lung Clinic Grosshansdorf (Germany).
“We have never prospectively investigated the correlation of the duration of a checkpoint blockade and the efficacy of treatment,” Dr. Reck said. “And this is a big problem.” It means “we really do not know how long we should treat the patient.”
To make matters muddier, some data do suggest that more therapy may be better. The recent Checkmate 153 trial, for instance, found that patients who had no signs of disease progression and who received 1-year fixed-duration nivolumab had significantly shorter progression-free and overall survival than those who received treatment indefinitely.
However, randomized trials with longer-term follow-up suggest durable responses can be maintained for years after immunotherapy is stopped.
Data from the KEYNOTE-024 trial, for instance, showed that more than 45% of patients with metastatic NSCLC and high tumor PD-L1 expression who received pembrolizumab for 2 years remained alive at 5 years without further treatment or disease progression. Another trial, KEYNOTE-407, demonstrated similar 5-year survival outcomes among patients with advanced squamous NSCLC, regardless of PD-L1 status, who completed 2 years of chemotherapy plus pembrolizumab followed by maintenance pembrolizumab.
With these studies, however, “we can only speculate about whether the proportion of patients alive without progression would be substantially higher if treatment with immunotherapy continued longer,” Dr. West wrote in a recent editorial .
Perhaps the most telling data so far come from a recent retrospective analysis from Dr. Sun and colleagues. The researchers directly compared survival outcomes among patients who continued receiving immunotherapy indefinitely with outcomes among patients for whom immunotherapy was discontinued at 2 years.
The JAMA Oncology study, which focused on 706 patients with NSCLC who completed 2 years of therapy, found that only 16% stopped receiving immune checkpoint inhibitor therapy at 2 years, whereas the remaining 84% continued receiving treatment indefinitely.
Among patients who continued receiving immunotherapy for 2 additional years, overall survival was not better than among those who stopped receiving immunotherapy at the 2-year mark. Even among the 11 patients whose condition progressed when therapy was discontinued, most still did well after treatment was resumed.
However, the retrospective design of the study limits its impact.
Without more definitive “data about when the treatment can be stopped,” many continue “indefinitely as long as the patient is tolerating treatment and the disease is not progressing,” Conor E. Steuer, MD, and Suresh S. Ramalingam, MD, of Winship Cancer Institute at Emory University, Atlanta, wrote in a recent review.
Impact on practice?
Dr. Sun views her team’s findings not as a recommendation to halt immunotherapy for every patient at 2 years but rather as “one piece of data that may provide reassurance to providers and patients who wish to stop at 2 years.”
Ultimately, however, the decision as to when or whether to stop immunotherapy for long-term responders is “an individualized one that requires shared decision-making and consideration of each patient’s clinical history, preferences, and risk tolerance,” Dr. Sun explained.
Dr. Reck agreed, noting that until prospective trials evaluate a fixed approach, the duration of immunotherapy “has to be determined by the treating physician and the individual patient.”
For a patient with metastatic NSCLC who is having an excellent response to checkpoint blockade, “we are somewhat afraid to stop the immunotherapy,” explained Dr. Reck, “because we are afraid the disease might relapse.” However, he noted, for patients who have a stable response to therapy, it may make sense to consider discontinuing checkpoint blockade.
Outside of survival outcomes, oncologists should also consider quality of life. Stopping treatment at 2 years comes with a “lower risk of toxic effects, less time in treatment for patients, and considerably lower costs for our health care system,” said Dr. West.
But for a fixed strategy to become more standard practice, the burden of proof is high, Dr. West said.
Jonathan W. Goldman, MD, says he understands the mentality, “If it’s going well, why would I change?”
In his experience, at 2 years of immunotherapy, most patients “say they’re feeling great” and “don’t mind coming in every 4 or 6 weeks, depending on the drug,” said Dr. Goldman, director of clinical trials in thoracic oncology at UCLA Medical Center in Santa Monica, Calif.
Dr. Goldman noted that in the future, instead of continuing immunotherapy indefinitely, clinicians may aim to maintain the patient “in the best response possible,” adding an intervention, such as stereotactic body radiotherapy or radiologic ablation, when needed.
“It may be that many of these long-term disease control patients are not cured in a traditional sense,” Dr. Goldman said, “but have controlled cancer that could potentially last years or even decades with ongoing care.”
Dr. Sun has relationships with Regeneron, GenMab, Seagen, and Bayer and has received institutional funding from Blueprint Research, Seagen Research, and IO Biotech Research. Dr. West has relationships with AstraZeneca, Genentech/Roche, Merck, and Regeneron outside the submitted work. Dr. Reck has relationships with Amgen, AstraZeneca, BMS, Boehringer-Ingelheim, Daiichi-Sankyo, GSK, Lilly, Merck, MSD, Mirati, Novartis, Roche Regeneron, and Pfizer.
A version of this article appeared on Medscape.com.