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Less Than 50% of Accelerated Approvals Show Clinical Benefit
despite being on the US market for more than 5 years, according to a new study.
Under the program, drugs are approved for marketing if they show benefit in surrogate markers thought to indicate efficacy. Progression-free survival, tumor response, and duration of response are the most used surrogate markers for accelerated approvals of cancer drugs. These are based largely on imaging studies that show either a stop in growth in the case of progression-free survival or tumor shrinkage in the case of tumor response.
Following accelerated approvals, companies are then supposed to show actual clinical benefit in confirmatory trials.
The problem with relying on surrogate markers for drug approvals is that they don’t always correlate with longer survival or improved quality of life, said Edward Cliff, MBBS, who presented the findings at the American Association for Cancer Research 2024 annual meeting (abstract 918). The study was also published in JAMA to coincide with the meeting presentation.
In some cancers, these markers work well, but in others they don’t, said Dr. Cliff, a hematology trainee at Brigham and Women’s Hospital, Boston, when the work was conducted, and now a hematology fellow at the Peter MacCallum Cancer Centre in Melbourne, Australia.
To determine whether cancer drugs granted accelerated approval ultimately show an overall survival or quality of life benefit, researchers reviewed 46 cancer drugs granted accelerated approvals between 2013 and 2017. Twenty (43%) were granted full approval after demonstrating survival or quality-of-life benefits.
Nine, however, were converted to full approvals on the basis of surrogate markers. These include a full approval for pembrolizumab in previously treated recurrent or refractory head and neck squamous cell carcinoma and a full approval for nivolumab for refractory locally advanced or metastatic urothelial carcinoma, both based on tumor response rate and duration of response.
Of the remaining 17 drugs evaluated in the trial, 10 have been withdrawn and seven do not yet have confirmatory trial results.
The reliance on surrogate markers means that these drugs are used for treatment, covered by insurance, and added to guidelines — all without solid evidence of real-world clinical benefit, said Dr. Cliff.
However, the goal should not be to do away with the accelerated approval process, because it sometimes does deliver powerful agents to patients quickly. Instead, Dr. Cliff told this news organization, the system needs to be improved so that “we keep the speed while getting certainty around clinical benefits” with robust and timely confirmatory trials.
In the meantime, “clinicians should communicate with patients about any residual uncertainty of clinical benefit when they offer novel therapies,” Dr. Cliff explained. “It’s important for them to have the information.”
There has been some progress on the issue. In December 2022, the US Congress passed the Food and Drug Administration Omnibus Reform Act. Among other things, the Act requires companies to have confirmation trials underway as a condition for accelerated approval, and to provide regular reports on their progress. The Act also expedites the withdrawal process for drugs that don’t show a benefit.
The Act has been put to the test twice recently. In February, FDA used the expedited process to remove the multiple myeloma drug melphalan flufenamide from the market. Melphalan flufenamide hadn’t been sold in the US for quite some time, so the process wasn’t contentious.
In March, Regeneron announced that accelerated approval for the follicular and diffuse B cell lymphoma drug odronextamab has been delayed pending enrollment in a confirmatory trial.
“There have been some promising steps,” Dr. Cliff said, but much work needs to be done.
Study moderator Shivaani Kummar, MD, agreed, noting that “the data is showing that the confirmatory trials aren’t happening at the pace which they should.”
But the solution is not to curtail approvals; it’s to make sure that accelerated approval commitments are met, said Dr. Kummar.
Still, “as a practicing oncologist, I welcome the accelerated pathway,” Dr. Kummar, a medical oncologist/hematologist at Oregon Health & Science University, Portland, told this news organization. “I want the availability to my patients.”
Having drugs approved on the basis of surrogate markers doesn’t necessarily mean patients are getting ineffective therapies, Dr. Kummar noted. For instance, if an agent just shrinks the tumor, it can sometimes still be “a huge clinical benefit because it can take the symptoms away.”
As for prescribing drugs based on accelerated approvals, she said she tells her patients that trials have been promising, but we don’t know what the long-term effects are. She and her patient then make a decision together.
The study was funded by Arnold Ventures. Dr. Kummar reported support from several companies, including Bayer, Gilead, and others. Dr. Cliff had no disclosures.
A version of this article appeared on Medscape.com.
despite being on the US market for more than 5 years, according to a new study.
Under the program, drugs are approved for marketing if they show benefit in surrogate markers thought to indicate efficacy. Progression-free survival, tumor response, and duration of response are the most used surrogate markers for accelerated approvals of cancer drugs. These are based largely on imaging studies that show either a stop in growth in the case of progression-free survival or tumor shrinkage in the case of tumor response.
Following accelerated approvals, companies are then supposed to show actual clinical benefit in confirmatory trials.
The problem with relying on surrogate markers for drug approvals is that they don’t always correlate with longer survival or improved quality of life, said Edward Cliff, MBBS, who presented the findings at the American Association for Cancer Research 2024 annual meeting (abstract 918). The study was also published in JAMA to coincide with the meeting presentation.
In some cancers, these markers work well, but in others they don’t, said Dr. Cliff, a hematology trainee at Brigham and Women’s Hospital, Boston, when the work was conducted, and now a hematology fellow at the Peter MacCallum Cancer Centre in Melbourne, Australia.
To determine whether cancer drugs granted accelerated approval ultimately show an overall survival or quality of life benefit, researchers reviewed 46 cancer drugs granted accelerated approvals between 2013 and 2017. Twenty (43%) were granted full approval after demonstrating survival or quality-of-life benefits.
Nine, however, were converted to full approvals on the basis of surrogate markers. These include a full approval for pembrolizumab in previously treated recurrent or refractory head and neck squamous cell carcinoma and a full approval for nivolumab for refractory locally advanced or metastatic urothelial carcinoma, both based on tumor response rate and duration of response.
Of the remaining 17 drugs evaluated in the trial, 10 have been withdrawn and seven do not yet have confirmatory trial results.
The reliance on surrogate markers means that these drugs are used for treatment, covered by insurance, and added to guidelines — all without solid evidence of real-world clinical benefit, said Dr. Cliff.
However, the goal should not be to do away with the accelerated approval process, because it sometimes does deliver powerful agents to patients quickly. Instead, Dr. Cliff told this news organization, the system needs to be improved so that “we keep the speed while getting certainty around clinical benefits” with robust and timely confirmatory trials.
In the meantime, “clinicians should communicate with patients about any residual uncertainty of clinical benefit when they offer novel therapies,” Dr. Cliff explained. “It’s important for them to have the information.”
There has been some progress on the issue. In December 2022, the US Congress passed the Food and Drug Administration Omnibus Reform Act. Among other things, the Act requires companies to have confirmation trials underway as a condition for accelerated approval, and to provide regular reports on their progress. The Act also expedites the withdrawal process for drugs that don’t show a benefit.
The Act has been put to the test twice recently. In February, FDA used the expedited process to remove the multiple myeloma drug melphalan flufenamide from the market. Melphalan flufenamide hadn’t been sold in the US for quite some time, so the process wasn’t contentious.
In March, Regeneron announced that accelerated approval for the follicular and diffuse B cell lymphoma drug odronextamab has been delayed pending enrollment in a confirmatory trial.
“There have been some promising steps,” Dr. Cliff said, but much work needs to be done.
Study moderator Shivaani Kummar, MD, agreed, noting that “the data is showing that the confirmatory trials aren’t happening at the pace which they should.”
But the solution is not to curtail approvals; it’s to make sure that accelerated approval commitments are met, said Dr. Kummar.
Still, “as a practicing oncologist, I welcome the accelerated pathway,” Dr. Kummar, a medical oncologist/hematologist at Oregon Health & Science University, Portland, told this news organization. “I want the availability to my patients.”
Having drugs approved on the basis of surrogate markers doesn’t necessarily mean patients are getting ineffective therapies, Dr. Kummar noted. For instance, if an agent just shrinks the tumor, it can sometimes still be “a huge clinical benefit because it can take the symptoms away.”
As for prescribing drugs based on accelerated approvals, she said she tells her patients that trials have been promising, but we don’t know what the long-term effects are. She and her patient then make a decision together.
The study was funded by Arnold Ventures. Dr. Kummar reported support from several companies, including Bayer, Gilead, and others. Dr. Cliff had no disclosures.
A version of this article appeared on Medscape.com.
despite being on the US market for more than 5 years, according to a new study.
Under the program, drugs are approved for marketing if they show benefit in surrogate markers thought to indicate efficacy. Progression-free survival, tumor response, and duration of response are the most used surrogate markers for accelerated approvals of cancer drugs. These are based largely on imaging studies that show either a stop in growth in the case of progression-free survival or tumor shrinkage in the case of tumor response.
Following accelerated approvals, companies are then supposed to show actual clinical benefit in confirmatory trials.
The problem with relying on surrogate markers for drug approvals is that they don’t always correlate with longer survival or improved quality of life, said Edward Cliff, MBBS, who presented the findings at the American Association for Cancer Research 2024 annual meeting (abstract 918). The study was also published in JAMA to coincide with the meeting presentation.
In some cancers, these markers work well, but in others they don’t, said Dr. Cliff, a hematology trainee at Brigham and Women’s Hospital, Boston, when the work was conducted, and now a hematology fellow at the Peter MacCallum Cancer Centre in Melbourne, Australia.
To determine whether cancer drugs granted accelerated approval ultimately show an overall survival or quality of life benefit, researchers reviewed 46 cancer drugs granted accelerated approvals between 2013 and 2017. Twenty (43%) were granted full approval after demonstrating survival or quality-of-life benefits.
Nine, however, were converted to full approvals on the basis of surrogate markers. These include a full approval for pembrolizumab in previously treated recurrent or refractory head and neck squamous cell carcinoma and a full approval for nivolumab for refractory locally advanced or metastatic urothelial carcinoma, both based on tumor response rate and duration of response.
Of the remaining 17 drugs evaluated in the trial, 10 have been withdrawn and seven do not yet have confirmatory trial results.
The reliance on surrogate markers means that these drugs are used for treatment, covered by insurance, and added to guidelines — all without solid evidence of real-world clinical benefit, said Dr. Cliff.
However, the goal should not be to do away with the accelerated approval process, because it sometimes does deliver powerful agents to patients quickly. Instead, Dr. Cliff told this news organization, the system needs to be improved so that “we keep the speed while getting certainty around clinical benefits” with robust and timely confirmatory trials.
In the meantime, “clinicians should communicate with patients about any residual uncertainty of clinical benefit when they offer novel therapies,” Dr. Cliff explained. “It’s important for them to have the information.”
There has been some progress on the issue. In December 2022, the US Congress passed the Food and Drug Administration Omnibus Reform Act. Among other things, the Act requires companies to have confirmation trials underway as a condition for accelerated approval, and to provide regular reports on their progress. The Act also expedites the withdrawal process for drugs that don’t show a benefit.
The Act has been put to the test twice recently. In February, FDA used the expedited process to remove the multiple myeloma drug melphalan flufenamide from the market. Melphalan flufenamide hadn’t been sold in the US for quite some time, so the process wasn’t contentious.
In March, Regeneron announced that accelerated approval for the follicular and diffuse B cell lymphoma drug odronextamab has been delayed pending enrollment in a confirmatory trial.
“There have been some promising steps,” Dr. Cliff said, but much work needs to be done.
Study moderator Shivaani Kummar, MD, agreed, noting that “the data is showing that the confirmatory trials aren’t happening at the pace which they should.”
But the solution is not to curtail approvals; it’s to make sure that accelerated approval commitments are met, said Dr. Kummar.
Still, “as a practicing oncologist, I welcome the accelerated pathway,” Dr. Kummar, a medical oncologist/hematologist at Oregon Health & Science University, Portland, told this news organization. “I want the availability to my patients.”
Having drugs approved on the basis of surrogate markers doesn’t necessarily mean patients are getting ineffective therapies, Dr. Kummar noted. For instance, if an agent just shrinks the tumor, it can sometimes still be “a huge clinical benefit because it can take the symptoms away.”
As for prescribing drugs based on accelerated approvals, she said she tells her patients that trials have been promising, but we don’t know what the long-term effects are. She and her patient then make a decision together.
The study was funded by Arnold Ventures. Dr. Kummar reported support from several companies, including Bayer, Gilead, and others. Dr. Cliff had no disclosures.
A version of this article appeared on Medscape.com.
FDA Expands Enhertu Indication to HER2-Positive Solid Tumors
The agent had already been approved for several cancer types, including certain patients with unresectable or metastatic HER2-positive breast cancer as well as adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who had received a prior trastuzumab-based regimen.
The current accelerated approval is the first tumor-agnostic approval of a HER2-directed therapy and antibody drug conjugate.
“Until approval of trastuzumab deruxtecan, patients with metastatic HER2-positive tumors have had limited treatment options,” Funda Meric-Bernstam, MD, chair of investigational cancer therapeutics at the University of Texas MD Anderson Cancer Center, Houston, said in an AstraZeneca press statement. “Based on the clinically meaningful response rates across clinical trials, this tumor-agnostic approval means that patients may now be treated with a HER2-directed medicine.”
Approval was based on findings in 192 patients enrolled in either the DESTINY-PanTumor02 trial, the DESTINY-Lung01 trial, or the DESTINY-CRC02 trial. Patients in the multicenter trials underwent treatment until disease progression, death, withdrawal of consent or unacceptable toxicity.
Confirmed objective response rates were 51.4%, 52.9%, and 46.9% in the three studies, respectively. Median duration of response was 19.4, 6.9, and 5.5 months, respectively.
The most common adverse reactions occurring in at least 20% of patients included decreased white blood cell count, hemoglobin, lymphocyte count, and neutrophil count, as well as nausea, fatigue, platelet count, vomiting, alopecia, diarrhea, stomatitis, and upper respiratory tract infection.
Full prescribing information includes a boxed warning about the risk for interstitial lung disease and embryo-fetal toxicity.
The recommended dosage is 5.4 mg/kg given as an intravenous infusion one every 3 weeks until disease progression or unacceptable toxicity.
A version of this article appeared on Medscape.com.
The agent had already been approved for several cancer types, including certain patients with unresectable or metastatic HER2-positive breast cancer as well as adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who had received a prior trastuzumab-based regimen.
The current accelerated approval is the first tumor-agnostic approval of a HER2-directed therapy and antibody drug conjugate.
“Until approval of trastuzumab deruxtecan, patients with metastatic HER2-positive tumors have had limited treatment options,” Funda Meric-Bernstam, MD, chair of investigational cancer therapeutics at the University of Texas MD Anderson Cancer Center, Houston, said in an AstraZeneca press statement. “Based on the clinically meaningful response rates across clinical trials, this tumor-agnostic approval means that patients may now be treated with a HER2-directed medicine.”
Approval was based on findings in 192 patients enrolled in either the DESTINY-PanTumor02 trial, the DESTINY-Lung01 trial, or the DESTINY-CRC02 trial. Patients in the multicenter trials underwent treatment until disease progression, death, withdrawal of consent or unacceptable toxicity.
Confirmed objective response rates were 51.4%, 52.9%, and 46.9% in the three studies, respectively. Median duration of response was 19.4, 6.9, and 5.5 months, respectively.
The most common adverse reactions occurring in at least 20% of patients included decreased white blood cell count, hemoglobin, lymphocyte count, and neutrophil count, as well as nausea, fatigue, platelet count, vomiting, alopecia, diarrhea, stomatitis, and upper respiratory tract infection.
Full prescribing information includes a boxed warning about the risk for interstitial lung disease and embryo-fetal toxicity.
The recommended dosage is 5.4 mg/kg given as an intravenous infusion one every 3 weeks until disease progression or unacceptable toxicity.
A version of this article appeared on Medscape.com.
The agent had already been approved for several cancer types, including certain patients with unresectable or metastatic HER2-positive breast cancer as well as adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who had received a prior trastuzumab-based regimen.
The current accelerated approval is the first tumor-agnostic approval of a HER2-directed therapy and antibody drug conjugate.
“Until approval of trastuzumab deruxtecan, patients with metastatic HER2-positive tumors have had limited treatment options,” Funda Meric-Bernstam, MD, chair of investigational cancer therapeutics at the University of Texas MD Anderson Cancer Center, Houston, said in an AstraZeneca press statement. “Based on the clinically meaningful response rates across clinical trials, this tumor-agnostic approval means that patients may now be treated with a HER2-directed medicine.”
Approval was based on findings in 192 patients enrolled in either the DESTINY-PanTumor02 trial, the DESTINY-Lung01 trial, or the DESTINY-CRC02 trial. Patients in the multicenter trials underwent treatment until disease progression, death, withdrawal of consent or unacceptable toxicity.
Confirmed objective response rates were 51.4%, 52.9%, and 46.9% in the three studies, respectively. Median duration of response was 19.4, 6.9, and 5.5 months, respectively.
The most common adverse reactions occurring in at least 20% of patients included decreased white blood cell count, hemoglobin, lymphocyte count, and neutrophil count, as well as nausea, fatigue, platelet count, vomiting, alopecia, diarrhea, stomatitis, and upper respiratory tract infection.
Full prescribing information includes a boxed warning about the risk for interstitial lung disease and embryo-fetal toxicity.
The recommended dosage is 5.4 mg/kg given as an intravenous infusion one every 3 weeks until disease progression or unacceptable toxicity.
A version of this article appeared on Medscape.com.
New Quality Measure Improves Follow-Up for CRC Screening
the developers said.
As part of their work, the researchers conducted a retrospective study of 20,581 adults aged 50-75 years from 38 health systems that showed that fewer than half (48%) had a follow-up colonoscopy within 180 days of an initial abnormal SBT for CRC.
“The low follow-up rates to an abnormal SBT were initially surprising,” first author Elizabeth L. Ciemins, PhD, MPH, MA, Research and Analytics, American Medical Group Association (AMGA), Alexandria, Virginia, told this news organization.
“However, once we interviewed clinicians and learned that this was not a measure they were tracking, along with their own incorrect assumptions of a much higher follow-up rate, the low rates made sense. As is commonly said, ‘you can’t change what you don’t measure,’” she said.
The CRC screening completion measure the researchers propose “builds on and addresses an important shortcoming in an existing measure and will help ensure complete screening for CRC,” they noted in their JAMA Network Open paper.
The key elements of the follow-up measure are the date and result of a SBT and the date of the follow-up colonoscopy — if it occurred, Dr. Ciemins explained.
“Currently, health systems are not consistently tracking this measure, but they have the data elements to do so, especially if they are doing colonoscopies in-house,” she said.
Field testing showed that use of this new measure is “feasible, valid, and reliable,” the authors said. Dr. Ciemins believed this CRC screening completion measure could be widely implemented.
“Three AMGA member health systems feasibility tested the data elements and found that they could reliably abstract the required elements from electronic health records (EHRs),” she told this news organization.
The researchers are currently testing the measure among 20 AMGA member health systems, that are submitting quarterly data on a version of the specified measure.
“Advancing this measure as a quality performance measure could significantly increase the early detection of CRC, thereby improving health and ultimately saving lives,” the authors concluded in their paper.
The Right Direction, But Questions Remain
The coauthors of a linked commentary said this research highlights the “suboptimal” rates of a timely follow-up colonoscopy after positive SBT results. They applauded the authors for “focusing attention on a meaningful approach to measuring high-quality CRC screening and providing guidance for standardized measurement.”
However, several questions arise from this study, “including whether 6 months is the ideal interval for colonoscopy completion after a positive SBT result, where this measure fits in the context of existing CRC screening measures, and how to implement it in practice,” Jennifer K. Maratt, MD, with Indiana University School of Medicine, Indianapolis, and coauthors wrote.
“This measure alone does not address all the gaps in the screening process, nor does it address barriers to colonoscopy completion, but it points us in the right direction for measuring the success of screening programs,” Dr. Maratt and her colleagues added.
The study was supported by a grant from the AARP. The authors and editorial writers had no relevant disclosures.
A version of this article appeared on Medscape.com.
the developers said.
As part of their work, the researchers conducted a retrospective study of 20,581 adults aged 50-75 years from 38 health systems that showed that fewer than half (48%) had a follow-up colonoscopy within 180 days of an initial abnormal SBT for CRC.
“The low follow-up rates to an abnormal SBT were initially surprising,” first author Elizabeth L. Ciemins, PhD, MPH, MA, Research and Analytics, American Medical Group Association (AMGA), Alexandria, Virginia, told this news organization.
“However, once we interviewed clinicians and learned that this was not a measure they were tracking, along with their own incorrect assumptions of a much higher follow-up rate, the low rates made sense. As is commonly said, ‘you can’t change what you don’t measure,’” she said.
The CRC screening completion measure the researchers propose “builds on and addresses an important shortcoming in an existing measure and will help ensure complete screening for CRC,” they noted in their JAMA Network Open paper.
The key elements of the follow-up measure are the date and result of a SBT and the date of the follow-up colonoscopy — if it occurred, Dr. Ciemins explained.
“Currently, health systems are not consistently tracking this measure, but they have the data elements to do so, especially if they are doing colonoscopies in-house,” she said.
Field testing showed that use of this new measure is “feasible, valid, and reliable,” the authors said. Dr. Ciemins believed this CRC screening completion measure could be widely implemented.
“Three AMGA member health systems feasibility tested the data elements and found that they could reliably abstract the required elements from electronic health records (EHRs),” she told this news organization.
The researchers are currently testing the measure among 20 AMGA member health systems, that are submitting quarterly data on a version of the specified measure.
“Advancing this measure as a quality performance measure could significantly increase the early detection of CRC, thereby improving health and ultimately saving lives,” the authors concluded in their paper.
The Right Direction, But Questions Remain
The coauthors of a linked commentary said this research highlights the “suboptimal” rates of a timely follow-up colonoscopy after positive SBT results. They applauded the authors for “focusing attention on a meaningful approach to measuring high-quality CRC screening and providing guidance for standardized measurement.”
However, several questions arise from this study, “including whether 6 months is the ideal interval for colonoscopy completion after a positive SBT result, where this measure fits in the context of existing CRC screening measures, and how to implement it in practice,” Jennifer K. Maratt, MD, with Indiana University School of Medicine, Indianapolis, and coauthors wrote.
“This measure alone does not address all the gaps in the screening process, nor does it address barriers to colonoscopy completion, but it points us in the right direction for measuring the success of screening programs,” Dr. Maratt and her colleagues added.
The study was supported by a grant from the AARP. The authors and editorial writers had no relevant disclosures.
A version of this article appeared on Medscape.com.
the developers said.
As part of their work, the researchers conducted a retrospective study of 20,581 adults aged 50-75 years from 38 health systems that showed that fewer than half (48%) had a follow-up colonoscopy within 180 days of an initial abnormal SBT for CRC.
“The low follow-up rates to an abnormal SBT were initially surprising,” first author Elizabeth L. Ciemins, PhD, MPH, MA, Research and Analytics, American Medical Group Association (AMGA), Alexandria, Virginia, told this news organization.
“However, once we interviewed clinicians and learned that this was not a measure they were tracking, along with their own incorrect assumptions of a much higher follow-up rate, the low rates made sense. As is commonly said, ‘you can’t change what you don’t measure,’” she said.
The CRC screening completion measure the researchers propose “builds on and addresses an important shortcoming in an existing measure and will help ensure complete screening for CRC,” they noted in their JAMA Network Open paper.
The key elements of the follow-up measure are the date and result of a SBT and the date of the follow-up colonoscopy — if it occurred, Dr. Ciemins explained.
“Currently, health systems are not consistently tracking this measure, but they have the data elements to do so, especially if they are doing colonoscopies in-house,” she said.
Field testing showed that use of this new measure is “feasible, valid, and reliable,” the authors said. Dr. Ciemins believed this CRC screening completion measure could be widely implemented.
“Three AMGA member health systems feasibility tested the data elements and found that they could reliably abstract the required elements from electronic health records (EHRs),” she told this news organization.
The researchers are currently testing the measure among 20 AMGA member health systems, that are submitting quarterly data on a version of the specified measure.
“Advancing this measure as a quality performance measure could significantly increase the early detection of CRC, thereby improving health and ultimately saving lives,” the authors concluded in their paper.
The Right Direction, But Questions Remain
The coauthors of a linked commentary said this research highlights the “suboptimal” rates of a timely follow-up colonoscopy after positive SBT results. They applauded the authors for “focusing attention on a meaningful approach to measuring high-quality CRC screening and providing guidance for standardized measurement.”
However, several questions arise from this study, “including whether 6 months is the ideal interval for colonoscopy completion after a positive SBT result, where this measure fits in the context of existing CRC screening measures, and how to implement it in practice,” Jennifer K. Maratt, MD, with Indiana University School of Medicine, Indianapolis, and coauthors wrote.
“This measure alone does not address all the gaps in the screening process, nor does it address barriers to colonoscopy completion, but it points us in the right direction for measuring the success of screening programs,” Dr. Maratt and her colleagues added.
The study was supported by a grant from the AARP. The authors and editorial writers had no relevant disclosures.
A version of this article appeared on Medscape.com.
Oncology Practice and Lab to Pay $4 Million in Kickback Case
The US Department of Justice (DOJ) announced on April 2 that Oncology San Antonio, PA, and its physicians have agreed to pay $1.3 million, and CorePath Laboratories, PA, has agreed to pay nearly $2.75 million plus accrued interest in civil settlements with the United States and Texas for alleged violations of the False Claims Act.
According to the DOJ, the diagnostic reference laboratory, CorePath Laboratories, conducted in-office bone marrow biopsies at Oncology San Antonio practice locations and performed diagnostic testing on the samples. CorePath Laboratories agreed to pay $115 for each biopsy referred by Oncology San Antonio physicians, and these biopsy payments were allegedly paid to the private practices of three physicians at Oncology San Antonio. This arrangement allegedly began in August 2016.
The DOJ claimed that the payments for referring biopsies constituted illegal kickbacks under the Anti-Kickback Statute, which prohibits offering or receiving payments to encourage referrals of services covered by federal healthcare programs like Medicare and Medicaid.
“Violations of the Anti-Kickback Statute involving oncology services can waste scarce federal healthcare program funds and corrupt the medical decision-making process,” Special Agent in Charge Jason E. Meadows with the US Department of Health and Human Services Office of Inspector General said in a statement.
Oncology San Antonio told this news organization that the cost and distraction of prolonged litigation were the primary factors in its decision to settle. “The decision to settle was an extremely difficult one because Oncology San Antonio was confident that it would have prevailed in any action,” the practice said via email.
This civil settlement with Oncology San Antonio also resolved allegations that a physician affiliated with the practice, Jayasree Rao, MD, provided unnecessary tests, services, and treatments to patients covered by Medicare, TRICARE, and Texas Medicaid in the San Antonio Metro Area and billed these federal healthcare programs for the unnecessary services.
The DOJ identified Slavisa Gasic, MD, a physician formerly employed by Dr. Rao, as a whistleblower in the investigation. When asked for comment, Oncology San Antonio alleged Dr. Gasic was “disgruntled for not being promoted.”
According to Oncology San Antonio, the contract for bone marrow biopsies was negotiated and signed by a former nonphysician officer of the company without the input of Oncology San Antonio physicians. The contract permitted bone marrow biopsies at Oncology San Antonio clinics instead of requiring older adult and sick patients to go to a different facility for these services.
“Oncology San Antonio and Rao vehemently denied Gasic’s allegations as wholly unfounded,” the company told this news organization.
Dr. Rao retired in March and is no longer practicing. CorePath Laboratories, PA, did not respond to this news organization’s request for comment.
According to the DOJ press release, the “investigation and resolution of this matter illustrate the government’s emphasis on combating healthcare fraud.”
A version of this article appeared on Medscape.com.
The US Department of Justice (DOJ) announced on April 2 that Oncology San Antonio, PA, and its physicians have agreed to pay $1.3 million, and CorePath Laboratories, PA, has agreed to pay nearly $2.75 million plus accrued interest in civil settlements with the United States and Texas for alleged violations of the False Claims Act.
According to the DOJ, the diagnostic reference laboratory, CorePath Laboratories, conducted in-office bone marrow biopsies at Oncology San Antonio practice locations and performed diagnostic testing on the samples. CorePath Laboratories agreed to pay $115 for each biopsy referred by Oncology San Antonio physicians, and these biopsy payments were allegedly paid to the private practices of three physicians at Oncology San Antonio. This arrangement allegedly began in August 2016.
The DOJ claimed that the payments for referring biopsies constituted illegal kickbacks under the Anti-Kickback Statute, which prohibits offering or receiving payments to encourage referrals of services covered by federal healthcare programs like Medicare and Medicaid.
“Violations of the Anti-Kickback Statute involving oncology services can waste scarce federal healthcare program funds and corrupt the medical decision-making process,” Special Agent in Charge Jason E. Meadows with the US Department of Health and Human Services Office of Inspector General said in a statement.
Oncology San Antonio told this news organization that the cost and distraction of prolonged litigation were the primary factors in its decision to settle. “The decision to settle was an extremely difficult one because Oncology San Antonio was confident that it would have prevailed in any action,” the practice said via email.
This civil settlement with Oncology San Antonio also resolved allegations that a physician affiliated with the practice, Jayasree Rao, MD, provided unnecessary tests, services, and treatments to patients covered by Medicare, TRICARE, and Texas Medicaid in the San Antonio Metro Area and billed these federal healthcare programs for the unnecessary services.
The DOJ identified Slavisa Gasic, MD, a physician formerly employed by Dr. Rao, as a whistleblower in the investigation. When asked for comment, Oncology San Antonio alleged Dr. Gasic was “disgruntled for not being promoted.”
According to Oncology San Antonio, the contract for bone marrow biopsies was negotiated and signed by a former nonphysician officer of the company without the input of Oncology San Antonio physicians. The contract permitted bone marrow biopsies at Oncology San Antonio clinics instead of requiring older adult and sick patients to go to a different facility for these services.
“Oncology San Antonio and Rao vehemently denied Gasic’s allegations as wholly unfounded,” the company told this news organization.
Dr. Rao retired in March and is no longer practicing. CorePath Laboratories, PA, did not respond to this news organization’s request for comment.
According to the DOJ press release, the “investigation and resolution of this matter illustrate the government’s emphasis on combating healthcare fraud.”
A version of this article appeared on Medscape.com.
The US Department of Justice (DOJ) announced on April 2 that Oncology San Antonio, PA, and its physicians have agreed to pay $1.3 million, and CorePath Laboratories, PA, has agreed to pay nearly $2.75 million plus accrued interest in civil settlements with the United States and Texas for alleged violations of the False Claims Act.
According to the DOJ, the diagnostic reference laboratory, CorePath Laboratories, conducted in-office bone marrow biopsies at Oncology San Antonio practice locations and performed diagnostic testing on the samples. CorePath Laboratories agreed to pay $115 for each biopsy referred by Oncology San Antonio physicians, and these biopsy payments were allegedly paid to the private practices of three physicians at Oncology San Antonio. This arrangement allegedly began in August 2016.
The DOJ claimed that the payments for referring biopsies constituted illegal kickbacks under the Anti-Kickback Statute, which prohibits offering or receiving payments to encourage referrals of services covered by federal healthcare programs like Medicare and Medicaid.
“Violations of the Anti-Kickback Statute involving oncology services can waste scarce federal healthcare program funds and corrupt the medical decision-making process,” Special Agent in Charge Jason E. Meadows with the US Department of Health and Human Services Office of Inspector General said in a statement.
Oncology San Antonio told this news organization that the cost and distraction of prolonged litigation were the primary factors in its decision to settle. “The decision to settle was an extremely difficult one because Oncology San Antonio was confident that it would have prevailed in any action,” the practice said via email.
This civil settlement with Oncology San Antonio also resolved allegations that a physician affiliated with the practice, Jayasree Rao, MD, provided unnecessary tests, services, and treatments to patients covered by Medicare, TRICARE, and Texas Medicaid in the San Antonio Metro Area and billed these federal healthcare programs for the unnecessary services.
The DOJ identified Slavisa Gasic, MD, a physician formerly employed by Dr. Rao, as a whistleblower in the investigation. When asked for comment, Oncology San Antonio alleged Dr. Gasic was “disgruntled for not being promoted.”
According to Oncology San Antonio, the contract for bone marrow biopsies was negotiated and signed by a former nonphysician officer of the company without the input of Oncology San Antonio physicians. The contract permitted bone marrow biopsies at Oncology San Antonio clinics instead of requiring older adult and sick patients to go to a different facility for these services.
“Oncology San Antonio and Rao vehemently denied Gasic’s allegations as wholly unfounded,” the company told this news organization.
Dr. Rao retired in March and is no longer practicing. CorePath Laboratories, PA, did not respond to this news organization’s request for comment.
According to the DOJ press release, the “investigation and resolution of this matter illustrate the government’s emphasis on combating healthcare fraud.”
A version of this article appeared on Medscape.com.
Prostate Cancer Tsunami Coming, Experts Caution
An “inevitable” global surge in prostate cancer is coming, with a worldwide doubling of cases to 2.9 million and an 85% increase in deaths to nearly 700,000 by the year 2040, the Lancet Commission on Prostate Cancer warned this week.
At a meeting of urologists in Paris, the commission said that the acceleration is already underway in high-income countries such as the United States and the United Kingdom but will gain momentum in low- and medium-income countries.
Nick James, MD, lead author of The Lancet report and professor of prostate and bladder cancer research at The Institute of Cancer Research in London, said that the surge, in part, is a medical success story.
Dr. James told this news organization.
“There is a big rise in the high-income countries. But we’re going to see a big rise in the number of 50-, 60-, 70-year-olds in the coming decades in the poorer countries, and with that comes more prostate cancer. High-income countries such as the UK and USA will also see smaller increases for the same reason.”
According to the report, to be presented April 6 at the 2024 European Association of Urology Congress in Paris, “The case for prostate cancer screening for all men aged 50-70 years (and all men of African origin aged 45–70 years) in high-income countries is strengthening with improved use of technologies such as MRI and growing evidence for the safety of active surveillance.”
Andrew Vickers, PhD, a biostatistician at Memorial Sloan Kettering Cancer Center in New York City, said that the Lancet Commission came to similar conclusions as he and an international group of researchers did in a 2023 policy paper in The BMJ. A major gap, Dr. Vickers said, is misuse of prostate-specific antigen (PSA) screening.
“We found that the ubiquitous policy compromise of letting patients decide for themselves about PSA has led to the worst possible outcomes of overuse in men unlikely to benefit, high rates of overdiagnosis and overtreatment, and economic and racial inequity,” Dr. Vickers said. “Our view is that PSA screening should be done well — by implementing straightforward harm-reduction strategies like restricting screening in older men and use of secondary tests before biopsy — or not at all.”
Dr. James said that undertreatment of advanced disease is widespread; only about 30%-40% of men in the United States receive combination hormone therapy for metastatic disease, for example. “Simply doing what we know works would improve outcomes,” he said.
Dr. James said that men of African ancestry are twice as likely to develop prostate cancer, but whether treatment should follow a different approach in these men is unclear. The new report stressed the need to include more men of African ancestry in research.
Brandon Mahal, MD, vice chair of research in radiation oncology the University of Miami Sylvester Comprehensive Cancer Center and a coauthor of the report, said that new approaches are needed to enable earlier diagnosis of prostate cancer in men in low- to middle-income countries, where most patients present with metastatic disease and are less likely to survive for long periods.
Dr. James recommended pop-up clinics and mobile testing to encourage men who are at high risk for prostate cancer but feel well to detect lethal cancers early.
In England, for example, Dr. James helped introduce an outreach program called The Man Van which provided free health checks, including PSA tests, to high-risk men in London.
“By bringing a van with quick and easy testing straight to men at work and in the community, and targeting those who have a higher risk of prostate cancer, we provided thousands of health checks which resulted in almost 100 cancer diagnoses in men who might otherwise have only seen a doctor once their cancer has progressed to a more advanced stage,” he said.
He noted that the medical community worldwide is ill-prepared for the onslaught of prostate cancer cases.
“The solution cannot be training more urologists, radiation oncologists, pathologists, and radiologists because it simply takes too long,” Dr. James said. However, increased use of nurses and artificial intelligence may help. “In my own hospital, biopsies are a nurse-led and -delivered service. AI is extraordinarily good at diagnosis already and will only get better,” he said.
In poorer countries, smartphones could fill gaps too. “The same technology that does face recognition already can say that’s a Gleason 7 prostate cancer,” Dr. James said. “It’s not being rolled out in countries like America of course because pathologists’ income is at risk.”
Dr. James, Dr. Vickers, and Dr. Mahal reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
An “inevitable” global surge in prostate cancer is coming, with a worldwide doubling of cases to 2.9 million and an 85% increase in deaths to nearly 700,000 by the year 2040, the Lancet Commission on Prostate Cancer warned this week.
At a meeting of urologists in Paris, the commission said that the acceleration is already underway in high-income countries such as the United States and the United Kingdom but will gain momentum in low- and medium-income countries.
Nick James, MD, lead author of The Lancet report and professor of prostate and bladder cancer research at The Institute of Cancer Research in London, said that the surge, in part, is a medical success story.
Dr. James told this news organization.
“There is a big rise in the high-income countries. But we’re going to see a big rise in the number of 50-, 60-, 70-year-olds in the coming decades in the poorer countries, and with that comes more prostate cancer. High-income countries such as the UK and USA will also see smaller increases for the same reason.”
According to the report, to be presented April 6 at the 2024 European Association of Urology Congress in Paris, “The case for prostate cancer screening for all men aged 50-70 years (and all men of African origin aged 45–70 years) in high-income countries is strengthening with improved use of technologies such as MRI and growing evidence for the safety of active surveillance.”
Andrew Vickers, PhD, a biostatistician at Memorial Sloan Kettering Cancer Center in New York City, said that the Lancet Commission came to similar conclusions as he and an international group of researchers did in a 2023 policy paper in The BMJ. A major gap, Dr. Vickers said, is misuse of prostate-specific antigen (PSA) screening.
“We found that the ubiquitous policy compromise of letting patients decide for themselves about PSA has led to the worst possible outcomes of overuse in men unlikely to benefit, high rates of overdiagnosis and overtreatment, and economic and racial inequity,” Dr. Vickers said. “Our view is that PSA screening should be done well — by implementing straightforward harm-reduction strategies like restricting screening in older men and use of secondary tests before biopsy — or not at all.”
Dr. James said that undertreatment of advanced disease is widespread; only about 30%-40% of men in the United States receive combination hormone therapy for metastatic disease, for example. “Simply doing what we know works would improve outcomes,” he said.
Dr. James said that men of African ancestry are twice as likely to develop prostate cancer, but whether treatment should follow a different approach in these men is unclear. The new report stressed the need to include more men of African ancestry in research.
Brandon Mahal, MD, vice chair of research in radiation oncology the University of Miami Sylvester Comprehensive Cancer Center and a coauthor of the report, said that new approaches are needed to enable earlier diagnosis of prostate cancer in men in low- to middle-income countries, where most patients present with metastatic disease and are less likely to survive for long periods.
Dr. James recommended pop-up clinics and mobile testing to encourage men who are at high risk for prostate cancer but feel well to detect lethal cancers early.
In England, for example, Dr. James helped introduce an outreach program called The Man Van which provided free health checks, including PSA tests, to high-risk men in London.
“By bringing a van with quick and easy testing straight to men at work and in the community, and targeting those who have a higher risk of prostate cancer, we provided thousands of health checks which resulted in almost 100 cancer diagnoses in men who might otherwise have only seen a doctor once their cancer has progressed to a more advanced stage,” he said.
He noted that the medical community worldwide is ill-prepared for the onslaught of prostate cancer cases.
“The solution cannot be training more urologists, radiation oncologists, pathologists, and radiologists because it simply takes too long,” Dr. James said. However, increased use of nurses and artificial intelligence may help. “In my own hospital, biopsies are a nurse-led and -delivered service. AI is extraordinarily good at diagnosis already and will only get better,” he said.
In poorer countries, smartphones could fill gaps too. “The same technology that does face recognition already can say that’s a Gleason 7 prostate cancer,” Dr. James said. “It’s not being rolled out in countries like America of course because pathologists’ income is at risk.”
Dr. James, Dr. Vickers, and Dr. Mahal reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
An “inevitable” global surge in prostate cancer is coming, with a worldwide doubling of cases to 2.9 million and an 85% increase in deaths to nearly 700,000 by the year 2040, the Lancet Commission on Prostate Cancer warned this week.
At a meeting of urologists in Paris, the commission said that the acceleration is already underway in high-income countries such as the United States and the United Kingdom but will gain momentum in low- and medium-income countries.
Nick James, MD, lead author of The Lancet report and professor of prostate and bladder cancer research at The Institute of Cancer Research in London, said that the surge, in part, is a medical success story.
Dr. James told this news organization.
“There is a big rise in the high-income countries. But we’re going to see a big rise in the number of 50-, 60-, 70-year-olds in the coming decades in the poorer countries, and with that comes more prostate cancer. High-income countries such as the UK and USA will also see smaller increases for the same reason.”
According to the report, to be presented April 6 at the 2024 European Association of Urology Congress in Paris, “The case for prostate cancer screening for all men aged 50-70 years (and all men of African origin aged 45–70 years) in high-income countries is strengthening with improved use of technologies such as MRI and growing evidence for the safety of active surveillance.”
Andrew Vickers, PhD, a biostatistician at Memorial Sloan Kettering Cancer Center in New York City, said that the Lancet Commission came to similar conclusions as he and an international group of researchers did in a 2023 policy paper in The BMJ. A major gap, Dr. Vickers said, is misuse of prostate-specific antigen (PSA) screening.
“We found that the ubiquitous policy compromise of letting patients decide for themselves about PSA has led to the worst possible outcomes of overuse in men unlikely to benefit, high rates of overdiagnosis and overtreatment, and economic and racial inequity,” Dr. Vickers said. “Our view is that PSA screening should be done well — by implementing straightforward harm-reduction strategies like restricting screening in older men and use of secondary tests before biopsy — or not at all.”
Dr. James said that undertreatment of advanced disease is widespread; only about 30%-40% of men in the United States receive combination hormone therapy for metastatic disease, for example. “Simply doing what we know works would improve outcomes,” he said.
Dr. James said that men of African ancestry are twice as likely to develop prostate cancer, but whether treatment should follow a different approach in these men is unclear. The new report stressed the need to include more men of African ancestry in research.
Brandon Mahal, MD, vice chair of research in radiation oncology the University of Miami Sylvester Comprehensive Cancer Center and a coauthor of the report, said that new approaches are needed to enable earlier diagnosis of prostate cancer in men in low- to middle-income countries, where most patients present with metastatic disease and are less likely to survive for long periods.
Dr. James recommended pop-up clinics and mobile testing to encourage men who are at high risk for prostate cancer but feel well to detect lethal cancers early.
In England, for example, Dr. James helped introduce an outreach program called The Man Van which provided free health checks, including PSA tests, to high-risk men in London.
“By bringing a van with quick and easy testing straight to men at work and in the community, and targeting those who have a higher risk of prostate cancer, we provided thousands of health checks which resulted in almost 100 cancer diagnoses in men who might otherwise have only seen a doctor once their cancer has progressed to a more advanced stage,” he said.
He noted that the medical community worldwide is ill-prepared for the onslaught of prostate cancer cases.
“The solution cannot be training more urologists, radiation oncologists, pathologists, and radiologists because it simply takes too long,” Dr. James said. However, increased use of nurses and artificial intelligence may help. “In my own hospital, biopsies are a nurse-led and -delivered service. AI is extraordinarily good at diagnosis already and will only get better,” he said.
In poorer countries, smartphones could fill gaps too. “The same technology that does face recognition already can say that’s a Gleason 7 prostate cancer,” Dr. James said. “It’s not being rolled out in countries like America of course because pathologists’ income is at risk.”
Dr. James, Dr. Vickers, and Dr. Mahal reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
For Some MDs, Long COVID Burnout Is a New Reality
Dhaval Desai, MD, was teaching his 4-year-old to ride a bike after another exhausting shift at the hospital during the summer after the first COVID-19 surge. He was putting on a happy face and forcing out a “Yay!” he did not feel. The pandemic had taken its toll, and he just wanted to lie down and be alone. Realizing that he was “scraping to find joy” was when he knew something was wrong.
“I was giving, giving, giving at work a lot, and I had little left to give at home,” said Dr. Desai, director of hospital medicine at Emory Saint Joseph’s Hospital and an assistant professor of medicine at Emory University in Atlanta, Georgia.
At work, he worried about his wife managing two kids — including a newborn — during the pandemic. At home, he stressed about work and the crush of patients with COVID the hospital was grappling to handle. He was exhausted, resentful, and angry, and it was jeopardizing what mattered most to him: His home life.
“It was all colliding…I realized, OK, I’m struggling,” he said.
Dr. Desai is one of thousands of physicians across the United States who have experienced burnout and depression, exacerbated by the pandemic. After 4 years, the impact is still being felt. Medscape’s 2024 annual report on this issue found that burnout and depression among doctors — while encouragingly better than the prior year — remain higher than before COVID. For doctors caring for patients with long COVID, those suffering from the debilitating aftereffects of an infection, the sense of helplessness when recovery is elusive can also weigh heavily.
Overall, more female physicians reported feeling burned out and depressed. Experts attributed this gap to issues including fewer women in supportive leadership and mentoring roles, compensation disparities, fewer career advancement opportunities, and more responsibilities caring for children and elders.
Multiple international studies and reports have highlighted the surge in burnout experienced by physicians and healthcare workers globally during the pandemic. Even before COVID, studies found the suicide rate among male and female US physicians was higher than the general population and higher than any other profession, including the military. The risk among female physicians, in particular, was 250%-400% higher.
“That’s really, on average, one a day, and that’s really unacceptable. No one should die by suicide, but a physician who knows the risks and knows that, should never do that,” said Dr. Desai about suicides overall among doctors.
The story of Lorna Breen had rattled Dr. Desai. Dr. Breen was a Manhattan physician who died by suicide in April 2020 after grappling with the city’s devastating first wave and then contracting COVID-19 herself. While Dr. Desai did not have thoughts of suicide, he was facing his own battles. Those experiences and the stigma around mental health prompted him to write his book, Burning Out on the Covid Front Lines: A Doctor’s Memoir of Fatherhood, Race and Perseverance in the Pandemic, with the hope that it can help others like him.
Mental Health Stigma
But despite the body of research and growing awareness toward addressing mental health among physicians, almost four in 10 doctors are wary of revealing their personal struggles.
More than half of those surveyed in the Medscape Medical News report said they had not consulted a mental health professional before and would not do so going forward either. The fear of tarnishing their reputation or even losing their license keeps doctors silent. Advocates and groups like the Dr. Lorna Breen Heroes’ Foundation are pushing for hospitals and healthcare systems to remove and rephrase invasive and stigmatizing language around mental health in licensure, credentialing, or insurance applications.
Burnout Triggers: Systemic Problems, Social Tensions
Burnout can make a person feel “depleted and used up” and is characterized by extreme tiredness, low energy, frustration about work, emotional distance or numbness, and difficulty with concentration, responsibilities, or creativity. It can make an individual feel helpless, alone, defeated, cynical, and without purpose and can also cause physical symptoms such as headaches, loss of appetite, insomnia, and body aches. Unaddressed, it can lead to depression, anxiety, and a variety of physical health issues.
“We can still be highly functional and not okay,” said Dr. Desai.
For doctors, burnout often builds over time from large and small systemic problems and inefficiencies, multiplied by a dozen or more patients each day: Not enough time for documentation, complicated paperwork, navigating byzantine health and insurance systems, and hitting roadblocks. The administrative work, combined with an enormous patient load, and staffing and resource shortages create barriers to care and cuts into the amount of time they can spend providing actual care.
These existing problems worsened as patients with COVID overwhelmed hospitals and clinics. At the same time, healthcare workers worried about caring for the sick, getting infected themselves, or having multiple staff falling ill at once. As each surge came and went, backlash, hostility, abuse, and even violence toward healthcare workers also increased. The discrimination some medical staff were subjected to compounded the burnout.
“When we’re not getting the support we need as physicians and healthcare workers, that adds to burnout, and I saw that in my colleagues,” said Dr. Desai.
Impact of Burnout
At the Mount Sinai Center for Post-COVID Care in New York City, doctors grapple with feelings of helplessness in caring for patients with long COVID who show little sign of recovery. That emotional toll can also be difficult, said director Zijian Chen, MD, who helped launch the clinic in May 2020.
“Sometimes you’re faced with patients who you’re trying to do everything for, but they’re not just not getting better,” said Dr. Chen. “It’s really frustrating because we want everybody to get better. So, there’s that lack of fulfillment there that can cause a sense of burnout.”
While the worst outcomes and death rates initially brought on by acute infections have lessened, long COVID clinics exemplify some of the ongoing challenges within healthcare. Many operate with insufficient financial and staffing resources despite wait-lists and a steady flow of new and returning patients. Even with the demand, a number of these clinics have shuttered, leaving patients without access to much-needed medical help.
“There are clinicians who are burning out. That is definitely something that I’ve seen,” said Monica Verduzco-Gutierrez, MD, a professor and chair of the Department of Rehabilitation Medicine at the University of Texas Health Science Center in San Antonio, Texas.
“[It] takes a lot of resources for a successful long COVID clinic. A lot of special funding may be drying up and couple that with clinicians burning out, then they’re going to shut their doors.”
And it’s not just long COVID clinics. Data have shown an overall exodus in healthcare, especially during the pandemic. One study found burnout was one of the “most impactful” predictors of a physician’s intention to leave the profession during the pandemic. The loss of talent and skills during a major health crisis can put the entire system under stress, with patients ultimately suffering from poorer care.
“Healthcare system fragility and the chaos is far worse than it was before. We are continuing to be forced to do more with less,” said Dr. Desai.
Alleviating Burnout
While it is difficult to assess whether burnout from the pandemic is transient, experts say this is an opportunity for health institutions to learn from these experiences and implement policies and actions that can help reduce the mental health strain on staff. One study found that changes made by organizations had a bigger positive impact on reducing burnout than individual changes.
Advocates say more support staff, more work flexibility, and higher compensation would significantly ease the burden that drives burnout and depression.
In addition, half the physicians surveyed in the Medscape Medical News report felt their employers were not acknowledging how pervasive burnout is at their workplace. Having a trusted peer or leader set an example by sharing his or her own challenging experiences and saying it›s time to address these struggles can be an enormously validating step forward, said Dr. Desai. Acknowledging his own difficulties was not only a huge weight off his shoulders but also helped surpris colleagues who sought him out for counsel.
“I’m not suggesting everybody get on medication,” he said. “But talking to a therapist, acknowledging there’s issues, restructuring your life to realize something’s off, and just knowing that you’re not alone? That’s huge.”
Dr. Desai said he still faces personal challenges but is in a much better place, doing well at work and at home. He talks to a therapist, is taking medication, and has developed better coping mechanisms. He is spending more time with his family, detaching for a few hours from work-related emails, learning to draw boundaries and say no, and trying to be more present and “intentional” in connecting with colleagues and patients.
“It’s okay to not be okay,” said Dr. Desai. “It’s okay to be vulnerable and acknowledge when we can’t do more.”
Are you in a crisis? Call or text 988 or text TALK to 741741. For immediate support for healthcare professionals, as well as resources for institutions and organizations, visit: afsp.org/suicide-prevention-for-healthcare-professionals/#facts-about-mental-health-and-suicide.
A version of this article appeared on Medscape.com.
Dhaval Desai, MD, was teaching his 4-year-old to ride a bike after another exhausting shift at the hospital during the summer after the first COVID-19 surge. He was putting on a happy face and forcing out a “Yay!” he did not feel. The pandemic had taken its toll, and he just wanted to lie down and be alone. Realizing that he was “scraping to find joy” was when he knew something was wrong.
“I was giving, giving, giving at work a lot, and I had little left to give at home,” said Dr. Desai, director of hospital medicine at Emory Saint Joseph’s Hospital and an assistant professor of medicine at Emory University in Atlanta, Georgia.
At work, he worried about his wife managing two kids — including a newborn — during the pandemic. At home, he stressed about work and the crush of patients with COVID the hospital was grappling to handle. He was exhausted, resentful, and angry, and it was jeopardizing what mattered most to him: His home life.
“It was all colliding…I realized, OK, I’m struggling,” he said.
Dr. Desai is one of thousands of physicians across the United States who have experienced burnout and depression, exacerbated by the pandemic. After 4 years, the impact is still being felt. Medscape’s 2024 annual report on this issue found that burnout and depression among doctors — while encouragingly better than the prior year — remain higher than before COVID. For doctors caring for patients with long COVID, those suffering from the debilitating aftereffects of an infection, the sense of helplessness when recovery is elusive can also weigh heavily.
Overall, more female physicians reported feeling burned out and depressed. Experts attributed this gap to issues including fewer women in supportive leadership and mentoring roles, compensation disparities, fewer career advancement opportunities, and more responsibilities caring for children and elders.
Multiple international studies and reports have highlighted the surge in burnout experienced by physicians and healthcare workers globally during the pandemic. Even before COVID, studies found the suicide rate among male and female US physicians was higher than the general population and higher than any other profession, including the military. The risk among female physicians, in particular, was 250%-400% higher.
“That’s really, on average, one a day, and that’s really unacceptable. No one should die by suicide, but a physician who knows the risks and knows that, should never do that,” said Dr. Desai about suicides overall among doctors.
The story of Lorna Breen had rattled Dr. Desai. Dr. Breen was a Manhattan physician who died by suicide in April 2020 after grappling with the city’s devastating first wave and then contracting COVID-19 herself. While Dr. Desai did not have thoughts of suicide, he was facing his own battles. Those experiences and the stigma around mental health prompted him to write his book, Burning Out on the Covid Front Lines: A Doctor’s Memoir of Fatherhood, Race and Perseverance in the Pandemic, with the hope that it can help others like him.
Mental Health Stigma
But despite the body of research and growing awareness toward addressing mental health among physicians, almost four in 10 doctors are wary of revealing their personal struggles.
More than half of those surveyed in the Medscape Medical News report said they had not consulted a mental health professional before and would not do so going forward either. The fear of tarnishing their reputation or even losing their license keeps doctors silent. Advocates and groups like the Dr. Lorna Breen Heroes’ Foundation are pushing for hospitals and healthcare systems to remove and rephrase invasive and stigmatizing language around mental health in licensure, credentialing, or insurance applications.
Burnout Triggers: Systemic Problems, Social Tensions
Burnout can make a person feel “depleted and used up” and is characterized by extreme tiredness, low energy, frustration about work, emotional distance or numbness, and difficulty with concentration, responsibilities, or creativity. It can make an individual feel helpless, alone, defeated, cynical, and without purpose and can also cause physical symptoms such as headaches, loss of appetite, insomnia, and body aches. Unaddressed, it can lead to depression, anxiety, and a variety of physical health issues.
“We can still be highly functional and not okay,” said Dr. Desai.
For doctors, burnout often builds over time from large and small systemic problems and inefficiencies, multiplied by a dozen or more patients each day: Not enough time for documentation, complicated paperwork, navigating byzantine health and insurance systems, and hitting roadblocks. The administrative work, combined with an enormous patient load, and staffing and resource shortages create barriers to care and cuts into the amount of time they can spend providing actual care.
These existing problems worsened as patients with COVID overwhelmed hospitals and clinics. At the same time, healthcare workers worried about caring for the sick, getting infected themselves, or having multiple staff falling ill at once. As each surge came and went, backlash, hostility, abuse, and even violence toward healthcare workers also increased. The discrimination some medical staff were subjected to compounded the burnout.
“When we’re not getting the support we need as physicians and healthcare workers, that adds to burnout, and I saw that in my colleagues,” said Dr. Desai.
Impact of Burnout
At the Mount Sinai Center for Post-COVID Care in New York City, doctors grapple with feelings of helplessness in caring for patients with long COVID who show little sign of recovery. That emotional toll can also be difficult, said director Zijian Chen, MD, who helped launch the clinic in May 2020.
“Sometimes you’re faced with patients who you’re trying to do everything for, but they’re not just not getting better,” said Dr. Chen. “It’s really frustrating because we want everybody to get better. So, there’s that lack of fulfillment there that can cause a sense of burnout.”
While the worst outcomes and death rates initially brought on by acute infections have lessened, long COVID clinics exemplify some of the ongoing challenges within healthcare. Many operate with insufficient financial and staffing resources despite wait-lists and a steady flow of new and returning patients. Even with the demand, a number of these clinics have shuttered, leaving patients without access to much-needed medical help.
“There are clinicians who are burning out. That is definitely something that I’ve seen,” said Monica Verduzco-Gutierrez, MD, a professor and chair of the Department of Rehabilitation Medicine at the University of Texas Health Science Center in San Antonio, Texas.
“[It] takes a lot of resources for a successful long COVID clinic. A lot of special funding may be drying up and couple that with clinicians burning out, then they’re going to shut their doors.”
And it’s not just long COVID clinics. Data have shown an overall exodus in healthcare, especially during the pandemic. One study found burnout was one of the “most impactful” predictors of a physician’s intention to leave the profession during the pandemic. The loss of talent and skills during a major health crisis can put the entire system under stress, with patients ultimately suffering from poorer care.
“Healthcare system fragility and the chaos is far worse than it was before. We are continuing to be forced to do more with less,” said Dr. Desai.
Alleviating Burnout
While it is difficult to assess whether burnout from the pandemic is transient, experts say this is an opportunity for health institutions to learn from these experiences and implement policies and actions that can help reduce the mental health strain on staff. One study found that changes made by organizations had a bigger positive impact on reducing burnout than individual changes.
Advocates say more support staff, more work flexibility, and higher compensation would significantly ease the burden that drives burnout and depression.
In addition, half the physicians surveyed in the Medscape Medical News report felt their employers were not acknowledging how pervasive burnout is at their workplace. Having a trusted peer or leader set an example by sharing his or her own challenging experiences and saying it›s time to address these struggles can be an enormously validating step forward, said Dr. Desai. Acknowledging his own difficulties was not only a huge weight off his shoulders but also helped surpris colleagues who sought him out for counsel.
“I’m not suggesting everybody get on medication,” he said. “But talking to a therapist, acknowledging there’s issues, restructuring your life to realize something’s off, and just knowing that you’re not alone? That’s huge.”
Dr. Desai said he still faces personal challenges but is in a much better place, doing well at work and at home. He talks to a therapist, is taking medication, and has developed better coping mechanisms. He is spending more time with his family, detaching for a few hours from work-related emails, learning to draw boundaries and say no, and trying to be more present and “intentional” in connecting with colleagues and patients.
“It’s okay to not be okay,” said Dr. Desai. “It’s okay to be vulnerable and acknowledge when we can’t do more.”
Are you in a crisis? Call or text 988 or text TALK to 741741. For immediate support for healthcare professionals, as well as resources for institutions and organizations, visit: afsp.org/suicide-prevention-for-healthcare-professionals/#facts-about-mental-health-and-suicide.
A version of this article appeared on Medscape.com.
Dhaval Desai, MD, was teaching his 4-year-old to ride a bike after another exhausting shift at the hospital during the summer after the first COVID-19 surge. He was putting on a happy face and forcing out a “Yay!” he did not feel. The pandemic had taken its toll, and he just wanted to lie down and be alone. Realizing that he was “scraping to find joy” was when he knew something was wrong.
“I was giving, giving, giving at work a lot, and I had little left to give at home,” said Dr. Desai, director of hospital medicine at Emory Saint Joseph’s Hospital and an assistant professor of medicine at Emory University in Atlanta, Georgia.
At work, he worried about his wife managing two kids — including a newborn — during the pandemic. At home, he stressed about work and the crush of patients with COVID the hospital was grappling to handle. He was exhausted, resentful, and angry, and it was jeopardizing what mattered most to him: His home life.
“It was all colliding…I realized, OK, I’m struggling,” he said.
Dr. Desai is one of thousands of physicians across the United States who have experienced burnout and depression, exacerbated by the pandemic. After 4 years, the impact is still being felt. Medscape’s 2024 annual report on this issue found that burnout and depression among doctors — while encouragingly better than the prior year — remain higher than before COVID. For doctors caring for patients with long COVID, those suffering from the debilitating aftereffects of an infection, the sense of helplessness when recovery is elusive can also weigh heavily.
Overall, more female physicians reported feeling burned out and depressed. Experts attributed this gap to issues including fewer women in supportive leadership and mentoring roles, compensation disparities, fewer career advancement opportunities, and more responsibilities caring for children and elders.
Multiple international studies and reports have highlighted the surge in burnout experienced by physicians and healthcare workers globally during the pandemic. Even before COVID, studies found the suicide rate among male and female US physicians was higher than the general population and higher than any other profession, including the military. The risk among female physicians, in particular, was 250%-400% higher.
“That’s really, on average, one a day, and that’s really unacceptable. No one should die by suicide, but a physician who knows the risks and knows that, should never do that,” said Dr. Desai about suicides overall among doctors.
The story of Lorna Breen had rattled Dr. Desai. Dr. Breen was a Manhattan physician who died by suicide in April 2020 after grappling with the city’s devastating first wave and then contracting COVID-19 herself. While Dr. Desai did not have thoughts of suicide, he was facing his own battles. Those experiences and the stigma around mental health prompted him to write his book, Burning Out on the Covid Front Lines: A Doctor’s Memoir of Fatherhood, Race and Perseverance in the Pandemic, with the hope that it can help others like him.
Mental Health Stigma
But despite the body of research and growing awareness toward addressing mental health among physicians, almost four in 10 doctors are wary of revealing their personal struggles.
More than half of those surveyed in the Medscape Medical News report said they had not consulted a mental health professional before and would not do so going forward either. The fear of tarnishing their reputation or even losing their license keeps doctors silent. Advocates and groups like the Dr. Lorna Breen Heroes’ Foundation are pushing for hospitals and healthcare systems to remove and rephrase invasive and stigmatizing language around mental health in licensure, credentialing, or insurance applications.
Burnout Triggers: Systemic Problems, Social Tensions
Burnout can make a person feel “depleted and used up” and is characterized by extreme tiredness, low energy, frustration about work, emotional distance or numbness, and difficulty with concentration, responsibilities, or creativity. It can make an individual feel helpless, alone, defeated, cynical, and without purpose and can also cause physical symptoms such as headaches, loss of appetite, insomnia, and body aches. Unaddressed, it can lead to depression, anxiety, and a variety of physical health issues.
“We can still be highly functional and not okay,” said Dr. Desai.
For doctors, burnout often builds over time from large and small systemic problems and inefficiencies, multiplied by a dozen or more patients each day: Not enough time for documentation, complicated paperwork, navigating byzantine health and insurance systems, and hitting roadblocks. The administrative work, combined with an enormous patient load, and staffing and resource shortages create barriers to care and cuts into the amount of time they can spend providing actual care.
These existing problems worsened as patients with COVID overwhelmed hospitals and clinics. At the same time, healthcare workers worried about caring for the sick, getting infected themselves, or having multiple staff falling ill at once. As each surge came and went, backlash, hostility, abuse, and even violence toward healthcare workers also increased. The discrimination some medical staff were subjected to compounded the burnout.
“When we’re not getting the support we need as physicians and healthcare workers, that adds to burnout, and I saw that in my colleagues,” said Dr. Desai.
Impact of Burnout
At the Mount Sinai Center for Post-COVID Care in New York City, doctors grapple with feelings of helplessness in caring for patients with long COVID who show little sign of recovery. That emotional toll can also be difficult, said director Zijian Chen, MD, who helped launch the clinic in May 2020.
“Sometimes you’re faced with patients who you’re trying to do everything for, but they’re not just not getting better,” said Dr. Chen. “It’s really frustrating because we want everybody to get better. So, there’s that lack of fulfillment there that can cause a sense of burnout.”
While the worst outcomes and death rates initially brought on by acute infections have lessened, long COVID clinics exemplify some of the ongoing challenges within healthcare. Many operate with insufficient financial and staffing resources despite wait-lists and a steady flow of new and returning patients. Even with the demand, a number of these clinics have shuttered, leaving patients without access to much-needed medical help.
“There are clinicians who are burning out. That is definitely something that I’ve seen,” said Monica Verduzco-Gutierrez, MD, a professor and chair of the Department of Rehabilitation Medicine at the University of Texas Health Science Center in San Antonio, Texas.
“[It] takes a lot of resources for a successful long COVID clinic. A lot of special funding may be drying up and couple that with clinicians burning out, then they’re going to shut their doors.”
And it’s not just long COVID clinics. Data have shown an overall exodus in healthcare, especially during the pandemic. One study found burnout was one of the “most impactful” predictors of a physician’s intention to leave the profession during the pandemic. The loss of talent and skills during a major health crisis can put the entire system under stress, with patients ultimately suffering from poorer care.
“Healthcare system fragility and the chaos is far worse than it was before. We are continuing to be forced to do more with less,” said Dr. Desai.
Alleviating Burnout
While it is difficult to assess whether burnout from the pandemic is transient, experts say this is an opportunity for health institutions to learn from these experiences and implement policies and actions that can help reduce the mental health strain on staff. One study found that changes made by organizations had a bigger positive impact on reducing burnout than individual changes.
Advocates say more support staff, more work flexibility, and higher compensation would significantly ease the burden that drives burnout and depression.
In addition, half the physicians surveyed in the Medscape Medical News report felt their employers were not acknowledging how pervasive burnout is at their workplace. Having a trusted peer or leader set an example by sharing his or her own challenging experiences and saying it›s time to address these struggles can be an enormously validating step forward, said Dr. Desai. Acknowledging his own difficulties was not only a huge weight off his shoulders but also helped surpris colleagues who sought him out for counsel.
“I’m not suggesting everybody get on medication,” he said. “But talking to a therapist, acknowledging there’s issues, restructuring your life to realize something’s off, and just knowing that you’re not alone? That’s huge.”
Dr. Desai said he still faces personal challenges but is in a much better place, doing well at work and at home. He talks to a therapist, is taking medication, and has developed better coping mechanisms. He is spending more time with his family, detaching for a few hours from work-related emails, learning to draw boundaries and say no, and trying to be more present and “intentional” in connecting with colleagues and patients.
“It’s okay to not be okay,” said Dr. Desai. “It’s okay to be vulnerable and acknowledge when we can’t do more.”
Are you in a crisis? Call or text 988 or text TALK to 741741. For immediate support for healthcare professionals, as well as resources for institutions and organizations, visit: afsp.org/suicide-prevention-for-healthcare-professionals/#facts-about-mental-health-and-suicide.
A version of this article appeared on Medscape.com.
Should Opioids Be Used for Chronic Cancer Pain?
from legal concerns to threats of violence, say the authors of new research.
These findings suggest that evidence-based, systematic guidance is needed to steer opioid usage in cancer survivorship, wrote lead author Hailey W. Bulls, PhD, of the University of Pittsburgh, and colleagues.
“Prescription opioids are considered the standard of care to treat moderate to severe cancer pain during active treatment, yet guidance in the posttreatment survivorship phase is much less clear,” the investigators wrote. “Existing clinical resources recognize that opioid prescribing in survivorship is complex and nuanced and that the relative benefits and risks in this population are not fully understood.”
Who Should Manage Chronic Cancer Pain?
Despite the knowledge gap, survivors are typically excluded from long-term opioid use studies, leaving providers in a largely data-free zone. Simultaneously, patients who had been receiving focused care during their cancer treatment find themselves with an ill-defined health care team.
“Without a clear transition of care, survivors may seek pain management services from a variety of specialties, including oncologists, palliative care clinicians, primary care clinicians, and pain management specialists,” the investigators wrote. “However, many clinicians may view pain management to be outside of their skill set and may not be well equipped to handle opioid continuation or deprescribing [or] to manage the potential consequences of long‐term opioid use like side effects, misuse, and/or opioid use disorder.”
What Factors Guide Opioid Prescribing Practices for Chronic Cancer Pain?
To learn more about prescribing practices in this setting, Dr. Bulls and colleagues conducted qualitative interviews with 20 providers representing four specialties: oncology (n = 5), palliative care (n = 8), primary care (n = 5), and pain management (n = 2). Eighteen of these participants were physicians and two were advanced practice providers. Average time in clinical practice was about 16 years.
These interviews yielded three themes.
First, no “medical home” exists for chronic pain management in cancer survivors.
“Although clinicians generally agreed that minimizing the role of opioids in chronic pain management in cancer survivors was desirable, they described a lack of common treatment protocols to guide pain management in survivorship,” the investigators wrote.
Second, the interviews revealed that prescribing strategies are partly driven by peer pressure, sometimes leading to tension between providers and feelings of self-doubt.
“I feel like there’s been this weird judgment thing that’s happened [to] the prescribers,” one primary care provider said during the interview. “Because, when I trained … pain was a vital sign, and we were supposed to treat pain, and now I feel like we’re all being judged for that.”
The third theme revolved around fear of consequences resulting from prescribing practices, including fears of violent repercussions.
“You may not know, but pain specialists have been shot in this country for [refusing to prescribe opioids],” one pain management specialist said during the interview. “There’s been a number of shootings of pain specialists who would not prescribe opioids. So, I mean, there’s real issues of violence.”
Meanwhile, a palliative care provider described legal pressure from the opposite direction:
“I think there’s a lot of fear of litigiousness … and loss of licenses. That sort of makes them pressure us into not prescribing opioids or sticking with a certain number per day that might not be therapeutic for a patient.”
Reflecting on these themes, the investigators identified “a fundamental uncertainty in survivorship pain management.”
What Strategies Might Improve Opioid Prescribing Practices for Chronic Cancer Pain?
After sharing their attitudes about prescribing opioids for chronic cancer pain, the clinicians were asked for suggestions to improve the situation.
They offered four main suggestions: create relevant guidelines, increase education and access to pain management options for clinicians, increase interdisciplinary communication across medical subspecialties, and promote multidisciplinary care in the survivorship setting.
Dr. Bulls and colleagues supported these strategies in their concluding remarks and called for more research.
This study was supported by the National Institute of Drug Abuse, the National Institutes of Health, the National Center for Advancing Translational Sciences, and the National Cancer Institute. The investigators disclosed relationships with Arcadia Health Solutions and Biomotivate.
from legal concerns to threats of violence, say the authors of new research.
These findings suggest that evidence-based, systematic guidance is needed to steer opioid usage in cancer survivorship, wrote lead author Hailey W. Bulls, PhD, of the University of Pittsburgh, and colleagues.
“Prescription opioids are considered the standard of care to treat moderate to severe cancer pain during active treatment, yet guidance in the posttreatment survivorship phase is much less clear,” the investigators wrote. “Existing clinical resources recognize that opioid prescribing in survivorship is complex and nuanced and that the relative benefits and risks in this population are not fully understood.”
Who Should Manage Chronic Cancer Pain?
Despite the knowledge gap, survivors are typically excluded from long-term opioid use studies, leaving providers in a largely data-free zone. Simultaneously, patients who had been receiving focused care during their cancer treatment find themselves with an ill-defined health care team.
“Without a clear transition of care, survivors may seek pain management services from a variety of specialties, including oncologists, palliative care clinicians, primary care clinicians, and pain management specialists,” the investigators wrote. “However, many clinicians may view pain management to be outside of their skill set and may not be well equipped to handle opioid continuation or deprescribing [or] to manage the potential consequences of long‐term opioid use like side effects, misuse, and/or opioid use disorder.”
What Factors Guide Opioid Prescribing Practices for Chronic Cancer Pain?
To learn more about prescribing practices in this setting, Dr. Bulls and colleagues conducted qualitative interviews with 20 providers representing four specialties: oncology (n = 5), palliative care (n = 8), primary care (n = 5), and pain management (n = 2). Eighteen of these participants were physicians and two were advanced practice providers. Average time in clinical practice was about 16 years.
These interviews yielded three themes.
First, no “medical home” exists for chronic pain management in cancer survivors.
“Although clinicians generally agreed that minimizing the role of opioids in chronic pain management in cancer survivors was desirable, they described a lack of common treatment protocols to guide pain management in survivorship,” the investigators wrote.
Second, the interviews revealed that prescribing strategies are partly driven by peer pressure, sometimes leading to tension between providers and feelings of self-doubt.
“I feel like there’s been this weird judgment thing that’s happened [to] the prescribers,” one primary care provider said during the interview. “Because, when I trained … pain was a vital sign, and we were supposed to treat pain, and now I feel like we’re all being judged for that.”
The third theme revolved around fear of consequences resulting from prescribing practices, including fears of violent repercussions.
“You may not know, but pain specialists have been shot in this country for [refusing to prescribe opioids],” one pain management specialist said during the interview. “There’s been a number of shootings of pain specialists who would not prescribe opioids. So, I mean, there’s real issues of violence.”
Meanwhile, a palliative care provider described legal pressure from the opposite direction:
“I think there’s a lot of fear of litigiousness … and loss of licenses. That sort of makes them pressure us into not prescribing opioids or sticking with a certain number per day that might not be therapeutic for a patient.”
Reflecting on these themes, the investigators identified “a fundamental uncertainty in survivorship pain management.”
What Strategies Might Improve Opioid Prescribing Practices for Chronic Cancer Pain?
After sharing their attitudes about prescribing opioids for chronic cancer pain, the clinicians were asked for suggestions to improve the situation.
They offered four main suggestions: create relevant guidelines, increase education and access to pain management options for clinicians, increase interdisciplinary communication across medical subspecialties, and promote multidisciplinary care in the survivorship setting.
Dr. Bulls and colleagues supported these strategies in their concluding remarks and called for more research.
This study was supported by the National Institute of Drug Abuse, the National Institutes of Health, the National Center for Advancing Translational Sciences, and the National Cancer Institute. The investigators disclosed relationships with Arcadia Health Solutions and Biomotivate.
from legal concerns to threats of violence, say the authors of new research.
These findings suggest that evidence-based, systematic guidance is needed to steer opioid usage in cancer survivorship, wrote lead author Hailey W. Bulls, PhD, of the University of Pittsburgh, and colleagues.
“Prescription opioids are considered the standard of care to treat moderate to severe cancer pain during active treatment, yet guidance in the posttreatment survivorship phase is much less clear,” the investigators wrote. “Existing clinical resources recognize that opioid prescribing in survivorship is complex and nuanced and that the relative benefits and risks in this population are not fully understood.”
Who Should Manage Chronic Cancer Pain?
Despite the knowledge gap, survivors are typically excluded from long-term opioid use studies, leaving providers in a largely data-free zone. Simultaneously, patients who had been receiving focused care during their cancer treatment find themselves with an ill-defined health care team.
“Without a clear transition of care, survivors may seek pain management services from a variety of specialties, including oncologists, palliative care clinicians, primary care clinicians, and pain management specialists,” the investigators wrote. “However, many clinicians may view pain management to be outside of their skill set and may not be well equipped to handle opioid continuation or deprescribing [or] to manage the potential consequences of long‐term opioid use like side effects, misuse, and/or opioid use disorder.”
What Factors Guide Opioid Prescribing Practices for Chronic Cancer Pain?
To learn more about prescribing practices in this setting, Dr. Bulls and colleagues conducted qualitative interviews with 20 providers representing four specialties: oncology (n = 5), palliative care (n = 8), primary care (n = 5), and pain management (n = 2). Eighteen of these participants were physicians and two were advanced practice providers. Average time in clinical practice was about 16 years.
These interviews yielded three themes.
First, no “medical home” exists for chronic pain management in cancer survivors.
“Although clinicians generally agreed that minimizing the role of opioids in chronic pain management in cancer survivors was desirable, they described a lack of common treatment protocols to guide pain management in survivorship,” the investigators wrote.
Second, the interviews revealed that prescribing strategies are partly driven by peer pressure, sometimes leading to tension between providers and feelings of self-doubt.
“I feel like there’s been this weird judgment thing that’s happened [to] the prescribers,” one primary care provider said during the interview. “Because, when I trained … pain was a vital sign, and we were supposed to treat pain, and now I feel like we’re all being judged for that.”
The third theme revolved around fear of consequences resulting from prescribing practices, including fears of violent repercussions.
“You may not know, but pain specialists have been shot in this country for [refusing to prescribe opioids],” one pain management specialist said during the interview. “There’s been a number of shootings of pain specialists who would not prescribe opioids. So, I mean, there’s real issues of violence.”
Meanwhile, a palliative care provider described legal pressure from the opposite direction:
“I think there’s a lot of fear of litigiousness … and loss of licenses. That sort of makes them pressure us into not prescribing opioids or sticking with a certain number per day that might not be therapeutic for a patient.”
Reflecting on these themes, the investigators identified “a fundamental uncertainty in survivorship pain management.”
What Strategies Might Improve Opioid Prescribing Practices for Chronic Cancer Pain?
After sharing their attitudes about prescribing opioids for chronic cancer pain, the clinicians were asked for suggestions to improve the situation.
They offered four main suggestions: create relevant guidelines, increase education and access to pain management options for clinicians, increase interdisciplinary communication across medical subspecialties, and promote multidisciplinary care in the survivorship setting.
Dr. Bulls and colleagues supported these strategies in their concluding remarks and called for more research.
This study was supported by the National Institute of Drug Abuse, the National Institutes of Health, the National Center for Advancing Translational Sciences, and the National Cancer Institute. The investigators disclosed relationships with Arcadia Health Solutions and Biomotivate.
FROM CANCER
Why Do So Many Doctors Embrace Superstitions and Rituals?
The second-floor operating rooms at Lehigh Valley Hospital in Allentown, Pennsylvania, are numbered sequentially — except when you get to what should be operation room (OR) 13. It’s OR M. The M doesn’t stand for Maternity or any other specialty. Rather in this high-tech, state-of-the art healthcare center, it’s there to ward off bad juju and evil spirits.
“Just as taller buildings usually don’t have a 13th floor or hotels don’t have a room 13, it revolves around the common superstition of the unlucky nature of number 13,” said a hospital spokesperson.
During the pandemic, the public was told repeatedly that modern medicine is science-based. But when I started talking to surgeons and other physicians for this article, I uncovered something decidedly unscientific.
In ORs and emergency rooms (ERs), small-town doctor’s offices, and mega hospitals, there’s a measure of dread before full moons and Friday the 13th, and no one dares utter the Q word (as in, “It sure is quiet today.”) That would risk bringing the wrath of the medical gods, and you’d earn the reputation of being a jinx or “black cloud.” Likewise, the songs “Stairway to Heaven” or “Another One Bites the Dust” will never be heard in any waiting room, elevator, or OR.
Indeed, when it comes to superstitions and rituals in medicine, it seems everyone has a story or a belief. …
A 2-Hour Ritual
Carmen Fong, MD, a colorectal surgeon in New York City, had a presurgical ritual that took her nearly 2 hours to complete. “I’d wake up at the same time every day, pack two hard-boiled eggs and a thermos of coffee in my small leather bag, walk to work via the same route, and swipe into the preop area while waving hi to the front desk,” she recounted. “I’d talk to the patient, sign the consent with the same ballpoint pen, go upstairs to my office, change into my scrubs [same cap and Danskos], then turn on my computer, and take a sip of coffee before heading back down to the OR. I’d always remove my badge and place it near the nurses’ workstation, then put on the patient’s SCDs [sequential compression devices] myself. I’d hold the oxygen mask while telling the patient, ‘See you later.’ Never ‘It will be okay’ or ‘Have a good sleep.’ Always ‘See you later.’ ”
Dr. Fong did this for 5 years prior to more than a thousand surgeries. She did it because it made her feel calm and in control, which translated to more successful operations. “It never failed me.”
Wonder Woman Clogs
Anureet Bajaj, MD, a plastic surgeon in Oklahoma City, wore Wonder Woman clogs in the OR for years because “they made me feel stronger, and my surgeries went better.” She’s also very specific about her OR playlist; “it must be ‘80s music.” And for a time, she wore a friendship bracelet that one of her employees made to commemorate getting through a particularly hard day. “If I forgot it, my heart sank, and my anxiety rose,” she said. “Wearing it gave me security and confidence that the day would go well.”
A Moment of Silence
Juliet Emamaullee, MD, PhD, is a liver and kidney transplant surgeon at Keck Hospital and Children’s Hospital Los Angeles. Because of the complexity of her operations, she must know every aspect of her patients’ medical history. This leads to a level of intimacy that most people never have with their doctors. “Transplant surgeons are playing god in many ways,” she said. “During procurement, after we prep and drape the donor and right before I make the incision, everyone in the OR has a moment of silence to acknowledge the donation. If the organ has been transported, then I’ll say a prayer to myself that I do good work with this generous gift of life.”
Magical Thinking
Before we go any further, I should clarify that there’s a difference between rituals and superstitions like the ones just shared and routines and practices such as handwashing or doublechecking that it’s the right hip and not the left. All pilots have a preflight checklist that’s necessary for safety, but some might also make the sign of the cross.
Lester Gottesman, MD, has been a surgeon at the Icahn School of Medicine at Mount Sinai Hospital in New York City for nearly 50 years. He believes rituals and superstitions are more prevalent in medicine than in any other profession, despite there being no definitive research confirming their effectiveness.
In fact, it’s the opposite.
One of the few studies to examine superstitions among physicians was published in the Annals of Surgery in 2021. Researchers analyzed the operational records of 27,914 consecutive patients who underwent general, visceral, or vascular surgery. They found no association of moon phases, zodiac signs, or Friday the 13th with poor outcomes. Having acute coronary syndrome on Friday the 13th also did not influence the 13-year mortality rate compared to other dates in the year. And although 70% of physicians believe that some colleagues are “black clouds,” an analysis of 96 physicians and 6149 admissions found no such pattern.
Granted, this is just one analysis, but the results aren’t surprising. No one really believes in this stuff. So, why does it persist?
Dr. Gottesman cited an episode from the popular medical TV show Grey’s Anatomy, in which chief surgeon Meredith Grey puts it this way: “Superstition lies in the space between what we can control and what we can’t. …We rely on superstitions because we are smart enough to know we don’t have all the answers and that life works in mysterious ways. Don’t diss the juju from wherever it comes.”
“Superstition and science both start at the same place — to explain an unexplainable event,” said Dr. Gottesman, who always checks his suture lines at the end of a surgery in the order in which he did them. “If science provides a coherent answer, so be it. If not, the human’s need for order will assign causality to otherwise inanimate objects, noncausal events, or divine influence.”
In other words, the more unknowns and trepidation, the greater the tendency toward what Dr. Gottesman called “magical thinking.” And when you consider healing’s long history, you realize that ritual and superstition defined medicine for centuries. Gottesman pointed out that it wasn’t until Hippocrates separated religion and superstition from disease around 430 BC that modern medicine was born. But because doctors still don’t know everything, an element of magic endures.
The question is, in this high-tech age, do these stubborn beliefs still have a place? Do they help or hinder doctors, and, most important, do they have any effect on patient outcomes?
Five Benefits
To reiterate, there are no studies showing that Wonder Woman clogs convey surgical superpowers or that eating two hard-boiled eggs boosts OR performance. But anecdotally, many doctors admit to experiencing noticeable perks from their quirks. Let’s start with the supposed benefits:
- Less stress: A quarter of US clinicians are considering switching careers, primarily due to burnout, according to a 2022 Bain survey. “The fact that [rituals and superstitions] are so prevalent in such a high-stress field can’t be coincidence,” said Dr. Fong. “Offloading some of the responsibility to whatever gods there may be is a way of taming our anxieties so we can function better.”
- Hyperfocus: Dr. Emamaullee played volleyball in high school and college. She suggested that her presurgical routine isn’t all that different from her warmup before a championship match. It’s habitual behavior that helps induce a state of heightened concentration, confidence, and immersion. Athletes call it being “in the zone” or in a “state of flow,” and Dr. Emamaullee said she experiences the same thing in the OR.
- More control: Remember those horrific images of patients with COVID-19 overwhelming ERs in Brooklyn and Queens during the pandemic? Dr. Fong was in the middle of that. “In crisis situations where there are more unknowns, rituals and superstitions become even more important,” she said. “I may not be able to control what’s happening, but I can control myself. Rituals help restore some normalcy and organization, and they give me a sense of calm.”
- Better performance: A series of general-population experiments published in the journal Psychological Science in 2010 concluded that “good-luck–related superstitions” boosted self-confidence in mastering upcoming tasks and improved motor dexterity, memory, and overall performance.
- Placebo effect: This phenomenon is well-established in medicine. Give someone a special pill or treatment, and a significant portion will claim benefit. “Placebo is magical thinking,” said Dr. Gottesman. “It has identifiable and quantifiable effects on human disease.” And perhaps on medical practitioners, too. If a doctor believes her friendship bracelet has special powers and helps her be a better physician, then it just might.
Four Drawbacks
- Compulsive behavior: When superstitious beliefs or repetitive behaviors begin causing personal distress, interfering with daily duties, or negatively affecting patient outcomes, then there’s a problem. There’s a story on Quora about a neurosurgeon who always ate two Hostess Ho Hos chocolate cakes before operations. When he forgot to do so one day, he supposedly left his patient on the table and ran off to eat them. Even if it’s urban legend, it’s a useful illustration of quirk disrupting work.
- Less flexibility: Every human body and every surgery is different. “When ritualistic behaviors or habits become so rigid that you lose the ability to adapt, then that becomes dangerous for the patient,” said Dr. Fong. “The art of medicine, not unlike jazz, often comes from the improvisation.”
- Self-fulfilling: Just as rituals and superstitions can empower and provide a sense of control, they can quickly turn on physicians who forget a part of their routine or leave their talisman on the bureau. Instead of confidence, they supply doubt. The karma becomes kryptonite.
- Avoiding responsibility: After years of friendship bracelets and Wonder Woman clogs, Dr. Bajaj is making a deliberate effort to excise magical thinking from her practice. “It can hold you back if you’re not careful,” she said. “If you start using it as a crutch when something goes wrong — like ‘Oh, I wasn’t wearing my clogs today and that’s why my flap failed’ — then you’re not doing your due diligence and figuring out what really happened.” Rather than placing the responsibility for her day going well on superstition, she’s trying to own it herself by living with more intent.
The Diagnosis
Most of the medical experts I spoke with didn’t think there was anything wrong with rituals or superstitions as long as they didn’t become compulsive or a convenient repository of blame.
“Rituals and superstitions are an acknowledgment that forces external to ourselves exist,” concluded Dr. Fong. “They’re like tiny offerings to whatever gods are out there to please be on our side. And we keep doing them because there’s a reward — better patient outcomes, which is all we want to achieve in the end. I say embrace them.”
A version of this article first appeared on Medscape.com.
The second-floor operating rooms at Lehigh Valley Hospital in Allentown, Pennsylvania, are numbered sequentially — except when you get to what should be operation room (OR) 13. It’s OR M. The M doesn’t stand for Maternity or any other specialty. Rather in this high-tech, state-of-the art healthcare center, it’s there to ward off bad juju and evil spirits.
“Just as taller buildings usually don’t have a 13th floor or hotels don’t have a room 13, it revolves around the common superstition of the unlucky nature of number 13,” said a hospital spokesperson.
During the pandemic, the public was told repeatedly that modern medicine is science-based. But when I started talking to surgeons and other physicians for this article, I uncovered something decidedly unscientific.
In ORs and emergency rooms (ERs), small-town doctor’s offices, and mega hospitals, there’s a measure of dread before full moons and Friday the 13th, and no one dares utter the Q word (as in, “It sure is quiet today.”) That would risk bringing the wrath of the medical gods, and you’d earn the reputation of being a jinx or “black cloud.” Likewise, the songs “Stairway to Heaven” or “Another One Bites the Dust” will never be heard in any waiting room, elevator, or OR.
Indeed, when it comes to superstitions and rituals in medicine, it seems everyone has a story or a belief. …
A 2-Hour Ritual
Carmen Fong, MD, a colorectal surgeon in New York City, had a presurgical ritual that took her nearly 2 hours to complete. “I’d wake up at the same time every day, pack two hard-boiled eggs and a thermos of coffee in my small leather bag, walk to work via the same route, and swipe into the preop area while waving hi to the front desk,” she recounted. “I’d talk to the patient, sign the consent with the same ballpoint pen, go upstairs to my office, change into my scrubs [same cap and Danskos], then turn on my computer, and take a sip of coffee before heading back down to the OR. I’d always remove my badge and place it near the nurses’ workstation, then put on the patient’s SCDs [sequential compression devices] myself. I’d hold the oxygen mask while telling the patient, ‘See you later.’ Never ‘It will be okay’ or ‘Have a good sleep.’ Always ‘See you later.’ ”
Dr. Fong did this for 5 years prior to more than a thousand surgeries. She did it because it made her feel calm and in control, which translated to more successful operations. “It never failed me.”
Wonder Woman Clogs
Anureet Bajaj, MD, a plastic surgeon in Oklahoma City, wore Wonder Woman clogs in the OR for years because “they made me feel stronger, and my surgeries went better.” She’s also very specific about her OR playlist; “it must be ‘80s music.” And for a time, she wore a friendship bracelet that one of her employees made to commemorate getting through a particularly hard day. “If I forgot it, my heart sank, and my anxiety rose,” she said. “Wearing it gave me security and confidence that the day would go well.”
A Moment of Silence
Juliet Emamaullee, MD, PhD, is a liver and kidney transplant surgeon at Keck Hospital and Children’s Hospital Los Angeles. Because of the complexity of her operations, she must know every aspect of her patients’ medical history. This leads to a level of intimacy that most people never have with their doctors. “Transplant surgeons are playing god in many ways,” she said. “During procurement, after we prep and drape the donor and right before I make the incision, everyone in the OR has a moment of silence to acknowledge the donation. If the organ has been transported, then I’ll say a prayer to myself that I do good work with this generous gift of life.”
Magical Thinking
Before we go any further, I should clarify that there’s a difference between rituals and superstitions like the ones just shared and routines and practices such as handwashing or doublechecking that it’s the right hip and not the left. All pilots have a preflight checklist that’s necessary for safety, but some might also make the sign of the cross.
Lester Gottesman, MD, has been a surgeon at the Icahn School of Medicine at Mount Sinai Hospital in New York City for nearly 50 years. He believes rituals and superstitions are more prevalent in medicine than in any other profession, despite there being no definitive research confirming their effectiveness.
In fact, it’s the opposite.
One of the few studies to examine superstitions among physicians was published in the Annals of Surgery in 2021. Researchers analyzed the operational records of 27,914 consecutive patients who underwent general, visceral, or vascular surgery. They found no association of moon phases, zodiac signs, or Friday the 13th with poor outcomes. Having acute coronary syndrome on Friday the 13th also did not influence the 13-year mortality rate compared to other dates in the year. And although 70% of physicians believe that some colleagues are “black clouds,” an analysis of 96 physicians and 6149 admissions found no such pattern.
Granted, this is just one analysis, but the results aren’t surprising. No one really believes in this stuff. So, why does it persist?
Dr. Gottesman cited an episode from the popular medical TV show Grey’s Anatomy, in which chief surgeon Meredith Grey puts it this way: “Superstition lies in the space between what we can control and what we can’t. …We rely on superstitions because we are smart enough to know we don’t have all the answers and that life works in mysterious ways. Don’t diss the juju from wherever it comes.”
“Superstition and science both start at the same place — to explain an unexplainable event,” said Dr. Gottesman, who always checks his suture lines at the end of a surgery in the order in which he did them. “If science provides a coherent answer, so be it. If not, the human’s need for order will assign causality to otherwise inanimate objects, noncausal events, or divine influence.”
In other words, the more unknowns and trepidation, the greater the tendency toward what Dr. Gottesman called “magical thinking.” And when you consider healing’s long history, you realize that ritual and superstition defined medicine for centuries. Gottesman pointed out that it wasn’t until Hippocrates separated religion and superstition from disease around 430 BC that modern medicine was born. But because doctors still don’t know everything, an element of magic endures.
The question is, in this high-tech age, do these stubborn beliefs still have a place? Do they help or hinder doctors, and, most important, do they have any effect on patient outcomes?
Five Benefits
To reiterate, there are no studies showing that Wonder Woman clogs convey surgical superpowers or that eating two hard-boiled eggs boosts OR performance. But anecdotally, many doctors admit to experiencing noticeable perks from their quirks. Let’s start with the supposed benefits:
- Less stress: A quarter of US clinicians are considering switching careers, primarily due to burnout, according to a 2022 Bain survey. “The fact that [rituals and superstitions] are so prevalent in such a high-stress field can’t be coincidence,” said Dr. Fong. “Offloading some of the responsibility to whatever gods there may be is a way of taming our anxieties so we can function better.”
- Hyperfocus: Dr. Emamaullee played volleyball in high school and college. She suggested that her presurgical routine isn’t all that different from her warmup before a championship match. It’s habitual behavior that helps induce a state of heightened concentration, confidence, and immersion. Athletes call it being “in the zone” or in a “state of flow,” and Dr. Emamaullee said she experiences the same thing in the OR.
- More control: Remember those horrific images of patients with COVID-19 overwhelming ERs in Brooklyn and Queens during the pandemic? Dr. Fong was in the middle of that. “In crisis situations where there are more unknowns, rituals and superstitions become even more important,” she said. “I may not be able to control what’s happening, but I can control myself. Rituals help restore some normalcy and organization, and they give me a sense of calm.”
- Better performance: A series of general-population experiments published in the journal Psychological Science in 2010 concluded that “good-luck–related superstitions” boosted self-confidence in mastering upcoming tasks and improved motor dexterity, memory, and overall performance.
- Placebo effect: This phenomenon is well-established in medicine. Give someone a special pill or treatment, and a significant portion will claim benefit. “Placebo is magical thinking,” said Dr. Gottesman. “It has identifiable and quantifiable effects on human disease.” And perhaps on medical practitioners, too. If a doctor believes her friendship bracelet has special powers and helps her be a better physician, then it just might.
Four Drawbacks
- Compulsive behavior: When superstitious beliefs or repetitive behaviors begin causing personal distress, interfering with daily duties, or negatively affecting patient outcomes, then there’s a problem. There’s a story on Quora about a neurosurgeon who always ate two Hostess Ho Hos chocolate cakes before operations. When he forgot to do so one day, he supposedly left his patient on the table and ran off to eat them. Even if it’s urban legend, it’s a useful illustration of quirk disrupting work.
- Less flexibility: Every human body and every surgery is different. “When ritualistic behaviors or habits become so rigid that you lose the ability to adapt, then that becomes dangerous for the patient,” said Dr. Fong. “The art of medicine, not unlike jazz, often comes from the improvisation.”
- Self-fulfilling: Just as rituals and superstitions can empower and provide a sense of control, they can quickly turn on physicians who forget a part of their routine or leave their talisman on the bureau. Instead of confidence, they supply doubt. The karma becomes kryptonite.
- Avoiding responsibility: After years of friendship bracelets and Wonder Woman clogs, Dr. Bajaj is making a deliberate effort to excise magical thinking from her practice. “It can hold you back if you’re not careful,” she said. “If you start using it as a crutch when something goes wrong — like ‘Oh, I wasn’t wearing my clogs today and that’s why my flap failed’ — then you’re not doing your due diligence and figuring out what really happened.” Rather than placing the responsibility for her day going well on superstition, she’s trying to own it herself by living with more intent.
The Diagnosis
Most of the medical experts I spoke with didn’t think there was anything wrong with rituals or superstitions as long as they didn’t become compulsive or a convenient repository of blame.
“Rituals and superstitions are an acknowledgment that forces external to ourselves exist,” concluded Dr. Fong. “They’re like tiny offerings to whatever gods are out there to please be on our side. And we keep doing them because there’s a reward — better patient outcomes, which is all we want to achieve in the end. I say embrace them.”
A version of this article first appeared on Medscape.com.
The second-floor operating rooms at Lehigh Valley Hospital in Allentown, Pennsylvania, are numbered sequentially — except when you get to what should be operation room (OR) 13. It’s OR M. The M doesn’t stand for Maternity or any other specialty. Rather in this high-tech, state-of-the art healthcare center, it’s there to ward off bad juju and evil spirits.
“Just as taller buildings usually don’t have a 13th floor or hotels don’t have a room 13, it revolves around the common superstition of the unlucky nature of number 13,” said a hospital spokesperson.
During the pandemic, the public was told repeatedly that modern medicine is science-based. But when I started talking to surgeons and other physicians for this article, I uncovered something decidedly unscientific.
In ORs and emergency rooms (ERs), small-town doctor’s offices, and mega hospitals, there’s a measure of dread before full moons and Friday the 13th, and no one dares utter the Q word (as in, “It sure is quiet today.”) That would risk bringing the wrath of the medical gods, and you’d earn the reputation of being a jinx or “black cloud.” Likewise, the songs “Stairway to Heaven” or “Another One Bites the Dust” will never be heard in any waiting room, elevator, or OR.
Indeed, when it comes to superstitions and rituals in medicine, it seems everyone has a story or a belief. …
A 2-Hour Ritual
Carmen Fong, MD, a colorectal surgeon in New York City, had a presurgical ritual that took her nearly 2 hours to complete. “I’d wake up at the same time every day, pack two hard-boiled eggs and a thermos of coffee in my small leather bag, walk to work via the same route, and swipe into the preop area while waving hi to the front desk,” she recounted. “I’d talk to the patient, sign the consent with the same ballpoint pen, go upstairs to my office, change into my scrubs [same cap and Danskos], then turn on my computer, and take a sip of coffee before heading back down to the OR. I’d always remove my badge and place it near the nurses’ workstation, then put on the patient’s SCDs [sequential compression devices] myself. I’d hold the oxygen mask while telling the patient, ‘See you later.’ Never ‘It will be okay’ or ‘Have a good sleep.’ Always ‘See you later.’ ”
Dr. Fong did this for 5 years prior to more than a thousand surgeries. She did it because it made her feel calm and in control, which translated to more successful operations. “It never failed me.”
Wonder Woman Clogs
Anureet Bajaj, MD, a plastic surgeon in Oklahoma City, wore Wonder Woman clogs in the OR for years because “they made me feel stronger, and my surgeries went better.” She’s also very specific about her OR playlist; “it must be ‘80s music.” And for a time, she wore a friendship bracelet that one of her employees made to commemorate getting through a particularly hard day. “If I forgot it, my heart sank, and my anxiety rose,” she said. “Wearing it gave me security and confidence that the day would go well.”
A Moment of Silence
Juliet Emamaullee, MD, PhD, is a liver and kidney transplant surgeon at Keck Hospital and Children’s Hospital Los Angeles. Because of the complexity of her operations, she must know every aspect of her patients’ medical history. This leads to a level of intimacy that most people never have with their doctors. “Transplant surgeons are playing god in many ways,” she said. “During procurement, after we prep and drape the donor and right before I make the incision, everyone in the OR has a moment of silence to acknowledge the donation. If the organ has been transported, then I’ll say a prayer to myself that I do good work with this generous gift of life.”
Magical Thinking
Before we go any further, I should clarify that there’s a difference between rituals and superstitions like the ones just shared and routines and practices such as handwashing or doublechecking that it’s the right hip and not the left. All pilots have a preflight checklist that’s necessary for safety, but some might also make the sign of the cross.
Lester Gottesman, MD, has been a surgeon at the Icahn School of Medicine at Mount Sinai Hospital in New York City for nearly 50 years. He believes rituals and superstitions are more prevalent in medicine than in any other profession, despite there being no definitive research confirming their effectiveness.
In fact, it’s the opposite.
One of the few studies to examine superstitions among physicians was published in the Annals of Surgery in 2021. Researchers analyzed the operational records of 27,914 consecutive patients who underwent general, visceral, or vascular surgery. They found no association of moon phases, zodiac signs, or Friday the 13th with poor outcomes. Having acute coronary syndrome on Friday the 13th also did not influence the 13-year mortality rate compared to other dates in the year. And although 70% of physicians believe that some colleagues are “black clouds,” an analysis of 96 physicians and 6149 admissions found no such pattern.
Granted, this is just one analysis, but the results aren’t surprising. No one really believes in this stuff. So, why does it persist?
Dr. Gottesman cited an episode from the popular medical TV show Grey’s Anatomy, in which chief surgeon Meredith Grey puts it this way: “Superstition lies in the space between what we can control and what we can’t. …We rely on superstitions because we are smart enough to know we don’t have all the answers and that life works in mysterious ways. Don’t diss the juju from wherever it comes.”
“Superstition and science both start at the same place — to explain an unexplainable event,” said Dr. Gottesman, who always checks his suture lines at the end of a surgery in the order in which he did them. “If science provides a coherent answer, so be it. If not, the human’s need for order will assign causality to otherwise inanimate objects, noncausal events, or divine influence.”
In other words, the more unknowns and trepidation, the greater the tendency toward what Dr. Gottesman called “magical thinking.” And when you consider healing’s long history, you realize that ritual and superstition defined medicine for centuries. Gottesman pointed out that it wasn’t until Hippocrates separated religion and superstition from disease around 430 BC that modern medicine was born. But because doctors still don’t know everything, an element of magic endures.
The question is, in this high-tech age, do these stubborn beliefs still have a place? Do they help or hinder doctors, and, most important, do they have any effect on patient outcomes?
Five Benefits
To reiterate, there are no studies showing that Wonder Woman clogs convey surgical superpowers or that eating two hard-boiled eggs boosts OR performance. But anecdotally, many doctors admit to experiencing noticeable perks from their quirks. Let’s start with the supposed benefits:
- Less stress: A quarter of US clinicians are considering switching careers, primarily due to burnout, according to a 2022 Bain survey. “The fact that [rituals and superstitions] are so prevalent in such a high-stress field can’t be coincidence,” said Dr. Fong. “Offloading some of the responsibility to whatever gods there may be is a way of taming our anxieties so we can function better.”
- Hyperfocus: Dr. Emamaullee played volleyball in high school and college. She suggested that her presurgical routine isn’t all that different from her warmup before a championship match. It’s habitual behavior that helps induce a state of heightened concentration, confidence, and immersion. Athletes call it being “in the zone” or in a “state of flow,” and Dr. Emamaullee said she experiences the same thing in the OR.
- More control: Remember those horrific images of patients with COVID-19 overwhelming ERs in Brooklyn and Queens during the pandemic? Dr. Fong was in the middle of that. “In crisis situations where there are more unknowns, rituals and superstitions become even more important,” she said. “I may not be able to control what’s happening, but I can control myself. Rituals help restore some normalcy and organization, and they give me a sense of calm.”
- Better performance: A series of general-population experiments published in the journal Psychological Science in 2010 concluded that “good-luck–related superstitions” boosted self-confidence in mastering upcoming tasks and improved motor dexterity, memory, and overall performance.
- Placebo effect: This phenomenon is well-established in medicine. Give someone a special pill or treatment, and a significant portion will claim benefit. “Placebo is magical thinking,” said Dr. Gottesman. “It has identifiable and quantifiable effects on human disease.” And perhaps on medical practitioners, too. If a doctor believes her friendship bracelet has special powers and helps her be a better physician, then it just might.
Four Drawbacks
- Compulsive behavior: When superstitious beliefs or repetitive behaviors begin causing personal distress, interfering with daily duties, or negatively affecting patient outcomes, then there’s a problem. There’s a story on Quora about a neurosurgeon who always ate two Hostess Ho Hos chocolate cakes before operations. When he forgot to do so one day, he supposedly left his patient on the table and ran off to eat them. Even if it’s urban legend, it’s a useful illustration of quirk disrupting work.
- Less flexibility: Every human body and every surgery is different. “When ritualistic behaviors or habits become so rigid that you lose the ability to adapt, then that becomes dangerous for the patient,” said Dr. Fong. “The art of medicine, not unlike jazz, often comes from the improvisation.”
- Self-fulfilling: Just as rituals and superstitions can empower and provide a sense of control, they can quickly turn on physicians who forget a part of their routine or leave their talisman on the bureau. Instead of confidence, they supply doubt. The karma becomes kryptonite.
- Avoiding responsibility: After years of friendship bracelets and Wonder Woman clogs, Dr. Bajaj is making a deliberate effort to excise magical thinking from her practice. “It can hold you back if you’re not careful,” she said. “If you start using it as a crutch when something goes wrong — like ‘Oh, I wasn’t wearing my clogs today and that’s why my flap failed’ — then you’re not doing your due diligence and figuring out what really happened.” Rather than placing the responsibility for her day going well on superstition, she’s trying to own it herself by living with more intent.
The Diagnosis
Most of the medical experts I spoke with didn’t think there was anything wrong with rituals or superstitions as long as they didn’t become compulsive or a convenient repository of blame.
“Rituals and superstitions are an acknowledgment that forces external to ourselves exist,” concluded Dr. Fong. “They’re like tiny offerings to whatever gods are out there to please be on our side. And we keep doing them because there’s a reward — better patient outcomes, which is all we want to achieve in the end. I say embrace them.”
A version of this article first appeared on Medscape.com.
Hospitals Cash In on a Private Equity-Backed Trend: Concierge Physician Care
Nonprofit hospitals created largely to serve the poor are adding concierge physician practices, charging patients annual membership fees of $2,000 or more for easier access to their doctors.
It’s a trend that began decades ago with physician practices. Thousands of doctors have shifted to the concierge model, in which they can increase their income while decreasing their patient load.
Northwestern Medicine in Chicago, Penn Medicine in Philadelphia, University Hospitals in the Cleveland area, and Baptist Health in Miami are among the large hospital systems offering concierge physician services. The fees, which can exceed $4,000 a year, are in addition to copayments, deductibles, and other charges not paid by patients’ insurance plans.
Critics of concierge medicine say the practice exacerbates primary care shortages, ensuring access only for the affluent, while driving up health care costs. But for tax-exempt hospitals, the financial benefits can be twofold.
“Hospitals are attracted to physicians that offer concierge services because their patients do not come with bad debts or a need for charity care, and most of them have private insurance which pays the hospital very well,” said Gerard Anderson, a hospital finance expert at Johns Hopkins University.
“They are the ideal patient, from the hospitals’ perspective.”
Concierge physicians typically limit their practices to a few hundred patients, compared with a couple of thousand for a traditional primary care doctor, so they can promise immediate access and longer visits.
“Every time we see these models expand, we are contracting the availability of primary care doctors for the general population,” said Jewel Mullen, associate dean for health equity at the University of Texas-Austin’s Dell Medical School. The former Connecticut health commissioner said concierge doctors join large hospital systems because of the institutions’ reputations, while hospitals sign up concierge physicians to ensure referrals to specialists and inpatient care. “It helps hospitals secure a bigger piece of their market,” she said.
Concierge physicians typically promise same-day or next-day appointments. Many provide patients their mobile phone number.
Aaron Klein, who oversees the concierge physician practices at Baptist Health, said the program was initially intended to serve donors.
“High-end donors wanted to make sure they have doctors to care for them,” he said.
Baptist opened its concierge program in 2019 and now has three practices across South Florida, where patients pay $2,500 a year.
“My philosophy is: It’s better to give world-class care to a few hundred patients rather than provide inadequate care to a few thousand patients,” Klein said.
Concierge physician practices started more than 20 years ago, mainly in upscale areas such as Boca Raton, Florida, and La Jolla, California. They catered mostly to wealthy retirees willing to pay extra for better physician access. Some of the first physician practices to enter the business were backed by private equity firms.
One of the largest, Boca Raton-based MDVIP, has more than 1,100 physicians and more than 390,000 patients. It was started in 2000, and since 2014 private equity firms have owned a majority stake in the company.
Some concierge physicians say their more attentive care means healthier patients. A study published last year by researchers at the University of California-Berkeley and University of Pennsylvania found no impact on mortality rates. What the study did find: higher costs.
Using Medicare claims data, the researchers found that concierge medicine enrollment corresponded with a 30%-50% increase in total health care spending by patients.
For hospitals, “this is an extension of them consolidating the market,” said Adam Leive, a study co-author and an assistant professor of public policy at UC Berkeley. Inova Health Care Services in Fairfax, Virginia, one of the state’s largest tax-exempt hospital chains, employs 18 concierge doctors, who each handle no more than 400 patients. Those patients pay $2,200 a year for the privilege.
George Salem, 70, of McLean, Virginia, has been a patient in Inova’s concierge practice for several years along with his wife. Earlier this year he slammed his finger in a hotel door, he said. As soon as he got home, he called his physician, who saw him immediately and stitched up the wound. He said he sees his doctor about 10 to 12 times a year.
“I loved my internist before, but it was impossible to get to see him,” Salem said. Immediate access to his doctor “very much gives me peace of mind,” he said.
Craig Cheifetz, a vice president at Inova who oversees the concierge program, said the hospital system took interest in the model after MDVIP began moving aggressively into the Washington, D.C., suburbs about a decade ago. Today, Inova’s program has 6,000 patients.
Cheifetz disputes the charge that concierge physician programs exacerbate primary care shortages. The model keeps doctors who were considering retiring early in the business with a lighter caseload, he said. And the fees amount to no more than a few dollars a day — about what some people spend on coffee, he said.
“Inova has an incredible primary care network for those who can’t afford the concierge care,” he said. “We are still providing all that is necessary in primary care for those who need it.”
Some hospitals are starting concierge physician practices far from their home locations. For example, Tampa General Hospital in Florida last year opened a concierge practice in upper-middle-class Palm Beach Gardens, a roughly three-hour drive from Tampa. Mount Sinai Health System in New York runs a concierge physician practice in West Palm Beach.
NCH Healthcare System in Naples, Florida, employs 12 concierge physicians who treat about 3,000 patients total. “We found a need in this community for those who wanted a more personalized health care experience,” said James Brinkert, regional administrator for the system. Members pay an annual fee of at least $3,500.
NCH patients whose doctors convert to concierge and who don’t want to pay the membership fee are referred to other primary care practices or to urgent care, Brinkert said.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF .
Nonprofit hospitals created largely to serve the poor are adding concierge physician practices, charging patients annual membership fees of $2,000 or more for easier access to their doctors.
It’s a trend that began decades ago with physician practices. Thousands of doctors have shifted to the concierge model, in which they can increase their income while decreasing their patient load.
Northwestern Medicine in Chicago, Penn Medicine in Philadelphia, University Hospitals in the Cleveland area, and Baptist Health in Miami are among the large hospital systems offering concierge physician services. The fees, which can exceed $4,000 a year, are in addition to copayments, deductibles, and other charges not paid by patients’ insurance plans.
Critics of concierge medicine say the practice exacerbates primary care shortages, ensuring access only for the affluent, while driving up health care costs. But for tax-exempt hospitals, the financial benefits can be twofold.
“Hospitals are attracted to physicians that offer concierge services because their patients do not come with bad debts or a need for charity care, and most of them have private insurance which pays the hospital very well,” said Gerard Anderson, a hospital finance expert at Johns Hopkins University.
“They are the ideal patient, from the hospitals’ perspective.”
Concierge physicians typically limit their practices to a few hundred patients, compared with a couple of thousand for a traditional primary care doctor, so they can promise immediate access and longer visits.
“Every time we see these models expand, we are contracting the availability of primary care doctors for the general population,” said Jewel Mullen, associate dean for health equity at the University of Texas-Austin’s Dell Medical School. The former Connecticut health commissioner said concierge doctors join large hospital systems because of the institutions’ reputations, while hospitals sign up concierge physicians to ensure referrals to specialists and inpatient care. “It helps hospitals secure a bigger piece of their market,” she said.
Concierge physicians typically promise same-day or next-day appointments. Many provide patients their mobile phone number.
Aaron Klein, who oversees the concierge physician practices at Baptist Health, said the program was initially intended to serve donors.
“High-end donors wanted to make sure they have doctors to care for them,” he said.
Baptist opened its concierge program in 2019 and now has three practices across South Florida, where patients pay $2,500 a year.
“My philosophy is: It’s better to give world-class care to a few hundred patients rather than provide inadequate care to a few thousand patients,” Klein said.
Concierge physician practices started more than 20 years ago, mainly in upscale areas such as Boca Raton, Florida, and La Jolla, California. They catered mostly to wealthy retirees willing to pay extra for better physician access. Some of the first physician practices to enter the business were backed by private equity firms.
One of the largest, Boca Raton-based MDVIP, has more than 1,100 physicians and more than 390,000 patients. It was started in 2000, and since 2014 private equity firms have owned a majority stake in the company.
Some concierge physicians say their more attentive care means healthier patients. A study published last year by researchers at the University of California-Berkeley and University of Pennsylvania found no impact on mortality rates. What the study did find: higher costs.
Using Medicare claims data, the researchers found that concierge medicine enrollment corresponded with a 30%-50% increase in total health care spending by patients.
For hospitals, “this is an extension of them consolidating the market,” said Adam Leive, a study co-author and an assistant professor of public policy at UC Berkeley. Inova Health Care Services in Fairfax, Virginia, one of the state’s largest tax-exempt hospital chains, employs 18 concierge doctors, who each handle no more than 400 patients. Those patients pay $2,200 a year for the privilege.
George Salem, 70, of McLean, Virginia, has been a patient in Inova’s concierge practice for several years along with his wife. Earlier this year he slammed his finger in a hotel door, he said. As soon as he got home, he called his physician, who saw him immediately and stitched up the wound. He said he sees his doctor about 10 to 12 times a year.
“I loved my internist before, but it was impossible to get to see him,” Salem said. Immediate access to his doctor “very much gives me peace of mind,” he said.
Craig Cheifetz, a vice president at Inova who oversees the concierge program, said the hospital system took interest in the model after MDVIP began moving aggressively into the Washington, D.C., suburbs about a decade ago. Today, Inova’s program has 6,000 patients.
Cheifetz disputes the charge that concierge physician programs exacerbate primary care shortages. The model keeps doctors who were considering retiring early in the business with a lighter caseload, he said. And the fees amount to no more than a few dollars a day — about what some people spend on coffee, he said.
“Inova has an incredible primary care network for those who can’t afford the concierge care,” he said. “We are still providing all that is necessary in primary care for those who need it.”
Some hospitals are starting concierge physician practices far from their home locations. For example, Tampa General Hospital in Florida last year opened a concierge practice in upper-middle-class Palm Beach Gardens, a roughly three-hour drive from Tampa. Mount Sinai Health System in New York runs a concierge physician practice in West Palm Beach.
NCH Healthcare System in Naples, Florida, employs 12 concierge physicians who treat about 3,000 patients total. “We found a need in this community for those who wanted a more personalized health care experience,” said James Brinkert, regional administrator for the system. Members pay an annual fee of at least $3,500.
NCH patients whose doctors convert to concierge and who don’t want to pay the membership fee are referred to other primary care practices or to urgent care, Brinkert said.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF .
Nonprofit hospitals created largely to serve the poor are adding concierge physician practices, charging patients annual membership fees of $2,000 or more for easier access to their doctors.
It’s a trend that began decades ago with physician practices. Thousands of doctors have shifted to the concierge model, in which they can increase their income while decreasing their patient load.
Northwestern Medicine in Chicago, Penn Medicine in Philadelphia, University Hospitals in the Cleveland area, and Baptist Health in Miami are among the large hospital systems offering concierge physician services. The fees, which can exceed $4,000 a year, are in addition to copayments, deductibles, and other charges not paid by patients’ insurance plans.
Critics of concierge medicine say the practice exacerbates primary care shortages, ensuring access only for the affluent, while driving up health care costs. But for tax-exempt hospitals, the financial benefits can be twofold.
“Hospitals are attracted to physicians that offer concierge services because their patients do not come with bad debts or a need for charity care, and most of them have private insurance which pays the hospital very well,” said Gerard Anderson, a hospital finance expert at Johns Hopkins University.
“They are the ideal patient, from the hospitals’ perspective.”
Concierge physicians typically limit their practices to a few hundred patients, compared with a couple of thousand for a traditional primary care doctor, so they can promise immediate access and longer visits.
“Every time we see these models expand, we are contracting the availability of primary care doctors for the general population,” said Jewel Mullen, associate dean for health equity at the University of Texas-Austin’s Dell Medical School. The former Connecticut health commissioner said concierge doctors join large hospital systems because of the institutions’ reputations, while hospitals sign up concierge physicians to ensure referrals to specialists and inpatient care. “It helps hospitals secure a bigger piece of their market,” she said.
Concierge physicians typically promise same-day or next-day appointments. Many provide patients their mobile phone number.
Aaron Klein, who oversees the concierge physician practices at Baptist Health, said the program was initially intended to serve donors.
“High-end donors wanted to make sure they have doctors to care for them,” he said.
Baptist opened its concierge program in 2019 and now has three practices across South Florida, where patients pay $2,500 a year.
“My philosophy is: It’s better to give world-class care to a few hundred patients rather than provide inadequate care to a few thousand patients,” Klein said.
Concierge physician practices started more than 20 years ago, mainly in upscale areas such as Boca Raton, Florida, and La Jolla, California. They catered mostly to wealthy retirees willing to pay extra for better physician access. Some of the first physician practices to enter the business were backed by private equity firms.
One of the largest, Boca Raton-based MDVIP, has more than 1,100 physicians and more than 390,000 patients. It was started in 2000, and since 2014 private equity firms have owned a majority stake in the company.
Some concierge physicians say their more attentive care means healthier patients. A study published last year by researchers at the University of California-Berkeley and University of Pennsylvania found no impact on mortality rates. What the study did find: higher costs.
Using Medicare claims data, the researchers found that concierge medicine enrollment corresponded with a 30%-50% increase in total health care spending by patients.
For hospitals, “this is an extension of them consolidating the market,” said Adam Leive, a study co-author and an assistant professor of public policy at UC Berkeley. Inova Health Care Services in Fairfax, Virginia, one of the state’s largest tax-exempt hospital chains, employs 18 concierge doctors, who each handle no more than 400 patients. Those patients pay $2,200 a year for the privilege.
George Salem, 70, of McLean, Virginia, has been a patient in Inova’s concierge practice for several years along with his wife. Earlier this year he slammed his finger in a hotel door, he said. As soon as he got home, he called his physician, who saw him immediately and stitched up the wound. He said he sees his doctor about 10 to 12 times a year.
“I loved my internist before, but it was impossible to get to see him,” Salem said. Immediate access to his doctor “very much gives me peace of mind,” he said.
Craig Cheifetz, a vice president at Inova who oversees the concierge program, said the hospital system took interest in the model after MDVIP began moving aggressively into the Washington, D.C., suburbs about a decade ago. Today, Inova’s program has 6,000 patients.
Cheifetz disputes the charge that concierge physician programs exacerbate primary care shortages. The model keeps doctors who were considering retiring early in the business with a lighter caseload, he said. And the fees amount to no more than a few dollars a day — about what some people spend on coffee, he said.
“Inova has an incredible primary care network for those who can’t afford the concierge care,” he said. “We are still providing all that is necessary in primary care for those who need it.”
Some hospitals are starting concierge physician practices far from their home locations. For example, Tampa General Hospital in Florida last year opened a concierge practice in upper-middle-class Palm Beach Gardens, a roughly three-hour drive from Tampa. Mount Sinai Health System in New York runs a concierge physician practice in West Palm Beach.
NCH Healthcare System in Naples, Florida, employs 12 concierge physicians who treat about 3,000 patients total. “We found a need in this community for those who wanted a more personalized health care experience,” said James Brinkert, regional administrator for the system. Members pay an annual fee of at least $3,500.
NCH patients whose doctors convert to concierge and who don’t want to pay the membership fee are referred to other primary care practices or to urgent care, Brinkert said.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF .
Physicians Received $12 Billion from Drug, Device Makers in Less Than 10 Years
A review of the federal Open Payments database found that the pharmaceutical and medical device industry paid physicians $12.1 billion over nearly a decade.
Almost two thirds of eligible physicians — 826,313 doctors — received a payment from a drug or device maker from 2013 to 2022, according to a study published online in JAMA on March 28. Overall, the median payment was $48 per physician.
Orthopedists received the largest amount of payments in aggregate, $1.3 billion, followed by neurologists and psychiatrists at $1.2 billion and cardiologists at $1.29 billion.
Geriatric and nuclear medicine specialists and trauma and pediatric surgeons received the least amount of money in aggregate, and the mean amount paid to a pediatric surgeon in the top 0.1% was just $338,183 over the 9-year study period.
Excluding 2013 (the database was established in August that year), the total value of payments was highest in 2019 at $1.6 billion, up from $1.34 billion in 2014. It was lowest in 2020, the peak year of the COVID-19 pandemic, but dipped to $864 billion that year and rebounded to $1.28 billion in 2022, wrote the authors.
The Open Payments database, administered by the Centers for Medicare & Medicaid Services, requires drug and device makers and group purchasing organizations to report payments made to physicians, including for consulting services, speaking fees, food and beverages, travel and lodging, education, gifts, grants, and honoraria.
The database was created to shed light on these payments, which have been linked in multiple studies to more prescribing of a particular drug or more use of a particular device.
The JAMA review appeared to show that with the exception of the pandemic year, the relationships have more or less stayed the same since Open Payments began.
“There’s been no sea change, no massive shift in how these interactions are happening,” said Deborah C. Marshall, MD, assistant professor in the Department of Radiation Oncology at the Icahn School of Medicine at Mount Sinai in New York City, who has studied industry payments.
“There’s no suggestion that anything is really changing other than that’s there is transparency,” said Robert Steinbrook, MD, director of the Health Research Group at Public Citizen.
Still, Dr. Steinbrook told this news organization, “it’s better to know this than to not know this.”
The unchanging nature of industry-physician relationships “suggests that to reduce the volume and magnitude of payments, more would need to be done,” he said.
“Really, this should be banned. Doctors should not be allowed to get gifts from pharmaceutical companies,” said Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices.
“The interactions wouldn’t be happening unless there was a purpose for them,” said Dr. Marshall. The relationships are “built with intention,” Dr. Marshall told this news organization.
Top Earners Range From $195,000 to $4.8 Million
Payments to the median physician over the study period ranged from $0 to $2339, but the mean payment to top earners — those in the top 0.1% — ranged from $194,933 for hospitalists to $4.8 million for orthopedic specialists.
Overall, the median payment was $48 per physician.
But small dollar amounts should not be discounted — even if it’s just a $25-catered lunch — said Aaron Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center in New York City who has studied industry-physician relationships. “The influence is not just in the dollar value,” Dr. Mitchell told this news organization. “It’s about the time listening to and the time in personal contact with industry representatives that these dollars are a marker for,” he said.
“There’s no such thing as a free lunch,” agreed Dr. Marshall. It’s “pretty well established” that lower-value payments do have influence, which is why academic institutions have established policies that limit gifts and meals and other payments from industry, she said.
Dr. Fugh-Berman said, “the size of the gift doesn’t really matter,” adding that research she conducted had shown that “accepting a meal increased not only the expense of the prescriptions that Medicare physicians wrote but also the number of prescriptions.”
Payments Mostly for High-Dollar Products
The top 25 drugs and devices that were related to industry payments tended to be high-cost brand-name products.
The top drug was Janssen’s Xarelto, an anticoagulant first approved in 2011 that costs about $600 a month, according to GoodRx. The drug has had annual sales of $4-$6 billion.
Xarelto was followed by Eliquis, another anticoagulant; Humira, used for a variety of autoimmune conditions including plaque psoriasis, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis; Invokana, Jardiance, and Farxiga, all for type 2 diabetes.
The top medical devices included the da Vinci Surgical System, Mako SmartRobotics, CoreValve Evolut, Natrelle Implants, and Impella, a heart pump that received a US Food and Drug Administration (FDA) warning that it was associated with a heightened risk for death.
Industry Influence May Lead to Higher Cost, Poor Quality Care
Multiple studies have shown that payments to physicians tend to lead to increased prescribing and, often, higher costs for Medicare, a health system, or patients.
“I’m sure there are still a lot of physicians out there who think they’re getting away with something, that they can take meals, or they can take consulting fees and not be influenced, but there’s overwhelming data showing that it always influences you,” said Dr. Fugh-Berman.
One study in 2020 that used the Open Payments database found that physicians increase prescribing of the drugs for which they receive payment in the months just after the payment. The authors also showed that physicians who are paid prescribe lower-quality drugs following the payment, “although the magnitude is small and unlikely to be clinically significant.”
Dr. Marshall said that more studies are needed to determine whether quality of care is being affected when a physician prescribes a drug after an industry payment.
For now, there seems to be little appetite among physicians to give up the payments, said Dr. Marshall and others.
Physicians in some specialties see the payments as “an implicit statement about their value,” said Dr. Marshall.
In oncology, having received a lot of payments “gets worn more as a badge of honor,” said Dr. Mitchell.
The clinicians believe that “by collaborating with industry we are providing scientific expertise to help develop the next generation of technology and cures,” Dr. Mitchell said, adding that they see the payments “as a mark of their impact.”
Among the JAMA study authors, Joseph S. Ross, MD, reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of the manuscript or its review. Dr. Ross also reported receiving grants from the FDA, Johnson and Johnson, the Medical Devices Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Steinbrook, Dr. Marshall, and Dr. Mitchell reported no relevant financial relationships. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.
A version of this article appeared on Medscape.com.
A review of the federal Open Payments database found that the pharmaceutical and medical device industry paid physicians $12.1 billion over nearly a decade.
Almost two thirds of eligible physicians — 826,313 doctors — received a payment from a drug or device maker from 2013 to 2022, according to a study published online in JAMA on March 28. Overall, the median payment was $48 per physician.
Orthopedists received the largest amount of payments in aggregate, $1.3 billion, followed by neurologists and psychiatrists at $1.2 billion and cardiologists at $1.29 billion.
Geriatric and nuclear medicine specialists and trauma and pediatric surgeons received the least amount of money in aggregate, and the mean amount paid to a pediatric surgeon in the top 0.1% was just $338,183 over the 9-year study period.
Excluding 2013 (the database was established in August that year), the total value of payments was highest in 2019 at $1.6 billion, up from $1.34 billion in 2014. It was lowest in 2020, the peak year of the COVID-19 pandemic, but dipped to $864 billion that year and rebounded to $1.28 billion in 2022, wrote the authors.
The Open Payments database, administered by the Centers for Medicare & Medicaid Services, requires drug and device makers and group purchasing organizations to report payments made to physicians, including for consulting services, speaking fees, food and beverages, travel and lodging, education, gifts, grants, and honoraria.
The database was created to shed light on these payments, which have been linked in multiple studies to more prescribing of a particular drug or more use of a particular device.
The JAMA review appeared to show that with the exception of the pandemic year, the relationships have more or less stayed the same since Open Payments began.
“There’s been no sea change, no massive shift in how these interactions are happening,” said Deborah C. Marshall, MD, assistant professor in the Department of Radiation Oncology at the Icahn School of Medicine at Mount Sinai in New York City, who has studied industry payments.
“There’s no suggestion that anything is really changing other than that’s there is transparency,” said Robert Steinbrook, MD, director of the Health Research Group at Public Citizen.
Still, Dr. Steinbrook told this news organization, “it’s better to know this than to not know this.”
The unchanging nature of industry-physician relationships “suggests that to reduce the volume and magnitude of payments, more would need to be done,” he said.
“Really, this should be banned. Doctors should not be allowed to get gifts from pharmaceutical companies,” said Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices.
“The interactions wouldn’t be happening unless there was a purpose for them,” said Dr. Marshall. The relationships are “built with intention,” Dr. Marshall told this news organization.
Top Earners Range From $195,000 to $4.8 Million
Payments to the median physician over the study period ranged from $0 to $2339, but the mean payment to top earners — those in the top 0.1% — ranged from $194,933 for hospitalists to $4.8 million for orthopedic specialists.
Overall, the median payment was $48 per physician.
But small dollar amounts should not be discounted — even if it’s just a $25-catered lunch — said Aaron Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center in New York City who has studied industry-physician relationships. “The influence is not just in the dollar value,” Dr. Mitchell told this news organization. “It’s about the time listening to and the time in personal contact with industry representatives that these dollars are a marker for,” he said.
“There’s no such thing as a free lunch,” agreed Dr. Marshall. It’s “pretty well established” that lower-value payments do have influence, which is why academic institutions have established policies that limit gifts and meals and other payments from industry, she said.
Dr. Fugh-Berman said, “the size of the gift doesn’t really matter,” adding that research she conducted had shown that “accepting a meal increased not only the expense of the prescriptions that Medicare physicians wrote but also the number of prescriptions.”
Payments Mostly for High-Dollar Products
The top 25 drugs and devices that were related to industry payments tended to be high-cost brand-name products.
The top drug was Janssen’s Xarelto, an anticoagulant first approved in 2011 that costs about $600 a month, according to GoodRx. The drug has had annual sales of $4-$6 billion.
Xarelto was followed by Eliquis, another anticoagulant; Humira, used for a variety of autoimmune conditions including plaque psoriasis, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis; Invokana, Jardiance, and Farxiga, all for type 2 diabetes.
The top medical devices included the da Vinci Surgical System, Mako SmartRobotics, CoreValve Evolut, Natrelle Implants, and Impella, a heart pump that received a US Food and Drug Administration (FDA) warning that it was associated with a heightened risk for death.
Industry Influence May Lead to Higher Cost, Poor Quality Care
Multiple studies have shown that payments to physicians tend to lead to increased prescribing and, often, higher costs for Medicare, a health system, or patients.
“I’m sure there are still a lot of physicians out there who think they’re getting away with something, that they can take meals, or they can take consulting fees and not be influenced, but there’s overwhelming data showing that it always influences you,” said Dr. Fugh-Berman.
One study in 2020 that used the Open Payments database found that physicians increase prescribing of the drugs for which they receive payment in the months just after the payment. The authors also showed that physicians who are paid prescribe lower-quality drugs following the payment, “although the magnitude is small and unlikely to be clinically significant.”
Dr. Marshall said that more studies are needed to determine whether quality of care is being affected when a physician prescribes a drug after an industry payment.
For now, there seems to be little appetite among physicians to give up the payments, said Dr. Marshall and others.
Physicians in some specialties see the payments as “an implicit statement about their value,” said Dr. Marshall.
In oncology, having received a lot of payments “gets worn more as a badge of honor,” said Dr. Mitchell.
The clinicians believe that “by collaborating with industry we are providing scientific expertise to help develop the next generation of technology and cures,” Dr. Mitchell said, adding that they see the payments “as a mark of their impact.”
Among the JAMA study authors, Joseph S. Ross, MD, reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of the manuscript or its review. Dr. Ross also reported receiving grants from the FDA, Johnson and Johnson, the Medical Devices Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Steinbrook, Dr. Marshall, and Dr. Mitchell reported no relevant financial relationships. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.
A version of this article appeared on Medscape.com.
A review of the federal Open Payments database found that the pharmaceutical and medical device industry paid physicians $12.1 billion over nearly a decade.
Almost two thirds of eligible physicians — 826,313 doctors — received a payment from a drug or device maker from 2013 to 2022, according to a study published online in JAMA on March 28. Overall, the median payment was $48 per physician.
Orthopedists received the largest amount of payments in aggregate, $1.3 billion, followed by neurologists and psychiatrists at $1.2 billion and cardiologists at $1.29 billion.
Geriatric and nuclear medicine specialists and trauma and pediatric surgeons received the least amount of money in aggregate, and the mean amount paid to a pediatric surgeon in the top 0.1% was just $338,183 over the 9-year study period.
Excluding 2013 (the database was established in August that year), the total value of payments was highest in 2019 at $1.6 billion, up from $1.34 billion in 2014. It was lowest in 2020, the peak year of the COVID-19 pandemic, but dipped to $864 billion that year and rebounded to $1.28 billion in 2022, wrote the authors.
The Open Payments database, administered by the Centers for Medicare & Medicaid Services, requires drug and device makers and group purchasing organizations to report payments made to physicians, including for consulting services, speaking fees, food and beverages, travel and lodging, education, gifts, grants, and honoraria.
The database was created to shed light on these payments, which have been linked in multiple studies to more prescribing of a particular drug or more use of a particular device.
The JAMA review appeared to show that with the exception of the pandemic year, the relationships have more or less stayed the same since Open Payments began.
“There’s been no sea change, no massive shift in how these interactions are happening,” said Deborah C. Marshall, MD, assistant professor in the Department of Radiation Oncology at the Icahn School of Medicine at Mount Sinai in New York City, who has studied industry payments.
“There’s no suggestion that anything is really changing other than that’s there is transparency,” said Robert Steinbrook, MD, director of the Health Research Group at Public Citizen.
Still, Dr. Steinbrook told this news organization, “it’s better to know this than to not know this.”
The unchanging nature of industry-physician relationships “suggests that to reduce the volume and magnitude of payments, more would need to be done,” he said.
“Really, this should be banned. Doctors should not be allowed to get gifts from pharmaceutical companies,” said Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices.
“The interactions wouldn’t be happening unless there was a purpose for them,” said Dr. Marshall. The relationships are “built with intention,” Dr. Marshall told this news organization.
Top Earners Range From $195,000 to $4.8 Million
Payments to the median physician over the study period ranged from $0 to $2339, but the mean payment to top earners — those in the top 0.1% — ranged from $194,933 for hospitalists to $4.8 million for orthopedic specialists.
Overall, the median payment was $48 per physician.
But small dollar amounts should not be discounted — even if it’s just a $25-catered lunch — said Aaron Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center in New York City who has studied industry-physician relationships. “The influence is not just in the dollar value,” Dr. Mitchell told this news organization. “It’s about the time listening to and the time in personal contact with industry representatives that these dollars are a marker for,” he said.
“There’s no such thing as a free lunch,” agreed Dr. Marshall. It’s “pretty well established” that lower-value payments do have influence, which is why academic institutions have established policies that limit gifts and meals and other payments from industry, she said.
Dr. Fugh-Berman said, “the size of the gift doesn’t really matter,” adding that research she conducted had shown that “accepting a meal increased not only the expense of the prescriptions that Medicare physicians wrote but also the number of prescriptions.”
Payments Mostly for High-Dollar Products
The top 25 drugs and devices that were related to industry payments tended to be high-cost brand-name products.
The top drug was Janssen’s Xarelto, an anticoagulant first approved in 2011 that costs about $600 a month, according to GoodRx. The drug has had annual sales of $4-$6 billion.
Xarelto was followed by Eliquis, another anticoagulant; Humira, used for a variety of autoimmune conditions including plaque psoriasis, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis; Invokana, Jardiance, and Farxiga, all for type 2 diabetes.
The top medical devices included the da Vinci Surgical System, Mako SmartRobotics, CoreValve Evolut, Natrelle Implants, and Impella, a heart pump that received a US Food and Drug Administration (FDA) warning that it was associated with a heightened risk for death.
Industry Influence May Lead to Higher Cost, Poor Quality Care
Multiple studies have shown that payments to physicians tend to lead to increased prescribing and, often, higher costs for Medicare, a health system, or patients.
“I’m sure there are still a lot of physicians out there who think they’re getting away with something, that they can take meals, or they can take consulting fees and not be influenced, but there’s overwhelming data showing that it always influences you,” said Dr. Fugh-Berman.
One study in 2020 that used the Open Payments database found that physicians increase prescribing of the drugs for which they receive payment in the months just after the payment. The authors also showed that physicians who are paid prescribe lower-quality drugs following the payment, “although the magnitude is small and unlikely to be clinically significant.”
Dr. Marshall said that more studies are needed to determine whether quality of care is being affected when a physician prescribes a drug after an industry payment.
For now, there seems to be little appetite among physicians to give up the payments, said Dr. Marshall and others.
Physicians in some specialties see the payments as “an implicit statement about their value,” said Dr. Marshall.
In oncology, having received a lot of payments “gets worn more as a badge of honor,” said Dr. Mitchell.
The clinicians believe that “by collaborating with industry we are providing scientific expertise to help develop the next generation of technology and cures,” Dr. Mitchell said, adding that they see the payments “as a mark of their impact.”
Among the JAMA study authors, Joseph S. Ross, MD, reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of the manuscript or its review. Dr. Ross also reported receiving grants from the FDA, Johnson and Johnson, the Medical Devices Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Steinbrook, Dr. Marshall, and Dr. Mitchell reported no relevant financial relationships. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.
A version of this article appeared on Medscape.com.
FROM JAMA