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Docs using AI? Some love it, most remain wary
When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.
“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.
Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.
He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”
The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.
Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.
More than half of the respondents not using AI said they first want more evidence that the technology works as intended.
“None of them work as advertised,” said one respondent.
MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.
Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.
Doctors may also be skeptical of AI based on their experience with EHRs, she said.
“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
Drawing the line at patient care
Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.
“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.
Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:
- Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
- Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
- Improving billing operations and predictive analytics.
Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.
They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
Is regulation needed?
Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.
“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.
In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.
Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.
In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.
There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
What should doctors do?
Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.
There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.
“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.
Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
A version of this article appeared on Medscape.com.
When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.
“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.
Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.
He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”
The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.
Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.
More than half of the respondents not using AI said they first want more evidence that the technology works as intended.
“None of them work as advertised,” said one respondent.
MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.
Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.
Doctors may also be skeptical of AI based on their experience with EHRs, she said.
“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
Drawing the line at patient care
Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.
“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.
Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:
- Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
- Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
- Improving billing operations and predictive analytics.
Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.
They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
Is regulation needed?
Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.
“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.
In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.
Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.
In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.
There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
What should doctors do?
Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.
There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.
“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.
Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
A version of this article appeared on Medscape.com.
When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.
“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.
Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.
He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”
The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.
Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.
More than half of the respondents not using AI said they first want more evidence that the technology works as intended.
“None of them work as advertised,” said one respondent.
MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.
Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.
Doctors may also be skeptical of AI based on their experience with EHRs, she said.
“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
Drawing the line at patient care
Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.
“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.
Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:
- Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
- Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
- Improving billing operations and predictive analytics.
Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.
They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
Is regulation needed?
Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.
“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.
In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.
Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.
In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.
There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
What should doctors do?
Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.
There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.
“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.
Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
A version of this article appeared on Medscape.com.
Your practice was bought out by private equity: Now what?
After her emergency medicine group was acquired by a staffing firm backed by a large private equity (PE) firm, Michelle Wiener, MD, said the workflow changes came swiftly.
“Our staffing has been greatly reduced,” the Detroit physician said. “At this point, we have no say in anything. We have no say in the scheduling. We aren’t allowed to see what is billed under our name. The morale has really gone down.”
Dr. Wiener, who practices at Ascension St. John Hospital, said she and fellow physicians have repeatedly brought their concerns to TeamHealth, which in 2015 took over St. John Emergency Services PC. TeamHealth is owned by PE giant Blackstone.
“It’s very frustrating,” Dr. Wiener said. “We’re taking it from all sides.”
Blackstone and Ascension St. John did not respond to this news organization’s request for comment.
TeamHealth would not respond directly to questions about the Ascension St. John Hospital physicians or their concerns.
Spokesman Josh Hopson provided only a general statement: “TeamHealth is committed to making sure that clinicians have the resources and support needed to provide first-class care to patients, particularly with regard to staffing and compensation. TeamHealth has and will always put patient care first, and that is not impacted by its ownership model.”
Acquisitions of medical practices and hospitals by PE firms are rapidly growing, with more than 1,400 PE deals in health care in 2021 totaling upwards of $208 billion, according to PitchBook Data Inc., a Seattle-based firm that tracks mergers and acquisitions.
Some physicians praise the partnerships as an opportunity to improve technology and efficiency, whereas others decry them as raising patient costs and lowering the quality of care. A recent UC Berkeley study found that PE ownership of medical practices was linked to consumer price increases for 8 of 10 specialties, most notably oncology and gastroenterology.
What should you expect after PE acquisition?
Since his practice partnered with a PE firm in 2020, Milwaukee-based otolaryngologist Madan Kandula, MD, said he has found the changes positive. The practice has grown and improved operations in finance, accounting, compliance, and information technology, said Dr. Kandula, founder and CEO of Advent, an ENT practice with 15 clinics in four Midwestern states.
Dr. Kandula said his group already had a sound business practice, and that the goal of partnering with a PE firm wasn’t to change day-to-day operations but to propel the organization forward.
“From patient load to visit time to how we staff our clinics, there has been no change,” he said. “My private equity firm does not, [and] cannot, impose their will on our clinical decisions.”
Experts say the impact of PE acquisitions on individual physicians often depends on where a doctor ranks in the organization, what stage they are in their career, and how much control they had over the deal.
“It’s the older physicians who are usually selling the practice and getting the big payout,” said Anjali Dooley, a St. Louis–based health law attorney who counsels physicians about PE deals. “The younger doctors are usually not part of the deal, as they may still be employees. They don’t have any negotiating power. Hopefully, there is some transparency, but sometimes there is not, and they are blindsided by the deal.”
When it comes to workload, most PE-owned groups are put on a production-based model, such as a wRVU-based model, said Roger Strode, a Chicago-based health law attorney who focuses on health care mergers and acquisitions. Most already operate under such a model, but there might be some changes after a buyout.
Staffing may also change, added Ms. Dooley. The PE firms may want to add partners or companies already in their portfolios to create efficiencies, causing training or workflow changes.
In a hospital buyout, changes may depend on whether a department is a significant revenue generator for the hospital, Ms. Dooley noted.
PE firms frequently favor higher revenue–generating specialties, such as neurosurgery, cardiology, orthopedics, gastroenterology, and plastic surgery. They closely scrutinize departments said that make less money, such as the emergency department or primary care, Ms. Dooley said. Physicians or teams that don’t fit the firm’s cost-efficiency plans may be terminated or replaced.
On the other hand, Mr. Strode said physicians may see improved electronic health records and collections.
“Some of your overall overhead costs may be reduced, because they’re better at it,” Mr. Strode said. “When you’ve got more scale, the cost per patient, the cost per hour, the cost per procedure, goes down, and the cost that’s applied against your production will go down. As [practices grow], they have more bargaining power with payers and you can potentially get better rates. At least, that’s the promise.”
Analysts note that PE health care acquisitions show no signs of slowing and that it pays for physicians to know what to expect and how to cope if their practice or hospital is acquired. Whether physicians have some control over a buyout or are blindsided by the transition, it’s critical to know what to consider, how workloads might change, and your options for settling in or settling up.
The PE industry has about $2 trillion lined up for potential investments in 2023, said Ms. Dooley.
“PE firms are looking at health care to expend some of this dry powder,” Ms. Dooley continued. “If done correctly, PE firms that are aware of health care regulations, compliance, and patient care issues can ... remove redundant services and improve ... efficiencies, but the bad is when that doesn’t happen, and the quality of care goes down or there are patient safety risks.”
How to prepare for and cope with PE partnerships
If your practice is considering a PE partnership, it’s important to explore the terms and conditions and carefully weigh the pros and cons, said Gary Herschman, a Newark, N.J.–based attorney who advises PE-owned physician groups.
“My recommendation is that physicians at a minimum conduct due diligence on all potential strategic options for their groups, and then make an informed decision regarding whether a partnership transaction is right for their group, as it’s not right for every group,” he said.
When Texas cardiologist Rick Snyder, MD, was considering PE partnerships, he spoke with physicians who made similar deals to determine whether they were satisfied years later, he said. In April, Snyder’s practice, HeartPlace, the largest physician-owned cardiology practice in Texas, was acquired by US Heart & Vascular, a practice management platform backed by PE firm Ares Management.
“I called every group that I knew that had done private equity for any meaningful amount of time,” Dr. Snyder said. “For the first year or two, everybody is in the honeymoon period. If the model is going to succeed or break down, it’s not going to be in the first year or two. So I wanted to talk to groups that had done this for a longer amount of time and find out what their pitfalls were. What would they have done differently? Has it been a productive relationship? Did they grow?”
Dr. Snyder, president of the Texas Medical Association, said his practice met with seven or eight firms before choosing one that best met their needs. His group wanted a platform that preserved their clinical autonomy, governance, and culture, he said. They also wanted to ensure they were not entering into a “buy and flip” scenario, but rather a “buy and build” plan.
“Thus, financial capital was not sufficient, they also had to have intellectual capital and relationship capital on their bench,” he said. “When we found the partner that embraced all of these factors as well as a history of buying and long-term building, we pulled the trigger and partnered with Ares and US Heart & Vascular Management. The partner we chose did not offer us the most money. We put a premium on these other criteria.”
“I always tell docs, know the culture of your group and your vision,” he said. “Before you go down that route, ask yourself what you want to accomplish and if it makes sense having a private equity partner to accomplish that vision with.”
For younger physicians or those with little control over buyouts, experts recommend they review their contracts and consider consulting with an attorney to better understand how the deal may affect their earnings and career prospects.
Those who have a much longer career runway need to weigh whether they want to work for a PE-linked practice, Mr. Strode said. For some, it’s time to check when their noncompete agreements end and find a position elsewhere.
Also, physicians should know their rights and the laws in their states regarding the corporate practice of medicine. Statutes vary by state, and knowing the provisions in your state helps doctors recognize their legal rights, learn possible exceptions to the requirements, and know the penalties for violations.
In Michigan, a group of physicians and other health professionals at Ascension St. John has voted to unionize. Doctors hope that the union, which includes advanced practice clinicians, nurse practitioners, and physician assistants, will help improve patient care and protect working conditions for staff, Dr. Wiener said.
She advises physicians who are unhappy after acquisitions to speak up and stick together.
“That’s the biggest thing I think physicians should start doing,” she said. “Support each other and stand up. You are stronger together.”
Why is PE so attracted to health care?
PE firms typically buy practices or hospitals, work to make the entities more profitable, and then sell them, with the goal of doubling or tripling their investment over a short period. In general, PE firms aim for annual returns exceeding 20% after 3-7 years.
These firms know that health care is relatively recession-proof, that providers have third-party payers, and that the industry is fragmented and requires more efficiency, Ms. Dooley said.
When PE practice acquisitions started gaining momentum about 12 years ago, traditional hospital-based specialties such as anesthesiology and radiology were prime targets, said Mr. Strode.
At the same time, increasing challenges in private practice, such as declining compensation from payers, pressure to participate in value-based care programs, and rising regional competitors have fueled more physician groups to partner with PE firms, Mr. Herschman noted.
Physicians who partner with PE firms often benefit by having new access to capital to grow their practices, cost savings through group purchasing, and the ability to compete with larger health groups, Mr. Herschman said.
Questions remain, however, about how PE involvement affects health care use and spending. An April 2023 JAMA Viewpoint article called out the lack of oversight and regulation in the health care/PE space, suggesting that a stronger framework for regulation and transparency is needed.
A 2022 study in JAMA Health Forum that examined changes in prices and utilization associated with the PE acquisitions of 578 dermatology, gastroenterology, and ophthalmology physician practices from 2016 to 2020 found that prices increased by an average of 11%, and volume rose by 16%, after acquisition.
“We found that acquisitions were associated with increases in health care spending and utilization, as well as some other patterns of care like potential upcoding,” said Jane M. Zhu, MD, an author of the study and assistant professor at Oregon Health & Science University in Portland.
Another recent study that Dr. Zhu coauthored, published in Health Affairs, found that physician practices acquired by PE firms experience greater staff turnover and rely more heavily on advanced practice professionals than doctors.
“To the extent that that turnover indicates physicians are dissatisfied after private equity comes in, that’s really important to investigate further,” Dr. Zhu said.
PE firms owned 4% of U.S. hospitals in 2021 and 11% of nursing homes, according to a Medicare Payment Advisory Commission (MedPAC) report. The report does not include 2021 data on medical practices but notes that from 2013 to 2016, PE firms acquired at least 2% of physician practices. Estimates of PE deals are probably lower than actual numbers because of the lack of comprehensive information sources, according to the MedPAC report.
A version of this article appeared on Medscape.com.
After her emergency medicine group was acquired by a staffing firm backed by a large private equity (PE) firm, Michelle Wiener, MD, said the workflow changes came swiftly.
“Our staffing has been greatly reduced,” the Detroit physician said. “At this point, we have no say in anything. We have no say in the scheduling. We aren’t allowed to see what is billed under our name. The morale has really gone down.”
Dr. Wiener, who practices at Ascension St. John Hospital, said she and fellow physicians have repeatedly brought their concerns to TeamHealth, which in 2015 took over St. John Emergency Services PC. TeamHealth is owned by PE giant Blackstone.
“It’s very frustrating,” Dr. Wiener said. “We’re taking it from all sides.”
Blackstone and Ascension St. John did not respond to this news organization’s request for comment.
TeamHealth would not respond directly to questions about the Ascension St. John Hospital physicians or their concerns.
Spokesman Josh Hopson provided only a general statement: “TeamHealth is committed to making sure that clinicians have the resources and support needed to provide first-class care to patients, particularly with regard to staffing and compensation. TeamHealth has and will always put patient care first, and that is not impacted by its ownership model.”
Acquisitions of medical practices and hospitals by PE firms are rapidly growing, with more than 1,400 PE deals in health care in 2021 totaling upwards of $208 billion, according to PitchBook Data Inc., a Seattle-based firm that tracks mergers and acquisitions.
Some physicians praise the partnerships as an opportunity to improve technology and efficiency, whereas others decry them as raising patient costs and lowering the quality of care. A recent UC Berkeley study found that PE ownership of medical practices was linked to consumer price increases for 8 of 10 specialties, most notably oncology and gastroenterology.
What should you expect after PE acquisition?
Since his practice partnered with a PE firm in 2020, Milwaukee-based otolaryngologist Madan Kandula, MD, said he has found the changes positive. The practice has grown and improved operations in finance, accounting, compliance, and information technology, said Dr. Kandula, founder and CEO of Advent, an ENT practice with 15 clinics in four Midwestern states.
Dr. Kandula said his group already had a sound business practice, and that the goal of partnering with a PE firm wasn’t to change day-to-day operations but to propel the organization forward.
“From patient load to visit time to how we staff our clinics, there has been no change,” he said. “My private equity firm does not, [and] cannot, impose their will on our clinical decisions.”
Experts say the impact of PE acquisitions on individual physicians often depends on where a doctor ranks in the organization, what stage they are in their career, and how much control they had over the deal.
“It’s the older physicians who are usually selling the practice and getting the big payout,” said Anjali Dooley, a St. Louis–based health law attorney who counsels physicians about PE deals. “The younger doctors are usually not part of the deal, as they may still be employees. They don’t have any negotiating power. Hopefully, there is some transparency, but sometimes there is not, and they are blindsided by the deal.”
When it comes to workload, most PE-owned groups are put on a production-based model, such as a wRVU-based model, said Roger Strode, a Chicago-based health law attorney who focuses on health care mergers and acquisitions. Most already operate under such a model, but there might be some changes after a buyout.
Staffing may also change, added Ms. Dooley. The PE firms may want to add partners or companies already in their portfolios to create efficiencies, causing training or workflow changes.
In a hospital buyout, changes may depend on whether a department is a significant revenue generator for the hospital, Ms. Dooley noted.
PE firms frequently favor higher revenue–generating specialties, such as neurosurgery, cardiology, orthopedics, gastroenterology, and plastic surgery. They closely scrutinize departments said that make less money, such as the emergency department or primary care, Ms. Dooley said. Physicians or teams that don’t fit the firm’s cost-efficiency plans may be terminated or replaced.
On the other hand, Mr. Strode said physicians may see improved electronic health records and collections.
“Some of your overall overhead costs may be reduced, because they’re better at it,” Mr. Strode said. “When you’ve got more scale, the cost per patient, the cost per hour, the cost per procedure, goes down, and the cost that’s applied against your production will go down. As [practices grow], they have more bargaining power with payers and you can potentially get better rates. At least, that’s the promise.”
Analysts note that PE health care acquisitions show no signs of slowing and that it pays for physicians to know what to expect and how to cope if their practice or hospital is acquired. Whether physicians have some control over a buyout or are blindsided by the transition, it’s critical to know what to consider, how workloads might change, and your options for settling in or settling up.
The PE industry has about $2 trillion lined up for potential investments in 2023, said Ms. Dooley.
“PE firms are looking at health care to expend some of this dry powder,” Ms. Dooley continued. “If done correctly, PE firms that are aware of health care regulations, compliance, and patient care issues can ... remove redundant services and improve ... efficiencies, but the bad is when that doesn’t happen, and the quality of care goes down or there are patient safety risks.”
How to prepare for and cope with PE partnerships
If your practice is considering a PE partnership, it’s important to explore the terms and conditions and carefully weigh the pros and cons, said Gary Herschman, a Newark, N.J.–based attorney who advises PE-owned physician groups.
“My recommendation is that physicians at a minimum conduct due diligence on all potential strategic options for their groups, and then make an informed decision regarding whether a partnership transaction is right for their group, as it’s not right for every group,” he said.
When Texas cardiologist Rick Snyder, MD, was considering PE partnerships, he spoke with physicians who made similar deals to determine whether they were satisfied years later, he said. In April, Snyder’s practice, HeartPlace, the largest physician-owned cardiology practice in Texas, was acquired by US Heart & Vascular, a practice management platform backed by PE firm Ares Management.
“I called every group that I knew that had done private equity for any meaningful amount of time,” Dr. Snyder said. “For the first year or two, everybody is in the honeymoon period. If the model is going to succeed or break down, it’s not going to be in the first year or two. So I wanted to talk to groups that had done this for a longer amount of time and find out what their pitfalls were. What would they have done differently? Has it been a productive relationship? Did they grow?”
Dr. Snyder, president of the Texas Medical Association, said his practice met with seven or eight firms before choosing one that best met their needs. His group wanted a platform that preserved their clinical autonomy, governance, and culture, he said. They also wanted to ensure they were not entering into a “buy and flip” scenario, but rather a “buy and build” plan.
“Thus, financial capital was not sufficient, they also had to have intellectual capital and relationship capital on their bench,” he said. “When we found the partner that embraced all of these factors as well as a history of buying and long-term building, we pulled the trigger and partnered with Ares and US Heart & Vascular Management. The partner we chose did not offer us the most money. We put a premium on these other criteria.”
“I always tell docs, know the culture of your group and your vision,” he said. “Before you go down that route, ask yourself what you want to accomplish and if it makes sense having a private equity partner to accomplish that vision with.”
For younger physicians or those with little control over buyouts, experts recommend they review their contracts and consider consulting with an attorney to better understand how the deal may affect their earnings and career prospects.
Those who have a much longer career runway need to weigh whether they want to work for a PE-linked practice, Mr. Strode said. For some, it’s time to check when their noncompete agreements end and find a position elsewhere.
Also, physicians should know their rights and the laws in their states regarding the corporate practice of medicine. Statutes vary by state, and knowing the provisions in your state helps doctors recognize their legal rights, learn possible exceptions to the requirements, and know the penalties for violations.
In Michigan, a group of physicians and other health professionals at Ascension St. John has voted to unionize. Doctors hope that the union, which includes advanced practice clinicians, nurse practitioners, and physician assistants, will help improve patient care and protect working conditions for staff, Dr. Wiener said.
She advises physicians who are unhappy after acquisitions to speak up and stick together.
“That’s the biggest thing I think physicians should start doing,” she said. “Support each other and stand up. You are stronger together.”
Why is PE so attracted to health care?
PE firms typically buy practices or hospitals, work to make the entities more profitable, and then sell them, with the goal of doubling or tripling their investment over a short period. In general, PE firms aim for annual returns exceeding 20% after 3-7 years.
These firms know that health care is relatively recession-proof, that providers have third-party payers, and that the industry is fragmented and requires more efficiency, Ms. Dooley said.
When PE practice acquisitions started gaining momentum about 12 years ago, traditional hospital-based specialties such as anesthesiology and radiology were prime targets, said Mr. Strode.
At the same time, increasing challenges in private practice, such as declining compensation from payers, pressure to participate in value-based care programs, and rising regional competitors have fueled more physician groups to partner with PE firms, Mr. Herschman noted.
Physicians who partner with PE firms often benefit by having new access to capital to grow their practices, cost savings through group purchasing, and the ability to compete with larger health groups, Mr. Herschman said.
Questions remain, however, about how PE involvement affects health care use and spending. An April 2023 JAMA Viewpoint article called out the lack of oversight and regulation in the health care/PE space, suggesting that a stronger framework for regulation and transparency is needed.
A 2022 study in JAMA Health Forum that examined changes in prices and utilization associated with the PE acquisitions of 578 dermatology, gastroenterology, and ophthalmology physician practices from 2016 to 2020 found that prices increased by an average of 11%, and volume rose by 16%, after acquisition.
“We found that acquisitions were associated with increases in health care spending and utilization, as well as some other patterns of care like potential upcoding,” said Jane M. Zhu, MD, an author of the study and assistant professor at Oregon Health & Science University in Portland.
Another recent study that Dr. Zhu coauthored, published in Health Affairs, found that physician practices acquired by PE firms experience greater staff turnover and rely more heavily on advanced practice professionals than doctors.
“To the extent that that turnover indicates physicians are dissatisfied after private equity comes in, that’s really important to investigate further,” Dr. Zhu said.
PE firms owned 4% of U.S. hospitals in 2021 and 11% of nursing homes, according to a Medicare Payment Advisory Commission (MedPAC) report. The report does not include 2021 data on medical practices but notes that from 2013 to 2016, PE firms acquired at least 2% of physician practices. Estimates of PE deals are probably lower than actual numbers because of the lack of comprehensive information sources, according to the MedPAC report.
A version of this article appeared on Medscape.com.
After her emergency medicine group was acquired by a staffing firm backed by a large private equity (PE) firm, Michelle Wiener, MD, said the workflow changes came swiftly.
“Our staffing has been greatly reduced,” the Detroit physician said. “At this point, we have no say in anything. We have no say in the scheduling. We aren’t allowed to see what is billed under our name. The morale has really gone down.”
Dr. Wiener, who practices at Ascension St. John Hospital, said she and fellow physicians have repeatedly brought their concerns to TeamHealth, which in 2015 took over St. John Emergency Services PC. TeamHealth is owned by PE giant Blackstone.
“It’s very frustrating,” Dr. Wiener said. “We’re taking it from all sides.”
Blackstone and Ascension St. John did not respond to this news organization’s request for comment.
TeamHealth would not respond directly to questions about the Ascension St. John Hospital physicians or their concerns.
Spokesman Josh Hopson provided only a general statement: “TeamHealth is committed to making sure that clinicians have the resources and support needed to provide first-class care to patients, particularly with regard to staffing and compensation. TeamHealth has and will always put patient care first, and that is not impacted by its ownership model.”
Acquisitions of medical practices and hospitals by PE firms are rapidly growing, with more than 1,400 PE deals in health care in 2021 totaling upwards of $208 billion, according to PitchBook Data Inc., a Seattle-based firm that tracks mergers and acquisitions.
Some physicians praise the partnerships as an opportunity to improve technology and efficiency, whereas others decry them as raising patient costs and lowering the quality of care. A recent UC Berkeley study found that PE ownership of medical practices was linked to consumer price increases for 8 of 10 specialties, most notably oncology and gastroenterology.
What should you expect after PE acquisition?
Since his practice partnered with a PE firm in 2020, Milwaukee-based otolaryngologist Madan Kandula, MD, said he has found the changes positive. The practice has grown and improved operations in finance, accounting, compliance, and information technology, said Dr. Kandula, founder and CEO of Advent, an ENT practice with 15 clinics in four Midwestern states.
Dr. Kandula said his group already had a sound business practice, and that the goal of partnering with a PE firm wasn’t to change day-to-day operations but to propel the organization forward.
“From patient load to visit time to how we staff our clinics, there has been no change,” he said. “My private equity firm does not, [and] cannot, impose their will on our clinical decisions.”
Experts say the impact of PE acquisitions on individual physicians often depends on where a doctor ranks in the organization, what stage they are in their career, and how much control they had over the deal.
“It’s the older physicians who are usually selling the practice and getting the big payout,” said Anjali Dooley, a St. Louis–based health law attorney who counsels physicians about PE deals. “The younger doctors are usually not part of the deal, as they may still be employees. They don’t have any negotiating power. Hopefully, there is some transparency, but sometimes there is not, and they are blindsided by the deal.”
When it comes to workload, most PE-owned groups are put on a production-based model, such as a wRVU-based model, said Roger Strode, a Chicago-based health law attorney who focuses on health care mergers and acquisitions. Most already operate under such a model, but there might be some changes after a buyout.
Staffing may also change, added Ms. Dooley. The PE firms may want to add partners or companies already in their portfolios to create efficiencies, causing training or workflow changes.
In a hospital buyout, changes may depend on whether a department is a significant revenue generator for the hospital, Ms. Dooley noted.
PE firms frequently favor higher revenue–generating specialties, such as neurosurgery, cardiology, orthopedics, gastroenterology, and plastic surgery. They closely scrutinize departments said that make less money, such as the emergency department or primary care, Ms. Dooley said. Physicians or teams that don’t fit the firm’s cost-efficiency plans may be terminated or replaced.
On the other hand, Mr. Strode said physicians may see improved electronic health records and collections.
“Some of your overall overhead costs may be reduced, because they’re better at it,” Mr. Strode said. “When you’ve got more scale, the cost per patient, the cost per hour, the cost per procedure, goes down, and the cost that’s applied against your production will go down. As [practices grow], they have more bargaining power with payers and you can potentially get better rates. At least, that’s the promise.”
Analysts note that PE health care acquisitions show no signs of slowing and that it pays for physicians to know what to expect and how to cope if their practice or hospital is acquired. Whether physicians have some control over a buyout or are blindsided by the transition, it’s critical to know what to consider, how workloads might change, and your options for settling in or settling up.
The PE industry has about $2 trillion lined up for potential investments in 2023, said Ms. Dooley.
“PE firms are looking at health care to expend some of this dry powder,” Ms. Dooley continued. “If done correctly, PE firms that are aware of health care regulations, compliance, and patient care issues can ... remove redundant services and improve ... efficiencies, but the bad is when that doesn’t happen, and the quality of care goes down or there are patient safety risks.”
How to prepare for and cope with PE partnerships
If your practice is considering a PE partnership, it’s important to explore the terms and conditions and carefully weigh the pros and cons, said Gary Herschman, a Newark, N.J.–based attorney who advises PE-owned physician groups.
“My recommendation is that physicians at a minimum conduct due diligence on all potential strategic options for their groups, and then make an informed decision regarding whether a partnership transaction is right for their group, as it’s not right for every group,” he said.
When Texas cardiologist Rick Snyder, MD, was considering PE partnerships, he spoke with physicians who made similar deals to determine whether they were satisfied years later, he said. In April, Snyder’s practice, HeartPlace, the largest physician-owned cardiology practice in Texas, was acquired by US Heart & Vascular, a practice management platform backed by PE firm Ares Management.
“I called every group that I knew that had done private equity for any meaningful amount of time,” Dr. Snyder said. “For the first year or two, everybody is in the honeymoon period. If the model is going to succeed or break down, it’s not going to be in the first year or two. So I wanted to talk to groups that had done this for a longer amount of time and find out what their pitfalls were. What would they have done differently? Has it been a productive relationship? Did they grow?”
Dr. Snyder, president of the Texas Medical Association, said his practice met with seven or eight firms before choosing one that best met their needs. His group wanted a platform that preserved their clinical autonomy, governance, and culture, he said. They also wanted to ensure they were not entering into a “buy and flip” scenario, but rather a “buy and build” plan.
“Thus, financial capital was not sufficient, they also had to have intellectual capital and relationship capital on their bench,” he said. “When we found the partner that embraced all of these factors as well as a history of buying and long-term building, we pulled the trigger and partnered with Ares and US Heart & Vascular Management. The partner we chose did not offer us the most money. We put a premium on these other criteria.”
“I always tell docs, know the culture of your group and your vision,” he said. “Before you go down that route, ask yourself what you want to accomplish and if it makes sense having a private equity partner to accomplish that vision with.”
For younger physicians or those with little control over buyouts, experts recommend they review their contracts and consider consulting with an attorney to better understand how the deal may affect their earnings and career prospects.
Those who have a much longer career runway need to weigh whether they want to work for a PE-linked practice, Mr. Strode said. For some, it’s time to check when their noncompete agreements end and find a position elsewhere.
Also, physicians should know their rights and the laws in their states regarding the corporate practice of medicine. Statutes vary by state, and knowing the provisions in your state helps doctors recognize their legal rights, learn possible exceptions to the requirements, and know the penalties for violations.
In Michigan, a group of physicians and other health professionals at Ascension St. John has voted to unionize. Doctors hope that the union, which includes advanced practice clinicians, nurse practitioners, and physician assistants, will help improve patient care and protect working conditions for staff, Dr. Wiener said.
She advises physicians who are unhappy after acquisitions to speak up and stick together.
“That’s the biggest thing I think physicians should start doing,” she said. “Support each other and stand up. You are stronger together.”
Why is PE so attracted to health care?
PE firms typically buy practices or hospitals, work to make the entities more profitable, and then sell them, with the goal of doubling or tripling their investment over a short period. In general, PE firms aim for annual returns exceeding 20% after 3-7 years.
These firms know that health care is relatively recession-proof, that providers have third-party payers, and that the industry is fragmented and requires more efficiency, Ms. Dooley said.
When PE practice acquisitions started gaining momentum about 12 years ago, traditional hospital-based specialties such as anesthesiology and radiology were prime targets, said Mr. Strode.
At the same time, increasing challenges in private practice, such as declining compensation from payers, pressure to participate in value-based care programs, and rising regional competitors have fueled more physician groups to partner with PE firms, Mr. Herschman noted.
Physicians who partner with PE firms often benefit by having new access to capital to grow their practices, cost savings through group purchasing, and the ability to compete with larger health groups, Mr. Herschman said.
Questions remain, however, about how PE involvement affects health care use and spending. An April 2023 JAMA Viewpoint article called out the lack of oversight and regulation in the health care/PE space, suggesting that a stronger framework for regulation and transparency is needed.
A 2022 study in JAMA Health Forum that examined changes in prices and utilization associated with the PE acquisitions of 578 dermatology, gastroenterology, and ophthalmology physician practices from 2016 to 2020 found that prices increased by an average of 11%, and volume rose by 16%, after acquisition.
“We found that acquisitions were associated with increases in health care spending and utilization, as well as some other patterns of care like potential upcoding,” said Jane M. Zhu, MD, an author of the study and assistant professor at Oregon Health & Science University in Portland.
Another recent study that Dr. Zhu coauthored, published in Health Affairs, found that physician practices acquired by PE firms experience greater staff turnover and rely more heavily on advanced practice professionals than doctors.
“To the extent that that turnover indicates physicians are dissatisfied after private equity comes in, that’s really important to investigate further,” Dr. Zhu said.
PE firms owned 4% of U.S. hospitals in 2021 and 11% of nursing homes, according to a Medicare Payment Advisory Commission (MedPAC) report. The report does not include 2021 data on medical practices but notes that from 2013 to 2016, PE firms acquired at least 2% of physician practices. Estimates of PE deals are probably lower than actual numbers because of the lack of comprehensive information sources, according to the MedPAC report.
A version of this article appeared on Medscape.com.
FDA approves elranatamab for multiple myeloma
The B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) was given Priority Review in February and had previously received Breakthrough Therapy Designation for relapsed or refractory multiple myeloma (RRMM), according to Pfizer.
FDA approval was based on favorable response and duration of response rates in the single-arm, phase 2 MagnetisMM-3 trial. The trial showed meaningful responses in heavily pretreated patients with RRMM who received elranatamab as their first BCMA-directed therapy.
The overall response rate in 97 BCMA-naive patients (cohort A) who previously received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, was 58%, with an estimated 82% maintaining the response for 9 months or longer. Median time to first response was 1.2 months.
In 63 patients who received at least four prior lines of therapy, which also included a BCMA-directed therapy, the overall response rate was 33% after median follow-up of 10.2 months. An estimated 84% maintained a response for at least 9 months.
Elranatamab was given subcutaneously at a dose of 76 mg weekly on a 28-day cycle with a step-up priming dose regimen. The priming regimen included 12 mg and 32 mg doses on days 1 and 4, respectively, during cycle 1. Patients who received at least six cycles and showed at least a partial response for 2 or more months had a biweekly dosing interval.
Elranatamab carries a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity, as well as warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo–fetal toxicity. Therefore, the agent is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS).
The boxed warning is included in the full prescribing information.
A confirmatory trial to gather additional safety and efficacy data was launched in 2022. Continued FDA approval is contingent on confirmed safety and efficacy data.
A version of this article first appeared on Medscape.com.
The B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) was given Priority Review in February and had previously received Breakthrough Therapy Designation for relapsed or refractory multiple myeloma (RRMM), according to Pfizer.
FDA approval was based on favorable response and duration of response rates in the single-arm, phase 2 MagnetisMM-3 trial. The trial showed meaningful responses in heavily pretreated patients with RRMM who received elranatamab as their first BCMA-directed therapy.
The overall response rate in 97 BCMA-naive patients (cohort A) who previously received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, was 58%, with an estimated 82% maintaining the response for 9 months or longer. Median time to first response was 1.2 months.
In 63 patients who received at least four prior lines of therapy, which also included a BCMA-directed therapy, the overall response rate was 33% after median follow-up of 10.2 months. An estimated 84% maintained a response for at least 9 months.
Elranatamab was given subcutaneously at a dose of 76 mg weekly on a 28-day cycle with a step-up priming dose regimen. The priming regimen included 12 mg and 32 mg doses on days 1 and 4, respectively, during cycle 1. Patients who received at least six cycles and showed at least a partial response for 2 or more months had a biweekly dosing interval.
Elranatamab carries a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity, as well as warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo–fetal toxicity. Therefore, the agent is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS).
The boxed warning is included in the full prescribing information.
A confirmatory trial to gather additional safety and efficacy data was launched in 2022. Continued FDA approval is contingent on confirmed safety and efficacy data.
A version of this article first appeared on Medscape.com.
The B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) was given Priority Review in February and had previously received Breakthrough Therapy Designation for relapsed or refractory multiple myeloma (RRMM), according to Pfizer.
FDA approval was based on favorable response and duration of response rates in the single-arm, phase 2 MagnetisMM-3 trial. The trial showed meaningful responses in heavily pretreated patients with RRMM who received elranatamab as their first BCMA-directed therapy.
The overall response rate in 97 BCMA-naive patients (cohort A) who previously received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, was 58%, with an estimated 82% maintaining the response for 9 months or longer. Median time to first response was 1.2 months.
In 63 patients who received at least four prior lines of therapy, which also included a BCMA-directed therapy, the overall response rate was 33% after median follow-up of 10.2 months. An estimated 84% maintained a response for at least 9 months.
Elranatamab was given subcutaneously at a dose of 76 mg weekly on a 28-day cycle with a step-up priming dose regimen. The priming regimen included 12 mg and 32 mg doses on days 1 and 4, respectively, during cycle 1. Patients who received at least six cycles and showed at least a partial response for 2 or more months had a biweekly dosing interval.
Elranatamab carries a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity, as well as warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo–fetal toxicity. Therefore, the agent is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS).
The boxed warning is included in the full prescribing information.
A confirmatory trial to gather additional safety and efficacy data was launched in 2022. Continued FDA approval is contingent on confirmed safety and efficacy data.
A version of this article first appeared on Medscape.com.
FDA OKs talquetamab, a first-in-class myeloma tx
Patients must have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
The agent, which also received breakthrough and orphan drug designation, is available only through the Tecvayli-Talvey Risk Evaluation and Mitigation Strategy (REMS) because of a boxed warning for life-threatening or fatal cytokine release syndrome (CRS) and neurological toxicity, including immune effector cell–associated neurotoxicity (ICANS), the FDA announced.
Talquetamab-tgvs was evaluated in the single-arm, open-label MonumenTAL-1 study of 187 patients who had previously been treated with at least four prior systemic therapies.
The overall response rate in 100 patients who received a subcutaneous dose of 0.4 mg/kg weekly was 73% and median duration of response was 9.5 months. The overall response rate in 87 patients who received a subcutaneous dose of 0.8 mg/kg biweekly was 73.6%, with about 85% of responders maintaining their response for at least 9 months. In this group, the median duration of response was not estimable.
Patients in the 0.4 mg/kg weekly dose group were treated following two step-up doses in the first week of therapy, and those in the 0.8 mg/kg biweekly group were treated following three step-up doses, until disease progression or unacceptable toxicity.
Adverse reactions occurring in at least 20% of the 339 patients in the safety population included CRS, dysgeusia (foul, metallic taste sensation), nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, decreased weight, dry mouth, pyrexia, xerosis, dysphagia, upper respiratory tract infection, and diarrhea.
Both the weekly 0.4 mg/kg and biweekly 0.8 mg/kg doses are recommended. The full dosing schedule is included in the prescribing information.
The approval follows a series of market withdrawals for other multiple myeloma drugs that initially received accelerated FDA approval. For instance, the FDA recently requested withdrawal of melphalan flufenamide (Pepaxto) after 2021 confirmatory trial results showed an increased risk of death. This agent had received accelerated approval in 2021. GlaxoSmithKline’s blood cancer drugs panobinostat (Farydak) and belantamab mafodotin-blmf (Blenrep) were also withdrawn based on confirmatory trial results.
Continued approval of talquetemab-tgvs for this indication is also contingent on verifying efficacy in confirmatory trials.
The new treatment approach represents a “welcome addition to the myeloma community,” Michael Andreini, president and chief executive officer of the Multiple Myeloma Research Foundation stated in a Janssen press release. “Although options for the treatment of multiple myeloma have expanded significantly in recent years, the disease remains incurable, and therefore, patients are in need of new treatment options.”
Health care professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
A version of this article first appeared on Medscape.com.
Patients must have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
The agent, which also received breakthrough and orphan drug designation, is available only through the Tecvayli-Talvey Risk Evaluation and Mitigation Strategy (REMS) because of a boxed warning for life-threatening or fatal cytokine release syndrome (CRS) and neurological toxicity, including immune effector cell–associated neurotoxicity (ICANS), the FDA announced.
Talquetamab-tgvs was evaluated in the single-arm, open-label MonumenTAL-1 study of 187 patients who had previously been treated with at least four prior systemic therapies.
The overall response rate in 100 patients who received a subcutaneous dose of 0.4 mg/kg weekly was 73% and median duration of response was 9.5 months. The overall response rate in 87 patients who received a subcutaneous dose of 0.8 mg/kg biweekly was 73.6%, with about 85% of responders maintaining their response for at least 9 months. In this group, the median duration of response was not estimable.
Patients in the 0.4 mg/kg weekly dose group were treated following two step-up doses in the first week of therapy, and those in the 0.8 mg/kg biweekly group were treated following three step-up doses, until disease progression or unacceptable toxicity.
Adverse reactions occurring in at least 20% of the 339 patients in the safety population included CRS, dysgeusia (foul, metallic taste sensation), nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, decreased weight, dry mouth, pyrexia, xerosis, dysphagia, upper respiratory tract infection, and diarrhea.
Both the weekly 0.4 mg/kg and biweekly 0.8 mg/kg doses are recommended. The full dosing schedule is included in the prescribing information.
The approval follows a series of market withdrawals for other multiple myeloma drugs that initially received accelerated FDA approval. For instance, the FDA recently requested withdrawal of melphalan flufenamide (Pepaxto) after 2021 confirmatory trial results showed an increased risk of death. This agent had received accelerated approval in 2021. GlaxoSmithKline’s blood cancer drugs panobinostat (Farydak) and belantamab mafodotin-blmf (Blenrep) were also withdrawn based on confirmatory trial results.
Continued approval of talquetemab-tgvs for this indication is also contingent on verifying efficacy in confirmatory trials.
The new treatment approach represents a “welcome addition to the myeloma community,” Michael Andreini, president and chief executive officer of the Multiple Myeloma Research Foundation stated in a Janssen press release. “Although options for the treatment of multiple myeloma have expanded significantly in recent years, the disease remains incurable, and therefore, patients are in need of new treatment options.”
Health care professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
A version of this article first appeared on Medscape.com.
Patients must have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
The agent, which also received breakthrough and orphan drug designation, is available only through the Tecvayli-Talvey Risk Evaluation and Mitigation Strategy (REMS) because of a boxed warning for life-threatening or fatal cytokine release syndrome (CRS) and neurological toxicity, including immune effector cell–associated neurotoxicity (ICANS), the FDA announced.
Talquetamab-tgvs was evaluated in the single-arm, open-label MonumenTAL-1 study of 187 patients who had previously been treated with at least four prior systemic therapies.
The overall response rate in 100 patients who received a subcutaneous dose of 0.4 mg/kg weekly was 73% and median duration of response was 9.5 months. The overall response rate in 87 patients who received a subcutaneous dose of 0.8 mg/kg biweekly was 73.6%, with about 85% of responders maintaining their response for at least 9 months. In this group, the median duration of response was not estimable.
Patients in the 0.4 mg/kg weekly dose group were treated following two step-up doses in the first week of therapy, and those in the 0.8 mg/kg biweekly group were treated following three step-up doses, until disease progression or unacceptable toxicity.
Adverse reactions occurring in at least 20% of the 339 patients in the safety population included CRS, dysgeusia (foul, metallic taste sensation), nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, decreased weight, dry mouth, pyrexia, xerosis, dysphagia, upper respiratory tract infection, and diarrhea.
Both the weekly 0.4 mg/kg and biweekly 0.8 mg/kg doses are recommended. The full dosing schedule is included in the prescribing information.
The approval follows a series of market withdrawals for other multiple myeloma drugs that initially received accelerated FDA approval. For instance, the FDA recently requested withdrawal of melphalan flufenamide (Pepaxto) after 2021 confirmatory trial results showed an increased risk of death. This agent had received accelerated approval in 2021. GlaxoSmithKline’s blood cancer drugs panobinostat (Farydak) and belantamab mafodotin-blmf (Blenrep) were also withdrawn based on confirmatory trial results.
Continued approval of talquetemab-tgvs for this indication is also contingent on verifying efficacy in confirmatory trials.
The new treatment approach represents a “welcome addition to the myeloma community,” Michael Andreini, president and chief executive officer of the Multiple Myeloma Research Foundation stated in a Janssen press release. “Although options for the treatment of multiple myeloma have expanded significantly in recent years, the disease remains incurable, and therefore, patients are in need of new treatment options.”
Health care professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
A version of this article first appeared on Medscape.com.
For CLL, BTKi combo bests chemoimmunotherapy
The analysis of the open-label FLAIR trial, published in The Lancet Oncology, tracked 771 patients with CLL for a median follow-up of 53 months (interquartile ratio, 41-61 months) and found that median progression-free survival was not reached with ibrutinib/rituximab versus 67 months with FCR (hazard ratio, 0.44, P < .0001).
“This paper is another confirmation to say that Bruton’s tyrosine kinase inhibitors are more powerful than even our strongest chemoimmunotherapy. That’s very reassuring,” said hematologist/oncologist Jan A. Burger, MD, PhD, of the University of Texas MD Anderson Cancer Center, Houston, in an interview. He did not take part in the analysis but is familiar with its findings.
There are caveats to the study. More patients in the ibrutinib/rituximab arm died of cardiac events, possibly reflecting a known risk of those drugs. And for unclear reasons, there was no difference in overall survival – a secondary endpoint – between the groups. The study authors speculate that this may be because some patients on FCR progressed and turned to effective second-line drugs.
Still, the findings are consistent with the landmark E1912 trial, the authors wrote, and adds “to a body of evidence that suggests that the use of ibrutinib-based regimens should be considered for patients with previously untreated CLL, especially those with IGHV-unmutated CLL.”
The study, partially funded by industry, was led by Peter Hillmen, PhD, of Leeds (England) Cancer Center.
According to Dr. Burger, FCR was the standard treatment for younger, fitter patients with CLL about 10-15 years ago. Then Bruton’s tyrosine kinase inhibitors such as ibrutinib entered the picture. But, as the new report notes, initial studies focused on older patients who weren’t considered fit enough to tolerate FCR.
The new study, like the E1912 trial, aimed to compare ibrutinib-rituximab versus FCR in younger, fitter patients.
From 2014 to 2018, researchers assigned 771 patients (median age, 62 years; IQR 56-67; 73% male; 95% White; 66% with World Health Organization performance status, 0) to FCR (n = 385) or ibrutinib/rituximab (n = 386).
Nearly three-quarters (74%) in the FCR group received six cycles of therapy, and 97% of those in the ibrutinib-rituximab group received six cycles of rituximab. Those in the ibrutinib-rituximab group also received daily doses of ibrutinib. Doses could be modified. The data cutoff was May 24, 2021.
Notably, there was no improvement in overall survival in the ibrutinib/rituximab group: 92.1% of patients lived 4 years versus 93.5% in the FCR group. This contrasts with an improvement in overall survival in the earlier E1912 study in the ibrutinib/rituximab group.
However, the study authors noted that overall survival in the FCR group is higher than in earlier studies, perhaps reflecting the wider availability of targeted therapy. The final study analysis will offer more insight into overall survival.
In an interview, hematologist David A. Bond, MD, of Ohio State University, Columbus, who is familiar with the study findings, said “the lack of an improvement in overall survival could be due to differences in available treatments at relapse, as the FLAIR study was conducted more recently than the prior E1912 study.” He added that “the younger ages in the E1912 study may have led to less risk for cardiovascular events or deaths for the patients treated with ibrutinib in the E1912 study.”
The previous E1912 trial showed a larger effect for ibrutinib/rituximab versus FCR on progression-free survival (HR, 0.37, P < .001 for E1912 and HR, 0.44, P< .0001 for the FLAIR trial). However, the study authors noted that FLAIR trial had older subjects (mean age, 62 vs 56.7 in the E1912 trial.)
As for grade 3 or 4 adverse events, leukopenia was most common in the FCR group (n = 203, 54%), compared with the ibrutinib/rituximab group (n = 55, 14%). Serious adverse events were reported in 205 (53%) of patients in the ibrutinib/rituximab group versus 203 (54%) patients in the FCR group.
All-cause infections, myelodysplastic syndrome, acute myeloid leukemia, Richter’s transformation, and other diagnosed cancers were rare but more common in the FCR group. Deaths from COVID-19 were the same at 3 in each group; 2 of 29 deaths in the FCR group and 3 of 30 deaths in the ibrutinib/rituximab group were considered to be likely linked to treatment.
Sudden unexplained or cardiac deaths were more common in the ibrutinib-rituximab group (n = 8, 2%) vs. the FCR group (n = 2, less than 1%).
Dr. Bond said “one of the takeaways for practicing hematologists from the FLAIR study is that cardiovascular complications and sudden cardiac death are clearly an issue for older patients with hypertension treated with ibrutinib. Patients should be monitored for signs or symptoms of cardiovascular disease and have close management of blood pressure.”
Dr. Burger also noted that cardiac problems are a known risk of ibrutinib. “Fortunately, we have second-generation Bruton’s tyrosine kinase inhibitors that could be chosen for patients when we are worried about side effects.”
He said that chemotherapy remains the preferred – or only – treatment in some parts of the world. And patients may prefer FCR to ibrutinib because of the latter drug’s side effects or a preference for therapy that doesn’t take as long.
The study was funded by Cancer Research UK and Janssen. The study authors reported relationships with companies such as Lilly, Janssen, AbbVie, AstraZeneca, BeiGene, Gilead, and many others. Dr. Burger reports financial support for clinical trials from Pharmacyclics, AstraZeneca, Biogen, and Janssen. Dr. Bond reported no disclosures.
The analysis of the open-label FLAIR trial, published in The Lancet Oncology, tracked 771 patients with CLL for a median follow-up of 53 months (interquartile ratio, 41-61 months) and found that median progression-free survival was not reached with ibrutinib/rituximab versus 67 months with FCR (hazard ratio, 0.44, P < .0001).
“This paper is another confirmation to say that Bruton’s tyrosine kinase inhibitors are more powerful than even our strongest chemoimmunotherapy. That’s very reassuring,” said hematologist/oncologist Jan A. Burger, MD, PhD, of the University of Texas MD Anderson Cancer Center, Houston, in an interview. He did not take part in the analysis but is familiar with its findings.
There are caveats to the study. More patients in the ibrutinib/rituximab arm died of cardiac events, possibly reflecting a known risk of those drugs. And for unclear reasons, there was no difference in overall survival – a secondary endpoint – between the groups. The study authors speculate that this may be because some patients on FCR progressed and turned to effective second-line drugs.
Still, the findings are consistent with the landmark E1912 trial, the authors wrote, and adds “to a body of evidence that suggests that the use of ibrutinib-based regimens should be considered for patients with previously untreated CLL, especially those with IGHV-unmutated CLL.”
The study, partially funded by industry, was led by Peter Hillmen, PhD, of Leeds (England) Cancer Center.
According to Dr. Burger, FCR was the standard treatment for younger, fitter patients with CLL about 10-15 years ago. Then Bruton’s tyrosine kinase inhibitors such as ibrutinib entered the picture. But, as the new report notes, initial studies focused on older patients who weren’t considered fit enough to tolerate FCR.
The new study, like the E1912 trial, aimed to compare ibrutinib-rituximab versus FCR in younger, fitter patients.
From 2014 to 2018, researchers assigned 771 patients (median age, 62 years; IQR 56-67; 73% male; 95% White; 66% with World Health Organization performance status, 0) to FCR (n = 385) or ibrutinib/rituximab (n = 386).
Nearly three-quarters (74%) in the FCR group received six cycles of therapy, and 97% of those in the ibrutinib-rituximab group received six cycles of rituximab. Those in the ibrutinib-rituximab group also received daily doses of ibrutinib. Doses could be modified. The data cutoff was May 24, 2021.
Notably, there was no improvement in overall survival in the ibrutinib/rituximab group: 92.1% of patients lived 4 years versus 93.5% in the FCR group. This contrasts with an improvement in overall survival in the earlier E1912 study in the ibrutinib/rituximab group.
However, the study authors noted that overall survival in the FCR group is higher than in earlier studies, perhaps reflecting the wider availability of targeted therapy. The final study analysis will offer more insight into overall survival.
In an interview, hematologist David A. Bond, MD, of Ohio State University, Columbus, who is familiar with the study findings, said “the lack of an improvement in overall survival could be due to differences in available treatments at relapse, as the FLAIR study was conducted more recently than the prior E1912 study.” He added that “the younger ages in the E1912 study may have led to less risk for cardiovascular events or deaths for the patients treated with ibrutinib in the E1912 study.”
The previous E1912 trial showed a larger effect for ibrutinib/rituximab versus FCR on progression-free survival (HR, 0.37, P < .001 for E1912 and HR, 0.44, P< .0001 for the FLAIR trial). However, the study authors noted that FLAIR trial had older subjects (mean age, 62 vs 56.7 in the E1912 trial.)
As for grade 3 or 4 adverse events, leukopenia was most common in the FCR group (n = 203, 54%), compared with the ibrutinib/rituximab group (n = 55, 14%). Serious adverse events were reported in 205 (53%) of patients in the ibrutinib/rituximab group versus 203 (54%) patients in the FCR group.
All-cause infections, myelodysplastic syndrome, acute myeloid leukemia, Richter’s transformation, and other diagnosed cancers were rare but more common in the FCR group. Deaths from COVID-19 were the same at 3 in each group; 2 of 29 deaths in the FCR group and 3 of 30 deaths in the ibrutinib/rituximab group were considered to be likely linked to treatment.
Sudden unexplained or cardiac deaths were more common in the ibrutinib-rituximab group (n = 8, 2%) vs. the FCR group (n = 2, less than 1%).
Dr. Bond said “one of the takeaways for practicing hematologists from the FLAIR study is that cardiovascular complications and sudden cardiac death are clearly an issue for older patients with hypertension treated with ibrutinib. Patients should be monitored for signs or symptoms of cardiovascular disease and have close management of blood pressure.”
Dr. Burger also noted that cardiac problems are a known risk of ibrutinib. “Fortunately, we have second-generation Bruton’s tyrosine kinase inhibitors that could be chosen for patients when we are worried about side effects.”
He said that chemotherapy remains the preferred – or only – treatment in some parts of the world. And patients may prefer FCR to ibrutinib because of the latter drug’s side effects or a preference for therapy that doesn’t take as long.
The study was funded by Cancer Research UK and Janssen. The study authors reported relationships with companies such as Lilly, Janssen, AbbVie, AstraZeneca, BeiGene, Gilead, and many others. Dr. Burger reports financial support for clinical trials from Pharmacyclics, AstraZeneca, Biogen, and Janssen. Dr. Bond reported no disclosures.
The analysis of the open-label FLAIR trial, published in The Lancet Oncology, tracked 771 patients with CLL for a median follow-up of 53 months (interquartile ratio, 41-61 months) and found that median progression-free survival was not reached with ibrutinib/rituximab versus 67 months with FCR (hazard ratio, 0.44, P < .0001).
“This paper is another confirmation to say that Bruton’s tyrosine kinase inhibitors are more powerful than even our strongest chemoimmunotherapy. That’s very reassuring,” said hematologist/oncologist Jan A. Burger, MD, PhD, of the University of Texas MD Anderson Cancer Center, Houston, in an interview. He did not take part in the analysis but is familiar with its findings.
There are caveats to the study. More patients in the ibrutinib/rituximab arm died of cardiac events, possibly reflecting a known risk of those drugs. And for unclear reasons, there was no difference in overall survival – a secondary endpoint – between the groups. The study authors speculate that this may be because some patients on FCR progressed and turned to effective second-line drugs.
Still, the findings are consistent with the landmark E1912 trial, the authors wrote, and adds “to a body of evidence that suggests that the use of ibrutinib-based regimens should be considered for patients with previously untreated CLL, especially those with IGHV-unmutated CLL.”
The study, partially funded by industry, was led by Peter Hillmen, PhD, of Leeds (England) Cancer Center.
According to Dr. Burger, FCR was the standard treatment for younger, fitter patients with CLL about 10-15 years ago. Then Bruton’s tyrosine kinase inhibitors such as ibrutinib entered the picture. But, as the new report notes, initial studies focused on older patients who weren’t considered fit enough to tolerate FCR.
The new study, like the E1912 trial, aimed to compare ibrutinib-rituximab versus FCR in younger, fitter patients.
From 2014 to 2018, researchers assigned 771 patients (median age, 62 years; IQR 56-67; 73% male; 95% White; 66% with World Health Organization performance status, 0) to FCR (n = 385) or ibrutinib/rituximab (n = 386).
Nearly three-quarters (74%) in the FCR group received six cycles of therapy, and 97% of those in the ibrutinib-rituximab group received six cycles of rituximab. Those in the ibrutinib-rituximab group also received daily doses of ibrutinib. Doses could be modified. The data cutoff was May 24, 2021.
Notably, there was no improvement in overall survival in the ibrutinib/rituximab group: 92.1% of patients lived 4 years versus 93.5% in the FCR group. This contrasts with an improvement in overall survival in the earlier E1912 study in the ibrutinib/rituximab group.
However, the study authors noted that overall survival in the FCR group is higher than in earlier studies, perhaps reflecting the wider availability of targeted therapy. The final study analysis will offer more insight into overall survival.
In an interview, hematologist David A. Bond, MD, of Ohio State University, Columbus, who is familiar with the study findings, said “the lack of an improvement in overall survival could be due to differences in available treatments at relapse, as the FLAIR study was conducted more recently than the prior E1912 study.” He added that “the younger ages in the E1912 study may have led to less risk for cardiovascular events or deaths for the patients treated with ibrutinib in the E1912 study.”
The previous E1912 trial showed a larger effect for ibrutinib/rituximab versus FCR on progression-free survival (HR, 0.37, P < .001 for E1912 and HR, 0.44, P< .0001 for the FLAIR trial). However, the study authors noted that FLAIR trial had older subjects (mean age, 62 vs 56.7 in the E1912 trial.)
As for grade 3 or 4 adverse events, leukopenia was most common in the FCR group (n = 203, 54%), compared with the ibrutinib/rituximab group (n = 55, 14%). Serious adverse events were reported in 205 (53%) of patients in the ibrutinib/rituximab group versus 203 (54%) patients in the FCR group.
All-cause infections, myelodysplastic syndrome, acute myeloid leukemia, Richter’s transformation, and other diagnosed cancers were rare but more common in the FCR group. Deaths from COVID-19 were the same at 3 in each group; 2 of 29 deaths in the FCR group and 3 of 30 deaths in the ibrutinib/rituximab group were considered to be likely linked to treatment.
Sudden unexplained or cardiac deaths were more common in the ibrutinib-rituximab group (n = 8, 2%) vs. the FCR group (n = 2, less than 1%).
Dr. Bond said “one of the takeaways for practicing hematologists from the FLAIR study is that cardiovascular complications and sudden cardiac death are clearly an issue for older patients with hypertension treated with ibrutinib. Patients should be monitored for signs or symptoms of cardiovascular disease and have close management of blood pressure.”
Dr. Burger also noted that cardiac problems are a known risk of ibrutinib. “Fortunately, we have second-generation Bruton’s tyrosine kinase inhibitors that could be chosen for patients when we are worried about side effects.”
He said that chemotherapy remains the preferred – or only – treatment in some parts of the world. And patients may prefer FCR to ibrutinib because of the latter drug’s side effects or a preference for therapy that doesn’t take as long.
The study was funded by Cancer Research UK and Janssen. The study authors reported relationships with companies such as Lilly, Janssen, AbbVie, AstraZeneca, BeiGene, Gilead, and many others. Dr. Burger reports financial support for clinical trials from Pharmacyclics, AstraZeneca, Biogen, and Janssen. Dr. Bond reported no disclosures.
FROM THE LANCET ONCOLOGY
We asked doctors using AI scribes: Just how good are they?
Andrea Partida, DO, an obstetrician and gynecologist in Enid, Okla., loves her new assistant.
The 15 or 20 minutes she used to spend on documentation for each patient visit is now 3. The 2-3 hours she’d spend charting outside clinic hours is maybe 1.
All that time saved allows her to see two to five more patients a day, provide better care to each patient, and get more involved in hospital leadership at Integris Health, where she works.
“I have a better work-life balance with my family,” Dr. Partida said. “I leave work at work and get home earlier.”
You’ve probably figured out the plot twist: Dr. Partida’s assistant is not a person – it’s artificial intelligence (AI).
Dr. Partida uses IRIS, a tool from OnPoint Healthcare Partners, part of a fast-growing niche of AI medical scribes designed to automate onerous data entry. The evolution of generative AI – specifically, large language models, such as ChatGPT – has led to a rapid explosion of these tools. Other companies in the space include Abridge, Ambience Healthcare, Augmedix, DeepScribe, Nuance (part of Microsoft), and Suki. The newest kid on the block, Amazon Web Services, announced the launch of HealthScribe in July.
These tools – some of which are already on the market, with more on the way – record patient visits and generate notes for treatment and billing. Earlier iterations combine AI with offsite human scribes who provide quality control. But more and more are fully automated, no human required. Some also offer video recording and foreign language translation.
The promise is alluring: Ease your workload and reclaim hours in your day so you can spend more time with patients or try that “work-life balance” thing you’ve heard so much about.
But do these tools fulfill that promise?
According to Dr. Partida and other doctors who spoke with this news organization, the answer is a resounding yes.
A tech solution for a tech problem
“I believe a lot of doctors see patients for free. They get paid to do paperwork,” said Anthony J. Mazzarelli, MD, JD, MBE, co-president and CEO of Cooper University Health Care, in Camden, N.J.
Indeed, for every hour U.S. clinicians spend with their patients, they may spend 2 more hours documenting in electronic health records (EHRs), estimates show. About half of doctors, especially those in primary care, report feeling burned out, and some 42% say they want to quit clinical practice.
Enter AI scribes.
“The holy grail in medicine right now is improving burnout while also maintaining or improving productivity and quality,” said Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford (Calif.) Health Care. “These ambient digital scribes have the potential to do just that.”
While anyone can buy these products, their use has been mostly limited to pilot programs and early adopters so far, said Dr. Garcia, who has been helping to pilot Nuance’s digital scribe, DAX, at Stanford.
But that’s expected to change quickly. “I don’t think the time horizon is a decade,” Dr. Garcia said. “I think within a matter of 2 or 3 years, these tools will be pervasive throughout health care.”
Since introducing these tools at Cooper, “our doctors’ paperwork burden is significantly lighter,” said Dr. Mazzarelli, who decides which technologies Cooper should invest in and who monitors their results. In Cooper studies, physicians who used DAX more than half the time spent 43% less time working on notes.
“They spend more time connecting with their patients, talking with them, and looking them in the eye,” Dr. Mazzarelli said. That, in turn, seems to improve patient outcomes, reduce doctor burnout and turnover, and lower costs.
The AI scribes, by virtue of eliminating the distraction of note taking, also allow doctors to give their full attention to the patient. “The patient relationship is the most important aspect of medicine,” said Raul Ayala, MD, MHCM, a family medicine physician at Adventist Health, in Hanford, Calif., who uses Augmedix. The digital scribe “helps us strengthen that relationship.”
What’s it like to use an AI medical scribe?
The scribes feature hardware (typically a smartphone or tablet) and software built on automatic speech recognition, natural language processing, and machine learning. Download an app to your device, and you’re ready to go. Use it to record in-person or telehealth visits.
In the first week, a company may help train you to use the hardware and software. You’ll likely start by using it for a few patient visits per day, ramping up gradually. Dr. Partida said she was comfortable using the system for all her patients in 6 weeks.
Each day, Dr. Partida logs in to a dedicated smartphone or tablet, opens the app, and reviews her schedule, including details she needs to prepare for each patient.
At the start of each patient visit, Dr. Partida taps the app icon to begin recording and lays the device nearby. She can pause as needed. At the end of the visit, she taps the icon again to stop recording.
The AI listens, creates the note, and updates relevant data in the EHR. The note includes patient problems, assessment, treatment plan, patient history, orders, and tasks for staff, along with medications, referrals, and preauthorizations. A human scribe, who is also a physician, reviews the information for accuracy and edits it as needed. By the next morning, the data are ready for Dr. Partida to review.
Fully automated versions can generate notes much faster. Jack Shilling, MD, MBA, an orthopedic surgeon at Cooper University Health Care, in Voorhees, N.J., uses DAX. A new feature called DAX Express – which uses OpenAI’s GPT-4 but no humans – provides him with a draft of his clinical notes in just seconds.
How accurate are AI notes?
The accuracy of those notes remains an open question, Dr. Garcia said – mostly because accuracy can be hard to define.
“If you asked five docs to write a note based on the same patient encounter, you’d get five different notes,” Dr. Garcia said. “That makes it hard to assess these technologies in a scientifically rigorous way.”
Still, the onus is on the physician to review the notes and edit them as needed, Dr. Garcia said. How light or heavy those edits are can depend on your unique preferences.
Dr. Shilling said he may need to lightly edit transcripts of his conversations with patients. “When someone tells me how long their knee hurts, slight variability in their transcribed words is tolerable,” he said. But for some things – such as physical exam notes and x-ray readings – he dictates directly into the device, speaking at a closer range and being less conversational, more exact in his speech.
Should you let patients know they’re being recorded?
The federal Health Insurance Portability and Accountability Act (HIPAA) does not require providers to inform patients that their face-to-face conversations are being recorded, said Daniel Lebovic, JD, corporate legal counsel at Compliancy Group, in Greenlawn, N.Y., a company that helps providers adhere to HIPAA rules.
But make sure you know the laws in your state and the policies at your health care practice. State laws may require providers to inform patients and to get patients’ consent in advance of being recorded.
All the doctors who spoke to this news organization said their patients are informed that they’ll be recorded and that they can opt out if they wish.
How much do AI scribes cost?
As the marketplace for these tools expands, companies are offering more products and services at different price points that target a range of organizations, from large health care systems to small private practices.
Price models vary, said Dr. Garcia. Some are based on the number of users, others on the number of notes, and still others on minutes.
Amazon’s HealthScribe is priced at 10 cents per minute. For 1,000 consultation transcripts per month, with each call averaging 15 minutes, it would take 15,000 minutes at a total cost of $1,500 for the month.
In general, the rapidly growing competition in this space could mean prices become more affordable, Dr. Garcia said. “It’s good that so many are getting into this game, because that means the price will come down and it will be a lot more accessible to everybody.”
A version of this article appeared on Medscape.com.
Andrea Partida, DO, an obstetrician and gynecologist in Enid, Okla., loves her new assistant.
The 15 or 20 minutes she used to spend on documentation for each patient visit is now 3. The 2-3 hours she’d spend charting outside clinic hours is maybe 1.
All that time saved allows her to see two to five more patients a day, provide better care to each patient, and get more involved in hospital leadership at Integris Health, where she works.
“I have a better work-life balance with my family,” Dr. Partida said. “I leave work at work and get home earlier.”
You’ve probably figured out the plot twist: Dr. Partida’s assistant is not a person – it’s artificial intelligence (AI).
Dr. Partida uses IRIS, a tool from OnPoint Healthcare Partners, part of a fast-growing niche of AI medical scribes designed to automate onerous data entry. The evolution of generative AI – specifically, large language models, such as ChatGPT – has led to a rapid explosion of these tools. Other companies in the space include Abridge, Ambience Healthcare, Augmedix, DeepScribe, Nuance (part of Microsoft), and Suki. The newest kid on the block, Amazon Web Services, announced the launch of HealthScribe in July.
These tools – some of which are already on the market, with more on the way – record patient visits and generate notes for treatment and billing. Earlier iterations combine AI with offsite human scribes who provide quality control. But more and more are fully automated, no human required. Some also offer video recording and foreign language translation.
The promise is alluring: Ease your workload and reclaim hours in your day so you can spend more time with patients or try that “work-life balance” thing you’ve heard so much about.
But do these tools fulfill that promise?
According to Dr. Partida and other doctors who spoke with this news organization, the answer is a resounding yes.
A tech solution for a tech problem
“I believe a lot of doctors see patients for free. They get paid to do paperwork,” said Anthony J. Mazzarelli, MD, JD, MBE, co-president and CEO of Cooper University Health Care, in Camden, N.J.
Indeed, for every hour U.S. clinicians spend with their patients, they may spend 2 more hours documenting in electronic health records (EHRs), estimates show. About half of doctors, especially those in primary care, report feeling burned out, and some 42% say they want to quit clinical practice.
Enter AI scribes.
“The holy grail in medicine right now is improving burnout while also maintaining or improving productivity and quality,” said Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford (Calif.) Health Care. “These ambient digital scribes have the potential to do just that.”
While anyone can buy these products, their use has been mostly limited to pilot programs and early adopters so far, said Dr. Garcia, who has been helping to pilot Nuance’s digital scribe, DAX, at Stanford.
But that’s expected to change quickly. “I don’t think the time horizon is a decade,” Dr. Garcia said. “I think within a matter of 2 or 3 years, these tools will be pervasive throughout health care.”
Since introducing these tools at Cooper, “our doctors’ paperwork burden is significantly lighter,” said Dr. Mazzarelli, who decides which technologies Cooper should invest in and who monitors their results. In Cooper studies, physicians who used DAX more than half the time spent 43% less time working on notes.
“They spend more time connecting with their patients, talking with them, and looking them in the eye,” Dr. Mazzarelli said. That, in turn, seems to improve patient outcomes, reduce doctor burnout and turnover, and lower costs.
The AI scribes, by virtue of eliminating the distraction of note taking, also allow doctors to give their full attention to the patient. “The patient relationship is the most important aspect of medicine,” said Raul Ayala, MD, MHCM, a family medicine physician at Adventist Health, in Hanford, Calif., who uses Augmedix. The digital scribe “helps us strengthen that relationship.”
What’s it like to use an AI medical scribe?
The scribes feature hardware (typically a smartphone or tablet) and software built on automatic speech recognition, natural language processing, and machine learning. Download an app to your device, and you’re ready to go. Use it to record in-person or telehealth visits.
In the first week, a company may help train you to use the hardware and software. You’ll likely start by using it for a few patient visits per day, ramping up gradually. Dr. Partida said she was comfortable using the system for all her patients in 6 weeks.
Each day, Dr. Partida logs in to a dedicated smartphone or tablet, opens the app, and reviews her schedule, including details she needs to prepare for each patient.
At the start of each patient visit, Dr. Partida taps the app icon to begin recording and lays the device nearby. She can pause as needed. At the end of the visit, she taps the icon again to stop recording.
The AI listens, creates the note, and updates relevant data in the EHR. The note includes patient problems, assessment, treatment plan, patient history, orders, and tasks for staff, along with medications, referrals, and preauthorizations. A human scribe, who is also a physician, reviews the information for accuracy and edits it as needed. By the next morning, the data are ready for Dr. Partida to review.
Fully automated versions can generate notes much faster. Jack Shilling, MD, MBA, an orthopedic surgeon at Cooper University Health Care, in Voorhees, N.J., uses DAX. A new feature called DAX Express – which uses OpenAI’s GPT-4 but no humans – provides him with a draft of his clinical notes in just seconds.
How accurate are AI notes?
The accuracy of those notes remains an open question, Dr. Garcia said – mostly because accuracy can be hard to define.
“If you asked five docs to write a note based on the same patient encounter, you’d get five different notes,” Dr. Garcia said. “That makes it hard to assess these technologies in a scientifically rigorous way.”
Still, the onus is on the physician to review the notes and edit them as needed, Dr. Garcia said. How light or heavy those edits are can depend on your unique preferences.
Dr. Shilling said he may need to lightly edit transcripts of his conversations with patients. “When someone tells me how long their knee hurts, slight variability in their transcribed words is tolerable,” he said. But for some things – such as physical exam notes and x-ray readings – he dictates directly into the device, speaking at a closer range and being less conversational, more exact in his speech.
Should you let patients know they’re being recorded?
The federal Health Insurance Portability and Accountability Act (HIPAA) does not require providers to inform patients that their face-to-face conversations are being recorded, said Daniel Lebovic, JD, corporate legal counsel at Compliancy Group, in Greenlawn, N.Y., a company that helps providers adhere to HIPAA rules.
But make sure you know the laws in your state and the policies at your health care practice. State laws may require providers to inform patients and to get patients’ consent in advance of being recorded.
All the doctors who spoke to this news organization said their patients are informed that they’ll be recorded and that they can opt out if they wish.
How much do AI scribes cost?
As the marketplace for these tools expands, companies are offering more products and services at different price points that target a range of organizations, from large health care systems to small private practices.
Price models vary, said Dr. Garcia. Some are based on the number of users, others on the number of notes, and still others on minutes.
Amazon’s HealthScribe is priced at 10 cents per minute. For 1,000 consultation transcripts per month, with each call averaging 15 minutes, it would take 15,000 minutes at a total cost of $1,500 for the month.
In general, the rapidly growing competition in this space could mean prices become more affordable, Dr. Garcia said. “It’s good that so many are getting into this game, because that means the price will come down and it will be a lot more accessible to everybody.”
A version of this article appeared on Medscape.com.
Andrea Partida, DO, an obstetrician and gynecologist in Enid, Okla., loves her new assistant.
The 15 or 20 minutes she used to spend on documentation for each patient visit is now 3. The 2-3 hours she’d spend charting outside clinic hours is maybe 1.
All that time saved allows her to see two to five more patients a day, provide better care to each patient, and get more involved in hospital leadership at Integris Health, where she works.
“I have a better work-life balance with my family,” Dr. Partida said. “I leave work at work and get home earlier.”
You’ve probably figured out the plot twist: Dr. Partida’s assistant is not a person – it’s artificial intelligence (AI).
Dr. Partida uses IRIS, a tool from OnPoint Healthcare Partners, part of a fast-growing niche of AI medical scribes designed to automate onerous data entry. The evolution of generative AI – specifically, large language models, such as ChatGPT – has led to a rapid explosion of these tools. Other companies in the space include Abridge, Ambience Healthcare, Augmedix, DeepScribe, Nuance (part of Microsoft), and Suki. The newest kid on the block, Amazon Web Services, announced the launch of HealthScribe in July.
These tools – some of which are already on the market, with more on the way – record patient visits and generate notes for treatment and billing. Earlier iterations combine AI with offsite human scribes who provide quality control. But more and more are fully automated, no human required. Some also offer video recording and foreign language translation.
The promise is alluring: Ease your workload and reclaim hours in your day so you can spend more time with patients or try that “work-life balance” thing you’ve heard so much about.
But do these tools fulfill that promise?
According to Dr. Partida and other doctors who spoke with this news organization, the answer is a resounding yes.
A tech solution for a tech problem
“I believe a lot of doctors see patients for free. They get paid to do paperwork,” said Anthony J. Mazzarelli, MD, JD, MBE, co-president and CEO of Cooper University Health Care, in Camden, N.J.
Indeed, for every hour U.S. clinicians spend with their patients, they may spend 2 more hours documenting in electronic health records (EHRs), estimates show. About half of doctors, especially those in primary care, report feeling burned out, and some 42% say they want to quit clinical practice.
Enter AI scribes.
“The holy grail in medicine right now is improving burnout while also maintaining or improving productivity and quality,” said Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford (Calif.) Health Care. “These ambient digital scribes have the potential to do just that.”
While anyone can buy these products, their use has been mostly limited to pilot programs and early adopters so far, said Dr. Garcia, who has been helping to pilot Nuance’s digital scribe, DAX, at Stanford.
But that’s expected to change quickly. “I don’t think the time horizon is a decade,” Dr. Garcia said. “I think within a matter of 2 or 3 years, these tools will be pervasive throughout health care.”
Since introducing these tools at Cooper, “our doctors’ paperwork burden is significantly lighter,” said Dr. Mazzarelli, who decides which technologies Cooper should invest in and who monitors their results. In Cooper studies, physicians who used DAX more than half the time spent 43% less time working on notes.
“They spend more time connecting with their patients, talking with them, and looking them in the eye,” Dr. Mazzarelli said. That, in turn, seems to improve patient outcomes, reduce doctor burnout and turnover, and lower costs.
The AI scribes, by virtue of eliminating the distraction of note taking, also allow doctors to give their full attention to the patient. “The patient relationship is the most important aspect of medicine,” said Raul Ayala, MD, MHCM, a family medicine physician at Adventist Health, in Hanford, Calif., who uses Augmedix. The digital scribe “helps us strengthen that relationship.”
What’s it like to use an AI medical scribe?
The scribes feature hardware (typically a smartphone or tablet) and software built on automatic speech recognition, natural language processing, and machine learning. Download an app to your device, and you’re ready to go. Use it to record in-person or telehealth visits.
In the first week, a company may help train you to use the hardware and software. You’ll likely start by using it for a few patient visits per day, ramping up gradually. Dr. Partida said she was comfortable using the system for all her patients in 6 weeks.
Each day, Dr. Partida logs in to a dedicated smartphone or tablet, opens the app, and reviews her schedule, including details she needs to prepare for each patient.
At the start of each patient visit, Dr. Partida taps the app icon to begin recording and lays the device nearby. She can pause as needed. At the end of the visit, she taps the icon again to stop recording.
The AI listens, creates the note, and updates relevant data in the EHR. The note includes patient problems, assessment, treatment plan, patient history, orders, and tasks for staff, along with medications, referrals, and preauthorizations. A human scribe, who is also a physician, reviews the information for accuracy and edits it as needed. By the next morning, the data are ready for Dr. Partida to review.
Fully automated versions can generate notes much faster. Jack Shilling, MD, MBA, an orthopedic surgeon at Cooper University Health Care, in Voorhees, N.J., uses DAX. A new feature called DAX Express – which uses OpenAI’s GPT-4 but no humans – provides him with a draft of his clinical notes in just seconds.
How accurate are AI notes?
The accuracy of those notes remains an open question, Dr. Garcia said – mostly because accuracy can be hard to define.
“If you asked five docs to write a note based on the same patient encounter, you’d get five different notes,” Dr. Garcia said. “That makes it hard to assess these technologies in a scientifically rigorous way.”
Still, the onus is on the physician to review the notes and edit them as needed, Dr. Garcia said. How light or heavy those edits are can depend on your unique preferences.
Dr. Shilling said he may need to lightly edit transcripts of his conversations with patients. “When someone tells me how long their knee hurts, slight variability in their transcribed words is tolerable,” he said. But for some things – such as physical exam notes and x-ray readings – he dictates directly into the device, speaking at a closer range and being less conversational, more exact in his speech.
Should you let patients know they’re being recorded?
The federal Health Insurance Portability and Accountability Act (HIPAA) does not require providers to inform patients that their face-to-face conversations are being recorded, said Daniel Lebovic, JD, corporate legal counsel at Compliancy Group, in Greenlawn, N.Y., a company that helps providers adhere to HIPAA rules.
But make sure you know the laws in your state and the policies at your health care practice. State laws may require providers to inform patients and to get patients’ consent in advance of being recorded.
All the doctors who spoke to this news organization said their patients are informed that they’ll be recorded and that they can opt out if they wish.
How much do AI scribes cost?
As the marketplace for these tools expands, companies are offering more products and services at different price points that target a range of organizations, from large health care systems to small private practices.
Price models vary, said Dr. Garcia. Some are based on the number of users, others on the number of notes, and still others on minutes.
Amazon’s HealthScribe is priced at 10 cents per minute. For 1,000 consultation transcripts per month, with each call averaging 15 minutes, it would take 15,000 minutes at a total cost of $1,500 for the month.
In general, the rapidly growing competition in this space could mean prices become more affordable, Dr. Garcia said. “It’s good that so many are getting into this game, because that means the price will come down and it will be a lot more accessible to everybody.”
A version of this article appeared on Medscape.com.
Drug name confusion: More than 80 new drug pairs added to the list
Zolpidem (Ambien) is a well-known sedative for sleep. Letairis (Ambrisentan) is a vasodilator for the treatment of pulmonary arterial hypertension. Citalopram (Celexa) is an antidepressant; escitalopram (Lexapro) is prescribed for anxiety and depression.
The aim is to increase awareness about the potential for a serious medication mistake when the wrong drug is given because of drug names that look and sound similar.
Awareness of these drug names, however, is just the first step in preventing medication mistakes. Health care providers should take a number of other steps as well, experts said.
ISMP launched its confusing drug names list, previously called look-alike, sound-alike (LASA) drugs, in 2008. The new list is an update of the 2019 version, said Michael J. Gaunt, PharmD, senior manager of error reporting programs for the ISMP, which focuses on the prevention of medication mistakes. The new entries were chosen on the basis of a number of factors, including ISMP’s analysis of recent medication mishap reports that were submitted to it.
The ISMP list now includes about 528 drug pairs, Dr. Gaunt said. The list is long, he said, partly because each pair is listed twice, so readers can cross reference. For instance, hydralazine and hydroxyzine are listed in one entry in the list, and hydroxyzine and hydralazine are listed in another.
Brand Institute in Miami has named, among other drugs, Entresto, Rybelsus, and Lunesta. The regulatory arm of the company, the Drug Safety Institute, “considers drug names that have been confused as an important part of our comprehensive drug name assessments,” Todd Bridges, global president of the institute, said in an emailed statement. Information on the confusing drug names are incorporated into the company’s proprietary algorithm and is used when developing brand names for drugs. “We continually update this algorithm as new drug names that are often confused are identified,” Mr. Bridges said.
Confusing drug names: Ongoing issue
The length of the list, as well as the latest additions, are not surprising, said Mary Ann Kliethermes, PharmD, director of medication safety and quality for the American Society of Health-System Pharmacists, a membership organization of about 60,000 pharmacists who practice in inpatient and outpatient settings.
“I’ve been in practice over 45 years,” she said, “and this has been a problem ever since I have been in practice.” The sheer volume of new drugs is one reason, she said. From 2013 through 2022, the U.S. Food and Drug Administration approved an average of 43 novel drugs per year, according to a report from its Center for Drug Evaluation and Research. “Since the 90s, this [confusion about similar drug names] has happened,” Dr. Kliethermes said.
According to a 2023 report, about 7,000-9,000 people die each year in the United States as the result of a medication error. However, it’s impossible to say for sure what percentage of those errors involve name confusion, Dr. Gaunt said.
Not all the mistakes are reported. Some that are reported are dramatic and deadly. In 2022, a Tennessee nurse was convicted of gross neglect and negligent homicide. She was sentenced to 3 years’ probation after she mistakenly gave vercuronium, an anesthetic agent, instead of the sedative Versed to a patient, and the woman died.
Updated list: A closer look
Many of the new drug pairs that are listed in the update are cephalosporins, said Dr. Kliethermes, who reviewed the new list for this news organization. In all, 20 of the latest 82 additions are cephalosporins. These include drugs such as cefazolin, which can be confused with cefotetan, and vice versa. These drugs have been around since the 1980s, she said, but “they needed to be on there.” Even in the 1980s, it was becoming difficult to differentiate them, and there were fewer drugs in that class then, she said.
Influenza vaccines made the new list, too. Fluzone High-Dose Quadrivalent can be confused with fluzone quadrivalent. Other new additions: hydrochlorothiazide and hydroxychloroquine, Lasik and Wakix, Pitressin and Pitocin, Remeron and Rozerem.
Beyond the list
While it’s not possible to pinpoint how big a problem name confusion is in causing medication mistakes, “it is certainly still an issue,” Dr. Gaunt said. A variety of practices can reduce that risk substantially, Dr. Gaunt and Dr. Kliethermes agreed.
Tall-man lettering. Both the FDA and the ISMP recommend the use of so-called tall-man lettering (TML), which involves the use of uppercase letters, sometimes in boldface, to distinguish similar names on product labels and elsewhere. Examples include vinBLAStine and vinCRIStine.
Electronic prescribing. “It eliminates the risk of handwriting confusion,” Dr. Gaunt said. However, electronic prescribing can have a downside, Dr. Kliethermes said. When ordering medication, a person may type in a few letters and may then be presented with a prompt that lists several drug names, and it can be easy to click the wrong one. For that reason, ISMP and other experts recommend typing at least five letters when searching for a medication in an electronic system.
Use both brand and generic names on labels and prescriptions.
Write the indication. That can serve as a double check. If a prescription for Ambien says “For sleep,” there’s probably less risk of filling a prescription for ambrisentan, the vasodilator.
Smart formulary additions. When hospitals add medications to their formularies, “part of that formulary assessment should include looking at the potential risk for errors,” Dr. Gaunt said. This involves keeping an eye out for confusing names and similar packaging. “Do that analysis up front and put in strategies to minimize that. Maybe you look for a different drug [for the same use] that has a different name.” Or choose a different manufacturer, so the medication would at least have a different container.
Use bar code scanning. Suppose a pharmacist goes to the shelf and pulls the wrong drug. “Bar code scanning provides the opportunity to catch the error,” Dr. Gaunt said. Many community pharmacies now have bar code scanning. ISMP just issued best practices for community pharmacies, Dr. Gaunt said, and these include the use of bar code scanning and other measures.
Educate consumers. Health care providers can educate consumers on how to minimize the risk of getting the wrong drug, Dr. Gaunt said. When patients are picking up a prescription, suggest they look at the container label; if it looks different from previous prescriptions of the same medicine, ask the pharmacist for an explanation. Some patients just pass it off, Dr. Gaunt said, figuring the pharmacist or health plan switched manufacturers of their medication.
Access the list. The entire list is on the ISMP site and is accessible after free registration.
Goal: Preventing confusion
The FDA has provided guidance for industry on naming drugs not yet approved so that the proposed names are not too similar in sound or appearance to those already on the market. Included in the lengthy document are checklists, such as, “Across a range of dialects, are the names consistently pronounced differently?” and “Are the lengths of the names dissimilar when scripted?” (Lengths are considered different if they differ by two or more letters.)
The FDA also offers the phonetic and orthographic computer analysis (POCA) program, a software tool that employs an advanced algorithm to evaluate similarities between two drug names. The data sources are updated regularly as new drugs are approved.
Liability update
The problem may be decreasing. In a 2020 report, researchers used pharmacists’ professional liability claim data from the Healthcare Providers Service Organization. They compared 2018 data on claims with 2013 data. The percentage of claims associated with wrong drug dispensing errors declined from 43.8% in 2013 to 36.8% in 2018. Wrong dose claims also declined, from 31.5% to 15.3%.
These researchers concluded that technology and automation have contributed to the prevention of medication errors caused by the use of the wrong drug and the wrong dose, but mistakes continue, owing to system and human errors.
A version of this article first appeared on Medscape.com.
Zolpidem (Ambien) is a well-known sedative for sleep. Letairis (Ambrisentan) is a vasodilator for the treatment of pulmonary arterial hypertension. Citalopram (Celexa) is an antidepressant; escitalopram (Lexapro) is prescribed for anxiety and depression.
The aim is to increase awareness about the potential for a serious medication mistake when the wrong drug is given because of drug names that look and sound similar.
Awareness of these drug names, however, is just the first step in preventing medication mistakes. Health care providers should take a number of other steps as well, experts said.
ISMP launched its confusing drug names list, previously called look-alike, sound-alike (LASA) drugs, in 2008. The new list is an update of the 2019 version, said Michael J. Gaunt, PharmD, senior manager of error reporting programs for the ISMP, which focuses on the prevention of medication mistakes. The new entries were chosen on the basis of a number of factors, including ISMP’s analysis of recent medication mishap reports that were submitted to it.
The ISMP list now includes about 528 drug pairs, Dr. Gaunt said. The list is long, he said, partly because each pair is listed twice, so readers can cross reference. For instance, hydralazine and hydroxyzine are listed in one entry in the list, and hydroxyzine and hydralazine are listed in another.
Brand Institute in Miami has named, among other drugs, Entresto, Rybelsus, and Lunesta. The regulatory arm of the company, the Drug Safety Institute, “considers drug names that have been confused as an important part of our comprehensive drug name assessments,” Todd Bridges, global president of the institute, said in an emailed statement. Information on the confusing drug names are incorporated into the company’s proprietary algorithm and is used when developing brand names for drugs. “We continually update this algorithm as new drug names that are often confused are identified,” Mr. Bridges said.
Confusing drug names: Ongoing issue
The length of the list, as well as the latest additions, are not surprising, said Mary Ann Kliethermes, PharmD, director of medication safety and quality for the American Society of Health-System Pharmacists, a membership organization of about 60,000 pharmacists who practice in inpatient and outpatient settings.
“I’ve been in practice over 45 years,” she said, “and this has been a problem ever since I have been in practice.” The sheer volume of new drugs is one reason, she said. From 2013 through 2022, the U.S. Food and Drug Administration approved an average of 43 novel drugs per year, according to a report from its Center for Drug Evaluation and Research. “Since the 90s, this [confusion about similar drug names] has happened,” Dr. Kliethermes said.
According to a 2023 report, about 7,000-9,000 people die each year in the United States as the result of a medication error. However, it’s impossible to say for sure what percentage of those errors involve name confusion, Dr. Gaunt said.
Not all the mistakes are reported. Some that are reported are dramatic and deadly. In 2022, a Tennessee nurse was convicted of gross neglect and negligent homicide. She was sentenced to 3 years’ probation after she mistakenly gave vercuronium, an anesthetic agent, instead of the sedative Versed to a patient, and the woman died.
Updated list: A closer look
Many of the new drug pairs that are listed in the update are cephalosporins, said Dr. Kliethermes, who reviewed the new list for this news organization. In all, 20 of the latest 82 additions are cephalosporins. These include drugs such as cefazolin, which can be confused with cefotetan, and vice versa. These drugs have been around since the 1980s, she said, but “they needed to be on there.” Even in the 1980s, it was becoming difficult to differentiate them, and there were fewer drugs in that class then, she said.
Influenza vaccines made the new list, too. Fluzone High-Dose Quadrivalent can be confused with fluzone quadrivalent. Other new additions: hydrochlorothiazide and hydroxychloroquine, Lasik and Wakix, Pitressin and Pitocin, Remeron and Rozerem.
Beyond the list
While it’s not possible to pinpoint how big a problem name confusion is in causing medication mistakes, “it is certainly still an issue,” Dr. Gaunt said. A variety of practices can reduce that risk substantially, Dr. Gaunt and Dr. Kliethermes agreed.
Tall-man lettering. Both the FDA and the ISMP recommend the use of so-called tall-man lettering (TML), which involves the use of uppercase letters, sometimes in boldface, to distinguish similar names on product labels and elsewhere. Examples include vinBLAStine and vinCRIStine.
Electronic prescribing. “It eliminates the risk of handwriting confusion,” Dr. Gaunt said. However, electronic prescribing can have a downside, Dr. Kliethermes said. When ordering medication, a person may type in a few letters and may then be presented with a prompt that lists several drug names, and it can be easy to click the wrong one. For that reason, ISMP and other experts recommend typing at least five letters when searching for a medication in an electronic system.
Use both brand and generic names on labels and prescriptions.
Write the indication. That can serve as a double check. If a prescription for Ambien says “For sleep,” there’s probably less risk of filling a prescription for ambrisentan, the vasodilator.
Smart formulary additions. When hospitals add medications to their formularies, “part of that formulary assessment should include looking at the potential risk for errors,” Dr. Gaunt said. This involves keeping an eye out for confusing names and similar packaging. “Do that analysis up front and put in strategies to minimize that. Maybe you look for a different drug [for the same use] that has a different name.” Or choose a different manufacturer, so the medication would at least have a different container.
Use bar code scanning. Suppose a pharmacist goes to the shelf and pulls the wrong drug. “Bar code scanning provides the opportunity to catch the error,” Dr. Gaunt said. Many community pharmacies now have bar code scanning. ISMP just issued best practices for community pharmacies, Dr. Gaunt said, and these include the use of bar code scanning and other measures.
Educate consumers. Health care providers can educate consumers on how to minimize the risk of getting the wrong drug, Dr. Gaunt said. When patients are picking up a prescription, suggest they look at the container label; if it looks different from previous prescriptions of the same medicine, ask the pharmacist for an explanation. Some patients just pass it off, Dr. Gaunt said, figuring the pharmacist or health plan switched manufacturers of their medication.
Access the list. The entire list is on the ISMP site and is accessible after free registration.
Goal: Preventing confusion
The FDA has provided guidance for industry on naming drugs not yet approved so that the proposed names are not too similar in sound or appearance to those already on the market. Included in the lengthy document are checklists, such as, “Across a range of dialects, are the names consistently pronounced differently?” and “Are the lengths of the names dissimilar when scripted?” (Lengths are considered different if they differ by two or more letters.)
The FDA also offers the phonetic and orthographic computer analysis (POCA) program, a software tool that employs an advanced algorithm to evaluate similarities between two drug names. The data sources are updated regularly as new drugs are approved.
Liability update
The problem may be decreasing. In a 2020 report, researchers used pharmacists’ professional liability claim data from the Healthcare Providers Service Organization. They compared 2018 data on claims with 2013 data. The percentage of claims associated with wrong drug dispensing errors declined from 43.8% in 2013 to 36.8% in 2018. Wrong dose claims also declined, from 31.5% to 15.3%.
These researchers concluded that technology and automation have contributed to the prevention of medication errors caused by the use of the wrong drug and the wrong dose, but mistakes continue, owing to system and human errors.
A version of this article first appeared on Medscape.com.
Zolpidem (Ambien) is a well-known sedative for sleep. Letairis (Ambrisentan) is a vasodilator for the treatment of pulmonary arterial hypertension. Citalopram (Celexa) is an antidepressant; escitalopram (Lexapro) is prescribed for anxiety and depression.
The aim is to increase awareness about the potential for a serious medication mistake when the wrong drug is given because of drug names that look and sound similar.
Awareness of these drug names, however, is just the first step in preventing medication mistakes. Health care providers should take a number of other steps as well, experts said.
ISMP launched its confusing drug names list, previously called look-alike, sound-alike (LASA) drugs, in 2008. The new list is an update of the 2019 version, said Michael J. Gaunt, PharmD, senior manager of error reporting programs for the ISMP, which focuses on the prevention of medication mistakes. The new entries were chosen on the basis of a number of factors, including ISMP’s analysis of recent medication mishap reports that were submitted to it.
The ISMP list now includes about 528 drug pairs, Dr. Gaunt said. The list is long, he said, partly because each pair is listed twice, so readers can cross reference. For instance, hydralazine and hydroxyzine are listed in one entry in the list, and hydroxyzine and hydralazine are listed in another.
Brand Institute in Miami has named, among other drugs, Entresto, Rybelsus, and Lunesta. The regulatory arm of the company, the Drug Safety Institute, “considers drug names that have been confused as an important part of our comprehensive drug name assessments,” Todd Bridges, global president of the institute, said in an emailed statement. Information on the confusing drug names are incorporated into the company’s proprietary algorithm and is used when developing brand names for drugs. “We continually update this algorithm as new drug names that are often confused are identified,” Mr. Bridges said.
Confusing drug names: Ongoing issue
The length of the list, as well as the latest additions, are not surprising, said Mary Ann Kliethermes, PharmD, director of medication safety and quality for the American Society of Health-System Pharmacists, a membership organization of about 60,000 pharmacists who practice in inpatient and outpatient settings.
“I’ve been in practice over 45 years,” she said, “and this has been a problem ever since I have been in practice.” The sheer volume of new drugs is one reason, she said. From 2013 through 2022, the U.S. Food and Drug Administration approved an average of 43 novel drugs per year, according to a report from its Center for Drug Evaluation and Research. “Since the 90s, this [confusion about similar drug names] has happened,” Dr. Kliethermes said.
According to a 2023 report, about 7,000-9,000 people die each year in the United States as the result of a medication error. However, it’s impossible to say for sure what percentage of those errors involve name confusion, Dr. Gaunt said.
Not all the mistakes are reported. Some that are reported are dramatic and deadly. In 2022, a Tennessee nurse was convicted of gross neglect and negligent homicide. She was sentenced to 3 years’ probation after she mistakenly gave vercuronium, an anesthetic agent, instead of the sedative Versed to a patient, and the woman died.
Updated list: A closer look
Many of the new drug pairs that are listed in the update are cephalosporins, said Dr. Kliethermes, who reviewed the new list for this news organization. In all, 20 of the latest 82 additions are cephalosporins. These include drugs such as cefazolin, which can be confused with cefotetan, and vice versa. These drugs have been around since the 1980s, she said, but “they needed to be on there.” Even in the 1980s, it was becoming difficult to differentiate them, and there were fewer drugs in that class then, she said.
Influenza vaccines made the new list, too. Fluzone High-Dose Quadrivalent can be confused with fluzone quadrivalent. Other new additions: hydrochlorothiazide and hydroxychloroquine, Lasik and Wakix, Pitressin and Pitocin, Remeron and Rozerem.
Beyond the list
While it’s not possible to pinpoint how big a problem name confusion is in causing medication mistakes, “it is certainly still an issue,” Dr. Gaunt said. A variety of practices can reduce that risk substantially, Dr. Gaunt and Dr. Kliethermes agreed.
Tall-man lettering. Both the FDA and the ISMP recommend the use of so-called tall-man lettering (TML), which involves the use of uppercase letters, sometimes in boldface, to distinguish similar names on product labels and elsewhere. Examples include vinBLAStine and vinCRIStine.
Electronic prescribing. “It eliminates the risk of handwriting confusion,” Dr. Gaunt said. However, electronic prescribing can have a downside, Dr. Kliethermes said. When ordering medication, a person may type in a few letters and may then be presented with a prompt that lists several drug names, and it can be easy to click the wrong one. For that reason, ISMP and other experts recommend typing at least five letters when searching for a medication in an electronic system.
Use both brand and generic names on labels and prescriptions.
Write the indication. That can serve as a double check. If a prescription for Ambien says “For sleep,” there’s probably less risk of filling a prescription for ambrisentan, the vasodilator.
Smart formulary additions. When hospitals add medications to their formularies, “part of that formulary assessment should include looking at the potential risk for errors,” Dr. Gaunt said. This involves keeping an eye out for confusing names and similar packaging. “Do that analysis up front and put in strategies to minimize that. Maybe you look for a different drug [for the same use] that has a different name.” Or choose a different manufacturer, so the medication would at least have a different container.
Use bar code scanning. Suppose a pharmacist goes to the shelf and pulls the wrong drug. “Bar code scanning provides the opportunity to catch the error,” Dr. Gaunt said. Many community pharmacies now have bar code scanning. ISMP just issued best practices for community pharmacies, Dr. Gaunt said, and these include the use of bar code scanning and other measures.
Educate consumers. Health care providers can educate consumers on how to minimize the risk of getting the wrong drug, Dr. Gaunt said. When patients are picking up a prescription, suggest they look at the container label; if it looks different from previous prescriptions of the same medicine, ask the pharmacist for an explanation. Some patients just pass it off, Dr. Gaunt said, figuring the pharmacist or health plan switched manufacturers of their medication.
Access the list. The entire list is on the ISMP site and is accessible after free registration.
Goal: Preventing confusion
The FDA has provided guidance for industry on naming drugs not yet approved so that the proposed names are not too similar in sound or appearance to those already on the market. Included in the lengthy document are checklists, such as, “Across a range of dialects, are the names consistently pronounced differently?” and “Are the lengths of the names dissimilar when scripted?” (Lengths are considered different if they differ by two or more letters.)
The FDA also offers the phonetic and orthographic computer analysis (POCA) program, a software tool that employs an advanced algorithm to evaluate similarities between two drug names. The data sources are updated regularly as new drugs are approved.
Liability update
The problem may be decreasing. In a 2020 report, researchers used pharmacists’ professional liability claim data from the Healthcare Providers Service Organization. They compared 2018 data on claims with 2013 data. The percentage of claims associated with wrong drug dispensing errors declined from 43.8% in 2013 to 36.8% in 2018. Wrong dose claims also declined, from 31.5% to 15.3%.
These researchers concluded that technology and automation have contributed to the prevention of medication errors caused by the use of the wrong drug and the wrong dose, but mistakes continue, owing to system and human errors.
A version of this article first appeared on Medscape.com.
Antibody shows promise in preventing GVHD
Early, intriguing research suggests that preventing acute graft-versus-host disease (GVHD) in the gut – a potentially life-threatening complication of allogeneic hematopoietic cell transplantation (allo-HCT) – could be accomplished by the administration of a single antibody that targets the anti-DLL4 Notch signaling pathway, without compromising the stem cell transplant.
“The major surprise was that none of the anti–DLL4-treated animals developed acute gastrointestinal GVHD for the entire duration of the study. This was a remarkable finding, given that intestinal GVHD is otherwise seen in the vast majority of nonhuman primate transplant recipients that receive either no prophylaxis, or prophylaxis with agents other than anti-DLL4 antibodies,” co–senior author Ivan Maillard, MD, PhD, a professor of medicine and vice chief for research in hematology-oncology at the University of Pennsylvania, Philadelphia, said in an interview.
“The timing was critical,” the authors noted in the study, recently published in Science Translational Medicine. “Intervening before any symptoms of GvHD appear made the long-term protection possible.”
While GVHD may be mild to moderate in chronic forms, acute cases can be serious, if not fatal, and nearly all severe acute GVHD prominently involves the gastrointestinal tract, which can drive activation of pathogenic T cells and potentially lead to tissue damage following allo-HCT.
Systemic corticosteroids are standard first-line treatment for acute GVHD. However, response rates generally range only from 40% to 60%, and there are concerns of side effects. Meanwhile, second-line treatments are of inconsistent benefit.
With previous studies on mice showing benefits of targeting Notch pathway inhibition, particularly DLL4, Dr. Maillard and colleagues further investigated the effects in nonhuman primates that were allo-HCT recipients, using the anti-DLL4 antibody REGN421, which has pharmacokinetic and toxicity information available from previous studies.
The nonhuman primates were treated with one of two dosing regimens: a single dose of REGN421 3 mg/kg at baseline, post HCT, (n = 7) or three weekly doses at days 0, 7 and 14, post transplant (n = 4). Those primates were compared with 11 primates receiving allo-HCT transplants that received supportive care only.
Primates receiving three weekly doses of REGN421 showed antibody concentrations of greater than 2 mcg/mL for more than 30 days post HCT. A single dose of REGN421 was associated with protection from acute GVHD at day 0, while three weekly doses showed protection at day 0, 7, and 14, consistent with an impact of REGN421 during the early phases of T-cell activation.
Compared with animals receiving only supportive care, prophylaxis with REGN421 was associated with delayed acute GVHD onset and lengthened survival.
Of the 11 primates treated with REGN421, none developed clinical signs of gastrointestinal acute GVHD, whereas the majority of those receiving standard care or other preventive interventions did.
“Detailed analysis of acute GVHD clinical presentations in REGN421-treated animals in comparison to no treatment controls revealed near complete protection from GI-acute GvHD with REGN421,” the authors reported.
Furthermore, pathology scores in the gastrointestinal tract were lower with REGN421 treatment, compared with the no-treatment cohort, and the scores matched those of healthy nontransplanted nonhuman primates.
The primates treated with REGN421 did ultimately develop other clinical and pathologic signs of skin, hepatic or pulmonary acute GVHD, but without gastrointestinal disease.
The treatment was not associated with any adverse effects on the allo-HCT, with primates receiving either a single dose or three weekly doses of REGN421 showing rapid donor engraftment after allo-HCT, including high bone marrow, whole blood, and T-cell donor chimerism.
“Reassuringly, short-term systemic DLL4 blockade with REGN421 did not trigger unexpected side effects in our nonhuman primate model, while preserving rapid engraftment as well hematopoietic and immune reconstitution.”
The mechanism preserving the engraftment, described as a “major surprise,” specifically involved DLL4 inhibition blocking the homing of pathogenic T cells to the gut while preserving homing of regulatory T cells that dampen the immune response, Dr. Maillard explained.
“This effect turned out to be at least in part through a posttranslational effect of DLL4/Notch blockade on integrin pairing at the T-cell surface,” he explained. “This was a novel and quite unexpected mechanism of action conserved from mice to nonhuman primates.”
The results are encouraging in terms of translating to humans because of their closer similarities in various physiological factors, Dr. Maillard said.
“The nonhuman primate model of transplantation [offers] a transplantation model very close to what is being performed in humans, as well as the opportunity to study an immune system very similar to that of humans in nonhuman primates,” he said.
Dr. Maillard noted that, while trials in humans are not underway yet, “we are in active discussions about it,” and the team is indeed interested in testing REGN421 itself, with the effects likely to be as a prophylactic strategy.
There are currently no approved anti-DLL4 antibody drugs for use in humans.
“Our approach is mostly promising as a preventive treatment, rather than as a secondary treatment for GVHD, because DLL4/Notch blockade seems most active when applied early after transplantation during the time of initial seeding of the gut by T cells (in mice, we had observed the critical time window for a successful intervention to be within 48 hours of transplantation),” Dr. Maillard said.“There remain questions about which other prophylactic treatments we should ideally combine anti-DLL4 antibodies with.”
Dr. Maillard has received research funding from Regeneron and Genentech and is a member of Garuda Therapeutics’s scientific advisory board.
Early, intriguing research suggests that preventing acute graft-versus-host disease (GVHD) in the gut – a potentially life-threatening complication of allogeneic hematopoietic cell transplantation (allo-HCT) – could be accomplished by the administration of a single antibody that targets the anti-DLL4 Notch signaling pathway, without compromising the stem cell transplant.
“The major surprise was that none of the anti–DLL4-treated animals developed acute gastrointestinal GVHD for the entire duration of the study. This was a remarkable finding, given that intestinal GVHD is otherwise seen in the vast majority of nonhuman primate transplant recipients that receive either no prophylaxis, or prophylaxis with agents other than anti-DLL4 antibodies,” co–senior author Ivan Maillard, MD, PhD, a professor of medicine and vice chief for research in hematology-oncology at the University of Pennsylvania, Philadelphia, said in an interview.
“The timing was critical,” the authors noted in the study, recently published in Science Translational Medicine. “Intervening before any symptoms of GvHD appear made the long-term protection possible.”
While GVHD may be mild to moderate in chronic forms, acute cases can be serious, if not fatal, and nearly all severe acute GVHD prominently involves the gastrointestinal tract, which can drive activation of pathogenic T cells and potentially lead to tissue damage following allo-HCT.
Systemic corticosteroids are standard first-line treatment for acute GVHD. However, response rates generally range only from 40% to 60%, and there are concerns of side effects. Meanwhile, second-line treatments are of inconsistent benefit.
With previous studies on mice showing benefits of targeting Notch pathway inhibition, particularly DLL4, Dr. Maillard and colleagues further investigated the effects in nonhuman primates that were allo-HCT recipients, using the anti-DLL4 antibody REGN421, which has pharmacokinetic and toxicity information available from previous studies.
The nonhuman primates were treated with one of two dosing regimens: a single dose of REGN421 3 mg/kg at baseline, post HCT, (n = 7) or three weekly doses at days 0, 7 and 14, post transplant (n = 4). Those primates were compared with 11 primates receiving allo-HCT transplants that received supportive care only.
Primates receiving three weekly doses of REGN421 showed antibody concentrations of greater than 2 mcg/mL for more than 30 days post HCT. A single dose of REGN421 was associated with protection from acute GVHD at day 0, while three weekly doses showed protection at day 0, 7, and 14, consistent with an impact of REGN421 during the early phases of T-cell activation.
Compared with animals receiving only supportive care, prophylaxis with REGN421 was associated with delayed acute GVHD onset and lengthened survival.
Of the 11 primates treated with REGN421, none developed clinical signs of gastrointestinal acute GVHD, whereas the majority of those receiving standard care or other preventive interventions did.
“Detailed analysis of acute GVHD clinical presentations in REGN421-treated animals in comparison to no treatment controls revealed near complete protection from GI-acute GvHD with REGN421,” the authors reported.
Furthermore, pathology scores in the gastrointestinal tract were lower with REGN421 treatment, compared with the no-treatment cohort, and the scores matched those of healthy nontransplanted nonhuman primates.
The primates treated with REGN421 did ultimately develop other clinical and pathologic signs of skin, hepatic or pulmonary acute GVHD, but without gastrointestinal disease.
The treatment was not associated with any adverse effects on the allo-HCT, with primates receiving either a single dose or three weekly doses of REGN421 showing rapid donor engraftment after allo-HCT, including high bone marrow, whole blood, and T-cell donor chimerism.
“Reassuringly, short-term systemic DLL4 blockade with REGN421 did not trigger unexpected side effects in our nonhuman primate model, while preserving rapid engraftment as well hematopoietic and immune reconstitution.”
The mechanism preserving the engraftment, described as a “major surprise,” specifically involved DLL4 inhibition blocking the homing of pathogenic T cells to the gut while preserving homing of regulatory T cells that dampen the immune response, Dr. Maillard explained.
“This effect turned out to be at least in part through a posttranslational effect of DLL4/Notch blockade on integrin pairing at the T-cell surface,” he explained. “This was a novel and quite unexpected mechanism of action conserved from mice to nonhuman primates.”
The results are encouraging in terms of translating to humans because of their closer similarities in various physiological factors, Dr. Maillard said.
“The nonhuman primate model of transplantation [offers] a transplantation model very close to what is being performed in humans, as well as the opportunity to study an immune system very similar to that of humans in nonhuman primates,” he said.
Dr. Maillard noted that, while trials in humans are not underway yet, “we are in active discussions about it,” and the team is indeed interested in testing REGN421 itself, with the effects likely to be as a prophylactic strategy.
There are currently no approved anti-DLL4 antibody drugs for use in humans.
“Our approach is mostly promising as a preventive treatment, rather than as a secondary treatment for GVHD, because DLL4/Notch blockade seems most active when applied early after transplantation during the time of initial seeding of the gut by T cells (in mice, we had observed the critical time window for a successful intervention to be within 48 hours of transplantation),” Dr. Maillard said.“There remain questions about which other prophylactic treatments we should ideally combine anti-DLL4 antibodies with.”
Dr. Maillard has received research funding from Regeneron and Genentech and is a member of Garuda Therapeutics’s scientific advisory board.
Early, intriguing research suggests that preventing acute graft-versus-host disease (GVHD) in the gut – a potentially life-threatening complication of allogeneic hematopoietic cell transplantation (allo-HCT) – could be accomplished by the administration of a single antibody that targets the anti-DLL4 Notch signaling pathway, without compromising the stem cell transplant.
“The major surprise was that none of the anti–DLL4-treated animals developed acute gastrointestinal GVHD for the entire duration of the study. This was a remarkable finding, given that intestinal GVHD is otherwise seen in the vast majority of nonhuman primate transplant recipients that receive either no prophylaxis, or prophylaxis with agents other than anti-DLL4 antibodies,” co–senior author Ivan Maillard, MD, PhD, a professor of medicine and vice chief for research in hematology-oncology at the University of Pennsylvania, Philadelphia, said in an interview.
“The timing was critical,” the authors noted in the study, recently published in Science Translational Medicine. “Intervening before any symptoms of GvHD appear made the long-term protection possible.”
While GVHD may be mild to moderate in chronic forms, acute cases can be serious, if not fatal, and nearly all severe acute GVHD prominently involves the gastrointestinal tract, which can drive activation of pathogenic T cells and potentially lead to tissue damage following allo-HCT.
Systemic corticosteroids are standard first-line treatment for acute GVHD. However, response rates generally range only from 40% to 60%, and there are concerns of side effects. Meanwhile, second-line treatments are of inconsistent benefit.
With previous studies on mice showing benefits of targeting Notch pathway inhibition, particularly DLL4, Dr. Maillard and colleagues further investigated the effects in nonhuman primates that were allo-HCT recipients, using the anti-DLL4 antibody REGN421, which has pharmacokinetic and toxicity information available from previous studies.
The nonhuman primates were treated with one of two dosing regimens: a single dose of REGN421 3 mg/kg at baseline, post HCT, (n = 7) or three weekly doses at days 0, 7 and 14, post transplant (n = 4). Those primates were compared with 11 primates receiving allo-HCT transplants that received supportive care only.
Primates receiving three weekly doses of REGN421 showed antibody concentrations of greater than 2 mcg/mL for more than 30 days post HCT. A single dose of REGN421 was associated with protection from acute GVHD at day 0, while three weekly doses showed protection at day 0, 7, and 14, consistent with an impact of REGN421 during the early phases of T-cell activation.
Compared with animals receiving only supportive care, prophylaxis with REGN421 was associated with delayed acute GVHD onset and lengthened survival.
Of the 11 primates treated with REGN421, none developed clinical signs of gastrointestinal acute GVHD, whereas the majority of those receiving standard care or other preventive interventions did.
“Detailed analysis of acute GVHD clinical presentations in REGN421-treated animals in comparison to no treatment controls revealed near complete protection from GI-acute GvHD with REGN421,” the authors reported.
Furthermore, pathology scores in the gastrointestinal tract were lower with REGN421 treatment, compared with the no-treatment cohort, and the scores matched those of healthy nontransplanted nonhuman primates.
The primates treated with REGN421 did ultimately develop other clinical and pathologic signs of skin, hepatic or pulmonary acute GVHD, but without gastrointestinal disease.
The treatment was not associated with any adverse effects on the allo-HCT, with primates receiving either a single dose or three weekly doses of REGN421 showing rapid donor engraftment after allo-HCT, including high bone marrow, whole blood, and T-cell donor chimerism.
“Reassuringly, short-term systemic DLL4 blockade with REGN421 did not trigger unexpected side effects in our nonhuman primate model, while preserving rapid engraftment as well hematopoietic and immune reconstitution.”
The mechanism preserving the engraftment, described as a “major surprise,” specifically involved DLL4 inhibition blocking the homing of pathogenic T cells to the gut while preserving homing of regulatory T cells that dampen the immune response, Dr. Maillard explained.
“This effect turned out to be at least in part through a posttranslational effect of DLL4/Notch blockade on integrin pairing at the T-cell surface,” he explained. “This was a novel and quite unexpected mechanism of action conserved from mice to nonhuman primates.”
The results are encouraging in terms of translating to humans because of their closer similarities in various physiological factors, Dr. Maillard said.
“The nonhuman primate model of transplantation [offers] a transplantation model very close to what is being performed in humans, as well as the opportunity to study an immune system very similar to that of humans in nonhuman primates,” he said.
Dr. Maillard noted that, while trials in humans are not underway yet, “we are in active discussions about it,” and the team is indeed interested in testing REGN421 itself, with the effects likely to be as a prophylactic strategy.
There are currently no approved anti-DLL4 antibody drugs for use in humans.
“Our approach is mostly promising as a preventive treatment, rather than as a secondary treatment for GVHD, because DLL4/Notch blockade seems most active when applied early after transplantation during the time of initial seeding of the gut by T cells (in mice, we had observed the critical time window for a successful intervention to be within 48 hours of transplantation),” Dr. Maillard said.“There remain questions about which other prophylactic treatments we should ideally combine anti-DLL4 antibodies with.”
Dr. Maillard has received research funding from Regeneron and Genentech and is a member of Garuda Therapeutics’s scientific advisory board.
FROM SCIENCE TRANSLATIONAL MEDICINE
MM: Newest IKEMA results back isatuximab
Median follow up was 44 months in the new update, about 2 additional years past the earlier report.
As in the earlier analysis, adding the anti-CD38 antibody to carfilzomib and dexamethasone brought substantial benefits, including a median progression free survival (PFS) of 35.7 months versus 19.2 months with placebo, as well as a higher rates of complete response (CR, 44.1% vs. 28.5%), minimal residual disease (MRD) negativity (33.5% vs. 15.4%), and MRD negativity CR (26.3% vs. 12.2%).
Although overall survival data are not yet mature, the probability of being alive at 42 months was 66.3% with isatuximab add-on versus 54.5% with placebo.
Investigators led by Thomas G. Martin, MD, director of the University of California, San Francisco, myeloma program, noted that median PFS of nearly 3 years “is the longest PFS reported to date with a PI-based regimen in the relapsed MM [multiple myeloma] setting.” The updated results further support the combination “as a standard of care treatment for patients with relapsed MM.”
Overall, the trial adds “another effective triplet in the treatment of patients with” relapsed/refractory MM, Sergio A. Giralt, MD, head of the division of hematologic malignancies at Memorial Sloan Kettering Cancer Center, New York, said when asked for comment. The study was published May 9 in Blood Cancer Journal.
Safety similar to interim analysis
IKEMA randomized 179 patients to isatuximab add-on and 123 to placebo. Patients had relapsed/refractory MM with one to three prior treatment lines. Isatuximab was dosed at10 mg/kg IV in the open-label trial, weekly in the first cycle then biweekly.
The PFS benefit held across various subgroups, including the elderly and others with poor prognoses.
In their write-up, the investigators acknowledged isatuximab’s rival anti-CD38 antibody, daratumumab (Darzalex), which is also approved in the United States for use in combination with carfilzomib and dexamethasone for relapsed/refractory MM after one to three treatment lines.
“Although inter-trial evaluations should be interpreted with caution,” they noted that PFS in the latest analysis of daratumumab’s CANDOR trial in combination with carfilzomib and dexamethasone was shorter than in IKEMA, 28.6 months versus 15.2 months with placebo.
Like efficacy, safety in latest update of IKEMA was similar to that of the interim analysis. However, while there was no difference in the incidence of all-cause serious treatment-emergent adverse events (TEAEs) in the earlier report, the incidence was higher with isatuximab than placebo in the newest findings (70.1% vs. 59.8%).
The investigators said the difference was likely because patients in the isatuximab arm stayed on treatment longer, a median of 94 weeks versus 61.9 weeks in the placebo arm, making adverse events more likely.
The most common, nonhematologic TEAEs were infusion reactions (45.8% in the isatuximab arm vs. 3.3% in the placebo group), diarrhea (39.5% vs. 32%), hypertension (37.9% vs 35.2%), upper respiratory tract infection (37.3% vs 27%), and fatigue (31.6% vs 20.5%).
Grade 3 or higher pneumonia occurred in 18.6% patients in the isatuximab arm versus 12.3% in the placebo group. The incidence of skin cancer was 6.2% with isatuximab versus 3.3%. The incidence of treatment-emergent fatal events remained similar between study arms, 5.6% with isatuximab versus 4.9% with placebo.
The study was funded by Sanofi, maker of isatuximab. Investigators included two Sanofi employees. Others reported a range of ties to the company, including Dr. Martin, who reported research funding and sitting on a Sanofi steering committee.
Median follow up was 44 months in the new update, about 2 additional years past the earlier report.
As in the earlier analysis, adding the anti-CD38 antibody to carfilzomib and dexamethasone brought substantial benefits, including a median progression free survival (PFS) of 35.7 months versus 19.2 months with placebo, as well as a higher rates of complete response (CR, 44.1% vs. 28.5%), minimal residual disease (MRD) negativity (33.5% vs. 15.4%), and MRD negativity CR (26.3% vs. 12.2%).
Although overall survival data are not yet mature, the probability of being alive at 42 months was 66.3% with isatuximab add-on versus 54.5% with placebo.
Investigators led by Thomas G. Martin, MD, director of the University of California, San Francisco, myeloma program, noted that median PFS of nearly 3 years “is the longest PFS reported to date with a PI-based regimen in the relapsed MM [multiple myeloma] setting.” The updated results further support the combination “as a standard of care treatment for patients with relapsed MM.”
Overall, the trial adds “another effective triplet in the treatment of patients with” relapsed/refractory MM, Sergio A. Giralt, MD, head of the division of hematologic malignancies at Memorial Sloan Kettering Cancer Center, New York, said when asked for comment. The study was published May 9 in Blood Cancer Journal.
Safety similar to interim analysis
IKEMA randomized 179 patients to isatuximab add-on and 123 to placebo. Patients had relapsed/refractory MM with one to three prior treatment lines. Isatuximab was dosed at10 mg/kg IV in the open-label trial, weekly in the first cycle then biweekly.
The PFS benefit held across various subgroups, including the elderly and others with poor prognoses.
In their write-up, the investigators acknowledged isatuximab’s rival anti-CD38 antibody, daratumumab (Darzalex), which is also approved in the United States for use in combination with carfilzomib and dexamethasone for relapsed/refractory MM after one to three treatment lines.
“Although inter-trial evaluations should be interpreted with caution,” they noted that PFS in the latest analysis of daratumumab’s CANDOR trial in combination with carfilzomib and dexamethasone was shorter than in IKEMA, 28.6 months versus 15.2 months with placebo.
Like efficacy, safety in latest update of IKEMA was similar to that of the interim analysis. However, while there was no difference in the incidence of all-cause serious treatment-emergent adverse events (TEAEs) in the earlier report, the incidence was higher with isatuximab than placebo in the newest findings (70.1% vs. 59.8%).
The investigators said the difference was likely because patients in the isatuximab arm stayed on treatment longer, a median of 94 weeks versus 61.9 weeks in the placebo arm, making adverse events more likely.
The most common, nonhematologic TEAEs were infusion reactions (45.8% in the isatuximab arm vs. 3.3% in the placebo group), diarrhea (39.5% vs. 32%), hypertension (37.9% vs 35.2%), upper respiratory tract infection (37.3% vs 27%), and fatigue (31.6% vs 20.5%).
Grade 3 or higher pneumonia occurred in 18.6% patients in the isatuximab arm versus 12.3% in the placebo group. The incidence of skin cancer was 6.2% with isatuximab versus 3.3%. The incidence of treatment-emergent fatal events remained similar between study arms, 5.6% with isatuximab versus 4.9% with placebo.
The study was funded by Sanofi, maker of isatuximab. Investigators included two Sanofi employees. Others reported a range of ties to the company, including Dr. Martin, who reported research funding and sitting on a Sanofi steering committee.
Median follow up was 44 months in the new update, about 2 additional years past the earlier report.
As in the earlier analysis, adding the anti-CD38 antibody to carfilzomib and dexamethasone brought substantial benefits, including a median progression free survival (PFS) of 35.7 months versus 19.2 months with placebo, as well as a higher rates of complete response (CR, 44.1% vs. 28.5%), minimal residual disease (MRD) negativity (33.5% vs. 15.4%), and MRD negativity CR (26.3% vs. 12.2%).
Although overall survival data are not yet mature, the probability of being alive at 42 months was 66.3% with isatuximab add-on versus 54.5% with placebo.
Investigators led by Thomas G. Martin, MD, director of the University of California, San Francisco, myeloma program, noted that median PFS of nearly 3 years “is the longest PFS reported to date with a PI-based regimen in the relapsed MM [multiple myeloma] setting.” The updated results further support the combination “as a standard of care treatment for patients with relapsed MM.”
Overall, the trial adds “another effective triplet in the treatment of patients with” relapsed/refractory MM, Sergio A. Giralt, MD, head of the division of hematologic malignancies at Memorial Sloan Kettering Cancer Center, New York, said when asked for comment. The study was published May 9 in Blood Cancer Journal.
Safety similar to interim analysis
IKEMA randomized 179 patients to isatuximab add-on and 123 to placebo. Patients had relapsed/refractory MM with one to three prior treatment lines. Isatuximab was dosed at10 mg/kg IV in the open-label trial, weekly in the first cycle then biweekly.
The PFS benefit held across various subgroups, including the elderly and others with poor prognoses.
In their write-up, the investigators acknowledged isatuximab’s rival anti-CD38 antibody, daratumumab (Darzalex), which is also approved in the United States for use in combination with carfilzomib and dexamethasone for relapsed/refractory MM after one to three treatment lines.
“Although inter-trial evaluations should be interpreted with caution,” they noted that PFS in the latest analysis of daratumumab’s CANDOR trial in combination with carfilzomib and dexamethasone was shorter than in IKEMA, 28.6 months versus 15.2 months with placebo.
Like efficacy, safety in latest update of IKEMA was similar to that of the interim analysis. However, while there was no difference in the incidence of all-cause serious treatment-emergent adverse events (TEAEs) in the earlier report, the incidence was higher with isatuximab than placebo in the newest findings (70.1% vs. 59.8%).
The investigators said the difference was likely because patients in the isatuximab arm stayed on treatment longer, a median of 94 weeks versus 61.9 weeks in the placebo arm, making adverse events more likely.
The most common, nonhematologic TEAEs were infusion reactions (45.8% in the isatuximab arm vs. 3.3% in the placebo group), diarrhea (39.5% vs. 32%), hypertension (37.9% vs 35.2%), upper respiratory tract infection (37.3% vs 27%), and fatigue (31.6% vs 20.5%).
Grade 3 or higher pneumonia occurred in 18.6% patients in the isatuximab arm versus 12.3% in the placebo group. The incidence of skin cancer was 6.2% with isatuximab versus 3.3%. The incidence of treatment-emergent fatal events remained similar between study arms, 5.6% with isatuximab versus 4.9% with placebo.
The study was funded by Sanofi, maker of isatuximab. Investigators included two Sanofi employees. Others reported a range of ties to the company, including Dr. Martin, who reported research funding and sitting on a Sanofi steering committee.
FROM BLOOD CANCER JOURNAL
Black women weigh emerging risks of ‘creamy crack’ hair straighteners
Deanna Denham Hughes was stunned when she was diagnosed with ovarian cancer in 2022. She was only 32. She had no family history of cancer, and tests found no genetic link. Ms. Hughes wondered why she, an otherwise healthy Black mother of two, would develop a malignancy known as a “silent killer.”
After emergency surgery to remove the mass, along with her ovaries, uterus, fallopian tubes, and appendix, Ms. Hughes said, she saw an Instagram post in which a woman with uterine cancer linked her condition to chemical hair straighteners.
“I almost fell over,” she said from her home in Smyrna, Ga.
When Ms. Hughes was about 4, her mother began applying a chemical straightener, or relaxer, to her hair every 6-8 weeks. “It burned, and it smelled awful,” Ms. Hughes recalled. “But it was just part of our routine to ‘deal with my hair.’ ”
The routine continued until she went to college and met other Black women who wore their hair naturally. Soon, Ms. Hughes quit relaxers.
Social and economic pressures have long compelled Black girls and women to straighten their hair to conform to Eurocentric beauty standards. But chemical straighteners are stinky and costly and sometimes cause painful scalp burns. Mounting evidence now shows they could be a health hazard.
Relaxers can contain carcinogens, such as formaldehyde-releasing agents, phthalates, and other endocrine-disrupting compounds, according to National Institutes of Health studies. The compounds can mimic the body’s hormones and have been linked to breast, uterine, and ovarian cancers, studies show.
African American women’s often frequent and lifelong application of chemical relaxers to their hair and scalp might explain why hormone-related cancers kill disproportionately more Black than White women, say researchers and cancer doctors.
“What’s in these products is harmful,” said Tamarra James-Todd, PhD, an epidemiology professor at Harvard T.H. Chan School of Public Health, Boston, who has studied straightening products for the past 20 years.
She believes manufacturers, policymakers, and physicians should warn consumers that relaxers might cause cancer and other health problems.
But regulators have been slow to act, physicians have been reluctant to take up the cause, and racism continues to dictate fashion standards that make it tough for women to quit relaxers, products so addictive they’re known as “creamy crack.”
Michelle Obama straightened her hair when Barack Obama served as president because she believed Americans were “not ready” to see her in braids, the former first lady said after leaving the White House. The U.S. military still prohibited popular Black hairstyles such as dreadlocks and twists while the nation’s first Black president was in office.
California in 2019 became the first of nearly two dozen states to ban race-based hair discrimination. Last year, the U.S. House of Representatives passed similar legislation, known as the CROWN Act, for Creating a Respectful and Open World for Natural Hair. But the bill failed in the Senate.
The need for legislation underscores the challenges Black girls and women face at school and in the workplace.
“You have to pick your struggles,” said Atlanta-based surgical oncologist Ryland J. Gore, MD. She informs her breast cancer patients about the increased cancer risk from relaxers. Despite her knowledge, however, Dr. Gore continues to use chemical straighteners on her own hair, as she has since she was about 7 years old.
“Your hair tells a story,” she said.
In conversations with patients, Dr. Gore sometimes talks about how African American women once wove messages into their braids about the route to take on the Underground Railroad as they sought freedom from slavery.
“It’s just a deep discussion,” one that touches on culture, history, and research into current hairstyling practices, she said. “The data is out there. So patients should be warned, and then they can make a decision.”
The first hint of a connection between hair products and health issues surfaced in the 1990s. Doctors began seeing signs of sexual maturation in Black babies and young girls who developed breasts and pubic hair after using shampoo containing estrogen or placental extract. When the girls stopped using the shampoo, the hair and breast development receded, according to a study published in the journal Clinical Pediatrics in 1998.
Since then, Dr. James-Todd and other researchers have linked chemicals in hair products to a variety of health issues more prevalent among Black women – from early puberty to preterm birth, obesity, and diabetes.
In recent years, researchers have focused on a possible connection between ingredients in chemical relaxers and hormone-related cancers, like the one Ms. Hughes developed, which tend to be more aggressive and deadly in Black women.
A 2017 study found White women who used chemical relaxers were nearly twice as likely to develop breast cancer as those who did not use them. Because the vast majority of the Black study participants used relaxers, researchers could not effectively test the association in Black women, said lead author Adana Llanos, PhD, associate professor of epidemiology at Columbia University’s Mailman School of Public Health, New York.
Researchers did test it in 2020.
The so-called Sister Study, a landmark National Institute of Environmental Health Sciences investigation into the causes of breast cancer and related diseases, followed 50,000 U.S. women whose sisters had been diagnosed with breast cancer and who were cancer-free when they enrolled. Regardless of race, women who reported using relaxers in the prior year were 18% more likely to be diagnosed with breast cancer. Those who used relaxers at least every 5-8 weeks had a 31% higher breast cancer risk.
Nearly 75% of the Black sisters used relaxers in the prior year, compared with 3% of the non-Hispanic White sisters. Three-quarters of Black women self-reported using the straighteners as adolescents, and frequent use of chemical straighteners during adolescence raised the risk of premenopausal breast cancer, a 2021 NIH-funded study in the International Journal of Cancer found.
Another 2021 analysis of the Sister Study data showed sisters who self-reported that they frequently used relaxers or pressing products doubled their ovarian cancer risk. In 2022, another study found frequent use more than doubled uterine cancer risk.
After researchers discovered the link with uterine cancer, some called for policy changes and other measures to reduce exposure to chemical relaxers.
“It is time to intervene,” Dr. Llanos and her colleagues wrote in a Journal of the National Cancer Institute editorial accompanying the uterine cancer analysis. While acknowledging the need for more research, they issued a “call for action.”
No one can say that using permanent hair straighteners will give you cancer, Dr. Llanos said in an interview. “That’s not how cancer works,” she said, noting that some smokers never develop lung cancer, despite tobacco use being a known risk factor.
The body of research linking hair straighteners and cancer is more limited, said Dr. Llanos, who quit using chemical relaxers 15 years ago. But, she asked rhetorically, “Do we need to do the research for 50 more years to know that chemical relaxers are harmful?”
Charlotte R. Gamble, MD, a gynecological oncologist whose Washington, D.C., practice includes Black women with uterine and ovarian cancer, said she and her colleagues see the uterine cancer study findings as worthy of further exploration – but not yet worthy of discussion with patients.
“The jury’s out for me personally,” she said. “There’s so much more data that’s needed.”
Meanwhile, Dr. James-Todd and other researchers believe they have built a solid body of evidence.
“There are enough things we do know to begin taking action, developing interventions, providing useful information to clinicians and patients and the general public,” said Traci N. Bethea, PhD, assistant professor in the Office of Minority Health and Health Disparities Research at Georgetown University.
Responsibility for regulating personal-care products, including chemical hair straighteners and hair dyes – which also have been linked to hormone-related cancers – lies with the Food and Drug Administration. But the FDA does not subject personal-care products to the same approval process it uses for food and drugs. The FDA restricts only 11 categories of chemicals used in cosmetics, while concerns about health effects have prompted the European Union to restrict the use of at least 2,400 substances.
In March, Reps. Ayanna Pressley (D-Mass.) and Shontel Brown (D-Ohio) asked the FDA to investigate the potential health threat posed by chemical relaxers. An FDA representative said the agency would look into it.
Natural hairstyles are enjoying a resurgence among Black girls and women, but many continue to rely on the creamy crack, said Dede Teteh, DrPH, assistant professor of public health at Chapman University, Irvine, Calif.
She had her first straightening perm at 8 and has struggled to withdraw from relaxers as an adult, said Dr. Teteh, who now wears locs. Not long ago, she considered chemically straightening her hair for an academic job interview because she didn’t want her hair to “be a hindrance” when she appeared before White professors.
Dr. Teteh led “The Cost of Beauty,” a hair-health research project published in 2017. She and her team interviewed 91 Black women in Southern California. Some became “combative” at the idea of quitting relaxers and claimed “everything can cause cancer.”
Their reactions speak to the challenges Black women face in America, Dr. Teteh said.
“It’s not that people do not want to hear the information related to their health,” she said. “But they want people to share the information in a way that it’s really empathetic to the plight of being Black here in the United States.”
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 – the independent source for health policy research, polling, and journalism.
Deanna Denham Hughes was stunned when she was diagnosed with ovarian cancer in 2022. She was only 32. She had no family history of cancer, and tests found no genetic link. Ms. Hughes wondered why she, an otherwise healthy Black mother of two, would develop a malignancy known as a “silent killer.”
After emergency surgery to remove the mass, along with her ovaries, uterus, fallopian tubes, and appendix, Ms. Hughes said, she saw an Instagram post in which a woman with uterine cancer linked her condition to chemical hair straighteners.
“I almost fell over,” she said from her home in Smyrna, Ga.
When Ms. Hughes was about 4, her mother began applying a chemical straightener, or relaxer, to her hair every 6-8 weeks. “It burned, and it smelled awful,” Ms. Hughes recalled. “But it was just part of our routine to ‘deal with my hair.’ ”
The routine continued until she went to college and met other Black women who wore their hair naturally. Soon, Ms. Hughes quit relaxers.
Social and economic pressures have long compelled Black girls and women to straighten their hair to conform to Eurocentric beauty standards. But chemical straighteners are stinky and costly and sometimes cause painful scalp burns. Mounting evidence now shows they could be a health hazard.
Relaxers can contain carcinogens, such as formaldehyde-releasing agents, phthalates, and other endocrine-disrupting compounds, according to National Institutes of Health studies. The compounds can mimic the body’s hormones and have been linked to breast, uterine, and ovarian cancers, studies show.
African American women’s often frequent and lifelong application of chemical relaxers to their hair and scalp might explain why hormone-related cancers kill disproportionately more Black than White women, say researchers and cancer doctors.
“What’s in these products is harmful,” said Tamarra James-Todd, PhD, an epidemiology professor at Harvard T.H. Chan School of Public Health, Boston, who has studied straightening products for the past 20 years.
She believes manufacturers, policymakers, and physicians should warn consumers that relaxers might cause cancer and other health problems.
But regulators have been slow to act, physicians have been reluctant to take up the cause, and racism continues to dictate fashion standards that make it tough for women to quit relaxers, products so addictive they’re known as “creamy crack.”
Michelle Obama straightened her hair when Barack Obama served as president because she believed Americans were “not ready” to see her in braids, the former first lady said after leaving the White House. The U.S. military still prohibited popular Black hairstyles such as dreadlocks and twists while the nation’s first Black president was in office.
California in 2019 became the first of nearly two dozen states to ban race-based hair discrimination. Last year, the U.S. House of Representatives passed similar legislation, known as the CROWN Act, for Creating a Respectful and Open World for Natural Hair. But the bill failed in the Senate.
The need for legislation underscores the challenges Black girls and women face at school and in the workplace.
“You have to pick your struggles,” said Atlanta-based surgical oncologist Ryland J. Gore, MD. She informs her breast cancer patients about the increased cancer risk from relaxers. Despite her knowledge, however, Dr. Gore continues to use chemical straighteners on her own hair, as she has since she was about 7 years old.
“Your hair tells a story,” she said.
In conversations with patients, Dr. Gore sometimes talks about how African American women once wove messages into their braids about the route to take on the Underground Railroad as they sought freedom from slavery.
“It’s just a deep discussion,” one that touches on culture, history, and research into current hairstyling practices, she said. “The data is out there. So patients should be warned, and then they can make a decision.”
The first hint of a connection between hair products and health issues surfaced in the 1990s. Doctors began seeing signs of sexual maturation in Black babies and young girls who developed breasts and pubic hair after using shampoo containing estrogen or placental extract. When the girls stopped using the shampoo, the hair and breast development receded, according to a study published in the journal Clinical Pediatrics in 1998.
Since then, Dr. James-Todd and other researchers have linked chemicals in hair products to a variety of health issues more prevalent among Black women – from early puberty to preterm birth, obesity, and diabetes.
In recent years, researchers have focused on a possible connection between ingredients in chemical relaxers and hormone-related cancers, like the one Ms. Hughes developed, which tend to be more aggressive and deadly in Black women.
A 2017 study found White women who used chemical relaxers were nearly twice as likely to develop breast cancer as those who did not use them. Because the vast majority of the Black study participants used relaxers, researchers could not effectively test the association in Black women, said lead author Adana Llanos, PhD, associate professor of epidemiology at Columbia University’s Mailman School of Public Health, New York.
Researchers did test it in 2020.
The so-called Sister Study, a landmark National Institute of Environmental Health Sciences investigation into the causes of breast cancer and related diseases, followed 50,000 U.S. women whose sisters had been diagnosed with breast cancer and who were cancer-free when they enrolled. Regardless of race, women who reported using relaxers in the prior year were 18% more likely to be diagnosed with breast cancer. Those who used relaxers at least every 5-8 weeks had a 31% higher breast cancer risk.
Nearly 75% of the Black sisters used relaxers in the prior year, compared with 3% of the non-Hispanic White sisters. Three-quarters of Black women self-reported using the straighteners as adolescents, and frequent use of chemical straighteners during adolescence raised the risk of premenopausal breast cancer, a 2021 NIH-funded study in the International Journal of Cancer found.
Another 2021 analysis of the Sister Study data showed sisters who self-reported that they frequently used relaxers or pressing products doubled their ovarian cancer risk. In 2022, another study found frequent use more than doubled uterine cancer risk.
After researchers discovered the link with uterine cancer, some called for policy changes and other measures to reduce exposure to chemical relaxers.
“It is time to intervene,” Dr. Llanos and her colleagues wrote in a Journal of the National Cancer Institute editorial accompanying the uterine cancer analysis. While acknowledging the need for more research, they issued a “call for action.”
No one can say that using permanent hair straighteners will give you cancer, Dr. Llanos said in an interview. “That’s not how cancer works,” she said, noting that some smokers never develop lung cancer, despite tobacco use being a known risk factor.
The body of research linking hair straighteners and cancer is more limited, said Dr. Llanos, who quit using chemical relaxers 15 years ago. But, she asked rhetorically, “Do we need to do the research for 50 more years to know that chemical relaxers are harmful?”
Charlotte R. Gamble, MD, a gynecological oncologist whose Washington, D.C., practice includes Black women with uterine and ovarian cancer, said she and her colleagues see the uterine cancer study findings as worthy of further exploration – but not yet worthy of discussion with patients.
“The jury’s out for me personally,” she said. “There’s so much more data that’s needed.”
Meanwhile, Dr. James-Todd and other researchers believe they have built a solid body of evidence.
“There are enough things we do know to begin taking action, developing interventions, providing useful information to clinicians and patients and the general public,” said Traci N. Bethea, PhD, assistant professor in the Office of Minority Health and Health Disparities Research at Georgetown University.
Responsibility for regulating personal-care products, including chemical hair straighteners and hair dyes – which also have been linked to hormone-related cancers – lies with the Food and Drug Administration. But the FDA does not subject personal-care products to the same approval process it uses for food and drugs. The FDA restricts only 11 categories of chemicals used in cosmetics, while concerns about health effects have prompted the European Union to restrict the use of at least 2,400 substances.
In March, Reps. Ayanna Pressley (D-Mass.) and Shontel Brown (D-Ohio) asked the FDA to investigate the potential health threat posed by chemical relaxers. An FDA representative said the agency would look into it.
Natural hairstyles are enjoying a resurgence among Black girls and women, but many continue to rely on the creamy crack, said Dede Teteh, DrPH, assistant professor of public health at Chapman University, Irvine, Calif.
She had her first straightening perm at 8 and has struggled to withdraw from relaxers as an adult, said Dr. Teteh, who now wears locs. Not long ago, she considered chemically straightening her hair for an academic job interview because she didn’t want her hair to “be a hindrance” when she appeared before White professors.
Dr. Teteh led “The Cost of Beauty,” a hair-health research project published in 2017. She and her team interviewed 91 Black women in Southern California. Some became “combative” at the idea of quitting relaxers and claimed “everything can cause cancer.”
Their reactions speak to the challenges Black women face in America, Dr. Teteh said.
“It’s not that people do not want to hear the information related to their health,” she said. “But they want people to share the information in a way that it’s really empathetic to the plight of being Black here in the United States.”
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 – the independent source for health policy research, polling, and journalism.
Deanna Denham Hughes was stunned when she was diagnosed with ovarian cancer in 2022. She was only 32. She had no family history of cancer, and tests found no genetic link. Ms. Hughes wondered why she, an otherwise healthy Black mother of two, would develop a malignancy known as a “silent killer.”
After emergency surgery to remove the mass, along with her ovaries, uterus, fallopian tubes, and appendix, Ms. Hughes said, she saw an Instagram post in which a woman with uterine cancer linked her condition to chemical hair straighteners.
“I almost fell over,” she said from her home in Smyrna, Ga.
When Ms. Hughes was about 4, her mother began applying a chemical straightener, or relaxer, to her hair every 6-8 weeks. “It burned, and it smelled awful,” Ms. Hughes recalled. “But it was just part of our routine to ‘deal with my hair.’ ”
The routine continued until she went to college and met other Black women who wore their hair naturally. Soon, Ms. Hughes quit relaxers.
Social and economic pressures have long compelled Black girls and women to straighten their hair to conform to Eurocentric beauty standards. But chemical straighteners are stinky and costly and sometimes cause painful scalp burns. Mounting evidence now shows they could be a health hazard.
Relaxers can contain carcinogens, such as formaldehyde-releasing agents, phthalates, and other endocrine-disrupting compounds, according to National Institutes of Health studies. The compounds can mimic the body’s hormones and have been linked to breast, uterine, and ovarian cancers, studies show.
African American women’s often frequent and lifelong application of chemical relaxers to their hair and scalp might explain why hormone-related cancers kill disproportionately more Black than White women, say researchers and cancer doctors.
“What’s in these products is harmful,” said Tamarra James-Todd, PhD, an epidemiology professor at Harvard T.H. Chan School of Public Health, Boston, who has studied straightening products for the past 20 years.
She believes manufacturers, policymakers, and physicians should warn consumers that relaxers might cause cancer and other health problems.
But regulators have been slow to act, physicians have been reluctant to take up the cause, and racism continues to dictate fashion standards that make it tough for women to quit relaxers, products so addictive they’re known as “creamy crack.”
Michelle Obama straightened her hair when Barack Obama served as president because she believed Americans were “not ready” to see her in braids, the former first lady said after leaving the White House. The U.S. military still prohibited popular Black hairstyles such as dreadlocks and twists while the nation’s first Black president was in office.
California in 2019 became the first of nearly two dozen states to ban race-based hair discrimination. Last year, the U.S. House of Representatives passed similar legislation, known as the CROWN Act, for Creating a Respectful and Open World for Natural Hair. But the bill failed in the Senate.
The need for legislation underscores the challenges Black girls and women face at school and in the workplace.
“You have to pick your struggles,” said Atlanta-based surgical oncologist Ryland J. Gore, MD. She informs her breast cancer patients about the increased cancer risk from relaxers. Despite her knowledge, however, Dr. Gore continues to use chemical straighteners on her own hair, as she has since she was about 7 years old.
“Your hair tells a story,” she said.
In conversations with patients, Dr. Gore sometimes talks about how African American women once wove messages into their braids about the route to take on the Underground Railroad as they sought freedom from slavery.
“It’s just a deep discussion,” one that touches on culture, history, and research into current hairstyling practices, she said. “The data is out there. So patients should be warned, and then they can make a decision.”
The first hint of a connection between hair products and health issues surfaced in the 1990s. Doctors began seeing signs of sexual maturation in Black babies and young girls who developed breasts and pubic hair after using shampoo containing estrogen or placental extract. When the girls stopped using the shampoo, the hair and breast development receded, according to a study published in the journal Clinical Pediatrics in 1998.
Since then, Dr. James-Todd and other researchers have linked chemicals in hair products to a variety of health issues more prevalent among Black women – from early puberty to preterm birth, obesity, and diabetes.
In recent years, researchers have focused on a possible connection between ingredients in chemical relaxers and hormone-related cancers, like the one Ms. Hughes developed, which tend to be more aggressive and deadly in Black women.
A 2017 study found White women who used chemical relaxers were nearly twice as likely to develop breast cancer as those who did not use them. Because the vast majority of the Black study participants used relaxers, researchers could not effectively test the association in Black women, said lead author Adana Llanos, PhD, associate professor of epidemiology at Columbia University’s Mailman School of Public Health, New York.
Researchers did test it in 2020.
The so-called Sister Study, a landmark National Institute of Environmental Health Sciences investigation into the causes of breast cancer and related diseases, followed 50,000 U.S. women whose sisters had been diagnosed with breast cancer and who were cancer-free when they enrolled. Regardless of race, women who reported using relaxers in the prior year were 18% more likely to be diagnosed with breast cancer. Those who used relaxers at least every 5-8 weeks had a 31% higher breast cancer risk.
Nearly 75% of the Black sisters used relaxers in the prior year, compared with 3% of the non-Hispanic White sisters. Three-quarters of Black women self-reported using the straighteners as adolescents, and frequent use of chemical straighteners during adolescence raised the risk of premenopausal breast cancer, a 2021 NIH-funded study in the International Journal of Cancer found.
Another 2021 analysis of the Sister Study data showed sisters who self-reported that they frequently used relaxers or pressing products doubled their ovarian cancer risk. In 2022, another study found frequent use more than doubled uterine cancer risk.
After researchers discovered the link with uterine cancer, some called for policy changes and other measures to reduce exposure to chemical relaxers.
“It is time to intervene,” Dr. Llanos and her colleagues wrote in a Journal of the National Cancer Institute editorial accompanying the uterine cancer analysis. While acknowledging the need for more research, they issued a “call for action.”
No one can say that using permanent hair straighteners will give you cancer, Dr. Llanos said in an interview. “That’s not how cancer works,” she said, noting that some smokers never develop lung cancer, despite tobacco use being a known risk factor.
The body of research linking hair straighteners and cancer is more limited, said Dr. Llanos, who quit using chemical relaxers 15 years ago. But, she asked rhetorically, “Do we need to do the research for 50 more years to know that chemical relaxers are harmful?”
Charlotte R. Gamble, MD, a gynecological oncologist whose Washington, D.C., practice includes Black women with uterine and ovarian cancer, said she and her colleagues see the uterine cancer study findings as worthy of further exploration – but not yet worthy of discussion with patients.
“The jury’s out for me personally,” she said. “There’s so much more data that’s needed.”
Meanwhile, Dr. James-Todd and other researchers believe they have built a solid body of evidence.
“There are enough things we do know to begin taking action, developing interventions, providing useful information to clinicians and patients and the general public,” said Traci N. Bethea, PhD, assistant professor in the Office of Minority Health and Health Disparities Research at Georgetown University.
Responsibility for regulating personal-care products, including chemical hair straighteners and hair dyes – which also have been linked to hormone-related cancers – lies with the Food and Drug Administration. But the FDA does not subject personal-care products to the same approval process it uses for food and drugs. The FDA restricts only 11 categories of chemicals used in cosmetics, while concerns about health effects have prompted the European Union to restrict the use of at least 2,400 substances.
In March, Reps. Ayanna Pressley (D-Mass.) and Shontel Brown (D-Ohio) asked the FDA to investigate the potential health threat posed by chemical relaxers. An FDA representative said the agency would look into it.
Natural hairstyles are enjoying a resurgence among Black girls and women, but many continue to rely on the creamy crack, said Dede Teteh, DrPH, assistant professor of public health at Chapman University, Irvine, Calif.
She had her first straightening perm at 8 and has struggled to withdraw from relaxers as an adult, said Dr. Teteh, who now wears locs. Not long ago, she considered chemically straightening her hair for an academic job interview because she didn’t want her hair to “be a hindrance” when she appeared before White professors.
Dr. Teteh led “The Cost of Beauty,” a hair-health research project published in 2017. She and her team interviewed 91 Black women in Southern California. Some became “combative” at the idea of quitting relaxers and claimed “everything can cause cancer.”
Their reactions speak to the challenges Black women face in America, Dr. Teteh said.
“It’s not that people do not want to hear the information related to their health,” she said. “But they want people to share the information in a way that it’s really empathetic to the plight of being Black here in the United States.”
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 – the independent source for health policy research, polling, and journalism.