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People experiencing long-term symptoms following acute COVID-19 infection are increasingly meeting criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a phenomenon that highlights the need for unified research and clinical approaches, speakers said at a press briefing March 25 held by the advocacy group MEAction.

“Post-COVID lingering illness was predictable. Similar lingering fatigue syndromes have been reported in the scientific literature for nearly 100 years, following a variety of well-documented infections with viruses, bacteria, fungi, and even protozoa,” said Anthony Komaroff, MD, professor of medicine at Harvard Medical School, Boston.

Core criteria for ME/CFS established by the Institute of Medicine in 2015 include substantial decrement in functioning for at least 6 months, postexertional malaise (PEM), or a worsening of symptoms following even minor exertion (often described as “crashes”), unrefreshing sleep, and cognitive impairment and/or orthostatic intolerance.

Patients with ME/CFS also commonly experience painful headaches, muscle or joint aches, and allergies/other sensitivities. Although many patients can trace their symptoms to an initiating infection, “the cause is often unclear because the diagnosis is often delayed for months or years after symptom onset,” said Lucinda Bateman, MD, founder of the Bateman Horne Center, Salt Lake City, who leads a clinician coalition that aims to improve ME/CFS management.

In an international survey of 3762 COVID-19 “long-haulers” published in a preprint in December of 2020, the most frequent symptoms reported at least 6 months after illness onset were fatigue in 78%, PEM in 72%, and cognitive dysfunction (“brain fog”) in 55%. At the time of the survey, 45% reported requiring reduced work schedules because of their illness, and 22% reported being unable to work at all.

Dr. Bateman said those findings align with her experience so far with 12 COVID-19 “long haulers” who self-referred to her ME/CFS and fibromyalgia specialty clinic. Nine of the 12 met criteria for postural orthostatic tachycardia syndrome (POTS) based on the 10-minute NASA Lean Test, she said, and half also met the 2016 American College of Rheumatology criteria for fibromyalgia.

“Some were severely impaired. We suspect a small fiber polyneuropathy in about half, and mast cell activation syndrome in more than half. We look forward to doing more testing,” Dr. Bateman said.

To be sure, Dr. Komaroff noted, there are some differences. “Long COVID” patients will often experience breathlessness and ongoing anosmia (loss of taste and smell), which aren’t typical of ME/CFS.

But, he said, “many of the symptoms are quite similar ... My guess is that ME/CFS is an illness with a final common pathway that can be triggered by different things,” said Dr. Komaroff, a senior physician at Brigham and Women’s Hospital in Boston, and editor-in-chief of the Harvard Health Letter.

Based on previous data about CFS suggesting a 10% rate of symptoms persisting at least a year following a variety of infectious agents and the predicted 200 million COVID-19 cases globally by the end of 2021, Dr. Komaroff estimated that about 20 million cases of “long COVID” would be expected in the next year.

‘A huge investment’

On the research side, the National Institutes of Health recently appropriated $1.15 billion dollars over the next 4 years to investigate “the heterogeneity in the recovery process after COVID and to develop treatments for those suffering from [postacute COVID-19 syndrome]” according to a Feb. 5, 2021, blog from the National Institute of Neurological Disorders and Stroke (NINDS).

That same day, another NINDS blog announced “new resources for large-scale ME/CFS research” and emphasized the tie-in with long–COVID-19 syndrome.

“That’s a huge investment. In my opinion, there will be several lingering illnesses following COVID,” Dr. Komaroff said, adding, “It’s my bet that long COVID will prove to be caused by certain kinds of abnormalities in the brain, some of the same abnormalities already identified in ME/CFS. Research will determine whether that’s right or wrong.”

In 2017, NINDS had announced a large increase in funding for ME/CFS research, including the creation of four dedicated research centers. In April 2019, NINDS held a 2-day conference highlighting that ongoing work, as reported by Medscape Medical News.

During the briefing, NINDS clinical director Avindra Nath, MD, described a comprehensive ongoing ME/CFS intramural study he’s been leading since 2016.

He’s now also overseeing two long–COVID-19 studies, one of which has a protocol similar to that of the ME/CFS study and will include individuals who are still experiencing long-term symptoms following confirmed cases of COVID-19. The aim is to screen about 1,300 patients. Several task forces are now examining all of these data together.

“Each aspect is now being analyzed … What we learn from one applies to the other,” Dr. Nath said.  
 

Advice for clinicians

In interviews, Dr. Bateman and Dr. Nath offered clinical advice for managing patients who meet ME/CFS criteria, whether they had confirmed or suspected COVID-19, a different infection, or unknown trigger(s).

Dr. Bateman advised that clinicians assess patients for each of the symptoms individually. “Besides exercise intolerance and PEM, the most commonly missed is orthostatic intolerance. It really doesn’t matter what the cause is, it’s amenable to supportive treatment. It’s one aspect of the illness that contributes to severely impaired function. My plea to all physicians would be for sure to assess for [orthostatic intolerance], and gain an understanding about activity management and avoiding PEM symptoms.”

Dr. Nath noted that an often-challenging situation is when tests for the infectious agent and other blood work come back negative, yet the patient still reports multiple debilitating symptoms. This has been a particular issue with long COVID-19, since many patients became ill early in the pandemic before the polymerase chain reaction (PCR) tests for SARS-CoV-2 were widely available.

“The physician can only order tests that are available at their labs. I think what the physician should do is handle symptoms symptomatically but also refer patients to specialists who are taking care of these patients or to research studies,” he said.

Dr. Bateman added, “Whether they had a documented COVID infection – we just have to let go of that in 2020. Way too many people didn’t have access to a test or the timing wasn’t amenable. If people meet criteria for ME/CFS, it’s irrelevant … It’s mainly a clinical diagnosis. It’s not reliant on identifying the infectious trigger.” 

Dr. Komaroff, who began caring for then-termed “chronic fatigue syndrome” patients and researching the condition more than 30 years ago, said that “every cloud has its silver lining. The increased focus on postinfectious fatigue syndrome is a silver lining in my mind around the terrible dark cloud that is the pandemic of COVID.”

Dr. Komaroff has received personal fees from Serimmune Inc., Ono Pharma, and Deallus, and grants from the NIH. Dr. Bateman is employed by the Bateman Horne Center, which receives grants from the NIH, and fees from Exagen Inc., and Teva Pharmaceutical. Dr. Nath is an NIH employee.

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

People experiencing long-term symptoms following acute COVID-19 infection are increasingly meeting criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a phenomenon that highlights the need for unified research and clinical approaches, speakers said at a press briefing March 25 held by the advocacy group MEAction.

“Post-COVID lingering illness was predictable. Similar lingering fatigue syndromes have been reported in the scientific literature for nearly 100 years, following a variety of well-documented infections with viruses, bacteria, fungi, and even protozoa,” said Anthony Komaroff, MD, professor of medicine at Harvard Medical School, Boston.

Core criteria for ME/CFS established by the Institute of Medicine in 2015 include substantial decrement in functioning for at least 6 months, postexertional malaise (PEM), or a worsening of symptoms following even minor exertion (often described as “crashes”), unrefreshing sleep, and cognitive impairment and/or orthostatic intolerance.

Patients with ME/CFS also commonly experience painful headaches, muscle or joint aches, and allergies/other sensitivities. Although many patients can trace their symptoms to an initiating infection, “the cause is often unclear because the diagnosis is often delayed for months or years after symptom onset,” said Lucinda Bateman, MD, founder of the Bateman Horne Center, Salt Lake City, who leads a clinician coalition that aims to improve ME/CFS management.

In an international survey of 3762 COVID-19 “long-haulers” published in a preprint in December of 2020, the most frequent symptoms reported at least 6 months after illness onset were fatigue in 78%, PEM in 72%, and cognitive dysfunction (“brain fog”) in 55%. At the time of the survey, 45% reported requiring reduced work schedules because of their illness, and 22% reported being unable to work at all.

Dr. Bateman said those findings align with her experience so far with 12 COVID-19 “long haulers” who self-referred to her ME/CFS and fibromyalgia specialty clinic. Nine of the 12 met criteria for postural orthostatic tachycardia syndrome (POTS) based on the 10-minute NASA Lean Test, she said, and half also met the 2016 American College of Rheumatology criteria for fibromyalgia.

“Some were severely impaired. We suspect a small fiber polyneuropathy in about half, and mast cell activation syndrome in more than half. We look forward to doing more testing,” Dr. Bateman said.

To be sure, Dr. Komaroff noted, there are some differences. “Long COVID” patients will often experience breathlessness and ongoing anosmia (loss of taste and smell), which aren’t typical of ME/CFS.

But, he said, “many of the symptoms are quite similar ... My guess is that ME/CFS is an illness with a final common pathway that can be triggered by different things,” said Dr. Komaroff, a senior physician at Brigham and Women’s Hospital in Boston, and editor-in-chief of the Harvard Health Letter.

Based on previous data about CFS suggesting a 10% rate of symptoms persisting at least a year following a variety of infectious agents and the predicted 200 million COVID-19 cases globally by the end of 2021, Dr. Komaroff estimated that about 20 million cases of “long COVID” would be expected in the next year.

‘A huge investment’

On the research side, the National Institutes of Health recently appropriated $1.15 billion dollars over the next 4 years to investigate “the heterogeneity in the recovery process after COVID and to develop treatments for those suffering from [postacute COVID-19 syndrome]” according to a Feb. 5, 2021, blog from the National Institute of Neurological Disorders and Stroke (NINDS).

That same day, another NINDS blog announced “new resources for large-scale ME/CFS research” and emphasized the tie-in with long–COVID-19 syndrome.

“That’s a huge investment. In my opinion, there will be several lingering illnesses following COVID,” Dr. Komaroff said, adding, “It’s my bet that long COVID will prove to be caused by certain kinds of abnormalities in the brain, some of the same abnormalities already identified in ME/CFS. Research will determine whether that’s right or wrong.”

In 2017, NINDS had announced a large increase in funding for ME/CFS research, including the creation of four dedicated research centers. In April 2019, NINDS held a 2-day conference highlighting that ongoing work, as reported by Medscape Medical News.

During the briefing, NINDS clinical director Avindra Nath, MD, described a comprehensive ongoing ME/CFS intramural study he’s been leading since 2016.

He’s now also overseeing two long–COVID-19 studies, one of which has a protocol similar to that of the ME/CFS study and will include individuals who are still experiencing long-term symptoms following confirmed cases of COVID-19. The aim is to screen about 1,300 patients. Several task forces are now examining all of these data together.

“Each aspect is now being analyzed … What we learn from one applies to the other,” Dr. Nath said.  
 

Advice for clinicians

In interviews, Dr. Bateman and Dr. Nath offered clinical advice for managing patients who meet ME/CFS criteria, whether they had confirmed or suspected COVID-19, a different infection, or unknown trigger(s).

Dr. Bateman advised that clinicians assess patients for each of the symptoms individually. “Besides exercise intolerance and PEM, the most commonly missed is orthostatic intolerance. It really doesn’t matter what the cause is, it’s amenable to supportive treatment. It’s one aspect of the illness that contributes to severely impaired function. My plea to all physicians would be for sure to assess for [orthostatic intolerance], and gain an understanding about activity management and avoiding PEM symptoms.”

Dr. Nath noted that an often-challenging situation is when tests for the infectious agent and other blood work come back negative, yet the patient still reports multiple debilitating symptoms. This has been a particular issue with long COVID-19, since many patients became ill early in the pandemic before the polymerase chain reaction (PCR) tests for SARS-CoV-2 were widely available.

“The physician can only order tests that are available at their labs. I think what the physician should do is handle symptoms symptomatically but also refer patients to specialists who are taking care of these patients or to research studies,” he said.

Dr. Bateman added, “Whether they had a documented COVID infection – we just have to let go of that in 2020. Way too many people didn’t have access to a test or the timing wasn’t amenable. If people meet criteria for ME/CFS, it’s irrelevant … It’s mainly a clinical diagnosis. It’s not reliant on identifying the infectious trigger.” 

Dr. Komaroff, who began caring for then-termed “chronic fatigue syndrome” patients and researching the condition more than 30 years ago, said that “every cloud has its silver lining. The increased focus on postinfectious fatigue syndrome is a silver lining in my mind around the terrible dark cloud that is the pandemic of COVID.”

Dr. Komaroff has received personal fees from Serimmune Inc., Ono Pharma, and Deallus, and grants from the NIH. Dr. Bateman is employed by the Bateman Horne Center, which receives grants from the NIH, and fees from Exagen Inc., and Teva Pharmaceutical. Dr. Nath is an NIH employee.

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

People experiencing long-term symptoms following acute COVID-19 infection are increasingly meeting criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a phenomenon that highlights the need for unified research and clinical approaches, speakers said at a press briefing March 25 held by the advocacy group MEAction.

“Post-COVID lingering illness was predictable. Similar lingering fatigue syndromes have been reported in the scientific literature for nearly 100 years, following a variety of well-documented infections with viruses, bacteria, fungi, and even protozoa,” said Anthony Komaroff, MD, professor of medicine at Harvard Medical School, Boston.

Core criteria for ME/CFS established by the Institute of Medicine in 2015 include substantial decrement in functioning for at least 6 months, postexertional malaise (PEM), or a worsening of symptoms following even minor exertion (often described as “crashes”), unrefreshing sleep, and cognitive impairment and/or orthostatic intolerance.

Patients with ME/CFS also commonly experience painful headaches, muscle or joint aches, and allergies/other sensitivities. Although many patients can trace their symptoms to an initiating infection, “the cause is often unclear because the diagnosis is often delayed for months or years after symptom onset,” said Lucinda Bateman, MD, founder of the Bateman Horne Center, Salt Lake City, who leads a clinician coalition that aims to improve ME/CFS management.

In an international survey of 3762 COVID-19 “long-haulers” published in a preprint in December of 2020, the most frequent symptoms reported at least 6 months after illness onset were fatigue in 78%, PEM in 72%, and cognitive dysfunction (“brain fog”) in 55%. At the time of the survey, 45% reported requiring reduced work schedules because of their illness, and 22% reported being unable to work at all.

Dr. Bateman said those findings align with her experience so far with 12 COVID-19 “long haulers” who self-referred to her ME/CFS and fibromyalgia specialty clinic. Nine of the 12 met criteria for postural orthostatic tachycardia syndrome (POTS) based on the 10-minute NASA Lean Test, she said, and half also met the 2016 American College of Rheumatology criteria for fibromyalgia.

“Some were severely impaired. We suspect a small fiber polyneuropathy in about half, and mast cell activation syndrome in more than half. We look forward to doing more testing,” Dr. Bateman said.

To be sure, Dr. Komaroff noted, there are some differences. “Long COVID” patients will often experience breathlessness and ongoing anosmia (loss of taste and smell), which aren’t typical of ME/CFS.

But, he said, “many of the symptoms are quite similar ... My guess is that ME/CFS is an illness with a final common pathway that can be triggered by different things,” said Dr. Komaroff, a senior physician at Brigham and Women’s Hospital in Boston, and editor-in-chief of the Harvard Health Letter.

Based on previous data about CFS suggesting a 10% rate of symptoms persisting at least a year following a variety of infectious agents and the predicted 200 million COVID-19 cases globally by the end of 2021, Dr. Komaroff estimated that about 20 million cases of “long COVID” would be expected in the next year.

‘A huge investment’

On the research side, the National Institutes of Health recently appropriated $1.15 billion dollars over the next 4 years to investigate “the heterogeneity in the recovery process after COVID and to develop treatments for those suffering from [postacute COVID-19 syndrome]” according to a Feb. 5, 2021, blog from the National Institute of Neurological Disorders and Stroke (NINDS).

That same day, another NINDS blog announced “new resources for large-scale ME/CFS research” and emphasized the tie-in with long–COVID-19 syndrome.

“That’s a huge investment. In my opinion, there will be several lingering illnesses following COVID,” Dr. Komaroff said, adding, “It’s my bet that long COVID will prove to be caused by certain kinds of abnormalities in the brain, some of the same abnormalities already identified in ME/CFS. Research will determine whether that’s right or wrong.”

In 2017, NINDS had announced a large increase in funding for ME/CFS research, including the creation of four dedicated research centers. In April 2019, NINDS held a 2-day conference highlighting that ongoing work, as reported by Medscape Medical News.

During the briefing, NINDS clinical director Avindra Nath, MD, described a comprehensive ongoing ME/CFS intramural study he’s been leading since 2016.

He’s now also overseeing two long–COVID-19 studies, one of which has a protocol similar to that of the ME/CFS study and will include individuals who are still experiencing long-term symptoms following confirmed cases of COVID-19. The aim is to screen about 1,300 patients. Several task forces are now examining all of these data together.

“Each aspect is now being analyzed … What we learn from one applies to the other,” Dr. Nath said.  
 

Advice for clinicians

In interviews, Dr. Bateman and Dr. Nath offered clinical advice for managing patients who meet ME/CFS criteria, whether they had confirmed or suspected COVID-19, a different infection, or unknown trigger(s).

Dr. Bateman advised that clinicians assess patients for each of the symptoms individually. “Besides exercise intolerance and PEM, the most commonly missed is orthostatic intolerance. It really doesn’t matter what the cause is, it’s amenable to supportive treatment. It’s one aspect of the illness that contributes to severely impaired function. My plea to all physicians would be for sure to assess for [orthostatic intolerance], and gain an understanding about activity management and avoiding PEM symptoms.”

Dr. Nath noted that an often-challenging situation is when tests for the infectious agent and other blood work come back negative, yet the patient still reports multiple debilitating symptoms. This has been a particular issue with long COVID-19, since many patients became ill early in the pandemic before the polymerase chain reaction (PCR) tests for SARS-CoV-2 were widely available.

“The physician can only order tests that are available at their labs. I think what the physician should do is handle symptoms symptomatically but also refer patients to specialists who are taking care of these patients or to research studies,” he said.

Dr. Bateman added, “Whether they had a documented COVID infection – we just have to let go of that in 2020. Way too many people didn’t have access to a test or the timing wasn’t amenable. If people meet criteria for ME/CFS, it’s irrelevant … It’s mainly a clinical diagnosis. It’s not reliant on identifying the infectious trigger.” 

Dr. Komaroff, who began caring for then-termed “chronic fatigue syndrome” patients and researching the condition more than 30 years ago, said that “every cloud has its silver lining. The increased focus on postinfectious fatigue syndrome is a silver lining in my mind around the terrible dark cloud that is the pandemic of COVID.”

Dr. Komaroff has received personal fees from Serimmune Inc., Ono Pharma, and Deallus, and grants from the NIH. Dr. Bateman is employed by the Bateman Horne Center, which receives grants from the NIH, and fees from Exagen Inc., and Teva Pharmaceutical. Dr. Nath is an NIH employee.

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

Every day Melissa Fulton, RN, MSN, FNP, APRN-C, shows up to work, she’s ready for another fight. An advanced practice nurse who specializes in multiple sclerosis care, Ms. Fulton said she typically spends more than a third of her time battling it out with insurance companies over drugs she knows her patients need but that insurers don’t want to cover. Instead, they want the patient to first receive less expensive and often less efficacious drugs, even if that goes against recommendations and, in some cases, against the patient’s medical history.

The maddening protocol – familiar to health care providers everywhere – is known as “step therapy.” It forces patients to try alternative medications – medications that often fail – before receiving the one initially prescribed. The process can take weeks or months, which is time that some patients don’t have. Step therapy was sold as a way to lower costs. However, beyond the ethically problematic notion of forcing sick patients to receiver cheaper alternatives that are ineffective, research has also shown it may actually be more costly in the long run.

Ms. Fulton, who works at Saunders Medical Center in Wahoo, Neb., is a veteran in the war against step therapy. She is used to pushing her appeals up the insurance company chain of command, past nonmedical reviewers, until her patient’s case finally lands on the desk of someone with a neurology background. She said that can take three or four appeals – a judge might even get involved – and the patient could still lose. “This happens constantly,” she said, “but we fight like hell.”

Fortunately, life may soon get a little easier for Ms. Fulton. In late March, a bill to restrict step therapy made it through the Nebraska state legislature and is on its way to the governor’s desk. The Step Therapy Reform Act doesn’t outright ban the practice; however, it will put guardrails in place. It requires that insurers respond to appeals within certain time frames, and it creates key exemptions.

When the governor signs off, Nebraska will join more than two dozen other states that already have step therapy restrictions on the books, according to Hannah Lynch, MPS, associate director of federal government relations and health policy at the National Psoriasis Foundation, a leading advocate to reform and protect against the insurance practice. “There’s a lot of frustration out there,” Ms. Lynch said. “It really hinders providers’ ability to make decisions they think will have the best outcomes.”

Driven by coalitions of doctors, nurses, and patients, laws reining in step therapy have been adopted at a relatively quick clip, mostly within the past 5 years. Recent additions include South Dakota and North Carolina, which adopted step therapy laws in 2020, and Arkansas, which passed a law earlier this year.

Ms. Lynch attributed growing support to rising out-of-pocket drug costs and the introduction of biologic drugs, which are often more effective but also more expensive. Like Nebraska’s law, most step therapy reform legislation carves out exemptions and requires timely appeals processes; however, many of the laws still have significant gaps, such as not including certain types of insurance plans.

Ideally, Ms. Lynch said, the protections would apply to all types of health plans that are regulated at the state level, such as Medicaid, state employee health plans, and coverage sold through state insurance exchanges. Closing loopholes in the laws is a top priority for advocates, she added, pointing to work currently underway in Arkansas to extend its new protections to Medicaid expansion patients.

“With so many outside stakeholders, you have to compromise – it’s a give and take,” Ms. Lynch said. Still, when it comes to fighting step therapy, she says, “Any protection on the books is always our first goal when we go into a state.”

Putting patients first

Lisa Arkin, MD, a pediatric dermatologist at the University of Wisconsin–Madison, said she finds herself “swimming upstream every day in the fight with insurance.” Her patients are typically on their second or third stop and have more complex disorders. Dr. Arkin said that the problem with step therapy is that it tries to squeeze all patients into the same box, even if the circumstances don’t fit.

Her state passed restrictions on step therapy in 2019, but the measures only went into effect last year. Under the Wisconsin law, patients can be granted an exemption if an alternative treatment is contraindicated, likely to cause harm, or expected to be ineffective. Patients can also be exempt if their current treatment is working.

Dr. Arkin, an outspoken advocate for curbing step therapy, says the Wisconsin law is “very strong.” However, because it only applies to certain health plans – state employee health plans and those purchased in the state’s health insurance exchange – fewer than half the state’s patients benefit from its protections. She notes that some of the most severe presentations she treats occur in patients who rely on Medicaid coverage and already face barriers to care.

“I’m a doctor who puts up a fuss [with insurers], but that’s not fair – we shouldn’t have to do that,” Dr. Arkin said. “To me, it’s really critical to make this an even playing field so this law affords protection to everyone I see in the clinic.”

Major medical associations caution against step therapy as well. The American Society of Clinical Oncology and the American Medical Association have called out the risks to patient safety and health. In fact, in 2019, after the Centers for Medicare & Medicaid Services gave new authority to Medicare Advantage plans to start using step therapy, dozens of national medical groups called out the agency for allowing a practice that could potentially hurt patients and undercut the physician-patient decision-making process.

Last year, in a new position paper from the American College of Physicians, authors laid out recommendations for combating step therapy’s side effects. These recommendations included making related data transparent to the public and minimizing the policy’s disruptions to care. Jacqueline W. Fincher, MD, MACP, a member of the committee that issued the position paper and who is a primary care physician in Georgia, said such insurance practices need to be designed with “strong input from frontline physicians, not clipboard physicians.

“What we want from insurers is understanding, transparency, and the least burdensome protocol to provide patients the care they need at a cost-effective price they can afford,” said Dr. Fincher, who is also the current president of the ACP. “The focus needs to be on what’s in the patient’s best interest.”
 

Every year a new fight

“We all dread January,” said Dr. Fincher. That is the worst month, she added, because new health benefits go into effect, which means patients who are responding well to certain treatments may suddenly face new restrictions.

Another aggravating aspect of step therapy? It is often difficult – if not impossible – to access information on specific step therapy protocols in a patient’s health plan in real time in the exam room, where treatment conversations actually take place. In a more patient-centered world, Dr. Fincher said, she would be able to use the electronic health record system to quickly identify whether a patient’s plan covers a particular treatment and, if not, what the alternatives are.

Georgia’s new step therapy law went into effect last year. Like laws in other states, it spells out step therapy exemptions and sets time frames in which insurers must respond to exceptions and appeals. Dr. Fincher, who spoke in favor of the new law, said she’s “happy for any step forward.” Still, the growing burden of prior authorization rules are an utter “time sink” for her and her staff.

“I have to justify my decisions to nondoctors before I even get to a doctor, and that’s really frustrating,” she said. “We’re talking about people here, not widgets.”

Advocates in Nevada are hoping this is the year a step therapy bill will make it into law in their state. As of March, one had yet to be introduced in the state legislature. Tom McCoy, director of state government affairs at the Nevada Chronic Care Collaborative, said existing Nevada law already prohibits nonmedical drug switching during a policy year; however, insurers can still make changes the following year.

A bill to rein in step therapy was proposed previously, Mr. McCoy said, but it never got off the ground. The collaborative, as well as about two dozen organizations representing Nevada providers and patients, are now calling on state lawmakers to make the issue a priority in the current session.

“The health plans have a lot of power – a lot,” Mr. McCoy said. “We’re hoping to get a [legislative] sponsor in 2021 ... but it’s also been a really hard year to connect legislators with patients and doctors, and being able to hear their stories really does make a difference.”

In Nebraska, Marcus Snow, MD, a rheumatologist at Nebraska Medicine, in Omaha, said that the state’s new step therapy law will be a “great first step in helping to provide some guardrails” around the practice. He noted that turnaround requirements for insurer responses are “sorely needed.” However, he said that, because the bill doesn’t apply to all health plans, many Nebraskans still won’t benefit.

Dealing with step therapy is a daily “headache” for Dr. Snow, who says navigating the bureaucracy of prior authorization seems to be getting worse every year. Like his peers around the country, he spends an inordinate amount of time pushing appeals up the insurance company ranks to get access to treatments he believes will be most effective. But Snow says that, more than just being a mountain of tiresome red tape, these practices also intrude on the patient-provider relationship, casting an unsettling sense of uncertainty that the ultimate decision about the best course of action isn’t up to the doctor and patient at all.

“In the end, the insurance company is the judge and jury of my prescription,” Dr. Snow said. “They’d argue I can still prescribe it, but if it costs $70,000 a year – I don’t know who can afford that.”

Ms. Lynch, at the National Psoriasis Foundation, said their step therapy advocacy will continue to take a two-pronged approach. They will push for new and expanded protections at both state and federal levels. Protections are needed at both levels to make sure that all health plans regulated by all entities are covered. In the U.S. Senate and the House, step therapy bills were reintroduced this year. They would apply to health plans subject to the federal Employee Retirement Income Security Act, which governs employer-sponsored health coverage, and could close a big gap in existing protections. Oregon, New Jersey, and Arizona are at the top of the foundation’s advocacy list this year, according to Ms. Lynch.

“Folks are really starting to pay more attention to this issue,” she said. “And hearing those real-world stories and frustrations is definitely one of the most effective tools we have.”

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

Every day Melissa Fulton, RN, MSN, FNP, APRN-C, shows up to work, she’s ready for another fight. An advanced practice nurse who specializes in multiple sclerosis care, Ms. Fulton said she typically spends more than a third of her time battling it out with insurance companies over drugs she knows her patients need but that insurers don’t want to cover. Instead, they want the patient to first receive less expensive and often less efficacious drugs, even if that goes against recommendations and, in some cases, against the patient’s medical history.

The maddening protocol – familiar to health care providers everywhere – is known as “step therapy.” It forces patients to try alternative medications – medications that often fail – before receiving the one initially prescribed. The process can take weeks or months, which is time that some patients don’t have. Step therapy was sold as a way to lower costs. However, beyond the ethically problematic notion of forcing sick patients to receiver cheaper alternatives that are ineffective, research has also shown it may actually be more costly in the long run.

Ms. Fulton, who works at Saunders Medical Center in Wahoo, Neb., is a veteran in the war against step therapy. She is used to pushing her appeals up the insurance company chain of command, past nonmedical reviewers, until her patient’s case finally lands on the desk of someone with a neurology background. She said that can take three or four appeals – a judge might even get involved – and the patient could still lose. “This happens constantly,” she said, “but we fight like hell.”

Fortunately, life may soon get a little easier for Ms. Fulton. In late March, a bill to restrict step therapy made it through the Nebraska state legislature and is on its way to the governor’s desk. The Step Therapy Reform Act doesn’t outright ban the practice; however, it will put guardrails in place. It requires that insurers respond to appeals within certain time frames, and it creates key exemptions.

When the governor signs off, Nebraska will join more than two dozen other states that already have step therapy restrictions on the books, according to Hannah Lynch, MPS, associate director of federal government relations and health policy at the National Psoriasis Foundation, a leading advocate to reform and protect against the insurance practice. “There’s a lot of frustration out there,” Ms. Lynch said. “It really hinders providers’ ability to make decisions they think will have the best outcomes.”

Driven by coalitions of doctors, nurses, and patients, laws reining in step therapy have been adopted at a relatively quick clip, mostly within the past 5 years. Recent additions include South Dakota and North Carolina, which adopted step therapy laws in 2020, and Arkansas, which passed a law earlier this year.

Ms. Lynch attributed growing support to rising out-of-pocket drug costs and the introduction of biologic drugs, which are often more effective but also more expensive. Like Nebraska’s law, most step therapy reform legislation carves out exemptions and requires timely appeals processes; however, many of the laws still have significant gaps, such as not including certain types of insurance plans.

Ideally, Ms. Lynch said, the protections would apply to all types of health plans that are regulated at the state level, such as Medicaid, state employee health plans, and coverage sold through state insurance exchanges. Closing loopholes in the laws is a top priority for advocates, she added, pointing to work currently underway in Arkansas to extend its new protections to Medicaid expansion patients.

“With so many outside stakeholders, you have to compromise – it’s a give and take,” Ms. Lynch said. Still, when it comes to fighting step therapy, she says, “Any protection on the books is always our first goal when we go into a state.”

Putting patients first

Lisa Arkin, MD, a pediatric dermatologist at the University of Wisconsin–Madison, said she finds herself “swimming upstream every day in the fight with insurance.” Her patients are typically on their second or third stop and have more complex disorders. Dr. Arkin said that the problem with step therapy is that it tries to squeeze all patients into the same box, even if the circumstances don’t fit.

Her state passed restrictions on step therapy in 2019, but the measures only went into effect last year. Under the Wisconsin law, patients can be granted an exemption if an alternative treatment is contraindicated, likely to cause harm, or expected to be ineffective. Patients can also be exempt if their current treatment is working.

Dr. Arkin, an outspoken advocate for curbing step therapy, says the Wisconsin law is “very strong.” However, because it only applies to certain health plans – state employee health plans and those purchased in the state’s health insurance exchange – fewer than half the state’s patients benefit from its protections. She notes that some of the most severe presentations she treats occur in patients who rely on Medicaid coverage and already face barriers to care.

“I’m a doctor who puts up a fuss [with insurers], but that’s not fair – we shouldn’t have to do that,” Dr. Arkin said. “To me, it’s really critical to make this an even playing field so this law affords protection to everyone I see in the clinic.”

Major medical associations caution against step therapy as well. The American Society of Clinical Oncology and the American Medical Association have called out the risks to patient safety and health. In fact, in 2019, after the Centers for Medicare & Medicaid Services gave new authority to Medicare Advantage plans to start using step therapy, dozens of national medical groups called out the agency for allowing a practice that could potentially hurt patients and undercut the physician-patient decision-making process.

Last year, in a new position paper from the American College of Physicians, authors laid out recommendations for combating step therapy’s side effects. These recommendations included making related data transparent to the public and minimizing the policy’s disruptions to care. Jacqueline W. Fincher, MD, MACP, a member of the committee that issued the position paper and who is a primary care physician in Georgia, said such insurance practices need to be designed with “strong input from frontline physicians, not clipboard physicians.

“What we want from insurers is understanding, transparency, and the least burdensome protocol to provide patients the care they need at a cost-effective price they can afford,” said Dr. Fincher, who is also the current president of the ACP. “The focus needs to be on what’s in the patient’s best interest.”
 

Every year a new fight

“We all dread January,” said Dr. Fincher. That is the worst month, she added, because new health benefits go into effect, which means patients who are responding well to certain treatments may suddenly face new restrictions.

Another aggravating aspect of step therapy? It is often difficult – if not impossible – to access information on specific step therapy protocols in a patient’s health plan in real time in the exam room, where treatment conversations actually take place. In a more patient-centered world, Dr. Fincher said, she would be able to use the electronic health record system to quickly identify whether a patient’s plan covers a particular treatment and, if not, what the alternatives are.

Georgia’s new step therapy law went into effect last year. Like laws in other states, it spells out step therapy exemptions and sets time frames in which insurers must respond to exceptions and appeals. Dr. Fincher, who spoke in favor of the new law, said she’s “happy for any step forward.” Still, the growing burden of prior authorization rules are an utter “time sink” for her and her staff.

“I have to justify my decisions to nondoctors before I even get to a doctor, and that’s really frustrating,” she said. “We’re talking about people here, not widgets.”

Advocates in Nevada are hoping this is the year a step therapy bill will make it into law in their state. As of March, one had yet to be introduced in the state legislature. Tom McCoy, director of state government affairs at the Nevada Chronic Care Collaborative, said existing Nevada law already prohibits nonmedical drug switching during a policy year; however, insurers can still make changes the following year.

A bill to rein in step therapy was proposed previously, Mr. McCoy said, but it never got off the ground. The collaborative, as well as about two dozen organizations representing Nevada providers and patients, are now calling on state lawmakers to make the issue a priority in the current session.

“The health plans have a lot of power – a lot,” Mr. McCoy said. “We’re hoping to get a [legislative] sponsor in 2021 ... but it’s also been a really hard year to connect legislators with patients and doctors, and being able to hear their stories really does make a difference.”

In Nebraska, Marcus Snow, MD, a rheumatologist at Nebraska Medicine, in Omaha, said that the state’s new step therapy law will be a “great first step in helping to provide some guardrails” around the practice. He noted that turnaround requirements for insurer responses are “sorely needed.” However, he said that, because the bill doesn’t apply to all health plans, many Nebraskans still won’t benefit.

Dealing with step therapy is a daily “headache” for Dr. Snow, who says navigating the bureaucracy of prior authorization seems to be getting worse every year. Like his peers around the country, he spends an inordinate amount of time pushing appeals up the insurance company ranks to get access to treatments he believes will be most effective. But Snow says that, more than just being a mountain of tiresome red tape, these practices also intrude on the patient-provider relationship, casting an unsettling sense of uncertainty that the ultimate decision about the best course of action isn’t up to the doctor and patient at all.

“In the end, the insurance company is the judge and jury of my prescription,” Dr. Snow said. “They’d argue I can still prescribe it, but if it costs $70,000 a year – I don’t know who can afford that.”

Ms. Lynch, at the National Psoriasis Foundation, said their step therapy advocacy will continue to take a two-pronged approach. They will push for new and expanded protections at both state and federal levels. Protections are needed at both levels to make sure that all health plans regulated by all entities are covered. In the U.S. Senate and the House, step therapy bills were reintroduced this year. They would apply to health plans subject to the federal Employee Retirement Income Security Act, which governs employer-sponsored health coverage, and could close a big gap in existing protections. Oregon, New Jersey, and Arizona are at the top of the foundation’s advocacy list this year, according to Ms. Lynch.

“Folks are really starting to pay more attention to this issue,” she said. “And hearing those real-world stories and frustrations is definitely one of the most effective tools we have.”

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

Every day Melissa Fulton, RN, MSN, FNP, APRN-C, shows up to work, she’s ready for another fight. An advanced practice nurse who specializes in multiple sclerosis care, Ms. Fulton said she typically spends more than a third of her time battling it out with insurance companies over drugs she knows her patients need but that insurers don’t want to cover. Instead, they want the patient to first receive less expensive and often less efficacious drugs, even if that goes against recommendations and, in some cases, against the patient’s medical history.

The maddening protocol – familiar to health care providers everywhere – is known as “step therapy.” It forces patients to try alternative medications – medications that often fail – before receiving the one initially prescribed. The process can take weeks or months, which is time that some patients don’t have. Step therapy was sold as a way to lower costs. However, beyond the ethically problematic notion of forcing sick patients to receiver cheaper alternatives that are ineffective, research has also shown it may actually be more costly in the long run.

Ms. Fulton, who works at Saunders Medical Center in Wahoo, Neb., is a veteran in the war against step therapy. She is used to pushing her appeals up the insurance company chain of command, past nonmedical reviewers, until her patient’s case finally lands on the desk of someone with a neurology background. She said that can take three or four appeals – a judge might even get involved – and the patient could still lose. “This happens constantly,” she said, “but we fight like hell.”

Fortunately, life may soon get a little easier for Ms. Fulton. In late March, a bill to restrict step therapy made it through the Nebraska state legislature and is on its way to the governor’s desk. The Step Therapy Reform Act doesn’t outright ban the practice; however, it will put guardrails in place. It requires that insurers respond to appeals within certain time frames, and it creates key exemptions.

When the governor signs off, Nebraska will join more than two dozen other states that already have step therapy restrictions on the books, according to Hannah Lynch, MPS, associate director of federal government relations and health policy at the National Psoriasis Foundation, a leading advocate to reform and protect against the insurance practice. “There’s a lot of frustration out there,” Ms. Lynch said. “It really hinders providers’ ability to make decisions they think will have the best outcomes.”

Driven by coalitions of doctors, nurses, and patients, laws reining in step therapy have been adopted at a relatively quick clip, mostly within the past 5 years. Recent additions include South Dakota and North Carolina, which adopted step therapy laws in 2020, and Arkansas, which passed a law earlier this year.

Ms. Lynch attributed growing support to rising out-of-pocket drug costs and the introduction of biologic drugs, which are often more effective but also more expensive. Like Nebraska’s law, most step therapy reform legislation carves out exemptions and requires timely appeals processes; however, many of the laws still have significant gaps, such as not including certain types of insurance plans.

Ideally, Ms. Lynch said, the protections would apply to all types of health plans that are regulated at the state level, such as Medicaid, state employee health plans, and coverage sold through state insurance exchanges. Closing loopholes in the laws is a top priority for advocates, she added, pointing to work currently underway in Arkansas to extend its new protections to Medicaid expansion patients.

“With so many outside stakeholders, you have to compromise – it’s a give and take,” Ms. Lynch said. Still, when it comes to fighting step therapy, she says, “Any protection on the books is always our first goal when we go into a state.”

Putting patients first

Lisa Arkin, MD, a pediatric dermatologist at the University of Wisconsin–Madison, said she finds herself “swimming upstream every day in the fight with insurance.” Her patients are typically on their second or third stop and have more complex disorders. Dr. Arkin said that the problem with step therapy is that it tries to squeeze all patients into the same box, even if the circumstances don’t fit.

Her state passed restrictions on step therapy in 2019, but the measures only went into effect last year. Under the Wisconsin law, patients can be granted an exemption if an alternative treatment is contraindicated, likely to cause harm, or expected to be ineffective. Patients can also be exempt if their current treatment is working.

Dr. Arkin, an outspoken advocate for curbing step therapy, says the Wisconsin law is “very strong.” However, because it only applies to certain health plans – state employee health plans and those purchased in the state’s health insurance exchange – fewer than half the state’s patients benefit from its protections. She notes that some of the most severe presentations she treats occur in patients who rely on Medicaid coverage and already face barriers to care.

“I’m a doctor who puts up a fuss [with insurers], but that’s not fair – we shouldn’t have to do that,” Dr. Arkin said. “To me, it’s really critical to make this an even playing field so this law affords protection to everyone I see in the clinic.”

Major medical associations caution against step therapy as well. The American Society of Clinical Oncology and the American Medical Association have called out the risks to patient safety and health. In fact, in 2019, after the Centers for Medicare & Medicaid Services gave new authority to Medicare Advantage plans to start using step therapy, dozens of national medical groups called out the agency for allowing a practice that could potentially hurt patients and undercut the physician-patient decision-making process.

Last year, in a new position paper from the American College of Physicians, authors laid out recommendations for combating step therapy’s side effects. These recommendations included making related data transparent to the public and minimizing the policy’s disruptions to care. Jacqueline W. Fincher, MD, MACP, a member of the committee that issued the position paper and who is a primary care physician in Georgia, said such insurance practices need to be designed with “strong input from frontline physicians, not clipboard physicians.

“What we want from insurers is understanding, transparency, and the least burdensome protocol to provide patients the care they need at a cost-effective price they can afford,” said Dr. Fincher, who is also the current president of the ACP. “The focus needs to be on what’s in the patient’s best interest.”
 

Every year a new fight

“We all dread January,” said Dr. Fincher. That is the worst month, she added, because new health benefits go into effect, which means patients who are responding well to certain treatments may suddenly face new restrictions.

Another aggravating aspect of step therapy? It is often difficult – if not impossible – to access information on specific step therapy protocols in a patient’s health plan in real time in the exam room, where treatment conversations actually take place. In a more patient-centered world, Dr. Fincher said, she would be able to use the electronic health record system to quickly identify whether a patient’s plan covers a particular treatment and, if not, what the alternatives are.

Georgia’s new step therapy law went into effect last year. Like laws in other states, it spells out step therapy exemptions and sets time frames in which insurers must respond to exceptions and appeals. Dr. Fincher, who spoke in favor of the new law, said she’s “happy for any step forward.” Still, the growing burden of prior authorization rules are an utter “time sink” for her and her staff.

“I have to justify my decisions to nondoctors before I even get to a doctor, and that’s really frustrating,” she said. “We’re talking about people here, not widgets.”

Advocates in Nevada are hoping this is the year a step therapy bill will make it into law in their state. As of March, one had yet to be introduced in the state legislature. Tom McCoy, director of state government affairs at the Nevada Chronic Care Collaborative, said existing Nevada law already prohibits nonmedical drug switching during a policy year; however, insurers can still make changes the following year.

A bill to rein in step therapy was proposed previously, Mr. McCoy said, but it never got off the ground. The collaborative, as well as about two dozen organizations representing Nevada providers and patients, are now calling on state lawmakers to make the issue a priority in the current session.

“The health plans have a lot of power – a lot,” Mr. McCoy said. “We’re hoping to get a [legislative] sponsor in 2021 ... but it’s also been a really hard year to connect legislators with patients and doctors, and being able to hear their stories really does make a difference.”

In Nebraska, Marcus Snow, MD, a rheumatologist at Nebraska Medicine, in Omaha, said that the state’s new step therapy law will be a “great first step in helping to provide some guardrails” around the practice. He noted that turnaround requirements for insurer responses are “sorely needed.” However, he said that, because the bill doesn’t apply to all health plans, many Nebraskans still won’t benefit.

Dealing with step therapy is a daily “headache” for Dr. Snow, who says navigating the bureaucracy of prior authorization seems to be getting worse every year. Like his peers around the country, he spends an inordinate amount of time pushing appeals up the insurance company ranks to get access to treatments he believes will be most effective. But Snow says that, more than just being a mountain of tiresome red tape, these practices also intrude on the patient-provider relationship, casting an unsettling sense of uncertainty that the ultimate decision about the best course of action isn’t up to the doctor and patient at all.

“In the end, the insurance company is the judge and jury of my prescription,” Dr. Snow said. “They’d argue I can still prescribe it, but if it costs $70,000 a year – I don’t know who can afford that.”

Ms. Lynch, at the National Psoriasis Foundation, said their step therapy advocacy will continue to take a two-pronged approach. They will push for new and expanded protections at both state and federal levels. Protections are needed at both levels to make sure that all health plans regulated by all entities are covered. In the U.S. Senate and the House, step therapy bills were reintroduced this year. They would apply to health plans subject to the federal Employee Retirement Income Security Act, which governs employer-sponsored health coverage, and could close a big gap in existing protections. Oregon, New Jersey, and Arizona are at the top of the foundation’s advocacy list this year, according to Ms. Lynch.

“Folks are really starting to pay more attention to this issue,” she said. “And hearing those real-world stories and frustrations is definitely one of the most effective tools we have.”

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

A controversial, big-budget breast cancer screening trial that has been chronically unable to attract enough female participants since its debut in 2017 got a vote of confidence from a special working group of the National Cancer Institute (NCI) on March 17.

The Tomosynthesis Mammography Imaging Screening Trial (TMIST) should continue, but with modification, the expert group concluded in its report.

The randomized trial, with an estimated cost of $100 million, compares two kinds of mammography screenings for breast cancer in healthy women. One group of patients is screened with digital breast tomosynthesis, also known as 3-D mammography; the other is screened with the older, less expensive 2-D digital technology.

Tomosynthesis is already considered superior in detecting small cancers and reducing callbacks and is increasingly being used in the real world, leading some experts in the field to say that TMIST is critically hampered by women’s and radiologists’ preference for 3-D mammography.

At a meeting of an NCI advisory board in September 2020, there was a suggestion that the federal agency may kill the trial.

But at the latest meeting, the working group proposed that the trial should live on.

One of the main problems with the trial has been recruitment; the recommended changes discussed at the meeting include reducing the number of women needed in the study (from 165,000 to 102,000), which would allow patient “accrual to be completed more quickly,” the working group noted. In addition, the target date for completing patient accrual would be moved to 2023, 3 years after the original completion date of 2020.

The group’s recommendations now go to NCI staff for scientific review. The NCI will then decide about implementing the proposed changes.

The trial, which is the NCI’s largest and most expensive screening study, has never come close to targeted monthly enrollment. It was enrolling fewer than 1,500 patients per month over a 2-year period, instead of the projected 5,500 per month, Philip Castle, PhD, MPH, director of the NCI’s Division of Cancer Prevention, said last year. He called for a review of TMIST’s “feasibility and relevance” in view of the increasing use of tomosynthesis in the United States, as well as other factors.

The new technology has been “rapidly adopted” by facilities in North America, the working group noted. As of December 2020, approximately 74% of breast cancer screening clinics in the United States had at least one tomosynthesis or 3-D system; 42% of the mammography machines were 3-D.

This trend of increasing use of 3-D machines might be too much for TMIST to surmount, said Nancy Davidson, MD, of the Fred Hutchinson Cancer Research Center, in Seattle, who chaired the working group.

“We are worried the challenges [to patient accrual] may persist due to the increasing adoption of three-dimensional breast tomosynthesis in the United States over time,” she said during the working group’s virtual presentation of the report to the NCI’s Clinical Trials and Translational Research Advisory Committee.

Committee member Smita Bhatia, MD, PhD, of the University of Alabama at Birmingham, wondered, “What are the ongoing barriers that [TMIST investigators] are going to face beside recruitment?”

Dr. Davidson answered by speaking, again, about market penetration of tomosynthesis machines and suggested that the recruitment problems and the availability of 3-D mammography are intertwined.

“Is this a technology that has or will arrive, at which point it may not be very easy to put the genie back in the bottle?” she asked.

That question has already been answered – widespread use of tomosynthesis is here to stay, argued Daniel Kopans, MD, of Harvard Medical School, Boston, who invented digital breast tomosynthesis but no longer benefits financially from his invention because the patent has expired.

“The horse is out of the barn,” Dr. Kopans said in an interview. By the time the study results are available, digital mammography will be a tool of the past, he said.

TMIST is a trial “that should never have been started in the first place, and it’s failing,” he said. “I was hoping they [the NCI] would say, ‘Let’s stop this because there’s not enough accrual.’ But it looks like they’re not.”

“TMIST is a waste of money,” said Dr. Kopans, repeating a criticism he has made in the past.
 

A drop in study power

The new recommendations for TMIST come about 1 year after Medscape Medical News reported that the study was lagging in enrollment of both patients and participating sites/physicians.

Last year, two TMIST study investigators said it had been difficult enlisting sites, in part because many radiologists and facilities – informed by their experience and previous research results – already believe that the 3-D technology is superior.

Currently, most 3-D systems are used in conjunction with 2-D. First, two static images of the breast are taken (2-D), and then the unit moves in an arc, taking multiple images of the breast (3-D). Thus, 3-D is widely described as allowing clinicians to flip through the images like “pages in a book” and as offering a superior read of the breast.

The NCI working group concedes that “there is evidence that screening utilizing tomosynthesis may reduce recall rates and improve cancer detection,” but it says the trial is needed to address “questions that still remain regarding the overall benefit to patients.”

Furthermore, tomosynthesis “may carry higher out-of-pocket costs for women and is more labor intensive and costly for health care systems in that it requires about twice as much reader time for interpretation,” the working group said.

The “main hypothesis of TMIST” is that “tomosynthesis will decrease the cumulative incidence of advanced breast cancers, a surrogate for mortality, compared to standard digital mammography,” posits the group.

Advanced breast cancer is defined in TMIST as invasive breast cancers that meet any of the following criteria:

• Distant metastases
• At least one lymph node macrometastasis
• Tumor size >1 cm and triple-negative or positive for human epidermal growth factor receptor
• Tumor size ≥ 20 mm unless of pure mucinous or other favorable histologies.

In the original study design, the sample size was estimated to be sufficient to provide 90% power to detect a 20% relative reduction in the proportion of advanced cancers in the intervention arm (tomosynthesis, or 3-D) compared to the control arm (digital mammography, or 2-D) 4.5 years from randomization.

Now, with fewer patients and a revised analytic approach, the study’s statistical power will be decreased to 80% from the original 90%.

Also, an advanced cancer is counted “if it occurs at any time while the participant is on study.”

Dr. Kopans says that is a problem.

“That is a huge mistake, since digital breast tomosynthesis cannot impact prevalent cancers. They are already there. This means that their ‘power calculation’ is wrong, and they won’t have the power that they are claiming,” he said.

Dr. Kopans explained that the first screen in TMIST will have “no effect on the number of advanced cancers.” That’s because the cancers will have already grown enough to become advanced, he said.

On the other hand, an initial screening might detect and thus lead to the removal of nonadvanced, smaller cancers, which, had they not been detected and removed, would have grown to become advanced cancers by the next year. Thus, the screenings done after the first year are the ones that potentially prove the effect of the intervention.

However, the working group report says that changes to the study will not affect anything other than a 10% reduction in the study’s power.

The working group is concerned about TMIST going on for years and years. For that reason, they recommended that the NCI establish “strict criteria for termination of the study” if accrual goals are not met. However, those parameters have not been developed, and it was not part of the study group’s mission to establish them.

The working group was sponsored by the NCI. Dr. Kopans reports consulting with DART Imaging in China.

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

A controversial, big-budget breast cancer screening trial that has been chronically unable to attract enough female participants since its debut in 2017 got a vote of confidence from a special working group of the National Cancer Institute (NCI) on March 17.

The Tomosynthesis Mammography Imaging Screening Trial (TMIST) should continue, but with modification, the expert group concluded in its report.

The randomized trial, with an estimated cost of $100 million, compares two kinds of mammography screenings for breast cancer in healthy women. One group of patients is screened with digital breast tomosynthesis, also known as 3-D mammography; the other is screened with the older, less expensive 2-D digital technology.

Tomosynthesis is already considered superior in detecting small cancers and reducing callbacks and is increasingly being used in the real world, leading some experts in the field to say that TMIST is critically hampered by women’s and radiologists’ preference for 3-D mammography.

At a meeting of an NCI advisory board in September 2020, there was a suggestion that the federal agency may kill the trial.

But at the latest meeting, the working group proposed that the trial should live on.

One of the main problems with the trial has been recruitment; the recommended changes discussed at the meeting include reducing the number of women needed in the study (from 165,000 to 102,000), which would allow patient “accrual to be completed more quickly,” the working group noted. In addition, the target date for completing patient accrual would be moved to 2023, 3 years after the original completion date of 2020.

The group’s recommendations now go to NCI staff for scientific review. The NCI will then decide about implementing the proposed changes.

The trial, which is the NCI’s largest and most expensive screening study, has never come close to targeted monthly enrollment. It was enrolling fewer than 1,500 patients per month over a 2-year period, instead of the projected 5,500 per month, Philip Castle, PhD, MPH, director of the NCI’s Division of Cancer Prevention, said last year. He called for a review of TMIST’s “feasibility and relevance” in view of the increasing use of tomosynthesis in the United States, as well as other factors.

The new technology has been “rapidly adopted” by facilities in North America, the working group noted. As of December 2020, approximately 74% of breast cancer screening clinics in the United States had at least one tomosynthesis or 3-D system; 42% of the mammography machines were 3-D.

This trend of increasing use of 3-D machines might be too much for TMIST to surmount, said Nancy Davidson, MD, of the Fred Hutchinson Cancer Research Center, in Seattle, who chaired the working group.

“We are worried the challenges [to patient accrual] may persist due to the increasing adoption of three-dimensional breast tomosynthesis in the United States over time,” she said during the working group’s virtual presentation of the report to the NCI’s Clinical Trials and Translational Research Advisory Committee.

Committee member Smita Bhatia, MD, PhD, of the University of Alabama at Birmingham, wondered, “What are the ongoing barriers that [TMIST investigators] are going to face beside recruitment?”

Dr. Davidson answered by speaking, again, about market penetration of tomosynthesis machines and suggested that the recruitment problems and the availability of 3-D mammography are intertwined.

“Is this a technology that has or will arrive, at which point it may not be very easy to put the genie back in the bottle?” she asked.

That question has already been answered – widespread use of tomosynthesis is here to stay, argued Daniel Kopans, MD, of Harvard Medical School, Boston, who invented digital breast tomosynthesis but no longer benefits financially from his invention because the patent has expired.

“The horse is out of the barn,” Dr. Kopans said in an interview. By the time the study results are available, digital mammography will be a tool of the past, he said.

TMIST is a trial “that should never have been started in the first place, and it’s failing,” he said. “I was hoping they [the NCI] would say, ‘Let’s stop this because there’s not enough accrual.’ But it looks like they’re not.”

“TMIST is a waste of money,” said Dr. Kopans, repeating a criticism he has made in the past.
 

A drop in study power

The new recommendations for TMIST come about 1 year after Medscape Medical News reported that the study was lagging in enrollment of both patients and participating sites/physicians.

Last year, two TMIST study investigators said it had been difficult enlisting sites, in part because many radiologists and facilities – informed by their experience and previous research results – already believe that the 3-D technology is superior.

Currently, most 3-D systems are used in conjunction with 2-D. First, two static images of the breast are taken (2-D), and then the unit moves in an arc, taking multiple images of the breast (3-D). Thus, 3-D is widely described as allowing clinicians to flip through the images like “pages in a book” and as offering a superior read of the breast.

The NCI working group concedes that “there is evidence that screening utilizing tomosynthesis may reduce recall rates and improve cancer detection,” but it says the trial is needed to address “questions that still remain regarding the overall benefit to patients.”

Furthermore, tomosynthesis “may carry higher out-of-pocket costs for women and is more labor intensive and costly for health care systems in that it requires about twice as much reader time for interpretation,” the working group said.

The “main hypothesis of TMIST” is that “tomosynthesis will decrease the cumulative incidence of advanced breast cancers, a surrogate for mortality, compared to standard digital mammography,” posits the group.

Advanced breast cancer is defined in TMIST as invasive breast cancers that meet any of the following criteria:

• Distant metastases
• At least one lymph node macrometastasis
• Tumor size >1 cm and triple-negative or positive for human epidermal growth factor receptor
• Tumor size ≥ 20 mm unless of pure mucinous or other favorable histologies.

In the original study design, the sample size was estimated to be sufficient to provide 90% power to detect a 20% relative reduction in the proportion of advanced cancers in the intervention arm (tomosynthesis, or 3-D) compared to the control arm (digital mammography, or 2-D) 4.5 years from randomization.

Now, with fewer patients and a revised analytic approach, the study’s statistical power will be decreased to 80% from the original 90%.

Also, an advanced cancer is counted “if it occurs at any time while the participant is on study.”

Dr. Kopans says that is a problem.

“That is a huge mistake, since digital breast tomosynthesis cannot impact prevalent cancers. They are already there. This means that their ‘power calculation’ is wrong, and they won’t have the power that they are claiming,” he said.

Dr. Kopans explained that the first screen in TMIST will have “no effect on the number of advanced cancers.” That’s because the cancers will have already grown enough to become advanced, he said.

On the other hand, an initial screening might detect and thus lead to the removal of nonadvanced, smaller cancers, which, had they not been detected and removed, would have grown to become advanced cancers by the next year. Thus, the screenings done after the first year are the ones that potentially prove the effect of the intervention.

However, the working group report says that changes to the study will not affect anything other than a 10% reduction in the study’s power.

The working group is concerned about TMIST going on for years and years. For that reason, they recommended that the NCI establish “strict criteria for termination of the study” if accrual goals are not met. However, those parameters have not been developed, and it was not part of the study group’s mission to establish them.

The working group was sponsored by the NCI. Dr. Kopans reports consulting with DART Imaging in China.

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

A controversial, big-budget breast cancer screening trial that has been chronically unable to attract enough female participants since its debut in 2017 got a vote of confidence from a special working group of the National Cancer Institute (NCI) on March 17.

The Tomosynthesis Mammography Imaging Screening Trial (TMIST) should continue, but with modification, the expert group concluded in its report.

The randomized trial, with an estimated cost of $100 million, compares two kinds of mammography screenings for breast cancer in healthy women. One group of patients is screened with digital breast tomosynthesis, also known as 3-D mammography; the other is screened with the older, less expensive 2-D digital technology.

Tomosynthesis is already considered superior in detecting small cancers and reducing callbacks and is increasingly being used in the real world, leading some experts in the field to say that TMIST is critically hampered by women’s and radiologists’ preference for 3-D mammography.

At a meeting of an NCI advisory board in September 2020, there was a suggestion that the federal agency may kill the trial.

But at the latest meeting, the working group proposed that the trial should live on.

One of the main problems with the trial has been recruitment; the recommended changes discussed at the meeting include reducing the number of women needed in the study (from 165,000 to 102,000), which would allow patient “accrual to be completed more quickly,” the working group noted. In addition, the target date for completing patient accrual would be moved to 2023, 3 years after the original completion date of 2020.

The group’s recommendations now go to NCI staff for scientific review. The NCI will then decide about implementing the proposed changes.

The trial, which is the NCI’s largest and most expensive screening study, has never come close to targeted monthly enrollment. It was enrolling fewer than 1,500 patients per month over a 2-year period, instead of the projected 5,500 per month, Philip Castle, PhD, MPH, director of the NCI’s Division of Cancer Prevention, said last year. He called for a review of TMIST’s “feasibility and relevance” in view of the increasing use of tomosynthesis in the United States, as well as other factors.

The new technology has been “rapidly adopted” by facilities in North America, the working group noted. As of December 2020, approximately 74% of breast cancer screening clinics in the United States had at least one tomosynthesis or 3-D system; 42% of the mammography machines were 3-D.

This trend of increasing use of 3-D machines might be too much for TMIST to surmount, said Nancy Davidson, MD, of the Fred Hutchinson Cancer Research Center, in Seattle, who chaired the working group.

“We are worried the challenges [to patient accrual] may persist due to the increasing adoption of three-dimensional breast tomosynthesis in the United States over time,” she said during the working group’s virtual presentation of the report to the NCI’s Clinical Trials and Translational Research Advisory Committee.

Committee member Smita Bhatia, MD, PhD, of the University of Alabama at Birmingham, wondered, “What are the ongoing barriers that [TMIST investigators] are going to face beside recruitment?”

Dr. Davidson answered by speaking, again, about market penetration of tomosynthesis machines and suggested that the recruitment problems and the availability of 3-D mammography are intertwined.

“Is this a technology that has or will arrive, at which point it may not be very easy to put the genie back in the bottle?” she asked.

That question has already been answered – widespread use of tomosynthesis is here to stay, argued Daniel Kopans, MD, of Harvard Medical School, Boston, who invented digital breast tomosynthesis but no longer benefits financially from his invention because the patent has expired.

“The horse is out of the barn,” Dr. Kopans said in an interview. By the time the study results are available, digital mammography will be a tool of the past, he said.

TMIST is a trial “that should never have been started in the first place, and it’s failing,” he said. “I was hoping they [the NCI] would say, ‘Let’s stop this because there’s not enough accrual.’ But it looks like they’re not.”

“TMIST is a waste of money,” said Dr. Kopans, repeating a criticism he has made in the past.
 

A drop in study power

The new recommendations for TMIST come about 1 year after Medscape Medical News reported that the study was lagging in enrollment of both patients and participating sites/physicians.

Last year, two TMIST study investigators said it had been difficult enlisting sites, in part because many radiologists and facilities – informed by their experience and previous research results – already believe that the 3-D technology is superior.

Currently, most 3-D systems are used in conjunction with 2-D. First, two static images of the breast are taken (2-D), and then the unit moves in an arc, taking multiple images of the breast (3-D). Thus, 3-D is widely described as allowing clinicians to flip through the images like “pages in a book” and as offering a superior read of the breast.

The NCI working group concedes that “there is evidence that screening utilizing tomosynthesis may reduce recall rates and improve cancer detection,” but it says the trial is needed to address “questions that still remain regarding the overall benefit to patients.”

Furthermore, tomosynthesis “may carry higher out-of-pocket costs for women and is more labor intensive and costly for health care systems in that it requires about twice as much reader time for interpretation,” the working group said.

The “main hypothesis of TMIST” is that “tomosynthesis will decrease the cumulative incidence of advanced breast cancers, a surrogate for mortality, compared to standard digital mammography,” posits the group.

Advanced breast cancer is defined in TMIST as invasive breast cancers that meet any of the following criteria:

• Distant metastases
• At least one lymph node macrometastasis
• Tumor size >1 cm and triple-negative or positive for human epidermal growth factor receptor
• Tumor size ≥ 20 mm unless of pure mucinous or other favorable histologies.

In the original study design, the sample size was estimated to be sufficient to provide 90% power to detect a 20% relative reduction in the proportion of advanced cancers in the intervention arm (tomosynthesis, or 3-D) compared to the control arm (digital mammography, or 2-D) 4.5 years from randomization.

Now, with fewer patients and a revised analytic approach, the study’s statistical power will be decreased to 80% from the original 90%.

Also, an advanced cancer is counted “if it occurs at any time while the participant is on study.”

Dr. Kopans says that is a problem.

“That is a huge mistake, since digital breast tomosynthesis cannot impact prevalent cancers. They are already there. This means that their ‘power calculation’ is wrong, and they won’t have the power that they are claiming,” he said.

Dr. Kopans explained that the first screen in TMIST will have “no effect on the number of advanced cancers.” That’s because the cancers will have already grown enough to become advanced, he said.

On the other hand, an initial screening might detect and thus lead to the removal of nonadvanced, smaller cancers, which, had they not been detected and removed, would have grown to become advanced cancers by the next year. Thus, the screenings done after the first year are the ones that potentially prove the effect of the intervention.

However, the working group report says that changes to the study will not affect anything other than a 10% reduction in the study’s power.

The working group is concerned about TMIST going on for years and years. For that reason, they recommended that the NCI establish “strict criteria for termination of the study” if accrual goals are not met. However, those parameters have not been developed, and it was not part of the study group’s mission to establish them.

The working group was sponsored by the NCI. Dr. Kopans reports consulting with DART Imaging in China.

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

Approximately 68 million cases of sexually transmitted infections are reported in the United States each year, yet antiquated approaches to STI prevention, in addition to health care inequities and lack of funding, have substantially prevented providers and officials from curbing the spread. In response to rising case numbers, the National Academies of Sciences, Engineering, and Medicine released a report this week with recommendations to modernize the nation’s STI surveillance and monitoring systems, increase the capabilities of the STI workforce, and address structural barriers to STI prevention and access to care.

Given the rising rates of STIs and the urgent, unmet need for prevention and treatment, the Centers for Disease Control and Prevention’s National Association of County and City Health Officials commissioned the National Academies to develop actionable recommendations to control STIs. The new report marks a long road toward the public’s willingness to discuss STDs, or what a 1997 Institute of Medicine report described as a “hidden epidemic” that had been largely neglected in public discourse.

Jeffrey Crowley, MPH, committee member and an author of the new National Academies report, said in an interview that, despite the increased openness to discuss STIs in today’s society, STD rates since the late 1990s have gotten much worse. Lack of appropriate governmental funding for research and drug development, structural inequities, and persisting stigmatization are key drivers for rising rates, explained Mr. Crowley.
 

Addressing structural barriers to STI prevention

Playing a prominent role in the National Academies report are issues of structural and institutional barriers to STI prevention and care. In the report, the authors argued that a policy-based approach should seek to promote sexual health and eliminate structural racism and inequities to drive improvements in STI management.

“We think it’s these structural factors that are central to all the inequities that play out,” said Mr. Crowley, “and they either don’t get any attention or, if they do get attention, people don’t really speak concretely enough about how we address them.”

The concrete steps, as outlined in the report, begin with addressing factors that involve the health care industry at large. Automatic STI screening as part of routine visits, alerts in electronic health records that remind clinicians to screen patients, and reminders to test patients can be initial low-cost actions health care systems can take to improve STI testing, particularly in marginalized communities. Mr. Crowley noted that greater evidence is needed to support further steps to address structural factors that contribute to barriers in STI screening and treatment access.

Given the complexities inherent in structural barriers to STI care, the report calls on a whole-government response, in partnership with affected communities, to normalize discussions involving sexual well-being. “We have to ask ourselves how we can build healthier communities and how can we integrate sexual health into that dialogue in a way that improves our response to STI prevention and control,” Mr. Crowley explained.
 

Harnessing AI and dating apps

The report also addresses the power of artificial intelligence to predict STI rates and to discover trends in risk factors, both of which may improve STI surveillance and assist in the development of tailored interventions. The report calls for policy that will enable companies and the government to capitalize on AI to evaluate large collections of data in EHRs, insurance claims databases, social media, search engines, and even dating apps.

In particular, dating apps could be an avenue through which the public and private sectors could improve STI prevention, diagnosis, and treatment. “People want to focus on this idea of whether these apps increase transmission risk,” said Mr. Crowley. “But we would say that this is asking the wrong question, because these technologies are not going away.” He noted that private and public enterprises could work together to leverage these technologies to increase awareness of prevention and testing.
 

Unifying the STI/HIV and COVID-19 workforce

The report also recommends that the nation unify the STI/HIV workforce with the COVID-19 workforce. Given the high levels of expertise in these professional working groups, the report suggests unification could potentially address both the current crisis and possible future disease outbreaks. Combining COVID-19 response teams with underresourced STI/HIV programs may also improve the delivery of STI testing, considering that STI testing programs have had to compete for resources during the pandemic.

Addressing stigma

The National Academies report also addresses the ongoing issue of stigma, which results from “blaming” individuals and the choices they make so as to create shame, embarrassment, and discrimination. Because of stigma, sexually active people may be unwilling to seek recommended screening, which can lead to delays in diagnosis and treatment and can increase the risk for negative health outcomes.

“As a nation, we’ve almost focused too intently on individual-level factors in a way that’s driven stigma and really hasn’t been helpful for combating the problem,” said Mr. Crowley. He added that, instead of focusing solely on individual-level choices, the nation should instead work to reframe sexual health as a key aspect of overall physical, mental, and emotional well-being. Doing so could create more opportunities to address structural barriers to STI prevention and ensure that more prevention and screening services are available in stigma-free environments.

“I know what we’re recommending is ambitious, but it’s not too big to be achieved, and we’re not saying tomorrow we’re going to transform the world,” Mr. Crowley concluded. “It’s a puzzle with many pieces, but the long-term impact is really all of these pieces fitting together so that, over time, we can reduce the burden STIs have on the population.”
 

Implications for real-world change

H. Hunter Handsfield, MD, professor emeritus of medicine for the Center for AIDS and STD at the University of Washington, Seattle, said in an interview that this report essentially is a response to evolving societal changes, new and emerging means of social engagement, and increased focus on racial/ethnic disparities. “These features have all come to the forefront of health care and general policy discussions in recent years,” said Dr. Handsfield, who was not part of the committee that developed the NAS report.

Greater scrutiny on public health infrastructure and its relationship with health disparities in the United States makes the publication of these new recommendations especially appropriate during this era of enhanced focus on social justice. Although the report features the tone and quality needed to bolster bipartisan support, said Dr. Handsfield, it’s hard to predict whether such support will come to fruition in today’s political environment.

In terms of the effects the recommendations may have on STI rates, Dr. Handsfield noted that cherry-picking elements from the report to direct policy may result in its having only a trivial impact. “The report is really an appropriate and necessary response, and almost all the recommendations made can be helpful,” he said, “but for true effectiveness, all the elements need to be implemented to drive policy and funding.”

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

Approximately 68 million cases of sexually transmitted infections are reported in the United States each year, yet antiquated approaches to STI prevention, in addition to health care inequities and lack of funding, have substantially prevented providers and officials from curbing the spread. In response to rising case numbers, the National Academies of Sciences, Engineering, and Medicine released a report this week with recommendations to modernize the nation’s STI surveillance and monitoring systems, increase the capabilities of the STI workforce, and address structural barriers to STI prevention and access to care.

Given the rising rates of STIs and the urgent, unmet need for prevention and treatment, the Centers for Disease Control and Prevention’s National Association of County and City Health Officials commissioned the National Academies to develop actionable recommendations to control STIs. The new report marks a long road toward the public’s willingness to discuss STDs, or what a 1997 Institute of Medicine report described as a “hidden epidemic” that had been largely neglected in public discourse.

Jeffrey Crowley, MPH, committee member and an author of the new National Academies report, said in an interview that, despite the increased openness to discuss STIs in today’s society, STD rates since the late 1990s have gotten much worse. Lack of appropriate governmental funding for research and drug development, structural inequities, and persisting stigmatization are key drivers for rising rates, explained Mr. Crowley.
 

Addressing structural barriers to STI prevention

Playing a prominent role in the National Academies report are issues of structural and institutional barriers to STI prevention and care. In the report, the authors argued that a policy-based approach should seek to promote sexual health and eliminate structural racism and inequities to drive improvements in STI management.

“We think it’s these structural factors that are central to all the inequities that play out,” said Mr. Crowley, “and they either don’t get any attention or, if they do get attention, people don’t really speak concretely enough about how we address them.”

The concrete steps, as outlined in the report, begin with addressing factors that involve the health care industry at large. Automatic STI screening as part of routine visits, alerts in electronic health records that remind clinicians to screen patients, and reminders to test patients can be initial low-cost actions health care systems can take to improve STI testing, particularly in marginalized communities. Mr. Crowley noted that greater evidence is needed to support further steps to address structural factors that contribute to barriers in STI screening and treatment access.

Given the complexities inherent in structural barriers to STI care, the report calls on a whole-government response, in partnership with affected communities, to normalize discussions involving sexual well-being. “We have to ask ourselves how we can build healthier communities and how can we integrate sexual health into that dialogue in a way that improves our response to STI prevention and control,” Mr. Crowley explained.
 

Harnessing AI and dating apps

The report also addresses the power of artificial intelligence to predict STI rates and to discover trends in risk factors, both of which may improve STI surveillance and assist in the development of tailored interventions. The report calls for policy that will enable companies and the government to capitalize on AI to evaluate large collections of data in EHRs, insurance claims databases, social media, search engines, and even dating apps.

In particular, dating apps could be an avenue through which the public and private sectors could improve STI prevention, diagnosis, and treatment. “People want to focus on this idea of whether these apps increase transmission risk,” said Mr. Crowley. “But we would say that this is asking the wrong question, because these technologies are not going away.” He noted that private and public enterprises could work together to leverage these technologies to increase awareness of prevention and testing.
 

Unifying the STI/HIV and COVID-19 workforce

The report also recommends that the nation unify the STI/HIV workforce with the COVID-19 workforce. Given the high levels of expertise in these professional working groups, the report suggests unification could potentially address both the current crisis and possible future disease outbreaks. Combining COVID-19 response teams with underresourced STI/HIV programs may also improve the delivery of STI testing, considering that STI testing programs have had to compete for resources during the pandemic.

Addressing stigma

The National Academies report also addresses the ongoing issue of stigma, which results from “blaming” individuals and the choices they make so as to create shame, embarrassment, and discrimination. Because of stigma, sexually active people may be unwilling to seek recommended screening, which can lead to delays in diagnosis and treatment and can increase the risk for negative health outcomes.

“As a nation, we’ve almost focused too intently on individual-level factors in a way that’s driven stigma and really hasn’t been helpful for combating the problem,” said Mr. Crowley. He added that, instead of focusing solely on individual-level choices, the nation should instead work to reframe sexual health as a key aspect of overall physical, mental, and emotional well-being. Doing so could create more opportunities to address structural barriers to STI prevention and ensure that more prevention and screening services are available in stigma-free environments.

“I know what we’re recommending is ambitious, but it’s not too big to be achieved, and we’re not saying tomorrow we’re going to transform the world,” Mr. Crowley concluded. “It’s a puzzle with many pieces, but the long-term impact is really all of these pieces fitting together so that, over time, we can reduce the burden STIs have on the population.”
 

Implications for real-world change

H. Hunter Handsfield, MD, professor emeritus of medicine for the Center for AIDS and STD at the University of Washington, Seattle, said in an interview that this report essentially is a response to evolving societal changes, new and emerging means of social engagement, and increased focus on racial/ethnic disparities. “These features have all come to the forefront of health care and general policy discussions in recent years,” said Dr. Handsfield, who was not part of the committee that developed the NAS report.

Greater scrutiny on public health infrastructure and its relationship with health disparities in the United States makes the publication of these new recommendations especially appropriate during this era of enhanced focus on social justice. Although the report features the tone and quality needed to bolster bipartisan support, said Dr. Handsfield, it’s hard to predict whether such support will come to fruition in today’s political environment.

In terms of the effects the recommendations may have on STI rates, Dr. Handsfield noted that cherry-picking elements from the report to direct policy may result in its having only a trivial impact. “The report is really an appropriate and necessary response, and almost all the recommendations made can be helpful,” he said, “but for true effectiveness, all the elements need to be implemented to drive policy and funding.”

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

Approximately 68 million cases of sexually transmitted infections are reported in the United States each year, yet antiquated approaches to STI prevention, in addition to health care inequities and lack of funding, have substantially prevented providers and officials from curbing the spread. In response to rising case numbers, the National Academies of Sciences, Engineering, and Medicine released a report this week with recommendations to modernize the nation’s STI surveillance and monitoring systems, increase the capabilities of the STI workforce, and address structural barriers to STI prevention and access to care.

Given the rising rates of STIs and the urgent, unmet need for prevention and treatment, the Centers for Disease Control and Prevention’s National Association of County and City Health Officials commissioned the National Academies to develop actionable recommendations to control STIs. The new report marks a long road toward the public’s willingness to discuss STDs, or what a 1997 Institute of Medicine report described as a “hidden epidemic” that had been largely neglected in public discourse.

Jeffrey Crowley, MPH, committee member and an author of the new National Academies report, said in an interview that, despite the increased openness to discuss STIs in today’s society, STD rates since the late 1990s have gotten much worse. Lack of appropriate governmental funding for research and drug development, structural inequities, and persisting stigmatization are key drivers for rising rates, explained Mr. Crowley.
 

Addressing structural barriers to STI prevention

Playing a prominent role in the National Academies report are issues of structural and institutional barriers to STI prevention and care. In the report, the authors argued that a policy-based approach should seek to promote sexual health and eliminate structural racism and inequities to drive improvements in STI management.

“We think it’s these structural factors that are central to all the inequities that play out,” said Mr. Crowley, “and they either don’t get any attention or, if they do get attention, people don’t really speak concretely enough about how we address them.”

The concrete steps, as outlined in the report, begin with addressing factors that involve the health care industry at large. Automatic STI screening as part of routine visits, alerts in electronic health records that remind clinicians to screen patients, and reminders to test patients can be initial low-cost actions health care systems can take to improve STI testing, particularly in marginalized communities. Mr. Crowley noted that greater evidence is needed to support further steps to address structural factors that contribute to barriers in STI screening and treatment access.

Given the complexities inherent in structural barriers to STI care, the report calls on a whole-government response, in partnership with affected communities, to normalize discussions involving sexual well-being. “We have to ask ourselves how we can build healthier communities and how can we integrate sexual health into that dialogue in a way that improves our response to STI prevention and control,” Mr. Crowley explained.
 

Harnessing AI and dating apps

The report also addresses the power of artificial intelligence to predict STI rates and to discover trends in risk factors, both of which may improve STI surveillance and assist in the development of tailored interventions. The report calls for policy that will enable companies and the government to capitalize on AI to evaluate large collections of data in EHRs, insurance claims databases, social media, search engines, and even dating apps.

In particular, dating apps could be an avenue through which the public and private sectors could improve STI prevention, diagnosis, and treatment. “People want to focus on this idea of whether these apps increase transmission risk,” said Mr. Crowley. “But we would say that this is asking the wrong question, because these technologies are not going away.” He noted that private and public enterprises could work together to leverage these technologies to increase awareness of prevention and testing.
 

Unifying the STI/HIV and COVID-19 workforce

The report also recommends that the nation unify the STI/HIV workforce with the COVID-19 workforce. Given the high levels of expertise in these professional working groups, the report suggests unification could potentially address both the current crisis and possible future disease outbreaks. Combining COVID-19 response teams with underresourced STI/HIV programs may also improve the delivery of STI testing, considering that STI testing programs have had to compete for resources during the pandemic.

Addressing stigma

The National Academies report also addresses the ongoing issue of stigma, which results from “blaming” individuals and the choices they make so as to create shame, embarrassment, and discrimination. Because of stigma, sexually active people may be unwilling to seek recommended screening, which can lead to delays in diagnosis and treatment and can increase the risk for negative health outcomes.

“As a nation, we’ve almost focused too intently on individual-level factors in a way that’s driven stigma and really hasn’t been helpful for combating the problem,” said Mr. Crowley. He added that, instead of focusing solely on individual-level choices, the nation should instead work to reframe sexual health as a key aspect of overall physical, mental, and emotional well-being. Doing so could create more opportunities to address structural barriers to STI prevention and ensure that more prevention and screening services are available in stigma-free environments.

“I know what we’re recommending is ambitious, but it’s not too big to be achieved, and we’re not saying tomorrow we’re going to transform the world,” Mr. Crowley concluded. “It’s a puzzle with many pieces, but the long-term impact is really all of these pieces fitting together so that, over time, we can reduce the burden STIs have on the population.”
 

Implications for real-world change

H. Hunter Handsfield, MD, professor emeritus of medicine for the Center for AIDS and STD at the University of Washington, Seattle, said in an interview that this report essentially is a response to evolving societal changes, new and emerging means of social engagement, and increased focus on racial/ethnic disparities. “These features have all come to the forefront of health care and general policy discussions in recent years,” said Dr. Handsfield, who was not part of the committee that developed the NAS report.

Greater scrutiny on public health infrastructure and its relationship with health disparities in the United States makes the publication of these new recommendations especially appropriate during this era of enhanced focus on social justice. Although the report features the tone and quality needed to bolster bipartisan support, said Dr. Handsfield, it’s hard to predict whether such support will come to fruition in today’s political environment.

In terms of the effects the recommendations may have on STI rates, Dr. Handsfield noted that cherry-picking elements from the report to direct policy may result in its having only a trivial impact. “The report is really an appropriate and necessary response, and almost all the recommendations made can be helpful,” he said, “but for true effectiveness, all the elements need to be implemented to drive policy and funding.”

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

Médecins Sans Frontières (MSF/Doctors Without Borders) announced early closure of its phase 2/3 trial of a 6-month multidrug regimen for multidrug-resistant tuberculosis (MDR-TB) because an independent data safety and monitoring board (DSMB) determined that the drug combination in the study regimen was superior to current therapy, according to a press release.

The trial, called TB PRACTECAL, compared the current local standard of care with a 6-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin. The interim analysis included 242 patients and the randomized, controlled trial was conducted in sites in Belarus, South Africa, and Uzbekistan.

The preliminary data will be shared with the World Health Organization soon and will also be submitted to a peer-reviewed journal. If it withstands further reviews, as is anticipated, the trial would support the first solely oral regimen for MDR-TB.

In 2019, an estimated 465,000 people developed MDR-TB and 182,000 died. The global burden of TB at that time was about 10 million new cases, many with coexisting HIV.

Current treatment for MDR-TB lasts 9-20 months and is complicated by the need for painful shots and toxic antibiotics. Side effects can include psychiatric problems from quinolones, isoniazid, ethambutol, or cycloserine; deafness from aminoglycosides; and bone marrow suppression from linezolid, among other toxicities.

It’s hoped that the shorter regimen will reduce toxicity and improve patient compliance. Poor adherence to treatment is a major driver of further drug resistance. Current regimens require up to 20 pills per day as well as daily injections.

In a prepared statement from MSF, David Moore, MD, MSc, London School of Hygiene and Tropical Medicine, a member of the TB-PRACTECAL trial’s steering committee, concluded: “The findings could transform the way we treat patients with drug-resistant forms of TB worldwide, who have been neglected for too long.”

This good news is particularly welcome as, in the time of COVID-19, “an estimated 1.4 million fewer people received care for tuberculosis in 2020 than in 2019,” according to the WHO. The drop, an overall 21% reduction in patients beginning treatment, ranged as high as 42% in Indonesia.

Although awaiting complete data, Madhukar Pai, MD, PhD, associate director of the McGill International TB Centre, McGill University, Montreal, shares Dr. Moore’s enthusiasm. In an interview, Dr. Pai compared MDR-TB with extensively drug-resistant TB (XDR-TB).

“I’m excited about the possibility that these trial results might help shorten MDR-TB treatment to 6 months,” said Dr. Pai. “That will be a huge relief to all patients battling drug-resistant disease. The 6-month BPaL regimen (bedaquiline, pretomanid, and linezolid) regimen works well in XDR-TB. So, I would expect the TB PRACTECAL regimen with one added drug (moxifloxacin) to work well in MDR-TB, which is less severe than XDR-TB. Between these two regimens, if we can bring down MDR and XDR treatment to 6 months, all oral, that would be a huge advance.”

The expense of bedaquiline has been a long-standing concern in the global health community. Janssen, a subsidiary of Johnson & Johnson, has reduced the price to $340 per 6-month treatment course for more than 135 eligible low- and middle-income countries.

Previously, the tiered pricing structure was different for low-, middle-, and high-income countries (U.S. $900, $3,000, and $30,000, respectively). “The global TB community has asked Janssen to drop the price of bedaquiline to a level no higher than $32 per month – double the price at which researchers estimated bedaquiline could be sold for a profit,” according to the Treatment Action Group A major source of contention over pricing has been that there has been considerable public investment in the drug›s development.

Dr. Pai concluded: “Bedaquiline is likely the most important drug in both 6-month regimens. We need to work harder to make bedaquiline, an excellent drug, more affordable and accessible.”

While the full data is not yet publicly available, TB PRACTECAL was a randomized, controlled, multicenter study. The fact that enrollment was discontinued early by the DSMB suggests the efficacy data was compelling and that this completely oral regimen will become the standard of care.

Dr. Stone is an infectious disease specialist and author of Resilience: One Family’s Story of Hope and Triumph Over Evil and of Conducting Clinical Research, the essential guide to the topic. A version of this article first appeared on Medscape.com.

Médecins Sans Frontières (MSF/Doctors Without Borders) announced early closure of its phase 2/3 trial of a 6-month multidrug regimen for multidrug-resistant tuberculosis (MDR-TB) because an independent data safety and monitoring board (DSMB) determined that the drug combination in the study regimen was superior to current therapy, according to a press release.

The trial, called TB PRACTECAL, compared the current local standard of care with a 6-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin. The interim analysis included 242 patients and the randomized, controlled trial was conducted in sites in Belarus, South Africa, and Uzbekistan.

The preliminary data will be shared with the World Health Organization soon and will also be submitted to a peer-reviewed journal. If it withstands further reviews, as is anticipated, the trial would support the first solely oral regimen for MDR-TB.

In 2019, an estimated 465,000 people developed MDR-TB and 182,000 died. The global burden of TB at that time was about 10 million new cases, many with coexisting HIV.

Current treatment for MDR-TB lasts 9-20 months and is complicated by the need for painful shots and toxic antibiotics. Side effects can include psychiatric problems from quinolones, isoniazid, ethambutol, or cycloserine; deafness from aminoglycosides; and bone marrow suppression from linezolid, among other toxicities.

It’s hoped that the shorter regimen will reduce toxicity and improve patient compliance. Poor adherence to treatment is a major driver of further drug resistance. Current regimens require up to 20 pills per day as well as daily injections.

In a prepared statement from MSF, David Moore, MD, MSc, London School of Hygiene and Tropical Medicine, a member of the TB-PRACTECAL trial’s steering committee, concluded: “The findings could transform the way we treat patients with drug-resistant forms of TB worldwide, who have been neglected for too long.”

This good news is particularly welcome as, in the time of COVID-19, “an estimated 1.4 million fewer people received care for tuberculosis in 2020 than in 2019,” according to the WHO. The drop, an overall 21% reduction in patients beginning treatment, ranged as high as 42% in Indonesia.

Although awaiting complete data, Madhukar Pai, MD, PhD, associate director of the McGill International TB Centre, McGill University, Montreal, shares Dr. Moore’s enthusiasm. In an interview, Dr. Pai compared MDR-TB with extensively drug-resistant TB (XDR-TB).

“I’m excited about the possibility that these trial results might help shorten MDR-TB treatment to 6 months,” said Dr. Pai. “That will be a huge relief to all patients battling drug-resistant disease. The 6-month BPaL regimen (bedaquiline, pretomanid, and linezolid) regimen works well in XDR-TB. So, I would expect the TB PRACTECAL regimen with one added drug (moxifloxacin) to work well in MDR-TB, which is less severe than XDR-TB. Between these two regimens, if we can bring down MDR and XDR treatment to 6 months, all oral, that would be a huge advance.”

The expense of bedaquiline has been a long-standing concern in the global health community. Janssen, a subsidiary of Johnson & Johnson, has reduced the price to $340 per 6-month treatment course for more than 135 eligible low- and middle-income countries.

Previously, the tiered pricing structure was different for low-, middle-, and high-income countries (U.S. $900, $3,000, and $30,000, respectively). “The global TB community has asked Janssen to drop the price of bedaquiline to a level no higher than $32 per month – double the price at which researchers estimated bedaquiline could be sold for a profit,” according to the Treatment Action Group A major source of contention over pricing has been that there has been considerable public investment in the drug›s development.

Dr. Pai concluded: “Bedaquiline is likely the most important drug in both 6-month regimens. We need to work harder to make bedaquiline, an excellent drug, more affordable and accessible.”

While the full data is not yet publicly available, TB PRACTECAL was a randomized, controlled, multicenter study. The fact that enrollment was discontinued early by the DSMB suggests the efficacy data was compelling and that this completely oral regimen will become the standard of care.

Dr. Stone is an infectious disease specialist and author of Resilience: One Family’s Story of Hope and Triumph Over Evil and of Conducting Clinical Research, the essential guide to the topic. A version of this article first appeared on Medscape.com.

Médecins Sans Frontières (MSF/Doctors Without Borders) announced early closure of its phase 2/3 trial of a 6-month multidrug regimen for multidrug-resistant tuberculosis (MDR-TB) because an independent data safety and monitoring board (DSMB) determined that the drug combination in the study regimen was superior to current therapy, according to a press release.

The trial, called TB PRACTECAL, compared the current local standard of care with a 6-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin. The interim analysis included 242 patients and the randomized, controlled trial was conducted in sites in Belarus, South Africa, and Uzbekistan.

The preliminary data will be shared with the World Health Organization soon and will also be submitted to a peer-reviewed journal. If it withstands further reviews, as is anticipated, the trial would support the first solely oral regimen for MDR-TB.

In 2019, an estimated 465,000 people developed MDR-TB and 182,000 died. The global burden of TB at that time was about 10 million new cases, many with coexisting HIV.

Current treatment for MDR-TB lasts 9-20 months and is complicated by the need for painful shots and toxic antibiotics. Side effects can include psychiatric problems from quinolones, isoniazid, ethambutol, or cycloserine; deafness from aminoglycosides; and bone marrow suppression from linezolid, among other toxicities.

It’s hoped that the shorter regimen will reduce toxicity and improve patient compliance. Poor adherence to treatment is a major driver of further drug resistance. Current regimens require up to 20 pills per day as well as daily injections.

In a prepared statement from MSF, David Moore, MD, MSc, London School of Hygiene and Tropical Medicine, a member of the TB-PRACTECAL trial’s steering committee, concluded: “The findings could transform the way we treat patients with drug-resistant forms of TB worldwide, who have been neglected for too long.”

This good news is particularly welcome as, in the time of COVID-19, “an estimated 1.4 million fewer people received care for tuberculosis in 2020 than in 2019,” according to the WHO. The drop, an overall 21% reduction in patients beginning treatment, ranged as high as 42% in Indonesia.

Although awaiting complete data, Madhukar Pai, MD, PhD, associate director of the McGill International TB Centre, McGill University, Montreal, shares Dr. Moore’s enthusiasm. In an interview, Dr. Pai compared MDR-TB with extensively drug-resistant TB (XDR-TB).

“I’m excited about the possibility that these trial results might help shorten MDR-TB treatment to 6 months,” said Dr. Pai. “That will be a huge relief to all patients battling drug-resistant disease. The 6-month BPaL regimen (bedaquiline, pretomanid, and linezolid) regimen works well in XDR-TB. So, I would expect the TB PRACTECAL regimen with one added drug (moxifloxacin) to work well in MDR-TB, which is less severe than XDR-TB. Between these two regimens, if we can bring down MDR and XDR treatment to 6 months, all oral, that would be a huge advance.”

The expense of bedaquiline has been a long-standing concern in the global health community. Janssen, a subsidiary of Johnson & Johnson, has reduced the price to $340 per 6-month treatment course for more than 135 eligible low- and middle-income countries.

Previously, the tiered pricing structure was different for low-, middle-, and high-income countries (U.S. $900, $3,000, and $30,000, respectively). “The global TB community has asked Janssen to drop the price of bedaquiline to a level no higher than $32 per month – double the price at which researchers estimated bedaquiline could be sold for a profit,” according to the Treatment Action Group A major source of contention over pricing has been that there has been considerable public investment in the drug›s development.

Dr. Pai concluded: “Bedaquiline is likely the most important drug in both 6-month regimens. We need to work harder to make bedaquiline, an excellent drug, more affordable and accessible.”

While the full data is not yet publicly available, TB PRACTECAL was a randomized, controlled, multicenter study. The fact that enrollment was discontinued early by the DSMB suggests the efficacy data was compelling and that this completely oral regimen will become the standard of care.

Dr. Stone is an infectious disease specialist and author of Resilience: One Family’s Story of Hope and Triumph Over Evil and of Conducting Clinical Research, the essential guide to the topic. A version of this article first appeared on Medscape.com.

The U.S. Senate voted mostly along party lines Wednesday to confirm Vice Adm. Vivek H. Murthy, MD, MBA, to serve as the 21st Surgeon General of the United States.

Seven Republicans – Bill Cassidy (La.), Susan Collins (Maine), Roger Marshall (Kan.), Susan Murkowski (Alaska), Rob Portman (Ohio), Mitt Romney (Utah), and Dan Sullivan (Alaska) – joined all the Democrats and independents in the 57-43 vote approving Dr. Murthy’s nomination.

Dr. Murthy, 43, previously served as the 19th Surgeon General, from December 2014 to April 2017, when he was asked to step down by President Donald J. Trump.

Surgeons General serve 4-year terms.

During his first tenure, Dr. Murthy issued the first-ever Surgeon General’s report on the crisis of addiction and issued a call to action to doctors to help battle the opioid crisis.

When Dr. Murthy was nominated by President-elect Joseph R. Biden Jr. in December, he was acting as cochair of the incoming administration’s COVID-19 transition advisory board.

Early in 2020, before the COVID-19 pandemic hit, Dr. Murthy published a timely book: “Together: The Healing Power of Human Connection in a Sometimes Lonely World”.

He earned his bachelor’s degree from Harvard and his MD and MBA degrees from Yale. He completed his internal medicine residency at Brigham and Women’s Hospital in Boston, where he also served as a hospitalist, and later joined Harvard Medical School as a faculty member in internal medicine.

He is married to Alice Chen, MD. The couple have two children.
 

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

The U.S. Senate voted mostly along party lines Wednesday to confirm Vice Adm. Vivek H. Murthy, MD, MBA, to serve as the 21st Surgeon General of the United States.

Seven Republicans – Bill Cassidy (La.), Susan Collins (Maine), Roger Marshall (Kan.), Susan Murkowski (Alaska), Rob Portman (Ohio), Mitt Romney (Utah), and Dan Sullivan (Alaska) – joined all the Democrats and independents in the 57-43 vote approving Dr. Murthy’s nomination.

Dr. Murthy, 43, previously served as the 19th Surgeon General, from December 2014 to April 2017, when he was asked to step down by President Donald J. Trump.

Surgeons General serve 4-year terms.

During his first tenure, Dr. Murthy issued the first-ever Surgeon General’s report on the crisis of addiction and issued a call to action to doctors to help battle the opioid crisis.

When Dr. Murthy was nominated by President-elect Joseph R. Biden Jr. in December, he was acting as cochair of the incoming administration’s COVID-19 transition advisory board.

Early in 2020, before the COVID-19 pandemic hit, Dr. Murthy published a timely book: “Together: The Healing Power of Human Connection in a Sometimes Lonely World”.

He earned his bachelor’s degree from Harvard and his MD and MBA degrees from Yale. He completed his internal medicine residency at Brigham and Women’s Hospital in Boston, where he also served as a hospitalist, and later joined Harvard Medical School as a faculty member in internal medicine.

He is married to Alice Chen, MD. The couple have two children.
 

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

The U.S. Senate voted mostly along party lines Wednesday to confirm Vice Adm. Vivek H. Murthy, MD, MBA, to serve as the 21st Surgeon General of the United States.

Seven Republicans – Bill Cassidy (La.), Susan Collins (Maine), Roger Marshall (Kan.), Susan Murkowski (Alaska), Rob Portman (Ohio), Mitt Romney (Utah), and Dan Sullivan (Alaska) – joined all the Democrats and independents in the 57-43 vote approving Dr. Murthy’s nomination.

Dr. Murthy, 43, previously served as the 19th Surgeon General, from December 2014 to April 2017, when he was asked to step down by President Donald J. Trump.

Surgeons General serve 4-year terms.

During his first tenure, Dr. Murthy issued the first-ever Surgeon General’s report on the crisis of addiction and issued a call to action to doctors to help battle the opioid crisis.

When Dr. Murthy was nominated by President-elect Joseph R. Biden Jr. in December, he was acting as cochair of the incoming administration’s COVID-19 transition advisory board.

Early in 2020, before the COVID-19 pandemic hit, Dr. Murthy published a timely book: “Together: The Healing Power of Human Connection in a Sometimes Lonely World”.

He earned his bachelor’s degree from Harvard and his MD and MBA degrees from Yale. He completed his internal medicine residency at Brigham and Women’s Hospital in Boston, where he also served as a hospitalist, and later joined Harvard Medical School as a faculty member in internal medicine.

He is married to Alice Chen, MD. The couple have two children.
 

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

One of the top research journals in the United States has placed its editor-in-chief on administrative leave pending the outcome of an investigation into a controversial podcast episode that critics labeled as racist.

The American Medical Association’s Joint Oversight Committee announced that Howard Bauchner, MD, is on leave beginning at the end of the day on March 25. Dr. Bauchner is the top editor at JAMA, the journal of the AMA.

“The decision to place the editor-in-chief on administrative leave neither implicates nor exonerates individuals and is standard operating procedure for such investigations,” the committee said in a statement.

More than 2,000 people signed a petition on Change.org calling for an investigation at JAMA over the February podcast episode, called “Structural Racism for Doctors: What Is It?”

Already, Edward H. Livingston, MD, the host of the podcast, has resigned as deputy editor of the journal.

During the podcast, Dr. Livingston, who is White, said, “Structural racism is an unfortunate term. Personally, I think taking racism out of the conversation will help. Many of us are offended by the concept that we are racist.”

The audio of the podcast has been deleted from JAMA’s website. In its place is audio of a statement from Dr. Bauchner. In his statement, which he released in the week prior to his being on leave, he said the comments in the podcast, which also featured Mitch Katz, MD, were “inaccurate, offensive, hurtful, and inconsistent with the standards of JAMA.”

Also deleted was a JAMA tweet promoting the podcast episode. The tweet said: “No physician is racist, so how can there be structural racism in health care? An explanation of the idea by doctors for doctors in this user-friendly podcast.”

This story will be updated.

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

One of the top research journals in the United States has placed its editor-in-chief on administrative leave pending the outcome of an investigation into a controversial podcast episode that critics labeled as racist.

The American Medical Association’s Joint Oversight Committee announced that Howard Bauchner, MD, is on leave beginning at the end of the day on March 25. Dr. Bauchner is the top editor at JAMA, the journal of the AMA.

“The decision to place the editor-in-chief on administrative leave neither implicates nor exonerates individuals and is standard operating procedure for such investigations,” the committee said in a statement.

More than 2,000 people signed a petition on Change.org calling for an investigation at JAMA over the February podcast episode, called “Structural Racism for Doctors: What Is It?”

Already, Edward H. Livingston, MD, the host of the podcast, has resigned as deputy editor of the journal.

During the podcast, Dr. Livingston, who is White, said, “Structural racism is an unfortunate term. Personally, I think taking racism out of the conversation will help. Many of us are offended by the concept that we are racist.”

The audio of the podcast has been deleted from JAMA’s website. In its place is audio of a statement from Dr. Bauchner. In his statement, which he released in the week prior to his being on leave, he said the comments in the podcast, which also featured Mitch Katz, MD, were “inaccurate, offensive, hurtful, and inconsistent with the standards of JAMA.”

Also deleted was a JAMA tweet promoting the podcast episode. The tweet said: “No physician is racist, so how can there be structural racism in health care? An explanation of the idea by doctors for doctors in this user-friendly podcast.”

This story will be updated.

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

One of the top research journals in the United States has placed its editor-in-chief on administrative leave pending the outcome of an investigation into a controversial podcast episode that critics labeled as racist.

The American Medical Association’s Joint Oversight Committee announced that Howard Bauchner, MD, is on leave beginning at the end of the day on March 25. Dr. Bauchner is the top editor at JAMA, the journal of the AMA.

“The decision to place the editor-in-chief on administrative leave neither implicates nor exonerates individuals and is standard operating procedure for such investigations,” the committee said in a statement.

More than 2,000 people signed a petition on Change.org calling for an investigation at JAMA over the February podcast episode, called “Structural Racism for Doctors: What Is It?”

Already, Edward H. Livingston, MD, the host of the podcast, has resigned as deputy editor of the journal.

During the podcast, Dr. Livingston, who is White, said, “Structural racism is an unfortunate term. Personally, I think taking racism out of the conversation will help. Many of us are offended by the concept that we are racist.”

The audio of the podcast has been deleted from JAMA’s website. In its place is audio of a statement from Dr. Bauchner. In his statement, which he released in the week prior to his being on leave, he said the comments in the podcast, which also featured Mitch Katz, MD, were “inaccurate, offensive, hurtful, and inconsistent with the standards of JAMA.”

Also deleted was a JAMA tweet promoting the podcast episode. The tweet said: “No physician is racist, so how can there be structural racism in health care? An explanation of the idea by doctors for doctors in this user-friendly podcast.”

This story will be updated.

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

“I’m the first person in my circle of family and friends to participate in a clinical trial.”

Five years ago, Rhonda Long was diagnosed with cholangiocarcinoma, a rare bile duct cancer that’s seen in only about 8,000 Americans each year.

At the time, Mrs. Long, who is Black, said her doctor in Dayton, Ohio, told her she was not a candidate for surgery and suggested palliative care. After seeking a second opinion at Duke University Medical Center, Durham, N.C., where her sister worked, the 51-year-old wife and mother of two had surgery, radiation, and chemotherapy there in North Carolina. When the chemo stopped working after 3 months, her oncologist at Duke referred her to a colleague at Massachusetts General Hospital in Boston, where she was accepted into a clinical trial.

“In 2019, I traveled to Boston from Dayton, Ohio, every 3 weeks for labs and scans, to make sure that the drug wasn’t doing more harm than good, making sure that the drug as developed was maintaining, shrinking, or even eliminating the disease. Physically and financially, it takes a toll on you and loved ones.”

Her medical insurance did not cover the direct expenses from the clinical trial, and she was spending $1,000-$1,500 each trip. Sometimes they drove the 15 hours to Boston, and sometimes they flew on the cheapest flight they could find.

It’s not an unfamiliar story: people traveling, often long distances, to take part in clinical trials they hope will save their lives.

The Lazarex Cancer Foundation of Danville, Calif., helped Mrs. Long do just that.

Marya Shegog, PhD, health equity and diversity coordinator at Lazarex, said that a patient travels an average of 500 miles to participate in a trial.

The financial hurdles often prevent patients from taking part in clinical trials, Dr. Shegog said. “When you are sick, and you have a disease that may be terminal, you start thinking about setting your things in order.”

Many patients have to make a decision.

“Do I bankrupt my family on trying and hoping that this drug works and helps me live longer, or do I start setting things in order so that when I’m gone, they’re okay or at least better than if I wouldn’t have spent all the money traveling back and forth.”

Dr. Shegog, a 17-year cancer survivor, says when she was battling cervical cancer, a clinical trial was never offered or explored.

Lazarex has been helping cancer patients who have run out of options for 15 years. It identifies clinical trial opportunities and reimburses patients for all travel costs. Last year, Lazarex reimbursed more than 1,000 cancer patients. And it has supported more than 6,000 people since opening its doors.

“Lazarex exists to help remove the barriers of people not being able to participate in trials,” Dr. Shegog said. “It’s systemic that the medical system does not treat patients the same and oftentimes does not offer or make aware the opportunities for African Americans to participate.”

But now, thanks in part to COVID-19, new possibilities are taking shape. The pandemic has changed the landscape for trials, forcing many of them to go virtual, which allows patients to schedule telehealth visits and get some services like bloodwork and CT or MRI scans closer to home. Mrs. Long’s trial eventually went virtual.

“It was absolutely fantastic,” she said. “Having the trial locally, it saves us money, it saves wear and tear on my body. Being in the car, being in an airport or in a plane and in a hotel, all of that wears on you physically.”

The move to virtual studies may have lasting effects on research and treatment.

“The current pandemic has forced us to reexamine all of the traditional burdens we place on patients as it relates to receiving cancer treatment,” said Hala Borno, MD, an assistant professor of medicine at the University of California, San Francisco. “Whether they’re coming to our health care facility to see a clinician, for diagnostics such as blood draws and scans, or to receive therapy, this pandemic has challenged us to explore other possibilities that minimize the risk of exposure to SARS-CoV-2. What I find striking is that it has helped us operationalize use of telemedicine and the delivery of care closer to home.”

This is especially encouraging news for minority patients whose participation in trials has for years lagged well behind that of Whites.

But travel is not the only reason. Racial disparities in clinical trials have long been an issue that’s just another part of the implicit bias in health care.

Compared with White people, Black people are largely at higher risk for heart disease, cancer, stroke, diabetes, asthma, and even mental health problems.

And it’s not just African Americans. Asians, Hispanics, Native Americans, and Alaska Natives are all underrepresented in trials at a time when there is growing evidence that drugs may have different effects on different populations.

Dr. Borno is an oncologist who specializes in prostate cancer, a disease that she says shows a “significant disparity,” where Black men are two times more likely to die from advanced prostate cancer, compared with white men. Yet Black men make up just 3% of advanced therapeutic trials.

“A lack of diversity and inclusion in clinical trials is unacceptable,” she said. “If we continue to underrecruit racial/ethnic minorities and older adults to therapeutic clinical trials, we will not be powered to make valid conclusions regarding safety and efficacy in those patient populations. As a result, we can do harm.”

Dr. Borno said that telehealth and telemedicine are not cure-alls, and digital health solutions don’t work for all patients. Approaches, she says, must be tailored to the individual, or disparities could worsen.

In 2020, the Food and Drug Administration approved 53 new drugs. Overall, 32,000 patients took part in these trials. On average, 75% were White, 8% were Black, 6% were Asian, and 11% were Hispanic.

Here’s one stark example of the issue. In 2015, the FDA approved ixazomib (Ninlaro), a promising new drug for multiple myeloma, a blood cancer that affects Black people at disproportionately higher rates than White people. In the United States, one in five people diagnosed with multiple myeloma are Black people. They are more than twice as likely to get the disease as White people. Yet during the clinical trial of 722 participants, only 13 patients, or 1.8%, were Black.

The American Cancer Society estimates that more than 600,000 Americans will die from cancer this year. Historically, Black Americans have the highest death rate and the shortest survival of any racial or ethnic group, stemming largely, it concluded, from centuries of structural racism.

According to Jamie Freedman, MD, head of U.S. medical affairs at Genentech, a global pharmaceutical company, the lack of diversity is often tied to where studies are run.

“Companies tend to choose major academic medical centers where there is a high volume of clinical trial work. When you go to the same tried and true hospitals repeatedly, the pool of patients becomes very homogeneous and tends to be primarily white,” he said. “It’s critical to bring more trials into the community setting by including new sites that can reach underrepresented groups, and Genentech is making significant progress in that area.”

Dr. Freedman believes that, while access is a big hurdle, it doesn’t end there.

“Many patients have a lack of trust in the health care system,” he said. “There are also issues around underserved communities being able to afford quality care, so it’s important to keep time and financial burdens in mind when designing trials to help mitigate barriers such as travel, parking, time off work, and child care.”

Genentech started its diversity and inclusion effort several years ago. Dr. Freeman said that, until more trials become diverse, Black Americans will continue to pay the price. “I think they’re losing their lives in part due to lack of access to these trials. And that is why Genentech and all of us in the health care industry need to change how we design and enroll these studies. We have a long way to go, but I think the steps we’re taking are leading us in the right direction.”

Jennifer Jones-McMeans, PhD, director of global clinical affairs at Abbott Pharmaceuticals, is a clinical research scientist who has designed and led many clinical trials.

She said that Abbott is actively working on solutions.

“We have designed our trials to reduce the barriers to participation and expand access,” she said. “This can be as simple as providing transportation services or home visits for those who are housebound. We’re taking it a step further and providing home health services where someone comes to the home and provides follow-up visits there.”

They also provide interpretation services to address any language barriers.

“We are reaching out to a new set of talented investigators who work closely with underrepresented communities. They are very much wedded and supportive of the communities they treat. By working with doctors within these communities, it expands access to new therapies.”

Spokesperson Keanna Ghazvini said that Pfizer Pharmaceuticals is also committed to increasing minority participation in trials.

“We know that if historically underserved populations are left out of clinical trials, they risk not benefiting from medical breakthroughs down the line,” she said.

The National Institutes of Health’s National Library of Medicine maintains the clinicaltrials.gov database.

There, you can find information on nearly 372,000 publicly and privately supported clinical trials happening in all 50 states and 219 countries. Many are funded by the NIH, but not all of these studies have been evaluated by the U.S. government.

Andrea Denicoff, a nurse consultant at the National Cancer Institute and head of clinical trials operations for the NCI’s National Clinical Trials Network, has been involved in clinical research at the NIH for 35 years.

“It’s really important that our publicly funded trials represent the people of the country,” she said. “There are some cancers that we’re doing a good job in enrolling minorities, and other cancers we need to do a much better job in having a diverse representation in our trials.”

Ms. Denicoff believed opening trials in places where people live is key, but having a diverse clinical trials team is as important.

“We need to reinforce that cancer centers across the country have open doors, and anyone with cancer feels comfortable getting care at that center, and that also includes discussing the option to participate in clinical trials when one might be available. We know from research that when people are invited and asked about trial participation and educated about them, they’ll be much more interested in joining them.”

Ms. Denicoff said that, during the pandemic, the NCI quickly came up with guidance to allow trial sites to send patients their oral study drugs and set up virtual visits. She believes it may help increase future access.

‘Lola Fashoyin-Aje, MD, associate director for science and policy to address disparities in the Oncology Center of Excellence at the FDA, says the agency firmly believes clinical trials should represent the patients who will ultimately get the drug if it’s approved.

But the FDA’s power to require diversity in trials is limited.

“It is important to point out that there are legal constraints which limit’s FDA’s authority to require specific proportional representation in clinical trials by demographic factors,” Dr. Fashoyin-Aje said.

Still, some researchers feel the FDA should play a bigger role. The question is: Should diversity be mandated?

Rhonda Long is now back in Boston to start a new trial, with a new drug that targets her specific mutation. She will be there for 2 months. Once again, Lazarex will help cover some of the cost.

She wants people of color to understand that they are missing out on the promise of new cancer drugs and extended life.

“I feel like there’s not enough emphasis on clinical trials, I don’t believe there’s enough emphasis on second opinions, I don’t think there’s enough emphasis that medicine happens outside our borders, outside of our communities. Clinical trials that don’t have a broad range of participants, how do we know how effective they are if Black and brown people, Asian or Latin American people aren’t represented in the trial?”

And with more trials adopting virtual elements, she said it’s time for minorities to get on board.

Dr. Freedman believed the groundwork is being laid for that to happen. “I don’t think we’ll ever return back to the way we used to do things, where everything has to be done at the clinical trial site. I just don’t think we’re ever going back.”

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

“I’m the first person in my circle of family and friends to participate in a clinical trial.”

Five years ago, Rhonda Long was diagnosed with cholangiocarcinoma, a rare bile duct cancer that’s seen in only about 8,000 Americans each year.

At the time, Mrs. Long, who is Black, said her doctor in Dayton, Ohio, told her she was not a candidate for surgery and suggested palliative care. After seeking a second opinion at Duke University Medical Center, Durham, N.C., where her sister worked, the 51-year-old wife and mother of two had surgery, radiation, and chemotherapy there in North Carolina. When the chemo stopped working after 3 months, her oncologist at Duke referred her to a colleague at Massachusetts General Hospital in Boston, where she was accepted into a clinical trial.

“In 2019, I traveled to Boston from Dayton, Ohio, every 3 weeks for labs and scans, to make sure that the drug wasn’t doing more harm than good, making sure that the drug as developed was maintaining, shrinking, or even eliminating the disease. Physically and financially, it takes a toll on you and loved ones.”

Her medical insurance did not cover the direct expenses from the clinical trial, and she was spending $1,000-$1,500 each trip. Sometimes they drove the 15 hours to Boston, and sometimes they flew on the cheapest flight they could find.

It’s not an unfamiliar story: people traveling, often long distances, to take part in clinical trials they hope will save their lives.

The Lazarex Cancer Foundation of Danville, Calif., helped Mrs. Long do just that.

Marya Shegog, PhD, health equity and diversity coordinator at Lazarex, said that a patient travels an average of 500 miles to participate in a trial.

The financial hurdles often prevent patients from taking part in clinical trials, Dr. Shegog said. “When you are sick, and you have a disease that may be terminal, you start thinking about setting your things in order.”

Many patients have to make a decision.

“Do I bankrupt my family on trying and hoping that this drug works and helps me live longer, or do I start setting things in order so that when I’m gone, they’re okay or at least better than if I wouldn’t have spent all the money traveling back and forth.”

Dr. Shegog, a 17-year cancer survivor, says when she was battling cervical cancer, a clinical trial was never offered or explored.

Lazarex has been helping cancer patients who have run out of options for 15 years. It identifies clinical trial opportunities and reimburses patients for all travel costs. Last year, Lazarex reimbursed more than 1,000 cancer patients. And it has supported more than 6,000 people since opening its doors.

“Lazarex exists to help remove the barriers of people not being able to participate in trials,” Dr. Shegog said. “It’s systemic that the medical system does not treat patients the same and oftentimes does not offer or make aware the opportunities for African Americans to participate.”

But now, thanks in part to COVID-19, new possibilities are taking shape. The pandemic has changed the landscape for trials, forcing many of them to go virtual, which allows patients to schedule telehealth visits and get some services like bloodwork and CT or MRI scans closer to home. Mrs. Long’s trial eventually went virtual.

“It was absolutely fantastic,” she said. “Having the trial locally, it saves us money, it saves wear and tear on my body. Being in the car, being in an airport or in a plane and in a hotel, all of that wears on you physically.”

The move to virtual studies may have lasting effects on research and treatment.

“The current pandemic has forced us to reexamine all of the traditional burdens we place on patients as it relates to receiving cancer treatment,” said Hala Borno, MD, an assistant professor of medicine at the University of California, San Francisco. “Whether they’re coming to our health care facility to see a clinician, for diagnostics such as blood draws and scans, or to receive therapy, this pandemic has challenged us to explore other possibilities that minimize the risk of exposure to SARS-CoV-2. What I find striking is that it has helped us operationalize use of telemedicine and the delivery of care closer to home.”

This is especially encouraging news for minority patients whose participation in trials has for years lagged well behind that of Whites.

But travel is not the only reason. Racial disparities in clinical trials have long been an issue that’s just another part of the implicit bias in health care.

Compared with White people, Black people are largely at higher risk for heart disease, cancer, stroke, diabetes, asthma, and even mental health problems.

And it’s not just African Americans. Asians, Hispanics, Native Americans, and Alaska Natives are all underrepresented in trials at a time when there is growing evidence that drugs may have different effects on different populations.

Dr. Borno is an oncologist who specializes in prostate cancer, a disease that she says shows a “significant disparity,” where Black men are two times more likely to die from advanced prostate cancer, compared with white men. Yet Black men make up just 3% of advanced therapeutic trials.

“A lack of diversity and inclusion in clinical trials is unacceptable,” she said. “If we continue to underrecruit racial/ethnic minorities and older adults to therapeutic clinical trials, we will not be powered to make valid conclusions regarding safety and efficacy in those patient populations. As a result, we can do harm.”

Dr. Borno said that telehealth and telemedicine are not cure-alls, and digital health solutions don’t work for all patients. Approaches, she says, must be tailored to the individual, or disparities could worsen.

In 2020, the Food and Drug Administration approved 53 new drugs. Overall, 32,000 patients took part in these trials. On average, 75% were White, 8% were Black, 6% were Asian, and 11% were Hispanic.

Here’s one stark example of the issue. In 2015, the FDA approved ixazomib (Ninlaro), a promising new drug for multiple myeloma, a blood cancer that affects Black people at disproportionately higher rates than White people. In the United States, one in five people diagnosed with multiple myeloma are Black people. They are more than twice as likely to get the disease as White people. Yet during the clinical trial of 722 participants, only 13 patients, or 1.8%, were Black.

The American Cancer Society estimates that more than 600,000 Americans will die from cancer this year. Historically, Black Americans have the highest death rate and the shortest survival of any racial or ethnic group, stemming largely, it concluded, from centuries of structural racism.

According to Jamie Freedman, MD, head of U.S. medical affairs at Genentech, a global pharmaceutical company, the lack of diversity is often tied to where studies are run.

“Companies tend to choose major academic medical centers where there is a high volume of clinical trial work. When you go to the same tried and true hospitals repeatedly, the pool of patients becomes very homogeneous and tends to be primarily white,” he said. “It’s critical to bring more trials into the community setting by including new sites that can reach underrepresented groups, and Genentech is making significant progress in that area.”

Dr. Freedman believes that, while access is a big hurdle, it doesn’t end there.

“Many patients have a lack of trust in the health care system,” he said. “There are also issues around underserved communities being able to afford quality care, so it’s important to keep time and financial burdens in mind when designing trials to help mitigate barriers such as travel, parking, time off work, and child care.”

Genentech started its diversity and inclusion effort several years ago. Dr. Freeman said that, until more trials become diverse, Black Americans will continue to pay the price. “I think they’re losing their lives in part due to lack of access to these trials. And that is why Genentech and all of us in the health care industry need to change how we design and enroll these studies. We have a long way to go, but I think the steps we’re taking are leading us in the right direction.”

Jennifer Jones-McMeans, PhD, director of global clinical affairs at Abbott Pharmaceuticals, is a clinical research scientist who has designed and led many clinical trials.

She said that Abbott is actively working on solutions.

“We have designed our trials to reduce the barriers to participation and expand access,” she said. “This can be as simple as providing transportation services or home visits for those who are housebound. We’re taking it a step further and providing home health services where someone comes to the home and provides follow-up visits there.”

They also provide interpretation services to address any language barriers.

“We are reaching out to a new set of talented investigators who work closely with underrepresented communities. They are very much wedded and supportive of the communities they treat. By working with doctors within these communities, it expands access to new therapies.”

Spokesperson Keanna Ghazvini said that Pfizer Pharmaceuticals is also committed to increasing minority participation in trials.

“We know that if historically underserved populations are left out of clinical trials, they risk not benefiting from medical breakthroughs down the line,” she said.

The National Institutes of Health’s National Library of Medicine maintains the clinicaltrials.gov database.

There, you can find information on nearly 372,000 publicly and privately supported clinical trials happening in all 50 states and 219 countries. Many are funded by the NIH, but not all of these studies have been evaluated by the U.S. government.

Andrea Denicoff, a nurse consultant at the National Cancer Institute and head of clinical trials operations for the NCI’s National Clinical Trials Network, has been involved in clinical research at the NIH for 35 years.

“It’s really important that our publicly funded trials represent the people of the country,” she said. “There are some cancers that we’re doing a good job in enrolling minorities, and other cancers we need to do a much better job in having a diverse representation in our trials.”

Ms. Denicoff believed opening trials in places where people live is key, but having a diverse clinical trials team is as important.

“We need to reinforce that cancer centers across the country have open doors, and anyone with cancer feels comfortable getting care at that center, and that also includes discussing the option to participate in clinical trials when one might be available. We know from research that when people are invited and asked about trial participation and educated about them, they’ll be much more interested in joining them.”

Ms. Denicoff said that, during the pandemic, the NCI quickly came up with guidance to allow trial sites to send patients their oral study drugs and set up virtual visits. She believes it may help increase future access.

‘Lola Fashoyin-Aje, MD, associate director for science and policy to address disparities in the Oncology Center of Excellence at the FDA, says the agency firmly believes clinical trials should represent the patients who will ultimately get the drug if it’s approved.

But the FDA’s power to require diversity in trials is limited.

“It is important to point out that there are legal constraints which limit’s FDA’s authority to require specific proportional representation in clinical trials by demographic factors,” Dr. Fashoyin-Aje said.

Still, some researchers feel the FDA should play a bigger role. The question is: Should diversity be mandated?

Rhonda Long is now back in Boston to start a new trial, with a new drug that targets her specific mutation. She will be there for 2 months. Once again, Lazarex will help cover some of the cost.

She wants people of color to understand that they are missing out on the promise of new cancer drugs and extended life.

“I feel like there’s not enough emphasis on clinical trials, I don’t believe there’s enough emphasis on second opinions, I don’t think there’s enough emphasis that medicine happens outside our borders, outside of our communities. Clinical trials that don’t have a broad range of participants, how do we know how effective they are if Black and brown people, Asian or Latin American people aren’t represented in the trial?”

And with more trials adopting virtual elements, she said it’s time for minorities to get on board.

Dr. Freedman believed the groundwork is being laid for that to happen. “I don’t think we’ll ever return back to the way we used to do things, where everything has to be done at the clinical trial site. I just don’t think we’re ever going back.”

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

“I’m the first person in my circle of family and friends to participate in a clinical trial.”

Five years ago, Rhonda Long was diagnosed with cholangiocarcinoma, a rare bile duct cancer that’s seen in only about 8,000 Americans each year.

At the time, Mrs. Long, who is Black, said her doctor in Dayton, Ohio, told her she was not a candidate for surgery and suggested palliative care. After seeking a second opinion at Duke University Medical Center, Durham, N.C., where her sister worked, the 51-year-old wife and mother of two had surgery, radiation, and chemotherapy there in North Carolina. When the chemo stopped working after 3 months, her oncologist at Duke referred her to a colleague at Massachusetts General Hospital in Boston, where she was accepted into a clinical trial.

“In 2019, I traveled to Boston from Dayton, Ohio, every 3 weeks for labs and scans, to make sure that the drug wasn’t doing more harm than good, making sure that the drug as developed was maintaining, shrinking, or even eliminating the disease. Physically and financially, it takes a toll on you and loved ones.”

Her medical insurance did not cover the direct expenses from the clinical trial, and she was spending $1,000-$1,500 each trip. Sometimes they drove the 15 hours to Boston, and sometimes they flew on the cheapest flight they could find.

It’s not an unfamiliar story: people traveling, often long distances, to take part in clinical trials they hope will save their lives.

The Lazarex Cancer Foundation of Danville, Calif., helped Mrs. Long do just that.

Marya Shegog, PhD, health equity and diversity coordinator at Lazarex, said that a patient travels an average of 500 miles to participate in a trial.

The financial hurdles often prevent patients from taking part in clinical trials, Dr. Shegog said. “When you are sick, and you have a disease that may be terminal, you start thinking about setting your things in order.”

Many patients have to make a decision.

“Do I bankrupt my family on trying and hoping that this drug works and helps me live longer, or do I start setting things in order so that when I’m gone, they’re okay or at least better than if I wouldn’t have spent all the money traveling back and forth.”

Dr. Shegog, a 17-year cancer survivor, says when she was battling cervical cancer, a clinical trial was never offered or explored.

Lazarex has been helping cancer patients who have run out of options for 15 years. It identifies clinical trial opportunities and reimburses patients for all travel costs. Last year, Lazarex reimbursed more than 1,000 cancer patients. And it has supported more than 6,000 people since opening its doors.

“Lazarex exists to help remove the barriers of people not being able to participate in trials,” Dr. Shegog said. “It’s systemic that the medical system does not treat patients the same and oftentimes does not offer or make aware the opportunities for African Americans to participate.”

But now, thanks in part to COVID-19, new possibilities are taking shape. The pandemic has changed the landscape for trials, forcing many of them to go virtual, which allows patients to schedule telehealth visits and get some services like bloodwork and CT or MRI scans closer to home. Mrs. Long’s trial eventually went virtual.

“It was absolutely fantastic,” she said. “Having the trial locally, it saves us money, it saves wear and tear on my body. Being in the car, being in an airport or in a plane and in a hotel, all of that wears on you physically.”

The move to virtual studies may have lasting effects on research and treatment.

“The current pandemic has forced us to reexamine all of the traditional burdens we place on patients as it relates to receiving cancer treatment,” said Hala Borno, MD, an assistant professor of medicine at the University of California, San Francisco. “Whether they’re coming to our health care facility to see a clinician, for diagnostics such as blood draws and scans, or to receive therapy, this pandemic has challenged us to explore other possibilities that minimize the risk of exposure to SARS-CoV-2. What I find striking is that it has helped us operationalize use of telemedicine and the delivery of care closer to home.”

This is especially encouraging news for minority patients whose participation in trials has for years lagged well behind that of Whites.

But travel is not the only reason. Racial disparities in clinical trials have long been an issue that’s just another part of the implicit bias in health care.

Compared with White people, Black people are largely at higher risk for heart disease, cancer, stroke, diabetes, asthma, and even mental health problems.

And it’s not just African Americans. Asians, Hispanics, Native Americans, and Alaska Natives are all underrepresented in trials at a time when there is growing evidence that drugs may have different effects on different populations.

Dr. Borno is an oncologist who specializes in prostate cancer, a disease that she says shows a “significant disparity,” where Black men are two times more likely to die from advanced prostate cancer, compared with white men. Yet Black men make up just 3% of advanced therapeutic trials.

“A lack of diversity and inclusion in clinical trials is unacceptable,” she said. “If we continue to underrecruit racial/ethnic minorities and older adults to therapeutic clinical trials, we will not be powered to make valid conclusions regarding safety and efficacy in those patient populations. As a result, we can do harm.”

Dr. Borno said that telehealth and telemedicine are not cure-alls, and digital health solutions don’t work for all patients. Approaches, she says, must be tailored to the individual, or disparities could worsen.

In 2020, the Food and Drug Administration approved 53 new drugs. Overall, 32,000 patients took part in these trials. On average, 75% were White, 8% were Black, 6% were Asian, and 11% were Hispanic.

Here’s one stark example of the issue. In 2015, the FDA approved ixazomib (Ninlaro), a promising new drug for multiple myeloma, a blood cancer that affects Black people at disproportionately higher rates than White people. In the United States, one in five people diagnosed with multiple myeloma are Black people. They are more than twice as likely to get the disease as White people. Yet during the clinical trial of 722 participants, only 13 patients, or 1.8%, were Black.

The American Cancer Society estimates that more than 600,000 Americans will die from cancer this year. Historically, Black Americans have the highest death rate and the shortest survival of any racial or ethnic group, stemming largely, it concluded, from centuries of structural racism.

According to Jamie Freedman, MD, head of U.S. medical affairs at Genentech, a global pharmaceutical company, the lack of diversity is often tied to where studies are run.

“Companies tend to choose major academic medical centers where there is a high volume of clinical trial work. When you go to the same tried and true hospitals repeatedly, the pool of patients becomes very homogeneous and tends to be primarily white,” he said. “It’s critical to bring more trials into the community setting by including new sites that can reach underrepresented groups, and Genentech is making significant progress in that area.”

Dr. Freedman believes that, while access is a big hurdle, it doesn’t end there.

“Many patients have a lack of trust in the health care system,” he said. “There are also issues around underserved communities being able to afford quality care, so it’s important to keep time and financial burdens in mind when designing trials to help mitigate barriers such as travel, parking, time off work, and child care.”

Genentech started its diversity and inclusion effort several years ago. Dr. Freeman said that, until more trials become diverse, Black Americans will continue to pay the price. “I think they’re losing their lives in part due to lack of access to these trials. And that is why Genentech and all of us in the health care industry need to change how we design and enroll these studies. We have a long way to go, but I think the steps we’re taking are leading us in the right direction.”

Jennifer Jones-McMeans, PhD, director of global clinical affairs at Abbott Pharmaceuticals, is a clinical research scientist who has designed and led many clinical trials.

She said that Abbott is actively working on solutions.

“We have designed our trials to reduce the barriers to participation and expand access,” she said. “This can be as simple as providing transportation services or home visits for those who are housebound. We’re taking it a step further and providing home health services where someone comes to the home and provides follow-up visits there.”

They also provide interpretation services to address any language barriers.

“We are reaching out to a new set of talented investigators who work closely with underrepresented communities. They are very much wedded and supportive of the communities they treat. By working with doctors within these communities, it expands access to new therapies.”

Spokesperson Keanna Ghazvini said that Pfizer Pharmaceuticals is also committed to increasing minority participation in trials.

“We know that if historically underserved populations are left out of clinical trials, they risk not benefiting from medical breakthroughs down the line,” she said.

The National Institutes of Health’s National Library of Medicine maintains the clinicaltrials.gov database.

There, you can find information on nearly 372,000 publicly and privately supported clinical trials happening in all 50 states and 219 countries. Many are funded by the NIH, but not all of these studies have been evaluated by the U.S. government.

Andrea Denicoff, a nurse consultant at the National Cancer Institute and head of clinical trials operations for the NCI’s National Clinical Trials Network, has been involved in clinical research at the NIH for 35 years.

“It’s really important that our publicly funded trials represent the people of the country,” she said. “There are some cancers that we’re doing a good job in enrolling minorities, and other cancers we need to do a much better job in having a diverse representation in our trials.”

Ms. Denicoff believed opening trials in places where people live is key, but having a diverse clinical trials team is as important.

“We need to reinforce that cancer centers across the country have open doors, and anyone with cancer feels comfortable getting care at that center, and that also includes discussing the option to participate in clinical trials when one might be available. We know from research that when people are invited and asked about trial participation and educated about them, they’ll be much more interested in joining them.”

Ms. Denicoff said that, during the pandemic, the NCI quickly came up with guidance to allow trial sites to send patients their oral study drugs and set up virtual visits. She believes it may help increase future access.

‘Lola Fashoyin-Aje, MD, associate director for science and policy to address disparities in the Oncology Center of Excellence at the FDA, says the agency firmly believes clinical trials should represent the patients who will ultimately get the drug if it’s approved.

But the FDA’s power to require diversity in trials is limited.

“It is important to point out that there are legal constraints which limit’s FDA’s authority to require specific proportional representation in clinical trials by demographic factors,” Dr. Fashoyin-Aje said.

Still, some researchers feel the FDA should play a bigger role. The question is: Should diversity be mandated?

Rhonda Long is now back in Boston to start a new trial, with a new drug that targets her specific mutation. She will be there for 2 months. Once again, Lazarex will help cover some of the cost.

She wants people of color to understand that they are missing out on the promise of new cancer drugs and extended life.

“I feel like there’s not enough emphasis on clinical trials, I don’t believe there’s enough emphasis on second opinions, I don’t think there’s enough emphasis that medicine happens outside our borders, outside of our communities. Clinical trials that don’t have a broad range of participants, how do we know how effective they are if Black and brown people, Asian or Latin American people aren’t represented in the trial?”

And with more trials adopting virtual elements, she said it’s time for minorities to get on board.

Dr. Freedman believed the groundwork is being laid for that to happen. “I don’t think we’ll ever return back to the way we used to do things, where everything has to be done at the clinical trial site. I just don’t think we’re ever going back.”

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

The new SARS-CoV-2 variants are not just problems for humans. 

New research shows they can also infect animals, and for the first time, variants have been able to infect mice, a development that may complicate efforts to rein in the global spread of the virus.

In addition, two new studies have implications for pets. Veterinarians in Texas and the United Kingdom have documented infections of B.1.1.7 – the fast-spreading variant first found in the United Kingdom – in dogs and cats. The animals in the U.K. study also had heart damage, but it’s unclear if the damage was caused by the virus or was already there and was found as a result of their infections.

Animal studies of SARS-CoV-2 and its emerging variants are urgent, said Sarah Hamer, DVM, PhD, a veterinarian and epidemiologist at Texas A&M University, College Station. 

She’s part of a network of scientists who are swabbing the pets of people who are diagnosed with COVID-19 to find out how often the virus passes from people to animals.

The collaboration is part of the One Health initiative through the Centers for Disease Control and Prevention. One Health aims to tackle infectious diseases by recognizing that people can’t be fully protected from pathogens unless animals and the environment are also safeguarded. “Over 70% of emerging diseases of humans have their origins in animal populations,” Dr. Hamer said. “So if we are only focusing on studying disease as it emerges in humans and ignoring where those pathogens have been transmitted or circulating for years, then we might miss the ability to detect early emergence. We might miss the ability to control these diseases before they become problems for human health.”
 

Variants move to mice

In new work, researchers at the Institut Pasteur in Paris have shown that the B.1.351 and P.1 variants of concern, which were first identified in South Africa and Brazil, respectively, can infect mice, giving the virus a potential new host. Older versions of the virus couldn’t infect mice because they weren’t able bind to receptors on their cells. These two variants can.

On one hand, that’s a good thing, because it will help scientists more easily conduct experiments in mice. Before, if they wanted to do an experiment with SARS-CoV-2 in mice, they had to use a special strain of mouse that was bred to carry human ACE2 receptors on their lung cells. Now that mice can become naturally infected, any breed will do, making it less costly and time-consuming to study the virus in animals.

On the other hand, the idea that the virus could have more and different ways to spread isn’t good news.

“From the beginning of the epidemic and since human coronaviruses emerged from animals, it has been very important to establish in which species the virus can replicate, in particular the species that live close to humans,” said Xavier Montagutelli, DVM, PhD, head of the Mouse Genetics Laboratory at the Institut Pasteur. His study was published as a preprint ahead of peer review on BioRXIV.

Once a virus establishes itself within a population of animals, it will continue to spread and change and may eventually be passed back to humans. It’s the reason that birds and pigs are closely monitored for influenza viruses.

So far, with SARS-CoV-2, only one animal has been found to catch and spread the virus and pass it back to people – farmed mink. Researchers have also documented SARS-CoV-2 antibodies in escaped mink living near mink farms in Utah, suggesting the virus has the potential to be transmitted to wild populations.

And the move of the virus into mice suggests that SARS-CoV-2 could establish itself in a population of wild animals that live close to humans.

“At this point, we have no evidence that wild mice are infected, or can become infected from humans,” Dr. Montagutelli said. He added that his findings emphasize the need to regularly test animals for signs of the infection. He said these surveys will need to be updated as more variants emerge.

“So far, we’ve been lucky that our livestock species aren’t really susceptible to this,” said Scott Weese, DVM, a professor at Ontario Veterinary College at the University of Guelph, who studies emerging infectious diseases that pass between animals and people.

While the outbreaks on mink farms have been bad, imagine what would happen, Dr. Weese said, if the virus moved to pigs.

“If this infects a barn with a few thousand pigs – which is like the mink scenario – but we have a lot more pig farms than mink farms,” he said.

“With these variants, we have to reset,” he said. “We’ve figured all this about animals and how it spreads or how it doesn’t, but now we need to repeat all those studies to make sure it’s the same thing.”
 

Pets catch variants, too

Pets living with people who are infected with SARS-CoV-2 can catch it from their owners, and cats are particularly susceptible, Dr. Weese said. 

Contact tracing studies, which also tested animals for signs of the virus, have found that about half of cats living with infected people have signs of infection, while 20%-30% of dogs were sick.

“It’s quite common,” for pets to get COVID, Dr. Weese said.

Now, two new studies have shown that pets can also be infected by the newer B.1.1.7 variant.

The first study, from researchers at Texas A&M, documented the variant in a dog and a cat from Brazos County, Texas. Neither the older black Lab mix or the older domestic shorthair cat had symptoms of COVID-19. They were tested as part of a project funded by the CDC.

Dr. Weese said pets are at risk by people who are infected, but they don’t seem to play a big role in spreading the disease to humans. So if you have pets, there’s no reason to worry that they could bring the virus home to you. You’re more likely to be a risk to them.

The second study, from a specialty animal hospital in southeast England, documented infection by the B.1.1.7 virus variant in 11 dogs and cats. Most of the pets had unusual symptoms, including inflamed hearts and heart damage.

Dr. Weese called this study interesting and said its findings deserve more investigation, but pointed out that the study can’t determine whether the infection caused the heart damage, or whether it was already there.

“This is a human virus. There’s no doubt about it. It can affect other species, but it likes people a lot better,” he said. “If you think about the big picture and what is the potential role of animals, pets are pretty low risk.”
 

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

The new SARS-CoV-2 variants are not just problems for humans. 

New research shows they can also infect animals, and for the first time, variants have been able to infect mice, a development that may complicate efforts to rein in the global spread of the virus.

In addition, two new studies have implications for pets. Veterinarians in Texas and the United Kingdom have documented infections of B.1.1.7 – the fast-spreading variant first found in the United Kingdom – in dogs and cats. The animals in the U.K. study also had heart damage, but it’s unclear if the damage was caused by the virus or was already there and was found as a result of their infections.

Animal studies of SARS-CoV-2 and its emerging variants are urgent, said Sarah Hamer, DVM, PhD, a veterinarian and epidemiologist at Texas A&M University, College Station. 

She’s part of a network of scientists who are swabbing the pets of people who are diagnosed with COVID-19 to find out how often the virus passes from people to animals.

The collaboration is part of the One Health initiative through the Centers for Disease Control and Prevention. One Health aims to tackle infectious diseases by recognizing that people can’t be fully protected from pathogens unless animals and the environment are also safeguarded. “Over 70% of emerging diseases of humans have their origins in animal populations,” Dr. Hamer said. “So if we are only focusing on studying disease as it emerges in humans and ignoring where those pathogens have been transmitted or circulating for years, then we might miss the ability to detect early emergence. We might miss the ability to control these diseases before they become problems for human health.”
 

Variants move to mice

In new work, researchers at the Institut Pasteur in Paris have shown that the B.1.351 and P.1 variants of concern, which were first identified in South Africa and Brazil, respectively, can infect mice, giving the virus a potential new host. Older versions of the virus couldn’t infect mice because they weren’t able bind to receptors on their cells. These two variants can.

On one hand, that’s a good thing, because it will help scientists more easily conduct experiments in mice. Before, if they wanted to do an experiment with SARS-CoV-2 in mice, they had to use a special strain of mouse that was bred to carry human ACE2 receptors on their lung cells. Now that mice can become naturally infected, any breed will do, making it less costly and time-consuming to study the virus in animals.

On the other hand, the idea that the virus could have more and different ways to spread isn’t good news.

“From the beginning of the epidemic and since human coronaviruses emerged from animals, it has been very important to establish in which species the virus can replicate, in particular the species that live close to humans,” said Xavier Montagutelli, DVM, PhD, head of the Mouse Genetics Laboratory at the Institut Pasteur. His study was published as a preprint ahead of peer review on BioRXIV.

Once a virus establishes itself within a population of animals, it will continue to spread and change and may eventually be passed back to humans. It’s the reason that birds and pigs are closely monitored for influenza viruses.

So far, with SARS-CoV-2, only one animal has been found to catch and spread the virus and pass it back to people – farmed mink. Researchers have also documented SARS-CoV-2 antibodies in escaped mink living near mink farms in Utah, suggesting the virus has the potential to be transmitted to wild populations.

And the move of the virus into mice suggests that SARS-CoV-2 could establish itself in a population of wild animals that live close to humans.

“At this point, we have no evidence that wild mice are infected, or can become infected from humans,” Dr. Montagutelli said. He added that his findings emphasize the need to regularly test animals for signs of the infection. He said these surveys will need to be updated as more variants emerge.

“So far, we’ve been lucky that our livestock species aren’t really susceptible to this,” said Scott Weese, DVM, a professor at Ontario Veterinary College at the University of Guelph, who studies emerging infectious diseases that pass between animals and people.

While the outbreaks on mink farms have been bad, imagine what would happen, Dr. Weese said, if the virus moved to pigs.

“If this infects a barn with a few thousand pigs – which is like the mink scenario – but we have a lot more pig farms than mink farms,” he said.

“With these variants, we have to reset,” he said. “We’ve figured all this about animals and how it spreads or how it doesn’t, but now we need to repeat all those studies to make sure it’s the same thing.”
 

Pets catch variants, too

Pets living with people who are infected with SARS-CoV-2 can catch it from their owners, and cats are particularly susceptible, Dr. Weese said. 

Contact tracing studies, which also tested animals for signs of the virus, have found that about half of cats living with infected people have signs of infection, while 20%-30% of dogs were sick.

“It’s quite common,” for pets to get COVID, Dr. Weese said.

Now, two new studies have shown that pets can also be infected by the newer B.1.1.7 variant.

The first study, from researchers at Texas A&M, documented the variant in a dog and a cat from Brazos County, Texas. Neither the older black Lab mix or the older domestic shorthair cat had symptoms of COVID-19. They were tested as part of a project funded by the CDC.

Dr. Weese said pets are at risk by people who are infected, but they don’t seem to play a big role in spreading the disease to humans. So if you have pets, there’s no reason to worry that they could bring the virus home to you. You’re more likely to be a risk to them.

The second study, from a specialty animal hospital in southeast England, documented infection by the B.1.1.7 virus variant in 11 dogs and cats. Most of the pets had unusual symptoms, including inflamed hearts and heart damage.

Dr. Weese called this study interesting and said its findings deserve more investigation, but pointed out that the study can’t determine whether the infection caused the heart damage, or whether it was already there.

“This is a human virus. There’s no doubt about it. It can affect other species, but it likes people a lot better,” he said. “If you think about the big picture and what is the potential role of animals, pets are pretty low risk.”
 

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

The new SARS-CoV-2 variants are not just problems for humans. 

New research shows they can also infect animals, and for the first time, variants have been able to infect mice, a development that may complicate efforts to rein in the global spread of the virus.

In addition, two new studies have implications for pets. Veterinarians in Texas and the United Kingdom have documented infections of B.1.1.7 – the fast-spreading variant first found in the United Kingdom – in dogs and cats. The animals in the U.K. study also had heart damage, but it’s unclear if the damage was caused by the virus or was already there and was found as a result of their infections.

Animal studies of SARS-CoV-2 and its emerging variants are urgent, said Sarah Hamer, DVM, PhD, a veterinarian and epidemiologist at Texas A&M University, College Station. 

She’s part of a network of scientists who are swabbing the pets of people who are diagnosed with COVID-19 to find out how often the virus passes from people to animals.

The collaboration is part of the One Health initiative through the Centers for Disease Control and Prevention. One Health aims to tackle infectious diseases by recognizing that people can’t be fully protected from pathogens unless animals and the environment are also safeguarded. “Over 70% of emerging diseases of humans have their origins in animal populations,” Dr. Hamer said. “So if we are only focusing on studying disease as it emerges in humans and ignoring where those pathogens have been transmitted or circulating for years, then we might miss the ability to detect early emergence. We might miss the ability to control these diseases before they become problems for human health.”
 

Variants move to mice

In new work, researchers at the Institut Pasteur in Paris have shown that the B.1.351 and P.1 variants of concern, which were first identified in South Africa and Brazil, respectively, can infect mice, giving the virus a potential new host. Older versions of the virus couldn’t infect mice because they weren’t able bind to receptors on their cells. These two variants can.

On one hand, that’s a good thing, because it will help scientists more easily conduct experiments in mice. Before, if they wanted to do an experiment with SARS-CoV-2 in mice, they had to use a special strain of mouse that was bred to carry human ACE2 receptors on their lung cells. Now that mice can become naturally infected, any breed will do, making it less costly and time-consuming to study the virus in animals.

On the other hand, the idea that the virus could have more and different ways to spread isn’t good news.

“From the beginning of the epidemic and since human coronaviruses emerged from animals, it has been very important to establish in which species the virus can replicate, in particular the species that live close to humans,” said Xavier Montagutelli, DVM, PhD, head of the Mouse Genetics Laboratory at the Institut Pasteur. His study was published as a preprint ahead of peer review on BioRXIV.

Once a virus establishes itself within a population of animals, it will continue to spread and change and may eventually be passed back to humans. It’s the reason that birds and pigs are closely monitored for influenza viruses.

So far, with SARS-CoV-2, only one animal has been found to catch and spread the virus and pass it back to people – farmed mink. Researchers have also documented SARS-CoV-2 antibodies in escaped mink living near mink farms in Utah, suggesting the virus has the potential to be transmitted to wild populations.

And the move of the virus into mice suggests that SARS-CoV-2 could establish itself in a population of wild animals that live close to humans.

“At this point, we have no evidence that wild mice are infected, or can become infected from humans,” Dr. Montagutelli said. He added that his findings emphasize the need to regularly test animals for signs of the infection. He said these surveys will need to be updated as more variants emerge.

“So far, we’ve been lucky that our livestock species aren’t really susceptible to this,” said Scott Weese, DVM, a professor at Ontario Veterinary College at the University of Guelph, who studies emerging infectious diseases that pass between animals and people.

While the outbreaks on mink farms have been bad, imagine what would happen, Dr. Weese said, if the virus moved to pigs.

“If this infects a barn with a few thousand pigs – which is like the mink scenario – but we have a lot more pig farms than mink farms,” he said.

“With these variants, we have to reset,” he said. “We’ve figured all this about animals and how it spreads or how it doesn’t, but now we need to repeat all those studies to make sure it’s the same thing.”
 

Pets catch variants, too

Pets living with people who are infected with SARS-CoV-2 can catch it from their owners, and cats are particularly susceptible, Dr. Weese said. 

Contact tracing studies, which also tested animals for signs of the virus, have found that about half of cats living with infected people have signs of infection, while 20%-30% of dogs were sick.

“It’s quite common,” for pets to get COVID, Dr. Weese said.

Now, two new studies have shown that pets can also be infected by the newer B.1.1.7 variant.

The first study, from researchers at Texas A&M, documented the variant in a dog and a cat from Brazos County, Texas. Neither the older black Lab mix or the older domestic shorthair cat had symptoms of COVID-19. They were tested as part of a project funded by the CDC.

Dr. Weese said pets are at risk by people who are infected, but they don’t seem to play a big role in spreading the disease to humans. So if you have pets, there’s no reason to worry that they could bring the virus home to you. You’re more likely to be a risk to them.

The second study, from a specialty animal hospital in southeast England, documented infection by the B.1.1.7 virus variant in 11 dogs and cats. Most of the pets had unusual symptoms, including inflamed hearts and heart damage.

Dr. Weese called this study interesting and said its findings deserve more investigation, but pointed out that the study can’t determine whether the infection caused the heart damage, or whether it was already there.

“This is a human virus. There’s no doubt about it. It can affect other species, but it likes people a lot better,” he said. “If you think about the big picture and what is the potential role of animals, pets are pretty low risk.”
 

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

In a record year for the Match, family medicine residencies filled 92.7% of their available positions in 2021, which were up 3.5% over last year, according to the National Resident Matching Program.

“Rather than faltering in these uncertain times, program fill rates increased across the board,” the NRMP said in a written statement. Overall, the 2021 Main Residency Match offered (35,194) and filled (33,353) more first-year (PGY-1) slots than ever before, for a fill rate of 94.8%, compared with 94.6% the year before.

Family medicine offered 4,823 positions in this year’s Match, up by 3.5% over 2020, and filled 4,472, for a 1-year increase of 3.7% and a fill rate of 92.7%. Just over 63% (3,046) of the available slots were given to U.S. seniors (MDs and DOs), while 25.4% went to international medical graduates. The corresponding PGY-1 numbers for the Match as a whole were 70.4% U.S. and 21.1% international medical graduates, based on NRMP data.

“In the last five years, the Main Residency Match has seen sizable increases in the number of positions offered” in family medicine – up by 1,467 (43.7%) since 2017 – and such growth over time may “be a predictor of future physician workforce supply,” the NRMP said. Family medicine also increased its share of all available residency positions from 11.6% in 2017 to 13.7% this year.

“Concerns about the impact of virtual recruitment on applicants’ matching into PGY-1 positions were not realized,” the NRMP noted, as “growth in registration was seen in every applicant group.” Compared with 2020, submissions of rank-order lists of programs were up by 2.8% for U.S. MD seniors, 7.9% for U.S. DO seniors, 2.5% for U.S.-citizen IMGs, and 15.0% for non–U.S.-citizen IMGs.

“The application and recruitment cycle was upended as a result of the pandemic, yet the results of the Match continue to demonstrate strong and consistent outcomes for participants,” said Donna L. Lamb, DHSc, MBA, who is president and CEO of the NRMP.

rfranki@mdedge.com

In a record year for the Match, family medicine residencies filled 92.7% of their available positions in 2021, which were up 3.5% over last year, according to the National Resident Matching Program.

“Rather than faltering in these uncertain times, program fill rates increased across the board,” the NRMP said in a written statement. Overall, the 2021 Main Residency Match offered (35,194) and filled (33,353) more first-year (PGY-1) slots than ever before, for a fill rate of 94.8%, compared with 94.6% the year before.

Family medicine offered 4,823 positions in this year’s Match, up by 3.5% over 2020, and filled 4,472, for a 1-year increase of 3.7% and a fill rate of 92.7%. Just over 63% (3,046) of the available slots were given to U.S. seniors (MDs and DOs), while 25.4% went to international medical graduates. The corresponding PGY-1 numbers for the Match as a whole were 70.4% U.S. and 21.1% international medical graduates, based on NRMP data.

“In the last five years, the Main Residency Match has seen sizable increases in the number of positions offered” in family medicine – up by 1,467 (43.7%) since 2017 – and such growth over time may “be a predictor of future physician workforce supply,” the NRMP said. Family medicine also increased its share of all available residency positions from 11.6% in 2017 to 13.7% this year.

“Concerns about the impact of virtual recruitment on applicants’ matching into PGY-1 positions were not realized,” the NRMP noted, as “growth in registration was seen in every applicant group.” Compared with 2020, submissions of rank-order lists of programs were up by 2.8% for U.S. MD seniors, 7.9% for U.S. DO seniors, 2.5% for U.S.-citizen IMGs, and 15.0% for non–U.S.-citizen IMGs.

“The application and recruitment cycle was upended as a result of the pandemic, yet the results of the Match continue to demonstrate strong and consistent outcomes for participants,” said Donna L. Lamb, DHSc, MBA, who is president and CEO of the NRMP.

rfranki@mdedge.com

In a record year for the Match, family medicine residencies filled 92.7% of their available positions in 2021, which were up 3.5% over last year, according to the National Resident Matching Program.

“Rather than faltering in these uncertain times, program fill rates increased across the board,” the NRMP said in a written statement. Overall, the 2021 Main Residency Match offered (35,194) and filled (33,353) more first-year (PGY-1) slots than ever before, for a fill rate of 94.8%, compared with 94.6% the year before.

Family medicine offered 4,823 positions in this year’s Match, up by 3.5% over 2020, and filled 4,472, for a 1-year increase of 3.7% and a fill rate of 92.7%. Just over 63% (3,046) of the available slots were given to U.S. seniors (MDs and DOs), while 25.4% went to international medical graduates. The corresponding PGY-1 numbers for the Match as a whole were 70.4% U.S. and 21.1% international medical graduates, based on NRMP data.

“In the last five years, the Main Residency Match has seen sizable increases in the number of positions offered” in family medicine – up by 1,467 (43.7%) since 2017 – and such growth over time may “be a predictor of future physician workforce supply,” the NRMP said. Family medicine also increased its share of all available residency positions from 11.6% in 2017 to 13.7% this year.

“Concerns about the impact of virtual recruitment on applicants’ matching into PGY-1 positions were not realized,” the NRMP noted, as “growth in registration was seen in every applicant group.” Compared with 2020, submissions of rank-order lists of programs were up by 2.8% for U.S. MD seniors, 7.9% for U.S. DO seniors, 2.5% for U.S.-citizen IMGs, and 15.0% for non–U.S.-citizen IMGs.

“The application and recruitment cycle was upended as a result of the pandemic, yet the results of the Match continue to demonstrate strong and consistent outcomes for participants,” said Donna L. Lamb, DHSc, MBA, who is president and CEO of the NRMP.

rfranki@mdedge.com