'Gabapentin: The Hope, the Harm, the Myth, the Reality'

 Since gabapentin was approved by the US Food and Drug Administration (FDA) for treatment of partial-onset seizures and postherpetic neuralgia, it has been used in many different ways, many off-label indications, and with several recent safety warnings.

Early Problems

After FDA approval in 1993 (for partial seizures), gabapentin was promoted by its maker (Park-Davis) for off-label indications, especially for pain. There was no FDA approval for that indication and the studies the company had done were deemed to have been manipulated in a subsequent lawsuit.^[1] Gabapentin became the nonopioid go-to medication for treatment of pain despite underwhelming evidence.

Studies on Neuropathy

Douglas S. Paauw, MD

In the largest trial of gabapentin for diabetic peripheral neuropathy, Rauck and colleagues found no significant difference in pain relief between gabapentin and placebo.^[2] A Cochrane review of gabapentin for neuropathic pain concluded that about 30%-40% of patients taking gabapentin for diabetic neuropathy achieved meaningful pain relief with gabapentin use, with a number needed to treat (NNT) of 6.6.^[3] The review also concluded that for postherpetic neuralgia (an FDA-approved indication) 78% of patients had moderate to substantial benefit with gabapentin (NNT 4.8 for moderate benefit).

Side Effects of Gabapentin

From the Cochrane review, the most common side effects were: dizziness (19%), somnolence (14%), peripheral edema (7%), and gait disturbance (14%). The number needed to harm for gabapentin was 7.^[5] The two side effects listed here that are often overlooked that I want to highlight are peripheral edema and gait disturbance. I have seen these both fairly frequently over the years. A side effect not found in the Cochrane review was weight gain. Weight gain with gabapentin was reported in a meta-analysis of drugs that can cause weight gain.^[4]

New Warnings

In December 2019, the FDA released a warning on the potential for serious respiratory problems with gabapentin and pregabalin in patients with certain risk factors: opioid use or use of other drugs that depress the central nervous system, COPD, and other severe lung diseases.^[5]Rahman and colleagues found that compared with nonuse, gabapentinoid use was associated with increased risk for severe COPD exacerbation (hazard ratio, 1.39; 95% confidence interval, 1.29-1.50).^[6]

Off-Label Uses

Primary care professionals frequently use gabapentin for two off-label indications that are incorporated into practice guidelines. Ryan et al. studied gabapentin in patients with refractory, unexplained chronic cough.^[7] In a randomized, placebo-controlled trial, gabapentin improved cough-specific quality of life compared with placebo (P = .004; NNT 3.58). Use of gabapentin for treatment of unexplained, refractory cough has been included in several chronic cough practice guidelines.^[8,9]

Gabapentin has been studied for the treatment of restless legs syndrome and has been recommended as an option to treat moderate to severe restless legs syndrome in the American Academy of Sleep Medicine Guidelines.^[10]

Pearl of the Month:

Gabapentin is used widely for many different pain syndromes. The best evidence is for postherpetic neuralgia and diabetic neuropathy. Be aware of the side effects and risks of use in patients with pulmonary disease and who are taking CNS-depressant medications.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose.

https://www.medscape.com/s/viewarticle/gabapentin-hope-harm-myth-reality-2024a1000fun

Controversy Surrounds Optimal Treatment for High-Risk Pulmonary Embolism

 The optimal course of treatment when managing acute, high-risk pulmonary embolism (PE) remains a contentious topic among respiratory specialists.

Systemic thrombolysis, specifically using recombinant tissue plasminogen activator (rtPA), is the current gold standard treatment for high-risk PE. However, the real-world application is less straightforward due to patient complexities. Some clinicians believe that advances in mechanical and surgical techniques have made rtPA a thing of the past. Others think there is still insufficient evidence to support alternatives as the standard of care.

Here at the European Respiratory Society (ERS) 2024 Congress, respiratory specialists presented contrasting viewpoints and the latest evidence on each side of the issue to provide a comprehensive framework for navigating the complex decision-making process required for effective treatment.

"High-risk PE is a mechanical problem and thus needs a mechanical solution," said Parth M. Rali, MD, an associate professor in thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia.

"The marketing on some of the mechanical techniques is very impressive," said Olivier Sanchez, MD, a pulmonologist in the Department of Pneumology and Intensive Care at the Georges Pompidou European Hospital in France. "But what is the evidence of such treatment in the setting of pulmonary embolism?"

Case Against rtPA Standard of Care

High-risk PE typically involves hemodynamically unstable patients presenting with conditions such as low blood pressure, cardiac arrest, or the need for mechanical circulatory support. There is a spectrum of severity within high-risk PE, making it a complex condition to manage, especially since many patients have comorbidities like anemia or active cancer, complicating treatment. "It's a very dynamic and fluid condition, and we can't take for granted that rtPA is a standard of care," Rali said.

Alternative treatments such as catheter-directed therapies, extracorporeal membrane oxygenation (ECMO), and surgical embolectomy are emerging as promising options, especially for patients who do not respond to or cannot receive rtPA. Mechanical treatments offer benefits in reducing clot burden and stabilizing patients, but they come with their own challenges.

ECMO can stabilize patients who are in shock or cardiac arrest, buying time for the clot to resolve or for further interventions like surgery or catheter-based treatments, said Rali. However, it is an invasive procedure requiring cannulation of large blood vessels, often involving significant resources and expertise.

Catheter-directed thrombolysis is a minimally invasive technique where a catheter is inserted directly into the pulmonary artery to deliver thrombolytic drugs at lower doses. This method allows for more targeted treatment of the clot, reducing the risk for systemic bleeding that comes with higher doses of thrombolytic agents used in systemic therapy, Rali explained. 

Rali reported results from the FLAME study, which investigated the effectiveness of FlowTriever mechanical thrombectomy compared with conventional therapies for high-risk PE. This prospective, multicenter observational study enrolled 53 patients in the FlowTriever arm and 61 in the context arm, which included patients treated with systemic thrombolysis or anticoagulation. The primary endpoint, a composite of adverse in-hospital outcomes, was reached in 17% of FlowTriever patients, significantly lower than the 32% performance goal and the 63.9% rate in the context arm. In-hospital mortality was dramatically lower in the FlowTriever arm (1.9%) compared to the context arm (29.5%). 

When catheter-based treatment fails, surgical pulmonary embolectomy is a last-resort option. "Only a minority of the high-risk PE [patients] would qualify for rtPA without harmful side effects," Rali concluded. "So think wise before you pull your trigger." 

rtPA Not a Matter of the Past

In high-risk PE, the therapeutic priority is rapid hemodynamic stabilization and restoration of pulmonary blood flow to prevent cardiovascular collapse. Systemic thrombolysis acts quickly, reducing pulmonary vascular resistance and obstruction within hours, said Sanchez. 

Presenting at the ERS Congress, he reported numerous studies, including 15 randomized controlled trials that demonstrated its effectiveness in high-risk PE. The PEITHO trial, in particular, demonstrated the ability of systemic thrombolysis to reduce all-cause mortality and hemodynamic collapse within 7 days. 

However, this benefit comes at the cost of increased bleeding risk, including a 10% rate of major bleeding and a 2% risk for intracranial hemorrhage. "These data come from old studies using invasive diagnostic procedures, and with current diagnostic procedures, the rate of bleeding is probably lower," Sanchez said. The risk of bleeding is also related to the type of thrombolytic agent, with tenecteplase being strongly associated with a higher risk of bleeding, while alteplase shows no increase in the risk of major bleeding, he added. New strategies like reduced-dose thrombolysis offer comparable efficacy and improved safety, as demonstrated in ongoing trials like  PEITHO-3, which aim to optimize the balance between efficacy and bleeding risk. Sanchez is the lead investigator of the PEITHO-3 study.

While rtPA might not be optimal for all patients, Sanchez thinks there is not enough evidence to replace it as a first-line treatment.

Existing studies on catheter-directed therapies often focus on surrogate endpoints, such as right-to-left ventricular ratio changes, rather than clinical outcomes like mortality, he said. Retrospective data suggest that catheter-directed therapies may reduce in-hospital mortality compared with systemic therapies, but they also increase the risk of intracranial bleeding, post-procedure complications, and device-related events.

Sanchez mentioned the same FLAME study described by Rali, which reported a 23% rate of device-related complications and 11% major bleeding in patients treated with catheter-directed therapies. 

"Systemic thrombolysis remains the first treatment of choice," Sanchez concluded. "The use of catheter-directed treatment should be discussed as an alternative in case of contraindications."

The Debate Continues

Numerous ongoing clinical studies, such as the FLARE trial, will address gaps in evidence and refine treatment protocols, potentially reshaping the standard of care in high-risk PE in the near future by providing new data on the efficacy and safety of existing and emerging therapies.

"The coming data will make it clearer what the best option is," Thamer Al Khouzaie, MD, a pulmonary medicine consultant at Johns Hopkins Aramco Healthcare in Dhahran, Saudi Arabia, told Medscape Medical News. For now, he said, systemic thrombolysis remains the best option for most patients because it is widely available, easily administered with intravenous infusion, and at a limited cost. Catheter-directed treatment and surgical options are only available in specialized centers, require expertise and training, and are also very expensive.

Rali, Sanchez, and Khouzaie report no relevant financial relationships.

https://www.medscape.com/viewarticle/controversy-surrounds-optimal-treatment-high-risk-pulmonary-2024a1000g7i

'Yellow Dye 5 May Be the Key to Invisibility'

 The same dye that gives Twinkies their yellowish hue could be the key to invisibility. 

Applying the dye to lab mice made their skin temporarily transparent, allowing Stanford University researchers to observe the rodents' digestive system, muscle fibers, and blood vessels, according to a study published September 5 in Science.

"It's a stunning result," said senior author Guosong Hong, PhD, who is assistant professor of materials science and engineering at Stanford. "If the same technique could be applied to humans, it could offer a variety of benefits in biology, diagnostics, and even cosmetics." 

The work drew upon optical concepts first described in the early 20th century to form a surprising theory: Applying a light-absorbing substance could render skin transparent by reducing the chaotic scattering of light as it strikes proteins, fats, and water in tissue. 

A search for a suitable light absorber led to FD&C Yellow 5, also called tartrazine, a synthetic color additive certified by the US Food and Drug Administration for use in foods, cosmetics, and medications. 

Rubbed on live mice (after areas of fur were removed using a drugstore depilatory cream), tartrazine rendered skin on their bellies, hind legs, and heads transparent within 5 minutes. With the naked eye, the researchers watched a mouse's intestines, bladder, and liver at work. Using a microscope, they observed muscle fibers and saw blood vessels in a living mouse's brain — all without making incisions. Transparency faded quickly when the dye was washed off.

Someday, the concept could be used in doctors' offices and hospitals, Hong said. 

"Instead of relying on invasive biopsies, doctors might be able to diagnose deep-seated tumors by simply examining a person's tissue without the need for invasive surgical removal," he said. "This technique could potentially make blood draws less painful by helping phlebotomists easily locate veins under the skin. It could also enhance procedures like laser tattoo removal by allowing more precise targeting of the pigment beneath the skin."

From Cake Frosting to Research

Yellow 5 food dye can be found in everything from cereal, soda, spices, and cake frosting to lipstick, mouthwash, shampoo, dietary supplements, and house paint. Although it's in some topical medications, more research is needed before it could be used in human diagnostics, said Christopher J. Rowlands, PhD, a senior lecturer in the Department of Bioengineering at Imperial College London, UK, where he studies biophotonic instrumentation — ways to image structures inside the body more quickly and clearly. 

But the finding could prove useful in research. In a commentary published in Science, Rowlands and his colleague Jon Gorecki, PhD, an experimental optical physicist also at Imperial College London, note that the dye could be an alternative to other optical clearing agents currently used in lab studies, such as glycerol, fructose, or acetic acid. Advantages are the effect is reversible and works at lower concentrations with fewer side effects. This could broaden the types of studies possible in lab animals, so researchers don't have to rely on naturally transparent creatures like nematodes and zebrafish. 

The dye could also be paired with imaging techniques such as magnetic resonance imaging (MRI) or electron microscopy. 

"Imaging techniques all have pros and cons," Rowlands said. "MRI can see all the way through the body albeit with limited resolution and contrast. Electron microscopy has excellent resolution but limited compatibility with live tissue and penetration depth. Optical microscopy has subcellular resolution, the ability to label things, excellent biocompatibility but less than 1 millimeter of penetration depth. This clearing method will give a substantial boost to optical imaging for medicine and biology."

The discovery could improve the depth imaging equipment can achieve by tenfold, according to the commentary. 

Brain research especially stands to benefit. "Neurobiology in particular will have great use for combinations of multiphoton, optogenetics, and tissue clearing to record and control neural activity over (potentially) the whole mouse brain," he said.

Refraction, Absorption, The Invisible Man

The dye discovery has distant echoes in H.G. Wells' 1897 novel The Invisible Man, Rowlands noted. In the book, a serum makes the main character invisible by changing the light scattering — or refractive index (RI) — of his cells to match the air around him.

The Stanford engineers looked to the past for inspiration, but not to fiction. They turned to a concept first described in the 1920s called the Kramers-Kronig relations, a mathematical principle that can be applied to relationships between the way light is refracted and absorbed in different materials. They also read up on Lorentz oscillation, which describes how electrons and atoms inside molecules react to light. 

They reasoned that light-absorbing compounds could equalize the differences between the light-scattering properties of proteins, lipids, and water that make skin opaque. 

With that, the search was on. The study's first author, postdoctoral researcher Zihao Ou, PhD, began testing strong dyes to find a candidate. Tartrazine was a front-runner. 

"We found that dye molecules are more efficient in raising the refractive index of water than conventional RI-matching agents, thus resulting in transparency at a much lower concentration," Huong said. "The underlying physics, explained by the Lorentz oscillator model and Kramers-Kronig relations, reveals that conventional RI matching agents like fructose are not as efficient because they are not 'colored' enough."

What's Next

Though the dye is already in products that people consume and apply to their skin, medical use is years away. In some people, tartrazine can cause skin or respiratory reactions. 

The National Science Foundation (NSF), which helped fund the research, posted a home or classroom activity related to the work on its website. It involves painting a tartrazine solution on a thin slice of raw chicken breast, making it transparent. The experiment should only be done while wearing a mask, eye protection, lab coat, and lab-quality nitrile gloves for protection, according to the NSF.

Meanwhile, Huong said his lab is looking for new compounds that will improve visibility through transparent skin, removing a red tone seen in the current experiments. And they're looking for ways to induce cells to make their own "see-through" compounds. 

"We are exploring methods for cells to express intensely absorbing molecules endogenously, enabling genetically encoded tissue transparency in live animals," he said.

https://www.medscape.com/viewarticle/not-kidding-yellow-dye-5-may-be-key-invisibility-2024a1000g75

'Brain Network Significantly Larger in People with Depression, Even in Childhood'

 Researchers have discovered that a brain network involved in reward processing and attention to stimuli is markedly bigger in people with depression, remains stable over time, is unaffected by mood changes, and can be detected in children before onset of depression symptoms.

Using a novel brain-mapping technique, researchers found that the frontostriatal salience network was expanded nearly twofold in the brains of most individuals studied with depression compared with controls.

"This expansion in cortex was trait-like, meaning it was stable over time and did not change as symptoms changed over time," lead author Charles Lynch, PhD, assistant professor of neuroscience, Department of Psychiatry, Weill Cornell Medicine in New York, told Medscape Medical News.

It could also be detected in children who later developed depression, suggesting it may serve as a biomarker of depression risk. Investigators said the findings could aid in prevention and early detection of depression, as well as the development of more personalized treatment.

The study was published online on September 4 in Nature.

Prewired for Depression?

Precision functional mapping is a relatively new approach to brain mapping in individuals that uses large amounts of fMRI data from hours of scans per person. The technique has been used to show differences in brain networks between and in healthy individuals but had not been used to study brain networks in people with depression.

"We leveraged our large longitudinal datasets — with many hours of functional MRI scanning per subject — to construct individual-specific maps of functional brain networks in each patient using precision functional mapping, instead of relying on group average," Lynch said.

In the primary analysis of 141 adults with major depression and 37 healthy controls, the frontostriatal salience network — which is involved in reward processing and attention to internal and external stimuli — was markedly larger in these individuals with depression.

"This is one of the first times these kinds of personalized maps have been created in individuals with depression, and this is how we first observed of the salience network being larger in individuals with depression," Lynch said.

In four of the six individuals, the salience network was expanded more than twofold, outside the range observed in all 37 healthy controls. On average, the salience network occupied 73% more of the cortical surface relative to the average in healthy controls.

The findings were replicated using independent samples of repeatedly sampled individuals with depression and in large-scale group average data.

The expansion of the salience network did not change over time and was unaffected by changes in mood state.

"These observations led us to propose that instead of driving changes in depressive symptoms over time, salience network expansion may be a stable marker of risk for developing depression," the study team wrote.

An analysis of brain scans from 57 children who went on to develop depressive symptoms during adolescence and an equal number of children who did not develop depressive symptoms supports this theory.

On average, the salience network occupied roughly 36% more of cortex in the children with no current or previous symptoms of depression at the time of their fMRI scans but who subsequently developed clinically significant symptoms of depression, relative to children with no depressive symptoms at any study time point, the researchers found.

Immediate Clinical Impact?

Reached for comment, Shaheen Lakhan, MD, PhD, neurologist and researcher based in Miami, said this research "exemplifies the promising intersection of neurology and digital health, where advanced neuroimaging and data-driven approaches can transform mental health care into a more precise and individualized practice," Lakhan told Medscape Medical News. "By identifying this brain network expansion, we're unlocking new possibilities for precision medicine in mental health."

Lakhan, who wasn't involved in this research, said identifying the expansion of the frontostriatal salience network in individuals with depression opens new avenues for developing novel therapeutics.

"By targeting this network through neuromodulation techniques like deep brain stimulation, transcranial magnetic stimulation, and prescription digital therapeutics, treatments can be more precisely tailored to individual neurobiological profiles," Lakhan said. "Additionally, this network expansion could serve as a biomarker for early detection, allowing for preventative strategies or personalized treatment plans, particularly for those at risk of developing depression."

In addition, a greater understanding of the mechanisms driving salience network expansion offers potential for discovering new pharmacological targets, Lakhan noted.

"Drugs that modulate synaptic plasticity or network connectivity might be developed to reverse or mitigate these neural changes. The findings also support the use of longitudinal monitoring to predict and preempt symptom emergence, improving outcomes through timely intervention. This research paves the way for more personalized, precise, and proactive approaches in treating depression," Lakhan concluded.

Also weighing in, Teddy Akiki, MD, with the Department of Psychiatry and Behavioral Sciences at Stanford Medicine in California, noted that the effect size of the frontostriatal salience network difference in depression is "remarkably larger than typically seen in neuroimaging studies of depression, which often describe subtle differences. The consistency across multiple datasets and across time at the individual level adds significant weight to these findings, suggesting that it is a trait marker rather than a state-dependent marker."

"The observation that this expansion is present even before the onset of depressive symptoms in adolescence suggests its potential as a biomarker for depression risk," Akiki told Medscape Medical News. "This approach could lead to earlier identification of at-risk individuals and potentially inform the development of targeted preventive interventions."

He cautioned that it remains to be seen whether interventions targeting the salience network can effectively prevent or treat depression.

This research was supported in part by the National Institute of Mental Health, the National Institute on Drug Addiction, the Hope for Depression Research Foundation and the Foundation for OCD Research. Lynch and coauthor Conor Liston are listed as inventors for Cornell University patent applications on neuroimaging biomarkers for depression which are pending or in preparation. Liston has served as a scientific advisor or consultant to Compass Pathways PLC, Delix Therapeutics, and Brainify.AI. Lakhan and Akiki had no relevant disclosures.

https://www.medscape.com/viewarticle/brain-network-significantly-larger-people-depression-even-2024a1000g6b

Attributing Patients' Conditions to 'Old Age'

 "I can't tell my patients the truth any longer because they get upset, as if I were insulting them."

This is what a colleague of mine said after his 85-year-old patient, whom I will call Kathy*, expressed dissatisfaction with the office visit. Attributing her knee pain to degenerative joint disease and explaining that this is a common occurrence "later in life" was apparently perceived as a slight. The x-ray report, clearly documenting the changes of arthritis, was not enough to satisfy Kathy who, reportedly, could not understand why her symptoms or condition should be attributed "just to old age." She was tired of hearing that so many of her ailments were part of the aging process.

I'm not foreign to this type of interaction, where patients seem to reject that physical and cognitive decline are expected with aging. Perhaps they are just in profound denial regarding the effects of age. Although the aging process differs significantly from person to person, it seems disingenuous that our patients could believe that age will have little to no effect on their functional abilities. "No one wants to admit they're old," my colleague concluded.

So, what's the best way to communicate with older adults about their age-related health conditions?

Reconciling a History of Ageism With an Aging Population

Society and nature are not kind toward elderly people. Ageism is a reality. Suffice to mention the recent dispute ignited by President Joe Biden's performance at the presidential debate with former President Donald Trump. Although some concerns were certainly legitimate, there is no doubt in my mind that the controversy was also spurred by the many prejudices against older adults.

The term "ageism" was coined in 1969opens in a new tab or window by Robert Neil Butler, MD, to describe discrimination against seniors. In a society obsessed with youth and beauty, ageist beliefs against older adults are commonplace, leading to derogatory attitudes, rejection, and isolation.

Long lives are our new normal, thanks in large part to modern medicine, with all the advancements in therapeutics and technology and improved living conditions. But long lives are not necessarily happy and fulfilling lives. A dear patient of mine, who was in her mid-80s and lived at home with her 93-year-old husband, always used to say, "The Golden Age is not so golden."

The optimistic scenarios of pro-aging writers, although inspiring, often don't account for the progressive and unpredictable nature of human frailty. Aging is a complex biological process caused by many co-conspirators: nuclear and mitochondrial DNA damage, progressive telomere shortening, defective DNA repair pathways, and cellular senescence, leading to unavoidable tissue and organ atrophy, with resulting loss of function. Many factors, including lifestyle, can have a positive or negative impact on biological aging. But the bottom line is that the depredation of age cannot be avoided, unless people die young.

Help Patients Navigate, Not Deny, Their Age

How can we reconcile our desire to live longer with the challenges brought on by aging and by society's treatment of older people? Between the threat of ageism on one hand and the many betrayals of the golden years on the other, is anyone surprised that some people might oppose the suggestion that they are losing physical and cognitive capabilities due to old age?

I am not anymore. I used to be puzzled by what I perceived to be a lack of common sense, a form of unreasonable denial, and a bold disregard for the truth despite all the available evidence. I'm not puzzled any longer. I am concerned.

I have seen too many of my patients, including family members, launching into exhausting and wasteful quests to find answers to their ailments that do not include the word "age." Being labeled with a specific disease seems to provide some people with a more palatable and more socially acceptable excuse for their decline.

"They will keep on changing doctors until they hear what they want to hear," another colleague commented when his 84-year-old patient consulted several neurologists to find the answer to his declining motor skills. Eventually, an expert in the field told him that although nothing was found on physical exam, "You might have a mild case of Parkinson's disease. If you feel like the medications help you, take them." Aging wasn't mentioned at any point in time during the office visit.

The problem is that, far from providing psychological relief, these alternative diagnoses might eventually result in more anxiety and depression, an endless sequence of time-consuming tests and doctors' appointments, hence a diminished quality of life, not to mention escalating medical costs. These "maybe" diagnoses, made with a cavalier attitude, might even prompt families to push their loved ones toward alternative living arrangements and nursing home placement, and not always in good faith. Family dynamics and societal expectations are very complex. A neurodegenerative disorder might be seen as a socially more acceptable reason to put "pops" away than just old age.

We should never forget that we are our patients' best advocates. This requires an honest and objective assessment of our aging patients, and frank, realistic conversations with both the patients and their families. Aging can be a messy business and there is not a lot of grace in it. People can choose to ignore it and look for answers elsewhere, but we, as physicians, should not become part of the problem. Fueling the denial comes at a great cost to our patients and society.

Let us instead help our patients navigate older age with sound medical advice and great compassion.

*Patient's name has been changed for confidentiality.

Fabrizia Faustinella, MD, PhD,opens in a new tab or window is an internist and faculty member at Baylor College of Medicine in Houston. She is also a Doctors for America A. Gene Copello health advocacy fellow.

https://www.medpagetoday.com/opinion/second-opinions/111838

Tennessee Medical Board Refuses to Enforce New International Med Grad Law

 Members of the Tennessee Board of Medical Examiners felt they were locked in an impossibly tough spot.

They had to choose between defying a new state lawopens in a new tab or window -- one their legal counsel sternly advised them to enforce lest they face costly lawsuits -- or approving a licensing pathwayopens in a new tab or window for international medical graduates (IMGs) who had never practiced or trained in the U.S.

"What we have to have, legally, to comply with our General Assembly, is a way for these people to come submit their application," chief deputy general counsel David Silvius told members during its July 30 board meetingopens in a new tab or window. And if the board refuses to make that process available, "if (an applicant) decides they want to sue you, that's what they'll do. ... The law says these people are entitled to come ask for a license," he said.

But several board members expressed horror with their options. They said the new statute gives them little to no way to assess applicants' competence, as they have when physicians are trained in the U.S.

During a nearly 90-minute debate, some board members said that if they allowed foreign-trained doctors to get in the door with so few qualifications, they'd be allowing potentially incompetent physicians to harm patients.

"I am now in a medical ethical dilemma as to whether my hands are tied to give people who may not be qualified a license to practice ... to do something that is not in the safety, healthcare, best interests of my citizens," board member John J. McGraw, MD, an orthopedic surgeon, told Silvius. "And if I do, then I may need to resign."

"This is a novel license ... and we're the first (state) to do it," said board president Melanie Blake, MD, an internist. "You're asking us to basically abandon the ethical oath that we took to be here."

Blake added her concern that the statute, called Chapter 211, required these foreign applicants to check boxes, with limited mechanism for the board to verify what they claim.

"I'm a little worried also about a criminal background check when someone's been living abroad for years, and then they come here and we run a check, and it looks perfect," Blake said. "But we don't know what they were doing in Iceland, or Sweden, when they were, you know, practicing euthanasia or whatever, you know, I don't know what we can know about them."

And, she said, "you don't have to pass a single exam to get this license."

To Silvius' warning of liability if the new law was not observed, board member Todd Tillmanns, MD, an ob/gyn, shot back: "We're opening ourselves to liability if we think someone is coming here to practice medicine or otherwise and is not someone that is safe or is practicing in a way that could endanger people."

Applicants may say that, "because you lived in another country with 3 years of practice, and we have no documentation of it, that's legitimate? 'Come on in and practice medicine in the state of Tennessee.' This is what we're so upset about. And it's not because we're standing on high. It's because we're protecting people," Tillmanns said. "There's a reason it takes so long."

Ignoring the Law

After much back and forth, the board voted not to create an application form for IMGs to use, and defied their legislative mandate. It approved posting an explanation of its policy on its website with an FAQopens in a new tab or window, which simply says, "At this time, the Board does not have an application."

That has left at least 60 IMGs who heard about the new law and wanted to move their practices to Tennessee twisting in the wind, job agent Stephan Cloutier, who helps link physicians with employers throughout the country, told MedPage Today.

He said most of 60 clients are from India, "among the best physicians in the world. They are really, really, qualified candidates," who all have Educational Commission for Foreign Medical Graduates (ECFMGopens in a new tab or window) certification, which is now part of Inthealth.

If it were enforced, the current law, which took effect July 1, would require the IMG to show an offer of employment from a setting with a post-graduate training program accredited by the Accreditation Council for Graduate Medical Education.

The applicant also must meet one of these requirements, a key word being "or":

• Demonstrated competency as determined by the Tennessee board
• Completed a 3-year post-graduate training program in the graduate's licensing country, or
• Has otherwise practiced as a medical professional performing the duties of a physician for at least 3 of the last 5 years outside the U.S.

New Law Will Supersede Old One

Yarnell Beatty, senior vice president and general counsel for the Tennessee Medical Association, told MedPage Today his group was vehemently opposed to Chapter 211, "so much so that we lobbied heavily to get the law changed" -- and they succeeded.

Chapter 929opens in a new tab or window passed, but does not take effect until January 1, 2025.

In addition to changing the name of the license from "temporary license of limited duration" to "foreign training license," the new statute replaces the word "or" with the word "and," so IMGs have to qualify for each requirement.

Until then, the more lenient legislation remains in effect.

"We don't know where they come from. We don't know if they're, you know, from war-torn countries or third-world countries where training isn't, you know, up to the standards of the United States. We just don't know," Beatty said.

"There's got to be some way that you can measure minimum competency," he added.

Authors of the Senate and House versions of the original legislation, Sen. Kerry Roberts and Rep. Sabi 'Doc' Kumar, a retired surgeon, did not respond to repeated requests for comment on the reasons they sponsored the legislation.

One reason might be Tennessee's shortage of physicians, especially in primary care.

According to federal data, Tennessee ranked 44thopens in a new tab or window in the nation for overall health in 2019, and in 2020, nearly all of its counties (90 of 95) were federally designated primary care health professional shortage areas, a problem that has gotten worse. Federal dataopens in a new tab or window show widespread shortages of mental health and dental providers as well throughout the state.

One disappointed physician who was eager to practice in rural Tennessee is Bryant Morrison, MD, a U.S. citizen licensed to practice in Baja California in Mexico. He graduated from Universidad Autónoma de Guadalajara School of Medicine in June 2002 and completed an internship at the Hospital General de Zapopan in Jalisco, Mexico the following year.

His Mexicali clinic has a contract to treat employees of Imperial County, California, who travel across the border for their care.

"It was incredulous that the board voted against providing an online application form even after being legally advised to do so by their own general counsel," Morrison told MedPage Today.

In foreign countries, he continued, general practitioners usually only complete a 1-year rotating internship prior to getting licensed and going to work, "similar to what many osteopathic physicians currently do in many rural communities in the United States."

Now, he said, foreign licensed physicians like himself must have completed a residency of at least 3 years in addition to 3 years of practice experience. That, he said, "will preclude general practitioners such as myself who have only completed a 1-year internship from participating and obtaining provisional licensure."

This requirement "will most likely limit the applicant pool resulting in very few foreign physicians coming to the state," he said.

Many foreign-educated physicians messaged MedPage Today saying they, too, were excited about a chance to practice in Tennessee, and now feel left in limbo. Most declined to allow their names or circumstances to be published out of concern it could endanger their job prospects.

https://www.medpagetoday.com/special-reports/exclusives/111837