For many years, sorafenib was the only FDA-approved systemic treatment for patients with uHCC. Initial case reports of remarkable responses of tumors to immunotherapy, and results of the Phase I/II CheckMate-040 clinical trial, led to the September 2017 FDA approval of nivolumab for the treatment of patients with uHCC after progression on sorafenib. Thereafter, several randomized clinical trials comparing sorafenib to immunotherapy and immunotherapy combinations were initiated, including the comparison of nivolumab to sorafenib. In June 2019 it was announced that this trial did not reach its prespecified endpoint, and the FDA approval for the uHCC indication was voluntarily withdrawn. In December 2021, Yau et al published the final results of the CheckMate-459 randomized trial that included 743 adult patients with advanced HCC randomly assigned to receive either nivolumab (n=371) or sorafenib (n=372) in the first line setting.  The primary endpoint was overall survival (OS) assessed in the intention-to-treat population. The median OS was 16.4 months (95% CI 13.9–18.4) with nivolumab and 14.7 months (11.9–17.2) with sorafenib (hazard ratio 0.85 [95% CI 0.72–1.02]; P = 0.075; minimum follow-up 22.8 months). Serious treatment-related adverse events were reported in 43 (12%) patients receiving nivolumab and 39 (11%) patients receiving sorafenib. The authors concluded that though first-line nivolumab treatment did not significantly improve OS compared with sorafenib, single-agent nivolumab might be considered a treatment option for patients in whom tyrosine kinase inhibitors or antiangiogenic drugs are not safe.

Cheng et al reported an update on the outcomes of the IMbrave150 study, 12 months after the primary analysis. This study established atezolizumab and bevacizumab as the current standard of care for the initial systemic treatment of patients with uHCC. The median OS was 19.2 months (95% CI 17.0-23.7) with atezolizumab/bevacizumab and 13.4 months (95% CI 11.4-16.9) with sorafenib (hazard ratio [HR], 0.66; 95% CI 0.52-0.85; descriptive P < 0.001). The overall response rate (ORR) was 30% with atezolizumab/bevacizumab, while treatment-related grade 3/4 adverse events occurred in 143 (43%) of 329 receiving atezolizumab/bevacizumab and 72 (46%) of 156 receiving sorafenib. Treatment-related grade 5 events occurred in 6 (2%) and 1 (<1%) patients. Therefore, atezolizumab/bevacizumab remains the first-line standard of care for patients with uHCC.

Finally, Jácome et al undertook a combined analysis of 3 randomized controlled trials (KEYNOTE-240, CheckMate-459, and IMbrave150), with 1,657 patients with uHCC and who were treated with either immunotherapy (n=985) or sorafenib (in the first-line setting) or placebo (in the sorafenib-refractory setting) (n=672). The conclusion of the meta-analysis was that checkpoint inhibitors were associated with superior OS (HR, 0.75; P = .006), progression-free survival (HR, 0.74; P = .03), and ORR (odds ratio [OR], 2.82; P < .001) and lower odds of grade 3 or 4 treatment-related adverse events (OR, 0.44; P = .04) than the comparators, confirming that immunotherapy remains an integral part of the treatment of patients with uHCC.

For many years, sorafenib was the only FDA-approved systemic treatment for patients with uHCC. Initial case reports of remarkable responses of tumors to immunotherapy, and results of the Phase I/II CheckMate-040 clinical trial, led to the September 2017 FDA approval of nivolumab for the treatment of patients with uHCC after progression on sorafenib. Thereafter, several randomized clinical trials comparing sorafenib to immunotherapy and immunotherapy combinations were initiated, including the comparison of nivolumab to sorafenib. In June 2019 it was announced that this trial did not reach its prespecified endpoint, and the FDA approval for the uHCC indication was voluntarily withdrawn. In December 2021, Yau et al published the final results of the CheckMate-459 randomized trial that included 743 adult patients with advanced HCC randomly assigned to receive either nivolumab (n=371) or sorafenib (n=372) in the first line setting.  The primary endpoint was overall survival (OS) assessed in the intention-to-treat population. The median OS was 16.4 months (95% CI 13.9–18.4) with nivolumab and 14.7 months (11.9–17.2) with sorafenib (hazard ratio 0.85 [95% CI 0.72–1.02]; P = 0.075; minimum follow-up 22.8 months). Serious treatment-related adverse events were reported in 43 (12%) patients receiving nivolumab and 39 (11%) patients receiving sorafenib. The authors concluded that though first-line nivolumab treatment did not significantly improve OS compared with sorafenib, single-agent nivolumab might be considered a treatment option for patients in whom tyrosine kinase inhibitors or antiangiogenic drugs are not safe.

Cheng et al reported an update on the outcomes of the IMbrave150 study, 12 months after the primary analysis. This study established atezolizumab and bevacizumab as the current standard of care for the initial systemic treatment of patients with uHCC. The median OS was 19.2 months (95% CI 17.0-23.7) with atezolizumab/bevacizumab and 13.4 months (95% CI 11.4-16.9) with sorafenib (hazard ratio [HR], 0.66; 95% CI 0.52-0.85; descriptive P < 0.001). The overall response rate (ORR) was 30% with atezolizumab/bevacizumab, while treatment-related grade 3/4 adverse events occurred in 143 (43%) of 329 receiving atezolizumab/bevacizumab and 72 (46%) of 156 receiving sorafenib. Treatment-related grade 5 events occurred in 6 (2%) and 1 (<1%) patients. Therefore, atezolizumab/bevacizumab remains the first-line standard of care for patients with uHCC.

Finally, Jácome et al undertook a combined analysis of 3 randomized controlled trials (KEYNOTE-240, CheckMate-459, and IMbrave150), with 1,657 patients with uHCC and who were treated with either immunotherapy (n=985) or sorafenib (in the first-line setting) or placebo (in the sorafenib-refractory setting) (n=672). The conclusion of the meta-analysis was that checkpoint inhibitors were associated with superior OS (HR, 0.75; P = .006), progression-free survival (HR, 0.74; P = .03), and ORR (odds ratio [OR], 2.82; P < .001) and lower odds of grade 3 or 4 treatment-related adverse events (OR, 0.44; P = .04) than the comparators, confirming that immunotherapy remains an integral part of the treatment of patients with uHCC.

For many years, sorafenib was the only FDA-approved systemic treatment for patients with uHCC. Initial case reports of remarkable responses of tumors to immunotherapy, and results of the Phase I/II CheckMate-040 clinical trial, led to the September 2017 FDA approval of nivolumab for the treatment of patients with uHCC after progression on sorafenib. Thereafter, several randomized clinical trials comparing sorafenib to immunotherapy and immunotherapy combinations were initiated, including the comparison of nivolumab to sorafenib. In June 2019 it was announced that this trial did not reach its prespecified endpoint, and the FDA approval for the uHCC indication was voluntarily withdrawn. In December 2021, Yau et al published the final results of the CheckMate-459 randomized trial that included 743 adult patients with advanced HCC randomly assigned to receive either nivolumab (n=371) or sorafenib (n=372) in the first line setting.  The primary endpoint was overall survival (OS) assessed in the intention-to-treat population. The median OS was 16.4 months (95% CI 13.9–18.4) with nivolumab and 14.7 months (11.9–17.2) with sorafenib (hazard ratio 0.85 [95% CI 0.72–1.02]; P = 0.075; minimum follow-up 22.8 months). Serious treatment-related adverse events were reported in 43 (12%) patients receiving nivolumab and 39 (11%) patients receiving sorafenib. The authors concluded that though first-line nivolumab treatment did not significantly improve OS compared with sorafenib, single-agent nivolumab might be considered a treatment option for patients in whom tyrosine kinase inhibitors or antiangiogenic drugs are not safe.

Cheng et al reported an update on the outcomes of the IMbrave150 study, 12 months after the primary analysis. This study established atezolizumab and bevacizumab as the current standard of care for the initial systemic treatment of patients with uHCC. The median OS was 19.2 months (95% CI 17.0-23.7) with atezolizumab/bevacizumab and 13.4 months (95% CI 11.4-16.9) with sorafenib (hazard ratio [HR], 0.66; 95% CI 0.52-0.85; descriptive P < 0.001). The overall response rate (ORR) was 30% with atezolizumab/bevacizumab, while treatment-related grade 3/4 adverse events occurred in 143 (43%) of 329 receiving atezolizumab/bevacizumab and 72 (46%) of 156 receiving sorafenib. Treatment-related grade 5 events occurred in 6 (2%) and 1 (<1%) patients. Therefore, atezolizumab/bevacizumab remains the first-line standard of care for patients with uHCC.

Finally, Jácome et al undertook a combined analysis of 3 randomized controlled trials (KEYNOTE-240, CheckMate-459, and IMbrave150), with 1,657 patients with uHCC and who were treated with either immunotherapy (n=985) or sorafenib (in the first-line setting) or placebo (in the sorafenib-refractory setting) (n=672). The conclusion of the meta-analysis was that checkpoint inhibitors were associated with superior OS (HR, 0.75; P = .006), progression-free survival (HR, 0.74; P = .03), and ORR (odds ratio [OR], 2.82; P < .001) and lower odds of grade 3 or 4 treatment-related adverse events (OR, 0.44; P = .04) than the comparators, confirming that immunotherapy remains an integral part of the treatment of patients with uHCC.

Artificial intelligence (AI) performs as well as expert uropathologists – and in some cases better than general pathologists – in diagnosing and grading prostate cancer, suggests a new study.

AI has shown promise in the diagnosis and grading of prostate cancer. However studies so far have been siloed, “with limited proof for generalization across diverse multinational cohorts, representing one of the central barriers to implementation of AI algorithms in clinical practice,” the investigators wrote in Nature Medicine.

Wouter Bulten, from the Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands, and coauthors reported the outcomes of the international PANDA histopathology competition, in which 1,290 deep learning algorithm developers were challenged to come up with reproducible algorithms that could match the findings of human experts. Deep learning is a form of machine learning in which artificial neural networks “learn” from large datasets and apply that learning in a similar way to the human brain. At least one AI product for detecting prostate cancer – the Paige Prostate system – has already been approved for clinical use in the United States. The Food and Drug Administration authorized marketing it in September 2021, as an adjunct to – but not replacement for – pathologist review.

The developers of the new algorithms participating in the competition were given a set of 10,616 digitized prostate biopsies to learn from, then were tested against a panel of either one to six – depending on the country – experienced uropathologists on a set of 393 digitized slides. A selection of 15 teams were then invited to take part in a validation phase with an additional 1,616 slides.

Within the first 10 days of the competition, one algorithm already achieved greater than 0.90 agreement with the uropathologists; by day 33, the median performance of all the teams in the competition was greater than 0.85 agreement with the human experts.
 

Algorithms correctly detected tumors in 99.7% of cases

The algorithms selected for validation showed even higher levels of agreement – 0.931 on average (95% confidence interval, 0.918-0.944). These algorithms correctly detected tumors in 99.7% of cases (95% CI, 98.1%-99.7%), and correctly identified 92.9% of negative results (95% CI, 91.9%-96.7%).

When it came to classifying the prostate cancers based on Gleason grade, the algorithms showed significantly more agreement with uropathologists than did an international panel of 13 or 20 general pathologists.

“This higher sensitivity shows promise for reducing pathologist workload by automated identification and exclusion of most benign biopsies from review,” the authors wrote.

The study found that the AI algorithms missed 1%-1.9% of cancers, but the general pathologists missed 1.8%-7.3%. The algorithms demonstrated a sensitivity of 96.4%-98.2% and specificity of 75%-100% for tumors, whereas the pathologists showed a sensitivity of 91.9-96.5% and specificity of 92.3%-95%.
 

Benign cases were misclassified

The main error that the algorithms made was misclassifying benign cases as ISUP GG 1 cancer. The authors commented that this was likely caused by a shift in the distribution of cases between the training data given to the algorithms and the data set they were validated on.

They also noted that, in one validation set, the algorithms overgraded a “substantial proportion” of ISUP GG 3 cases as GG 4, whereas general pathologists tended to undergrade cases, particularly in the higher-grade cancers.

“These differences suggest that general pathologists supported by AI could reach higher agreements with uropathologists, potentially alleviating some of the rater variability associated with Gleason grading,” they wrote.

The authors also pointed out that the algorithms were validated on individual biopsies from each patient, whereas in the clinical context, a pathologist would likely have multiple biopsies from a single patient.

“Future studies can focus on patient-level evaluation of tissue samples, taking multiple cores and sections into account for the final diagnosis,” they wrote.

The study was supported by the Dutch Cancer Society, Netherlands Organization for Scientific Research, Google, Verily Life Sciences, Swedish Research Council, Swedish Cancer Society, Swedish eScience Research Center, EIT Health, Karolinska Institutet, Åke Wiberg Foundation, Prostatacancerförbundet, Academy of Finland, Cancer Foundation Finland, and ERAPerMed. The authors declared a range of grants and funding outside the study, including from Philips Digital Pathology Solutions. Several authors declared patents related to prostate cancer diagnoses, and 10 were employees of Google.

Artificial intelligence (AI) performs as well as expert uropathologists – and in some cases better than general pathologists – in diagnosing and grading prostate cancer, suggests a new study.

AI has shown promise in the diagnosis and grading of prostate cancer. However studies so far have been siloed, “with limited proof for generalization across diverse multinational cohorts, representing one of the central barriers to implementation of AI algorithms in clinical practice,” the investigators wrote in Nature Medicine.

Wouter Bulten, from the Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands, and coauthors reported the outcomes of the international PANDA histopathology competition, in which 1,290 deep learning algorithm developers were challenged to come up with reproducible algorithms that could match the findings of human experts. Deep learning is a form of machine learning in which artificial neural networks “learn” from large datasets and apply that learning in a similar way to the human brain. At least one AI product for detecting prostate cancer – the Paige Prostate system – has already been approved for clinical use in the United States. The Food and Drug Administration authorized marketing it in September 2021, as an adjunct to – but not replacement for – pathologist review.

The developers of the new algorithms participating in the competition were given a set of 10,616 digitized prostate biopsies to learn from, then were tested against a panel of either one to six – depending on the country – experienced uropathologists on a set of 393 digitized slides. A selection of 15 teams were then invited to take part in a validation phase with an additional 1,616 slides.

Within the first 10 days of the competition, one algorithm already achieved greater than 0.90 agreement with the uropathologists; by day 33, the median performance of all the teams in the competition was greater than 0.85 agreement with the human experts.
 

Algorithms correctly detected tumors in 99.7% of cases

The algorithms selected for validation showed even higher levels of agreement – 0.931 on average (95% confidence interval, 0.918-0.944). These algorithms correctly detected tumors in 99.7% of cases (95% CI, 98.1%-99.7%), and correctly identified 92.9% of negative results (95% CI, 91.9%-96.7%).

When it came to classifying the prostate cancers based on Gleason grade, the algorithms showed significantly more agreement with uropathologists than did an international panel of 13 or 20 general pathologists.

“This higher sensitivity shows promise for reducing pathologist workload by automated identification and exclusion of most benign biopsies from review,” the authors wrote.

The study found that the AI algorithms missed 1%-1.9% of cancers, but the general pathologists missed 1.8%-7.3%. The algorithms demonstrated a sensitivity of 96.4%-98.2% and specificity of 75%-100% for tumors, whereas the pathologists showed a sensitivity of 91.9-96.5% and specificity of 92.3%-95%.
 

Benign cases were misclassified

The main error that the algorithms made was misclassifying benign cases as ISUP GG 1 cancer. The authors commented that this was likely caused by a shift in the distribution of cases between the training data given to the algorithms and the data set they were validated on.

They also noted that, in one validation set, the algorithms overgraded a “substantial proportion” of ISUP GG 3 cases as GG 4, whereas general pathologists tended to undergrade cases, particularly in the higher-grade cancers.

“These differences suggest that general pathologists supported by AI could reach higher agreements with uropathologists, potentially alleviating some of the rater variability associated with Gleason grading,” they wrote.

The authors also pointed out that the algorithms were validated on individual biopsies from each patient, whereas in the clinical context, a pathologist would likely have multiple biopsies from a single patient.

“Future studies can focus on patient-level evaluation of tissue samples, taking multiple cores and sections into account for the final diagnosis,” they wrote.

The study was supported by the Dutch Cancer Society, Netherlands Organization for Scientific Research, Google, Verily Life Sciences, Swedish Research Council, Swedish Cancer Society, Swedish eScience Research Center, EIT Health, Karolinska Institutet, Åke Wiberg Foundation, Prostatacancerförbundet, Academy of Finland, Cancer Foundation Finland, and ERAPerMed. The authors declared a range of grants and funding outside the study, including from Philips Digital Pathology Solutions. Several authors declared patents related to prostate cancer diagnoses, and 10 were employees of Google.

Artificial intelligence (AI) performs as well as expert uropathologists – and in some cases better than general pathologists – in diagnosing and grading prostate cancer, suggests a new study.

AI has shown promise in the diagnosis and grading of prostate cancer. However studies so far have been siloed, “with limited proof for generalization across diverse multinational cohorts, representing one of the central barriers to implementation of AI algorithms in clinical practice,” the investigators wrote in Nature Medicine.

Wouter Bulten, from the Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands, and coauthors reported the outcomes of the international PANDA histopathology competition, in which 1,290 deep learning algorithm developers were challenged to come up with reproducible algorithms that could match the findings of human experts. Deep learning is a form of machine learning in which artificial neural networks “learn” from large datasets and apply that learning in a similar way to the human brain. At least one AI product for detecting prostate cancer – the Paige Prostate system – has already been approved for clinical use in the United States. The Food and Drug Administration authorized marketing it in September 2021, as an adjunct to – but not replacement for – pathologist review.

The developers of the new algorithms participating in the competition were given a set of 10,616 digitized prostate biopsies to learn from, then were tested against a panel of either one to six – depending on the country – experienced uropathologists on a set of 393 digitized slides. A selection of 15 teams were then invited to take part in a validation phase with an additional 1,616 slides.

Within the first 10 days of the competition, one algorithm already achieved greater than 0.90 agreement with the uropathologists; by day 33, the median performance of all the teams in the competition was greater than 0.85 agreement with the human experts.
 

Algorithms correctly detected tumors in 99.7% of cases

The algorithms selected for validation showed even higher levels of agreement – 0.931 on average (95% confidence interval, 0.918-0.944). These algorithms correctly detected tumors in 99.7% of cases (95% CI, 98.1%-99.7%), and correctly identified 92.9% of negative results (95% CI, 91.9%-96.7%).

When it came to classifying the prostate cancers based on Gleason grade, the algorithms showed significantly more agreement with uropathologists than did an international panel of 13 or 20 general pathologists.

“This higher sensitivity shows promise for reducing pathologist workload by automated identification and exclusion of most benign biopsies from review,” the authors wrote.

The study found that the AI algorithms missed 1%-1.9% of cancers, but the general pathologists missed 1.8%-7.3%. The algorithms demonstrated a sensitivity of 96.4%-98.2% and specificity of 75%-100% for tumors, whereas the pathologists showed a sensitivity of 91.9-96.5% and specificity of 92.3%-95%.
 

Benign cases were misclassified

The main error that the algorithms made was misclassifying benign cases as ISUP GG 1 cancer. The authors commented that this was likely caused by a shift in the distribution of cases between the training data given to the algorithms and the data set they were validated on.

They also noted that, in one validation set, the algorithms overgraded a “substantial proportion” of ISUP GG 3 cases as GG 4, whereas general pathologists tended to undergrade cases, particularly in the higher-grade cancers.

“These differences suggest that general pathologists supported by AI could reach higher agreements with uropathologists, potentially alleviating some of the rater variability associated with Gleason grading,” they wrote.

The authors also pointed out that the algorithms were validated on individual biopsies from each patient, whereas in the clinical context, a pathologist would likely have multiple biopsies from a single patient.

“Future studies can focus on patient-level evaluation of tissue samples, taking multiple cores and sections into account for the final diagnosis,” they wrote.

The study was supported by the Dutch Cancer Society, Netherlands Organization for Scientific Research, Google, Verily Life Sciences, Swedish Research Council, Swedish Cancer Society, Swedish eScience Research Center, EIT Health, Karolinska Institutet, Åke Wiberg Foundation, Prostatacancerförbundet, Academy of Finland, Cancer Foundation Finland, and ERAPerMed. The authors declared a range of grants and funding outside the study, including from Philips Digital Pathology Solutions. Several authors declared patents related to prostate cancer diagnoses, and 10 were employees of Google.

Health care’s modern-day version of the Greek chorus is growing louder and more persistent. My colleagues and I have long been among them.

In news conferences, journal articles, and podcasts, this chorus is pleading with the public to pay attention to its message: SARs-CoV-2 is not done with us. Omicron can kill; it can infect the vaccinated.

We have found, like everyone else, that Omicron runs on its rules; with Delta, two vaccine shots were able to lower the positivity rate. With Omicron, two shots have not been enough.

The WHO used the word “surprise” in its November announcement that Omicron was a variant of “concern.”

So did Trevor Bedford, a computational biologist and infectious disease scientist at the Fred Hutchinson Cancer Center in Seattle, who said that Omicron “took me and everyone by surprise.”¹ Speaking on KevinMD’s podcast, he told his host that with the degree of immunity in the global population, he was expecting subsequent evolving strains to have minor, subtle genetic mutations, akin to how flu varies from year to year. What was a surprise was the giant leap in evolution that occurred with Omicron, which contains 36 mutations in the spike protein and approximately 50 mutations in total. Because of these mutations, the original two-shot mRNA COVID vaccines becomes only 40% effective against symptomatic disease after several months (thankfully a booster shot increases this to ~80%).² But the decreased vaccine protection without a booster, along with relaxation of mitigation measures, brought us to where we are now.

In Chicago, we knew the Omicron variant would move quickly, considering how it moved through South Africa and the United Kingdom. What we didn’t anticipate was that in one week’s time, our hospital would need to add another 100 dedicated COVID ICU beds. Nor did we anticipate the extent that Omicron would affect staffing levels in the same amount of time.

At our hospital, we have eliminated elective surgeries that require a hospital stay, which includes surgeries for cancer. One of my colleagues, Ryan Merkow, MD, a surgical oncologist, remarked recently he had to cancel half of his scheduled surgeries because of a lack of hospital space.³

Dispelling Myths

What is concerning about this current wave is how many unvaccinated are hospitalized. Because Omicron is so infectious and because of lower vaccination rates in younger adults and children, we have a younger group of adults and children admitted with COVID, who had been uninfected by previous surges.

A major myth that makes health care workers so frustrated is the tale that Omicron is milder. Unvaccinated people infected with this variant are seriously ill and are dying. Despite its “mild” label, once a patient is hospitalized, Omicron can be just as severe as its predecessors.⁴ For many, getting vaccinated is the difference between staying at home with some symptoms and being in the ICU.

As of January 10, according to the CDC, although 88% of people over the age of 65 are vaccinated, only 37.5% have gotten boosters which are key to restoring protection against Omicron. And among children, only 54% between 12- and 17-years-old are fully vaccinated, and a mere 17% of children aged 5 to 11 have gotten both of their shots.

Remember the conversations regarding natural immunity? Omicron has muffled that conversation. Those who have been infected with SARS-Co-V2 before can still get infected and very ill with Omicron. So now is the time to get vaccinated.

Transmissibility

We knew SARS-CoV-2 could spread 1 of 2 ways: large virus-carrying droplets that enter through the nose, mouth, and eyes, as well as miniscule airborne droplets of virus that float in the air and travel further than 6 feet. However, prior to Omicron, transmission of these smaller droplets via the air was not as frequent. But with Omicron, while it still travels by larger respiratory droplets, it appears to have more airborne spread.

In late December, The Lancet Regional Health published results of research conducted one month earlier at a designated quarantine hotel in Hong Kong.⁵ The index case was housed in the room across a hallway from the second case, who developed their case 8 days into quarantine. Testing showed the Omicron variant in both cases. Environmental testing of the walls and ceiling suggested airborne spread of the virus in places unreachable by large respiratory droplets.

Now with Omicron, people need to wear high-filtering masks that fit tight against the face, such as a N95, KN-95, or KF-94 if possible. And when removing the mask to eat and drink, one should be in well-ventilated areas, away from others.

People should avoid getting Omicron, regardless of vaccination status. This variant is so infectious that, compared to the Delta variant, people are twice as likely to infect others that live with them. And infecting others leads to a chain of transmission that can close schools, take over hospital beds, and disable or kill the most vulnerable in our communities.

Public and private behavior, and public policy

In July, months before that WHO announced Omicron’s existence, Rella and colleagues reported in Scientific Reports on the outcome of a new model designed to show how a vaccine-resistant strain could rapidly transmit through a highly vaccinated population if transmission mitigation interventions are dropped too soon.⁶

The authors wrote that the success of a vaccine-resistant strain making inroads into a population depends on the obvious – it finds populations with a low rate of vaccination. What is not so obvious, the authors wrote, is that a vaccine-resistant virus does its worst when transmission is not well controlled in a highly vaccinated population. What can prevent a surge like this are social behaviors and public policy that decrease the chain of transmission of SARS-CoV-2, such as vaccination, masking, and testing.

It is people’s behavior, and ineffective public policy, that are so frustrating to us. The WHO’s secretary general warned against relying solely on vaccines in December. “Vaccines alone will not get any country out of this crisis.”

Omicron takes a new mindset. What we were doing before is not protecting now. Unchecked spread is overwhelming our health care systems and putting the vulnerable in our population at risk. The ramification of this unchecked spread reaches everywhere – into the economy, our educational system, and our nation’s mental health.

When the pandemic started, the policies to control its spread rested on local government and public agencies; we all would have been better served had there been a unified, national response to an infectious threat that does not obey municipal or state boundaries.

 The universal sentiment among health care workers is frustration with local and state governments that are either dictating policy that can harm the public we are trying to protect.

As of September, at least 23 state legislatures have passed laws changing a governor’s executive power reach. Many have taken it away. Others are fighting in the courts over mask mandates.

As for when the pandemic will subside, that appears to be up to the public and public policy makers. They will determine how long this will last and how many will die or be disabled before its end.

Health care’s modern-day version of the Greek chorus is growing louder and more persistent. My colleagues and I have long been among them.

In news conferences, journal articles, and podcasts, this chorus is pleading with the public to pay attention to its message: SARs-CoV-2 is not done with us. Omicron can kill; it can infect the vaccinated.

We have found, like everyone else, that Omicron runs on its rules; with Delta, two vaccine shots were able to lower the positivity rate. With Omicron, two shots have not been enough.

The WHO used the word “surprise” in its November announcement that Omicron was a variant of “concern.”

So did Trevor Bedford, a computational biologist and infectious disease scientist at the Fred Hutchinson Cancer Center in Seattle, who said that Omicron “took me and everyone by surprise.”¹ Speaking on KevinMD’s podcast, he told his host that with the degree of immunity in the global population, he was expecting subsequent evolving strains to have minor, subtle genetic mutations, akin to how flu varies from year to year. What was a surprise was the giant leap in evolution that occurred with Omicron, which contains 36 mutations in the spike protein and approximately 50 mutations in total. Because of these mutations, the original two-shot mRNA COVID vaccines becomes only 40% effective against symptomatic disease after several months (thankfully a booster shot increases this to ~80%).² But the decreased vaccine protection without a booster, along with relaxation of mitigation measures, brought us to where we are now.

In Chicago, we knew the Omicron variant would move quickly, considering how it moved through South Africa and the United Kingdom. What we didn’t anticipate was that in one week’s time, our hospital would need to add another 100 dedicated COVID ICU beds. Nor did we anticipate the extent that Omicron would affect staffing levels in the same amount of time.

At our hospital, we have eliminated elective surgeries that require a hospital stay, which includes surgeries for cancer. One of my colleagues, Ryan Merkow, MD, a surgical oncologist, remarked recently he had to cancel half of his scheduled surgeries because of a lack of hospital space.³

Dispelling Myths

What is concerning about this current wave is how many unvaccinated are hospitalized. Because Omicron is so infectious and because of lower vaccination rates in younger adults and children, we have a younger group of adults and children admitted with COVID, who had been uninfected by previous surges.

A major myth that makes health care workers so frustrated is the tale that Omicron is milder. Unvaccinated people infected with this variant are seriously ill and are dying. Despite its “mild” label, once a patient is hospitalized, Omicron can be just as severe as its predecessors.⁴ For many, getting vaccinated is the difference between staying at home with some symptoms and being in the ICU.

As of January 10, according to the CDC, although 88% of people over the age of 65 are vaccinated, only 37.5% have gotten boosters which are key to restoring protection against Omicron. And among children, only 54% between 12- and 17-years-old are fully vaccinated, and a mere 17% of children aged 5 to 11 have gotten both of their shots.

Remember the conversations regarding natural immunity? Omicron has muffled that conversation. Those who have been infected with SARS-Co-V2 before can still get infected and very ill with Omicron. So now is the time to get vaccinated.

Transmissibility

We knew SARS-CoV-2 could spread 1 of 2 ways: large virus-carrying droplets that enter through the nose, mouth, and eyes, as well as miniscule airborne droplets of virus that float in the air and travel further than 6 feet. However, prior to Omicron, transmission of these smaller droplets via the air was not as frequent. But with Omicron, while it still travels by larger respiratory droplets, it appears to have more airborne spread.

In late December, The Lancet Regional Health published results of research conducted one month earlier at a designated quarantine hotel in Hong Kong.⁵ The index case was housed in the room across a hallway from the second case, who developed their case 8 days into quarantine. Testing showed the Omicron variant in both cases. Environmental testing of the walls and ceiling suggested airborne spread of the virus in places unreachable by large respiratory droplets.

Now with Omicron, people need to wear high-filtering masks that fit tight against the face, such as a N95, KN-95, or KF-94 if possible. And when removing the mask to eat and drink, one should be in well-ventilated areas, away from others.

People should avoid getting Omicron, regardless of vaccination status. This variant is so infectious that, compared to the Delta variant, people are twice as likely to infect others that live with them. And infecting others leads to a chain of transmission that can close schools, take over hospital beds, and disable or kill the most vulnerable in our communities.

Public and private behavior, and public policy

In July, months before that WHO announced Omicron’s existence, Rella and colleagues reported in Scientific Reports on the outcome of a new model designed to show how a vaccine-resistant strain could rapidly transmit through a highly vaccinated population if transmission mitigation interventions are dropped too soon.⁶

The authors wrote that the success of a vaccine-resistant strain making inroads into a population depends on the obvious – it finds populations with a low rate of vaccination. What is not so obvious, the authors wrote, is that a vaccine-resistant virus does its worst when transmission is not well controlled in a highly vaccinated population. What can prevent a surge like this are social behaviors and public policy that decrease the chain of transmission of SARS-CoV-2, such as vaccination, masking, and testing.

It is people’s behavior, and ineffective public policy, that are so frustrating to us. The WHO’s secretary general warned against relying solely on vaccines in December. “Vaccines alone will not get any country out of this crisis.”

Omicron takes a new mindset. What we were doing before is not protecting now. Unchecked spread is overwhelming our health care systems and putting the vulnerable in our population at risk. The ramification of this unchecked spread reaches everywhere – into the economy, our educational system, and our nation’s mental health.

When the pandemic started, the policies to control its spread rested on local government and public agencies; we all would have been better served had there been a unified, national response to an infectious threat that does not obey municipal or state boundaries.

 The universal sentiment among health care workers is frustration with local and state governments that are either dictating policy that can harm the public we are trying to protect.

As of September, at least 23 state legislatures have passed laws changing a governor’s executive power reach. Many have taken it away. Others are fighting in the courts over mask mandates.

As for when the pandemic will subside, that appears to be up to the public and public policy makers. They will determine how long this will last and how many will die or be disabled before its end.

Health care’s modern-day version of the Greek chorus is growing louder and more persistent. My colleagues and I have long been among them.

In news conferences, journal articles, and podcasts, this chorus is pleading with the public to pay attention to its message: SARs-CoV-2 is not done with us. Omicron can kill; it can infect the vaccinated.

We have found, like everyone else, that Omicron runs on its rules; with Delta, two vaccine shots were able to lower the positivity rate. With Omicron, two shots have not been enough.

The WHO used the word “surprise” in its November announcement that Omicron was a variant of “concern.”

So did Trevor Bedford, a computational biologist and infectious disease scientist at the Fred Hutchinson Cancer Center in Seattle, who said that Omicron “took me and everyone by surprise.”¹ Speaking on KevinMD’s podcast, he told his host that with the degree of immunity in the global population, he was expecting subsequent evolving strains to have minor, subtle genetic mutations, akin to how flu varies from year to year. What was a surprise was the giant leap in evolution that occurred with Omicron, which contains 36 mutations in the spike protein and approximately 50 mutations in total. Because of these mutations, the original two-shot mRNA COVID vaccines becomes only 40% effective against symptomatic disease after several months (thankfully a booster shot increases this to ~80%).² But the decreased vaccine protection without a booster, along with relaxation of mitigation measures, brought us to where we are now.

In Chicago, we knew the Omicron variant would move quickly, considering how it moved through South Africa and the United Kingdom. What we didn’t anticipate was that in one week’s time, our hospital would need to add another 100 dedicated COVID ICU beds. Nor did we anticipate the extent that Omicron would affect staffing levels in the same amount of time.

At our hospital, we have eliminated elective surgeries that require a hospital stay, which includes surgeries for cancer. One of my colleagues, Ryan Merkow, MD, a surgical oncologist, remarked recently he had to cancel half of his scheduled surgeries because of a lack of hospital space.³

Dispelling Myths

What is concerning about this current wave is how many unvaccinated are hospitalized. Because Omicron is so infectious and because of lower vaccination rates in younger adults and children, we have a younger group of adults and children admitted with COVID, who had been uninfected by previous surges.

A major myth that makes health care workers so frustrated is the tale that Omicron is milder. Unvaccinated people infected with this variant are seriously ill and are dying. Despite its “mild” label, once a patient is hospitalized, Omicron can be just as severe as its predecessors.⁴ For many, getting vaccinated is the difference between staying at home with some symptoms and being in the ICU.

As of January 10, according to the CDC, although 88% of people over the age of 65 are vaccinated, only 37.5% have gotten boosters which are key to restoring protection against Omicron. And among children, only 54% between 12- and 17-years-old are fully vaccinated, and a mere 17% of children aged 5 to 11 have gotten both of their shots.

Remember the conversations regarding natural immunity? Omicron has muffled that conversation. Those who have been infected with SARS-Co-V2 before can still get infected and very ill with Omicron. So now is the time to get vaccinated.

Transmissibility

We knew SARS-CoV-2 could spread 1 of 2 ways: large virus-carrying droplets that enter through the nose, mouth, and eyes, as well as miniscule airborne droplets of virus that float in the air and travel further than 6 feet. However, prior to Omicron, transmission of these smaller droplets via the air was not as frequent. But with Omicron, while it still travels by larger respiratory droplets, it appears to have more airborne spread.

In late December, The Lancet Regional Health published results of research conducted one month earlier at a designated quarantine hotel in Hong Kong.⁵ The index case was housed in the room across a hallway from the second case, who developed their case 8 days into quarantine. Testing showed the Omicron variant in both cases. Environmental testing of the walls and ceiling suggested airborne spread of the virus in places unreachable by large respiratory droplets.

Now with Omicron, people need to wear high-filtering masks that fit tight against the face, such as a N95, KN-95, or KF-94 if possible. And when removing the mask to eat and drink, one should be in well-ventilated areas, away from others.

People should avoid getting Omicron, regardless of vaccination status. This variant is so infectious that, compared to the Delta variant, people are twice as likely to infect others that live with them. And infecting others leads to a chain of transmission that can close schools, take over hospital beds, and disable or kill the most vulnerable in our communities.

Public and private behavior, and public policy

In July, months before that WHO announced Omicron’s existence, Rella and colleagues reported in Scientific Reports on the outcome of a new model designed to show how a vaccine-resistant strain could rapidly transmit through a highly vaccinated population if transmission mitigation interventions are dropped too soon.⁶

The authors wrote that the success of a vaccine-resistant strain making inroads into a population depends on the obvious – it finds populations with a low rate of vaccination. What is not so obvious, the authors wrote, is that a vaccine-resistant virus does its worst when transmission is not well controlled in a highly vaccinated population. What can prevent a surge like this are social behaviors and public policy that decrease the chain of transmission of SARS-CoV-2, such as vaccination, masking, and testing.

It is people’s behavior, and ineffective public policy, that are so frustrating to us. The WHO’s secretary general warned against relying solely on vaccines in December. “Vaccines alone will not get any country out of this crisis.”

Omicron takes a new mindset. What we were doing before is not protecting now. Unchecked spread is overwhelming our health care systems and putting the vulnerable in our population at risk. The ramification of this unchecked spread reaches everywhere – into the economy, our educational system, and our nation’s mental health.

When the pandemic started, the policies to control its spread rested on local government and public agencies; we all would have been better served had there been a unified, national response to an infectious threat that does not obey municipal or state boundaries.

 The universal sentiment among health care workers is frustration with local and state governments that are either dictating policy that can harm the public we are trying to protect.

As of September, at least 23 state legislatures have passed laws changing a governor’s executive power reach. Many have taken it away. Others are fighting in the courts over mask mandates.

As for when the pandemic will subside, that appears to be up to the public and public policy makers. They will determine how long this will last and how many will die or be disabled before its end.

The Food and Drug Administration on Jan. 14 approved two oral JAK-1 inhibitors for patients with moderate-to-severe atopic dermatitis (AD) – upadacitinib and abrocitinib – making them the first oral JAK-inhibitors available for this indication in the United States.

“It’s big news because a few years ago we didn’t have any systemic treatments that are safer than the classical immunosuppressants like cyclosporine and methotrexate,” Emma Guttman-Yassky, MD, PhD, Waldman professor and system chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York, told this news organization commenting on upadacitinib’s approval.

Olivier Le Moal/Getty Images

Upadacitinib

The approval of upadacitinib (Rinvoq), marketed by AbbVie, for moderate to severe AD in patients ages 12 and older, comes on the heels of findings from three pivotal phase 3 studies involving more than 2,500 adults and children 12 years of age and older with moderate to severe AD: Measure Up 1 and 2, led by Dr. Guttman-Yassky, which evaluated upadacitinib compared with placebo, and AD UP, which compared upadacitinib along with topical corticosteroids, compared with placebo.

Across the three studies, upadacitinib – both 15 mg and 30 mg once daily monotherapy – met all primary and secondary endpoints at week 16, with some patients achieving higher levels of skin clearance based on the Eczema Area and Severity Index 90 (EASI-90) and EASI-100.

“I always say that patients with AD need options,” Dr. Guttman-Yassky said. “We need biologics. We need oral medications. Not everybody likes an injectable. The plus of the class of JAK inhibitors in general is the quick onset of action.” Many patients in her clinic are maintained on upadacitinib more than two years later “and are super happy,” she said. “Many of them failed cyclosporine and other immunosuppressants such as methotrexate and prednisone.”

She predicted that health insurance companies will find coverage cost-effective “because it sets a new bar for efficacy, and because many patients have failed other treatments.”

Abrocitinib

Abrocitinib (Cibinqo), marketed by Pfizer, was approved for adults with moderate to severe AD. The approval was based on results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients. The recommended doses are 100 mg and 200 mg, with the 200 mg dose recommended for patients who are not responding to the 100 mg dose.

The labeling of abrocitinib and upadacitinib include a boxed warning for JAK inhibitors, regarding the risk of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.

Dr. Guttman-Yassky has served as a principal investigator for AbbVie and has received consulting fees from the company.




 

The Food and Drug Administration on Jan. 14 approved two oral JAK-1 inhibitors for patients with moderate-to-severe atopic dermatitis (AD) – upadacitinib and abrocitinib – making them the first oral JAK-inhibitors available for this indication in the United States.

“It’s big news because a few years ago we didn’t have any systemic treatments that are safer than the classical immunosuppressants like cyclosporine and methotrexate,” Emma Guttman-Yassky, MD, PhD, Waldman professor and system chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York, told this news organization commenting on upadacitinib’s approval.

Olivier Le Moal/Getty Images

Upadacitinib

The approval of upadacitinib (Rinvoq), marketed by AbbVie, for moderate to severe AD in patients ages 12 and older, comes on the heels of findings from three pivotal phase 3 studies involving more than 2,500 adults and children 12 years of age and older with moderate to severe AD: Measure Up 1 and 2, led by Dr. Guttman-Yassky, which evaluated upadacitinib compared with placebo, and AD UP, which compared upadacitinib along with topical corticosteroids, compared with placebo.

Across the three studies, upadacitinib – both 15 mg and 30 mg once daily monotherapy – met all primary and secondary endpoints at week 16, with some patients achieving higher levels of skin clearance based on the Eczema Area and Severity Index 90 (EASI-90) and EASI-100.

“I always say that patients with AD need options,” Dr. Guttman-Yassky said. “We need biologics. We need oral medications. Not everybody likes an injectable. The plus of the class of JAK inhibitors in general is the quick onset of action.” Many patients in her clinic are maintained on upadacitinib more than two years later “and are super happy,” she said. “Many of them failed cyclosporine and other immunosuppressants such as methotrexate and prednisone.”

She predicted that health insurance companies will find coverage cost-effective “because it sets a new bar for efficacy, and because many patients have failed other treatments.”

Abrocitinib

Abrocitinib (Cibinqo), marketed by Pfizer, was approved for adults with moderate to severe AD. The approval was based on results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients. The recommended doses are 100 mg and 200 mg, with the 200 mg dose recommended for patients who are not responding to the 100 mg dose.

The labeling of abrocitinib and upadacitinib include a boxed warning for JAK inhibitors, regarding the risk of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.

Dr. Guttman-Yassky has served as a principal investigator for AbbVie and has received consulting fees from the company.




 

The Food and Drug Administration on Jan. 14 approved two oral JAK-1 inhibitors for patients with moderate-to-severe atopic dermatitis (AD) – upadacitinib and abrocitinib – making them the first oral JAK-inhibitors available for this indication in the United States.

“It’s big news because a few years ago we didn’t have any systemic treatments that are safer than the classical immunosuppressants like cyclosporine and methotrexate,” Emma Guttman-Yassky, MD, PhD, Waldman professor and system chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York, told this news organization commenting on upadacitinib’s approval.

Olivier Le Moal/Getty Images

Upadacitinib

The approval of upadacitinib (Rinvoq), marketed by AbbVie, for moderate to severe AD in patients ages 12 and older, comes on the heels of findings from three pivotal phase 3 studies involving more than 2,500 adults and children 12 years of age and older with moderate to severe AD: Measure Up 1 and 2, led by Dr. Guttman-Yassky, which evaluated upadacitinib compared with placebo, and AD UP, which compared upadacitinib along with topical corticosteroids, compared with placebo.

Across the three studies, upadacitinib – both 15 mg and 30 mg once daily monotherapy – met all primary and secondary endpoints at week 16, with some patients achieving higher levels of skin clearance based on the Eczema Area and Severity Index 90 (EASI-90) and EASI-100.

“I always say that patients with AD need options,” Dr. Guttman-Yassky said. “We need biologics. We need oral medications. Not everybody likes an injectable. The plus of the class of JAK inhibitors in general is the quick onset of action.” Many patients in her clinic are maintained on upadacitinib more than two years later “and are super happy,” she said. “Many of them failed cyclosporine and other immunosuppressants such as methotrexate and prednisone.”

She predicted that health insurance companies will find coverage cost-effective “because it sets a new bar for efficacy, and because many patients have failed other treatments.”

Abrocitinib

Abrocitinib (Cibinqo), marketed by Pfizer, was approved for adults with moderate to severe AD. The approval was based on results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients. The recommended doses are 100 mg and 200 mg, with the 200 mg dose recommended for patients who are not responding to the 100 mg dose.

The labeling of abrocitinib and upadacitinib include a boxed warning for JAK inhibitors, regarding the risk of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.

Dr. Guttman-Yassky has served as a principal investigator for AbbVie and has received consulting fees from the company.




 

The Isotretinoin Products Manufacturers Group (IPMG) reports that most users of the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) should now have access to their accounts, one month after a modified program was launched, the Food and Drug Administration announced on Jan. 14.

The IPMG has “created a new tool within the system to help resolve account access for some user groups without using the call center. This tool is intended to allow prescribers and designees to send login links directly to their patients’ desired email address through the Manage Patients page of the iPLEDGE REMS portal,” the FDA statement said.

“Prescribers can also send login links to their designees still having difficulty accessing their iPLEDGE account,” and users should check their emails for messages from iPLEDGE, including spam folders, the FDA advises. The iPLEDGE strategy is designed to prevent fetal exposure to isotretinoin, which is highly teratogenic.

Days after the new, gender-neutral approach to the isotretinoin risk mitigation program was launched on Dec. 13, the FDA convened an emergency meeting with representatives from the American Academy of Dermatology Association (AADA) to discuss the problematic rollout of the program, which was described as disastrous, chaotic, and a failure, with dermatologists on Twitter and elsewhere expressing anger and frustration over not being able to access the program or reach the call center.

A statement by the FDA on Dec. 23 followed, urging manufacturers to develop solutions for the website and to work with the AADA and pharmacy organizations to find solutions that would minimize treatment interruptions during the transition.

The modified REMS, launched on Dec. 13, is designed to make it more inclusive for transgender patients prescribed isotretinoin. Instead of three risk categories (females of reproductive potential, females not of reproductive potential, and males), patients who are prescribed isotretinoin for acne are assigned to one of two risk categories: those who can get pregnant and those who cannot get pregnant.

In the Jan. 14 statement, the FDA notes that the agency is continuing to work with the IPMG regarding the problems clinicians, pharmacists, and patients have had with accessing iPLEDGE over the last month.

“Although there has been progress, there is a significant amount of work still to be done,” the FDA acknowledged. “While we consider potential steps within the scope of FDA’s authorities, we will continue to meet with the IPMG for updates on the status of the problems with the iPLEDGE REMS and their progress towards having the system work as intended for all users.”

The Isotretinoin Products Manufacturers Group (IPMG) reports that most users of the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) should now have access to their accounts, one month after a modified program was launched, the Food and Drug Administration announced on Jan. 14.

The IPMG has “created a new tool within the system to help resolve account access for some user groups without using the call center. This tool is intended to allow prescribers and designees to send login links directly to their patients’ desired email address through the Manage Patients page of the iPLEDGE REMS portal,” the FDA statement said.

“Prescribers can also send login links to their designees still having difficulty accessing their iPLEDGE account,” and users should check their emails for messages from iPLEDGE, including spam folders, the FDA advises. The iPLEDGE strategy is designed to prevent fetal exposure to isotretinoin, which is highly teratogenic.

Days after the new, gender-neutral approach to the isotretinoin risk mitigation program was launched on Dec. 13, the FDA convened an emergency meeting with representatives from the American Academy of Dermatology Association (AADA) to discuss the problematic rollout of the program, which was described as disastrous, chaotic, and a failure, with dermatologists on Twitter and elsewhere expressing anger and frustration over not being able to access the program or reach the call center.

A statement by the FDA on Dec. 23 followed, urging manufacturers to develop solutions for the website and to work with the AADA and pharmacy organizations to find solutions that would minimize treatment interruptions during the transition.

The modified REMS, launched on Dec. 13, is designed to make it more inclusive for transgender patients prescribed isotretinoin. Instead of three risk categories (females of reproductive potential, females not of reproductive potential, and males), patients who are prescribed isotretinoin for acne are assigned to one of two risk categories: those who can get pregnant and those who cannot get pregnant.

In the Jan. 14 statement, the FDA notes that the agency is continuing to work with the IPMG regarding the problems clinicians, pharmacists, and patients have had with accessing iPLEDGE over the last month.

“Although there has been progress, there is a significant amount of work still to be done,” the FDA acknowledged. “While we consider potential steps within the scope of FDA’s authorities, we will continue to meet with the IPMG for updates on the status of the problems with the iPLEDGE REMS and their progress towards having the system work as intended for all users.”

The Isotretinoin Products Manufacturers Group (IPMG) reports that most users of the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) should now have access to their accounts, one month after a modified program was launched, the Food and Drug Administration announced on Jan. 14.

The IPMG has “created a new tool within the system to help resolve account access for some user groups without using the call center. This tool is intended to allow prescribers and designees to send login links directly to their patients’ desired email address through the Manage Patients page of the iPLEDGE REMS portal,” the FDA statement said.

“Prescribers can also send login links to their designees still having difficulty accessing their iPLEDGE account,” and users should check their emails for messages from iPLEDGE, including spam folders, the FDA advises. The iPLEDGE strategy is designed to prevent fetal exposure to isotretinoin, which is highly teratogenic.

Days after the new, gender-neutral approach to the isotretinoin risk mitigation program was launched on Dec. 13, the FDA convened an emergency meeting with representatives from the American Academy of Dermatology Association (AADA) to discuss the problematic rollout of the program, which was described as disastrous, chaotic, and a failure, with dermatologists on Twitter and elsewhere expressing anger and frustration over not being able to access the program or reach the call center.

A statement by the FDA on Dec. 23 followed, urging manufacturers to develop solutions for the website and to work with the AADA and pharmacy organizations to find solutions that would minimize treatment interruptions during the transition.

The modified REMS, launched on Dec. 13, is designed to make it more inclusive for transgender patients prescribed isotretinoin. Instead of three risk categories (females of reproductive potential, females not of reproductive potential, and males), patients who are prescribed isotretinoin for acne are assigned to one of two risk categories: those who can get pregnant and those who cannot get pregnant.

In the Jan. 14 statement, the FDA notes that the agency is continuing to work with the IPMG regarding the problems clinicians, pharmacists, and patients have had with accessing iPLEDGE over the last month.

“Although there has been progress, there is a significant amount of work still to be done,” the FDA acknowledged. “While we consider potential steps within the scope of FDA’s authorities, we will continue to meet with the IPMG for updates on the status of the problems with the iPLEDGE REMS and their progress towards having the system work as intended for all users.”

• PATIENT SATISFACTION WITH TREATMENT
• REDUCING ITCH
• BURDEN OF DISEASE IN BLACK PATIENTS
• BATHING RECOMMENDATIONS

Read More

• PATIENT SATISFACTION WITH TREATMENT
• REDUCING ITCH
• BURDEN OF DISEASE IN BLACK PATIENTS
• BATHING RECOMMENDATIONS

Read More

• PATIENT SATISFACTION WITH TREATMENT
• REDUCING ITCH
• BURDEN OF DISEASE IN BLACK PATIENTS
• BATHING RECOMMENDATIONS

Read More

This commentary was submitted as a rebuttal to “PA name change bad for patients and the profession.”

To the Editor:

At a time when COVID-19 cases are climbing and health care workers are struggling to meet the needs of our nation’s healthcare system, the commentary by Rebekah Bernard, MD, divides health care providers and demeans the education, experience, and value of physician associates (PA) and nurse practitioners (NP) in our opinion.

The ill timing of this negative message is equally matched by her mischaracterization of the PA title change and PA efforts to eliminate outdated administrative barriers, as well as her baseless attack on NP education and clinical training.

Let us be clear about one thing: What patients really want and deserve is access to high-quality care delivered by the health care provider of their choice. Patients deserve health care providers who are committed to modern, integrated, and coordinated health care delivery, led by professionals who are dedicated to ensuring that everyone is practicing to the full extent of their education, clinical experience, and scope of practice. Patients deserve health care providers who respect each other and work together to embrace solutions that will improve health care for the future.

Decades of research confirm the high quality of PA- and NP-delivered health care. The evidence is in, and it is irrefutable: PA- and NP-delivered care is associated with improved access to care, lower health care costs, and fewer avoidable emergency room visits.

With regard to the PA title change, the fact is this: Changing the profession’s title does not change what PAs do or affect a PA’s scope of practice. The new title – physician associate – directly addresses the common misperception that PAs merely “assist” physicians. It is in the best interest of patients and the health care system for PAs to hold a professional title that ensures clarity about the work that PAs do.

For the sake of patients, we urge Bernard and her organization to stop continuously attacking other professions and focus on what really matters – providing access to safe, effective, equitable, high-quality care to all patients.

We are committed to patient-centered, coordinated health care, and we continue to work with like-minded physicians and other colleagues to make this a reality.

Ms. Orozco is president and chair of the board of directors for the American Academy of Physician Associates. Dr. Kapu is president of the American Association of Nurse Practitioners.


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

This commentary was submitted as a rebuttal to “PA name change bad for patients and the profession.”

To the Editor:

At a time when COVID-19 cases are climbing and health care workers are struggling to meet the needs of our nation’s healthcare system, the commentary by Rebekah Bernard, MD, divides health care providers and demeans the education, experience, and value of physician associates (PA) and nurse practitioners (NP) in our opinion.

The ill timing of this negative message is equally matched by her mischaracterization of the PA title change and PA efforts to eliminate outdated administrative barriers, as well as her baseless attack on NP education and clinical training.

Let us be clear about one thing: What patients really want and deserve is access to high-quality care delivered by the health care provider of their choice. Patients deserve health care providers who are committed to modern, integrated, and coordinated health care delivery, led by professionals who are dedicated to ensuring that everyone is practicing to the full extent of their education, clinical experience, and scope of practice. Patients deserve health care providers who respect each other and work together to embrace solutions that will improve health care for the future.

Decades of research confirm the high quality of PA- and NP-delivered health care. The evidence is in, and it is irrefutable: PA- and NP-delivered care is associated with improved access to care, lower health care costs, and fewer avoidable emergency room visits.

With regard to the PA title change, the fact is this: Changing the profession’s title does not change what PAs do or affect a PA’s scope of practice. The new title – physician associate – directly addresses the common misperception that PAs merely “assist” physicians. It is in the best interest of patients and the health care system for PAs to hold a professional title that ensures clarity about the work that PAs do.

For the sake of patients, we urge Bernard and her organization to stop continuously attacking other professions and focus on what really matters – providing access to safe, effective, equitable, high-quality care to all patients.

We are committed to patient-centered, coordinated health care, and we continue to work with like-minded physicians and other colleagues to make this a reality.

Ms. Orozco is president and chair of the board of directors for the American Academy of Physician Associates. Dr. Kapu is president of the American Association of Nurse Practitioners.


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

This commentary was submitted as a rebuttal to “PA name change bad for patients and the profession.”

To the Editor:

At a time when COVID-19 cases are climbing and health care workers are struggling to meet the needs of our nation’s healthcare system, the commentary by Rebekah Bernard, MD, divides health care providers and demeans the education, experience, and value of physician associates (PA) and nurse practitioners (NP) in our opinion.

The ill timing of this negative message is equally matched by her mischaracterization of the PA title change and PA efforts to eliminate outdated administrative barriers, as well as her baseless attack on NP education and clinical training.

Let us be clear about one thing: What patients really want and deserve is access to high-quality care delivered by the health care provider of their choice. Patients deserve health care providers who are committed to modern, integrated, and coordinated health care delivery, led by professionals who are dedicated to ensuring that everyone is practicing to the full extent of their education, clinical experience, and scope of practice. Patients deserve health care providers who respect each other and work together to embrace solutions that will improve health care for the future.

Decades of research confirm the high quality of PA- and NP-delivered health care. The evidence is in, and it is irrefutable: PA- and NP-delivered care is associated with improved access to care, lower health care costs, and fewer avoidable emergency room visits.

With regard to the PA title change, the fact is this: Changing the profession’s title does not change what PAs do or affect a PA’s scope of practice. The new title – physician associate – directly addresses the common misperception that PAs merely “assist” physicians. It is in the best interest of patients and the health care system for PAs to hold a professional title that ensures clarity about the work that PAs do.

For the sake of patients, we urge Bernard and her organization to stop continuously attacking other professions and focus on what really matters – providing access to safe, effective, equitable, high-quality care to all patients.

We are committed to patient-centered, coordinated health care, and we continue to work with like-minded physicians and other colleagues to make this a reality.

Ms. Orozco is president and chair of the board of directors for the American Academy of Physician Associates. Dr. Kapu is president of the American Association of Nurse Practitioners.


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