MDedge Infectious Disease

Most of the United States will see significant growth in COVID-19 cases during the next four weeks, according to the latest forecasting models by the PolicyLab at Children’s Hospital of Philadelphia.

Courtesy NIAID-RML

Large metropolitan areas, especially those in the Northeast, are already seeing a major increase in cases following Thanksgiving, and that trend is expected to continue.

“Why? Simply stated, the large amount of Thanksgiving travel and gatherings undermined the nation’s pandemic footing and has elevated disease burden in areas of the country that were fortunate to have lower case rates before the holidays,” the forecasters wrote.

Case numbers in New York City are expected to double throughout December, the forecasters said. Similar growth could happen across Boston, Philadelphia, and Baltimore.

Overall, COVID-19 cases, hospitalizations, and deaths are rising across the United States but remain below levels seen during the summer and last winter’s surges, according to the New York Times. The increase is still being driven by the Delta variant, though it remains unclear how the Omicron variant, which has been detected in 27 states, could affect the trends in the coming weeks.

During the past week, the United States has reported an average of more than 120,000 new cases each day, the newspaper reported, which is an increase of 38% from two weeks ago.

The daily average of COVID-19 hospitalizations is around 64,000, which marks an increase of 22% from two weeks ago. More than 1,300 deaths are being reported each day, which is up 26%.

Numerous states are reporting double the cases from two weeks ago, stretching across the country from states in the Northeast such as Connecticut and Rhode Island to southern states such as North Carolina and Texas and western states such as California.

The Great Lakes region and the Northeast are seeing some of the most severe increases, the newspaper reported. New Hampshire leads the United States in recent cases per capita, and Maine has reported more cases in the past week than in any other seven-day period during the pandemic.

Michigan has the country’s highest hospitalization rate, and federal medical teams have been sent to the state to help with the surge in patients, according to The Detroit News. Michigan’s top public health officials described the surge as a “critical” and “deeply concerning” situation on Dec. 10, and they requested 200 more ventilators from the Strategic National Stockpile.

Indiana, Maine, and New York have also requested aid from the National Guard, according to USA Today. Health officials in those states urged residents to get vaccines or booster shots and wear masks in indoor public settings.

The Omicron variant can evade some vaccine protection, but booster shots can increase efficacy and offer more coverage, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said Dec. 12.

“If you want to be optimally protected, absolutely get a booster,” he said on ABC’s “This Week.”

In addition, New York Gov. Kathy Hochul has announced a statewide mask mandate, which will take effect Dec. 13. Masks will be required in all indoor public spaces and businesses, unless the location implements a vaccine requirement instead, the news outlet reported.

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

Most of the United States will see significant growth in COVID-19 cases during the next four weeks, according to the latest forecasting models by the PolicyLab at Children’s Hospital of Philadelphia.

Courtesy NIAID-RML

Large metropolitan areas, especially those in the Northeast, are already seeing a major increase in cases following Thanksgiving, and that trend is expected to continue.

“Why? Simply stated, the large amount of Thanksgiving travel and gatherings undermined the nation’s pandemic footing and has elevated disease burden in areas of the country that were fortunate to have lower case rates before the holidays,” the forecasters wrote.

Case numbers in New York City are expected to double throughout December, the forecasters said. Similar growth could happen across Boston, Philadelphia, and Baltimore.

Overall, COVID-19 cases, hospitalizations, and deaths are rising across the United States but remain below levels seen during the summer and last winter’s surges, according to the New York Times. The increase is still being driven by the Delta variant, though it remains unclear how the Omicron variant, which has been detected in 27 states, could affect the trends in the coming weeks.

During the past week, the United States has reported an average of more than 120,000 new cases each day, the newspaper reported, which is an increase of 38% from two weeks ago.

The daily average of COVID-19 hospitalizations is around 64,000, which marks an increase of 22% from two weeks ago. More than 1,300 deaths are being reported each day, which is up 26%.

Numerous states are reporting double the cases from two weeks ago, stretching across the country from states in the Northeast such as Connecticut and Rhode Island to southern states such as North Carolina and Texas and western states such as California.

The Great Lakes region and the Northeast are seeing some of the most severe increases, the newspaper reported. New Hampshire leads the United States in recent cases per capita, and Maine has reported more cases in the past week than in any other seven-day period during the pandemic.

Michigan has the country’s highest hospitalization rate, and federal medical teams have been sent to the state to help with the surge in patients, according to The Detroit News. Michigan’s top public health officials described the surge as a “critical” and “deeply concerning” situation on Dec. 10, and they requested 200 more ventilators from the Strategic National Stockpile.

Indiana, Maine, and New York have also requested aid from the National Guard, according to USA Today. Health officials in those states urged residents to get vaccines or booster shots and wear masks in indoor public settings.

The Omicron variant can evade some vaccine protection, but booster shots can increase efficacy and offer more coverage, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said Dec. 12.

“If you want to be optimally protected, absolutely get a booster,” he said on ABC’s “This Week.”

In addition, New York Gov. Kathy Hochul has announced a statewide mask mandate, which will take effect Dec. 13. Masks will be required in all indoor public spaces and businesses, unless the location implements a vaccine requirement instead, the news outlet reported.

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

Most of the United States will see significant growth in COVID-19 cases during the next four weeks, according to the latest forecasting models by the PolicyLab at Children’s Hospital of Philadelphia.

Courtesy NIAID-RML

Large metropolitan areas, especially those in the Northeast, are already seeing a major increase in cases following Thanksgiving, and that trend is expected to continue.

“Why? Simply stated, the large amount of Thanksgiving travel and gatherings undermined the nation’s pandemic footing and has elevated disease burden in areas of the country that were fortunate to have lower case rates before the holidays,” the forecasters wrote.

Case numbers in New York City are expected to double throughout December, the forecasters said. Similar growth could happen across Boston, Philadelphia, and Baltimore.

Overall, COVID-19 cases, hospitalizations, and deaths are rising across the United States but remain below levels seen during the summer and last winter’s surges, according to the New York Times. The increase is still being driven by the Delta variant, though it remains unclear how the Omicron variant, which has been detected in 27 states, could affect the trends in the coming weeks.

During the past week, the United States has reported an average of more than 120,000 new cases each day, the newspaper reported, which is an increase of 38% from two weeks ago.

The daily average of COVID-19 hospitalizations is around 64,000, which marks an increase of 22% from two weeks ago. More than 1,300 deaths are being reported each day, which is up 26%.

Numerous states are reporting double the cases from two weeks ago, stretching across the country from states in the Northeast such as Connecticut and Rhode Island to southern states such as North Carolina and Texas and western states such as California.

The Great Lakes region and the Northeast are seeing some of the most severe increases, the newspaper reported. New Hampshire leads the United States in recent cases per capita, and Maine has reported more cases in the past week than in any other seven-day period during the pandemic.

Michigan has the country’s highest hospitalization rate, and federal medical teams have been sent to the state to help with the surge in patients, according to The Detroit News. Michigan’s top public health officials described the surge as a “critical” and “deeply concerning” situation on Dec. 10, and they requested 200 more ventilators from the Strategic National Stockpile.

Indiana, Maine, and New York have also requested aid from the National Guard, according to USA Today. Health officials in those states urged residents to get vaccines or booster shots and wear masks in indoor public settings.

The Omicron variant can evade some vaccine protection, but booster shots can increase efficacy and offer more coverage, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said Dec. 12.

“If you want to be optimally protected, absolutely get a booster,” he said on ABC’s “This Week.”

In addition, New York Gov. Kathy Hochul has announced a statewide mask mandate, which will take effect Dec. 13. Masks will be required in all indoor public spaces and businesses, unless the location implements a vaccine requirement instead, the news outlet reported.

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

Although the risk for liver cancer diminishes for patients with hepatitis C virus (HCV) infections for whom the virus is eliminated with direct-acting antiviral (DAA) drugs, these patients are not out of the woods, and those who do not have a sustained viral response (SVR) are at substantially higher risk of developing hepatocellular carcinoma (HCC), results of a large study show.

Among the patients with liver cirrhosis from HCV infections treated at 30 centers in Italy, a large percentage had an SVR after treatment with DAA drugs. Only a small percentage of this group subsequently developed HCC.

In contrast, not having an SVR was associated with a more than sevenfold higher risk for liver cancer, said Loreta A. Kondili, MD, PhD, from the Center for Global Health at the Istituto Superiore di Sanità, Rome, during a presentation of the findings at The Liver Meeting 2021: American Association for the Study of Liver Diseases (AASLD), held online.

“Failure to achieve SVR after DAA treatment is strongly associated with the probability of HCC development. Older age, [HCV] genotype 3, and low platelet counts and albumin levels are independent factors of HCC development despite viral eradication,” she said.
 

Cohort study

The study findings come from the PITER Cohort Study, a prospective, multicenter observational study of a representative sample of patients with HCV.

Dr. Kondili and colleagues assessed the medium- and long-term effects of DAA therapy on HCC rates among patients with HCV-induced liver cirrhosis. Patients who had undergone a liver transplant or who had been previously diagnosed with HCC were excluded.

The investigators identified a total of 2,214 DAA-treated patients, of whom 149 (6.7%) developed de novo HCC after a median follow-up of 30 months.

From the total group, 2,064 (93%) patients had an SVR, 119 of whom (5.8%) developed HCC. Of these patients who developed HCC, 80% were diagnosed with stage B or C disease in accordance with the Barcelona Clinic Liver Cancer staging system.

For the remaining 150 patients who did not have an SVR, 30 (20%) developed de novo HCC, a difference that translated into an adjusted hazard ratio (aHR) for HCC of 7.38 (P < .01).

The time from the end of DAA therapy to a diagnosis of HCC was shorter for patients who did not have an SVR. For these patients, the 2-year HCC-free survival rate was 81%, compared with 98% for patients who had an SVR (P < .001).

As reported by Dr. Kondili, among patients who achieved an SVR, the variables significantly associated with HCC risk included older age (aHR, 1.06), platelet counts greater than the reference limit of 150,000 μL (aHR, 2.43), albumin levels >3.5 g/dL (aHR, 2.36), and diabetes (aHR, 1.53; all these variables were significant by confidence intervals).

In all, 26% of these patients died during the follow-up period, and 7.6% underwent liver transplant.

Of the patients still alive at the end of the follow-up period, 38% had active HCC.
 

Long-term follow-up required

“It’s useful to think of hepatitis C as a viral infection on one hand [and] a liver disease on the other,” commented Raymond T. Chung, MD, director of the Hepatology and Liver Center and vice chief of gastroenterology at Massachusetts General Hospital, Boston.

“In terms of thinking of elimination, we can eradicate the virus in most patients with virtually 100% success with antivirals. This has given us a false sense of comfort that it’s a ‘one and done’ process, and patients can more or less enjoy the rest of their lives free of hepatitis C,” he said.

Dr. Chung, who was not involved in the study, emphasized that despite the elimination of the virus, patients may still have significant liver fibrosis or cirrhosis. It is imperative that these patients be monitored for signs of cancer, he said.

“This is what’s important about staging patients and understanding how severe their liver disease is, because if there is advanced fibrosis, bridging fibrosis, or cirrhosis, these are patients who are going to require long-term oncology care. Their infectious disease is eliminated, but the liver disease remains,” he said.

Dr. Chung also noted that rates of liver cancer, decompensation, and liver failure are higher among patients with untreated HCV than among patients whose HCV has been eradicated or suppressed with drug treatment. In addition, patients with untreated HCV are at greater risk of requiring transplant than are patients with HCV that was treated, and there remains a residual cancer risk for patients who become HCV seronegative.

The study was funded by the Italian Ministry of Health. Dr. Kondili has financial relationships with Gilead Science and AbbVie. Dr. Chung reported no relevant financial relationships.

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

Although the risk for liver cancer diminishes for patients with hepatitis C virus (HCV) infections for whom the virus is eliminated with direct-acting antiviral (DAA) drugs, these patients are not out of the woods, and those who do not have a sustained viral response (SVR) are at substantially higher risk of developing hepatocellular carcinoma (HCC), results of a large study show.

Among the patients with liver cirrhosis from HCV infections treated at 30 centers in Italy, a large percentage had an SVR after treatment with DAA drugs. Only a small percentage of this group subsequently developed HCC.

In contrast, not having an SVR was associated with a more than sevenfold higher risk for liver cancer, said Loreta A. Kondili, MD, PhD, from the Center for Global Health at the Istituto Superiore di Sanità, Rome, during a presentation of the findings at The Liver Meeting 2021: American Association for the Study of Liver Diseases (AASLD), held online.

“Failure to achieve SVR after DAA treatment is strongly associated with the probability of HCC development. Older age, [HCV] genotype 3, and low platelet counts and albumin levels are independent factors of HCC development despite viral eradication,” she said.
 

Cohort study

The study findings come from the PITER Cohort Study, a prospective, multicenter observational study of a representative sample of patients with HCV.

Dr. Kondili and colleagues assessed the medium- and long-term effects of DAA therapy on HCC rates among patients with HCV-induced liver cirrhosis. Patients who had undergone a liver transplant or who had been previously diagnosed with HCC were excluded.

The investigators identified a total of 2,214 DAA-treated patients, of whom 149 (6.7%) developed de novo HCC after a median follow-up of 30 months.

From the total group, 2,064 (93%) patients had an SVR, 119 of whom (5.8%) developed HCC. Of these patients who developed HCC, 80% were diagnosed with stage B or C disease in accordance with the Barcelona Clinic Liver Cancer staging system.

For the remaining 150 patients who did not have an SVR, 30 (20%) developed de novo HCC, a difference that translated into an adjusted hazard ratio (aHR) for HCC of 7.38 (P < .01).

The time from the end of DAA therapy to a diagnosis of HCC was shorter for patients who did not have an SVR. For these patients, the 2-year HCC-free survival rate was 81%, compared with 98% for patients who had an SVR (P < .001).

As reported by Dr. Kondili, among patients who achieved an SVR, the variables significantly associated with HCC risk included older age (aHR, 1.06), platelet counts greater than the reference limit of 150,000 μL (aHR, 2.43), albumin levels >3.5 g/dL (aHR, 2.36), and diabetes (aHR, 1.53; all these variables were significant by confidence intervals).

In all, 26% of these patients died during the follow-up period, and 7.6% underwent liver transplant.

Of the patients still alive at the end of the follow-up period, 38% had active HCC.
 

Long-term follow-up required

“It’s useful to think of hepatitis C as a viral infection on one hand [and] a liver disease on the other,” commented Raymond T. Chung, MD, director of the Hepatology and Liver Center and vice chief of gastroenterology at Massachusetts General Hospital, Boston.

“In terms of thinking of elimination, we can eradicate the virus in most patients with virtually 100% success with antivirals. This has given us a false sense of comfort that it’s a ‘one and done’ process, and patients can more or less enjoy the rest of their lives free of hepatitis C,” he said.

Dr. Chung, who was not involved in the study, emphasized that despite the elimination of the virus, patients may still have significant liver fibrosis or cirrhosis. It is imperative that these patients be monitored for signs of cancer, he said.

“This is what’s important about staging patients and understanding how severe their liver disease is, because if there is advanced fibrosis, bridging fibrosis, or cirrhosis, these are patients who are going to require long-term oncology care. Their infectious disease is eliminated, but the liver disease remains,” he said.

Dr. Chung also noted that rates of liver cancer, decompensation, and liver failure are higher among patients with untreated HCV than among patients whose HCV has been eradicated or suppressed with drug treatment. In addition, patients with untreated HCV are at greater risk of requiring transplant than are patients with HCV that was treated, and there remains a residual cancer risk for patients who become HCV seronegative.

The study was funded by the Italian Ministry of Health. Dr. Kondili has financial relationships with Gilead Science and AbbVie. Dr. Chung reported no relevant financial relationships.

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

Although the risk for liver cancer diminishes for patients with hepatitis C virus (HCV) infections for whom the virus is eliminated with direct-acting antiviral (DAA) drugs, these patients are not out of the woods, and those who do not have a sustained viral response (SVR) are at substantially higher risk of developing hepatocellular carcinoma (HCC), results of a large study show.

Among the patients with liver cirrhosis from HCV infections treated at 30 centers in Italy, a large percentage had an SVR after treatment with DAA drugs. Only a small percentage of this group subsequently developed HCC.

In contrast, not having an SVR was associated with a more than sevenfold higher risk for liver cancer, said Loreta A. Kondili, MD, PhD, from the Center for Global Health at the Istituto Superiore di Sanità, Rome, during a presentation of the findings at The Liver Meeting 2021: American Association for the Study of Liver Diseases (AASLD), held online.

“Failure to achieve SVR after DAA treatment is strongly associated with the probability of HCC development. Older age, [HCV] genotype 3, and low platelet counts and albumin levels are independent factors of HCC development despite viral eradication,” she said.
 

Cohort study

The study findings come from the PITER Cohort Study, a prospective, multicenter observational study of a representative sample of patients with HCV.

Dr. Kondili and colleagues assessed the medium- and long-term effects of DAA therapy on HCC rates among patients with HCV-induced liver cirrhosis. Patients who had undergone a liver transplant or who had been previously diagnosed with HCC were excluded.

The investigators identified a total of 2,214 DAA-treated patients, of whom 149 (6.7%) developed de novo HCC after a median follow-up of 30 months.

From the total group, 2,064 (93%) patients had an SVR, 119 of whom (5.8%) developed HCC. Of these patients who developed HCC, 80% were diagnosed with stage B or C disease in accordance with the Barcelona Clinic Liver Cancer staging system.

For the remaining 150 patients who did not have an SVR, 30 (20%) developed de novo HCC, a difference that translated into an adjusted hazard ratio (aHR) for HCC of 7.38 (P < .01).

The time from the end of DAA therapy to a diagnosis of HCC was shorter for patients who did not have an SVR. For these patients, the 2-year HCC-free survival rate was 81%, compared with 98% for patients who had an SVR (P < .001).

As reported by Dr. Kondili, among patients who achieved an SVR, the variables significantly associated with HCC risk included older age (aHR, 1.06), platelet counts greater than the reference limit of 150,000 μL (aHR, 2.43), albumin levels >3.5 g/dL (aHR, 2.36), and diabetes (aHR, 1.53; all these variables were significant by confidence intervals).

In all, 26% of these patients died during the follow-up period, and 7.6% underwent liver transplant.

Of the patients still alive at the end of the follow-up period, 38% had active HCC.
 

Long-term follow-up required

“It’s useful to think of hepatitis C as a viral infection on one hand [and] a liver disease on the other,” commented Raymond T. Chung, MD, director of the Hepatology and Liver Center and vice chief of gastroenterology at Massachusetts General Hospital, Boston.

“In terms of thinking of elimination, we can eradicate the virus in most patients with virtually 100% success with antivirals. This has given us a false sense of comfort that it’s a ‘one and done’ process, and patients can more or less enjoy the rest of their lives free of hepatitis C,” he said.

Dr. Chung, who was not involved in the study, emphasized that despite the elimination of the virus, patients may still have significant liver fibrosis or cirrhosis. It is imperative that these patients be monitored for signs of cancer, he said.

“This is what’s important about staging patients and understanding how severe their liver disease is, because if there is advanced fibrosis, bridging fibrosis, or cirrhosis, these are patients who are going to require long-term oncology care. Their infectious disease is eliminated, but the liver disease remains,” he said.

Dr. Chung also noted that rates of liver cancer, decompensation, and liver failure are higher among patients with untreated HCV than among patients whose HCV has been eradicated or suppressed with drug treatment. In addition, patients with untreated HCV are at greater risk of requiring transplant than are patients with HCV that was treated, and there remains a residual cancer risk for patients who become HCV seronegative.

The study was funded by the Italian Ministry of Health. Dr. Kondili has financial relationships with Gilead Science and AbbVie. Dr. Chung reported no relevant financial relationships.

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

The new Omicron variant could make it more likely that people will need a fourth coronavirus vaccine earlier than expected, Pfizer officials said on Dec. 8.

The standard two doses may be less effective against the variant, the company announced earlier in the day, and a booster dose increases neutralizing antibodies.

But the timeline might need to be moved up for a fourth dose. Previously, Pfizer CEO Albert Bourla, PhD, said another dose might be needed about a year after a third shot. Now the company’s scientists believe that a fourth shot, which targets the Omicron variant, could be required sooner.

“With Omicron, we need to wait and see because we have very little information. We may need it faster,” Dr. Bourla said on CNBC’s Squawk Box.

“But for right now, the most important thing is that we have winter in front of us,” he said. “From a healthcare perspective, it is important to understand that we need to be well-protected to go through the winter.”

A third dose should provide protection throughout the winter, Dr. Bourla said. That may buy time until the early spring to develop new shots that target Omicron, which Pfizer could have ready by March, according to  Bloomberg News.

As of the afternoon of Dec. 8, 43 people in 19 states had tested positive for the Omicron variant, according to The Associated Press. More than 75% had been vaccinated, and a third had had booster shots. About a third had traveled internationally.

Nearly all of them have had mild symptoms so far, the AP reported, with the most common symptoms being a cough, congestion, and fatigue. One person has been hospitalized, but no deaths have been reported so far.

The CDC is still trying to determine how the Omicron variant may affect the course of the pandemic and whether the strain is more contagious or causes more severe disease.

“What we generally know is the more mutations a variant has, the higher level you need your immunity to be,” Rochelle Walensky, MD, director of the CDC, told the AP.

“We want to make sure we bolster everybody’s immunity,” she said. “And that’s really what motivated the decision to expand our guidance [on boosters for all adults].”

The Omicron variant has been reported in 57 countries so far, World Health Organization officials reported Dec. 8, and they expect that number to continue growing.

“Certain features of Omicron, including its global spread and large number of mutations, suggest it could have a major impact on the course of the pandemic. Exactly what that impact will be is still difficult to know,” Tedros Adhanom Ghebreyesus, PhD, the World Health Organization’s director-general, said during a media briefing.

Several studies suggest that Omicron leads to a rapid increase in transmission, he said, though scientists are still trying to understand whether it can “outcompete Delta.” Data from South Africa also suggests a higher risk of reinfection with Omicron, though it appears to cause milder disease than Delta, he noted.

“Even though we still need answers to some crucial questions, we are not defenseless against Omicron or Delta,” he said. “The steps countries take today, and in the coming days and weeks, will determine how Omicron unfolds.”

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

The new Omicron variant could make it more likely that people will need a fourth coronavirus vaccine earlier than expected, Pfizer officials said on Dec. 8.

The standard two doses may be less effective against the variant, the company announced earlier in the day, and a booster dose increases neutralizing antibodies.

But the timeline might need to be moved up for a fourth dose. Previously, Pfizer CEO Albert Bourla, PhD, said another dose might be needed about a year after a third shot. Now the company’s scientists believe that a fourth shot, which targets the Omicron variant, could be required sooner.

“With Omicron, we need to wait and see because we have very little information. We may need it faster,” Dr. Bourla said on CNBC’s Squawk Box.

“But for right now, the most important thing is that we have winter in front of us,” he said. “From a healthcare perspective, it is important to understand that we need to be well-protected to go through the winter.”

A third dose should provide protection throughout the winter, Dr. Bourla said. That may buy time until the early spring to develop new shots that target Omicron, which Pfizer could have ready by March, according to  Bloomberg News.

As of the afternoon of Dec. 8, 43 people in 19 states had tested positive for the Omicron variant, according to The Associated Press. More than 75% had been vaccinated, and a third had had booster shots. About a third had traveled internationally.

Nearly all of them have had mild symptoms so far, the AP reported, with the most common symptoms being a cough, congestion, and fatigue. One person has been hospitalized, but no deaths have been reported so far.

The CDC is still trying to determine how the Omicron variant may affect the course of the pandemic and whether the strain is more contagious or causes more severe disease.

“What we generally know is the more mutations a variant has, the higher level you need your immunity to be,” Rochelle Walensky, MD, director of the CDC, told the AP.

“We want to make sure we bolster everybody’s immunity,” she said. “And that’s really what motivated the decision to expand our guidance [on boosters for all adults].”

The Omicron variant has been reported in 57 countries so far, World Health Organization officials reported Dec. 8, and they expect that number to continue growing.

“Certain features of Omicron, including its global spread and large number of mutations, suggest it could have a major impact on the course of the pandemic. Exactly what that impact will be is still difficult to know,” Tedros Adhanom Ghebreyesus, PhD, the World Health Organization’s director-general, said during a media briefing.

Several studies suggest that Omicron leads to a rapid increase in transmission, he said, though scientists are still trying to understand whether it can “outcompete Delta.” Data from South Africa also suggests a higher risk of reinfection with Omicron, though it appears to cause milder disease than Delta, he noted.

“Even though we still need answers to some crucial questions, we are not defenseless against Omicron or Delta,” he said. “The steps countries take today, and in the coming days and weeks, will determine how Omicron unfolds.”

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

The new Omicron variant could make it more likely that people will need a fourth coronavirus vaccine earlier than expected, Pfizer officials said on Dec. 8.

The standard two doses may be less effective against the variant, the company announced earlier in the day, and a booster dose increases neutralizing antibodies.

But the timeline might need to be moved up for a fourth dose. Previously, Pfizer CEO Albert Bourla, PhD, said another dose might be needed about a year after a third shot. Now the company’s scientists believe that a fourth shot, which targets the Omicron variant, could be required sooner.

“With Omicron, we need to wait and see because we have very little information. We may need it faster,” Dr. Bourla said on CNBC’s Squawk Box.

“But for right now, the most important thing is that we have winter in front of us,” he said. “From a healthcare perspective, it is important to understand that we need to be well-protected to go through the winter.”

A third dose should provide protection throughout the winter, Dr. Bourla said. That may buy time until the early spring to develop new shots that target Omicron, which Pfizer could have ready by March, according to  Bloomberg News.

As of the afternoon of Dec. 8, 43 people in 19 states had tested positive for the Omicron variant, according to The Associated Press. More than 75% had been vaccinated, and a third had had booster shots. About a third had traveled internationally.

Nearly all of them have had mild symptoms so far, the AP reported, with the most common symptoms being a cough, congestion, and fatigue. One person has been hospitalized, but no deaths have been reported so far.

The CDC is still trying to determine how the Omicron variant may affect the course of the pandemic and whether the strain is more contagious or causes more severe disease.

“What we generally know is the more mutations a variant has, the higher level you need your immunity to be,” Rochelle Walensky, MD, director of the CDC, told the AP.

“We want to make sure we bolster everybody’s immunity,” she said. “And that’s really what motivated the decision to expand our guidance [on boosters for all adults].”

The Omicron variant has been reported in 57 countries so far, World Health Organization officials reported Dec. 8, and they expect that number to continue growing.

“Certain features of Omicron, including its global spread and large number of mutations, suggest it could have a major impact on the course of the pandemic. Exactly what that impact will be is still difficult to know,” Tedros Adhanom Ghebreyesus, PhD, the World Health Organization’s director-general, said during a media briefing.

Several studies suggest that Omicron leads to a rapid increase in transmission, he said, though scientists are still trying to understand whether it can “outcompete Delta.” Data from South Africa also suggests a higher risk of reinfection with Omicron, though it appears to cause milder disease than Delta, he noted.

“Even though we still need answers to some crucial questions, we are not defenseless against Omicron or Delta,” he said. “The steps countries take today, and in the coming days and weeks, will determine how Omicron unfolds.”

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

The Food and Drug Administration has authorized booster doses of Pfizer’s COVID-19 vaccine, clearing the way for millions of teenagers to get a third dose of vaccine starting 6 months after their second dose.

The FDA said it was basing its emergency authorization of boosters for 16- and 17-year-olds on data from 200 individuals who were 18-55 years of age when they received a booster dose. They are requiring Pfizer to collect data on safety in postauthorization studies.

“The FDA has determined that the benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death,” the agency said in a news release.

Israel has been giving booster doses of Pfizer’s vaccine to everyone 12 and up since late August. Data from that country show that myocarditis cases continue to be very rare, even in younger age groups, and are mild and temporary.

The authorization comes as the effectiveness of the current vaccines against the new Omicron variant has become a point of intense scientific inquiry.

Early studies suggest that booster doses may be necessary to keep Omicron at bay, at least until new variant-specific vaccines are ready next spring.

Current evidence suggests that the protection of the vaccines is holding up well against severe disease and death, at least with Delta and early iterations of the virus.

How well they will do against Omicron, and how severe Omicron infections may be for different age groups, remain open questions.

On Dec. 8, the World Health Organization urged countries not to wait for all the science to come in, but to act now to contain any potential threat.

The first pieces of evidence on Omicron suggest that it is highly contagious, perhaps even more than Delta, though early reports suggest symptoms caused by this version of the new coronavirus may be less severe than in previous waves. Experts have cautioned that the true severity of Omicron infections isn’t yet known, since the first cases have been detected in younger people, who tend to have milder COVID-19 symptoms than those of adults and seniors.

“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release. “As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”

In mid-November, the FDA authorized boosters of the Pfizer vaccine for all individuals 18 and older, but the agency held off on expanding the use of boosters for younger age groups, partly because they have the highest risk of myocarditis, a very rare side effect.

Myocarditis cases seem to be temporary, with patients making a full recovery, though they need to be monitored in the hospital. The risk of myocarditis with a COVID-19 infection is many times higher than it is from a vaccine.

There have been little data to support the need for boosters in this age group, because children and teens tend to experience milder COVID-19 disease, though they are still at risk for post–COVID-19 complications such as long COVID and a delayed reaction to the virus called Post Acute Sequelae of SARS-CoV2 Infection among Children, or PAS-C.

All that changed with the arrival of Omicron.

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

The Food and Drug Administration has authorized booster doses of Pfizer’s COVID-19 vaccine, clearing the way for millions of teenagers to get a third dose of vaccine starting 6 months after their second dose.

The FDA said it was basing its emergency authorization of boosters for 16- and 17-year-olds on data from 200 individuals who were 18-55 years of age when they received a booster dose. They are requiring Pfizer to collect data on safety in postauthorization studies.

“The FDA has determined that the benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death,” the agency said in a news release.

Israel has been giving booster doses of Pfizer’s vaccine to everyone 12 and up since late August. Data from that country show that myocarditis cases continue to be very rare, even in younger age groups, and are mild and temporary.

The authorization comes as the effectiveness of the current vaccines against the new Omicron variant has become a point of intense scientific inquiry.

Early studies suggest that booster doses may be necessary to keep Omicron at bay, at least until new variant-specific vaccines are ready next spring.

Current evidence suggests that the protection of the vaccines is holding up well against severe disease and death, at least with Delta and early iterations of the virus.

How well they will do against Omicron, and how severe Omicron infections may be for different age groups, remain open questions.

On Dec. 8, the World Health Organization urged countries not to wait for all the science to come in, but to act now to contain any potential threat.

The first pieces of evidence on Omicron suggest that it is highly contagious, perhaps even more than Delta, though early reports suggest symptoms caused by this version of the new coronavirus may be less severe than in previous waves. Experts have cautioned that the true severity of Omicron infections isn’t yet known, since the first cases have been detected in younger people, who tend to have milder COVID-19 symptoms than those of adults and seniors.

“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release. “As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”

In mid-November, the FDA authorized boosters of the Pfizer vaccine for all individuals 18 and older, but the agency held off on expanding the use of boosters for younger age groups, partly because they have the highest risk of myocarditis, a very rare side effect.

Myocarditis cases seem to be temporary, with patients making a full recovery, though they need to be monitored in the hospital. The risk of myocarditis with a COVID-19 infection is many times higher than it is from a vaccine.

There have been little data to support the need for boosters in this age group, because children and teens tend to experience milder COVID-19 disease, though they are still at risk for post–COVID-19 complications such as long COVID and a delayed reaction to the virus called Post Acute Sequelae of SARS-CoV2 Infection among Children, or PAS-C.

All that changed with the arrival of Omicron.

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

The Food and Drug Administration has authorized booster doses of Pfizer’s COVID-19 vaccine, clearing the way for millions of teenagers to get a third dose of vaccine starting 6 months after their second dose.

The FDA said it was basing its emergency authorization of boosters for 16- and 17-year-olds on data from 200 individuals who were 18-55 years of age when they received a booster dose. They are requiring Pfizer to collect data on safety in postauthorization studies.

“The FDA has determined that the benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death,” the agency said in a news release.

Israel has been giving booster doses of Pfizer’s vaccine to everyone 12 and up since late August. Data from that country show that myocarditis cases continue to be very rare, even in younger age groups, and are mild and temporary.

The authorization comes as the effectiveness of the current vaccines against the new Omicron variant has become a point of intense scientific inquiry.

Early studies suggest that booster doses may be necessary to keep Omicron at bay, at least until new variant-specific vaccines are ready next spring.

Current evidence suggests that the protection of the vaccines is holding up well against severe disease and death, at least with Delta and early iterations of the virus.

How well they will do against Omicron, and how severe Omicron infections may be for different age groups, remain open questions.

On Dec. 8, the World Health Organization urged countries not to wait for all the science to come in, but to act now to contain any potential threat.

The first pieces of evidence on Omicron suggest that it is highly contagious, perhaps even more than Delta, though early reports suggest symptoms caused by this version of the new coronavirus may be less severe than in previous waves. Experts have cautioned that the true severity of Omicron infections isn’t yet known, since the first cases have been detected in younger people, who tend to have milder COVID-19 symptoms than those of adults and seniors.

“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release. “As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”

In mid-November, the FDA authorized boosters of the Pfizer vaccine for all individuals 18 and older, but the agency held off on expanding the use of boosters for younger age groups, partly because they have the highest risk of myocarditis, a very rare side effect.

Myocarditis cases seem to be temporary, with patients making a full recovery, though they need to be monitored in the hospital. The risk of myocarditis with a COVID-19 infection is many times higher than it is from a vaccine.

There have been little data to support the need for boosters in this age group, because children and teens tend to experience milder COVID-19 disease, though they are still at risk for post–COVID-19 complications such as long COVID and a delayed reaction to the virus called Post Acute Sequelae of SARS-CoV2 Infection among Children, or PAS-C.

All that changed with the arrival of Omicron.

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

Under pressure from Republican state lawmakers, the Tennessee Board of Medical Examiners has removed from its website its recent policy statement that physicians who spread false information about COVID-19 vaccinations risk suspension or revocation of their medical license.

The board’s 7-3 vote on December 7 to delete the statement followed repeated threats by a powerful state House Republican to dissolve the board and appoint all new members if it did not immediately take it down.

The Tennessee board’s statement was a verbatim restatement of a warning to physicians issued by the Federation of State Medical Boards in July. The federation cited a “dramatic increase” in dissemination of misinformation and disinformation about the COVID-19 vaccine by physicians. It said that’s dangerous because physicians enjoy a high degree of public credibility.

Across the country, state medical licensing boards and state and national medical associations and specialty boards are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians, which they say are increasing public confusion, political conflict, and preventable illnesses and deaths.

There have been only a small number of disciplinary actions by medical boards against physicians for spreading false COVID-19 information. Critics say the boards have been weak in responding to these dangerous violations of medical standards. As an example, they cite the State Medical Board of Ohio’s September renewal of the medical license of Sherri Tenpenny, DO, who had previously testified before Ohio lawmakers that COVID-19 vaccines magnetize their recipients and “interface” with cell phone towers.

“I’m not satisfied with what medical boards have done, and we are ramping up our efforts to press the boards to hold these physicians accountable,” said Nick Sawyer, MD, an emergency physician in Sacramento, Calif., who heads a group of healthcare professionals called No License for Disinformation.

Still, Tennessee board members insisted that the board’s policy of disciplining physicians who disseminate false information about COVID-19 vaccinations remains in effect, because state law empowers the board to take action against doctors whose unprofessional behavior endangers the public.

“COVID misinformation and disinformation has caused undue loss of life and jobs and other incalculable loss in our society,” said Melanie Blake, MD, MBA, a Chattanooga internist who’s president of the board. “Physicians have a responsibility to uphold their oath and put forward consensus-driven medical principles.”

But state Rep. John Ragan, the Republican co-chairman of the Joint Government Operations Committee, told the Tennessean newspaper that deleting the statement from the board’s website was equivalent to rescinding the policy. Ragan, who identifies himself as a business consultant and retired Air Force pilot, did not respond to a request for comment for this article.

Blake acknowledged that removing the statement from the board’s website has the potential to confuse Tennessee physicians. And the pressure from GOP lawmakers, who overwhelmingly control the Tennessee legislature, could discourage investigations and disciplinary actions against physicians who allegedly spread COVID-19 misinformation, she added. “It’s hard for me to answer whether this puts a chill on us,” she said.

In September, the Tennessee board, besides approving the general statement that physicians who spread COVID-19 disinformation could face licensure action, also directed the State Department of Health to prioritize investigations of physicians who spread outrageous claims. The board cited statements such as the vaccines are poisonous, cause infertility, contain microchips, or magnetize the body.

In response, the Tennessee General Assembly passed a bill in late October prohibiting the board from implementing any disciplinary process regarding the prescribing of “medication for COVID-19” without review and approval by Ragan’s committee. It’s not clear whether that language covers vaccines.

Last summer, in a similar move, Ragan threatened to dissolve the State Department of Health because its top vaccination official wrote a letter to medical providers explaining that state law allowed them to give COVID-19 vaccinations to minors older than 14 without parental consent. That official, Michelle Fiscus, MD, was fired in July.

Republican Sen. Richard Briggs, MD, a cardiothoracic surgeon who voted against the October legislation affecting COVID-related disciplinary actions, criticized his GOP colleagues’ interference in the medical board’s licensure decisions. “The mission of the board is to protect the health and safety of Tennessee citizens, and this was in complete conflict with that mission,” he said.

The Federation of State Medical Boards similarly condemned the Tennessee lawmakers’ moves. “The FSMB strongly opposes restricting a board’s authority to evaluate the standard of care and assess potential risk for patient harm,” a spokesman said. “Any interference, politically motivated or otherwise, is unhelpful and dangerous.”

But Arthur Caplan, PhD, a professor of bioethics at NYU School of Medicine, doubts that state medical boards are up to the task of policing disinformation spread by physicians. That’s because they ultimately are under the control of elected state officials, who may force the boards to base policy on ideology rather than science.

He said medical board members in Florida and another GOP-controlled state have told him they do not want to pursue disciplinary actions against physicians for COVID-19 misinformation for fear of political backlash.

Michele Heisler, MD, medical director of Physicians for Human Rights, agreed that the Tennessee situation highlights the looming political threat to the independence of state medical boards. She urged other medical organizations, particularly medical specialty boards, to step in.

“As a profession, we need to take a stance against this,” said Heisler, who’s a professor of internal medicine and public health at the University of Michigan. “Our credibility as physicians is at stake.”

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

Under pressure from Republican state lawmakers, the Tennessee Board of Medical Examiners has removed from its website its recent policy statement that physicians who spread false information about COVID-19 vaccinations risk suspension or revocation of their medical license.

The board’s 7-3 vote on December 7 to delete the statement followed repeated threats by a powerful state House Republican to dissolve the board and appoint all new members if it did not immediately take it down.

The Tennessee board’s statement was a verbatim restatement of a warning to physicians issued by the Federation of State Medical Boards in July. The federation cited a “dramatic increase” in dissemination of misinformation and disinformation about the COVID-19 vaccine by physicians. It said that’s dangerous because physicians enjoy a high degree of public credibility.

Across the country, state medical licensing boards and state and national medical associations and specialty boards are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians, which they say are increasing public confusion, political conflict, and preventable illnesses and deaths.

There have been only a small number of disciplinary actions by medical boards against physicians for spreading false COVID-19 information. Critics say the boards have been weak in responding to these dangerous violations of medical standards. As an example, they cite the State Medical Board of Ohio’s September renewal of the medical license of Sherri Tenpenny, DO, who had previously testified before Ohio lawmakers that COVID-19 vaccines magnetize their recipients and “interface” with cell phone towers.

“I’m not satisfied with what medical boards have done, and we are ramping up our efforts to press the boards to hold these physicians accountable,” said Nick Sawyer, MD, an emergency physician in Sacramento, Calif., who heads a group of healthcare professionals called No License for Disinformation.

Still, Tennessee board members insisted that the board’s policy of disciplining physicians who disseminate false information about COVID-19 vaccinations remains in effect, because state law empowers the board to take action against doctors whose unprofessional behavior endangers the public.

“COVID misinformation and disinformation has caused undue loss of life and jobs and other incalculable loss in our society,” said Melanie Blake, MD, MBA, a Chattanooga internist who’s president of the board. “Physicians have a responsibility to uphold their oath and put forward consensus-driven medical principles.”

But state Rep. John Ragan, the Republican co-chairman of the Joint Government Operations Committee, told the Tennessean newspaper that deleting the statement from the board’s website was equivalent to rescinding the policy. Ragan, who identifies himself as a business consultant and retired Air Force pilot, did not respond to a request for comment for this article.

Blake acknowledged that removing the statement from the board’s website has the potential to confuse Tennessee physicians. And the pressure from GOP lawmakers, who overwhelmingly control the Tennessee legislature, could discourage investigations and disciplinary actions against physicians who allegedly spread COVID-19 misinformation, she added. “It’s hard for me to answer whether this puts a chill on us,” she said.

In September, the Tennessee board, besides approving the general statement that physicians who spread COVID-19 disinformation could face licensure action, also directed the State Department of Health to prioritize investigations of physicians who spread outrageous claims. The board cited statements such as the vaccines are poisonous, cause infertility, contain microchips, or magnetize the body.

In response, the Tennessee General Assembly passed a bill in late October prohibiting the board from implementing any disciplinary process regarding the prescribing of “medication for COVID-19” without review and approval by Ragan’s committee. It’s not clear whether that language covers vaccines.

Last summer, in a similar move, Ragan threatened to dissolve the State Department of Health because its top vaccination official wrote a letter to medical providers explaining that state law allowed them to give COVID-19 vaccinations to minors older than 14 without parental consent. That official, Michelle Fiscus, MD, was fired in July.

Republican Sen. Richard Briggs, MD, a cardiothoracic surgeon who voted against the October legislation affecting COVID-related disciplinary actions, criticized his GOP colleagues’ interference in the medical board’s licensure decisions. “The mission of the board is to protect the health and safety of Tennessee citizens, and this was in complete conflict with that mission,” he said.

The Federation of State Medical Boards similarly condemned the Tennessee lawmakers’ moves. “The FSMB strongly opposes restricting a board’s authority to evaluate the standard of care and assess potential risk for patient harm,” a spokesman said. “Any interference, politically motivated or otherwise, is unhelpful and dangerous.”

But Arthur Caplan, PhD, a professor of bioethics at NYU School of Medicine, doubts that state medical boards are up to the task of policing disinformation spread by physicians. That’s because they ultimately are under the control of elected state officials, who may force the boards to base policy on ideology rather than science.

He said medical board members in Florida and another GOP-controlled state have told him they do not want to pursue disciplinary actions against physicians for COVID-19 misinformation for fear of political backlash.

Michele Heisler, MD, medical director of Physicians for Human Rights, agreed that the Tennessee situation highlights the looming political threat to the independence of state medical boards. She urged other medical organizations, particularly medical specialty boards, to step in.

“As a profession, we need to take a stance against this,” said Heisler, who’s a professor of internal medicine and public health at the University of Michigan. “Our credibility as physicians is at stake.”

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

Under pressure from Republican state lawmakers, the Tennessee Board of Medical Examiners has removed from its website its recent policy statement that physicians who spread false information about COVID-19 vaccinations risk suspension or revocation of their medical license.

The board’s 7-3 vote on December 7 to delete the statement followed repeated threats by a powerful state House Republican to dissolve the board and appoint all new members if it did not immediately take it down.

The Tennessee board’s statement was a verbatim restatement of a warning to physicians issued by the Federation of State Medical Boards in July. The federation cited a “dramatic increase” in dissemination of misinformation and disinformation about the COVID-19 vaccine by physicians. It said that’s dangerous because physicians enjoy a high degree of public credibility.

Across the country, state medical licensing boards and state and national medical associations and specialty boards are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians, which they say are increasing public confusion, political conflict, and preventable illnesses and deaths.

There have been only a small number of disciplinary actions by medical boards against physicians for spreading false COVID-19 information. Critics say the boards have been weak in responding to these dangerous violations of medical standards. As an example, they cite the State Medical Board of Ohio’s September renewal of the medical license of Sherri Tenpenny, DO, who had previously testified before Ohio lawmakers that COVID-19 vaccines magnetize their recipients and “interface” with cell phone towers.

“I’m not satisfied with what medical boards have done, and we are ramping up our efforts to press the boards to hold these physicians accountable,” said Nick Sawyer, MD, an emergency physician in Sacramento, Calif., who heads a group of healthcare professionals called No License for Disinformation.

Still, Tennessee board members insisted that the board’s policy of disciplining physicians who disseminate false information about COVID-19 vaccinations remains in effect, because state law empowers the board to take action against doctors whose unprofessional behavior endangers the public.

“COVID misinformation and disinformation has caused undue loss of life and jobs and other incalculable loss in our society,” said Melanie Blake, MD, MBA, a Chattanooga internist who’s president of the board. “Physicians have a responsibility to uphold their oath and put forward consensus-driven medical principles.”

But state Rep. John Ragan, the Republican co-chairman of the Joint Government Operations Committee, told the Tennessean newspaper that deleting the statement from the board’s website was equivalent to rescinding the policy. Ragan, who identifies himself as a business consultant and retired Air Force pilot, did not respond to a request for comment for this article.

Blake acknowledged that removing the statement from the board’s website has the potential to confuse Tennessee physicians. And the pressure from GOP lawmakers, who overwhelmingly control the Tennessee legislature, could discourage investigations and disciplinary actions against physicians who allegedly spread COVID-19 misinformation, she added. “It’s hard for me to answer whether this puts a chill on us,” she said.

In September, the Tennessee board, besides approving the general statement that physicians who spread COVID-19 disinformation could face licensure action, also directed the State Department of Health to prioritize investigations of physicians who spread outrageous claims. The board cited statements such as the vaccines are poisonous, cause infertility, contain microchips, or magnetize the body.

In response, the Tennessee General Assembly passed a bill in late October prohibiting the board from implementing any disciplinary process regarding the prescribing of “medication for COVID-19” without review and approval by Ragan’s committee. It’s not clear whether that language covers vaccines.

Last summer, in a similar move, Ragan threatened to dissolve the State Department of Health because its top vaccination official wrote a letter to medical providers explaining that state law allowed them to give COVID-19 vaccinations to minors older than 14 without parental consent. That official, Michelle Fiscus, MD, was fired in July.

Republican Sen. Richard Briggs, MD, a cardiothoracic surgeon who voted against the October legislation affecting COVID-related disciplinary actions, criticized his GOP colleagues’ interference in the medical board’s licensure decisions. “The mission of the board is to protect the health and safety of Tennessee citizens, and this was in complete conflict with that mission,” he said.

The Federation of State Medical Boards similarly condemned the Tennessee lawmakers’ moves. “The FSMB strongly opposes restricting a board’s authority to evaluate the standard of care and assess potential risk for patient harm,” a spokesman said. “Any interference, politically motivated or otherwise, is unhelpful and dangerous.”

But Arthur Caplan, PhD, a professor of bioethics at NYU School of Medicine, doubts that state medical boards are up to the task of policing disinformation spread by physicians. That’s because they ultimately are under the control of elected state officials, who may force the boards to base policy on ideology rather than science.

He said medical board members in Florida and another GOP-controlled state have told him they do not want to pursue disciplinary actions against physicians for COVID-19 misinformation for fear of political backlash.

Michele Heisler, MD, medical director of Physicians for Human Rights, agreed that the Tennessee situation highlights the looming political threat to the independence of state medical boards. She urged other medical organizations, particularly medical specialty boards, to step in.

“As a profession, we need to take a stance against this,” said Heisler, who’s a professor of internal medicine and public health at the University of Michigan. “Our credibility as physicians is at stake.”

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

The Pfizer/BioNTech booster lowers the risk for confirmed illness, severe illness, and death from COVID-19, according to two large studies from Israel published Dec. 8, 2021, in the New England Journal of Medicine.

Both studies were completed before the advent of the Omicron variant.

In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.

This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).

The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).

Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).

Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.

In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.

The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
 

Death risk down by 90%

A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.

Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.

The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.

The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.

The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”

The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.

None of the authors involved in both studies reported relevant financial relationships.

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

The Pfizer/BioNTech booster lowers the risk for confirmed illness, severe illness, and death from COVID-19, according to two large studies from Israel published Dec. 8, 2021, in the New England Journal of Medicine.

Both studies were completed before the advent of the Omicron variant.

In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.

This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).

The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).

Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).

Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.

In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.

The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
 

Death risk down by 90%

A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.

Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.

The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.

The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.

The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”

The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.

None of the authors involved in both studies reported relevant financial relationships.

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

The Pfizer/BioNTech booster lowers the risk for confirmed illness, severe illness, and death from COVID-19, according to two large studies from Israel published Dec. 8, 2021, in the New England Journal of Medicine.

Both studies were completed before the advent of the Omicron variant.

In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.

This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).

The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).

Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).

Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.

In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.

The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
 

Death risk down by 90%

A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.

Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.

The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.

The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.

The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”

The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.

None of the authors involved in both studies reported relevant financial relationships.

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

The 7-year-old boy sat at the edge of a stretcher in the emergency department, looking miserable, as his mother recounted his symptoms to a senior resident physician on duty. Low-grade fever, fatigue, and myalgias prompted rapid SARS-CoV-2 testing at his school. That test, as well as a repeat test at the pediatrician’s office, were negative. A triage protocol in the emergency department prompted a third test, which was also negative.

“Everyone has told me that it’s likely just a different virus,” the mother said. “But then his cheek started to swell. Have you ever seen anything like this?”

The boy turned his head, revealing a diffuse swelling that extended down his right cheek to the angle of his jaw.

“Only in textbooks,” the resident physician responded.

It is a credit to our national immunization program that most practicing clinicians have never actually seen a case of mumps. Before vaccination was introduced in 1967, infection in childhood was nearly universal. Unilateral or bilateral tender swelling of the parotid gland is the typical clinical finding. Low-grade fever, myalgias, decreased appetite, malaise, and headache may precede parotid swelling in some patients. Other patients infected with mumps may have only respiratory symptoms, and some may have no symptoms at all.

Two doses of measles-mumps-rubella vaccine have been recommended for children in the United States since 1989, with the first dose administered at 12-15 months of age. According to data collected through the National Immunization Survey, more than 92% of children in the United States receive at least one dose of measles-mumps-rubella vaccine by 24 months of age. The vaccine is immunogenic, with 94% of recipients developing measurable mumps antibody (range, 89%-97%). The vaccine has been a public health success: Overall, mumps cases declined more than 99% between 1967 and 2005.

But in the mid-2000s, mumps cases started to rise again, with more than 28,000 reported between 2007 and 2019. Annual cases ranged from 229 to 6,369 and while large, localized outbreaks have contributed to peak years, mumps has been reported from all 50 states and the District of Columbia. According to a recently published paper in Pediatrics, nearly a third of these cases occurred in children <18 years of age and most had been appropriately immunized for age.

Of the 9,172 cases reported in children, 5,461 or 60% occurred between 2015 and 2019. Of these, 55% were in boys. While cases occurred in children of all ages, 54% were in children 11-17 years of age, and 33% were in children 5-10 years of age. Non-Hispanic Asian and/or Pacific Islander children accounted for 38% of cases. Only 2% of cases were associated with international travel and were presumed to have been acquired outside the United States

The reason for the increase in mumps cases in recent years is not well understood. Outbreaks in fully immunized college students have prompted concern about poor B-cell memory after vaccination resulting in waning immunity over time. In the past, antibodies against mumps were boosted by exposure to wild-type mumps virus but such exposures have become fortunately rare for most of us. Cases in recently immunized children suggest there is more to the story. Notably, there is a mismatch between the genotype A mumps virus contained in the current MMR and MMRV vaccines and the genotype G virus currently circulating in the United States.

With the onset of the pandemic and implementation of mitigation measures to prevent the spread of COVID-19, circulation of some common respiratory viruses, including respiratory syncytial virus and influenza, was sharply curtailed. Mumps continued to circulate, albeit at reduced levels, with 616 cases reported in 2020. In 2021, 30 states and jurisdictions reported 139 cases through Dec. 1.

Clinicians should suspect mumps in all cases of parotitis, regardless of an individual’s age, vaccination status, or travel history. Laboratory testing is required to distinguish mumps from other infectious and noninfectious causes of parotitis. Infectious causes include gram-positive and gram-negative bacterial infection, as well as other viral infections, including Epstein-Barr virus, coxsackie viruses, parainfluenza, and rarely, influenza. Case reports also describe parotitis coincident with SARS-CoV-2 infection.

When parotitis has been present for 3 days or less, a buccal swab for RT-PCR should be obtained, massaging the parotid gland for 30 seconds before specimen collection. When parotitis has been present for >3 days, a mumps Immunoglobulin M serum antibody should be collected in addition to the buccal swab PCR. A negative IgM does not exclude the possibility of infection, especially in immunized individuals. Mumps is a nationally notifiable disease, and all confirmed and suspect cases should be reported to the state or local health department.

Back in the emergency department, the mother was counseled about the potential diagnosis of mumps and the need for her son to isolate at home for 5 days after the onset of the parotid swelling. She was also educated about potential complications of mumps, including orchitis, aseptic meningitis and encephalitis, and hearing loss. Fortunately, complications are less common in individuals who have been immunized, and orchitis rarely occurs in prepubertal boys.

The resident physician also confirmed that other members of the household had been appropriately immunized for age. While the MMR vaccine does not prevent illness in those already infected with mumps and is not indicated as postexposure prophylaxis, providing vaccine to those not already immunized can protect against future exposures. A third dose of MMR vaccine is only indicated in the setting of an outbreak and when specifically recommended by public health authorities for those deemed to be in a high-risk group. Additional information about mumps is available at www.cdc.gov/mumps/hcp.html#report.
 

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].

The 7-year-old boy sat at the edge of a stretcher in the emergency department, looking miserable, as his mother recounted his symptoms to a senior resident physician on duty. Low-grade fever, fatigue, and myalgias prompted rapid SARS-CoV-2 testing at his school. That test, as well as a repeat test at the pediatrician’s office, were negative. A triage protocol in the emergency department prompted a third test, which was also negative.

“Everyone has told me that it’s likely just a different virus,” the mother said. “But then his cheek started to swell. Have you ever seen anything like this?”

The boy turned his head, revealing a diffuse swelling that extended down his right cheek to the angle of his jaw.

“Only in textbooks,” the resident physician responded.

It is a credit to our national immunization program that most practicing clinicians have never actually seen a case of mumps. Before vaccination was introduced in 1967, infection in childhood was nearly universal. Unilateral or bilateral tender swelling of the parotid gland is the typical clinical finding. Low-grade fever, myalgias, decreased appetite, malaise, and headache may precede parotid swelling in some patients. Other patients infected with mumps may have only respiratory symptoms, and some may have no symptoms at all.

Two doses of measles-mumps-rubella vaccine have been recommended for children in the United States since 1989, with the first dose administered at 12-15 months of age. According to data collected through the National Immunization Survey, more than 92% of children in the United States receive at least one dose of measles-mumps-rubella vaccine by 24 months of age. The vaccine is immunogenic, with 94% of recipients developing measurable mumps antibody (range, 89%-97%). The vaccine has been a public health success: Overall, mumps cases declined more than 99% between 1967 and 2005.

But in the mid-2000s, mumps cases started to rise again, with more than 28,000 reported between 2007 and 2019. Annual cases ranged from 229 to 6,369 and while large, localized outbreaks have contributed to peak years, mumps has been reported from all 50 states and the District of Columbia. According to a recently published paper in Pediatrics, nearly a third of these cases occurred in children <18 years of age and most had been appropriately immunized for age.

Of the 9,172 cases reported in children, 5,461 or 60% occurred between 2015 and 2019. Of these, 55% were in boys. While cases occurred in children of all ages, 54% were in children 11-17 years of age, and 33% were in children 5-10 years of age. Non-Hispanic Asian and/or Pacific Islander children accounted for 38% of cases. Only 2% of cases were associated with international travel and were presumed to have been acquired outside the United States

The reason for the increase in mumps cases in recent years is not well understood. Outbreaks in fully immunized college students have prompted concern about poor B-cell memory after vaccination resulting in waning immunity over time. In the past, antibodies against mumps were boosted by exposure to wild-type mumps virus but such exposures have become fortunately rare for most of us. Cases in recently immunized children suggest there is more to the story. Notably, there is a mismatch between the genotype A mumps virus contained in the current MMR and MMRV vaccines and the genotype G virus currently circulating in the United States.

With the onset of the pandemic and implementation of mitigation measures to prevent the spread of COVID-19, circulation of some common respiratory viruses, including respiratory syncytial virus and influenza, was sharply curtailed. Mumps continued to circulate, albeit at reduced levels, with 616 cases reported in 2020. In 2021, 30 states and jurisdictions reported 139 cases through Dec. 1.

Clinicians should suspect mumps in all cases of parotitis, regardless of an individual’s age, vaccination status, or travel history. Laboratory testing is required to distinguish mumps from other infectious and noninfectious causes of parotitis. Infectious causes include gram-positive and gram-negative bacterial infection, as well as other viral infections, including Epstein-Barr virus, coxsackie viruses, parainfluenza, and rarely, influenza. Case reports also describe parotitis coincident with SARS-CoV-2 infection.

When parotitis has been present for 3 days or less, a buccal swab for RT-PCR should be obtained, massaging the parotid gland for 30 seconds before specimen collection. When parotitis has been present for >3 days, a mumps Immunoglobulin M serum antibody should be collected in addition to the buccal swab PCR. A negative IgM does not exclude the possibility of infection, especially in immunized individuals. Mumps is a nationally notifiable disease, and all confirmed and suspect cases should be reported to the state or local health department.

Back in the emergency department, the mother was counseled about the potential diagnosis of mumps and the need for her son to isolate at home for 5 days after the onset of the parotid swelling. She was also educated about potential complications of mumps, including orchitis, aseptic meningitis and encephalitis, and hearing loss. Fortunately, complications are less common in individuals who have been immunized, and orchitis rarely occurs in prepubertal boys.

The resident physician also confirmed that other members of the household had been appropriately immunized for age. While the MMR vaccine does not prevent illness in those already infected with mumps and is not indicated as postexposure prophylaxis, providing vaccine to those not already immunized can protect against future exposures. A third dose of MMR vaccine is only indicated in the setting of an outbreak and when specifically recommended by public health authorities for those deemed to be in a high-risk group. Additional information about mumps is available at www.cdc.gov/mumps/hcp.html#report.
 

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].

The 7-year-old boy sat at the edge of a stretcher in the emergency department, looking miserable, as his mother recounted his symptoms to a senior resident physician on duty. Low-grade fever, fatigue, and myalgias prompted rapid SARS-CoV-2 testing at his school. That test, as well as a repeat test at the pediatrician’s office, were negative. A triage protocol in the emergency department prompted a third test, which was also negative.

“Everyone has told me that it’s likely just a different virus,” the mother said. “But then his cheek started to swell. Have you ever seen anything like this?”

The boy turned his head, revealing a diffuse swelling that extended down his right cheek to the angle of his jaw.

“Only in textbooks,” the resident physician responded.

It is a credit to our national immunization program that most practicing clinicians have never actually seen a case of mumps. Before vaccination was introduced in 1967, infection in childhood was nearly universal. Unilateral or bilateral tender swelling of the parotid gland is the typical clinical finding. Low-grade fever, myalgias, decreased appetite, malaise, and headache may precede parotid swelling in some patients. Other patients infected with mumps may have only respiratory symptoms, and some may have no symptoms at all.

Two doses of measles-mumps-rubella vaccine have been recommended for children in the United States since 1989, with the first dose administered at 12-15 months of age. According to data collected through the National Immunization Survey, more than 92% of children in the United States receive at least one dose of measles-mumps-rubella vaccine by 24 months of age. The vaccine is immunogenic, with 94% of recipients developing measurable mumps antibody (range, 89%-97%). The vaccine has been a public health success: Overall, mumps cases declined more than 99% between 1967 and 2005.

But in the mid-2000s, mumps cases started to rise again, with more than 28,000 reported between 2007 and 2019. Annual cases ranged from 229 to 6,369 and while large, localized outbreaks have contributed to peak years, mumps has been reported from all 50 states and the District of Columbia. According to a recently published paper in Pediatrics, nearly a third of these cases occurred in children <18 years of age and most had been appropriately immunized for age.

Of the 9,172 cases reported in children, 5,461 or 60% occurred between 2015 and 2019. Of these, 55% were in boys. While cases occurred in children of all ages, 54% were in children 11-17 years of age, and 33% were in children 5-10 years of age. Non-Hispanic Asian and/or Pacific Islander children accounted for 38% of cases. Only 2% of cases were associated with international travel and were presumed to have been acquired outside the United States

The reason for the increase in mumps cases in recent years is not well understood. Outbreaks in fully immunized college students have prompted concern about poor B-cell memory after vaccination resulting in waning immunity over time. In the past, antibodies against mumps were boosted by exposure to wild-type mumps virus but such exposures have become fortunately rare for most of us. Cases in recently immunized children suggest there is more to the story. Notably, there is a mismatch between the genotype A mumps virus contained in the current MMR and MMRV vaccines and the genotype G virus currently circulating in the United States.

With the onset of the pandemic and implementation of mitigation measures to prevent the spread of COVID-19, circulation of some common respiratory viruses, including respiratory syncytial virus and influenza, was sharply curtailed. Mumps continued to circulate, albeit at reduced levels, with 616 cases reported in 2020. In 2021, 30 states and jurisdictions reported 139 cases through Dec. 1.

Clinicians should suspect mumps in all cases of parotitis, regardless of an individual’s age, vaccination status, or travel history. Laboratory testing is required to distinguish mumps from other infectious and noninfectious causes of parotitis. Infectious causes include gram-positive and gram-negative bacterial infection, as well as other viral infections, including Epstein-Barr virus, coxsackie viruses, parainfluenza, and rarely, influenza. Case reports also describe parotitis coincident with SARS-CoV-2 infection.

When parotitis has been present for 3 days or less, a buccal swab for RT-PCR should be obtained, massaging the parotid gland for 30 seconds before specimen collection. When parotitis has been present for >3 days, a mumps Immunoglobulin M serum antibody should be collected in addition to the buccal swab PCR. A negative IgM does not exclude the possibility of infection, especially in immunized individuals. Mumps is a nationally notifiable disease, and all confirmed and suspect cases should be reported to the state or local health department.

Back in the emergency department, the mother was counseled about the potential diagnosis of mumps and the need for her son to isolate at home for 5 days after the onset of the parotid swelling. She was also educated about potential complications of mumps, including orchitis, aseptic meningitis and encephalitis, and hearing loss. Fortunately, complications are less common in individuals who have been immunized, and orchitis rarely occurs in prepubertal boys.

The resident physician also confirmed that other members of the household had been appropriately immunized for age. While the MMR vaccine does not prevent illness in those already infected with mumps and is not indicated as postexposure prophylaxis, providing vaccine to those not already immunized can protect against future exposures. A third dose of MMR vaccine is only indicated in the setting of an outbreak and when specifically recommended by public health authorities for those deemed to be in a high-risk group. Additional information about mumps is available at www.cdc.gov/mumps/hcp.html#report.
 

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].

The year is rapidly approaching an end, and with it, we can perhaps look forward to better and brighter days in 2022. With daylight savings, seasonal depression, and cold and flu season making a comeback as temperatures across the Northern Hemisphere drop, some strange remedies have been appearing on TikTok – as they often do.

The good: doctor reveals the truth about dieting

Chisom Ikeji, MD, is a critical care clinical fellow at the University of Pittsburgh Medical Center and on TikTok under the username @drchizmd. In a TikTok with almost 200,000 views and over 18,000 likes, Dr. Ikeji explains to all New Year’s resolution-makers that dieting isn’t all it’s cracked up to be. “Dieting leads to perpetually losing weight and gaining weight on a cycle,” she says, “so that your body never really settles at its set point weight.”

Celebrities and your friends who drink lemon water in the morning may tout all sorts of fad diets and some of them might even work. But Dr. Ikeji explains that diets with gimmicks don’t have lasting power and create cycles of losing and gaining weight. Additionally, associating “points” with foods, or separating them into “good” or “bad” categories, encourages habits that can lead to disordered eating.

The best way to keep weight off is to make actual lifestyle changes that stick. In contrast, going back to dieting every year (the rapid cycle of losing and gaining weight is called  “yo-yo” dieting) can have a bad impact on your health, including increased risk of heart disease and metabolism issues.

“The best thing you can do for your body, and to help you lose weight, is to stop dieting,” Dr. Ikeji says. “Incorporate whole foods into your diet and make sure you move your body. If you don’t, you’ll be chasing that diet into your 80s and feeling guilty over a piece of cake forever. That’s no way to live life.”
 

The bad: vitamin C contraceptive

In this TikTok, user @itsdiosa reveals her contraception hack for anyone with a uterus who may be having unprotected sex. She claims that for those who forget to take the Plan B pill, vitamin C is a worthwhile substitute in preventing unwanted pregnancy. She recommends taking four or five vitamin C tablets a day for a few days for the return of a normal period.

Not surprisingly, Vitamin C isn’t safe or reliable and doesn’t have studies to back up @itsdiosa’s claim. If anything, all you’ll get from taking too much vitamin C is diarrhea and a stomachache.

Karan Rajan, MBBS, from Imperial College London and the University of Sunderland in the United Kingdom, responded to the TikTok to confirm that this claim isn’t backed up by science.

“Vitamin C doesn’t start or stop a period. Period,” he commented on the video.
 

The ugly: garlic sinus decongestant

Now this one went viral one went viral with over 5.2 million likes. In this TikTok, @hwannah5 and her boyfriend try out a trend that involves putting a clove of peeled garlic in each nostril in order to clear up congestion. The bubbles of ooey gooey snot coming out of her boyfriend’s nose certainly make it seem like it’s working, but what’s really going on?

This is hardly new; people have been putting strange things in nasal rinses for some time now and garlic is a tried-and-true favorite. Garlic does have some medically valid uses. These studies have shown that garlic taken orally may improve insulin in people with diabetes, slightly lower cholesterol, and reduce blood pressure in people with hypertension. When it comes to home remedies, people have historically used garlic as an antiseptic, antibacterial, and antifungal agent, though these claims are not widely supported by research. But taking a garlic supplement and sticking raw garlic up your nose are two very different things.

New York-based board-certified dermatologist Whitney Bowe, MD, weighed in on the viral trend.

In her own reaction video, she explained: “Guys, this is actually not safe. What’s happening is the garlic is actually triggering something called contact dermatitis and the mucosa is trying to protect itself by secreting tons of mucus. It’s creating swelling.”

For those tempted by this smelly “remedy,” a few drops of essential oil in a steamy shower is a much more pleasant (and significantly less gross) way to treat congestion.

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

The year is rapidly approaching an end, and with it, we can perhaps look forward to better and brighter days in 2022. With daylight savings, seasonal depression, and cold and flu season making a comeback as temperatures across the Northern Hemisphere drop, some strange remedies have been appearing on TikTok – as they often do.

The good: doctor reveals the truth about dieting

Chisom Ikeji, MD, is a critical care clinical fellow at the University of Pittsburgh Medical Center and on TikTok under the username @drchizmd. In a TikTok with almost 200,000 views and over 18,000 likes, Dr. Ikeji explains to all New Year’s resolution-makers that dieting isn’t all it’s cracked up to be. “Dieting leads to perpetually losing weight and gaining weight on a cycle,” she says, “so that your body never really settles at its set point weight.”

Celebrities and your friends who drink lemon water in the morning may tout all sorts of fad diets and some of them might even work. But Dr. Ikeji explains that diets with gimmicks don’t have lasting power and create cycles of losing and gaining weight. Additionally, associating “points” with foods, or separating them into “good” or “bad” categories, encourages habits that can lead to disordered eating.

The best way to keep weight off is to make actual lifestyle changes that stick. In contrast, going back to dieting every year (the rapid cycle of losing and gaining weight is called  “yo-yo” dieting) can have a bad impact on your health, including increased risk of heart disease and metabolism issues.

“The best thing you can do for your body, and to help you lose weight, is to stop dieting,” Dr. Ikeji says. “Incorporate whole foods into your diet and make sure you move your body. If you don’t, you’ll be chasing that diet into your 80s and feeling guilty over a piece of cake forever. That’s no way to live life.”
 

The bad: vitamin C contraceptive

In this TikTok, user @itsdiosa reveals her contraception hack for anyone with a uterus who may be having unprotected sex. She claims that for those who forget to take the Plan B pill, vitamin C is a worthwhile substitute in preventing unwanted pregnancy. She recommends taking four or five vitamin C tablets a day for a few days for the return of a normal period.

Not surprisingly, Vitamin C isn’t safe or reliable and doesn’t have studies to back up @itsdiosa’s claim. If anything, all you’ll get from taking too much vitamin C is diarrhea and a stomachache.

Karan Rajan, MBBS, from Imperial College London and the University of Sunderland in the United Kingdom, responded to the TikTok to confirm that this claim isn’t backed up by science.

“Vitamin C doesn’t start or stop a period. Period,” he commented on the video.
 

The ugly: garlic sinus decongestant

Now this one went viral one went viral with over 5.2 million likes. In this TikTok, @hwannah5 and her boyfriend try out a trend that involves putting a clove of peeled garlic in each nostril in order to clear up congestion. The bubbles of ooey gooey snot coming out of her boyfriend’s nose certainly make it seem like it’s working, but what’s really going on?

This is hardly new; people have been putting strange things in nasal rinses for some time now and garlic is a tried-and-true favorite. Garlic does have some medically valid uses. These studies have shown that garlic taken orally may improve insulin in people with diabetes, slightly lower cholesterol, and reduce blood pressure in people with hypertension. When it comes to home remedies, people have historically used garlic as an antiseptic, antibacterial, and antifungal agent, though these claims are not widely supported by research. But taking a garlic supplement and sticking raw garlic up your nose are two very different things.

New York-based board-certified dermatologist Whitney Bowe, MD, weighed in on the viral trend.

In her own reaction video, she explained: “Guys, this is actually not safe. What’s happening is the garlic is actually triggering something called contact dermatitis and the mucosa is trying to protect itself by secreting tons of mucus. It’s creating swelling.”

For those tempted by this smelly “remedy,” a few drops of essential oil in a steamy shower is a much more pleasant (and significantly less gross) way to treat congestion.

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

The year is rapidly approaching an end, and with it, we can perhaps look forward to better and brighter days in 2022. With daylight savings, seasonal depression, and cold and flu season making a comeback as temperatures across the Northern Hemisphere drop, some strange remedies have been appearing on TikTok – as they often do.

The good: doctor reveals the truth about dieting

Chisom Ikeji, MD, is a critical care clinical fellow at the University of Pittsburgh Medical Center and on TikTok under the username @drchizmd. In a TikTok with almost 200,000 views and over 18,000 likes, Dr. Ikeji explains to all New Year’s resolution-makers that dieting isn’t all it’s cracked up to be. “Dieting leads to perpetually losing weight and gaining weight on a cycle,” she says, “so that your body never really settles at its set point weight.”

Celebrities and your friends who drink lemon water in the morning may tout all sorts of fad diets and some of them might even work. But Dr. Ikeji explains that diets with gimmicks don’t have lasting power and create cycles of losing and gaining weight. Additionally, associating “points” with foods, or separating them into “good” or “bad” categories, encourages habits that can lead to disordered eating.

The best way to keep weight off is to make actual lifestyle changes that stick. In contrast, going back to dieting every year (the rapid cycle of losing and gaining weight is called  “yo-yo” dieting) can have a bad impact on your health, including increased risk of heart disease and metabolism issues.

“The best thing you can do for your body, and to help you lose weight, is to stop dieting,” Dr. Ikeji says. “Incorporate whole foods into your diet and make sure you move your body. If you don’t, you’ll be chasing that diet into your 80s and feeling guilty over a piece of cake forever. That’s no way to live life.”
 

The bad: vitamin C contraceptive

In this TikTok, user @itsdiosa reveals her contraception hack for anyone with a uterus who may be having unprotected sex. She claims that for those who forget to take the Plan B pill, vitamin C is a worthwhile substitute in preventing unwanted pregnancy. She recommends taking four or five vitamin C tablets a day for a few days for the return of a normal period.

Not surprisingly, Vitamin C isn’t safe or reliable and doesn’t have studies to back up @itsdiosa’s claim. If anything, all you’ll get from taking too much vitamin C is diarrhea and a stomachache.

Karan Rajan, MBBS, from Imperial College London and the University of Sunderland in the United Kingdom, responded to the TikTok to confirm that this claim isn’t backed up by science.

“Vitamin C doesn’t start or stop a period. Period,” he commented on the video.
 

The ugly: garlic sinus decongestant

Now this one went viral one went viral with over 5.2 million likes. In this TikTok, @hwannah5 and her boyfriend try out a trend that involves putting a clove of peeled garlic in each nostril in order to clear up congestion. The bubbles of ooey gooey snot coming out of her boyfriend’s nose certainly make it seem like it’s working, but what’s really going on?

This is hardly new; people have been putting strange things in nasal rinses for some time now and garlic is a tried-and-true favorite. Garlic does have some medically valid uses. These studies have shown that garlic taken orally may improve insulin in people with diabetes, slightly lower cholesterol, and reduce blood pressure in people with hypertension. When it comes to home remedies, people have historically used garlic as an antiseptic, antibacterial, and antifungal agent, though these claims are not widely supported by research. But taking a garlic supplement and sticking raw garlic up your nose are two very different things.

New York-based board-certified dermatologist Whitney Bowe, MD, weighed in on the viral trend.

In her own reaction video, she explained: “Guys, this is actually not safe. What’s happening is the garlic is actually triggering something called contact dermatitis and the mucosa is trying to protect itself by secreting tons of mucus. It’s creating swelling.”

For those tempted by this smelly “remedy,” a few drops of essential oil in a steamy shower is a much more pleasant (and significantly less gross) way to treat congestion.

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

Starting Dec. 8, the Centers for Disease Control and Prevention recommends all clinicians talk to their sexually active adolescent and adult patients about HIV pre-exposure prophylaxis (PrEP) at least once and prescribe the prevention pills to anyone who asks for them, whether or not you understand their need for it.

“PrEP is a part of good primary care,” Demetre Daskalakis, MD, CDC’s director of the division of HIV/AIDS prevention, said in an interview. “Listening to people and what they need, as opposed to assessing what you think they need, is a seismic shift in how PrEP should be offered.”

The expanded recommendation comes as part of the 2021 update to the U.S. Public Health Service’s PrEP prescribing guidelines. It’s the third iteration since the Food and Drug Administration approved the first HIV prevention pill in 2012, and the first to include guidance on how to prescribe and monitor an injectable version of PrEP, which the FDA may approve as early as December 2021.

There are currently two pills, Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences and generic) and Descovy (emtricitabine/tenofovir alafenamide, Gilead Sciences). The pills have been found to be up to 99% effective in preventing HIV acquisition. The new injectable cabotegravir appears to be even more effective.

The broadened guidance is part of an effort from the country’s top health officials to expand PrEP prescribing from infectious disease specialists and sexual health clinics to health care professionals, including gynecologists, internal medicine physicians, and family practice clinicians. It appears to be necessary. In 2020, just 25% of the 1.2 million Americans who could benefit from PrEP were taking it, according to CDC data.

But those rates belie stark disparities in PrEP use by race and gender. The vast majority of those using PrEP are White Americans and men. About 66% of White Americans who could benefit from PrEP used it in 2020, and more than a quarter of the men who could benefit used it. By contrast, just 16% of Latinx people who could benefit had a prescription. And fewer than 1 in 10 Black Americans, who make up nearly half of those with indications for PrEP, had a prescription. The same was true for the women who could benefit.

Researchers and data from early PrEP demonstration projects have documented that clinicians are less likely to refer or prescribe the HIV prevention pills to Black people, especially the Black cisgender and transgender women and same-gender-loving men who bear the disproportionate burden of new cases in the United States, as well as fail to prescribe the medication to people who inject drugs.
 

Normalizing PrEP in primary care

When Courtney Sherman, DNP, APRN, first heard about PrEP in the early 2010s, she joked that her reaction was: “You’re ridiculous. You’re making that up. That’s not real.”

Ms. Sherman is now launching a tele-PrEP program from CAN Community Health, a nonprofit network of community health centers in southern Florida. The tele-PrEP program is meant to serve people in Florida and beyond, to increase access to the pill in areas with few health care professionals, or clinicians unwilling to prescribe it.

“When I go other places, I can’t do what I do for a living without getting some sort of bizarre comment or look,” she said. But the looks don’t just come from family, friends, or her children’s teachers. They come from colleagues, too. “What I’ve learned is that anybody – anybody – can be impacted [by HIV] and the illusion that ‘those people who live over there do things that me and my kind don’t do’ is just garbage.”

That’s the PrEP stigma that the universal PrEP counseling in the guidelines is meant to override, said Dr. Daskalakis. Going forward, he said that informing people about PrEP should be treated as normally as counseling people about smoking.

“You can change the blank: You talk to all adolescents and adults about not smoking,” he said. “This is: ‘Tell adolescents and adults about ways you can prevent HIV, and PrEP is one of them.’ ”

The guidelines also simplify for monitoring lab levels for the current daily pills, checking creatinine clearance levels twice a year in people older than age 50 and once a year in those younger than 50 taking the oral pills. Dr. Daskalakis said that should ease the burden of monitoring PrEP patients for health care professionals with busy caseloads.

It’s a move that drew praise from Shawnika Hull, PhD, assistant professor of health communications at Rutgers University, New Brunswick, N.J.. Dr. Hull’s recent data showed that clinicians who espoused more biased racial views were also less likely to prescribe PrEP to Black women who asked for it.

“Public health practitioners and scientists have been advocating for this as a strategy, as one way to address several ongoing barriers to PrEP specifically but also equity in PrEP,” said Dr. Hull. “This sort of universal provision of information is really an important strategy to try to undo some of the deeply intertwined barriers to uptake.”
 

‘Don’t grill them’

The updated guidelines keep the number and proportion of Americans who could benefit from PrEP the same: 1.2 million Americans, with nearly half of those Black. And the reasons people would qualify for PrEP remain the same: inconsistent condom use, sharing injection drug equipment, and a STI diagnosis in the last 6 months. There are also 57 jurisdictions, including seven rural states, where dating and having sex carries an increased risk of acquiring HIV because of high rates of untreated HIV in the community.

That’s why the other big change in the update is guidance to prescribe PrEP to whoever asks for it, whether the patient divulges their risk or not. Or as Dr. Daskalakis puts it: “If someone asks for PrEP, don’t grill them.”

There are lots of reasons that someone might ask for PrEP without divulging their risk behaviors, said Dr. Daskalakis, who was an infectious disease doctor in New York back in 2012 (and a member of the FDA committee) when the first pill for PrEP was approved. He said he’s seen this particularly with women who ask about it. Asking for PrEP ends up being an “ice breaker” to discussing the woman’s sexual and injection drug use history, which can then improve the kinds of tests and vaccinations clinicians suggest for her.

“So many women will open the door and say, ‘I want to do this,’ and not necessarily want to go into the details,” he said. “Now, will they go into the details later? Absolutely. That’s how you create trust and connection.”
 

A mandate and a guideline

Leisha McKinley-Beach, MPH, a member of the U.S. Women and PrEP Working Group, has been urging greater funding and mandates to expand PrEP to women since the first pill was approved. And still, Ms. McKinley-Beach said she recently met a woman who worked for a community group scheduling PrEP appointments for gay men. But the woman didn’t know that she, too, could take it. 

The American Academy of Family Physicians recommends health care professionals offer PrEP to those who can benefit. The American College of Obstetricians and Gynecologists have a 2014 committee opinion stating that PrEP “may be a useful tool for women at highest risk of HIV acquisition.”

But the ACOG opinion is not a recommendation, stating that it “should not be construed as dictating an exclusive course of treatment or procedure to be followed.” Ms. McKinley-Beach said she hopes that the new CDC guidelines will prompt ACOG and other professional organizations to issue statements to include PrEP education in all health assessments. A spokesperson for ACOG said that the organization had not seen the new CDC guidelines and had no statement on them, but pointed out that the 2014 committee opinion is one of the “highest level of documents we produce.

“We have failed for nearly a decade to raise awareness that PrEP is also a prevention strategy for women,” Ms. McKinley-Beach said in an interview. “In many ways, we’re still back in 2012 as it relates to women.”

Dr. Hull reported having done previous research funded by Gilead Sciences and having received consulting fees from Gilead Sciences in 2018. Ms. McKinley-Beach reported receiving honoraria from ViiV Healthcare. Ms. Sherman and Dr. Daskalakis disclosed no relevant financial relationships.

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

Starting Dec. 8, the Centers for Disease Control and Prevention recommends all clinicians talk to their sexually active adolescent and adult patients about HIV pre-exposure prophylaxis (PrEP) at least once and prescribe the prevention pills to anyone who asks for them, whether or not you understand their need for it.

“PrEP is a part of good primary care,” Demetre Daskalakis, MD, CDC’s director of the division of HIV/AIDS prevention, said in an interview. “Listening to people and what they need, as opposed to assessing what you think they need, is a seismic shift in how PrEP should be offered.”

The expanded recommendation comes as part of the 2021 update to the U.S. Public Health Service’s PrEP prescribing guidelines. It’s the third iteration since the Food and Drug Administration approved the first HIV prevention pill in 2012, and the first to include guidance on how to prescribe and monitor an injectable version of PrEP, which the FDA may approve as early as December 2021.

There are currently two pills, Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences and generic) and Descovy (emtricitabine/tenofovir alafenamide, Gilead Sciences). The pills have been found to be up to 99% effective in preventing HIV acquisition. The new injectable cabotegravir appears to be even more effective.

The broadened guidance is part of an effort from the country’s top health officials to expand PrEP prescribing from infectious disease specialists and sexual health clinics to health care professionals, including gynecologists, internal medicine physicians, and family practice clinicians. It appears to be necessary. In 2020, just 25% of the 1.2 million Americans who could benefit from PrEP were taking it, according to CDC data.

But those rates belie stark disparities in PrEP use by race and gender. The vast majority of those using PrEP are White Americans and men. About 66% of White Americans who could benefit from PrEP used it in 2020, and more than a quarter of the men who could benefit used it. By contrast, just 16% of Latinx people who could benefit had a prescription. And fewer than 1 in 10 Black Americans, who make up nearly half of those with indications for PrEP, had a prescription. The same was true for the women who could benefit.

Researchers and data from early PrEP demonstration projects have documented that clinicians are less likely to refer or prescribe the HIV prevention pills to Black people, especially the Black cisgender and transgender women and same-gender-loving men who bear the disproportionate burden of new cases in the United States, as well as fail to prescribe the medication to people who inject drugs.
 

Normalizing PrEP in primary care

When Courtney Sherman, DNP, APRN, first heard about PrEP in the early 2010s, she joked that her reaction was: “You’re ridiculous. You’re making that up. That’s not real.”

Ms. Sherman is now launching a tele-PrEP program from CAN Community Health, a nonprofit network of community health centers in southern Florida. The tele-PrEP program is meant to serve people in Florida and beyond, to increase access to the pill in areas with few health care professionals, or clinicians unwilling to prescribe it.

“When I go other places, I can’t do what I do for a living without getting some sort of bizarre comment or look,” she said. But the looks don’t just come from family, friends, or her children’s teachers. They come from colleagues, too. “What I’ve learned is that anybody – anybody – can be impacted [by HIV] and the illusion that ‘those people who live over there do things that me and my kind don’t do’ is just garbage.”

That’s the PrEP stigma that the universal PrEP counseling in the guidelines is meant to override, said Dr. Daskalakis. Going forward, he said that informing people about PrEP should be treated as normally as counseling people about smoking.

“You can change the blank: You talk to all adolescents and adults about not smoking,” he said. “This is: ‘Tell adolescents and adults about ways you can prevent HIV, and PrEP is one of them.’ ”

The guidelines also simplify for monitoring lab levels for the current daily pills, checking creatinine clearance levels twice a year in people older than age 50 and once a year in those younger than 50 taking the oral pills. Dr. Daskalakis said that should ease the burden of monitoring PrEP patients for health care professionals with busy caseloads.

It’s a move that drew praise from Shawnika Hull, PhD, assistant professor of health communications at Rutgers University, New Brunswick, N.J.. Dr. Hull’s recent data showed that clinicians who espoused more biased racial views were also less likely to prescribe PrEP to Black women who asked for it.

“Public health practitioners and scientists have been advocating for this as a strategy, as one way to address several ongoing barriers to PrEP specifically but also equity in PrEP,” said Dr. Hull. “This sort of universal provision of information is really an important strategy to try to undo some of the deeply intertwined barriers to uptake.”
 

‘Don’t grill them’

The updated guidelines keep the number and proportion of Americans who could benefit from PrEP the same: 1.2 million Americans, with nearly half of those Black. And the reasons people would qualify for PrEP remain the same: inconsistent condom use, sharing injection drug equipment, and a STI diagnosis in the last 6 months. There are also 57 jurisdictions, including seven rural states, where dating and having sex carries an increased risk of acquiring HIV because of high rates of untreated HIV in the community.

That’s why the other big change in the update is guidance to prescribe PrEP to whoever asks for it, whether the patient divulges their risk or not. Or as Dr. Daskalakis puts it: “If someone asks for PrEP, don’t grill them.”

There are lots of reasons that someone might ask for PrEP without divulging their risk behaviors, said Dr. Daskalakis, who was an infectious disease doctor in New York back in 2012 (and a member of the FDA committee) when the first pill for PrEP was approved. He said he’s seen this particularly with women who ask about it. Asking for PrEP ends up being an “ice breaker” to discussing the woman’s sexual and injection drug use history, which can then improve the kinds of tests and vaccinations clinicians suggest for her.

“So many women will open the door and say, ‘I want to do this,’ and not necessarily want to go into the details,” he said. “Now, will they go into the details later? Absolutely. That’s how you create trust and connection.”
 

A mandate and a guideline

Leisha McKinley-Beach, MPH, a member of the U.S. Women and PrEP Working Group, has been urging greater funding and mandates to expand PrEP to women since the first pill was approved. And still, Ms. McKinley-Beach said she recently met a woman who worked for a community group scheduling PrEP appointments for gay men. But the woman didn’t know that she, too, could take it. 

The American Academy of Family Physicians recommends health care professionals offer PrEP to those who can benefit. The American College of Obstetricians and Gynecologists have a 2014 committee opinion stating that PrEP “may be a useful tool for women at highest risk of HIV acquisition.”

But the ACOG opinion is not a recommendation, stating that it “should not be construed as dictating an exclusive course of treatment or procedure to be followed.” Ms. McKinley-Beach said she hopes that the new CDC guidelines will prompt ACOG and other professional organizations to issue statements to include PrEP education in all health assessments. A spokesperson for ACOG said that the organization had not seen the new CDC guidelines and had no statement on them, but pointed out that the 2014 committee opinion is one of the “highest level of documents we produce.

“We have failed for nearly a decade to raise awareness that PrEP is also a prevention strategy for women,” Ms. McKinley-Beach said in an interview. “In many ways, we’re still back in 2012 as it relates to women.”

Dr. Hull reported having done previous research funded by Gilead Sciences and having received consulting fees from Gilead Sciences in 2018. Ms. McKinley-Beach reported receiving honoraria from ViiV Healthcare. Ms. Sherman and Dr. Daskalakis disclosed no relevant financial relationships.

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

Starting Dec. 8, the Centers for Disease Control and Prevention recommends all clinicians talk to their sexually active adolescent and adult patients about HIV pre-exposure prophylaxis (PrEP) at least once and prescribe the prevention pills to anyone who asks for them, whether or not you understand their need for it.

“PrEP is a part of good primary care,” Demetre Daskalakis, MD, CDC’s director of the division of HIV/AIDS prevention, said in an interview. “Listening to people and what they need, as opposed to assessing what you think they need, is a seismic shift in how PrEP should be offered.”

The expanded recommendation comes as part of the 2021 update to the U.S. Public Health Service’s PrEP prescribing guidelines. It’s the third iteration since the Food and Drug Administration approved the first HIV prevention pill in 2012, and the first to include guidance on how to prescribe and monitor an injectable version of PrEP, which the FDA may approve as early as December 2021.

There are currently two pills, Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences and generic) and Descovy (emtricitabine/tenofovir alafenamide, Gilead Sciences). The pills have been found to be up to 99% effective in preventing HIV acquisition. The new injectable cabotegravir appears to be even more effective.

The broadened guidance is part of an effort from the country’s top health officials to expand PrEP prescribing from infectious disease specialists and sexual health clinics to health care professionals, including gynecologists, internal medicine physicians, and family practice clinicians. It appears to be necessary. In 2020, just 25% of the 1.2 million Americans who could benefit from PrEP were taking it, according to CDC data.

But those rates belie stark disparities in PrEP use by race and gender. The vast majority of those using PrEP are White Americans and men. About 66% of White Americans who could benefit from PrEP used it in 2020, and more than a quarter of the men who could benefit used it. By contrast, just 16% of Latinx people who could benefit had a prescription. And fewer than 1 in 10 Black Americans, who make up nearly half of those with indications for PrEP, had a prescription. The same was true for the women who could benefit.

Researchers and data from early PrEP demonstration projects have documented that clinicians are less likely to refer or prescribe the HIV prevention pills to Black people, especially the Black cisgender and transgender women and same-gender-loving men who bear the disproportionate burden of new cases in the United States, as well as fail to prescribe the medication to people who inject drugs.
 

Normalizing PrEP in primary care

When Courtney Sherman, DNP, APRN, first heard about PrEP in the early 2010s, she joked that her reaction was: “You’re ridiculous. You’re making that up. That’s not real.”

Ms. Sherman is now launching a tele-PrEP program from CAN Community Health, a nonprofit network of community health centers in southern Florida. The tele-PrEP program is meant to serve people in Florida and beyond, to increase access to the pill in areas with few health care professionals, or clinicians unwilling to prescribe it.

“When I go other places, I can’t do what I do for a living without getting some sort of bizarre comment or look,” she said. But the looks don’t just come from family, friends, or her children’s teachers. They come from colleagues, too. “What I’ve learned is that anybody – anybody – can be impacted [by HIV] and the illusion that ‘those people who live over there do things that me and my kind don’t do’ is just garbage.”

That’s the PrEP stigma that the universal PrEP counseling in the guidelines is meant to override, said Dr. Daskalakis. Going forward, he said that informing people about PrEP should be treated as normally as counseling people about smoking.

“You can change the blank: You talk to all adolescents and adults about not smoking,” he said. “This is: ‘Tell adolescents and adults about ways you can prevent HIV, and PrEP is one of them.’ ”

The guidelines also simplify for monitoring lab levels for the current daily pills, checking creatinine clearance levels twice a year in people older than age 50 and once a year in those younger than 50 taking the oral pills. Dr. Daskalakis said that should ease the burden of monitoring PrEP patients for health care professionals with busy caseloads.

It’s a move that drew praise from Shawnika Hull, PhD, assistant professor of health communications at Rutgers University, New Brunswick, N.J.. Dr. Hull’s recent data showed that clinicians who espoused more biased racial views were also less likely to prescribe PrEP to Black women who asked for it.

“Public health practitioners and scientists have been advocating for this as a strategy, as one way to address several ongoing barriers to PrEP specifically but also equity in PrEP,” said Dr. Hull. “This sort of universal provision of information is really an important strategy to try to undo some of the deeply intertwined barriers to uptake.”
 

‘Don’t grill them’

The updated guidelines keep the number and proportion of Americans who could benefit from PrEP the same: 1.2 million Americans, with nearly half of those Black. And the reasons people would qualify for PrEP remain the same: inconsistent condom use, sharing injection drug equipment, and a STI diagnosis in the last 6 months. There are also 57 jurisdictions, including seven rural states, where dating and having sex carries an increased risk of acquiring HIV because of high rates of untreated HIV in the community.

That’s why the other big change in the update is guidance to prescribe PrEP to whoever asks for it, whether the patient divulges their risk or not. Or as Dr. Daskalakis puts it: “If someone asks for PrEP, don’t grill them.”

There are lots of reasons that someone might ask for PrEP without divulging their risk behaviors, said Dr. Daskalakis, who was an infectious disease doctor in New York back in 2012 (and a member of the FDA committee) when the first pill for PrEP was approved. He said he’s seen this particularly with women who ask about it. Asking for PrEP ends up being an “ice breaker” to discussing the woman’s sexual and injection drug use history, which can then improve the kinds of tests and vaccinations clinicians suggest for her.

“So many women will open the door and say, ‘I want to do this,’ and not necessarily want to go into the details,” he said. “Now, will they go into the details later? Absolutely. That’s how you create trust and connection.”
 

A mandate and a guideline

Leisha McKinley-Beach, MPH, a member of the U.S. Women and PrEP Working Group, has been urging greater funding and mandates to expand PrEP to women since the first pill was approved. And still, Ms. McKinley-Beach said she recently met a woman who worked for a community group scheduling PrEP appointments for gay men. But the woman didn’t know that she, too, could take it. 

The American Academy of Family Physicians recommends health care professionals offer PrEP to those who can benefit. The American College of Obstetricians and Gynecologists have a 2014 committee opinion stating that PrEP “may be a useful tool for women at highest risk of HIV acquisition.”

But the ACOG opinion is not a recommendation, stating that it “should not be construed as dictating an exclusive course of treatment or procedure to be followed.” Ms. McKinley-Beach said she hopes that the new CDC guidelines will prompt ACOG and other professional organizations to issue statements to include PrEP education in all health assessments. A spokesperson for ACOG said that the organization had not seen the new CDC guidelines and had no statement on them, but pointed out that the 2014 committee opinion is one of the “highest level of documents we produce.

“We have failed for nearly a decade to raise awareness that PrEP is also a prevention strategy for women,” Ms. McKinley-Beach said in an interview. “In many ways, we’re still back in 2012 as it relates to women.”

Dr. Hull reported having done previous research funded by Gilead Sciences and having received consulting fees from Gilead Sciences in 2018. Ms. McKinley-Beach reported receiving honoraria from ViiV Healthcare. Ms. Sherman and Dr. Daskalakis disclosed no relevant financial relationships.

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

Despite the best efforts of my institution’s spam filter, I’ve realized that I spend at least 4 minutes every day of the week removing junk email from my in basket: EMR vendors, predatory journals trying to lure me into paying their outrageous publication fees, people who want to help me with my billing software (evidently that .edu extension hasn’t clicked for them yet), headhunters trying to fill specialty positions in other states, market researchers offering a gift card for 40 minutes filling out a survey.

If you do the math, 4 minutes daily is 1,460 minutes per year. That’s an entire day of my life lost each year to this useless nonsense, which I never agreed to receive in the first place. Now multiply that by the 22 million health care workers in the United States, or even just by the 985,000 licensed physicians in this country. Then factor in the $638 per hour in gross revenue generated by the average primary care physician, as a conservative, well-documented value.

By my reckoning, these bozos owe the United States alone over $15 billion in lost GDP each year.

So why don’t we shut it down!? The CAN-SPAM Act of 2003 attempted to at least mitigate the problem. It applies only to commercial entities (I know, I’d love to report some political groups, too). To avoid violating the law and risking fines of up to $16,000 per individual email, senders must:

• Not use misleading header info (including domain name and email address)
• Not use deceptive subject lines
• Clearly label the email as an ad
• Give an actual physical address of the sender
• Tell recipients how to opt out of future emails
• Honor opt-out requests within 10 business days
• Monitor the activities of any subcontractor sending email on their behalf

I can say with certainty that much of the trash in my inbox violates at least one of these. But that doesn’t matter if there is not an efficient way to report the violators and ensure that they’ll be tracked down. Hard enough if they live here, impossible if the email is routed from overseas, as much of it clearly is.

If you receive email in violation of the act, experts recommend that you write down the email address and the business name of the sender, fill out a complaint form on the Federal Trade Commission website, or send an email to [email protected], then send an email to your Internet service provider’s abuse desk. If you’re not working within a big institution like mine that has hot and cold running IT personnel that operate their own abuse prevention office, the address you’ll need is likely abuse@domain_name or postmaster@domain_name. Just hitting the spam button at the top of your browser/email software may do the trick. There’s more good advice at the FTC’s consumer spam page.

The people not violating the law, though, are wasting my time every bit as flagrantly. How are they getting my email address in the first place?

The answer came, ironically, to my email inbox in the form of one of those emails that did indeed violate the law.

Dr. Hitchcock is assistant professor, department of radiation oncology, at the University of Florida, Gainesville. She reported receiving research grant money from Merck. A version of this article first appeared on Medscape.com.

Despite the best efforts of my institution’s spam filter, I’ve realized that I spend at least 4 minutes every day of the week removing junk email from my in basket: EMR vendors, predatory journals trying to lure me into paying their outrageous publication fees, people who want to help me with my billing software (evidently that .edu extension hasn’t clicked for them yet), headhunters trying to fill specialty positions in other states, market researchers offering a gift card for 40 minutes filling out a survey.

If you do the math, 4 minutes daily is 1,460 minutes per year. That’s an entire day of my life lost each year to this useless nonsense, which I never agreed to receive in the first place. Now multiply that by the 22 million health care workers in the United States, or even just by the 985,000 licensed physicians in this country. Then factor in the $638 per hour in gross revenue generated by the average primary care physician, as a conservative, well-documented value.

By my reckoning, these bozos owe the United States alone over $15 billion in lost GDP each year.

So why don’t we shut it down!? The CAN-SPAM Act of 2003 attempted to at least mitigate the problem. It applies only to commercial entities (I know, I’d love to report some political groups, too). To avoid violating the law and risking fines of up to $16,000 per individual email, senders must:

• Not use misleading header info (including domain name and email address)
• Not use deceptive subject lines
• Clearly label the email as an ad
• Give an actual physical address of the sender
• Tell recipients how to opt out of future emails
• Honor opt-out requests within 10 business days
• Monitor the activities of any subcontractor sending email on their behalf

I can say with certainty that much of the trash in my inbox violates at least one of these. But that doesn’t matter if there is not an efficient way to report the violators and ensure that they’ll be tracked down. Hard enough if they live here, impossible if the email is routed from overseas, as much of it clearly is.

If you receive email in violation of the act, experts recommend that you write down the email address and the business name of the sender, fill out a complaint form on the Federal Trade Commission website, or send an email to [email protected], then send an email to your Internet service provider’s abuse desk. If you’re not working within a big institution like mine that has hot and cold running IT personnel that operate their own abuse prevention office, the address you’ll need is likely abuse@domain_name or postmaster@domain_name. Just hitting the spam button at the top of your browser/email software may do the trick. There’s more good advice at the FTC’s consumer spam page.

The people not violating the law, though, are wasting my time every bit as flagrantly. How are they getting my email address in the first place?

The answer came, ironically, to my email inbox in the form of one of those emails that did indeed violate the law.

Dr. Hitchcock is assistant professor, department of radiation oncology, at the University of Florida, Gainesville. She reported receiving research grant money from Merck. A version of this article first appeared on Medscape.com.

Despite the best efforts of my institution’s spam filter, I’ve realized that I spend at least 4 minutes every day of the week removing junk email from my in basket: EMR vendors, predatory journals trying to lure me into paying their outrageous publication fees, people who want to help me with my billing software (evidently that .edu extension hasn’t clicked for them yet), headhunters trying to fill specialty positions in other states, market researchers offering a gift card for 40 minutes filling out a survey.

If you do the math, 4 minutes daily is 1,460 minutes per year. That’s an entire day of my life lost each year to this useless nonsense, which I never agreed to receive in the first place. Now multiply that by the 22 million health care workers in the United States, or even just by the 985,000 licensed physicians in this country. Then factor in the $638 per hour in gross revenue generated by the average primary care physician, as a conservative, well-documented value.

By my reckoning, these bozos owe the United States alone over $15 billion in lost GDP each year.

So why don’t we shut it down!? The CAN-SPAM Act of 2003 attempted to at least mitigate the problem. It applies only to commercial entities (I know, I’d love to report some political groups, too). To avoid violating the law and risking fines of up to $16,000 per individual email, senders must:

• Not use misleading header info (including domain name and email address)
• Not use deceptive subject lines
• Clearly label the email as an ad
• Give an actual physical address of the sender
• Tell recipients how to opt out of future emails
• Honor opt-out requests within 10 business days
• Monitor the activities of any subcontractor sending email on their behalf

I can say with certainty that much of the trash in my inbox violates at least one of these. But that doesn’t matter if there is not an efficient way to report the violators and ensure that they’ll be tracked down. Hard enough if they live here, impossible if the email is routed from overseas, as much of it clearly is.

If you receive email in violation of the act, experts recommend that you write down the email address and the business name of the sender, fill out a complaint form on the Federal Trade Commission website, or send an email to [email protected], then send an email to your Internet service provider’s abuse desk. If you’re not working within a big institution like mine that has hot and cold running IT personnel that operate their own abuse prevention office, the address you’ll need is likely abuse@domain_name or postmaster@domain_name. Just hitting the spam button at the top of your browser/email software may do the trick. There’s more good advice at the FTC’s consumer spam page.

The people not violating the law, though, are wasting my time every bit as flagrantly. How are they getting my email address in the first place?

The answer came, ironically, to my email inbox in the form of one of those emails that did indeed violate the law.

Dr. Hitchcock is assistant professor, department of radiation oncology, at the University of Florida, Gainesville. She reported receiving research grant money from Merck. A version of this article first appeared on Medscape.com.